[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Rules and Regulations]
[Pages 51420-51426]
[FR Doc No: 2019-20675]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2019-0262; FRL-10000-27-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Redesignation Requests and Maintenance Plans for Delaware
County and Lebanon County 2012 Fine Particulate Matter Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
requests for redesignation to attainment status as well as state
implementation plan (SIP) revisions submitted by the Commonwealth of
Pennsylvania. On January 23, 2019 and February 11, 2019, respectively,
the Pennsylvania Department of Environmental Protection (PADEP)
submitted requests for EPA to redesignate the Delaware County and
Lebanon County nonattainment areas (the Delaware and Lebanon Areas or
the Areas) to attainment of the 2012 annual fine particulate matter
(PM2.5) national ambient air quality standards (NAAQS). EPA
is granting PADEP's requests and determining that the Delaware and
Lebanon Areas meet the 2012 annual PM2.5 NAAQS, based on the
most recent three years of certified air quality data. The effect of
this action is to change the designation status of the Delaware and
Lebanon Areas from nonattainment to attainment for the 2012 annual
PM2.5 NAAQS, thereby removing the requirement for a
nonattainment new source review (NNSR) permitting program and stopping
the sanctions clock associated with a finding of failure to submit NNSR
updates for the 2012 annual PM2.5 NAAQS. EPA is also
approving PADEP's plans to ensure that the Delaware and Lebanon Areas
continue to meet the 2012 PM2.5 NAAQS through 2030
(maintenance plans) as revisions to the Pennsylvania SIP. The
maintenance plans for the Delaware and Lebanon Areas include 2014,
2022, and 2030 motor vehicle emissions budgets (MVEBs) for mobile
sources of PM2.5 and nitrogen oxides (NOX).
Finally, EPA is finding these 2014, 2022, and 2030 MVEBs for
PM2.5 and NOX adequate and is approving these
MVEBs into the Pennsylvania SIP for transportation conformity purposes.
This action is being taken under the Clean Air Act (CAA).

DATES: This final rule is effective on October 30, 2019.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2019-0262. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., confidential business
information (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 through
https://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Maria A. Pino, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2181. Ms. Pino can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 18, 2014, the EPA Administrator signed a final action
promulgating initial designations for the 2012 primary PM2.5
NAAQS based on 2011-2013 air quality monitoring data for the majority
of the United States. 80 FR 2206 (January 15, 2015). In that action,
the Delaware Area, which consists of Delaware County, Pennsylvania, and
the Lebanon Area, which consists of Lebanon County, Pennsylvania, were
designated as moderate nonattainment areas for the 2012 annual
PM2.5 NAAQS. See 40 CFR 81.339.
    On April 6, 2018, EPA published a ``finding of failure to submit''
required SIP elements for the 2012 annual PM2.5 NAAQS for
several nonattainment areas nationwide, including the Delaware and
Lebanon Areas. See 83 FR 14759. EPA's finding of failure to submit,
effective May 7, 2018, included a determination that Pennsylvania had
not met its obligations for the NNSR permit program because
Pennsylvania did not regulate emissions of volatile organic compounds
(VOCs) and ammonia (NH3) as PM2.5 precursors.
Sanctions associated with this finding for the Delaware and Lebanon
Areas will take effect on November 7, 2019, unless EPA fully approves
the Pennsylvania's redesignation requests by November 7, 2019. As NNSR
is not required in attainment areas, upon final redesignation of the
Delaware and Lebanon Areas to attainment, the NNSR updates will no
longer be required for the Areas, thus nullifying the findings of
failure to submit and stopping the sanctions clock.
    On January 23, 2019 and February 11, 2019, respectively, PADEP
submitted requests for EPA to redesignate the Delaware and Lebanon
Areas to attainment of the 2012 annual PM2.5 NAAQS. Section
107(d)(3)(E) of the CAA allows redesignation of an area to attainment
of the NAAQS provided that: (1) The Administrator (EPA) 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) of the CAA; (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, applicable Federal air pollutant control regulations, and other
permanent and enforceable emission reductions; (4) the Administrator
has fully approved a maintenance plan for the area as meeting the
requirements of section 175A of the CAA; and (5) the state containing
the area has met all requirements applicable to the area for purposes
of redesignation under section 110 and part D of title I of the CAA.
EPA evaluated Pennsylvania's redesignation requests for the Delaware
and Lebanon County Areas and determined that they met these criteria.
Therefore, EPA proposed approval of Pennsylvania's redesignation
requests and the associated maintenance plans for the Delaware and
Lebanon County Areas in a notice of proposed pulemaking (NPRM) on July
16, 2019 (84 FR 33886).

II. Summary of SIP Revision and EPA Analysis

    EPA is taking several actions related to the redesignation of the
Delaware and Lebanon Areas to attainment of the 2012 annual
PM2.5 NAAQS. EPA is finding that the Delaware and Lebanon
moderate nonattainment areas are attaining the 2012 annual
PM2.5 NAAQS. EPA is approving Pennsylvania's 2012 annual
PM2.5

maintenance plans for the Delaware and Lebanon Areas as revisions to
the Pennsylvania SIP that include MVEBs for PM2.5 and
NOX for the years 2014, 2022, and 2030. Further, EPA is
finding that Pennsylvania meets the requirements for redesignation of
the Delaware and Lebanon Areas to attainment of the 2012 annual
PM2.5 NAAQS under section 107(d)(3)(E) of the CAA. EPA is
thus granting Pennsylvania's request to change the designation of the
Delaware and Lebanon Areas from nonattainment to attainment of the 2012
annual PM2.5 NAAQS. Finally, EPA is finding the 2014, 2022,
and 2030 MVEBs for PM2.5 and NOX adequate for
transportation conformity purposes and is finalizing the approval of
the MVEBs into the Pennsylvania SIP. The comment period for these MVEBs
began upon publication of the NPRM with EPA's posting of the
availability of Pennsylvania's maintenance plan submittal for the
Delaware and Lebanon Areas on EPA's Adequacy website which can be found
at https://www.epa.gov/state-and-local-transportation.
    Other specific requirements of Pennsylvania's redesignation
requests, maintenance plans, and associated MVEBs, and the rationale
for EPA's proposed action are explained in the NPRM and will not be
restated here.

III. Public Comments and EPA Response

    During the public comment period on EPA's July 16, 2019 NPRM for
this rulemaking, EPA received comments from one anonymous commenter.
Those comments and EPA's responses are discussed below. All of the
comments received and any submitted attachments are included in the
docket for this action, available online at www.regulations.gov, Docket
ID: EPA-R03-OAR-2019-0262.
    Comment 1: The commenter argues that EPA's own data indicates that
the annual readings from the Delaware County monitors are going up,
from 11.0 micrograms per cubic meter ([micro]g/m\3\) in 2016 to 9.1
[micro]g/m\3\ in 2017 to 12.1 [micro]g/m\3\ in 2018.
    EPA Response 1: EPA disagrees with this comment. It is more
relevant to look at trends in the design value (DV), which is a
statistic or summary metric based on the most recent three years of
monitored data that describes the air quality status of a given
location relative to the level of the NAAQS, rather than trends in
annual mean at a given monitoring site, for two reasons: First, design
values can be directly compared to the NAAQS, since they are in the
same form as the NAAQS. In appendix N to 40 CFR part 50,
``Interpretation of the National Ambient Air Quality Standards for
PM2.5,'' the annual PM2.5 design value is defined
as the ``3-year average of PM2.5 annual mean mass
concentrations for each eligible monitoring site.'' As stated in EPA's
regulations at 40 CFR 50.18, ``The primary annual PM2.5
standard is met when the annual arithmetic mean concentration, as
determined in accordance with appendix N of this part, is less than or
equal to 12.0 [micro]g/m\3\.'' Pursuant to section 4.1 of appendix N of
40 CFR part 50, the primary annual PM2.5 NAAQS is met ``when
the annual PM2.5 NAAQS DV is less than or equal to 12.0
[micro]g/m\3\ at each eligible monitoring site.'' Second, because the
DV is calculated as a three-year average, it better accounts for year
to year variability in meteorological conditions and economic factors
that may impact the emissions and/or particulate matter formation in an
area, and thereby affect the annual mean at a given monitoring site.
The ten-year trends in DVs at the two Delaware County monitoring sites
are shown in Table 1. This data is publicly available, and can be found
at EPA's Air Quality Design Values website: https://www.epa.gov/air-trends/air-quality-design-values.

                                                                      Table 1--Delaware County DVs, 2007-2009 to 2016-2018
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                                                                                Design value([micro]g/m3)
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                            Site ID                              2007-2009    2008-2010    2009-2011    2010-2012    2011-2013    2012-2014    2013-2015    2014-2016    2015-2017    2016-2018
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42-045-0002...................................................         13.7         13.3         12.9         13.1         12.4         12.3         11.6         11.5         10.3         10.7
42-045-0109 *.................................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........  ...........          9.4          9.4
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* This site started operating on January 1, 2015. Its first valid design value was the 2015-2017 design value.

    Figure 1 graphically depicts the ten-year DV trend at site 42-045-
0002. EPA did not plot the trend for site 42-045-0109, as it only has
two valid design values. Through a linear regression analysis, Figure 1
shows a downward trend for site 42-045-0002, with the 2015-2017 DV
noticeably lower than the ten-year trend line, and the 2016-2018 DV
slightly above.

[GRAPHIC] [TIFF OMITTED] TR30SE19.026

    EPA also examined annual mean data for the primary monitor \1\ at
site 42-045-0002 for a similar timeframe. This data was obtained from
EPA's Air Quality System (AQS) database, and is set out in Table 2.
This data has been added to the docket for this final action, available
online at https://www.regulations.gov, Docket ID: EPA-R03-OAR-2019-
0262.
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    \1\ The primary monitor at site 42-045-0002 was POC 1 for 2007-
2009, and POC 3 for 2010-2018. ``POC'' refers to the Parameter
Occurrence Code. POCs are used to distinguish between different
monitors at one site that are measuring the same ``parameter'' (i.e.
PM2.5).

                               Table 2--Delaware County 2007-2018 Annual Means at the Primary Monitor at Site 42-045-0002
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                                                              Annual mean  ([micro]g/m\3\)
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    2007         2008         2009         2010         2011         2012         2013         2014         2015         2016        2017        2018
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    14.45        13.84        13.01        13.53        12.96        13.12        11.48        12.66        10.74        11.04         9.07       11.38
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    Figure 2 graphically depicts the annual mean trend at the primary
monitor at site 42-045-0002. Figure 2 shows that the 2017 annual mean
is noticeably lower than the trend line, and the 2018 annual mean is
noticeably higher. Similar variability in annual means is seen
throughout the 12-year period. This is expected, since annual means are
more sensitive to annual changes in weather patterns and emissions than
DVs. However, Figure 2 shows a downward trend for the primary monitor
at site 42-045-0002, which is consistent with improved air quality.

[GRAPHIC] [TIFF OMITTED] TR30SE19.027

    Comment 2: The commenter states that the data in 2018 doesn't
appear to be complete since there were only three complete quarters and
the report indicates values with an * as values that are not complete.
    EPA Response 2: EPA disagrees with this comment. The 2018 data
included in the docket for the proposed rulemaking action was
preliminary data, which was not yet certified by Pennsylvania. This
data has since been certified and EPA has finalized the 2016-2018 DVs.
The certified 2016-2018 data in AQS for Delaware and Lebanon Counties
is shown in Table 3. This data has been added to the docket for this
final action, available online at https://www.regulations.gov, Docket
ID: EPA-R03-OAR-2019-0262.

                                           Table 3--2016-2018 Annual Means, Complete Quarters, and DVs at Delaware County and Lebanon County Monitors
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                                                                                Annual means ([micro]g/m\3\)                          Complete quarters                   2016-2016
                                                                                ------------------------------------------------------------------------------------------------  design value
                  Area/county                              Monitor ID                                                                                ([micro]g/
                                                                                2016            2017            2018            2016            2017            2018            m\3\)
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Delaware......................................  42-045-0002.....................            11.0             9.1        \2\ 12.1               4               4               4            10.7
Delaware......................................  42-045-0109.....................             9.3             8.3            10.8               4               4               3             9.4
Lebanon.......................................  42-075-0100.....................             9.7             9.3             8.8               4               4               4             9.3
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    The Lebanon County monitor and monitor 42-045-0002 in Delaware
County both have four complete quarters of data for all three years,
2016 to 2018. Monitor 42-045-0109 has four complete quarters in 2016
and 2017, and three complete quarters in 2018. However, this monitor
has a valid design value because, as provide in 40 CFR part 50,
appendix N, 4.1(c)(ii), it passed the ``maximum quarterly value data
substitution test.'' An annual PM2.5 NAAQS DV that is equal
to or below the level of the NAAQS can be validated if it passes the
maximum quarterly value data substitution test. This type of data
substitution is permitted only if there is at least 50 percent data
capture in each quarter that is deficient of 75 percent data capture in
each of the three years under consideration. Data substitution will be
performed in all quarter periods that have less than 75 percent data
capture but at least 50 percent data capture. If any quarter has less
than 50 percent data capture, then this substitution test cannot be
used.
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    \2\ Note that the 2018 annual mean reported in Table 3 is
different than annual mean reported in Table 2. This difference is
due to the fact that design values are calculated from site-level
data rather than monitor-level data. For more information, see
appendix N to 40 CFR part 50.
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    Comment 3: The commenter argues that ``EPA's data for the Delaware
County monitors simply show consistently borderline attainment and not
verifiable emission reductions.''
    EPA Response 3: EPA disagrees with this comment because as shown in
EPA's response to Comment 1, the DVs at both Delaware County monitors
are below the level of the NAAQS, and the DVs at monitor 42-045-0002
show a linear downward trend consistent with attainment of the 2012
PM2.5 NAAQS.
    Comment 4: The commenter also claims that ``[t]he Lancaster monitor
only has 2 complete quarters in 2018, so why would EPA even consider
this data?''
    EPA Response 4: EPA assumes that the commenter is referring to the
Lebanon County monitor, and not any monitor in Lancaster, which is not
the subject of this rulemaking action. As explained in EPA's response
to comment #2, at the time of EPA's proposed rulemaking action, the
2018 data was preliminary. EPA subsequently finalized the 2016-2018
design values. As shown in Table 3, the final, certified data for 2018
has four complete quarters, and the final 2016-2018 DV is 9.3 [micro]g/
m\3\, which is well below the level of the 2012 annual PM2.5
NAAQS, 12.0 [micro]g/m\3\.
    Comment 5: The commenter urges EPA to ``[u]se the most current air
quality data, not data from mid-2018 that doesn't have fully complete
data!''

    EPA Response 5: As stated in responses to Comments 2 and 4,
complete, certified 2018 data was not available at the time of EPA's
proposed rulemaking action. Since that time, Pennsylvania has certified
its 2018 data and EPA has since finalized the 2016-2018 DVs. That data
is reported in Table 3.
    Comment 6: The commenter takes issue with the technical support
documents (TSDs) for Delaware and Lancaster Counties and opines that
EPA's evaluation was not a thorough evaluation that explains why
Pennsylvania's emissions projections are adequate.
    EPA Response 6: Pennsylvania submitted their attainment and
projection year emission inventories in accordance with EPA's Emission
Inventory Guidance for Implementation of Ozone and Particulate Matter
National Ambient Air Quality Standards (NAAQS) and Regional Haze
Regulations (May 2017) \3\ and following EPA's Memorandum Procedures
for Processing Requests to Redesignate Areas to Attainment (Calcagni 9/
4/92 memo).\4\ For the 2014 attainment year and maintenance plan base
year, Pennsylvania used EPA's National Emissions Inventory (NEI) to
fulfill the requirement for submitting point, nonpoint, and nonroad
emissions. Additional technical documentation on the development of the
NEI can be found on EPA's NEI website for the 2014 NEI (https://www.epa.gov/air-emissions-inventories/2014-national-emissions-inventory-nei-data). Onroad emissions were developed following EPA's
MOVES2014 and 2014a Technical Guidance: Using MOVES to Prepare
Emissions Inventories for State Implementation Plans and Transportation
Conformity.\5\ EPA reviewed the inventories following the emissions
inventory guidance to insure the emissions submitted fulfilled the
requirements set forth for maintenance and projected inventories.
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    \3\ This guidance document is available online on EPA's Air
Emissions Inventories website, at https://www.epa.gov/air-emissions-inventories/air-emissions-inventory-guidance-implementation-ozone-and-particulate.
    \4\ This guidance document is in the docket for this action,
available online at https://www.regulations.gov, Docket ID: EPA-R03-
OAR-2019-0262.
    \5\ This guidance document is available online at https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100V7EY.pdf.
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    Comment 7: The commenter states that EPA neglected to provide a
detailed review of the Motor Vehicle Emission Simulator (MOVES)
modeling files and supporting documents used in the development of the
emissions inventories. Specifically, they note that the sample files
include compressed natural gas (CNG) and ethanol (E85) selections. The
commenter argues that the areas surrounding Delaware and Lancaster
Counties do not contain E85 or CNG filling stations, making those
selections in the modeling files inappropriate. Further, they contend
that modeling file selections for ``urban'' road type should not have
been made for the primarily rural areas included in the analysis.
    EPA Response 7: To clarify, Pennsylvania's redesignation requests
and associated maintenance plans are for Delaware and Lebanon Counties,
not Lancaster County as stated by the commenter. Therefore, EPA will
address the commenter's concerns as applying to Delaware and Lebanon
counties, as Lancaster County is not the subject of this rulemaking
action.
    EPA disagrees with the commenter's characterization of whether a
necessary review of modeling files supporting the redesignation request
was performed. As stated in EPA's MVEB TSD \6\ at section III, Review
of the Submitted Modeling Utilizing the Motor Vehicle Emission
Simulator (MOVES2014a), EPA reviewed all modeling files and
methodologies provided by Pennsylvania and found them appropriate and
consistent with relevant EPA guidance. Specifically, the commenter
notes cases where the modeling files appear to indicate: (1) Types of
fuels that are not distributed in Lebanon and Delaware counties, and
(2) road types that do not exist in Lebanon and Delaware counties.
However, the selections made in the ``Sample Input Files.PDF''
supporting documents included in Pennsylvania's submittal are entirely
consistent with the EPA's ``MOVES2014, MOVES2014a, and MOVES2014b
Technical Guidance: Using MOVES to Prepare Emission Inventories for
State Implementation Plans and Transportation Conformity'' (referred to
as MOVES Technical Guidance).\7\ Section 3.5 of EPA's MOVES Technical
Guidance states, ``For SIP and regional conformity analyses, users
should select all fuel types and all vehicle types to properly estimate
an emissions inventory.'' Pennsylvania correctly followed the MOVES
Technical Guidance and selected all vehicles and all fuel types.
Section 3.6 of EPA's MOVES Technical Guidance recommends that ``users
should select all road types,'' regardless of whether such roads exist
in the county being modeled. This is to ensure that all possible
activity is captured, as it is possible to ``lose'' vehicle miles
traveled if all roads are not selected in MOVES. Pennsylvania correctly
selected all road types. Additionally, for all other selections made in
the modeling files provided, as well as the modeling decisions
documented in Pennsylvania's submittal, EPA similarly compared those
with the relevant sections of the MOVES Technical Guidance. For this
redesignation request, it was determined by EPA that the appropriate
modeling selections were made, and the resulting mobile source
inventory was sufficient to meet the relevant CAA requirements.
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    \6\ EPA's MVEB TSD, ``Adequacy Findings for the Motor Vehicle
Emissions Budgets (MVEBs) in the 2012 Fine Particulate Matter
(PM2.5) National Ambient Air Quality Standard (NAAQS)
Maintenance Plan for the Lebanon County, Pennsylvania (PA) 2012
PM2.5 Nonattainment Area'' is available online at https://www.regulations.gov, Docket ID: EPA-R03-OAR-2019-0262.
    \7\ For more information, see ``MOVES2014, MOVES2014a, and
MOVES2014b Technical Guidance: Using MOVES to Prepare Emission
Inventories for State Implementation Plans and Transportation
Conformity'', Assessment and Standards Division, Office of
Transportation and Air Quality, U.S. Environmental Protection
Agency, August 2018, available online at https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100V7EY.pdf.
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IV. Final Action

    EPA's review of the records for these redesignation requests
indicates that the Delaware and Lebanon Areas meet the requirements for
redesignation to attainment for the 2012 annual PM2.5 NAAQS.
Therefore, EPA is granting PADEP's redesignation requests and
determining that the Delaware and Lebanon Areas meet the 2012 annual
PM2.5 NAAQS. The effect of this final action is to change
the designation status of the Delaware and Lebanon Areas from
nonattainment to attainment for the 2012 annual PM2.5 NAAQS,
thereby removing the requirement for a nonattainment new source review
permitting program and stopping the sanctions clock associated with a
finding of failure to submit NNSR updates for the 2012 annual
PM2.5 NAAQS. EPA is also approving PADEP's maintenance plans
for the Delaware and Lebanon Areas as revisions to the Pennsylvania
SIP. EPA is also finding the 2014, 2022, and 2030 PM2.5 and
NOX MVEBs contained in the maintenance plans for the
Delaware and Lebanon Areas adequate and approving these MVEBs into the
Pennsylvania SIP for transportation conformity purposes.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, redesignation of an area to attainment and the

accompanying approval of the maintenance plan under CAA section
107(d)(3)(E) are actions that affect the status of geographical areas
and do not impose any additional regulatory requirements on sources
beyond those required by state law. A redesignation to attainment does
not in and of itself impose any new requirements, but rather results in
the application of requirements contained in the CAA for areas that
have been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40
CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to
approve state choices, provided that they meet the criteria of the CAA.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    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 action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 29, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action, approving Pennsylvania's redesignation requests
and maintenance plans for the 2012 PM2.5 NAAQS for the
Delaware and Lebanon Areas 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

40 CFR Part 81

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

    Dated: September 13, 2019.
Diana Esher,
Acting Regional Administrator, Region III.
    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
entries for ``Delaware County 2012 annual PM2.5 maintenance
plan'' and ``Lebanon County 2012 annual PM2.5 maintenance
plan'' at the end of the table to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

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    Name of non-regulatory SIP      Applicable geographic       State                               Additional
             revision                        area          submittal date    EPA approval date      explanation
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                                                  * * * * * * *
Delaware County 2012 annual PM2.5   Delaware County......         1/23/19  9/30/19 [Insert
 maintenance plan.                                                          Federal Register
                                                                            citation].
Lebanon County 2012 annual PM2.5    Lebanon County.......         2/11/19  9/30/19 [Insert
 maintenance plan.                                                          Federal Register
                                                                            citation].
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* * * * *

0
3. Section 52.2059 is amended by adding paragraphs (x) and (y) to read
as follows:

Sec.  52.2059  Control strategy: Particulate matter.

* * * * *
    (x) EPA approves the maintenance plan for the Delaware County
nonattainment area for the 2012 annual fine particulate matter
(PM2.5) NAAQS submitted by the Commonwealth of Pennsylvania
on January 23, 2019. The maintenance plan includes the 2014, 2022, and
2030 PM2.5 and nitrogen oxides (NOX) mobile
vehicle emissions budgets (MVEBs) to be applied to all future
transportation conformity determinations and analyses for the Delaware
County area for the 2012 annual PM2.5 NAAQS.

        Delaware County Area's Motor Vehicle Emission Budgets for the 2012 Annual NAAQS in Tons per Year
----------------------------------------------------------------------------------------------------------------
                                                                                Effective date of SIP
   Type of control strategy SIP              Year               PM2.5            NOX              approval
----------------------------------------------------------------------------------------------------------------
Maintenance Plan..................  2014.................             136           4,652  September 30, 2019.
                                    2022 Predicted.......              75           1,833
                                    Safety Margin........               4             183
                                    2022 Budget..........              79           2,016
                                    2030 Predicted.......              53             869
                                    Safety Margin........               0              87
                                    2030 Budget..........              53             956
----------------------------------------------------------------------------------------------------------------

    (y) EPA approves the maintenance plan for the Lebanon County
nonattainment area for the 2012 annual fine particulate matter
(PM2.5) NAAQS submitted by the Commonwealth of Pennsylvania
on February 11, 2019. The maintenance plan includes the 2014, 2022, and
2030 PM2.5 and nitrogen oxides (NOX) mobile
vehicle emissions budgets (MVEBs) to be applied to all future
transportation conformity determinations and analyses for the Lebanon
County area for the 2012 annual PM2.5 NAAQS.

          Lebanon County Area Motor Vehicle Emission Budgets for the 2012 Annual NAAQS in Tons per Year
----------------------------------------------------------------------------------------------------------------
                                                                                Effective date of SIP
   Type of control strategy SIP              Year               PM2.5            NOX              approval
----------------------------------------------------------------------------------------------------------------
Maintenance Plan..................  2014.................              87           3,131  September 30, 2019.
                                    2022 Predicted.......              45           1,697
                                    Safety Margin........               5             170
                                    2022 Budget..........              50           1,867
                                    2030 Predicted.......              28           1,249
                                    Safety Margin........               3             125
                                    2030 Budget..........              31           1,374
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

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

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

Subpart C--Section 107 Attainment Status Designations

0
5. In Sec.  81.339, the table ``Pennsylvania--2012 Annual
PM2.5 NAAQS (Primary)'' is amended by revising the entries
for ``Delaware County, PA'' and ``Lebanon County, PA'' to read as
follows:

Sec.  81.339  Pennsylvania.

* * * * *

                                 Pennsylvania--2012 Annual PM2.5 NAAQS (Primary)
----------------------------------------------------------------------------------------------------------------
                                                Designation                           Classification
       Designated area \1\       -------------------------------------------------------------------------------
                                       Date \2\              Type              Date \2\              Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Delaware County, PA:
    Delaware County.............  October 30, 2019..  Attainment........
Lebanon County, PA:
    Lebanon County..............  October 30, 2019..  Attainment........

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Includes areas of Indian country located in each county or area, except as otherwise specified.
\2\ This date is April 15, 2015, unless otherwise noted.

* * * * *
[FR Doc. 2019-20675 Filed 9-27-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Rules and Regulations]
[Page 10165-10168]
[DOCID:fr05mr10-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 524, and 526

[Docket No. FDA-2009-N-0665]

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 18 new animal drug
applications (NADAs) and 1 abbreviated new animal drug application
(ANADA) from Fort Dodge Animal Health, Division of Wyeth, a wholly
owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica,
Inc. (Boehringer). In addition, FDA is amending the animal drug
regulations to reflect a change of sponsor for 15 NADAs from Fort Dodge
Animal Health, Division of Wyeth Holdings Corp., a wholly owned
subsidiary of Pfizer, Inc., to Boehringer.

DATES: This rule is effective March 5, 2010.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York,
NY 10017 (Pfizer) has informed FDA that it has transferred ownership
of, and all rights and interest in, the following 18 approved NADAs and
1 approved ANADA to Boehringer Ingelheim Vetmedica, Inc., 2621 North
Belt Highway, St. Joseph, MO 64506-2002 (Boehringer): NADA 15-030, 32-
702, 34-879, 45-290, 55-021, 55-022, 55-030, 55-048, 55-054, 55 058,
97-222, 108-114, 119-688, 140-684, 140-806, 140-854, 141-096, and 141-
274; and ANADA 200-088. In addition, Fort Dodge Animal Health, Division
of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, has
informed FDA that it has transferred ownership of, and all rights and
interest in, the following 15 approved NADAs to Boehringer: NADA 6-084,
8-774, 12-198, 13-624, 33-127, 33-318, 33-319, 33-373, 40-181, 46-146,
65-269, 99-388, 122-271, 122-272, and 141-108. Accordingly, the agency
is amending the regulations in 21 CFR parts 520, 522, 524, and 526 to
reflect the transfer of ownership. In addition, several sections are
being revised to reflect the current format.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Parts 520, 522, 524, and 526

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
522, 524, and 526 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  520.23 to read as follows:

Sec.  520.23  Acepromazine.

    (a) Specifications. Each tablet contains 5, 10, or 25 milligrams
(mg) acepromazine maleate.
    (b) Sponsors. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 0.25 to 1.0 mg per
pound (/lb) body weight orally.
    (ii) Indications for use. As an aid in tranquilization and as a
preanesthetic agent.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 0.5 to 1.0 mg/lb body weight orally.
    (ii) Indications for use. As a tranquilizer.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
3. Revise Sec.  520.314 to read as follows:

Sec.  520.314  Cefadroxil.

    (a) Specifications.--(1) Each tablet contains 50, 100, or 200
milligrams (mg) or 1 gram of cefadroxil.
    (2) Each milliliter of suspension constituted from powder contains
50 mg of cefadroxil.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs.
Administer 10 mg per pound (/lb) body weight twice daily orally.
    (ii) Cats. Administer 10 mg/lb body weight once daily orally.
    (2) Indications for use--(i) Dogs. For the treatment of skin and
soft tissue infections including cellulitis, pyoderma, dermatitis,
wound infections, and abscesses due to susceptible strains of
Staphylococcus aureus. For the treatment of genitourinary tract
infections (cystitis) due to susceptible strains of Escherichia coli,
Proteus mirabilis, and S. aureus.
    (ii) Cats. For the treatment of skin and soft tissue infections
including abscesses, wound infections, cellulitis, and dermatitis
caused by susceptible strains of Pasteurella multocida, S. aureus,
Staphylococcus epidermidis, and Streptococcus spp.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  520.315  [Removed]

0
4. Remove Sec.  520.315.

0
5. In Sec.  520.645, in paragraph (b), remove ``000856'' and in its
place add ``000010''; and revise paragraphs (d)(1)(i)and (d)(1)(iii) to
read as follows:

Sec.  520.645  Difloxacin.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Administer 5 to 10 mg per kilogram (2.3 to 4.6 mg per
pound) of body weight orally once a day for 2 to 3 days beyond
cessation of clinical signs of disease up to a maximum of 30 days.
* * * * *

    (iii) Limitations. Federal law prohibits the extra-label use of
this drug in food-producing animals. Federal law restricts this drug to
use by or on the order of a licensed veterinarian.
* * * * *

0
6. In Sec.  520.870, in paragraph (b), remove ``053501'' and in its
place add ``No. 000010''; revise paragraphs (d)(1)(i)and (d)(1)(iii to
read as follows:

Sec.  520.870  Etodolac.

* * * * *
    (d) * * *
    (1) * * *
    (i) Amount. Administer 10 to 15 mg per kilogram (4.5 to 6.8 mg per
pound) of body weight per day orally.
* * * * *
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
* * * * *

0
7. Revise Sec.  520.1130 to read as follows:

Sec.  520.1130  Hetacillin.

    (a) Specifications.--(1) Each capsule or tablet contains hetacillin
potassium equivalent to 50, 100, or 200 milligrams (mg) of ampicillin.
    (2) Each milliliter of suspension contains hetacillin potassium
equivalent to 50 mg of ampicillin.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount--(i) Dogs.
Administer 5 mg per pound (/lb) of body weight orally, twice daily. In
severe infections, administer 5 mg/lb three times daily, or up to 10
mg/lb twice daily. For stubborn urinary tract infections, administer up
to 20 mg/lb twice daily.
    (ii) Cats. Administer 50 mg twice daily.
    (2) Indications for use. For the treatment of respiratory tract
infections, urinary tract infections, gastrointestinal infections, skin
infections, soft tissue infections, and postsurgical infections
associated with strains of organisms susceptible to hetacillin
potassium.
    (3) Limitations. Federal law restricts this drug to use only by or
on the order of a licensed veterinarian.

Sec.  520.1130a  [Removed]

0
8. Remove Sec.  520.1130a.

Sec.  520.1130b  [Removed]

0
9. Remove Sec.  520.1130b.

Sec.  520.1130c  [Removed]

0
10. Remove Sec.  520.1130c.

Sec.  520.1630  [Amended]

0
11. In paragraph (b) of Sec.  520.1630, remove ``000856'' and in its
place add ``No. 000010''.

0
12. Revise Sec.  520.2200 to read as follows:

Sec.  520.2200  Sulfachlorpyridazine.

    (a) Specifications.--(1) Sodium sulfachlorpyridazine powder.
    (2) Each bolus contains 2 grams sulfachlorpyridazine.
    (3) Each tablet contains 250 milligrams (mg) sulfachlorpyridazine.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.630 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Calves--(i) Amount. Administer 30 to 45 mg sulfachlorpyridazine
powder per pound (/lb) of body weight per day in milk or milk replacer,
or in a bolus, in divided doses twice daily for 1 to 5 days.
    (ii) Indications for use. For the treatment of diarrhea caused or
complicated by Escherichia coli (colibacillosis).
    (iii) Limitations. Treated ruminating calves must not be
slaughtered for food during treatment or for 7 days after the last
treatment. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for veal.
    (2) Swine--(i) Amount. Administer 20 to 35 mg/lb body weight per
day, in divided doses twice daily for 1 to 5 days:
    (A) In drinking water or
    (B) For individual treatment, in an oral suspension containing 50
mg per milliliter.
    (ii) Indications for use. For the treatment of diarrhea caused or
complicated by E. coli (colibacillosis).
    (iii) Limitations. Treated swine must not be slaughtered for food
during treatment or for 4 days after the last treatment.
    (3) Dogs--(i) Amount. Administer tablets orally at 500 mg per 10 to
15 lb of body weight daily, in two or three divided doses.
    (ii) Indications for use. As an aid in the treatment of infectious
tracheobronchitis and infections caused by E. coli, and in the
treatment of infections caused by other Gram-positive and Gram-negative
organisms that are susceptible to sulfonamide therapy.
    (iii) Limitations. Federal law restricts this drug to use only by
or on the order of a licensed veterinarian.

Sec.  520.2200a  [Removed]

0
13. Remove Sec.  520.2200a.

Sec.  520.2200b  [Removed]

0
14. Remove Sec.  520.2200b.

Sec.  520.2200c  [Removed]

0
15. Remove Sec.  520.2200c.

Sec.  520.2260a  [Amended]

0
16. In paragraph (a)(1) of Sec.  520.2260a, remove ``053501'' and in
its place add ``000010''.

Sec.  520.2261a  [Amended]

0
17. In Sec.  520.2261a, in the first sentence of paragraph (a), remove
``053501'' and in its place add ``000010''; and remove paragraph (d).

Sec.  520.2261b  [Amended]

0
18. In paragraph (b) of Sec.  520.2261b, remove ``053501'' and in its
place add ``000010''.

Sec.  520.2345d  [Amended]

0
19. In paragraphs (b)(3), (d)(1)(iii), and (d)(2)(iii) of Sec.
520.2345d, remove ``053501'' and in its place add ``000010''.

Sec.  520.2481  [Removed]

0
20. Remove Sec.  520.2481.

Sec.  520.2482  [Removed]

0
21. Remove Sec.  520.2482.

0
22. Add Sec.  520.2483 to read as follows:

Sec.  520.2483  Triamcinolone.

    (a) Specifications.--(1) Each tablet contains 0.5 milligram (mg) or
1.5 mg triamcinolone acetonide.
    (2) Each 15 grams of powder contains 10 mg triamcinolone acetonide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. See Sec.  510.410 of this chapter.
    (d) Conditions of use--(1) Dogs and cats. Use tablets described in
paragraph (a)(1) of this section as follows:
    (i) Amount. Administer 0.05 mg per pound (/lb) of body weight daily
by mouth; up to 0.1 mg per pound (/lb) of body weight daily, if
response to the smaller dose is inadequate. Therapy may be initiated
with a single injection of triamcinolone acetonide suspension as in
Sec.  522.2483 of this chapter, in which case triamcinolone acetonide
tablets should be administered beginning 5 to 7 days after the
injection.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Horses. Use oral powder described in paragraph (a)(2) of this
section as follows:

    (i) Amount. Administer 0.005 to 0.01 mg/lb of body weight twice
daily, sprinkled (top-dressed) on a small portion of feed. Therapy may
be initiated with a single injection of triamcinolone acetonide
suspension as in Sec.  522.2483 of this chapter, in which case
triamcinolone acetonide oral powder should be administered beginning 3
or 4 days after the injection.
    (ii) Indications for use. As an anti-inflammatory agent.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Do not use in horses intended for
human consumption.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
23. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
24. Revise Sec.  522.23 to read as follows:

Sec.  522.23  Acepromazine.

    (a) Specifications. Each milliliter of solution contains 10
milligrams (mg) acepromazine maleate.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 000010 for use as in paragraphs (d) and (e) of this
section.
    (2) No. 059130 for use as in paragraph (d) of this section.
    (c) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
    (d) Conditions of use. It is used in dogs, cats, and horses as
follows:
    (1) Amount. Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight;
Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100
lbs of body weight.
    (2) Indications for use. As a tranquilizer.
    (e) Conditions of use. It is used in dogs as follows:
    (1) Amount. Dogs: 0.25 to 0.5 mg/lb of body weight.
    (2) Indications for use. As an aid in tranquilization and as a
preanesthetic agent.

Sec.  522.90b  [Amended]

0
25. In Sec.  522.90b, in the section heading, remove ``sterile''; and
in paragraph (b)(1), remove ``000856'' and in its place add ``No.
000010''.

Sec.  522.775  [Amended]

0
26. In paragraph (b) of Sec.  522.775, remove ``000856'' and in its
place add ``000010''.

Sec.  522.870  [Amended]

0
27. In paragraph (b) of Sec.  522.870, remove ``000856'' and in its
place add ``000010''.

Sec.  522.1145  [Amended]

0
28. In paragraph (c)(2) of Sec.  522.1145, remove ``000856'' and in its
place add ``No. 000010''.

Sec.  522.1222a  [Amended]

0
29. In paragraph (b) of Sec.  522.1222a, remove ``000856,''.

0
30. Revise Sec.  522.2200 to read as follows:

Sec.  522.2200  Sulfachlorpyridazine.

    (a) Specifications. Each milliliter of solution contains sodium
sulfachlorpyridazine equivalent to 200 milligrams (mg)
sulfachlorpyridazine.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.630 of this chapter.
    (d) Conditions of use in calves. It is used as follows:
    (1) Amount. Administer 30 to 45 mg per pound (/lb) of body weight
in divided doses by twice daily injection for 1 to 5 days.
    (2) Indications for use. For the treatment of diarrhea caused or
complicated by Escherichia coli (colibacillosis).
    (3) Limitations. Treated calves must not be slaughtered for food
during treatment or for 5 days after the last treatment. A withdrawal
period has not been established for this product in preruminating
calves. Do not use in calves to be processed for veal.

0
31. Amend Sec.  522.2260 as follows:
0
a. Revise the section heading;
0
b. Revise paragraphs (a) and (b);
0
c. Remove paragraph (d);
0
d. Redesignate paragraph (e) as (d); and
0
e. Revise newly redesignated paragraph (d) introductory text and
paragraph (d)(1).
0
The revisions read as follows:

Sec.  522.2260  Sulfamethazine.

    (a) Specifications. Each milliliter of solution contains 250
milligrams sulfamethazine sodium.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in cattle--(1) Amount. 20 milliliters for
each 50 pounds of body weight (100 milligrams per pound) initially; 20
milliliters per 100 pounds of body weight (50 milligrams per pound)
daily, thereafter.
* * * * *

0
32. Revise Sec.  522.2483 to read as follows:

Sec.  522.2483  Triamcinolone.

    (a) Specifications. Each milliliter of suspension contains 2 or 6
milligrams (mg) triamcinolone acetonide.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs and cats--(i) Amount--(A)
Intramuscular or subcutaneous. For inflammatory, arthritic, or allergic
disorders, administer 0.05 to 0.1 mg per pound (/lb) of body weight as
a single injection. For dermatologic disorders, administer 0.1 mg per
pound (/lb) of body weight as a single injection. If symptoms recur,
the dose may be repeated, or oral corticosteroid therapy may be
instituted.
    (B) Intralesional. Administer 1.2 to 1.8 mg, divided in several
injections around the lesion, spaced 0.5 to 2.5 centimeters apart,
depending on lesion size. At any one site, the dose injected should not
exceed 0.6 mg. and should be well into the cutis to prevent rupture of
the epidermis. When treating animals with multiple lesions, do not
exceed a total dose of 6 mg.
    (C) Intra-articular and intrasynovial. Administer 1 to 3 mg as a
single injection, depending on the size of the joint and severity of
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial
results are inadequate or too transient, dosage may be increased, not
to exceed 3 mg.
    (ii) Indications for use. For the treatment of inflammation and
related disorders, and the management and treatment of acute arthritis
and allergic and dermatologic disorders.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Horses--(i) Amount--(A) Intramuscular or subcutaneous.
Administer 0.01 to 0.02 mg/lb of body weight as a single injection.
Usual dose is 12 to 20 mg.
    (B) Intra-articular and intrasynovial. Administer 6 to 18 mg as a
single injection, depending on the size of the joint and severity of
symptoms. After 3 or 4 days, repeat dosage if indicated. If initial
results are inadequate or too transient, dosage may be increased, not
to exceed 18 mg.
    (ii) Indications for use. For the treatment of inflammation and
related disorders.
    (iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

Sec.  522.2662  [Amended]

0
33. In paragraph (b)(2) of Sec.  522.2662, remove ``000856'' and in its
place add ``000010''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
34. The authority citation for 21 CFR part 524 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  524.2481  [Redesignated as Sec.  524.2483]

0
35. Redesignate Sec.  524.2481 as Sec.  524.2483.

Sec.  524.2483  [Amended]

0
36. In paragraph (b) of newly redesignated Sec.  524.2483, remove
``015914, 053501, and 054925'' and in its place add ``000010, 015914,
and 054925''.

PART 526--INTRAMAMMARY DOSAGE FORMS

0
37. The authority citation for 21 CFR part 526 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  526.363  [Amended]

0
38. In paragraph (b) of Sec.  526.363, remove ``000856'' and in its
place add ``000010''.

Sec.  526.365  [Amended]

0
39. In paragraph (b) of Sec.  526.365, remove ``000856'' and in its
place add ``000010''.

0
40. In Sec.  526.464a, revise the section heading and paragraph (c) to
read as follows:

Sec.  526.464a  Cloxacillin benzathine.

* * * * *
    (c) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter for
use in dairy cows.
* * * * *

Sec.  526.1130  [Amended]

0
41. In Sec.  526.1130, in paragraph (b), remove ``000856'' and in its
place add ``000010''; and in paragraph (c)(3), remove the first
sentence.

    Dated: February 26, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-4560 Filed 3-4-10; 8:45 am]
BILLING CODE 4160-01-S


Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 1-Triacontanol

                    Docket ID Number: EPA-HQ-OPP-2016-0259
                              Date: June 13, 2017

Section 408(c)(2)(A)(i) of FFDCA allows the U.S. Environmental Protection Agency (EPA or the Agency) to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that the exemption is "safe." Section 408(c)(2)(A)(ii) of FFDCA defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption, and to "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...." Additionally, FFDCA section 408(b)(2)(D) requires that the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."
The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of pesticides. Second, the EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
I.  Summary of Petitioned-for Tolerance Exemption
In the Federal Register of August 18, 2016 (81 FR 55191) (FRL-9950-22), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6F8459) by CH Biotech R&D, Co., LTD. (the Petitioner), c/o Spring Trading Company, 203 Dogwood Trail, Magnolia, TX 77354. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of 1-triacontanol (TA) in or on food commodity crops or in products to treat animals. The notice referenced a summary of the petition prepared by the Petitioner, which is available in Docket ID Number EPA-HQ-OPP-2016-0259 via http://www.regulations.gov.
II. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, the EPA reviewed the available scientific data and other relevant information on TA, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

A.  Overview of 1-Triacontanol

1-Triacontanol, a long chain fatty alcohol (LCOH), is a naturally occurring plant growth regulator (PGR) existing in plant wax and insect wax widely. As a PGR, it is used to promote germination, root, stem and leaf growth and flowering (early ripening), improve the seed quality, enhance the plant's capacity for cold and drought resistance, increase production and improve quality of product grown. In terms of the mechanism of action, TA is absorbed through the plant's stem and leaf, and may promote plant growth, increase accumulation of dry matter, improve the permeability of cell membranes, increase chlorophyll content, improve photosynthetic intensity, and increase activity of amylase, oxidase and peroxidase.

TA is ubiquitous in the environment and constitutes a regular part of the human diet as it is found in plant and insect waxes. TA occurs in concentrations of 11-62% in grains and sugarcane (Ref. 1). Additionally, policosanols, fatty acids containing TA, can be found up to 10% as a solidifying agent in gel like substances such as olive oil (Ref. 2). TA is used for its health benefits and is incorporated into pharmaceuticals for its anti-inflammatory properties and to protect against gastric ulcers (Ref. 3). Policosanols lower total cholesterol by 17-21% when taken at doses of 10-20 mg per day (Ref. 4). Additionally, TA constitutes the majority of long chain alcohols found in beeswax, naturally secreted through the bee's abdomen (Ref. 5).

Significant residues of TA on treated commodities are not anticipated as a result of its use as a pesticide especially given the rapid biodegradation of TA. Moreover, residues of TA in drinking water are unlikely given its insolubility in water.

There is a history of human exposure to TA due to its use in the cosmetic and pharmaceutical industries, surface lubricants, and its occurrences in a variety of plants for human consumption, such as tea leaves, sugarcane and grain wax. The Organization for Economic Co-operation and Development (OECD) noted that the sum of C14 - C18 chain length fatty alcohols [including octadecanol (C18), hexadecanol (C16), and tetradecanol (C14)] ranged from 217 to 1825 micrograms per gram human waste (μg/g) sent to sewage treatment (Ref.6). These measurements of long chain alcohol in environmental matrices reflect the combination of both natural and anthropogenic sources to these chemicals.

An aggregate risk assessment for TA for dietary (food and drinking water) exposures was not conducted as no toxicological endpoints have been identified in the toxicity database.  EPA has determined under the FFDCA that there is reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to TA.

There are no human health or environmental risks of concern associated with this assessment.  Therefore, EPA has no objection to the registration of the proposed MP and EP, and proposes to establish an exemption from the requirement of a tolerance for residues of 1-triacontanol in or on food commodities when used in accordance with label directions and good agricultural practices.

For a summary of the data upon which EPA relied, and its review and conclusions based on that data, please refer to the sections below.

Based on the data submitted in support of this petition (summarized in Unit II. B., below) and the comprehensive risk assessment conducted by the Agency, EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to TA, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination because available toxicology data indicate that the active ingredient is of low acute toxicity and is not a developmental toxicant, a mutagen, or toxic via repeat oral exposure.

B.  Biochemical Pesticide Toxicology Data Requirements
Based on the submitted data and the results of studies using comparable long chain fatty alcohols, there are no human health risks of concern associated with TA, and there is sufficient information to justify an exemption from the requirement of a tolerance for this compound when used as a plant growth regulator on all food commodities. Acute studies on TA show that this long chain fatty alcohol is Toxicology Category IV for Acute Oral Toxicity, Acute Dermal Toxicity, Acute Eye irritation, and Primary Dermal irritation. TA is not a dermal sensitizer. All applicable mammalian toxicology data requirements supporting the request for an exemption from the requirement of a tolerance for residues of TA when used pre-harvest to fruiting vegetables, cereal grains, stone fruits, nut crops, and cotton have been fulfilled with data or waiver requests/rationales submitted by the petitioner. Waivers were submitted and accepted for sub chronic toxicology studies including the 90-Day Oral study (OSCPP 870.2600); Developmental Toxicity study (OSCPP 870.3700); Genetic toxicity testing (OSCPP 870.5100, 870.5300, 870.5375, 870.5395, 870.5450, 870.5900). Data was bridged with long chain alcohols (structurally similar to TA), including 1-Docosanol (C22), Policosanol (C24 to C34), and D-002 a substance purified from beeswax, containing a mixture of the higher aliphatic alcohols (C24, C26, C28, C30, C32, and C34) the major component of D-002 is TA (C30), followed by Octacosanol (C28) and Docotriacontanol (C32). The following is a summary of EPA's review of the toxicity profile of this biochemical:

Acute Toxicity: Acute toxicity studies on TA confirm a low toxicity profile. The acute toxicity data are of low toxicity for all routes of exposure, with the exception of eye irritation and dermal sensitization.

1.	OCSPP Guideline 870.1100: TA was evaluated for acute oral toxicity potential in female albino rats when administered as a gavage dose at 5,000 mg/kg. The study was terminated following stopping rules of this procedure. No mortality occurred during the study. There were no clinical signs of toxicity during the study. Animals exhibited weekly weight gain during the study. Gross necropsy conducted at terminal sacrifice revealed no observable abnormalities. The acute oral LD50, indicated by the data, was determined to be greater than 5,000 mg/kg. 1-Triacontanol is classified as Toxicity Category IV for acute oral toxicity.

2.	OCSPP Guideline 820.1200: TA was evaluated for dermal toxicity potential and relative skin irritancy when a single dose moistened with 1.0 mL of com oil/g test substance, at 5050 mg/kg, was applied to the intact skin of albino rats. No mortality occurred during the study. The only clinical sign was emaciation in one animal on Day 7. There were no signs of dermal irritation at any time throughout the study. Animals exhibited weekly weight gain, except for two that lost weight between Days 0 and 7. Gross necropsy conducted at study termination revealed no observable abnormalities. The LD50 was determined to be greater than 5,050 mg/kg. 1-Triacontanol is classified as Toxicity Category IV for acute dermal toxicity.

    OCSPP Guideline 870.1300: The acute inhalation median lethal concentration (LC50) in rats cannot be generated as TA is insoluble in water. In an attempt to conduct such a study, an aerosol was generated by pumping test substance into a pressure operated Spraying System Company air atomizer (1/4 JSS), and then spraying the resulting aerosol directly into the exposure chamber. Chamber air flow was maintained through use of a calibrated orifice plate, sufficient to ensure an oxygen content of at least 19% of the exposure atmosphere. Concentration of test substance in the exposure atmosphere was determined gravimetrically during the assay. Gravimetric concentration was determined by passing a known volume of exposure air through a pre-weighed filter and dividing the amount of test substance deposited on the filter by volume of air which passed through the filter. Exposure concentrations are calculated from these data by a computer program utilizing Probit analysis. Particle size and MMAD were not determined. The exposure concentrations ranged from 0.22 - 0.58 mg/L. These levels would not provide meaningful acute inhalation toxicity data. The OECD noted that inhalation of vapors of long chain alcohols in the range of C6-C22 at levels up to the saturated vapor pressure is unlikely to be associated with significant toxicity.  The OECD provides unique tools and protocols for assessing human health and the environment that are accepted by the Environmental Protection Agency. Based on the weight of evidence (WOE) approach, considering all the available TA hazard and exposure data, EPA has determined that an acute inhalation study is not required at this time. This approach included the following considerations: (1) low vapor pressure of 7.11x10[-11] mm Hg limits vapor exposure; (2) the weight of evidence provided by OECD (Ref. 6): SIDS Initial Assessment Report for SIAM 22 (long chain alcohols) and (3) the acute toxicology studies (Toxicology Category IV), suggest that this compound, which is like comparable LCOH, is of low toxicity.

4.    OCSPP Guideline 870.2400: For primary eye irritation, EPA has classified TA as minimally irritating.
   An acute eye irritation study was conducted on three albino rabbits using test substance 1-Triacontanol.
   Test substance, 0.1 mL by volume (99.9 mg), was placed into the conjunctival sac of the right eye of
   each animal selected for testing. All treated eyes were washed with room temperature deionized (DI)
   water for one minute after recording the 24-hour observation. There were no positive effects exhibited
   in any eye after treatment to rats. TA is minimally irritating and is assigned Toxicity category IV.

 5.	OCSPP Guideline 870.2500: A primary dermal irritation study for TA was conducted on rabbits. There was one intact test site per animal. Each test site was treated with 500 mg of test substance moistened with 0.5 mL of corn oil and covered with semi-permeable dressing. TA was maintained in contact with the skin for 4 hours. Observations for dermal irritation and defects were made at 1, 24, 48 and 72 hours after removal of the dressings. Based on 0.2 PII, TA is rated as slightly irritating. TA is regarded as Toxicity category IV.
 6.	OCSPP Guideline 870.2600: A dermal sensitization study was conducted on short-haired albino guinea pigs to determine if test substance TA produced a sensitizing reaction. Naive control group animals remained untreated during induction phase of the study. Test group animals were treated with 400 mg of test substance moistened with 0.4 mL of corn oil (selected from range-finding). Test animals were treated once weekly for three weeks, for a total of three treatments. After a two-week rest period, all animals (both groups) were challenged at a virgin test site with an application of 400 mg of test substance moistened with 0.4 mL of corn oil. The test substance produced no reaction in either Test animals or Naive control animals after the challenge treatment.  TA is not a dermal sensitizer.

Mutagenicity, OCSPP Guidelines 870.5100, 870.5300, 870.5375: TA did not show a positive response with any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor induced rat liver. Studies on docosanol, policosanol, and D-002 also showed negative effects of these fatty alcohols on Bacterial Reverse Mutation and Ames Testing.

Based on a WOE approach, considering all the available TA hazard and exposure data, EPA had determined that a Bacterial Reverse Mutation study is not required at this time. This approach included the following considerations: (1) study on similar compound, 1-Docosanol (C22), showed negative results; and (2) For long chain alcohols that are C15 or greater, it is unlikely that they would exhibit chronic toxicity because the relationship between carbon number and chronic toxicity suggests that the solubility of the alcohol would limit the bioavailable dissolved fraction to sub-toxic concentrations (Ref. 6).

Subchronic Toxicity:

 OCSPP Guideline 870.3100: 90-day oral data requirement is required to be addressed for uses of a pesticide on foods. Policosanol (C24-C34) was reviewed in the long chain alcohol study submitted. After 12 months of treatment to Sprague-Dawley rats (20/group), by gavage at dosage levels of 0, 250, 500, and 1,000 mg/kg/day, there were no treatment related effects on body weight gain, food consumption, hematology and clinical chemistry parameters or organ weights. No difference between groups was observed upon microscopic examination of tissue. The determined NOAEL was > 1,000 mg/kg/day. Based on a WOE approach, considering all the available TA hazard and other LCOH (bridging data) and exposure data, EPA has determined that a 90-Day Oral study on TA is not required at this time.  This approach included the following considerations: (1) 90-day Oral Toxicity study conducted on a mixture of long chain fatty alcohols, Policosanol (C24 to C34) that have similar chemistry as 1-Triacontanol (C30) showed NOAEL > 1,000 mg/kg/day; and (2) the acute toxicology studies demonstrate Toxicology Category IV, suggesting that the compound is of low toxicity on an acute basis.

 OCSPP Guideline 870.3250: The 90-day dermal data requirement is conditionally required to support uses involving purposeful application to the human skin or uses that would result in prolonged dermal exposure and if data from a 90-day oral study are not required, or the active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route and the metabolite is of toxicological concern. The Agency has waived this data requirement for TA at this time. During use of the pesticide, applicators and handlers are required to wear appropriate PPE (long-sleeved shirt, long pants, shoes, socks, gloves and chemical resistant gloves). These PPE requirements mitigate the potential for repeated dermal exposure. Additionally, prolonged dermal exposure is also not anticipated as TA is expected to degrade rapidly once introduced into the environment. There were no significant differences from control in any treatment group for the absolute organ weights, the organs weight relative to brain weight or the organ weights relative to body weights for dermal testing. There were no other abnormal observations recorded for any animal at necropsy. The histopathology examination revealed no microscopic test-article related findings. The effects of the administration of TA on mortality, body weights, food consumption, in-life observations, hematology, clinical chemistry, gross pathology, organ weights and histopathology indicate the no-observable adverse effect level (NOAEL) of TA is greater than 1,000 mg/kg body weight when administered dermally over 92 days for 5 days a week.

 OCSPP Guideline 870.3465: 90-day inhalation data requirement is conditionally required if there is a likelihood of significant levels of repeated inhalation exposure to the pesticide as a gas, vapor or aerosol. Previously, EPA's Office of Pesticide Programs (OPP) used a set of criteria to determine whether or not an inhalation study could be waived. These criteria considered the scientific information available for the chemical, including the following: (1) severe irritation and corrosivity, (2) low volatility, and (3) large aerosol particle size. In 2009, OPP developed an issue paper on risk assessment approaches for semi-volatile pesticides. As part of that issue paper, an analysis was conducted on a comparison of oral and inhalation experimental toxicology studies.  In general, this analysis showed that the degree to which oral PODs were protective of potential inhalation toxicity varied.  In many cases the oral POD was protective, but in some, the inhalation PODs were significantly more sensitive. Currently, OPP uses a WOE approach which builds upon experience using the previously used criteria listed above and informed by the 2009 Science Advisory Panel (SAP).  As approaches for route to route extrapolation evolve and improve in the future, OPP may, if appropriate, bring additional considerations into the WOE analysis.  Inhalation exposure can be to vapors, droplets, and/or particles/dusts.  The form of this exposure is determined by a number of factors including physical-chemical properties, use pattern, and exposure scenario.  Based on a WOE approach, considering all the available TA hazard and exposure data, EPA has determined that a 90-Day Inhalation study is not required at this time.  This approach included the following considerations: (1) TA is insoluble in water (1.35 x 10[-5] mg/L at 25[0]C) and a liquid aerosol could not be generated in an attempt at assessing acute toxicity; (2) The exposure concentrations for the Acute Inhalation study ranged from 0.22 - 0.58 mg/L. These levels, however, could not provide meaningful acute inhalation toxicity data; (3) TA has a low vapor pressure (7.1x10[-11] mm Hg) and cannot be aerosolized to obtain an exposure concentration high enough to determine the acute toxicity potential; (4) WOE (Ref. 6) suggest that inhalation of vapors of long chain alcohols in the range C6 - C22 at levels up to the saturated vapor pressure (the pressure at which fluid passes from gaseous to liquid phase for a given temperature) is unlikely to be associated with significant toxicity.  Gravimetric concentration was determined by passing a known volume of exposure air through a pre-weighed filter and dividing the amount of test substance deposited on the filter by volume of air which passed through the filter. Exposure concentrations are calculated from these data by a computer program utilizing Probit analysis; (5) the acute toxicology studies demonstrate Toxicology Category IV; and (6) Potential low exposure in the environment.

Developmental Toxicity, OCSPP Guideline 870.3700:  The developmental study requirement was satisfied by the submission of two existing studies from the peer reviewed scientific literature. One study administered 10% aqueous gum acacia by gavage to female Sprague-Dawley rats at dose levels of 0, 5.00, 50.0, and 500.0 mg/kg/day from day 6 to day 15 of gestation. A second study administered policosanol to pregnant rabbits at dose levels of 0, 500, and 1000 mg/kg/day from gestation day 6 through day 18. Based on a WOE approach, considering all the available TA hazard and exposure data, EPA has determined that a Prenatal Development study is not required at this time. This approach included the following considerations: (1) Oral Toxicity studies conducted on a mixture of long chain alcohols, Policosanol (C24 to C34) that have similar chemistry as 1-Triacontanol (C30) (OECD, 2006) in both rats and rabbits; (2) Bridging data using Policosanol show that no adverse effects were found on dams and fetuses regarding body weights, the mean number of corpora lutea, implantations, resorption or dead and live fetuses and no treatment related visceral or skeletal findings were observed. The NOAEL (rabbit) for maternal and developmental toxicity was > 1,000 mg/kg/day and for rats > 500 mg/kg/day; (3) the acute toxicology studies demonstrate Toxicology Category IV, suggesting that the compound is of low toxicity on an acute basis. These studies followed OECD protocols for assessing the potential effects of chemicals on human health and the environment. These standard methods are accepted by the U.S. Environmental Protection Agency and (4) Residues at harvest should be low given application timing.

III.  Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). An aggregate risk assessment for TA for dietary (food and drinking water) exposures was not conducted as no toxicological endpoints have been identified in the toxicity database.  Furthermore, there is reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to TA.

Other Non-occupational Exposure: Other non-occupational exposure to 1-triacontanol from pesticidal use is not expected to occur as the TA biodegrades rapidly and is applied at low application rates. There are no residential uses for TA that would result in non-occupational exposure.

IV.  Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA has not found TA to share a common mechanism of toxicity with any other substances, and TA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, the EPA has assumed that TA does not have a common mechanism of toxicity with other substances. Following from this, the EPA concludes that there are no cumulative effects associated with TA that need to be considered. For information regarding the EPA's efforts to determine chemicals that have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the EPA's website at http://www.epa.gov/pesticides/cumulative.

V.  Determination of Safety for the United States Population, Infants and Children

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, the EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that the EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless the EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor.

There are no human health or environmental risks of concern associated with this assessment. Furthermore, there is reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to TA.

EPA has determined that there are no foreseeable dietary risks to the U.S. population, including infants and children, from the use of TA as a pesticide (plant growth regulator) in or on food commodities when used in accordance with label directions and good agricultural practices.

The available data and information indicate that the chemical is of low toxicity, minimal eye irritant, not a dermal sensitizer and not a developmental toxicant. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of TA when it is used as labeled and in accordance with good agricultural practices. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because the data and information available on TA do not demonstrate significant toxic potential to mammals, including infants and children.

VI.  Conclusions
EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of 1-triacontanol (TA). Therefore, an exemption is established for residues of the biochemical pesticide 1-triacontanol in or on food commodities when used in accordance with label directions and good agricultural practices.

VII.  References

 University of the Ryukysus (2008). Determination of Long-chain Alcohol and Aldehyde
      Contents in the Non-Centrifuged Cane Sugar Kokuto. Okinawa, Japan, August 2008. 583-588pp. (Available at: https://www.jstage.jst.go.jp/article/fstr/14/6/14_6_583/_pdf).

 Trends in Food Science & Technology (2016). Edible Oleogels for the Oral Delivery of
      Lipid Soluble Molecules" Composition and Structural Design Considerations. Ontario, Canada, August 2016. 59-73pp. (Available at: https://www.journals.elsevier.com/trends-in-food-science-and-technology).

 The Japanese Society of Pharmacognosy and Springer (2011). Evaluation of anti
      inflammatory and antinociceptive effects of D-002 (beeswax alcohols). Havana, Cuba, January 2011. 330-335pp. (Available at: https://link.springer.com/content/pdf/10.1007%2Fs11418-010-0496-4.pdf)

 American Heart Journal (2002). Policosanol: Clinical Pharmacology and Therapeutic
      Significance of a New Lipid-Lowering Agent. Rotenburg an der Fulda and Bonn, Germany, February 2002. 356-365pp. (Available at: http://www.sciencedirect.com/science/article/pii/S0002870302585008?via%3Dihub)

 USDA (2005). Isolation of Long-Chain Aliphatic Alcohols from Beeswax Using Lipase
      Catalyzed Methanolysis in Supercritical Carbon Dioxide. Peoria, Illinois, August 2005. 173-177pp. (Available at: http://www.sciencedirect.com/science/article/pii/S0896844605001713).

 OECD  2006. SIDS Initial Assessment
      Report for SIAM 22. Organisation for Economic Cooperation and Development (OECD). Paris, France, 18-21 April 2006. TOME 1: SIAR. Category: Long Chain Alcohols, 294pp. (Available at: http://www.oecd.org/documents/63/0,2340,en_2649_34379_1897983_1_1_1_37465,00.html).


Assessing the Effect of Five Gasoline Properties on Exhaust Emissions from Light-Duty Vehicles certified to Tier-2 Standards

                       Analysis of Data from EPA Phase 3

                                (EPAct/V2/E-89)

                                 Appendix  Q.4

                         Model Fitting Information for
                                Ethane (Bag 2)

This appendix summarizes model fitting for Bag-2 Ethane.  Model-fitting techniques and approaches summarized in Section 8.7. Features of the data and modeling for this compound are listed below.
Fuel-parameter matrix:	REDUCED
Media contamination:	NO
No. measurements:	62
No. censored values:	1
Modeling approach:	MIXED MODEL
Estimated Dependent Variable model:	NO

                          Models fit for Bag-2 Ethane
Model term
                                   Notation
                                     Model

                                     Full
                                      FM1
                                     etOH
Ze
                                      ●
                                      x
                                     Arom
Za
                                      ●
                                      ●
                                      T50
Z5
                                      ●
                                      ●
                                      T90
Z9
                                      ●
                                      ●

[1] Indicates "Full minus 1," etc.

Fitting history for Bag-2 Ethane  -  with "FM1" selected as best fit model.
                                Fit Parameters

                             Test with respect to
                                     Full

                             Test with respect to
                                Previous Model
Model
p
-2lnL
BIC[1]

                                                                        Dev.[1]
                                                                              d
                                                                    Pr>χ[2]

                                                                           Dev.
                                                                              d
                                                                    Pr>χ[2]
Full
5
84.42
95.68

                                                                         0.6829
                                                                              1
                                                                           0.41

FM1
4
85.96
95.62

                                                                         2.2256
                                                                              2
                                                                           0.33

                                                                           1.54
                                                                              1
                                                                           0.21
[1] A lower value indicates a better fit.

[1] The deviation is the difference in
the -2loglik statistics for the
nested and reference models,
respectively, per Equation 14.

Coefficients and Type-III Tests of Effect for the Full and Best-Fit Models  -  Ethane (Bag 2).
Effect

                                  Full Model

                             Best-Fit Model (MM1)

Estimate
Std.Err.
d.f.
t-value
Pr>t

Estimate
Std.Err.
d.f.
t-value
Pr>t
Intercept

                                                                        -7.7241
                                                                         0.7325
                                                                           5.00
                                                                          -10.5
                                                                        0.00013

                                                                        -7.7241
                                                                         0.7320
                                                                           5.00
                                                                         -10.55
                                                                        0.00013
Ze

                                                                        0.07345
                                                                        0.05873
                                                                          57.00
                                                                           1.25
                                                                           0.22

Za

                                                                        -0.1260
                                                                        0.05151
                                                                          57.00
                                                                          -2.45
                                                                          0.018

                                                                        -0.1092
                                                                        0.05041
                                                                          57.00
                                                                          -2.17
                                                                          0.034
Z5

                                                                         0.1815
                                                                        0.05727
                                                                          57.00
                                                                           3.17
                                                                         0.0025

                                                                         0.1452
                                                                        0.05006
                                                                          57.00
                                                                           2.90
                                                                         0.0053
Z9

                                                                         0.1322
                                                                        0.04994
                                                                          57.00
                                                                           2.65
                                                                          0.010

                                                                         0.1270
                                                                        0.05044
                                                                          57.00
                                                                           2.52
                                                                          0.015

                                                                         2.6785

                                                                         2.6669

                                                                         0.1458

                                                                         0.1517