  SEQ CHAPTER \h \r 1 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2006-0353; FRL-     ]

Approval and Promulgation of Air Quality Implementation Plans; Maryland;
Redesignation of the Kent and Queen Anne’s 8-Hour Ozone Nonattainment
Area to Attainment and Approval of the Maintenance Plan

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:   EPA is proposing to approve a redesignation request and a
State Implementation Plan (SIP) revision for the Kent and Queen
Anne’s,  MD (herein referred to as the “Kent and Queen Anne’s
area”) area from nonattainment to attainment of the 8-hour ozone
National Ambient Air Quality Standard (NAAQS).  The Maryland Department
of the Environment (MDE) is requesting that Kent and Queen Anne’s
County, Maryland (herein known as “Kent and Queen Anne’s area”) be
redesignated as attainment for the 8-hour ozone NAAQS.  The Kent and
Queen Anne’s- 8-hour ozone nonattainment area is comprised of two
counties (Kent and Queen Anne’s Counties, Maryland).  EPA is proposing
to approve the ozone redesignation request for the Kent and Queen
Anne’s area.  In conjunction with its redesignation request, the MDE
submitted a SIP revision consisting of a maintenance plan for Kent and
Queen Anne’s that provides for continued attainment of the 8-hour
ozone NAAQS for the next 12 years.  EPA is proposing to make a
determination that Kent and Queen Anne’s has attained the 8-hour ozone
NAAQS based upon three years of complete, quality-assured ambient air
quality ozone monitoring data for 2003-2005.  EPA’s proposed approval
of the 8-hour ozone redesignation request is based on its determination
that Kent and Queen Anne’s has met the criteria for redesignation to
attainment specified in the Clean Air Act (CAA).  EPA is providing
information on the status of its adequacy determination for the motor
vehicle emission budgets (MVEBs) that are identified in the Kent and
Queen Anne’s maintenance plan for purposes of transportation
conformity, and is also proposing to approve those MVEBs.  EPA is
proposing approval of the redesignation request and of the maintenance
plan revision to the Maryland SIP in accordance with the requirements of
the CAA.

DATES:  Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2006-0353 by one of the following methods:

A.  	Federal eRulemaking Portal:      HYPERLINK
"http://www.regulations.gov"  www.regulations.gov .  Follow the on-line
instructions for submitting comments.

B.	E-mail:   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
C.  	Mail:  EPA-R03-OAR-2006-0353, Makeba Morris, Chief, Air Quality
Planning Branch, D. 	Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street,

Philadelphia, Pennsylvania 19103.

Hand Delivery: At the previously-listed EPA Region III address.  Such
deliveries are

only accepted during the Docket’s normal hours of operation, and
special arrangements should be made for deliveries of boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2006-0353.  EPA's policy is that all comments received will
be included in the public docket without change, and may be made
available online at     HYPERLINK "http://www.regulations.gov"
www.regulations.gov , including any personal information provided,
unless the comment includes information claimed to be Confidential
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HYPERLINK "http://www.regulations.gov"  www.regulations.gov  website 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     HYPERLINK "http://www.regulations.gov"
www.regulations.gov , your e-mail address will be automatically captured
and included as part of the comment that is placed in the public 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.

Docket:  All documents in the electronic docket are listed in the
HYPERLINK "http://www.regulations.gov"  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     HYPERLINK "http://www.regulations.gov"
www.regulations.gov  or in hard copy during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.  Copies of the
State submittal are available at the Maryland Department of Environment,
1800 Washington Boulevard, Maryland, 21230.

FOR FURTHER INFORMATION CONTACT:  Helene Drago,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Throughout this document whenever “we”, “us”, or “our” is
used, we mean EPA.

TABLE OF CONTENTS

I.   	What Actions are EPA Proposing to Take?

II.   	What is the Background for These Proposed Actions?

III.  	What are the Criteria for Redesignation to Attainment?

IV.  	Why is EPA Taking These Actions?

V.  	What Would be the Effect of these Actions?

VI.  	What is EPA’s Analysis of the State’s Request?

VII.  	Are the Motor Vehicle Emissions Budgets Established and
Identified in the Kent and Queen Anne’s Maintenance Plan Adequate and
Approvable?

VIII.  	Proposed Action

Statutory and Executive Order Reviews

I.  What Actions are EPA Proposing to Take?

On May 2 and 19, 2006, MDE formally submitted a request to redesignate
Kent and Queen Anne’s from nonattainment to attainment of the 8-hour
NAAQS for ozone.  On May 2, 2006, Maryland submitted a maintenance plan
for Kent and Queen Anne’s as a SIP revision, to ensure continued
attainment over the next 12 years.  Kent and Queen Anne’s is currently
designated as a marginal 8-hour ozone nonattainment area.  EPA is
proposing to determine that Kent and Queen Anne’s has attained the
8-hour ozone NAAQS and that it has met the requirements for
redesignation pursuant to section 107(d)(3)(E) of the CAA.  EPA is,
therefore, proposing to approve the redesignation request to change the
designation of Kent and Queen Anne’s from nonattainment to attainment
for the 8-hour ozone NAAQS.  EPA is also proposing to approve the
maintenance plan SIP revision for Kent and Queen Anne’s, such approval
being one of the CAA requirements for approval of a redesignation
request.  The maintenance plan is designed to ensure continued
attainment throughout the Kent and Queen Anne’s area for the next 12
years.  Additionally, EPA is announcing its action on the adequacy
process for the MVEBs identified in the Kent and Queen Anne’s
maintenance plan, and proposing to approve the MVEBs identified for
volatile organic compounds (VOC) and nitrogen oxides (NOx) for
transportation conformity purposes.  These MVEBs are state MVEBs for the
Kent and Queen Anne’s 8-hour ozone area.  Concurrently, the State is
requesting that EPA approve the maintenance plan as meeting the
requirements of CAA 175A(b) with respect to the 1-hour ozone maintenance
plan update.

II. What is the Background for These Proposed Actions?

A.  General

Ground-level ozone is not emitted directly by sources.  Rather,
emissions of NOx and VOC react in the presence of sunlight to form
ground-level ozone.  The air pollutants NOx and VOC are referred to as
precursors of ozone.  The CAA establishes a process for air quality
management through the attainment and maintenance of 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.  EPA designated, as nonattainment,
any area violating the 8-hour ozone NAAQS based on the air quality data
for the three years of 2001-2003.  These were the most recent three
years of data at the time EPA designated 8-hour areas.  The Kent and
Queen Anne’s area was designated as marginal 8-hour ozone
nonattainment status in a Federal Register notice signed on September
15, 2004 and published on September 22, 2004 (69 FR 56697).  On October
21, 2004 (69 FR 61766), EPA approved a redesignation request and
maintanence plan for Kent and Queen Anne’s for the 1-hour ozone NAAQS.
 On June 15, 2005 (69 FR 23951, 23996), the 1-hour ozone NAAQS was
revoked in the Kent and Queen Anne’s area (as well as most other areas
of the country).  See 40 CFR 50.9(b); 69 FR 23996 (April 30, 2004); and
see 70 FR 44470 (August 3, 2005).

The CAA, Title I, Part D, contains two sets of provisions – subpart 1
and subpart 2– that address planning and control requirements for
nonattainment areas.  Subpart 1 (which 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 EPA refers to as “classified”
nonattainment) provides more specific requirements for ozone
nonattainment areas.  Some 8-hour ozone nonattainment areas are subject
only to the provisions of subpart 1.  Other areas are also subject to
the provisions of subpart 2.  Under EPA’s 8-hour ozone implementation
rule, signed on April 15, 2004, an area was classified under subpart 2
based on its 8-hour ozone design value (i.e., the 3-year average annual
fourth-highest daily maximum 8-hour average ozone concentration), if it
had a 1-hour design value at or above 0.121 ppm (the lowest 1-hour
design value in the CAA for subpart 2 requirements).  All other areas
are covered under subpart 1, based upon their 8-hour design values.  In
2004, the Kent and Queen Anne’s area was classifed a marginal 8-hour
ozone nonattainment area based upon air quality monitoring data from
2001-2003, and is subject to the requirements of subpart 2.

Under 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 data completeness
requirements.  The data completeness requirements are 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 40 CFR part 50.  The ozone
monitoring data indicates that the Kent and Queen Anne’s area has a
design value of 0.082 ppm for the 3-year period of 2003-2005, using
complete, quality assured data. Therefore, the ambient ozone data for
the Kent and Queen Anne’s area indicates no violations of the 8-hour
ozone standard.  Final monitoring data for 2005 indicates continued
attainment of the 8-hour ozone standard in the Kent and Queen Anne’s
area.

B.  The Kent and Queen Anne’s Area

The Kent and Queen Anne’s area consists of Kent and Queen Anne’s
Counties, Maryland.  Prior to its designation as an 8-hour ozone
nonattainment area, the Kent and Queen Anne’s area was a maintenance
area for the 1-hour ozone nonattainment NAAQS.

On May 2 and 19, 2006, the MDE requested that the Kent and Queen
Anne’s area be redesignated to attainment for the 8-hour ozone
standard.  The redesignation request referenced 3 years of complete,
quality-assured data for the period of 2003-2005, indicating that the
8-hour NAAQS for ozone had been achieved in Kent and Queen Anne’s.
The data satisfies the CAA requirements when the 3-year average of the
annual fourth-highest daily maximum 8-hour average ozone concentration
(commonly referred to as the area’s design value) is less than or
equal to 0.08 ppm (i.e., 0.084 ppm when rounding is considered).  Under
the CAA, a nonattainment area may be redesignated if sufficient
complete, quality-assured data is available to determine that the area
has attained the standard and the area meets the other CAA redesignation
requirements set forth in section 107(d)(3)(E).

III. What are the Criteria for Redesignation to Attainment?

The CAA provides the requirements for redesignating a nonattainment area
to attainment.  Specifically, section 107(d)(3)(E) of the CAA, allows
for redesignation, providing that:

(1) EPA determines that the area has attained the applicable NAAQS;

(2) EPA has fully approved the applicable implementation plan for the
area under section 110(k); (3) EPA 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) EPA 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:

“Ozone and Carbon Monoxide Design Value Calculations”, Memorandum
from Bill   Laxton, June 18, 1990;

“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;

“Contingency Measures for Ozone and Carbon Monoxide (CO)
Redesignations,” Memorandum from G. T. Helms, Chief, Ozone/Carbon
Monoxide Programs Branch, June 1, 1992;

“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 (Act) Deadlines,” Memorandum from John Calcagni
Director, Air Quality Management Division, October 28, 1992;

“Technical Support Documents (TSD’s) for Redesignation Ozone and
Carbon Monoxide (CO) Nonattainment Areas,” Memorandum from G.T. Helms,
Chief, Ozone/Carbon Monoxide Programs Branch, August 17, 1993;

“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;

Memorandum from D. Kent Berry, Acting Director, Air Quality Management
Division, to Air Division Directors, Regions 1-10, “Use of Actual
Emissions in Maintenance Demonstrations for Ozone and CO Nonattainment
Areas,” dated November 30, 1993;

“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

“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 May 2 and 19, 2006, the MDE requested redesignation of the Kent and
Queen Anne’s area to attainment for the 8-hour ozone standard.  On May
2, 2006, the MDE submitted a maintenance plan for the Kent and Queen
Anne’s area as a SIP revision, to assure continued attainment of the
8-hour ozone NAAQS over the next 12 years, until 2018.  Concurrently,
Maryland is requesting that EPA approve a revision to the 1-hour ozone
maintenance plan as required under CAA 175A(b).  EPA is proposing to
approve the maintenance plan to fulfill the requirement of section
175A(b) for submission of a maintenance plan update eight years after
Kent and Queen Anne’s was redesignated to attainment of the 1-hour
ozone NAAQS.  EPA believes that such an update must ensure that the
maintenance plan in the SIP provides maintenance of the NAAQS for a
period of 20 years after an area is initially redesignated to
attainment.  EPA can propose approval because the maintenance plan,
which demonstrates maintenance of the 8-hour ozone NAAQS through 2018,
also demonstrates maintenance of the 1-hour ozone NAAQS through 2018,
even though the latter standard is no longer in effect.  Kent and Queen
Anne’s was redesignated to attainment of the 1-hour ozone NAAQS on
October 21, 2004 (69 FR 61766), and, the initial 1-hour ozone
maintenance plan provided for maintenance through the end of the
maintanence period.   Section 51.905(e) of the “Final Rule To
Implement the 8-Hour Requirements - Phase 1" April 30, 2004 (69 FR
23999) specifies the conditions that must be satisfied before EPA may
approve a modification to a 1-hour maintenance plan which: (1) removes
the obligation to submit a maintenance plan for the 1-hour ozone NAAQS
eight years after approval of the initial 1-hour maintenance plan and/or
(2) removes the obligation to implement contingency measures upon a
violation of the 1-hour NAAQS.  EPA believes that section 51.905(e) of
the final rule allows a State to make either one or both of these
modifications to a 1-hour maintenance plan SIP once EPA approves a
maintenance plan for the 8-hour NAAQS.  The maintenance plan will not
trigger the contingency plan upon a violation of the 1-hour ozone NAAQS,
but upon a violation of the 8-hour ozone NAAQS.  EPA believes that the
8-hour standard is now the proper standard which should trigger the
contingency plan now that the 1-hour NAAQS has been revoked and now that
approval of the maintenance plan would allow the State to remove a
violation of the 1-hour NAAQS obligation from the SIP.  EPA has
determined that the Kent and Queen Anne’s area has attained the
standard and has met the requirements for redesignation set forth in
section 107(d)(3)(E).

V. What Would be the Effect of These Actions?

Approval of the redesignation request would change the designation of
Kent and Queen Anne’s from nonattainment to attainment for the 8-hour
ozone NAAQS found at 40 CFR part 81.  It would also incorporate into the
Maryland SIP a maintenance plan ensuring continued attainment of the
8-hour ozone NAAQS in Kent and Queen Anne’s for the next 12 years,
until 2018.  The maintenance plan includes contingency measures to
remedy any future violations of the 8-hour NAAQS (should they occur),
and identifies the MVEBs for NOx and VOC for transportation conformity
purposes for the years 2009 and 2018.  These MVEBs are displayed in the
following table:

Table 1: Motor Vehicle Emissions Budgets in Tons per Day (tpd)

Year	NOx	VOC

2009	5.11	2.72

2018	2.38	1.62

VI. What is EPA’s Analysis of the State’s Request?

EPA is proposing to determine that the Kent and Queen Anne’s area has
attained the 8-hour ozone standard and that all other redesignation
criteria have been met.  The following is a description of how the
MDE’s May 2 and 19, 2006 submittals satisfy the requirements of
section 107(d)(3)(E) of the CAA.

A.  The Kent and Queen Anne’s Area Has Attained the 8-Hour Ozone NAAQS

EPA is proposing to determine that the Kent and Queen Anne’s 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 the area, over each year
must not exceed the ozone standard of 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 Air Quality Subsystem (AQS).  The monitors generally
should have remained at the same location for the duration of the
monitoring period required for demonstrating attainment.

In the Kent and Queen Anne’s area there is one ozone monitor, located
in Kent County, that measures air quality with respect to ozone.  As
part of its redesignation request, Maryland referenced ozone monitoring
data for the years 2003-2005 for the Kent and Queen Anne’s area.  This
data has been quality assured and is recorded in AIRS.  The fourth high
8-hour daily maximum concentrations, along with the three-year averages,
are summarized in Table 2.

Table 2: Kent and Queen Anne’s Counties Nonattainment Area Fourth
Highest 8-hour Average Values; Millington Monitor.

Year	Annual 4th High Reading (ppm)

2003	0.086

2004	0.078

2005	0.084

The average for the 3-year period 2003 through 2005 is 0.082 ppm

The air quality data for 2003-2005 show that the entire Kent and Queen
Anne’s area has attained the standard with a design value of 0.082
ppm.  The data collected at the Kent and Queen Anne’s area monitors
satisfy the CAA requirement that 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 MDE’s request for redesignation for
Kent and Queen Anne’s indicates that the data is complete and was
quality assured in accordance with 40 CFR part 58.  The MDE uses AQS as
the permanent database to maintain its data and quality assures the data
transfers and content for accuracy.  In addition, as discussed below
with respect to the maintenance plan, MDE has committed to continue
monitoring in accordance with 40 CFR part 58.  In summary, EPA has
determined that the data referenced by Maryland and data taken from AQS
indicates that the Kent and Queen Anne’s area has attained the 8-hour
ozone NAAQS.

B.  The Kent and Queen Anne’s Area Has Met All Applicable Requirements
Under Section 110 and Part D of the CAA and Has a Fully Approved SIP
Under Section 110(k) of the CAA

EPA has determined that the Kent and Queen Anne’s area has met all SIP
requirements applicable for purposes of this redesignation under section
110 of the CAA (General SIP Requirements) and that it meets all
applicable SIP requirements under Part D of Title I of the CAA, in
accordance with section 107(d)(3)(E)(v).  In addition, EPA has
determined that the SIP is fully approved with respect to all
requirements applicable for purposes of redesignation in accordance with
section 107(d)(3)(E)(ii).  In making these proposed determinations, EPA
ascertained what requirements are applicable to the Kent and Queen
Anne’s area, and determined that the applicable portions of the SIP
meeting these requirements are fully approved under section 110(k) of
the CAA.  We note that SIPs must be fully approved only with respect to
applicable requirements.

The September 4, 1992 Calcagni memorandum (“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) with respect to
the timing of applicable requirements.  Under this interpretation, to
qualify for redesignation, states requesting redesignation to attainment
must meet only the relevant CAA requirements that came 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).  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.
Section 175A(c) of the CAA.  Sierra Club v. EPA, 375 F.3d 537 (7th Cir.
2004).  See also 68 FR at 25424, 25427 (May 12, 2003) (redesignation of
St. Louis).

1.  Section 110 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.
The general SIP elements and requirements set forth in section 110(a)(2)
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 requirement (Prevention of Significant
Deterioration (PSD);

Provisions for the implementation of Part D requirements for 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.

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 transport of
air pollutants in accordance with the NOx SIP Call, October 27, 1998 (63
FR 57356), amendments to the NOx SIP Call, May 14, 1999 (64 FR 26298)
and March 2, 2000 (65 FR 11222), and the Clean Air Interstate Rule
(CAIR), May 12, 2005 (70 FR 25162).  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 classifications 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 these 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.  Maryland will still be subject to these requirements
after the Kent and Queen Anne’s 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 policy is consistent with
EPA’s existing policy on applicability of conformity (i.e., for
redesignations) and oxygenated fuels requirement.  See Reading,
Pennsylvania, proposed and final rulemakings 61 FR 53174-53176 (October
10, 1996), 62 FR 24826 (May 7, 1997); Cleveland-Akron-Lorain, Ohio,
final rulemaking 61 FR 20458 (May 7, 1996); and Tampa, Florida, final
rulemaking 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 53099 (October 19, 2001).
Similarly, with respect to the NOx SIP Call rules, EPA noted in its
Phase 1 Final Rule to Implement the 8-hour Ozone NAAQS, that the NOx SIP
Call rules are not “an ‘applicable requirement’ for purposes of
section 110(l) because the NOx rules apply regardless of an area’s
attainment or nonattainment status for the 8-hour (or the 1-hour)
NAAQS.” 69 FR 23951, 23983 (April 30, 2004).

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, because, as we
explain later in this notice, no Part D requirements applicable for
purposes of redesignation under the 8-hour standard became due prior to
submission of the redesignation request.

Because the Maryland SIP satisfy all of the applicable general SIP
elements and requirements set forth in section 110(a)(2), EPA concludes
that Maryland has satisfied the criterion of section 107(d)(3)(E)
regarding section 110 of the Act.

2.  Part D Nonattainment Area Requirements Under the 8-Hour Standard

The Kent and Queen Anne’s area was designated a marginal nonattainment
area for the 8-hour ozone standard.  Sections 172-176 of the CAA, found
in subpart 1 of Part D, set forth the basic nonattainment requirements
for all nonattainment areas.  As discussed previously, there are no
outstanding Part D submittals under the 1-hour standard for this area.

Section 182 of the CAA, found in subpart 2 of Part D, establishes
additional specific requirements depending on the area’s nonattainment
classification.  The Kent and Queen Anne’s area is classified as a
subpart 2 marginal nonattainment area

With respect to the 8-hour standard, EPA proposes to determine that the
Maryland SIP meets all applicable SIP requirements under Part D of the
CAA, because no 8-hour ozone standard Part D requirements applicable for
purposes of redesignation became due prior to submission of the area’s
redesignation request.  Because the State submitted a complete
redesignation request for Kent and Queen Anne’s prior to the deadline
for any submissions required under the 8-hour standard, we have
determined that the Part D requirements do not apply to Kent and Queen
Anne’s for the purposes of redesignation.

In addition to the fact that Part D requirements applicable for purposes
of redesignation did not become due prior to submission of the
redesignation request, EPA believes it is reasonable to interpret the
general conformity and NSR requirements as not requiring approval prior
to redesignation.

With respect to 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 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 relating to consultation, enforcement and enforceability
that the CAA required the EPA to promulgate.

EPA believes it is reasonable to interpret the conformity SIP
requirements as not applying for purposes of evaluating the
redesignation request under section 107(d) since 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, 438-440 (6th Cir. 2001), upholding this interpretation.  See
also 60 FR 62748 (Dec. 7, 1995).

EPA has also interpreted the section 184 Ozone Transport Region
requirements, including the NSR program, as not being applicable for
purposes of redesignation.  The rationale for this is based on two
factors.  First, the requirement to submit SIP revisions for the section
184 requirements continues to apply to areas in the OTR after
redesignation to attainment.  Therefore the State remains obligated to
have NSR, as well as RACT and Vehicle Inspection and Maintenance
programs even after redesignation.  Second, the section 184 control
measures are region-wide requirements and do not apply to the area by
virtue of its designation and classification.   See 61 FR 53174,
53175-53176 (October 10, 1996) and 62 FR 24826, 24830-32 (May 7, 1997).

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, because 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 NSR Requirements
or Areas Requesting Redesignation to Attainment.”  Maryland has
demonstrated that the area will be able to maintain the standard without
Part D NSR in effect in Kent and Queen Anne’s, and therefore, Maryland
need not have a fully approved Part D NSR program prior to approval of
the redesignation request.  Maryland’s SIP-approved PSD program will
become effective in Kent and Queen Anne’s upon redesignation to
attainment.  See rulemakings for Detroit, Michigan (60 FR 12467-12468,
March 7, 1995); Cleveland-Akron-Lorrain, Ohio (61 FR 20458, 20469-70,
May 7, 1996); Louisville, Kentucky (66 FR 53665, October 23, 2001);
Grand Rapids, Michigan (61 FR 31834-31837, June 21, 1996).

3.  Kent and Queen Anne’s has a fully approved SIP for the purposes of
redesignation

EPA has fully approved the Maryland SIP for the purposes of this
redesignation.  EPA may rely on prior SIP approvals in approving a
redesignation request.  Calcagni Memo, 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 25425
(May 12, 2003) and citations therein.  The Kent and Queen Anne’s area
was a 1-hour maintenance area at the time of its designation as a
marginal 8-hour ozone nonattainment area on September 22, 2004.  Because
Kent and Queen Anne’s was a 1-hour maintenance area, all previous Part
D SIP submittal requirements were fulfilled at the time the area was
redesignated to attainment of the 1-hour ozone NAAQS (69 FR 61766,
October 21, 2004) or have been fulfilled with the submittal of the
8-hour maintenance plan for the area. Because there are no outstanding
SIP submission requirements applicable for the purposes of redesignation
of Kent and Queen Anne’s, the applicable implementation plan satisfies
all pertinent SIP requirements.  As indicated previously, EPA believes
that the section 110 elements not connected with Part D nonattainment
plan submissions and not linked to the area’s nonattainment status are
not applicable requirements for purposes of redesignation.  EPA also
believes that no 8-hour Part D requirements applicable for purposes of
redesignation have yet become due for the Kent and Queen Anne’s area,
and therefore they need not be approved into the SIP prior to
redesignation.

4.  The Air Quality Improvement in the Kent and Queen Anne’s 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 Kent and Queen Anne’s area is due to
permanent and enforceable reductions in emissions resulting from
implementation of the SIP, Federal measures, and other state-adopted
measures.  Emissions reductions attributable to these rules in Kent and
Queen Anne’s are shown in Table 3.

Table 3: Total VOC and NOx Emissions for 2002 and 2005 (tpd)

Volatile Organic Compounds (VOC)

Year	Point	Area *	Nonroad	Mobile	Total

Year 2002	0.12	5.12	11.0	4.18	20.4

Year 2005	0.12	5.31	10.0	3.15	18.6

Diff. (02-05)	0.0	+0.19	-1.00	-1.03	-1.84

Nitrogen Oxides (NOx)

Year	Point	Area *	Nonroad	Mobile	Total

Year 2002	0.07	0.23	3.74	7.96	12.0

Year 2005	0.07	0.25	3.77	6.57	10.7

Diff. (02-05)	0.0	+0.02	+0.03	-1.39	-1.34

Between 2002 and 2005, VOC emissions were reduced by 1.84 tpd, and NOx
emissions were reduced by 1.34 tpd, due to the following permanent and
enforceable measures implemented or in the process of being implemented
in the Kent and Queen Anne’s area.

Nearly all of the reductions in VOC are attributable to mobile onroad
and nonroad source emission controls and all of the reductions in NOx
are attributable to the implementation of mobile source programs.
Maryland noted a major portion of the decrease in ozone precursors was
due to the Federal Motor Vehicle Control Program.  Over a period of
time, older, poorer performing on-road vehicles have been gradually
replaced with newer vehicles that must meet increasingly stringent
tailpipe standards.

Other regulations, such as the non-road diesel, 69 FR 38958 (June 29,
2004), the heavy duty engine and vehicle standards, 66 FR 5002 (January
18, 2001) and the new Tier 2 tailpipe standards for automobiles, 65 FR
6698 (February 10, 2000), are also expected to greatly reduce emissions
throughout the country and thereby reduce emissions impacting the Kent
and Queen Anne’s area monitor.  The Tier 2 standards came into effect
in 2004, and by 2030, EPA expects that the new Tier 2 standards will
reduce NOx emissions by about 74 percent nationally.  EPA believes that
permanent and enforceable emissions reductions are the cause of the
long-term improvement in ozone levels and are the cause of the area
achieving attainment of the 8-hour ozone standard.

There is very little major point source activity in the Kent and Queen
Anne’s Counties area and thus point source emissions are very low.
Growth in point sources will be controlled through the offset
requirements under the PSD permitting program.  Any major source that
wishes to locate in Kent or Queen Anne’s Counties will need to procure
emissions offsets at a ratio of 1.15 to 1 for NOx and VOC.   In addition
to emission reductions in the Kent and Queen Anne’s Counties,
background concentrations of ozone in the area will decrease as a result
of the many ozone precursor reduction strategies implemented in the
Baltimore and Washington DC severe 8-hour ozone nonattainment areas.
Long range transport of NOx will also be reduced the NOx SIP Call Rule
and Clean Air Interstate Rule.

5.  Kent and Queen Anne’s has a fully approved maintenance plan
pursuant to section 175A of the CAA

In conjunction with its request to redesignate the Kent and Queen
Anne’s area to attainment status, Maryland submitted a SIP revision to
provide for maintenance of the 8-hour ozone NAAQS in Kent and Queen
Anne’s for at least 12 years after redesignation.  Maryland is
requesting that EPA approve this SIP revision as meeting the requirement
of CAA 175A(b) and replace the 1-hour ozone maintenance plan update
requirement.

Under 40 CFR 51.905(e), the EPA may approve a SIP revision requesting
the removal of the obligation to implement contingency measures upon a
violation of the 1-hour ozone NAAQS when the State submits and EPA
approves an attainment demonstration for the 8-hour ozone NAAQS for an
area initially designated nonattainment for the 8-hour NAAQS or a
maintenance SIP for the 8-hour NAAQS for an area initially designated
attainment for the 8-hour NAAQS.  The rationale behind 40 CFR 51.905(e)
is to ensure that the Kent and Queen Anne’s area maintains the
applicable ozone standard (the 8-hour standard in areas where the 1-hour
standard has been revoked).  EPA believes this rationale analogously
applies to areas that were not initially designated, but are
redesignated as attainment with the 8-hour ozone NAAQS.  Therefore, EPA
intends to treat redesignated areas as though they had been initially
designated attainment of the 8-hour ozone NAAQS, and accordingly
proposes to relieve the Kent and Queen Anne’s area of its maintenance
plan obligations with respect to the 1-hour standard.  Once approved,
the maintenance plan for the 8-hour ozone NAAQS will ensure that the SIP
for the Kent and Queen Anne’s area meets the requirements of the CAA
regarding maintenance of the applicable 8-hour ozone standard.

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 approval of a redesignation
of an area to attainment.  Eight years after the redesignation, the
State must submit a revised maintenance plan demonstrating that
attainment will continue to be maintained for the next 10-year period
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 the following provisions:

(a) an attainment emissions inventory;

(b) a maintenance demonstration;

(c) a monitoring network;

(d) verification of continued attainment; and

(e) a contingency plan.

Analysis of the Kent and Queen Anne’s Area Maintenance Plan

(a)  Attainment Inventory – the attainment inventory includes the
emissions during the time period associated with the monitoring data
showing attainment.  MDE determined that the appropriate attainment
inventory year is 2005.  That year establishes a reasonable year within
the three-year block of 2003-2005 as a baseline and accounts for
reductions attributable to implementation of the CAA requirements to
date.  The 2005 inventory is consistent with EPA guidance, is based on
actual (typical summer day( emissions of VOC, NOx, and Carbon Monoxide
(CO) during 2004, and consists of a list of sources and their associated
emissions.   To develop the NOx and VOC base year emissions inventories,
MDE used the approaches outlined in the document titled “Inventory
Preparation Plan/ Quality Assurance Plan for Maryland.”  The 2005
point source data was “grown” using the 2002 base year inventory.
MDE projected the 2002 base year inventory using EPA’s EGAS Model
(version 5.0) for all inventory years.  EGAS (version 5.0) generates
emission growth factors by sector.  The 2005 area source data was
projected using a variety of methods including the EGAS model (version
5.0) and forecasts prepared by the Baltimore Metropolitan Council.  The
nonroad inventory was developed using NONROAD model (version 2004).  The
on road mobile source inventory was generated using the HPMS module of
the PPSuite software.  MDE used MOBILE model (version 6.2) to assess the
mobile source emission levels in the counties and estimate the benefits
gained from mobile control measures.  This estimate assumes the
following emissions control programs, which are or will be permanent and
enforceable: Federal Motor Vehicle Control Program, the 1992 Reid Vapor
Pressure Program, Tier 1 and 2 controls on new vehicles, Evaporative
Emissions Control Program, Federal Reformulated Gasoline Program,
Enhanced I/M Program in Queen Anne's County, Stage I Vapor Recovery, On
Board Controls and National Low Emissions Vehicle (NLEV) Program,
federal HDDE rule and low sulfur fuels regulations.

(b)  Maintenance Demonstration - On May 2 and 19, 2006, MDE submitted a
maintenance plan as required by section 175A of the CAA.  The Kent and
Queen Anne’s plan shows maintenance of the 8-hour ozone NAAQS by
demonstrating that current and future emissions of VOC and NOx remain at
or below the attainment year 2005 emissions levels throughout Kent and
Queen Anne’s through the year 2018.  The Kent and Queen Anne’s
maintenance demonstration need not be based on modeling.  See Wall v.
EPA, 265 F.3d 426 (6th Cir. 2001); Sierra Club v. EPA, 375 F.3d 537 (7th
Cir. 2004).  See also 66 FR 53094, 53099-53100 (October 19, 2001), 68 FR
25418, 25430-32 (May 12, 2003).

Tables 4 and 5 specify the Kent and Queen Anne’s VOC and NOx emissions
for 2005, 2009, and 2018.  The MDE chose 2009 as an interim year in the
12-year maintenance demonstration period to demonstrate that the VOC and
NOx emissions are not projected to increase above the 2005 attainment
level during the time of the 12-year maintenance period.

Table 4: Total VOC Emissions for 2005-2018 (tons per day)

Source Category 	2005 VOC Emissions      	2009 VOC Emissions	2018 VOC
Emissions

Mobile	3.15	2.45	1.55

Nonroad	10.00	8.25	5.96

Area	5.31	5.54	5.17

Point	0.12	0.13	0.16

Total 	18.58	16.37	12.84

2018 VOC Safety Margin:  5.74 tpd

Table 5: Total NOx Emissions 2005-2018 (tons per day)

Source Category 	2005 NOx Emissions      	2009 NOx Emissions	2018 NOx
Emissions

Mobile	6.57	4.82	2.14

Nonroad	3.77	3.66	3.03

Area	0.25	0.26	0.28

Point	0.07	0.07	0.08

Total 	10.66	8.81	5.53

 2018 NOx Safety Margin:  5.13 tpd

Additionally, the following mobile programs are either effective or due
to become effective and will further contribute to the maintenance
demonstration of the 8-hour ozone NAAQS:

Heavy duty diesel on-road (2004/2007) and low-sulfur on-road (2006); 66
FR 5002 (January 18, 2001); and

Non-road emissions standards (2008) and off-road diesel fuel
(2007/2010); 69 FR 39858 (June 29, 2004).

Based upon the comparison of the projected emissions and the attainment
year emissions along with the additional measures, EPA concludes that
MDE has successfully demonstrated that the 8-hour ozone standard should
be maintained in the Kent and Queen Anne’s area.

(c)  Monitoring Network - There is currently one monitor, the Millington
monitor, measuring ozone in the Kent and Queen Anne’s area, which is
located in Kent County.  Maryland will continue to operate its current
air quality monitor in accordance with 40 CFR part 58.

Verification of Continued Attainment - The State of Maryland has the
legal authority to implement and enforce specified measures necessary to
attain and maintain the NAAQS.  Additionally, Federal programs such as
Tier 2/Low Sulfur Gasoline Rule, 2007 On-Road Diesel Engine Rule, and
Federal Non-road Engine/Equipment Rules will continue to be implemented
on a national level.  These programs help provide the reductions
necessary for the Kent and Queen Anne’s- area to maintain attainment.

In addition to maintaining the key elements of its regulatory program,
Maryland requires ambient and source emissions data to track attainment
and maintenance.  The MDE proposes to fully update its point, area, and
mobile emission inventories at 3-year intervals as required by the
Consolidated Emissions Reporting Rule (CERR) and Section 187(a)(5) of
the CAA.  MDE will compare actual inventories to projected inventories,
to determine if emission levels exceed the attainment year levels.  If
there is an attainment year inventory excursion, MDE will assess the
need to trigger contingency measures implementation procedures.   In
addition,  MDE shall also continue to operate the existing ozone
monitoring station in the area pursuant to 40 CFR part 58 throughout the
maintenance period and submit quality-assured ozone data to EPA through
the AIRS system.

 (e) The Maintenance Plan’s Contingency Measures - The contingency
plan provisions are designed to promptly correct a violation of the
NAAQS that occurs after redesignation.  Section 175A of the Act requires
that a maintenance plan include such contingency measures as EPA deems
necessary to ensure that the State will promptly correct a violation of
the NAAQS that occurs after redesignation.  The maintenance plan should
identify the events that would “trigger” the adoption and
implementation of a contingency measure(s), the contingency measure(s)
that would be adopted and implemented, and the schedule indicating the
time frame by which the State would adopt and implement the measure(s).

The ability of the Kent and Queen Anne’s area to stay in compliance
with the 8-hour ozone standard after redesignation depends upon VOC and
NOx emissions in the area remaining at or below 2005 levels.  The
State’s maintenance plan projects VOC and NOx emissions to decrease
and stay below 2005 levels through the year 2018.  The State’s
maintenance plan outlines the procedures for the adoption and
implementation of  contingency measures to further reduce emissions
should a violation occur. They are as follows:

After the 4th exceedance of the 8-hour ozone NAAQS (0.08ppm) occurs
within any given calendar year, the MDE will consider that fourth
exceedance and any subsequent exceedance as

the trigger by which an immediate recalculation of the design value for
the Millington Monitor

would be required. If the recalculated design value is shown to be above
the 8-hour NAAQS

(0.08ppm) then Maryland would initiate the following schedule:

1) Within 2 weeks of the “trigger”- MDE will notify Kent and Queen
Anne’s Counties

and other stakeholders of the violations and will schedule an initial
work group

meeting concerning contingency measures.

2) Within 6 weeks of the “trigger” - MDE will convene a stakeholder
group to evaluate

the selection and implementation of the contingency measures. The
stakeholder group

will be composed of interested state and local government agencies;
business,

environmental and health representatives; citizens and other interested
parties

3) Within 12 weeks of the “trigger”- A public meeting will be held
on the proposed

contingency measures

4) Within 18 weeks of the “trigger”- MDE/ Stakeholders will meet to
consider public

comments and finalize a list of planned contingency measures

5) After the list of planning of measures is finalized as identified
above in step 4 it will

take approximately 12 months from that date to go through any required
rulemaking

processes.

6) Within 24 months of the “trigger” - Agreed-upon contingency
measures will be

implemented in the impacted counties

The following measures may be considered contingency measures:

Industrial Commercial Institutional (ICI) Boiler RACT

Commuter/traffic measures such as Potential expansion of park and ride
lots, expanded transit services, enhance opportunities for
telecommuting/flexible hours/ compressed work schedules

Expand Air Quality Action Day activities such as put off any painting
until later; don’t use aerosol consumer products; avoid mowing lawns
with gasoline-powered mowers;  start charcoal with an electric or
chimney-type fire starter instead of lighter fluid; take public
transportation; try telecommuting

Clean Air Partners public education outreach

Expansion of E-government services at state and county level

Bicycle and pedestrian enhancements such as additional trails and bike
lanes

Emissions testing for truck transport

Land use/transportation policies

Promote non-motorized transport

Promote tree planting standards that favor trees with low VOC biogenic
emissions

Promote energy saving plan for county government

Gas can and lawnmower replacement

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.  EPA believes that the maintenance plan SIP revision
submitted by Maryland for Kent and Queen Anne’s meets the requirements
of section 175A of the Act.

VII. Are the Motor Vehicle Emissions Budgets Established and Identified
in the Kent and Queen Anne’s Maintenance Plan Adequate and Approvable?

A.  What Are the Motor Vehicle Emissions Budgets (MVEBs)?

Under the CAA, States are required to submit, at various times, control
strategy SIPs and maintenance plans in ozone areas.  These control
strategy SIPs (i.e. RFP SIPs and attainment demonstration SIPs) and
maintenance plans identify and establish MVEBs for certain criteria
pollutants and/or their precursors to address pollution from on-road
mobile sources.  In the maintenance plan the MVEBs are termed “on-road
mobile source emissions budgets.”  Pursuant to 40 CFR part 93 and
51.112, MVEBs must be established in an ozone maintenance plan.  A MVEB
is the portion of the total allowable emissions that is allocated to
highway and transit vehicle use and emissions.  A 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 and revise the MVEBs in control strategy
SIPs and maintenance plans.

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 or reasonable progress towards
the national ambient air quality standards.  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 budget contained therein
“adequate” for

use in determining transportation conformity.  After 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 state implementation plan as required by section 176(c) of the CAA.
EPA’s substantive criteria for determining “adequacy” of a 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.

The MVEBs for Kent and Queen Anne’s are listed in Table 1 of this
document for the 2009, and 2018 years and are the projected emissions
for the on-road mobile sources plus any portion of the safety margin
allocated to the MVEBs (safety margin allocation for 2009 and 2018
only).  These emission budgets, when approved by EPA, must be used for
transportation conformity determinations.

B.  What Is a Safety Margin?

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.  The following example is for the 2018 safety margin:  Kent
and Queen Anne’s first attained the 8-hour ozone NAAQS during the 2003
to 2005 time period.  The State used 2005 as the year to determine
attainment levels of emissions for the Kent and Queen Anne’s area.
The total emissions from point, area, mobile on-road, and mobile
non-road sources in 2005 equaled 18.58 tpd of VOC and 10.66 tpd of NOx.
The MDE projected emissions out to the year 2018 and projected a total
of 12.84 tpd of VOC and 5.53 tpd of NOx from all sources in Kent and
Queen Anne’s.  The safety margin for 2018 would be the difference
between these amounts, or 5.74 tpd of VOC and 5.13 tpd of NOx.  The
emissions up to the level of the attainment year including the safety
margins are projected to maintain the area's air quality consistent with
the 8-hour ozone NAAQS.  The safety margin is the extra emissions
reduction below the attainment levels that can be allocated for
emissions by various sources as long as the total emission levels are
maintained at or below the attainment levels.  Table 6 shows the safety
margins for the 2009 and 2018 years.

Table 6:  2009 and 2018 Safety Margins for Kent and Queen Anne’s

Inventory Year	VOC Emissions (tpd)	NOx Emissions (tpd)

2005 Attainment	18.58	10.66

2009 Interim	16.37	8.81

2009 Safety Margin	2.21	1.85

2004 Attainment	18.58	10.66

2018 Final	12.84	5.53

2018 Safety Margin	5.74	5.13

Table 7:  2009 and 2018 Final MVEBs for Kent and Queen Anne’s

Inventory Year	VOC Emissions (tpd)	NOx Emissions (tpd)

2009 projected on-road mobile source projected emissions	2.45	4.82

2009 Safety Margin Allocated to MVEBs	0.27	0.29

2009 MVEBs	2.72	5.11

2018 projected on-road mobile source projected emissions	1.55	2.14

2018 Safety Margin Allocated to MVEBs	0.07	0.24

2018 MVEBs	1.62	2.38

The MDE allocated 0.29 tpd NOx and 0.27 tpd VOC to the 2009 interim VOC
projected on-road mobile source emissions projection and the 2009
interim NOx projected on-road mobile source emissions projection to
arrive at the 2009 MVEBs.  For the 2018 MVEBs the MDE allocated 0.24 tpd
NOx and 0.07 tpd VOC from the 2018 safety margins to arrive at the 2018
MVEBs.  Once allocated to the mobile source budgets these portions of
the safety margins are no longer available, and may no longer be
allocated to any other source category.  Table 7 shows the final 2009
and 2018 MVEBS for the Kent and Queen Anne’s area.

C.  Why Are the MVEBs Approvable?

The 2009 and 2018 MVEBs for Kent and Queen Anne’s are approvable
because the MVEBs for NOx and VOC, including the allocated safety
margins, continue to maintain the total emissions at or below the
attainment year inventory levels as required by the transportation
conformity regulations.

D.  What Is the Adequacy and Approval Process for the MVEBs in the Kent
and Queen Anne’s Maintenance Plan?

The MVEBs for the Kent and Queen Anne’s area maintenance plan are
being posted to EPA's conformity Web site concurrent with this proposal.
 The public comment period will end at the same time as the public
comment period for this proposed rule.  In this case, EPA is
concurrently processing the action on the maintenance plan and the
adequacy process for the MVEBs contained therein.  In this proposed
rule, EPA is proposing to find the MVEBs adequate and also proposing to
approve the MVEBs as part of the maintenance plan.  The MVEBs cannot be
used for transportation conformity until the maintenance plan update and
associated MVEBs are approved in a final Federal Register notice, or EPA
otherwise finds the budgets adequate in a separate action following the
comment period.

If EPA receives adverse written comments with respect to the proposed
approval of the Kent and Queen Anne’s area MVEBs, or any other aspect
of our proposed approval of this updated maintenance plan, we will
respond to the comments on the MVEBs in our final action or proceed with
the adequacy process as a separate action.  Our action on the Kent and
Queen Anne’s MVEBs will also be announced on EPA's conformity Web
site:    HYPERLINK "http://www.epa.gov/otaq/stateresources/index.html"
http://www.epa.gov/otaq/stateresources/index.html   (once there, click
on “Transportation Conformity”, then look for “Adequacy Review of
SIP Submissions”).

VIII.   Proposed Actions

EPA is proposing to determine that the Kent and Queen Anne’s area has
attained the 8-hour ozone NAAQS.  EPA is also proposing to approve the
redesignation of the Kent and Queen Anne’s area from nonattainment to
attainment for the 8-hour ozone NAAQS.  EPA has evaluated Maryland’s
redesignation request and 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
Kent and Queen Anne’s area has attained the 8-hour ozone standard.
The final approval of this redesignation request would change the
designation of Kent and Queen Anne’s from nonattainment to attainment
for the 8-hour ozone standard.  EPA is also proposing to approve the
associated maintenance plan for the Kent and Queen Anne’s area,
submitted on May 2 and 19, 2006, as a revision to the Maryland SIP.  EPA
is proposing to approve the maintenance plan for the Kent and Queen
Anne’s area because it meets the requirements of section 175A as
described previously in this notice.  EPA is also proposing to approve
the MVEBs submitted by the Maryland for Kent and Queen Anne’s area in
conjunction with its redesignation request.  EPA is soliciting public
comments on the issues discussed in this document.  These comments will
be considered before taking final action.

IX. Statutory and Executive Order Reviews

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed 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 Fed. Reg. 28355 (May 22, 2001)).  This action
merely proposes to approve state law as meeting Federal requirements and
imposes no additional requirements beyond those imposed by state law.
Redesignation of an area to attainment under section 107(d)(3)(e) of the
Clean Air Act 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.
Redesignation of an area to attainment under section 107(d)(3)(E) of the
Clean Air Act 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 proposed 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 proposes to approve 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 (Public Law 104-4).  This proposed
rule also does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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),
because it merely proposes to affect the status of a geographical area,
does not impose any new requirements on sources, or allow the 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 proposed rule also is not
subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because
it is not economically significant.

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.  Redesignation is an
action that affects the status of a geographical area and does not
impose any new requirements on sources.  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.  As required by section 3 of
Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this
proposed rule, EPA has taken the necessary steps to eliminate drafting
errors and ambiguity, minimize potential litigation, and provide a clear
legal standard for affected conduct.  EPA has complied with Executive
Order 12630 (53 FR 8859, March 15, 1988) by examining the takings
implications of the rule in accordance with the “Attorney General’s
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings” issued under the executive order.  This rule
proposing to approve the redesignation of the Kent and Queen Anne’s
area to attainment for the 8-hour ozone NAAQS, the associated
maintenance plan, and the MVEBs identified in the maintenance plan, does
not impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

This rule proposing to approve the redesignation of Kent and Queen
Anne’s to attainment for the 8-hour ozone NAAQS, the associated
maintenance plan, and the MVEBs identified in the maintenance plan, does
not impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects

40 CFR Part 52

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

40 CFR Part 81

Air pollution control, National Parks, Wilderness Areas.

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

							  /s/

___________________________         	____________________________

Dated:  September 28, 2006			William T. Wisniewski, Acting

						Regional Administrator,

						Region III.

  PAGE   4

  PAGE   9

  PAGE   29

  PAGE   42


appeared to be a target of cyprodinil, causing mild anemia in rats exposed subchronically
(reductions in hematocrit and hemoglobin and microcytosis).  Although increases in thyroid

Page 9 of 36
weight and/or hypertrophy of thyroid follicular cells were observed at higher doses in the rat 28-
day oral-toxicity studies (both feeding and oral gavage) and in the 90-day oral-toxicity study in
rats, treatment-related changes in thyroid weights or gross/microscopic observations were not
observed in the chronic rat study or in other studies (thyroid hormones were not evaluated in any
study).
No neurotoxicity studies have been submitted for cyprodinil.  However, the available
data do not indicate a need for neurotoxicological testing.  No clinical signs suggestive of
neurobehavioral alterations or evidence of neuropathological effects were observed in the
available oral-toxicity studies.  There was also no evidence of a neurodevelopmental effect in the
rat or rabbit developmental-toxicity studies or in the rat two-generation reproductive-toxicity
study.
Based on pharmacokinetic/metabolism studies in the rat biphasic first order kinetics were
noted for absorption and excretion of cyprodinil, with durations of 0.3-1.2 hours for the first
phase, and 27-65 hours for the second phase.  Excretion was rapid and almost complete, with
urine as the principle route of excretion (48-68%), and >90% of the administered dose detected
in the urine and feces within 48 hours.
There was no evidence of increased susceptibility in the developmental rat or rabbit study
following in utero exposure or in the two-generation reproduction study following pre- and post-
natal exposure.  Fetal toxicity, manifested as significantly lower fetal weights and an increased
incidence of delayed ossification in the rat and a slight increase in litters showing extra ribs
(13 ) in the rabbit, was reported in developmental toxicity studies.  In a rat two-generation
th
reproduction study, significantly lower pup weights for F and F offspring were observed.
1
2
However, each of these fetal/neonatal effects occurred at the same dose levels at which maternal
toxicity (decreased body weight gain) was observed and were considered to be secondary to
maternal toxicity.
Based on the results of the available toxicity studies, there is no evidence for
neurotoxicity or immunotoxicity.  However, in accordance with the revised 40 CFR Part 158
Toxicology Data Requirements, a Neurotoxicity Battery (870.6200a and b) and an
Immunotoxicity study (870.7800) are required (Appendix A and B).
The complete toxicity profile for cyprodinil is provided in Appendix 1.2, Tables 2 and 3.
3.2
FQPA Hazard Considerations
The toxicity database for cyprodinil is sufficient for a full hazard evaluation and is
considered adequate to evaluate risks to infants and children.  Acceptable developmental toxicity
studies in the rat and rabbit and acceptable multi- and single generation reproduction studies in
the rat have been submitted.
3.2.1
Developmental Toxicity

Page 10 of 36
<IP_ADDRESS> Rat Developmental Study
In a developmental toxicity study (MRID 43709033), cyprodinil technical (99.5%) was
administered in 3% aqueous corn starch suspension by oral gavage to 20-23 Tif:RAIf(SPF)
females albino rats per dose of 0, 20, 200 or 1000 mg/kg/day or gestation days 6-15.
Treatment related findings included reduced locomotor activity (one high dose female),
significantly lower mean body weight (16%), body weight gain (65%), gravid uterine weight
(18%), and mean carcass weight (10%), and significantly decreased food consumption (32-42%)
in high-dose females.  The LOAEL for maternal toxicity is 1000 mg/kg/day based on lower body
weight/body weight gain and reduced food consumption. The NOAEL was 200 mg/kg/day.
There were significantly lower mean fetal weights (11%) in the high-dose group
compared to controls as well as a significant increase in skeletal anomalies in the high-dose
group relative to the control, which was due to abnormal ossification (4/20 litters in the high
dose group compared to 0 in any other group), primarily as absent or reduced metacarpal 5
ossification.  The skeletal anomalies/variations were considered to be a transient developmental
delay that occurs secondary to the maternal toxicity noted in the high-dose group. The LOAEL
for developmental toxicity is 1000 mg/kg/day based on lower mean fetal weights and an
increased incidence of delayed ossification.  The NOAEL for developmental toxicity is 200
mg/kg/day.
<IP_ADDRESS>Rabbit Developmental Study
In a developmental toxicity study (MRID 43709032), cyprodinil technical (99.5%) was
administered in 3% aqueous corn starch suspension to 19 inseminated female rabbits (Russian
Chbb:HM, SPF)/dose by gavage at dose levels of 0, 5, 30, 150, or 400 mg/kg/day from days 7
through 19 of gestation. Mean maternal body weight gain (p <0.01) and food consumption (not
significant) decreased, mainly during the first week of treatment in the 400 mg/kg/day group.
Mean body weight gain was 622% less than controls (p <0.01) in this group between days 7 and
13 of gestation. The maternal LOAEL is 400 mg/kg/day, based on decreased body weight gain.
The maternal NOAEL is 150 mg/kg/day.
Fetuses at the 400 mg/kg/day dose exhibited indications of an increased incidence of a
13th rib (not significant). Although there were indications of developmental delays in fetal
skeletons, such as poor or absent ossification of the sternebrae and metacarpals at all dose levels,
only the extra rib is likely to be compound related. Uni- or bilateral hyperflexion of the carpal
joint at the 400 and 150 mg/kg/day doses (not significant) was not associated with the skeletal
changes. The fetal developmental LOAEL is 400 mg/kg/day based on a slight increase of litters
showing extra (13th) ribs. The fetal developmental NOAEL is 150 mg/kg/day.
3.2.2  Reproductive Toxicity
In a two-generation reproduction study (MRID No. 43709034), Tif:RAIf rats (30

Page 11 of 36
rats/sex/dose), with one litter per generation received cyprodinil (99.5 %) in the diet at doses of,
10, 100, 1000 or 4000 ppm (actual intake, males: 0, 0.7, 6.7, 68 or 273; females: 0, 0.8, 8.2, 81 or
326 mg/kg/day) for a 10 week pre-mating period.  Signs of toxicity at 4000 ppm consisted of
lower body weights (12.5%) in the F0 females after the pre-mating period. Increased liver weight
in 1000 (marginal) and 4000 ppm males and females was not supported by histopathological
findings.  Although these were considered treatment related, they were considered to be non-
adverse.  The LOAEL for maternal systemic toxicity is 4000 ppm (about 326 mg/kg/day) based
on lower body weights in the F0 females during the pre-mating period. The NOAEL for maternal
systemic toxicity was 1000 ppm (about 81 mg/kg/day).  Reviewers determined that pre-mating
body weight gain (not absolute body weight) should be used as the basis of the NOAEL.  Signs
of reproductive toxicity included significantly lower F1 and F2 pup weights in the high-dose
group during lactation, which continued to be lower than controls post-weaning and after the
pre-mating period (examination in F1 generation only).  The LOAEL for
reproductive/developmental toxicity is 4000 ppm (about 326 mg/kg/day) based on decreased pup
weights (F1 and F2).  The NOAEL for reproductive toxicity is 1000 ppm (about 81 mg/kg/day).
3.2.3
Pre-and/or Postnatal Toxicity
The database is considered adequate for selection of study endpoints and determination
of a dose/response to characterize the potential prenatal or postnatal toxicity of cyprodinil to
infants and children.  No increase in susceptibility was seen in developmental toxicity studies in
rat and rabbit or reproductive toxicity studies in the rat.  Toxicity to offspring was observed at
dose levels the same or greater than those causing maternal or parental toxicity.  Based on the
results of developmental and reproductive toxicity studies, there is not a concern for increased
qualitative and/or quantitative susceptibility following in utero exposure to cyprodinil.
A developmental neurotoxicity study is not required.   Based on available data there is no
evidence of neurotoxic potential for cyprodinil.  Neurotoxicity was not observed in the prenatal
developmental toxicity studies in either rats or rabbits.
3.2.4 Immunotoxicity
There are no indications in the available studies that organs associated with immune
function, such as the thymus and spleen, are affected by cyprodinil.  There are no effects seen on
the developing immune system in the existing studies.  An immunotoxicity study is required,
however, under 40 CFR Part 158 as a part of the new data requirements for registration of a
pesticide (food and non-food uses).
3.2.5 FQPA Factor
Since there are adequate developmental studies in rats and rabbits and an adequate multi-
generation study in rats, and no residual uncertainties that indicate the need for a factor, the
FQPA factor has been reduced to 1X.

Page 12 of 36
3.3
Toxicity Endpoint Selection
3.3.1
Acute Reference Dose (aRfD) – Females 13-49
Selected Study: Developmental toxicity in the rabbit; MRID 43709032. See Section 3.2.1
Dose and Endpoint for Establishing a POD:  NOAEL = 150 mg/kg/day day based
developmental LOAEL of 400 mg/kg/day was based on a slight increase in the incidence of
litters showing extra (13 ) ribs, which is presumed to occur after a single exposure.
th
Uncertainty Factor (UF): 100x (10x for interspecies variation and 10x for intraspecies
variation)
Acute RfD =     150 mg/kg (NOAEL) =     1.5 mg/kg
100 (UF)
3.3.2
Acute Reference Dose (aRfD) – General Population
For the general population, no effects that could be attributed to a single exposure were
observed in the oral-toxicity studies, including the developmental toxicity studies in rats and
rabbits. Therefore, an acute RfD was not established for this population subgroup.
3.3.3  Chronic Reference Dose (cRfD) - All Populations
Selected Study: Combined Chronic Toxicity/Carcinogenicity-Rat;  MRID  43737602,
44429401 and 44417902
In a 24-month chronic toxicity/oncogenicity study  Tif:RAIf rats (50 rats/sex/dose -
carcinogenicity portion, plus 20/sex/dose laboratory investigations) were fed diets containing 0,
5, 75, 1000 or 2000 ppm (M - 0.177, 2.7, 35.6 or 73.6 mg/kg/day; F - 0.204,3.22,41.2 or 87.1
mg/kg/day) cyprodinil (99.2-99.6%).  An additional 10/sex/dose were fed test diets for 12
months (interim sacrifice).  Survival was slightly lower in males at 2000 ppm relative to control
and other dose groups.  Toxicologically significant findings included increased liver weights in
high-dose males (10.7%) and a dose-related increase in the incidence of spongiosis hepatis in the
liver of 1000 and 2000 ppm males (5, 5, 3, 17 and 23 %, controls to high dose). For chronic
toxicity, the NOAEL was 75 ppm (2.7 mg/kg/day) and the LOAEL was 1000 ppm (35.6
mg/kg/day) based on degenerative liver lesions (spongiosis hepatis) in males.
Dose and Endpoint for Establishing a POD:  2.7 mg/kg/day (NOAEL) based on the
histopathological alterations in the liver (spongiosis hepatis) in males at 35.6 mg/kg/day
(LOAEL).
Uncertainty Factor (UF): 100x (10x for interspecies variation and 10x for intraspecies

Page 13 of 36
variation)
Comments about Study/Endpoint: The selected NOAEL is the lowest NOAEL observed
in the most sensitive species following long-term exposure.
Chronic RfD =     2.7 mg/kg (NOAEL) =     0.027 mg/kg
100 (UF)
3.3.4
Classification of Carcinogenic Potential
Based on the lack of evidence of carcinogenicity in mice and rats at doses that were
judged to be adequate to assess the carcinogenic potential, cyprodinil was classified as “not
likely to be carcinogenic to humans”, according to EPA Proposed Guidelines for Carcinogen
Risk Assessment (July 1999).
3.4
Recommendation for Aggregate Exposure Risk Assessments
When there are potential residential exposures to the pesticide, aggregate risk assessment
must consider exposures from three major sources: oral, dermal and inhalation exposures.  Since
there are no residential incidental oral exposures to cyprodinil, aggregate exposure from food
and non-food oral exposures is not required.  However, an aggregate risk assessment of
combined short-term dermal, inhalation and background dietary exposure is required for
residential handlers because PODs selected for these exposure routes are based on common
toxicological effects (i.e., liver effects).
3.5 Summary of Endpoints Selected for Risk Assessment
Toxicological doses/endpoints selected for the cyprodinil risk assessment are provided in
Table 6 and 7.

Page 14 of 36
Table 6. Summary of Toxicological Doses and Endpoints for Cyprodinil  for Use in Dietary Human Health Risk Assessments
Exposure/Scenario
Point of
Departure
Uncertainty/F
QPA Safety
Factors
RfD, PAD, LOC
for Risk
Assessment
Study and Toxicological Effects
Acute Dietary
Females 13-50 years
NOAEL = 150
mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x
Acute RfD = 1.5
mg/kg/day
aPAD = 1.5
mg/kg/day
Developmental Toxicity - rabbit
Developmental LOAEL = 400 mg/kg/day
based on slight increase of litters showing
extra ribs (13 ).
th
Chronic Dietary
(All Populations)
NOAEL= 2.7
mg/kg/day
UFA= 10x
UFH=10x
FQPA SF= 1x
Chronic RfD =
0.027
mg/kg/day
cPAD =
0.027mg/kg/day
2-Year Chronic Toxicity/ Carcinogenicity- rat
LOAEL = 35.6 mg/kg/day based on
degenerative liver lesions (spongiosis hepatis)
in males.
Cancer (all routes)
Classification: “Not likely to be carcinogenic to humans”
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to
mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.
NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.
UF = uncertainty factor.  UF = extrapolation from animal to human (interspecies).  UF = potential variation in sensitivity
A
H
among members of the human population (intraspecies).
SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose.
MOE = margin of exposure.
LOC = level of concern.  N/A = not applicable.
Table 7.  Summary of Toxicological Doses and Endpoints for Cyprodinil  for Use in Residential Human Health Risk
Assessments
Exposure/
Scenario
Point of
Departure
Uncertainty
Factors
Level of Concern
for Risk
Assessment
Study and Toxicological Effects
Dermal  Short-Term
(1-30 days)
(dermal absorption
rate = 30%)
Oral NOAEL=
62 mg/kg/day
UF = 10x
A
UF =10x
H
Residential LOC
for MOE = 100
28-Day Feeding/Range-finding - rat
LOAEL = 299 mg/kg/day based on decreased
body-weight gain, increased cholesterol and
phospholipid levels, microcytosis, and
hepatocyte hypertrophy.
Inhalation Short- Term
(1-30 days)
Oral NOAEL=
62 mg/kg/day
UF = 10x
A
UF =10x
H
Residential LOC
for MOE = 100
28-Day Feeding/Range-finding - rat
LOAEL = 299 mg/kg/day based on decreased
body-weight gain, increased cholesterol and
phospholipid levels, microcytosis, and
hepatocyte hypertrophy.
Cancer (all routes)
Not likely human carcinogen
3.6 Endocrine Disruption
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) “may have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the Administrator may
designate.”   Following recommendations of its Endocrine Disruptor and Testing Advisory

Page 15 of 36
Committee (EDSTAC), EPA determined that there was a scientific basis for including, as
part of the program, the androgen and thyroid hormone systems, in addition to the estrogen
hormone system.  EPA also adopted EDSTAC’s recommendation that the Program include
evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA
and, to the extent that effects in wildlife may help determine whether a substance may have
an effect in humans, FFDCA authority to require the wildlife evaluations. As the science
develops and resources allow, screening of additional hormone systems may be added to the
Endocrine Disruptor Screening Program (EDSP).
When additional appropriate screening and/or testing protocols being considered under
the Agency’s EDSP have been developed, cyprodinil may be subjected to further screening
and/or testing to better characterize effects related to endocrine disruption.
4.0
DIETARY AND DRINKING WATER EXPOSURE ASSESSMENT
4.1
Residue Chemistry Profile
4.1.1
Metabolism in Primary Crops
The metabolism of cyprodinil has been studied in apple, peach, potato, tomato, and
wheat.  The residue of concern in plants is the parent compound cyprodinil as determined by the
HED Metabolism Assessment Review Committee (MARC) (D243198, G. Kramer, 3/11/98).
The metabolism of cyprodinil in plants is adequately understood and additional plant metabolism
data are not required for this proposed use on canola.
4.1.2
Metabolism in Livestock
The nature of the residue in ruminants is adequately understood based on acceptable
lactating goat metabolism studies.  HED has concluded that the residues of concern for both risk
assessment and the tolerance definition should include the combined residues of cyprodinil and
free and conjugated CGA-304075, expressed in parent equivalents (D345970 and D345182, G.
Kramer, 6/4/08).  Therefore, HED recommends that the current tolerance expression for animal
commodities be changed to reflect both parent and metabolite CGA-304075 (4-[(4-cyclopropyl-
6-methyl-2-2-pyrimidinyl)amino]-phenol).
A poultry metabolism for cyprodinil has not been previously submitted as none of the
registered uses included poultry feedstuffs.  However, with this petition for tolerances on canola
seed, there is now the potential for dietary exposure of poultry to cyprodinil residues through the
consumption of canola meal containing cyprodinil residues.  Based on the proposed tolerance
level for canola seed, the potential dietary exposure of poultry to cyprodinil residues is extremely
low (0.005 ppm).  Therefore, for purposes of this petition, HED will waive the requirement for a
poultry metabolism study.
Residues of concern for dietary and drinking water risk assessment and tolerance

Page 16 of 36
expression for cyprodinil are provided in Table 8.
Table 8:  Summary of MARC Decisions for Cyprodinil
Residues of Concern
<s>1</s>
Matrix
For Risk Assessment
<s>2</s>
For Tolerance Expression
Plants cyprodinil
cyprodinil
Livestock
cyprodinil and CGA-304075
cyprodinil and CGA-304075
Water
cyprodinil and CGA 249287
cyprodinil
4.1.3  Residue Analytical Methods
<IP_ADDRESS> Enforcement Methods
Adequate HPLC/UV methods with column switching (Syngenta Methods AG-631 and
AG-631B) are available for enforcing tolerances of cyprodinil on plant commodities.  The LOQs
for these methods range from 0.01 to 0.05 ppm depending on the plant commodities.  Method
AG-631B also contains procedures for confirmatory analysis by GC/NPD.
An adequate HPLC/MS method (GRM010.01A) is also available for enforcing tolerances
in livestock commodities.  This method determines residues of both parent and the metabolite
CGA-304075 (free and conjugated), expressed as parent.  The LOQ is 0.01 ppm for each analyte
for a combined LOQ of 0.02 ppm.
<IP_ADDRESS> Multiresidue Methods
Data are available depicting the recovery of cyprodinil and its metabolite CGA-232449
through FDA Multiresidue method testing protocols (C through E).  Acceptable recoveries were
obtained for cyprodinil in apples fortified at 0.50 ppm using Protocol D.  These data were
forwarded to FDA (G. Kramer, 11/28/1995).
4.1.4
Storage Stability
No storage stability data are available on an oil seed crop.  However, in conjugation with
the canola field trials and processing studies, Syngenta has initiated a storage stability study
using control samples of canola seeds, meal and oil fortified with cyprodinil at 0.2 ppm.  Data
from this on-going storage stability study should be submitted.  Once these data are available,
the stability of cyprodinil in canola seeds, meal and oil will be assessed.  In the interim, the
stability data on avocadoes can be used to support the residue data on canola seeds and meal, as
avocadoes are a neutral fruit that contain 15-30% oil by weight.
4.1.5
Residues in Crops

Page 17 of 36
Sixteen canola field trials were conducted in Canada in Zones 5, 7, and 14 during 2007
using a WDG formulation containing 37.5% cyprodinil and 25% fludioxonil.  The WDG
formulation was applied to canola as a single broadcast foliar application at flowering  at a
cyprodinil rate of 0.31-0.35 lb ai/A (1x rate) using ground equipment.  Single control and
duplicate treated samples of canola seed were harvested (cut) from each test at 35-53 days after
treatment (DAT), and samples were field-dried for 2-32 days prior to collection.  Additional
samples were harvested from two sites at 44, 48, 53, and 57 DAT or 35, 42, 49, and 56 DAT to
assess residue decline.  Samples were stored frozen from collection to analysis for up to 200
days.  Following a single broadcast foliar application residues were non-detectable (<0.006 ppm)
in/on 29 out of 32 samples.  Residues were above the LOQ in only one sample (0.021) and were
detectable in two more samples (0.007 and 0.017 ppm).  Average residues were 0.02 ppm in/on
canola seeds, and the HAFT residues were <0.02 ppm.  No pattern of residue decline could be
determined as residues were ND in/on all seed samples from the two residue decline tests.
Provided that adequate supporting storage stability data are submitted for cyprodinil in frozen
canola seed, the submitted canola field trial data are adequate and fulfill the field trial
requirements for imported canola.
4.1.6
Residues in Livestock
Adequate cattle feeding studies are available for cyprodinil.  As canola meal is a
significant feedstuff for livestock, the maximum dietary burden of (MDB) was recalculated for