[Federal Register: November 6, 2006 (Volume 71, Number 214)]
[Rules and Regulations]
[Page 64891-64902]
[DOCID:fr06no06-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R04-OAR-2006-0676-200622(a); FRL-8239-5]

Approval and Promulgation of Implementation Plans and Designation
of Areas for Air Quality Planning Purposes; North Carolina;
Redesignation of the Rocky Mount 8-Hour Ozone Nonattainment Area to
Attainment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: On June 19, 2006, the State of North Carolina, through the
North Carolina Department of Environment and Natural Resources
(NCDENR), Division of Air Quality, submitted a final request: to
redesignate the Rocky Mount 8-hour ozone nonattainment area to
attainment for the 8-hour ozone National Ambient Air Quality Standard
(NAAQS), and to approve a North Carolina State Implementation Plan
(SIP) revision containing a maintenance plan for Rocky Mount, North
Carolina. The Rocky Mount 8-hour ozone nonattainment area is comprised
of two counties, Edgecombe and Nash. EPA is approving the 8-hour ozone
redesignation request for the Rocky Mount 8-hour ozone nonattainment
area. Additionally, EPA is approving the 8-hour ozone maintenance plan
for Rocky Mount, North Carolina. This approval is based on EPA's
determination that the State of North Carolina has demonstrated that
the Rocky Mount area has met the criteria for redesignation to
attainment specified in the Clean Air Act (CAA), including the
determination that the entire Rocky Mount 8-hour ozone nonattainment
area has attained the 8-hour ozone standard. In this action, EPA is
also finding adequate and approving the 2008 and 2017 motor vehicle
emissions budgets (MVEBs) for nitrogen oxides (NOX) (for
both Edgecombe and Nash counties) that are contained in the 8-hour
ozone maintenance plan for the Rocky Mount nonattainment area. North
Carolina has established subarea MVEBs at the county level so each
county must consider its individual subarea MVEBs for the purposes of
implementing transportation conformity. Further, in this action, EPA is
finding adequate and approving the insignificance determination for
volatile organic compounds' (VOCs) contribution from motor vehicle
emissions to the 8-hour ozone pollution in the Rocky Mount, North
Carolina area.

DATES: This rule is effective on January 5, 2007, without further
notice, unless EPA receives adverse written comments by December 6,
2006. If EPA receives such comments, it will publish a timely
withdrawal of the direct final rule in the Federal Register and inform
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No EPA-R04-
OAR-2006-0676, by one of the following methods:
    1. http://www.regulations.gov : Follow the online instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2006-0676'', Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier. Deliver your comments to: Nacosta C.
Ward or Amanetta Wood, Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960. Such deliveries are only accepted during
the Regional Office's normal hours of operation. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No.: ``EPA-R04-OAR-
2006-0676''. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit through
http://www.regulations.gov or e-mail, information that you consider to be CBI

or otherwise protected. The http://www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of

encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov
 or in hard copy at the Regulatory Development

Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward of the Regulatory
Development Section or Amanetta Wood of the Air Quality Modeling and
Transportation Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER> or<PHONE_NUMBER>. Ms. Nacosta Ward can be reached
via electronic mail at<EMAIL_ADDRESS>Ms. Amanetta Wood can also
be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What Are the Actions EPA Is Taking?
II. What Is the Background for the Actions?
III What Are the Criteria for Redesignation?
IV. Why Is EPA Taking These Actions?
V. What Is the Effect of EPA's Actions?
VI. What Is EPA's Analysis of the Request?
VII. What Is an Adequacy Determination?
VIII. What Is the Status of EPA's Adequacy Determination for the
Rocky Mount Area's Proposed New NOX Subarea MVEBs for the
Years 2008 and 2017?
IX. What Is the Status of EPA's Adequacy Determination for the Rocky
Mount Area's Proposed Insignificance Finding for VOCs from Motor
Vehicles?
X. Final Action on the Redesignation Request, the Maintenance Plan
SIP Revision Including Approval of the 2008 and 2017 NOX
MVEBs, and the VOCs Insignificance Finding.
XI. Statutory and Executive Order Reviews

I. What Are the Actions EPA Is Taking?

    Through this rulemaking, EPA is taking several related actions. EPA
is making the determination that the Rocky Mount 8-hour ozone
nonattainment area has attained the 8-hour ozone standard, and has met
the requirements for redesignation under section 107(d)(3)(E) of the
CAA. The Rocky Mount area is a basic 8-hour ozone nonattainment area.
The Rocky Mount 8-hour ozone nonattainment area is comprised of
Edgecombe and Nash counties. EPA is approving a request to change the
legal designation of the Rocky Mount area from nonattainment to
attainment for the 8-hour ozone NAAQS.
    EPA is also approving North Carolina's 8-hour ozone maintenance
plan for the Rocky Mount area (such approval being one of the CAA
criteria for redesignation to attainment status). The maintenance plan
is designed to help keep the Rocky Mount area in attainment for the 8-
hour ozone NAAQS for the next 12 years, and includes an insignificance
finding for VOCs for the entire Rocky Mount, North Carolina area, and
new NOX subarea MVEBs for the years 2008 and 2017 for
Edgecombe and Nash counties.
    Additionally, through this rulemaking, EPA is announcing its action
on the Adequacy Process for the newly-established 2008 and 2017
NOX MVEBs for the Rocky Mount 8-hour ozone area. Further,
EPA is announcing its action on the Adequacy Process for the
insignificance finding related to VOCs from motor vehicles for the
Rocky Mount 8-hour ozone area. The Adequacy comment period for the new
NOX MVEBs and the VOCs insignificance finding began on
August 8, 2006, with EPA's posting of the availability of this
submittal on EPA's Adequacy Web site (at http://www.epa.gov/otaq/stateresources/transconf/currsips.htm
). The Adequacy comment period for

these MVEBs and VOCs insignificance finding closed on September 7,
2006. No requests or adverse comments on this submittal were received
during EPA's Adequacy comment period. Please see section VII of this
rulemaking for further explanation of this process.

II. What Is the Background for the Actions?

    Ground-level ozone is not emitted directly by sources. Rather,
emissions of NOX and VOCs react in the presence of sunlight
to form ground-level ozone. NOX and VOCs are referred to as
precursors of ozone. The CAA establishes a process for air quality
management through the NAAQS.
    On July 18, 1997, EPA promulgated a revised 8-hour ozone standard
of 0.08 parts per million (ppm). This new standard is more stringent
than the previous 1-hour ozone standard. Under EPA regulations at 40
CFR part 50, the 8-hour ozone standard is attained when the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ambient air quality ozone concentrations is less than or equal to 0.08
ppm (i.e. 0.084 ppm when rounding is considered). (See 69 FR 23857
(April 30, 2004) for further information). Ambient air quality
monitoring data for the 3-year period must meet a data completeness
requirement. The ambient air quality monitoring data completeness
requirement is met when the average percent of days with valid ambient
monitoring data is greater than 90 percent, and no single year has less
than 75 percent data completeness as determined in Appendix I of part
50. Specifically, section 2.3 of 40 CFR part 50, Appendix I,
``Comparisons with the Primary and Secondary Ozone Standards'' states:
``The primary and secondary ozone ambient air quality standards are met
at an ambient air quality monitoring site when the 3-year average of
the annual fourth-highest daily maximum 8-hour average ozone
concentration is less than or equal to 0.08 ppm. The number of
significant figures in the level of the standard dictates the rounding
convention for comparing the computed 3-year average annual fourth-
highest daily maximum 8-hour average ozone concentration with the level
of the standard. The third decimal place of the computed value is
rounded, with values equal to or greater than 5 rounding up. Thus, a
computed 3-year average ozone concentration of 0.085 ppm is the
smallest value that is greater than 0.08 ppm.''
    The CAA required EPA to designate as nonattainment any area that
was violating the 8-hour ozone NAAQS based on the three most recent
years of ambient air quality data. The Rocky Mount 8-hour ozone
nonattainment area was designated using 2001 to 2003 ambient air
quality data. The Federal Register notice making these designations was
signed on April 15, 2004, and published on April 30, 2004, (69 FR
23857). The CAA contains two sets of provisions--subpart 1 and subpart
2--that address planning and control requirements for ozone
nonattainment areas. (Both are found in title I, part D.) Subpart 1
(which covers areas that EPA refers to as ``basic'' nonattainment)
contains general, less

prescriptive, requirements for nonattainment areas for any pollutant--
including ozone--governed by a NAAQS. Subpart 2 (which covers areas
that EPA refers to as ``classified'' nonattainment) provides more
specific requirements for certain ozone nonattainment areas. Some 8-
hour ozone nonattainment areas are subject only to the provisions of
subpart 1. Other 8-hour ozone nonattainment areas are also subject to
the provisions of subpart 2. Under EPA's Phase 1 8-hour Ozone
Implementation Rule, signed on April 15, 2004, an area was to be
classified under subpart 2 based on its 8-hour ozone design value
(i.e., the 3-year average of the annual fourth-highest daily maximum 8-
hour average ozone concentrations), if it had a 1-hour design value at
or above 0.121 ppm (the lowest 1-hour design value in Table 1 of
subpart 2). All other areas are covered under subpart 1, based upon
their 8-hour ambient air quality design values. The Rocky Mount area
was originally designated as a ``basic'' 8-hour ozone nonattainment
area by EPA on April 30, 2004, (69 FR 23857) and is subject to subpart
1 of part D. In 2005, the ambient ozone data for the Rocky Mount
nonattainment area indicated no further violation of the 8-hour ozone
standard, using data from the 3-year period of 2003-2005 (with the
2003-2005 design value of 0.079 ppm), to demonstrate attainment.
Available monitoring data through July 2006 indicates continued
attainment of the 8-hour ozone standard. These data are depicted in
Table 1 below:

                         Table 1.--Current Air Quality Data in the Rocky Mount, NC Area
     Air Quality System Monitoring Data for Edgecombe County (Leggett monitor AIRS ID 37-065-0099)
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                                                 April 2006        May 2006        June 2006        July 2006
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Monthly Maximum 8-hour ozone Values (ppm)...            .074             .077             .074             .068
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    On June 19, 2006, the State of North Carolina requested
redesignation to attainment for the 8-hour ozone standard for the Rocky
Mount, North Carolina 8-hour ozone nonattainment area. The
redesignation request includes three years of complete, quality-assured
ambient air quality data for the ozone seasons of 2003 through 2005,
indicating the 8-hour ozone NAAQS had been achieved for the Rocky Mount
area. The ozone season for this area is from April 1 until October 31
of a calendar year. Under the CAA, nonattainment areas may be
redesignated to attainment if sufficient, complete, quality-assured
data is available for the Administrator to determine that the area has
attained the standard and the area meets the other CAA redesignation
requirements in section 107(d)(3)(E).

III. What Are the Criteria for Redesignation?

    The CAA provides the requirements for redesignating a nonattainment
area to attainment. Specifically, section 107(d)(3)(E) allows for
redesignation providing that: (1) The Administrator determines that the
area has attained the applicable NAAQS; (2) the Administrator has fully
approved the applicable implementation plan for the area under section
110(k); (3) the Administrator determines that the improvement in air
quality is due to permanent and enforceable reductions in emissions
resulting from implementation of the applicable SIP and applicable
Federal air pollutant control regulations and other permanent and
enforceable reductions; (4) the Administrator has fully approved a
maintenance plan for the area as meeting the requirements of section
175A; and, (5) the State containing such area has met all requirements
applicable to the area under section 110 and part D.
    EPA provided guidance on redesignation in the General Preamble for
the Implementation of Title I of the CAA Amendments of 1990, on April
16, 1992 (57 FR 13498), and supplemented this guidance on April 28,
1992 (57 FR 18070). EPA has provided further guidance on processing
redesignation requests in the following documents:

    1. ``Ozone and Carbon Monoxide Design Value Calculations,''
Memorandum from Bill Laxton, June 18, 1990;
    2. ``Maintenance Plans for Redesignation of Ozone and Carbon
Monoxide Nonattainment Areas,'' Memorandum from G. T. Helms, Chief,
Ozone/Carbon Monoxide Programs Branch, April 30, 1992;
    3. ``Contingency Measures for Ozone and Carbon Monoxide (CO)
Redesignations,'' Memorandum from G. T. Helms, Chief, Ozone/Carbon
Monoxide Programs Branch, June 1, 1992;
    4. ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992;
    5. ``State Implementation Plan (SIP) Actions Submitted in
Response to Clean Air Act (ACT) Deadlines,'' Memorandum from John
Calcagni, Director, Air Quality Management Division, October 28,
1992;
    6. ``Technical Support Documents (TSD's) for Redesignation of
Ozone and Carbon Monoxide (CO) Nonattainment Areas, Memorandum from
G. T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, August
17, 1993;
    7. ``State Implementation Plan (SIP) Requirements for Areas
Submitting Requests for Redesignation to Attainment of the Ozone and
Carbon Monoxide (CO) National Ambient Air Quality Standards (NAAQS)
On or After November 15, 1992,'' Memorandum from Michael H. Shapiro,
Acting Assistant Administrator for Air and Radiation, September 17,
1993;
    8. ``Use of Actual Emissions in Maintenance Demonstrations for
Ozone and CO Nonattainment Areas,'' Memorandum from D. Kent Berry,
Acting Director, Air Quality Management Division, November 30, 1993;
    9. ``Part D New Source Review (Part D NSR) Requirements for
Areas Requesting Redesignation to Attainment,'' Memorandum from Mary
D. Nichols, Assistant Administrator for Air and Radiation, October
14, 1994; and
    10. ``Reasonable Further Progress, Attainment Demonstration, and
Related Requirements for Ozone Nonattainment Areas Meeting the Ozone
National Ambient Air Quality Standard,'' Memorandum from John S.
Seitz, Director, Office of Air Quality Planning and Standards, May
10, 1995.

IV. Why Is EPA Taking These Actions?

    On June 19, 2006, the State of North Carolina requested
redesignation of the Rocky Mount 8-hour ozone nonattainment area to
attainment for the 8-hour ozone standard. EPA believes that the State
of North Carolina has demonstrated that the Rocky Mount area has
attained the standard and has met the requirements for redesignation
set forth in section 107(d)(3)(E) of CAA.

V. What Is the Effect of EPA's Actions?

    Approval of this redesignation request would change the official
designation of Edgecombe and Nash counties in North Carolina for the 8-
hour ozone NAAQS found at 40 CFR part 81. It would also incorporate
into the North Carolina SIP a plan for maintaining the 8-hour ozone
NAAQS in the area through 2017. The maintenance plan includes
contingency measures to remedy future violations of the 8-hour ozone
NAAQS, and establishes MVEBs of 2,756 kilograms

per day (kg/d) (3.03 tons per day (tpd)), and 9,757 kg/d (10.77 tpd)
for NOX for the year 2008 for Edgecombe and Nash counties,
respectively. For the year 2017, the NOX MVEBs for Edgecombe
and Nash counties are 1,383 kg/d (1.53 tpd) and 4,558 kg/d (5.03 tpd),
respectively. Additionally, the maintenance plan includes an
insignificance finding for VOCs' contribution from motor vehicles to
the 8-hour ozone pollution in the Rocky Mount, North Carolina area.
EPA's affirmative adequacy finding and approval for this insignificance
determination waives the regional emissions analysis requirement (not
the transportation conformity requirement) for VOCs for this area. The
regional emissions analysis is one, but not the only, requirement for
implementing transportation conformity.

VI. What Is EPA's Analysis of the Request?

    EPA is making the determination that the Rocky Mount 8-hour ozone
nonattainment area has attained the 8-hour ozone standard, and that all
other redesignation criteria have been met. The basis for EPA's
determination is as follows:
    (1) The Rocky Mount area has attained the 8-hour ozone NAAQS.
    EPA is making the determination that the area has attained the 8-
hour ozone NAAQS. For ozone, an area may be considered to be attaining
the 8-hour ozone NAAQS if there are no violations, as determined in
accordance with 40 CFR 50.10 and Appendix I of part 50, based on three
complete, consecutive calendar years of quality-assured air quality
monitoring data. To attain this standard, the 3-year average of the
fourth-highest daily maximum 8-hour average ozone concentrations
measured at each monitor within an area over each year must not exceed
0.08 ppm. Based on the rounding convention described in 40 CFR part 50,
Appendix I, the standard is attained if the design value is 0.084 ppm
or below. The data must be collected and quality-assured in accordance
with 40 CFR part 58, and recorded in the EPA Air Quality System (AQS).
The monitors generally should have remained at the same location for
the duration of the monitoring period required for demonstrating
attainment.
    NCDENR submitted ozone monitoring data to EPA for the ozone season
from 2003 to 2005. There is currently one monitor measuring ozone,
located in the town of Leggett in Edgecombe County, which provides air
quality data for the entire Rocky Mount 8-hour ozone nonattainment
area. This data has been quality assured and is recorded in AQS. The
fourth-highest averages for 2003, 2004 and 2005, and the 3-year average
of these values (i.e. design value), are summarized in Table 2:

               Table 2.--Quality Assured Monitoring Data in the Rocky Mount, NC Area for 2003-2005
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                                                    4th Highest 8-hour ozone values (ppm)          Design Value
                                             ---------------------------------------------------      (ppm)
                   County                                                                       ----------------
                                                    2003             2004             2005          2003-2005
----------------------------------------------------------------------------------------------------------------
Edgecombe (Leggett Monitor).................           0.088            0.072            0.079            0.079
----------------------------------------------------------------------------------------------------------------

    In addition, as discussed below with respect to the maintenance
plan, NCDENR has indicated a commitment to continue monitoring in the
Rocky Mount area in accordance with 40 CFR part 58 by requiring the use
of the data from the monitor in Edgecombe County to verify continued
maintenance of the 8-hour ozone NAAQS. On September 11, 2006, NCDENR
submitted a letter to EPA clarifying this commitment. NCDENR will
operate and continue monitoring at the Leggett ozone monitor throughout
the maintenance period and until there is a change approved by EPA to
discontinue operation, relocate or otherwise affect the ambient
monitoring network in place. In summary, EPA believes that the data
submitted by North Carolina provides an adequate demonstration that the
Rocky Mount 8-hour ozone nonattainment area has attained the 8-hour
ozone NAAQS.
    (2) North Carolina has a fully approved SIP under section 110(k)
for Edgecombe and Nash Counties and (5) has met all applicable
requirements under section 110 and part D of the CAA.
    Below is a summary of how these two criteria were met.
    EPA has determined that North Carolina has met all applicable SIP
requirements for the Rocky Mount area under section 110 of the CAA
(general SIP requirements). EPA has also determined that the North
Carolina SIP satisfies the criterion that it meets applicable SIP
requirements under part D of title I of the CAA (requirements specific
to subpart 1 basic 8-hour ozone nonattainment areas) in accordance with
section 107(d)(3)(E)(v). In addition, EPA has determined that the SIP
is fully approved with respect to all applicable requirements in
accordance with section 107(d)(3)(E)(ii). In making these
determinations, EPA ascertained which requirements are applicable to
the area and that if applicable they are fully approved under section
110(k). SIPs must be fully approved only with respect to applicable
requirements.
    a. Rocky Mount, North Carolina has met all applicable requirements
under section 110 and part D of the CAA.
    The September 4, 1992, Calcagni memorandum (see ``Procedures for
Processing Requests to Redesignate Areas to Attainment,'' Memorandum
from John Calcagni, Director, Air Quality Management Division,
September 4, 1992) describes EPA's interpretation of section
107(d)(3)(E). Under this interpretation, to qualify for redesignation,
states requesting redesignation to attainment must meet only the
relevant CAA requirements that come due prior to the submittal of a
complete redesignation request. See also Michael Shapiro memorandum,
September 17, 1993, and 60 FR 12459, 12465-66 (March 7, 1995)
(redesignation of Detroit-Ann Arbor, MI). Applicable requirements of
the CAA that come due subsequent to the area's submittal of a complete
redesignation request remain applicable until a redesignation is
approved, but are not required as a prerequisite to redesignation. See
section 175A(c) of the CAA; Sierra Club v. EPA, 375 F.3d 537 (7th Cir.
2004). See also 68 FR 25424, 25427 (May 12, 2003) (redesignation of St.
Louis, MO).
    General SIP requirements: Section 110(a)(2) of title I of the CAA
delineates the general requirements for a SIP, which include
enforceable emissions limitations and other control measures, means, or
techniques, provisions for the establishment and operation of
appropriate devices necessary to collect data on ambient air quality,
and programs to enforce the limitations. General SIP elements and
requirements are delineated in section 110(a)(2) of title I, part A of
the CAA. These requirements include, but are not

limited to, the following: Submittal of a SIP that has been adopted by
the state after reasonable public notice and hearing; provisions for
establishment and operation of appropriate procedures needed to monitor
ambient air quality; implementation of a source permit program;
provisions for the implementation of part C requirements (Prevention of
Significant Deterioration (PSD) and provisions for the implementation
of part D requirements (New Source Review (NSR) permit programs);
provisions for air pollution modeling; and provisions for public and
local agency participation in planning and emission control rule
development. These requirements are discussed in the following EPA
documents: ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992; ``State Implementation Plan
(SIP) Actions Submitted in Response to Clean Air Act (CAA) Deadlines,''
memorandum from John Calcagni, Director, Air Quality Management
Division, October 28, 1992; and ``State Implementation Plan (SIP)
Requirements for Areas Submitting Requests for Redesignation to
Attainment of the Ozone and Carbon Monoxide (CO) National Ambient Air
Quality Standards (NAAQS) on or after November 15, 1992,'' Memorandum
from Michael H. Shapiro, Acting Assistant Administrator, September 17,
1993. See also guidance documents listed in section III above.
    Section 110(a)(2)(D) requires that SIPs contain certain measures to
prevent sources in a state from significantly contributing to air
quality problems in another state. To implement this provision, EPA has
required certain states to establish programs to address the transport
of air pollutants (NOX SIP Call, Clean Air Interstate Rule
(CAIR)). North Carolina's final CAIR submittal was received by EPA on
August 15, 2006. However, the section 110(a)(2)(D) requirements for a
state are not linked with a particular nonattainment area's designation
and classification in that state. EPA believes that the requirements
linked with a particular nonattainment area's designation and
classification are the relevant measures to evaluate in reviewing a
redesignation request. The transport SIP submittal requirements, where
applicable, continue to apply to a state regardless of the designation
of any one particular area in the state.
    Thus, we do not believe that the CAA's interstate transport
requirements should be construed to be applicable requirements for
purposes of redesignation. In addition, EPA believes that the other
section 110 elements not connected with nonattainment plan submissions
and not linked with an area's attainment status are not applicable
requirements for purposes of redesignation. The State will still be
subject to these requirements after the area is redesignated. The
section 110 and part D requirements, which are linked with a particular
area's designation and classification, are the relevant measures to
evaluate in reviewing a redesignation request. This approach is
consistent with EPA's existing policy on applicability (i.e., for
redesignations) of conformity and oxygenated fuels requirements, as
well as with section 184 ozone transport requirements. See Reading,
Pennsylvania, proposed and final rulemakings (61 FR 53174-53176,
October 10, 1996), (62 FR 24826, May 7, 1997); Cleveland-Akron-Loraine,
Ohio, final rulemaking (61 FR 20458, May 7, 1996); and Tampa, Florida,
final rulemaking at (60 FR 62748, December 7, 1995). See also the
discussion on this issue in the Cincinnati redesignation (65 FR 37890,
June 19, 2000), and in the Pittsburgh redesignation (66 FR 50399,
October 19, 2001).
    EPA believes that section 110 elements not linked to the area's
nonattainment status are not applicable for purposes of redesignation.
Any section 110 requirements that are linked to the part D requirements
for 8-hour ozone nonattainment areas are not yet due, since, as
explained below, no part D requirements applicable for purposes of
redesignation under the 8-hour ozone standard became due prior to the
submission of the redesignation request. Therefore, as discussed above,
for purposes of redesignation, they are not considered applicable
requirements. Nonetheless, EPA notes that it has previously approved
provisions in the North Carolina SIP addressing section 110 elements
under the 1-hour ozone standard (51 FR 19834, June 3, 1986). EPA
believes that the section 110 SIP approved for the 1-hour ozone
standard is sufficient to meet requirements under the 8-hour ozone
standard as well.
    Part D requirements: EPA has also determined that the North
Carolina SIP meets applicable SIP requirements under part D of the CAA
since no requirements became due prior to the submission of the area's
redesignation request. Sections 172-176 of the CAA, found in subpart 1
of part D, set forth the basic nonattainment requirements applicable to
all nonattainment areas. Section 182 of the CAA, found in subpart 2 of
part D, establishes additional specific requirements depending on the
area's nonattainment classification. Subpart 2 is not applicable to the
Rocky Mount area.
    Part D, subpart 1 applicable SIP requirements: For purposes of
evaluating this redesignation request, the applicable part D, subpart 1
SIP requirements for all nonattainment areas are contained in sections
172(c)(1)-(9). A thorough discussion of the requirements contained in
section 172 can be found in the General Preamble for Implementation of
Title I (57 FR 13498). No requirements applicable for purposes of
redesignation under part D became due prior to the submission of the
redesignation request, and therefore none are applicable to the area
for purposes of redesignation. For example, the requirements for an
attainment demonstration that meets the requirements of section
172(c)(1) are not yet applicable, nor are the requirements for
Reasonably Achievable Control Technology (RACT) and Reasonably
Available Control Measures (RACM) (section 172(c)(1)), reasonable
further progress (RFP) (section 172(c)(2)), and contingency measures
(section 172(c)(9)).
    In addition to the fact that no part D requirements applicable for
purposes of redesignation became due prior to submission of the
redesignation request and therefore are not applicable, EPA believes it
is reasonable to interpret the conformity and NSR requirements as not
requiring approval prior to redesignation.
    Section 176 Conformity Requirements: Section 176(c) of the CAA
requires states to establish criteria and procedures to ensure that
Federally supported or funded projects conform to the air quality
planning goals in the applicable SIP. The requirement to determine
conformity applies to transportation plans, programs and projects
developed, funded or approved under title 23 of the United States Code
(U.S.C.) and the Federal Transit Act (``transportation conformity'') as
well as to all other Federally supported or funded projects (``general
conformity''). State conformity revisions must be consistent with
Federal conformity regulations that the CAA required the EPA to
promulgate.
    EPA believes it is reasonable to interpret the conformity
requirements as not applying for purposes of evaluating the
redesignation request under section 107(d) because state conformity
rules are still required after redesignation and Federal conformity
rules apply where state rules have not been approved. See Wall v. EPA,
265 F.3d 426 (6th Cir. 2001), upholding this interpretation. See

also 60 FR 62748 (Dec. 7, 1995, Tampa, FL).
    EPA has also determined that areas being redesignated need not
comply with the requirement that a NSR program be approved prior to
redesignation, provided that the area demonstrates maintenance of the
standard without part D NSR in effect since PSD requirements will apply
after redesignation. The rationale for this view is described in a
memorandum from Mary Nichols, Assistant Administrator for Air and
Radiation, dated October 14, 1994, entitled ``Part D New Source Review
(Part D NSR) Requirements for Areas Requesting Redesignation to
Attainment.'' North Carolina has demonstrated that the area will be
able to maintain the standard without part D NSR in effect, and
therefore, the State need not have a fully approved part D NSR program
prior to approval of the redesignation request. The State's PSD program
will become effective in the area upon redesignation to attainment. See
rulemakings for Detroit, MI (60 FR 12467-12468, March 7, 1995);
Cleveland-Akron-Lorraine, OH (61 FR 20458, 20469-20470, May 7, 1996);
Louisville, KY (66 FR 53665, October 23, 2001); Grand Rapids, Michigan
(61 FR 31834-31837, June 21, 1996). Thus, the area has satisfied all
applicable requirements for purposes of redesignation under section 110
and part D of the CAA.
    b. The area has a fully approved applicable SIP under section
110(k) of the CAA.
    EPA has fully approved the applicable North Carolina SIP for the
Rocky Mount area under section 110(k) of the Clean Air Act for all
requirements applicable for purposes of redesignation. EPA may rely on
prior SIP approvals in approving a redesignation request, see Calcagni
Memo at p. 3; Southwestern Pennsylvania Growth Alliance v. Browner, 144
F.3d 984, 989-90 (6th Cir. 1998); Wall v. EPA, 265 F.3d 426 (6th Cir.
2001), plus any additional measures it may approve in conjunction with
a redesignation action. See 68 FR 25426 (May 12, 2003) and citations
therein. Following passage of the CAA of 1970, North Carolina has
adopted and submitted, and EPA has fully approved at various times,
provisions addressing the various 1-hour ozone standard SIP elements
applicable in the Rocky Mount area (51 FR 19834, June 3, 1986).
    As indicated above, EPA believes that the section 110 elements not
connected with nonattainment plan submissions and not linked to the
area's nonattainment status are not applicable requirements for
purposes of redesignation. EPA also believes that since the part D
requirements applicable for purposes of redesignation did not become
due prior to submission of the redesignation request, they also are
therefore not applicable requirements for purposes of redesignation.
    (3) The air quality improvement in the Rocky Mount 8-hour ozone
area is due to permanent and enforceable reductions in emissions
resulting from implementation of the SIP and applicable Federal air
pollution control regulations and other permanent and enforceable
reductions.
    EPA believes that the State has demonstrated that the observed air
quality improvement in the area is due to permanent and enforceable
reductions in emissions resulting from implementation of the SIP,
Federal measures, and other state-adopted measures. EPA has determined
that the implementation of the following permanent and enforceable
emissions controls, that occurred from 2002-2005, have reduced local
VOC and NOX emissions and brought the area into attainment:
     EPA's Tier 2 Vehicle Standards;
     EPA's Heavy-Duty Gasoline and Diesel Highway and Vehicle
Standards;
     Federal controls on non-road spark ignition engines and
recreational engine standard engines in 2003;
     State Clean Air Bill;
     State NOX SIP Call rule;
     State Clean Smokestacks Act;
     State Open Burning Ban;
     State Air Toxics Control Program;
     Prevention of Significant Deterioration;
     State Heavy Duty Diesel Gap Filling Rule.
    In addition to the reductions mentioned above, the State of North
Carolina has implemented an Air Awareness Program which is a public
outreach program to reduce air pollution through voluntary action by
individuals and organizations.
    The State has demonstrated that the implementation of permanent and
enforceable emissions controls have reduced local VOC and
NOX emissions. Most of the reductions are attributable to
Federal programs such as EPA's Tier 2/Low Sulfur Gasoline program and
other national clean fuel programs that began implementation in 2004.
Additionally, the State has indicated in its submittal that the Rocky
Mount area has benefited from emissions reductions that have been
achieved and will continue to be achieved through implementation of the
NOX SIP Call, beginning in 2002. The State has also
demonstrated that year-to-year meteorological changes and trends are
not the likely source of the overall, long-term improvement in ozone
levels. Also, the following non-highway mobile source reduction
programs were implemented during the 2002-2005 period: small spark-
ignition engines, large-spark ignition engines, locomotives and land-
based diesel engines. EPA believes that permanent and enforceable
emissions reductions in and surrounding the nonattainment area are the
cause of the long-term improvement in ozone levels, and are the cause
of the area achieving attainment of the ozone standard.
    (4) The area has a fully approved maintenance plan pursuant to
section 175A of the CAA.
    In its request to redesignate the Rocky Mount 8-hour ozone
nonattainment area to attainment status, NCDENR submitted a SIP
revision to provide for the maintenance of the 8-hour ozone NAAQS in
the Rocky Mount area for at least 10 years after the effective date of
redesignation to attainment.

a. What Is Required in a Maintenance Plan?

    Section 175A of the CAA sets forth the elements of a maintenance
plan for areas seeking redesignation from nonattainment to attainment.
Under section 175A, the plan must demonstrate continued attainment of
the applicable NAAQS for at least 10 years after the Administrator
approves a redesignation to attainment. Eight years after the
redesignation, the State must submit a revised maintenance plan which
demonstrates that attainment will continue to be maintained for the 10
years following the initial 10-year period. To address the possibility
of future NAAQS violations, the maintenance plan must contain such
contingency measures, with a schedule for implementation as EPA deems
necessary to assure prompt correction of any future 8-hour ozone
violations. Section 175A of the CAA sets forth the elements of a
maintenance plan for areas seeking redesignation from nonattainment to
attainment. The Calcagni memorandum, dated September 4, 1992, provides
additional guidance on the content of a maintenance plan. An ozone
maintenance plan should address five requirements: the attainment
emissions inventory, maintenance demonstration, monitoring,
verification of continued attainment, and a contingency plan.

b. Attainment Emissions Inventory

    The Rocky Mount area has selected 2005 as ``the attainment year''
for purposes of demonstrating attainment of the 8-hour ozone NAAQS. The
2005 VOC and NOX emissions for the Rocky

Mount area were developed consistent with EPA guidance and are
summarized in the table in the following subsection.

c. Maintenance Demonstration

    The June 19, 2006, submittal includes a 12-year maintenance plan
for the Rocky Mount area. This demonstration:
    (i) shows compliance and maintenance of the 8-hour ozone standard
by assuring that current and future emissions of VOC and NOX
remain at or below attainment year 2005 emissions levels. The year 2005
was chosen as the attainment year because it is one of the most recent
three years (i.e., 2003, 2004, and 2005) for which the Rocky Mount area
has clean air quality data for the 8-hour ozone standard.
    (ii) uses 2005 as the attainment year and includes future inventory
projected years for 2008, 2011, 2014, and 2017.
    (iii) identifies an ``out year,'' at least 10 years after the time
necessary for EPA to review and approve the maintenance plan. Per 40
CFR part 93, a MVEB was established for the last year of the
maintenance plan. See sections VIII and IX below.
    (iv) provides the following actual and projected emissions
inventories for the Rocky Mount area depicted in Tables 3 through 8:

                              Table 3.-- NOX Emissions (tpd) for Edgecombe County*
----------------------------------------------------------------------------------------------------------------
         Source category               2005            2008            2011            2014            2017
----------------------------------------------------------------------------------------------------------------
Point...........................            2.95            2.68            2.70            2.73            2.76
Area............................            0.53            0.54            0.55            0.56            0.57
On-Road Mobile..................            3.36            2.73            2.14            1.62            1.27
Nonroad.........................            2.35            2.10            1.82            1.60            1.40
                                 -------------------------------------------------------------------------------
    Total Emissions.............            9.19            8.05            7.21            6.51            6.00
----------------------------------------------------------------------------------------------------------------
*The total emissions in the tables above only include man-made emissions and not biogenic emissions.

                                 Table 4.-- NOX Emissions (tpd) for Nash County*
----------------------------------------------------------------------------------------------------------------
         Source category               2005            2008            2011            2014            2017
----------------------------------------------------------------------------------------------------------------
Point...........................            0.60            0.60            0.63            0.69            0.72
Area............................            1.08            1.12            1.16            1.20            1.24
On-Road Mobile..................           12.07            9.70            7.42            5.39            4.16
Nonroad.........................            2.10            1.90            1.69            1.48            1.29
                                 -------------------------------------------------------------------------------
    Total Emissions.............           15.85           13.32           10.90            8.76            7.41
----------------------------------------------------------------------------------------------------------------
*The total emissions in the tables above only include man-made emissions and not biogenic emissions.

                      Table 5.--Total NOX Emissions (tpd) for Edgecombe and Nash Counties*
----------------------------------------------------------------------------------------------------------------
         Source category               2005            2008            2011            2014            2017
----------------------------------------------------------------------------------------------------------------
Point...........................            3.55            3.28            3.33            3.42            3.48
Area............................            1.61            1.66            1.71            1.76            1.81
On-Road Mobile..................           15.43           12.43            9.56            7.01            5.43
Nonroad.........................            4.45            4.00            3.51            3.08            2.69
                                 -------------------------------------------------------------------------------
    Total Emissions.............           25.04           21.37           18.11           15.27           13.41
================================================================================================================
Safety Margin**.................             n/a            3.67            6.93            9.77           11.63
----------------------------------------------------------------------------------------------------------------
* The total emissions in the tables above only include man-made emissions and not biogenic emissions.
** A safety margin is the difference between the attainment level of emissions (from all sources) and the
  projected level of emissions (from all sources) in the maintenance plan. The attainment level of emissions is
  the level of emissions during one of the years in which the area met the NAAQS. North Carolina has calculated
  the NOX safety margin for the Rocky Mount area in its submittal which is summarized in Table 5.

                               Table 6.--VOC Emissions (tpd) for Edgecombe County*
----------------------------------------------------------------------------------------------------------------
         Source category               2005            2008            2011            2014            2017
----------------------------------------------------------------------------------------------------------------
Point...........................            3.86            4.35            4.74            5.20            5.65
Area............................            5.62            5.88            6.12            6.35            6.58
On-Road Mobile..................            2.50            2.08            1.83            1.50            1.27
Nonroad.........................            0.95            0.78            0.70            0.68            0.65
                                 -------------------------------------------------------------------------------
    Total Emissions.............           12.93           13.09           13.39           13.73           14.15
----------------------------------------------------------------------------------------------------------------
* The total emissions in the tables above only include man-made emissions and not biogenic emissions.

                                 Table 7.--VOC Emissions (tpd) for Nash County*
----------------------------------------------------------------------------------------------------------------
         Source category               2005            2008            2011            2014            2017
----------------------------------------------------------------------------------------------------------------
Point...........................            1.35            1.45            1.56            1.65            1.78
Area............................            7.04            7.43            7.79            8.14            8.52

On-Road Mobile..................            5.98            4.96            4.37            4.05            3.09
Nonroad.........................            1.39            1.17            1.07            1.05            1.08
                                 -------------------------------------------------------------------------------
    Total Emissions.............           15.76           15.01           14.79           14.89          14.47
----------------------------------------------------------------------------------------------------------------
* The total emissions in the tables above only include man-made emissions and not biogenic emissions.

                      Table 8.--Total VOC Emissions (tpd) for Edgecombe and Nash Counties*
----------------------------------------------------------------------------------------------------------------
         Source category               2005            2008            2011            2014            2017
----------------------------------------------------------------------------------------------------------------
Point...........................            5.21            5.80            6.30            6.85            7.43
Area............................           12.66           13.31           13.91           14.49           15.10
On-Road Mobile..................            8.48            7.04            6.20            5.55            4.36
Nonroad.........................            2.34            1.95            1.77            1.73            1.73
                                 -------------------------------------------------------------------------------
    Total Emissions.............           28.69           28.10           28.18           28.62           28.62
================================================================================================================
Safety Margin***................             n/a            0.59            0.51            0.07           0.07
----------------------------------------------------------------------------------------------------------------
* The total emissions in the tables above only include man-made emissions and not biogenic emissions.
*** A safety margin is the difference between the attainment level of emissions (from all sources) and the
  projected level of emissions (from all sources) in the maintenance plan. The attainment level of emissions is
  the level of emissions during one of the years in which the area met the NAAQS. North Carolina has calculated
  the VOC safety margin for the Rocky Mount area in its submittal which is summarized in Table 8.

    North Carolina has decided to allocate a portion of the available
safety margin to the NOX subarea MVEBs for 2008 and 2017.
This allocation and the resulting available safety margin is discussed
further in section VIII of this rulemaking.

d. Monitoring Network

    There is currently one monitor measuring ozone, the Leggett
monitor, located within Edgecombe County, North Carolina, which
provides air quality data for the entire Rocky Mount 8-hour
nonattainment area. North Carolina has committed to continue operation
of the Leggett ozone monitor in compliance with 40 CFR part 58, and has
addressed the requirement for monitoring.

e. Verification of Continued Attainment

    The State has the legal authority to enforce and implement the
requirements of the ozone maintenance plan for the Rocky Mount area.
This includes the authority to adopt, implement and enforce any
subsequent emissions control contingency measures determined to be
necessary to correct future ozone attainment problems.
    North Carolina will track the progress of the maintenance plan by
performing future reviews of actual emissions for the area using the
latest emissions factors, models and methodologies. For these periodic
inventories the State will review the assumptions made for the purpose
of the maintenance demonstration concerning projected growth of
activity levels. If any of these assumptions appear to have changed
substantially, the State will re-project emissions.

f. Contingency Plan

    The contingency plan provisions are designed to promptly correct a
violation of the NAAQS that occurs after redesignation. Section 175A of
the CAA requires that a maintenance plan include such contingency
measures as EPA deems necessary to assure that a state will promptly
correct a violation of the NAAQS that occurs after redesignation. The
maintenance plan should identify the contingency measures to be
adopted, a schedule and procedure for adoption and implementation, and
a time limit for action by a state. A state should also identify
specific indicators to be used to determine when the contingency
measures need to be implemented. The maintenance plan must include a
requirement that a state will implement all measures with respect to
control of the pollutant that were contained in the SIP before
redesignation of the area to attainment in accordance with section
175A(d). This requirement is met because all SIP measures are retained
for maintenance.
    In the June 19, 2006, submittal, North Carolina affirms that a
combination of all programs instituted by the State and EPA have
resulted in cleaner air in the Rocky Mount area and the anticipated
future benefits from these programs are expected to result in continued
maintenance of the 8-hour ozone NAAQS in this area. This submittal also
includes a contingency plan which provides tracking and triggering
mechanisms to determine when contingency measures are needed and a
process of developing and adopting appropriate control measures. The
primary trigger of the contingency plan will be a violation of the 8-
hour ozone NAAQS at the Leggett monitor, or when the three-year average
of the fourth-highest values is equal to or greater than 0.085 ppm. The
trigger date will be 60 days from the date that the State observes a
fourth-highest value that, when averaged with the two previous ozone
season's fourth highest values, would result in a three-year average
equal to or greater than 0.085 ppm. The second trigger will apply where
no actual violation of the 8-hour ozone standard has occurred, but
where the State finds monitored ozone levels indicating that an actual
ozone NAAQS violation may be imminent. A pattern will be deemed to
exist when there are two consecutive ozone seasons in which the fourth-
highest values are 0.085 ppm or greater. The trigger date will be 60
days from the date that the State observes a fourth-highest value of
0.085 ppm or greater, following a season in which the fourth-highest
value was 0.085 ppm or greater.
    Once the primary or secondary trigger is activated, North Carolina
will commence analyses including trajectory analyses of high ozone
days, and emissions inventory assessment to determine those emission
control measures that will be required for attainment and maintaining
the 8-hour ozone standard. North Carolina commits that by May 1 of the
year following the ozone season in which the primary (a

violation of the 8-hour ozone NAAQS occurs) or secondary trigger has
been activated, that they will complete sufficient analyses to begin
adoption of necessary rules for ensuring attainment and maintenance of
the 8-hour ozone NAAQS. North Carolina also commits that such rules
would become State-effective by the following January 1, unless
legislative review is required. Specifically, the State will consider
one or more of the following contingency measures to re-attain the
standard:
     RACT for NOX on stationary sources in Nash and
Edgecombe counties;
     Diesel inspection and maintenance program \1\;
---------------------------------------------------------------------------

    \1\ At this time, there is not an approved method for
determining emission reductions from a Diesel Inspection and
Maintenance program. Therefore, there is no technical basis to award
emission credits for a heavy duty diesel inspection and maintenance
program in the SIP. However, we do not want to preclude future
technical changes that may make awarding such emission credits
possible. If it is necessary to implement contingency measures for
this area, North Carolina, in coordination with EPA, will evaluate
the feasibility of this program as a contingency measure at that
time. If a technical basis for emission credits is not available,
other contingency measures will need to be implemented.
---------------------------------------------------------------------------

     Implementation of diesel retrofit programs, including
incentives for performing retrofits;
     Implementation of additional controls in upwind areas.
    In addition to the measures listed above, the future Consolidated
Emissions Reporting Rule inventories that coincide with the attainment,
interim, and final year inventories will be compared to determine if
additional steps are necessary for continued maintenance of the 8-hour
ozone standard in this area.
    EPA has concluded that the maintenance plan adequately addresses
the five basic components of a maintenance plan: attainment inventory,
maintenance demonstration, monitoring network, verification of
continued attainment, and a contingency plan. The maintenance plan SIP
revision submitted by North Carolina for the Rocky Mount area meets the
requirements of section 175A of the CAA.

VII. What Is an Adequacy Determination?

    Under the CAA, states are required to submit, at various times,
control strategy SIPs and maintenance plans in ozone areas. These
control strategy SIPs (e.g., reasonable further progress SIPs and
attainment demonstration SIPs) and maintenance plans create MVEBs for
criteria pollutants and/or their precursors to address pollution from
cars and trucks. Per 40 CFR part 93, a MVEB is established for the last
year of the maintenance plan. A state may adopt MVEBs for other years
as well. The MVEB is the portion of the total allowable emissions in
the maintenance demonstration that is allocated to highway and transit
vehicle use and emissions. The MVEB serves as a ceiling on emissions
from an area's planned transportation system. The MVEB concept is
further explained in the preamble to the November 24, 1993,
transportation conformity rule (58 FR 62188). The preamble also
describes how to establish the MVEB in the SIP and revise the MVEB.
    Under section 176(c) of the CAA, new transportation projects, such
as the construction of new highways, must ``conform'' to (i.e., be
consistent with) the part of the State's air quality plan that
addresses pollution from cars and trucks. ``Conformity'' to the SIP
means that transportation activities will not cause new air quality
violations, worsen existing violations, or delay timely attainment of
the NAAQS. If a transportation plan does not ``conform,'' most new
projects that would expand the capacity of roadways cannot go forward.
Regulations at 40 CFR part 93 set forth EPA policy, criteria, and
procedures for demonstrating and assuring conformity of such
transportation activities to a SIP.
    When reviewing submitted ``control strategy'' SIPs or maintenance
plans containing MVEBs, EPA must affirmatively find the MVEB contained
therein ``adequate'' for use in determining transportation conformity.
Once EPA affirmatively finds the submitted MVEB is adequate for
transportation conformity purposes, that MVEB can be used by state and
federal agencies in determining whether proposed transportation
projects ``conform'' to the SIP as required by section 176(c) of the
Clean Air Act. EPA's substantive criteria for determining ``adequacy''
of an MVEB are set out in 40 CFR 93.118(e)(4).
    EPA's process for determining ``adequacy'' consists of three basic
steps: public notification of a SIP submission, a public comment
period, and EPA's adequacy finding. This process for determining the
adequacy of submitted SIP MVEBs was initially outlined in EPA's May 14,
1999 guidance, ``Conformity Guidance on Implementation of March 2,
1999, Conformity Court Decision.'' This guidance was finalized in the
Transportation Conformity Rule Amendments for the ``New 8-Hour Ozone
and PM2.5 National Ambient Air Quality Standards and Miscellaneous
Revisions for Existing Areas; Transportation Conformity Rule
Amendments--Response to Court Decision and Additional Rule Change'' on
July 1, 2004 (69 FR 40004). EPA follows this guidance and rulemaking in
making its adequacy determinations.
    In addition, in certain instances, the transportation conformity
rule allows areas not to establish a MVEB where it is demonstrated that
the regional motor vehicle emissions for a particular pollutant/
precursor is an insignificant contributor to the air quality problem in
an area. The general criteria for insignificance findings can be found
in 40 CFR 93.109(k). Insignificance findings are based on a number of
factors, including the percentage of motor vehicle emissions in context
of the total SIP inventory, the current state of air quality as
determined by monitoring data for that NAAQS, the absence of SIP motor
vehicle control measures, and historical trends and future projections
of the growth of motor vehicle emissions. EPA's rationale for the
allowance of insignificance findings can be found in the July 1, 2004,
revision to the transportation conformity rule at 69 FR 40004.
Specifically, the rationale is explained on page 40061 under the
subsection entitled ``B. Areas With Insignificant Motor Vehicle
Emissions.'' Any insignificance finding that EPA makes is subject to
the adequacy and approval process for EPA's action on the SIP.
    In summary, upon the effective date of EPA's adequacy finding or
approval of such a SIP, an insignificance finding waives the regional
emissions analysis requirements (for the purpose of transportation
conformity implementation) for an insignificant pollutant or precursor
in areas where EPA finds that the SIP's motor vehicle emissions for a
pollutant or precursor for a given standard are an insignificant
contributor to an area's regional air quality problem. Areas with
insignificant regional motor vehicle emissions for a pollutant or
precursor are still required to make a conformity determination that
satisfies other relevant requirements. Additionally, areas are required
to satisfy the regional emissions analysis requirements for pollutants
or precursors for which EPA has not made a finding of insignificance.
For the Rocky Mount area, EPA is making an insignificance finding with
regard to VOCs. This insignificance finding is discussed in more detail
in Section IX below.

VIII. What Is the Status of EPA's Adequacy Determination for the Rocky
Mount Area's Proposed New NOX Subarea MVEBs for the Years
2008 and 2017?

    The Rocky Mount area's maintenance plan submission contains new
NOX subarea MVEBs for the years 2008 and 2017 for Edgecombe
and Nash counties. The availability of the SIP submission with the 2008
and 2017 NOX subarea MVEBs was announced for public comment
on EPA's adequacy Web page on August 7, 2006, at: http://www.epa.gov/otaq/stateresources/transconf/currsips.htm.
 The EPA public comment

period on the adequacy of the 2008 and 2017 NOX subarea
MVEBs for the Edgecombe and Nash counties closed on September 7, 2006.
EPA did not receive any adverse comments or requests for the submittal.
    Through this rulemaking, EPA is finding adequate and approving
those MVEBs for use to determine transportation conformity because EPA
has determined that the area maintains the standard with emissions at
the levels of the budgets. Tables 9 and 10 below define the 2008 and
2017 NOX subarea MVEBs for both Edgecombe and Nash counties
in the Rocky Mount, North Carolina area.

                     Table 9.--Edgecombe County 8-Hour Ozone Maintenance Area MVEBs for NOX
----------------------------------------------------------------------------------------------------------------
                                                               2008                            2017
                                                 ---------------------------------------------------------------
                                                      kg/day            tpd           kg/day            tpd
----------------------------------------------------------------------------------------------------------------
On-Road Mobile Emissions........................           2,483            2.73           1,143            1.27
Safety Margin Allocated to MVEB.................             273            0.30             240            0.26
NOX MVEB........................................           2,756            3.03           1,383            1.53
----------------------------------------------------------------------------------------------------------------

                       Table 10.--Nash County 8-Hour Ozone Maintenance Area MVEBs for NOX
----------------------------------------------------------------------------------------------------------------
                                                               2008                            2017
                                                 ---------------------------------------------------------------
                                                      kg/day            tpd           kg/day            tpd
----------------------------------------------------------------------------------------------------------------
On-Road Mobile Emissions........................           8,790            9.70           3,767            4.16
Safety Margin Allocated to MVEB.................             967            1.07             791            0.87
NOX MVEB........................................           9,757           10.77           4,558            5.03
----------------------------------------------------------------------------------------------------------------

    A total of 1,240 kg (1.37 tpd) and 1,031kg (1.14 tpd) of the 2008
and 2017 safety margin, respectively, were added to the MVEB for the
Rocky Mount area. As the tables above indicate, for Edgecombe County,
this equates to an allocation of 273 kg/day (0.30 tpd) and 204 kg/day
(0.26 tpd) for NOX in the years 2008 and 2017, respectively;
for Nash County, this equates to 967 kg/day (1.07 tpd) and 791 kg/day
(0.87 tpd) for NOX in the years 2008 and 2017, respectively.
Thus, after this allocation, the available NOX safety margin
for the Rocky Mount area in 2008 is 2.30 tpd and in 2017 is 10.49 tpd.

IX. What Is the Status of EPA's Adequacy Determination for the Rocky
Mount Area's Proposed Insignificance Finding for VOCs From Motor
Vehicles?

    In addition to NOX subarea MVEBs, the Rocky Mount area's
maintenance plan submission contains a finding of insignificance for
VOCs' contribution from motor vehicles to the 8-hour ozone pollution in
the Rocky Mount area. The availability of the SIP submission with the
VOC insignificance finding was announced for public comment on EPA's
adequacy Web page on August 7, 2006, at: http://www.epa.gov/otaq/stateresources/transconf/currsips.htm.
 The EPA public comment period on

the adequacy of the VOC insignificance finding for the Rocky Mount,
North Carolina, area closed on September 7, 2006. EPA did not receive
any adverse comments or requests for the submittal.
    For the purposes of transportation conformity, EPA agrees with the
State of North Carolina's insignificance finding for VOCs' contribution
from motor vehicles in the Rocky Mount, North Carolina area. EPA finds
that North Carolina's SIP submittal meets the criteria in the
transportation conformity rule for an insignificance finding for VOCs
considering the high level of biogenic emissions in the area. That is,
EPA finds that the SIP submittal demonstrates that, as to VOCs,
regional motor vehicle emissions are an insignificant contributor to 8-
hour ozone pollution in the Rocky Mount area. This finding is based on
the following: (1) The on-road VOC emissions are less than 10 percent
in the future in both Edgecombe and Nash counties, and the biogenic
emissions account for about 90 percent of the VOC emissions in future
years; (2) figures 4.1.6-5 and 4.1.6-6, located in Appendix C.3--Mobile
Source Inventory Documentation on pages 4-24 and 4-25 show on-road VOC
emissions declining by about 50 percent by 2017 and vehicle miles
traveled (VMT) going up by about 25 to 30 percent by 2017; and (3) the
sensitivity analysis that was done, where the State ran a photochemical
model for a 39-day scenario with a modeled 30 percent reduction in man-
made VOC emissions, showed that 8-hour ozone levels were not affected
by this reduction in VOC emissions. In the year 2009, even with
anticipated growth in VMT, the mobile source inventory is less than 8
percent of the total inventory for VOC emissions, whereas biogenic
emissions account for at least 84 percent of the total inventory for
VOC emissions. As noted in North Carolina's submittal, the biogenic
sector is the most abundant source of VOCs in North Carolina and
accounts for approximately 90 percent of the total VOCs statewide. EPA
agrees with North Carolina that VOC emissions are due to the
overwhelming abundance of biogenic VOCs in the area and throughout
North Carolina. EPA also considered the implementation of an inspection
and maintenance program (I/M) in Edgecombe and Nash counties as of
January 1, 2005. The total amount of VOC emission reductions achieved
by this I/M program in Edgecombe and Nash counties, as a whole, is 0.51
tpd in 2008 and 0.89 tpd in 2017.
    Weighing all the factors for an insignificance finding,
particularly the biogenic contribution to the overall VOC inventory,
EPA has determined that VOCs' contribution from motor vehicle emissions
to the 8-hour ozone pollution for this area are insignificant. Based on
the information described above, EPA is

finding adequate and approving the insignificance finding for VOCs'
contribution from motor vehicle emissions to the 8-hour ozone pollution
for the Rocky Mount, North Carolina area. EPA's insignificance finding
should be considered and specifically noted in the transportation
conformity documentation that is prepared for this area.

X. Final Action on the Redesignation Request, the Maintenance Plan SIP
Revision Including Approval of the 2008 and 2017 NOX MVEBs,
and the VOCs Insignificance Finding

    EPA is making the determination that the Rocky Mount area has
attained the 8-hour ozone NAAQS. EPA is approving the redesignation of
the Rocky Mount area from nonattainment to attainment for the 8-hour
ozone NAAQS. After evaluating the State of North Carolina's
redesignation request, EPA has determined that it meets the
redesignation criteria set forth in section 107(d)(3)(E) of the CAA.
EPA believes that the redesignation request and monitoring data
demonstrate that the Rocky Mount area has attained the 8-hour ozone
standard. The final approval of this redesignation request changes the
official designation for the Rocky Mount, North Carolina area from
nonattainment to attainment for the 8-hour ozone standard.
    EPA is also approving the maintenance plan SIP revision. Approval
of the maintenance plan for the Rocky Mount area is appropriate,
because the State of North Carolina has demonstrated that the plan
meets the requirements of section 175A as described more fully in this
rulemaking. Additionally, EPA is finding adequate and approving the new
2008 and 2017 NOX MVEBs. Within 24 months from the effective
date of this action, the transportation partners will need to
demonstrate conformity to these new MVEBs pursuant to 40 CFR 93.104(e),
as amended by new section 172(c)(2)(E) of the CAA (added by the Safe,
Accountable, Flexible, Efficient Transportation Equity Act--A Legacy
for Users (SAFETEA-LU), which was signed into law on August 10, 2005).
Further, EPA is approving the State of North Carolina's insignificance
finding for VOCs' contribution from motor vehicles to Rocky Mount,
North Carolina's 8-hour ozone pollution. EPA is publishing this rule
without prior approval because the Agency views this as
noncontroversial and anticipates no adverse comment. However, in the
Proposed Rules section of today's Federal Register EPA is publishing a
proposal to approve the redesignation and maintenance plan that will
serve as the proposal if adverse comments are filed. This rule will be
effective on January 5, 2007 unless EPA receives adverse comments by
December 6, 2006. If EPA receives adverse comment, EPA will publish a
timely withdrawal in the Federal Register informing the public that the
rule will not take effect. EPA will address the public comments in a
subsequent final rule based on the proposed rule. EPA will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. If no such comments
are received, the public is advised that this rule will be effective on
January 5, 2007 and no further action will be taken on the proposed
rule.

XI. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Redsignation of an area to attainment under section 107(d)(3)(E) of the
CAA does not impose any new requirements on small entities.
Redesignation is an action that affects the status of a geographical
area and does not impose any new regulatory requirements on sources.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
states, on the relationship between the national government and the
states, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely affects the status of a
geographical area, does not impose any new requirements on sources, or
allow a state to avoid adopting or implementing other requirements, and
does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. This rule also is
not subject to Executive Order 13045 ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it is not economically significant and because the
Agency does not have reason to believe that the rule concerns an
environmental health risk or safety risk that may disproportionately
affect children.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by January 5, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: October 24, 2006.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

0
40 CFR parts 52 and 81 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart II--North Carolina

0
2. Section 52.1770(e), is amended by adding a new entry at the end of
the table for ``8-Hour Ozone Maintenance plan for the Rocky Mount,
North Carolina area'' to read as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (e) * * *

                              EPA-Approved North Carolina Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                                                                Federal Register
              Provision                  State effective date      EPA approval date             citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
8-Hour Ozone Maintenance plan for the  06/19/2006.............  11/06/2006 [Insert       .......................
 Rocky Mount, North Carolina area                                first page of
 (Edgecombe and Nash Counties).                                  publication].
----------------------------------------------------------------------------------------------------------------

PART 81--[AMENDED]

0
1. The authority citation for part 81 continues to read as follows:

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

0
2. In section 81.334, the table entitled ``North Carolina-Ozone (8-Hour
Standard)'' is amended under ``Rocky Mount, NC'' by revising the
entries for ``Edgecombe County'' and ``Nash County'' to read as
follows:

Sec.  81.334  North Carolina.

* * * * *

                                     North Carolina-Ozone (8-Hour Standard)
----------------------------------------------------------------------------------------------------------------
                                             Designation \a\                     Category/classification
        Designated area         --------------------------------------------------------------------------------
                                       Date\1\              Type               Date\1\               Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Rocky Mount, NC:
    Edgecombe County...........  January 5, 2007...  Attainment.                              ..................
    Nash County................  January 5, 2007...  Attainment.                              ..................

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian Country located in each county or area, except as otherwise specified.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *
 [FR Doc. E6-18584 Filed 11-3-06; 8:45 am]

BILLING CODE 6560-50-P


Summary of views and comments received regarding proposed recommendations for ADUFA V

Docket No. FDA-2011-N-0656
 June 2021

Introduction

The Animal Drug User Fee Act (ADUFA) authorizes the Food and Drug Administration (FDA) to collect user fees for the review of animal drug applications.  The reauthorization of ADUFA IV expires on October 1, 2023.  FDA began the reauthorization process, in preparation for ADUFA V, with a public meeting held on May 20, 2021.  A docket was opened and will remain open until December 1, 2022, for the public to submit written comments.

Background

The statutory language of ADUFA states:

   ``(d) REAUTHORIZATION. --
       ``(1) CONSULTATION. -- In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of animal drug applications for the first 5 fiscal years after fiscal year 2013, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with --
          ``(A) the Committee on Energy and Commerce of the House of Representatives;
          ``(B) the Committee on Health, Education, Labor, and Pensions of the Senate;
          ``(C) scientific and academic experts;
          ``(D) veterinary professionals;
          ``(E) representatives of patient and consumer advocacy groups; and
          ``(F) the regulated industry.
       ``(2) PRIOR PUBLIC INPUT. -- Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall --
          ``(A) publish a notice in the Federal Register requesting public input on the reauthorization;
          ``(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);
          ``(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and
          ``(D) publish the comments on the Food and Drug Administration's Internet Web site.

Summary of Public Comments

As of June 20, 2021, FDA has received three comments: two from consumer advocacy groups and one from regulated industry.  Commenters noted the importance of the ADUFA program to ensuring continued strong commitment to the safety and efficacy of new and existing new animal drugs.
One consumer advocacy group (1) stated their support of the implementation of the FDA's judicious antimicrobial use guidance documents #209 and #213; and (2) commented that the reauthorization process should not be used to advance post-market approval activities that could potentially threaten successful Congressional reauthorization of ADUFA.
Another consumer advocacy group (1) asked FDA to consider ADUFA funding to monitor the unethical and illegal marketing of veterinary drugs; (2) stated that NARMS and efforts to collect sales and use data of antimicrobials fall under activities included in the process for the review of animal drug applications and therefore should receive funding; and (3) stated that FDA must ask Congress to support the use of ADUFA funds to inform science-based decision making.
Regulated industry commented that they will strive for enhancements in ADUFA V to strengthen FDA/sponsor interactions, increase productivity, promote consistency, and create accountability to bring safe and effective products to the market.  They are in support of the goals laid out in the Foods and Veterinary Medicine Strategic Plan and will work with FDA to use ADUFA V to help move the program closer to achieving these results.  Regulated industry would also like to collaborate with CVM to adopt a more "risk-informed" and "risk-appropriate" approach to the animal drug review process.  They stated that a priority for ADUFA V should be to protect animal and human health by establishing a risk-appropriate and efficient review and approval process, like that of other regulatory authorities.  They feel this process must allow for safe and effective innovative therapies to be brought to market in an expeditious manner to address a wider range of animal health needs.

Conclusion

The process for the reauthorization of ADUFA has benefited from opportunities for
stakeholders to provide input on recommendations with respect to the goals of ADUFA V.  FDA greatly appreciates the substantive and thoughtful input provided by stakeholders at the public meeting in addition to the docket comments described above.  This input will help FDA better understand and incorporate stakeholder perspectives and priorities and will contribute to a stronger set of proposed recommendations.