[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Rules and Regulations]
[Page 3442-3444]
[DOCID:fr21ja09-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0862; FRL-8763-5]

Finding of Failure To Submit a Required State Implementation Plan
Revision for 1-Hour Ozone Standard, California--San Joaquin Valley--
Reasonably Available Control Technology

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finding that California has failed to submit, for the
San Joaquin Valley extreme 1-hour ozone nonattainment area, a State
Implementation Plan (SIP) revision required by Clean Air Act (CAA)
sections 172(c)(1), 182(b)(2) and 182(f). These CAA sections require
that SIPs provide for the implementation of reasonably available
control technology on major stationary sources of volatile organic
compounds (VOC) and oxides of nitrogen (NOX) as well as
certain other sources. Under the CAA, this finding triggers the 18-
month time clock for mandatory application of sanctions and 2-year time
clock for a federal implementation plan.

DATES: Effective Date: This rule is effective on January 21, 2009.

ADDRESSES: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region 9, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the Regional Office location (e.g.,
copyrighted material). To inspect the hard copy materials, please
schedule an appointment during normal business hours with the contact
listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Andrew Steckel, EPA Region IX, (415)
947-4115<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

I. Background

A. The San Joaquin Valley's 1-Hour Ozone Classification and Planning
Requirements

    The San Joaquin Valley 1-hour ozone nonattainment area (SJV)
includes the following counties in California's central valley: San
Joaquin, Stanislaus, Merced, Madera, Fresno, Kings, Tulare, and part of
Kern. 40 CFR 81.305. When the CAA was amended in 1990, each area of the
country that was designated nonattainment for the 1-hour ozone national
ambient air quality standard (NAAQS), including the SJV, was classified
by operation of law as ``marginal,'' ``moderate,'' ``serious,''
``severe'' or ``extreme'' depending on the severity of the area's air
quality problem. CAA sections 107(d)(1)(C) and 181(a). Each successive
classification carries with it increasingly stringent requirements that
build on the previous classification's requirements.
    Based on its air quality during the 1987-1989 period, the SJV was
initially classified as serious with an attainment date of no later
than November 15, 1999. See 56 FR 56694 (November 6, 1991) and CAA
section 181(a)(1). On November 8, 2001, the SJV was reclassified as
severe (effective December 10, 2001) for failure to attain the 1-hour
ozone standard by the serious area attainment date. 66 FR 56476. CAA
section 181(a) and (b)(2).
    On January 9, 2004, California requested that EPA reclassify the
SJV from severe to extreme for the 1-hour ozone standard under the
Act's voluntary reclassification provisions in section 181(b)(3). See
letter from Catherine Witherspoon, ARB, to Wayne Nastri, EPA, January
9, 2004. On April 16, 2004, we granted the State's request. 69 FR
20550. In that action, we required the State to submit by November 15,
2004 an extreme area plan for the SJV \1\ that provides for the
attainment of the 1-hour ozone standard as expeditiously as
practicable, but no later than November 15, 2010. We also stated that
the plan must meet the specific provisions of CAA section 182(e). Under
section 182(e), extreme area plans are required to meet the
requirements for severe area plans and the additional requirements for
extreme areas.\2\
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    \1\ There are several tribal areas in the SJV. Because
California has not been approved to administer any CAA programs in
Indian country, the requirement to submit a revised SIP did not
include these tribal areas.
    \2\ The CAA specifically excludes certain serious area
requirements from the extreme area requirements, e.g., the section
182(c)(6), (7) and (8) provisions for new source review.
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    Among these requirements are the provisions for the implementation
of reasonably available control technology (RACT) in sections 172(c)(1)
and 182(b)(2). At a minimum, the CAA requires RACT for major VOC
sources and for VOC source categories for which EPA has issued Control
Techniques Guideline (CTG) documents. For extreme areas, such as the
SJV, CAA section 182(e) defines a major source as a stationary source
that emits or has the potential to emit 10 tons per year of VOC. CAA
section 182(f) requires that RACT also apply to major stationary
sources of NOX.

B. The San Joaquin Valley's 1-Hour Ozone RACT Provisions

    The SJV Air Pollution Control District (SJVAPCD or the District)
adopted the ``Extreme Ozone Attainment Demonstration Plan'' on October
8, 2004 and amended it on October 20, 2005 to, among other things,
substitute for the original chapter a new ``Chapter 4: Control
Strategy'' which includes the 1-hour ozone RACT provisions. The State
submitted the plan and amendment on November 15, 2004 and March 6,
2006, respectively. See letters from Catherine Witherspoon, ARB, to
Wayne Nastri, EPA, November 15, 2004 and March 6, 2006. The plan and
amendment, collectively, will be referred to as the ``2004 SIP'' in
this rule.
    Section 4.2.5 of the 2004 SIP identified four specific source
categories where further analysis and new or modified rules might be
needed to meet the RACT requirements for sources down to the 10 tpy
emissions level. The District concluded that only these categories
would need additional work because its existing rules were already
sufficiently stringent. As discussed below, the State withdrew the RACT
provisions of the 2004 SIP in September, 2008.\3\
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    \3\ On October 16, 2008 we proposed to approve the balance of
the 2004 SIP as well as additional documents comprising the State's
1-hour ozone plan for the SJV. See 73 FR 61381.
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C. The San Joaquin Valley's 8-Hour Ozone Classification and Anti-
Backsliding Requirements

    In an April 30, 2004 final rule, EPA designated and classified
areas of the country under the more protective 8-hour ozone standard
codified in 40 CFR 50.10. The SJV was designated nonattainment and
classified under title 1, part D, subpart 2 of the CAA as serious for
the 8-hour standard. 69 FR 23858. On the same date, EPA also issued a
final rule entitled ``Final Rule To Implement the 8-Hour Ozone National
Ambient Air Quality Standard--Phase 1'' (Phase 1 Rule). 69 FR 23951.
Among other matters, this rule revoked the 1-hour ozone standard in the
SJV (as well as in most other areas of the country), effective June 15,
2005. See 40 CFR 50.9(b); 69 FR 23951, 23996 and 70 FR 44470 (August 3,
2005). The Phase 1 Rule also set forth anti-backsliding principles to
ensure continued progress toward attainment of the 8-hour ozone
standard by

identifying which 1-hour ozone requirements remain applicable after
revocation of that standard. One of the requirements retained, and thus
continues to apply to the SJV, is the requirement to implement RACT.
See 40 CFR 51.905(a)(1)(i) and 51.900(f)(1).\4\
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    \4\ These provisions were not affected by the decision of the
U.S. Court of Appeals for the District of Columbia Circuit vacating
portions of EPA's Phase 1 Rule. See South Coast Air Quality
Management Dist. v. EPA, 472 F.3d 882 (D.C. Cir. 2006) as clarified
in South Coast Air Quality Management Dist. v. EPA, 489 F.3d 1295
(D.C. Cir. 2007).
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    On November 29, 2005, EPA issued the ``Final Rule to Implement the
8-Hour Ozone National Ambient Air Quality Standard--Phase 2'' (Phase 2
Rule). 70 FR 71612. For areas classified under subpart 2, such as the
SJV, the Phase 2 rule required submittal of a RACT SIP for the 8-hour
standard by September 15, 2006. See 40 CFR 51.912(a). It also required
submittal for subpart 2 areas of full attainment and rate of progress
plans by June 15, 2007. See 40 CFR 51.908(a) and 51.910(a).

D. The San Joaquin Valley's 8-Hour Ozone RACT SIP

    The District adopted on August 17, 2006 and the State submitted as
a SIP revision on January 31, 2007, an 8-hour ozone RACT demonstration
addressing sources down to the 25 tpy level. See letter from Catherine
Witherspoon, ARB, to Deborah Jordan, EPA, January 31, 2007. SJVAPCD
also requested a voluntary reclassification to extreme for the 8-hour
standard as allowed by CAA section 181(b)(3) and 40 CFR 51.903(b). On
November 16, 2007, California submitted the District's 2007 8-hour
ozone plan. See letter from James Goldstene, ARB, to Wayne Nastri, EPA.
The State also concurred with the District's request for a voluntary
reclassification to extreme. Once granted, the major source threshold
under the 8-hour standard will drop to 10 tpy of either VOC or
NOX and thus be the same for both the 1-hour and 8-hour
ozone standards.\5\
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    \5\ Under CAA section 181(b)(3), we must grant a state's
voluntary request to ``bump up'' an ozone nonattainment area in that
state to a higher classification. The bump-up is effective only
after EPA publishes a rule in the Federal Register formally granting
the request. We are in the process of preparing that rule.
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    In September 2008, the District began a comprehensive reevaluation
of its rules to determine their compliance with the RACT requirements.
This reevaluation is in part to address issues that EPA has raised
regarding the District's 2006 8-hour ozone RACT SIP and in part to
assure that the rules cover sources in the SJV down to the extreme area
major source threshold of 10 tpy. See letter from Andrew Steckel, EPA,
to George Heinen, SJVAPCD, May 6, 2008. The District's intent is to
take any needed rule revisions to its Board for adoption by Spring,
2009. See letter from Deborah Jordan, EPA, to Seyed Sadredin, SJVAPCD,
September 9, 2008.

E. Withdrawal of the 1-Hour Ozone RACT Provisions

    On September 5, 2008, the State formally withdrew the RACT portion
of the 2004 SIP, specifically section 4.2.5, indicating that the
District would satisfy its continuing RACT obligation for the 1-hour
ozone standard with a revised 8-hour ozone RACT SIP that it is
currently developing. Letter from James N. Goldstene, ARB, to Wayne
Nastri, EPA, with enclosures, September 5, 2008. As stated above, we
have proposed approval of the balance of the SIP revisions submitted by
the State to address the 1-hour ozone standard for the SJV. See 73 FR
61381.

II. Final Action

A. Finding of Failure To Submit Required SIP Revision

    As a result of the withdrawal of section 4.2.5 of the 2004 SIP, we
are today making a finding that California has failed to submit a SIP
revision providing for the implementation of RACT as required by CAA
sections 172(c)(1), 182(b)(2) and 182(f) in the San Joaquin Valley
extreme 1-hour ozone nonattainment area.
    If California does not submit a complete plan revision, including
all required RACT rules and a supporting RACT demonstration, to meet
CAA sections 172(c)(1), 182(b)(2) and 182(f) within 18 months of the
effective date of today's finding, the offset sanction identified in
CAA section 179(b) will be applied in the affected area. Section 179(b)
and 40 CFR 52.31. If the State has still not made a complete submittal
6 months after the offset sanction is imposed, then the highway funding
sanction will apply in the affected area, in accordance with 40 CFR
52.31.\6\ The State can end these sanction clocks or lift any imposed
sanctions by making a complete submittal addressing the RACT
requirements for the San Joaquin Valley 1-hour ozone extreme area.
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    \6\ In a 1994 rulemaking, EPA established the Agency's selection
of the sequence of these two sanctions: The offset sanction under
section 179(b)(2) shall apply at 18 months, followed 6 months later
by the highway sanction under section 179(b)(1) of the Act. EPA does
not choose to deviate from this presumptive sequence in this
instance. For more details on the timing and implementation of the
sanctions, see 59 FR 39832 (August 4, 1994), promulgating 40 CFR
52.31, ``Selection of sequence of mandatory sanctions for findings
made pursuant to section 179 of the Clean Air Act.''
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    In addition to the sanctions, CAA section 110(c)(1) provides that
EPA must promulgate a federal implementation plan addressing the 1-hour
ozone RACT requirements in the SJV no later than 2 years after today's
finding unless we approve the State's RACT submittal within that time.

B. Effective Date under the Administrative Procedures Act

    Today's action will be effective on January 21, 2009. Under the
Administrative Procedures Act (APA), 5 U.S.C. 553(d)(3), an agency
rulemaking may take effect before 30 days after the date of publication
in the Federal Register if an agency has good cause to specify an
earlier effective date. This action concerns a required CAA submittal
that is already overdue. We have previously cautioned California that
the SIP submittal was overdue and that we were considering taking this
action. In addition, this action simply starts a ``clock'' that will
not result in sanctions against the State for 18 months, and that the
State may ``turn off'' by making a complete SIP submittal. These
reasons support an effective date prior to 30 days after the date of
publication.

C. Notice-and-Comment Under the Administrative Procedures Act

    This is a final action that is not subject to the notice-and-
comment requirements of the APA, 5 U.S.C. 533(b). EPA believes that
because of the limited time provided by the CAA to make findings of
failure to submit, Congress did not intend such findings to be subject
to notice-and-comment rulemaking. However, to the extent such findings
are subject to notice-and-comment rulemaking, we invoke the good cause
exception pursuant to the APA, 5 U.S.C. 553(b)(3)(B). Notice and
comment are unnecessary because no EPA judgment is involved in making a
non-substantive finding of failure to submit SIPs required by the CAA.
Furthermore, notice and comment would be contrary to the public
interest because it would divert EPA resources from the critical
substantive review of complete SIPs. See 58 FR 51270, 51272, note 17
(October 1, 1993); 59 FR 39832, 39853 (August 4, 1994).

V. Administrative Requirements

A. Executive Orders

    This final action is not a ``significant regulatory action'' as
defined in Executive Order 12866 ``Regulatory Planning and Review'' (58
FR 51735

(October 4, 1993)) and therefore not subject to review under this
Executive Order.
    This final action is not a ``significant energy action'' as defined
in Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy.
    This final action is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885 (April 23, 1997)) because it is not economically
significant as defined in Executive Order 12866 and because we have no
reason to believe the environmental health or safety risks addressed by
this action present a disproportionate risk to children.
    This final action is not subject to Executive Order 13132,
``Federalism'' (64 FR 43255 (August 10, 1999)). It will not have
substantial direct effects on the State, on the relationship between
the national government and the State, or on the distribution of power
and responsibilities among the various levels of government. The CAA
established the scheme whereby states take the lead in developing plans
to meet the NAAQS and the Federal Government acts as a backstop where
states fail to take the required actions. This rule will not modify the
relationship of the State and EPA for purposes of developing programs
to implement the NAAQS.
    This final action is not subject to Executive Order 13175,
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249 (November 6, 2000)). It will not have substantial direct effects
on tribal governments, on the relationship between the Federal
government and Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.

B. Federal Acts

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities.
    This final rule is not subject to the RFA because it was not
subject to notice and comment rulemaking under the APA or any other
statute. In addition we have invoked the ``good cause'' exception to
notice and comment rulemaking under 5 U.S.C. 553(b) for this rule.
    Under section 202 of the Unfunded Mandates Reform Act of 1995, we
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
private sector, of $100 million or more. Today's action does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. The CAA provision discussed in
this rule requires states to submit SIPs, and this rule merely provides
a finding that California has not met that requirement. Accordingly, no
additional costs to State, local, or tribal governments, or to the
private sector, result from this action.
    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 (15 U.S.C. 272) directs EPA to use ``voluntary
consensus standards'' (VCS) in its regulatory activities unless doing
so would be inconsistent with applicable law or otherwise impractical.
VCS are technical standards that are developed or adopted by VCS
bodies. This action does not involve technical standards; therefore, we
did not consider the use of any VCS.
    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This rule is not a ``major'' rule as defined by 5 U.S.C.
804(2) and will be effective January 21, 2009.

C. Petitions for Judicial Review

    Under CAA section 307(b)(1), petitions for judicial review of this
action must be filed in the United States Court of Appeals for the
appropriate circuit by March 23, 2009. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. See CAA section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovermental relations, Ozone, Volatile organic
compounds.

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

    Dated: January 8, 2009.
Laura Yoshii,
Acting Regional Administrator, Region IX.
 [FR Doc. E9-1107 Filed 1-16-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4476-4477]
[FR Doc No: 2019-02507]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0573]

Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Blood Products Advisory
Committee (BPAC). The general function of the committee is to provide
advice and recommendations to the Agency on regulatory issues related
to blood and products derived from blood. Matters considered at the
meeting will include testing of the blood supply for Zika virus, topics
relevant to blood donation by men who have sex with men, and an
overview of research programs in the Laboratory of

Biochemistry and Vascular Biology. At least one portion of the meeting
will be closed to the public.

DATES: The meeting will be held on March 20, 2019, from 8:30 a.m. to
4:45 p.m., and March 21, 2019, from 8:30 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    For those unable to attend in person, the meeting will also be
webcast and will be available at the following link: https://collaboration.fda.gov/bpac0319.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002,
240-402-8006<EMAIL_ADDRESS>Joanne Lipkind, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 6270, Silver Spring, MD 20993-0002,
240-402-8106<EMAIL_ADDRESS>or the FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting. For those unable to attend in person, the meeting will
also be available via webcast. The webcast will be available at the
following link for both days: https://collaboration.fda.gov/bpac0319.

SUPPLEMENTARY INFORMATION:
    Agenda: On March 20, 2019, in the morning, BPAC will meet in open
session to discuss and make recommendations on strategies to reduce the
risk of Zika virus (ZIKV) transmission by blood and blood components.
The committee will discuss whether universal testing of blood donations
for ZIKV is an appropriate strategy considering the decline of the ZIKV
epidemic in the United States and worldwide. In the afternoon, the
committee will meet in open session to hear an overview of the research
programs in the Laboratory of Biochemistry and Vascular Biology in the
Division of Blood Components and Devices, Office of Blood Research and
Review, Center for Biologics Evaluation and Research, FDA.
    On March 21, 2019, the committee will meet in open session to
discuss blood donation policies regarding men who have sex with men
(MSM). The committee will hear presentations on the current
epidemiology of HIV in the United States; global developments in MSM
blood donor deferral policies; and data on HIV incidence and prevalence
among blood donors from the Transfusion-Transmitted Infection
Monitoring System. The committee will discuss a proposed HIV risk
questionnaire study. In addition, the committee will discuss a proposal
for the use of pathogen reduction technology as an alternative
procedure to a time-based deferral for MSM.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: On March 20, 2019, from 8:30 a.m. to 4 p.m., and on
March 21, 2019, from 8:30 a.m. to 5 p.m., the meeting is open to the
public. Interested persons may present data, information, or views,
orally or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before March 13,
2019. On March 20, 2019, oral presentations from the public will be
scheduled between approximately 11:10 a.m. to 11:40 a.m. and 3:15 p.m.
to 3:45 p.m. On March 21, 2019, oral presentations from the public will
be scheduled between approximately 11:25 a.m. and 11:55 a.m. and
between 3 p.m. and 4 p.m. Those individuals interested in making formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before March 5, 2019. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by March 6,
2019.
    Closed Committee Deliberations: On March 20, 2019, from 4 p.m. to
4:45 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory
committee regarding the progress of the investigator's research will,
along with other information, be used in making personnel and staffing
decisions regarding individual scientists. We believe that public
discussion of these recommendations on individual scientists would
constitute an unwarranted invasion of personal privacy.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Prabhakara Atreya (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02507 Filed 2-14-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Rules and Regulations]
[Pages 27494-27506]
[FR Doc No: 2022-09925]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0511; Project Identifier AD-2022-00397-T;
Amendment 39-22043; AD 2022-10-05]
RIN 2120-AA64

Airworthiness Directives; Gulfstream Aerospace Corporation
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2020-05-
12, which applied to all Gulfstream Aerospace Corporation Model GVII-
G500 and GVII-G600 airplanes. AD 2020-05-12 required revising the
existing airplane flight manual (AFM) to incorporate revised
limitations and procedures. This AD was prompted by reports of two
landing incidents in which the alpha limiter engaged in the landing
flare in unstable air, resulting in high rate of descent landings and
damage to the airplanes. This AD retains certain requirements, and also
adds and replaces certain AFM sections with more restrictive
limitations and procedures. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective May 9, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 13,
2020 (85 FR 14562, March 13, 2020).
    The FAA must receive comments on this AD by June 23, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; fax 912-965-
3520; email [email protected]; internet http://www.gulfstream.com/customer-support. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0511.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0511; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this

final rule, any comments received, and other information. The street
address for the Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Sanford Proveaux, Aerospace Engineer,
Certificate Management and Safety Oversight Section, FAA, Atlanta ACO
Branch, 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-
5566; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued AD 2020-05-12, Amendment 39-19860 (85 FR 14562,
March 13, 2020) (AD 2020-05-12), for all Gulfstream Aerospace
Corporation Model GVII-G500 and GVII-G600 airplanes. AD 2020-05-12
required revising the existing AFM to limit the maximum crosswind
component for landing and increase the normal approach speeds, based on
steady-state winds and wind gusts. AD 2020-05-12 was prompted by a
report of a landing incident, which occurred on February 6, 2020, where
the alpha (angle of attack) limiter engaged during the landing flare in
unstable air, resulting in a high rate of descent landing and damage to
the airplane. The FAA issued AD 2020-05-12 to address inappropriate
alpha limiter engagement during the landing flare, which can limit
pilot pitch authority during a critical phase of flight near the
ground, and result in a high rate of descent landing with possible
consequent loss of control of the airplane on landing.

Actions Since AD 2020-05-12 Was Issued

    After the FAA issued AD 2020-05-12, a second landing event occurred
on April 4, 2022. As in the first event, the alpha limiter engaged
during the landing flare in unstable air, resulting in a high rate of
descent landing and damage to the airplane. In both events, the angle
of attack (AOA) protection function (alpha limiter) of the flight
control computer (FCC) engaged and overrode the pilot pitch control
inputs which the flight control law erroneously predicted would exceed
the stall AOA. This resulted in a high rate of descent landing on the
runway. Additionally, the pilots in both events had full aft-stick
input when the aircraft contacted the runway, and the full-up pitch
control did not arrest the high rate of descent landing.
    The Model GVII-G500 and GVII-G600 alpha limiter function of the FCC
is designed to prevent aerodynamic stalls and operates when airborne
and operating in normal control law. The FCC uses many inputs including
current AOA, rate of change of AOA, and pilot control stick inputs to
determine alpha limiter activation. If the FCC predicts that critical
AOA values will be exceeded, the FCC will activate the alpha limiting
function. The FCC may activate the alpha limiting function when the AOA
is not close to stall. Depending on the rate of AOA increase and pilot
stick input, the alpha limiter may command nose down elevator to
prevent a stall. It is clear from an analysis of both events that
unintended alpha limiter engagement is primarily caused by rapid,
large, and oscillating pilot control inputs near approach reference
speeds, induced by unstable atmospheric conditions and gusty winds.
    The aircraft level hazard is that inappropriate alpha limiter
engagement during the landing flare, which can limit the pilot's
ability to control pitch during a critical phase of flight near the
ground, can result in a high rate of descent landing with possible
consequent loss of control of the airplane on landing. It has been
determined that the operating limitations mandated by AD 2020-05-12 are
not adequate to prevent another occurrence. For these reasons, the AFM
wind and gust operating limitations have been further restricted in
this AD.

Pilot Adherence to AFM Revisions To Mitigate the Unsafe Condition of
Unintended Alpha Limiter Engagement

    These more restrictive operating limitations do not relieve a pilot
from their other regulatory obligations, including verifying
destination wind forecasts prior to departure, monitoring winds en
route, verifying that the approach briefing includes a cockpit brief of
winds and weather, and confirming that the winds are still within
acceptable limits just prior to landing. Pilots are responsible for
becoming familiar with this information when performing preflight
actions under 14 CFR part 91.103, 91.151, and 91.167. Furthermore,
these limitations can only be exceeded when the pilot is exercising
their authority under 14 CFR part 91.3.

FAA's Determination

    The FAA is issuing this AD because the agency has determined the
unsafe condition described previously is likely to exist or develop in
other products of the same type design.

Related Service Information Under 1 CFR Part 51

    This AD retains certain requirements of AD 2020-05-12, which
requires the following sections of Gulfstream GVII-G500 Airplane Flight
Manual, GAC-AC-GVII-G500-OPS-0001, Revision 5, dated March 3, 2020,
which the Director of the Federal Register approved for incorporation
by reference as of March 13, 2020 (85 FR 14562, March 13, 2020).
     Section 01-27-10, ``Normal Control Laws,'' of Chapter 01,
``LIMITATIONS.''
     Step 8., ``Final Approach Fix,'' of Section 04-08-40,
``One Engine Inoperative Landing Procedure,'' of Chapter 04,
``EMERGENCY PROCEDURES.''
     Step 11., ``Landing,'' of Section 03-12-10, ``Zero Flaps
or Partial Flaps Landings,'' of Chapter 03, ``ABNORMAL PROCEDURES.''
     Step 15., ``Approach Speed,'' of Section 01-03-40,
``Airspeed Limitations,'' of Chapter 01, ``LIMITATIONS.''
    This AD also requires the following sections of Gulfstream GVII-
G600 Airplane Flight Manual, GAC-AC-GVII-G600-OPS-0001, Revision 3,
dated March 3, 2020, which the Director of the Federal Register
approved for incorporation by reference as of March 13, 2020 (85 FR
14562, March 13, 2020).
     Section 01-27-10, ``Normal Control Laws,'' of Chapter 01,
``LIMITATIONS.''
     Steps 3. and 4. of Section 01-34-40, ``Takeoff and Landing
Data (TOLD),'' of Chapter 01, ``LIMITATIONS.''
     Step 8., ``Final Approach Fix,'' of Section 04-08-40,
``One Engine Inoperative Landing Procedure,'' of Chapter 04,
``EMERGENCY PROCEDURES.''
     Step 11., ``Landing,'' of Section 03-12-10, ``Zero Flaps
or Partial Flaps Landings,'' of Chapter 03, ``ABNORMAL PROCEDURES.''
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

AD Requirements

    This AD retains some of the AFM revisions required by AD 2020-05-
12, as listed under the Related Service Information under 1 CFR part 51
section of this final rule.
    For Model GVII-G500 airplanes, this AD also requires revising the
following sections of the existing AFM to include more restrictive
limitations and procedures.
     ``Wind Conditions'' of Section 01-02-10: ``Runway, Slope,
and Wind Conditions,'' of Chapter 01, ``LIMITATIONS.''
     ``Day and Night, Visual and Instrument Flight Rules'' of
Section 01-03-10: ``Types of Airplane Operations Permitted,'' of
Chapter 01, ``LIMITATIONS.''

     ``Approach Speed'' of Section 01-03-40: ``Airspeed
Limitations,'' of Chapter 01, ``LIMITATIONS.''
     Section 01-22-10: ``Autothrottle,'' of Chapter 01,
``LIMITATIONS.''
     ``WARNING'' information preceding ``Approach/Landing
Airspeeds'' of Section 02-05-50: ``Landing,'' of Chapter 02, ``NORMAL
OPERATIONS.''
     ``Introduction'' and ``Example'' sections of Section 05-
11-10: ``Threshold Speeds'' of Chapter 05, ``PERFORMANCE.''
    For Model GVII-G600 airplanes, this AD also requires adding or
replacing the following sections of the existing AFM to include more
restrictive limitations and procedures.
     ``Wind Conditions'' of Section 01-02-10: ``Runway, Slope,
and Wind Conditions,'' of Chapter 01, ``LIMITATIONS.''
     ``Day and Night, Visual and Instrument Flight Rules'' of
Section 01-03-10: ``Types of Airplane Operations Permitted,'' of
Chapter 01, ``LIMITATIONS.''
     ``Approach Speed'' of Section 01-03-40: ``Airspeed
Limitations,'' of Chapter 01, ``LIMITATIONS.''
     Section 01-22-10: ``Autothrottle,'' of Chapter 01,
``LIMITATIONS.''
     ``WARNING'' information preceding ``Approach/Landing
Airspeeds'' of Section 02-05-50: ``Landing,'' of Chapter 02, ``NORMAL
OPERATIONS.''
     ``Introduction'' and ``Example'' sections of Section 05-
11-10: ``Threshold Speeds'' of Chapter 05, ``PERFORMANCE.''

Interim Action

    The FAA considers this AD to be an interim action. The manufacturer
is developing a modification that will address the unsafe condition
identified in this AD. Once this modification is developed, approved,
and available, the FAA might consider additional rulemaking.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies forgoing notice and comment prior to adoption of this rule
because inappropriate alpha limiter engagement during the landing flare
can limit pilot pitch authority during a critical phase of flight near
the ground and could result in a high rate of descent landing with
possible consequent loss of control of the airplane. Given the
significance of the risk presented by this unsafe condition, it must be
immediately addressed. Accordingly, notice and opportunity for prior
public comment are impracticable and contrary to the public interest
pursuant to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2022-0511 and Project Identifier
AD-2022-00397-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Sanford
Proveaux, Aerospace Engineer, Certificate Management and Safety
Oversight Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue,
College Park, GA 30337; phone:<PHONE_NUMBER>; email:
[email protected]. Any commentary that the FAA receives that is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 120 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
AFM revision..........................  1 work-hour x $85 per                 $0             $85         $10,200
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2020-05-12, Amendment 39-19860
(85 FR 14562, March 13, 2022); and
0
b. Adding the following new AD:

2022-10-05 Gulfstream Aerospace Corporation: Amendment 39-22043;
Docket No. FAA-2022-0511; Project Identifier AD-2022-00397-T.

(a) Effective Date

    This airworthiness directive (AD) is effective May 9, 2022.

(b) Affected ADs

    This AD replaces AD 2020-05-12, Amendment 39-19860 (85 FR 14562,
March 13, 2020) (AD 2020-05-12).

(c) Applicability

    This AD applies to all Gulfstream Aerospace Corporation Model
GVII-G500 and GVII-G600 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Unsafe Condition

    This AD was prompted by reports of two landing incidents in
which the alpha limiter engaged in the landing flare in unstable
air, resulting in high rate of descent landings and damage to the
airplanes. The FAA is issuing this AD to address inappropriate alpha
limiter engagement during the landing flare, which can limit pilot
pitch authority during a critical phase of flight near the ground,
and result in a high rate of descent landing with possible
consequent loss of control of the airplane on landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Requirements for Certain AFM Revisions for GVII-G500, With
Revised Paragraph References

    This introductory text to paragraph (g) restates the
requirements of the introductory text to paragraph (g) of AD 2020-
05-12, with revised paragraph references. For Model GVII-G500
airplanes: Within 5 days after March 13, 2020 (the effective date of
AD 2020-05-12), revise the existing airplane flight manual (AFM) for
your airplane to incorporate the information specified in paragraphs
(g)(1) through (4) of this AD.
    (1) This paragraph (g)(1) restates the information in paragraph
(g)(3) of AD 2020-05-12, with no changes. Section 01-27-10, ``Normal
Control Laws,'' of Chapter 01, ``LIMITATIONS,'' of the Gulfstream
GVII-G500 Airplane Flight Manual, GAC-AC-GVII-G500-OPS-0001,
Revision 5, dated March 3, 2020.
    (2) This paragraph (g)(2) restates the information in paragraph
(g)(4) of AD 2020-05-12, with no changes. Step 5. of Section 01-34-
40, ``Takeoff and Landing Data (TOLD),'' of Chapter 01,
``LIMITATIONS,'' of the Gulfstream GVII-G500 Airplane Flight Manual,
GAC-AC-GVII-G500-OPS-0001, Revision 5, dated March 3, 2020.
    (3) This paragraph (g)(3) restates the information in paragraph
(g)(6) of AD 2020-05-12, with no changes. Step 11. ``Landing,'' of
Section 03-12-10, ``Zero Flaps or Partial Flaps Landings,'' of
Chapter 03, ``ABNORMAL PROCEDURES,'' of the Gulfstream GVII-G500
Airplane Flight Manual, GAC-AC-GVII-G500-OPS-0001, Revision 5, dated
March 3, 2020.
    (4) This paragraph (g)(4) restates the information in paragraph
(g)(7) of AD 2020-05-12, with no changes. Step 8. ``Final Approach
Fix,'' of Section 04-08-40, ``One Engine Inoperative Landing
Procedure,'' of Chapter 04, ``EMERGENCY PROCEDURES,'' of the
Gulfstream GVII-G500 Airplane Flight Manual, GAC-AC-GVII-G500-OPS-
0001, Revision 5, dated March 3, 2020.

(h) Retained Requirements for Certain AFM Revisions for GVII-G600, With
Revised Paragraph References

    This introductory text to paragraph (h) restates the
requirements of the introductory text to paragraph (h) of AD 2020-
05-12, with revised paragraph references. For Model GVII-G600
airplanes: Within 5 days after March 13, 2020 (the effective date of
AD 2020-05-12), revise the existing AFM for your airplane to
incorporate the information specified in paragraphs (h)(1) through
(4) of this AD.
    (1) This paragraph (h)(1) restates the information in paragraph
(h)(3) of AD 2020-05-12, with no changes. Section 01-27-10, ``Normal
Control Laws,'' of Chapter 01, ``LIMITATIONS,'' of the Gulfstream
GVII-G600 Airplane Flight Manual, GAC-AC-GVII-G600-OPS-0001,
Revision 3, dated March 3, 2020.
    (2) This paragraph (h)(2) restates the information in paragraph
(h)(4) of AD 2020-05-12, with no changes. Steps 3. and 4. of Section
01-34-40, ``Takeoff and Landing Data (TOLD),'' of Chapter 01,
``LIMITATIONS,'' of the Gulfstream GVII-G600 Airplane Flight Manual,
GAC-AC-GVII-G600-OPS-0001, Revision 3, dated March 3, 2020.
    (3) This paragraph (h)(3) restates the information in paragraph
(h)(6) of AD 2020-05-12, with no changes. Step 11., ``Landing,'' of
Section 03-12-10, ``Zero Flaps or Partial Flaps Landings,'' of
Chapter 03, ``ABNORMAL PROCEDURES,'' of the Gulfstream GVII-G600
Airplane Flight Manual, GAC-AC-GVII-G600-OPS-0001, Revision 3, dated
March 3, 2020.
    (4) This paragraph (h)(4) restates the information in paragraph
(h)(7) of AD 2020-05-12, with no changes. Step 8., ``Final Approach
Fix,'' of Section 04-08-40, ``One Engine Inoperative Landing
Procedure,'' of Chapter 04, ``EMERGENCY PROCEDURES,'' of the
Gulfstream GVII-G600 Airplane Flight Manual, GAC-AC-GVII-G600-OPS-
0001, Revision 3, dated March 3, 2020.

(i) New Requirements: AFM Revision for GVII-G500

    For Model GVII-G500 airplanes: Within 3 days after the effective
date of this AD, revise the existing AFM for your airplane as
specified in paragraphs (i)(1) through (6) of this AD.
    (1) Replace the information in ``Wind Conditions'' of Section
01-02-10: ``Runway, Slope, and Wind Conditions,'' of Chapter 01,
``LIMITATIONS,'' with the information in figure 1 to paragraph
(i)(1) of this AD.
BILLING CODE 4910-13-P

[GRAPHIC] [TIFF OMITTED] TR09MY22.039

    (2) Replace the information in ``Day and Night, Visual and
Instrument Flight Rules'' of Section 01-03-10: ``Types of Airplane
Operations Permitted,'' of Chapter 01, ``LIMITATIONS,'' with the
information in figure 2 to paragraph (i)(2) of this AD.
[GRAPHIC] [TIFF OMITTED] TR09MY22.040

    (3) Replace the information in ``Approach Speed'' of Section 01-
03-40: ``Airspeed Limitations,'' of Chapter 01, ``LIMITATIONS,''
with the information in figure 3 to paragraph (i)(3) of this AD.

[GRAPHIC] [TIFF OMITTED] TR09MY22.041

    (4) To Section 01-22-10: ``Autothrottle,'' of Chapter 01,
``LIMITATIONS,'' add the information in figure 4 to paragraph (i)(4)
of this AD.
[GRAPHIC] [TIFF OMITTED] TR09MY22.042

    (5) Replace the ``WARNING'' information preceding ``Approach/
Landing Airspeeds'' of Section 02-05-50: ``Landing,'' of Chapter 02,
``NORMAL OPERATIONS,'' with the information in figure 5 to paragraph
(i)(5) of this AD.
[GRAPHIC] [TIFF OMITTED] TR09MY22.043

    (6) Replace the ``Introduction'' and ``Examples'' sections of
Section 05-11-10: ``Threshold Speeds'' of Chapter 05,
``PERFORMANCE,'' with the information in figure 6 to paragraph
(i)(6) of this AD.

[GRAPHIC] [TIFF OMITTED] TR09MY22.044

(j) New Requirements: AFM Revision for GVII-G600

    For Model GVII-G600 airplanes: Within 3 days after the effective
date of this AD, revise the existing AFM for your airplane as
specified in paragraphs (j)(1) through (6) of this AD.
    (1) Replace the information in ``Wind Conditions'' of Section
01-02-10: ``Runway, Slope, and Wind Conditions,'' of Chapter 01,
``LIMITATIONS,'' with the information in figure 7 to paragraph
(j)(1) of this AD.
[GRAPHIC] [TIFF OMITTED] TR09MY22.045

    (2) Replace the information in ``Day and Night, Visual and
Instrument Flight Rules'' of Section 01-03-10: ``Types of Airplane
Operations Permitted,'' of Chapter 01, ``LIMITATIONS,'' with the
information in figure 8 to paragraph (j)(2) of this AD.
[GRAPHIC] [TIFF OMITTED] TR09MY22.046

    (3) Replace the information in ``Approach Speed'' of Section 01-
03-40: ``Airspeed Limitations,'' of Chapter 01, ``LIMITATIONS,''
with the information in figure 9 to paragraph (j)(3) of this AD.

[GRAPHIC] [TIFF OMITTED] TR09MY22.047

    (4) To Section 01-22-10: ``Autothrottle,'' of Chapter 01,
``LIMITATIONS,'' add the information in figure 10 to paragraph
(j)(4) of this AD.
[GRAPHIC] [TIFF OMITTED] TR09MY22.048

    (5) Replace the ``WARNING'' information preceding ``Approach/
Landing Airspeeds'' of Section 02-05-50: ``Landing,'' of Chapter 02,
``NORMAL OPERATIONS,'' with the information in figure 11 to
paragraph (j)(5) of this AD.
[GRAPHIC] [TIFF OMITTED] TR09MY22.049

    (6) Replace the ``Introduction'' and ``Examples'' sections of
Section 05-11-10: ``Threshold Speeds'' of Chapter 05,
``PERFORMANCE,'' with the information in figure 12 to paragraph
(j)(6) of this AD.

[GRAPHIC] [TIFF OMITTED] TR09MY22.050

BILLING CODE 4910-13-C

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or responsible Flight Standards Office,
as appropriate. If sending information directly to the manager of
the certification office, send it to the attention of the person
identified in paragraph (l) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) AMOC 7A0-22-06968, dated April 29, 2022, was approved as an
AMOC for the requirements for AD 2020-05-12, and is approved as an
AMOC for the requirements of paragraphs (g) and (h) of this AD.
Other AMOCs previously issued for the requirements of AD 2020-05-12
are not approved as an AMOC for the requirements of this AD.

(l) Related Information

    For more information about this AD, contact Sanford Proveaux,
Aerospace Engineer, Certificate Management and Safety Oversight
Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College
Park, GA 30337; phone:<PHONE_NUMBER>; email:
[email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
March 13, 2020 (85 FR 14562, March 13, 2020).
    (i) Gulfstream GVII-G500 Airplane Flight Manual, GAC-AC-GVII-
G500-OPS-0001, Revision 5, dated March 3, 2020.
    (A) Section 01-27-10, ``Normal Control Laws,'' of Chapter 01,
``LIMITATIONS.''
    (B) Step 8., ``Final Approach Fix,'' of Section 04-08-40, ``One
Engine Inoperative Landing Procedure,'' of Chapter 04, ``EMERGENCY
PROCEDURES.''
    (C) Step 11., ``Landing,'' of Section 03-12-10, ``Zero Flaps or
Partial Flaps Landings,'' of Chapter 03, ``ABNORMAL PROCEDURES.''
    (D) Step 15., ``Approach Speed,'' of Section 01-03-40,
``Airspeed Limitations,'' of Chapter 01, ``LIMITATIONS.''
    (ii) Gulfstream GVII-G600 Airplane Flight Manual, GAC-AC-GVII-
G600-OPS-0001, Revision 3, dated March 3, 2020.
    (A) Section 01-27-10, ``Normal Control Laws,'' of Chapter 01,
``LIMITATIONS.''
    (B) Steps 3. and 4. of Section 01-34-40, ``Takeoff and Landing
Data (TOLD),'' of Chapter 01, ``LIMITATIONS.''
    (C) Step 8., ``Final Approach Fix,'' of Section 04-08-40, ``One
Engine Inoperative Landing Procedure,'' of Chapter 04, ``EMERGENCY
PROCEDURES.''
    (D) Step 11., ``Landing,'' of Section 03-12-10, ``Zero Flaps or
Partial Flaps Landings,'' of Chapter 03, ``ABNORMAL PROCEDURES.''
    (4) For service information identified in this AD, contact
Gulfstream Aerospace Corporation, Technical Publications Dept., P.O.
Box 2206, Savannah, GA 31402-2206; telephone<PHONE_NUMBER>; fax 912-
965-3520; email [email protected]; internet http://www.gulfstream.com/customer-support.
    (5) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 2, 2022.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-09925 Filed 5-5-22; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Rules and Regulations]
[Pages 9772-9777]
[FR Doc No: 2016-04070]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0709; FRL-9941-92]

Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
trifloxystrobin in or on multiple commodities which are identified and
discussed later in this document. Bayer CropScience requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 26, 2016. Objections and
requests for hearings must be received on or before April 26, 2016, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0709, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0709 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 26, 2016. Addresses for

mail and hand delivery of objections and hearing requests are provided
in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0709, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 11, 2015 (80 FR 7559) (FRL-
9921-94), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8288) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.555 be amended by establishing tolerances for residues of the
fungicide trifloxystrobin, benzeneacetic acid, (E, E)-[alpha]-
(methoxyimino)-2-[[[[1-[3-(trifluoromethyl)phenyl]ethylidene]
amino]oxy]methyl]-, methyl ester, and the free form of its acid
metabolite CGA-321113, (E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-
phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid, calculated as the
stoichiometric equivalent of trifloxystrobin, in or on leafy greens
(crop subgroup 4A) at 30 parts per million (ppm); herb (crop subgroup
19A) at 200 ppm; spice (crop subgroup 19B), except black pepper) at 30
ppm; head and stem brassica (crop subgroup 5A) at 2 ppm; leafy brassica
greens (crop subgroup 5B) at 30 ppm; tuberous and corm vegetables (crop
subgroup 1C) at 0.04 ppm; small fruit vine climbing (except fuzzy
kiwifruit) (crop subgroup 13-07F) at 2.0 ppm; and low growing berry
(crop subgroup 13-07G) at 1.5 ppm. Bayer CropScience, also requested
that the existing tolerance for leafy petioles (subgroup 4B) be amended
from 3.5 ppm to 9 ppm. That document referenced a summary of the
petition prepared by Bayer CropScience, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the commodity terms for several tolerances to reflect the
correct commodity definition. The reason for these changes are
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance 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. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for trifloxystrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with trifloxystrobin
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Trifloxystrobin exhibits very low toxicity following single oral,
dermal and inhalation exposures. It is a strong dermal sensitizer and a
mild dermal and eye irritant. In repeated dose tests in rats, the liver
is the target organ for trifloxystrobin; toxicity is induced following
oral and dermal exposure for 28 days. Liver effects characterized by an
increase in liver weights and an increased incidence of hepatocellular
hypertrophy and/or hepatocellular necrosis were seen in rats, mice, and
dogs. There is no concern for neurotoxicity or immunotoxicity in the
database. In the rabbit developmental toxicity study, an increase in
the incidence of fused sternabrae was seen at a dose 10 times higher
than the maternal lowest observed adverse effect level (LOAEL). In the
rat reproduction study, both parents and offspring showed decreases in
body weight during lactation. The rat and rabbit developmental and the
rat reproduction toxicity data do not demonstrate an increase in
susceptibility in the fetus or other offspring. Trifloxystrobin is
classified as: ``Not likely to be Carcinogenic to Humans'' based on
both the negative results in the battery of mutagenicity tests (except
at a cytoxic dose in one in vitro test), and from the long-term
carcinogenicity studies in rats and mice. Specific information on the
studies received and the nature of the adverse effects caused by
trifloxystrobin as well as the no-observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies are discussed in the document ``Trifloxystrobin. Aggregate
Human Health Risk Assessment for the Proposed New Uses on Leafy Greens
(Crop Subgroup 4A), Head and Stem Brassica Vegetables (Crop Subgroup
5A), Leafy Brassica Greens (Crop Subgroup 5B), Herbs (Crop Group 19A),
and Spices, Except Black Pepper (Crop Subgroup 19B); to Amend the
Current Tolerance on Leafy Petioles (Crop Subgroup 4B); and to Convert
the Potato Tolerance to the Tuberous and Corm Vegetables Subgroup (Crop
Subgroup 1C), Convert the Grape Tolerance to the Small Fruit Vine
Climbing (Subgroup 13-07F), and Convert the Strawberry Tolerance to the
Low Growing Berries (Subgroup 13-07G).,'' dated December 1, 2015.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for trifloxystrobin used
for human risk assessment is discussed in Unit III B of the final rule
published in the Federal Register of June 11, 2010. However, subsequent
to that Federal Register publication, EPA reassessed the liver effects
seen in the 28-day dermal toxicity study according to current policy,
and determined that since these effects should not be considered
adverse, no toxicity endpoint was identified. The NOAEL for the 28-day
dermal study was set at 1,000 mg/kg/day and the LOAEL was not
established. Therefore, the endpoints assessed as part of this action
exclude the endpoint for dermal exposure identified in the table
published in the above-referenced Federal Register on June 11, 2010.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trifloxystrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing trifloxystrobin
tolerances in 40 CFR 180.555. EPA assessed dietary exposures from
trifloxystrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for trifloxystrobin. In estimating acute dietary exposure EPA conducted
an analysis using the Dietary Exposure Evaluation Model (DEEM-FCID)
Version 3.16. This model uses 2003-2008 food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). An acute
dietary assessment was conducted assuming tolerance level residues and
100 percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model (DEEM-FCID)
Version 3.16. This model uses 2003-2008 food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA). As to
residue levels in food, EPA assumed 100% crop treated, tolerance level
residues, anticipated residues for some crops, and default processing
factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that trifloxystrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for trifloxystrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of trifloxystrobin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW) models, the estimated drinking water concentrations (EDWCs) of
trifloxystrobin and its major degradation product for acute exposures
are estimated to be 29 parts per billion (ppb) for surface water, and
427 ppb for ground water. For chronic non-cancer exposure assessments,
EDWCs are estimated to be 23 ppb for surface water and 365 ppb for
ground water. Modeled estimates of drinking water concentrations were
directly entered into the acute (427 ppb) and chronic (365 ppb) dietary
assessments in the Dietary Exposure Evaluation Model--Food Commodity
Intake Database (DEEM-FCID) food categories of ``water, direct, all
sources'' and ``water, indirect, all sources.''
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Trifloxystrobin is currently registered for the following uses that
could result in residential exposures: Ornamental plants and turfgrass.
EPA assessed residential exposure from relevant registered
trifloxystrobin products using the Agency's 2012 Residential Standard
Operating Procedures (SOPs) along with updates in dermal risk
assessment hazard and policy regarding body weight in addition to the
following assumptions:
    i. Residential handler exposures. Residential handler exposure is
expected to be short-term only. Intermediate-term exposures are not
likely because of the intermittent nature of applications by
homeowners. Dermal handler exposures were not assessed since no adverse
systemic dermal hazard was identified for trifloxystrobin.
    ii. Residential post-application exposures. Because dermal hazard
has not been identified for trifloxystrobin, a quantitative post-
application assessment for dermal exposure is not necessary and the
only exposure scenarios quantitatively assessed are for children

1 to <2 years old who may experience short-term incidental oral
exposure to trifloxystrobin from treated turf. Incidental oral granule
ingestion is not applicable because there is no endpoint identified for
the acute dietary duration for infants and children. Intermediate-term
incidental oral post-application exposures are not expected because
trifloxystrobin is not persistent in soil or water; furthermore, the
short-term incidental oral risk estimates would be protective of the
possible intermediate-term incidental oral exposures because the POD
for both durations is the same. Post-application inhalation exposure is
expected to be negligible for the proposed residential uses.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. 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
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found trifloxystrobin to share a common mechanism of
toxicity with any other substances, and trifloxystrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
trifloxystrobin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that 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 EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no indication of
increased quantitative or qualitative susceptibility to trifloxystrobin
in rats or rabbits. In the prenatal developmental study in rats, there
was no developmental toxicity at and up to the limit dose. In the
prenatal developmental study in rabbits, developmental toxicity was
seen at a dose that was higher than the dose causing maternal toxicity.
In the multigeneration study, offspring and parental LOAELs are at the
same dose level.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for trifloxystrobin is complete.
    ii. There is no indication that trifloxystrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that trifloxystrobin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The exposure databases are complete or are estimated based
on data that reasonably account for potential exposures. The exposure
assessments will not underestimate the potential dietary (food and
drinking water) or non-dietary exposures for infants and children from
the use of trifloxystrobin. The acute and chronic dietary food exposure
assessment was conservatively based on 100 PCT assumptions and
conservative ground water drinking water modeling estimates. The
dietary drinking water assessment utilizes water concentration values
generated by models and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations, and are not likely to be exceeded. In
addition, the residential post-application assessment is based upon the
residential SOPs employing surrogate study data and reasonable ``worst-
case'' assumptions. These data and assessments are reliable and are not
expected to underestimate exposure and risk posed by trifloxystrobin to
adults or children as well as incidental oral exposure of young
children (1-2 years old).

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to trifloxystrobin will occupy 3.1% of the aPAD for females 13-49 years
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
trifloxystrobin from food and water will utilize 71% of the cPAD for
infants (<1 year old), the population group receiving the greatest
exposure.
    Based on the explanation in Unit III.C.3., regarding residential
use patterns, chronic residential exposure to residues of
trifloxystrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Trifloxystrobin is currently registered for uses that could result
in short-term residential exposure, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to trifloxystrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 300 for adults
and 120 for children 1 to < 2 years old. Because EPA's level of concern
for trifloxystrobin is a MOE of 100 or below, these MOEs are not of
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic

exposure to food and water (considered to be a background exposure
level). Although the Agency identified an intermediate-term endpoint,
the Agency does not expect trifloxystrobin to result in intermediate-
term residential exposure, due to the intermittent nature of homeowner
applications and its short soil half-life (about 2 days). Therefore,
the Agency relies on the chronic risk assessment to account for
intermediate-term risk and concludes that trifloxystrobin does not pose
an intermediate-term aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, trifloxystrobin is not expected to pose a cancer risk to
humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen
phosphorus detection (GC/NPD), Method AG-659A) is available to enforce
the tolerance expression for the combined residues of trifloxystrobin
and CGA-321113 in plant and livestock commodities. The lowest level of
method validation (LLMV) is equivalent to the limit of quantitation
(LOQ) which was 0.010 ppm for each analyte in/on all matrices.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established MRLs for trifloxystrobin in or on
lettuce, head at 15 ppm; celery at 1 ppm; brussel sprouts at 0.1 ppm;
cabbage at 0.5 ppm; flower head Brassicas (includes broccoli; broccoli,
Chinese; and cauliflower) at 0.5 ppm; potato at 0.2 ppm; grape at 3
ppm; and strawberry at 1 ppm. These MRLs are different than the
tolerances established for trifloxystrobin in the United States.
    These tolerances, with exception to grape and potato, cannot be
harmonized with the Codex MRLs because the MRLs for those commodities
are expressed in terms of trifloxystrobin (parent only) while U.S.
tolerances are based on the combined residues of trifloxystrobin and
its acid metabolite CGA-321113, expressed in parent equivalents.
Therefore, harmonization is not possible for these commodities as the
Codex MRLs are too low based on the U.S. residue definition for
tolerance enforcement. For grape and potato, the U.S. is establishing
MRLs for the requested representative crop groups; fruit, small vine
climbing, except fuzzy kiwifruit, subgroup 13-07F and vegetable,
tuberous and corm, subgroup 1C. These MRLs will be lower than Codex,
but identical to Canadian MRLs (for grape and potato). This will permit
harmonization with the existing Canadian MRLs as requested by the
petitioner and facilitate trade with Canada.

C. Revisions to Petitioned-For Tolerances

    The Agency is revising the commodity terms for the requested
tolerances to reflect the common commodity vocabulary currently used by
the Agency. Specifically, head and stem Brassica subgroup 5A was
changed to Brassica, head and stem, subgroup 5A; leafy Brassica
subgroup 5B was changed to Brassica, leafy greens, subgroup 5B;
tuberous and corm vegetable subgroup 1C was changed to vegetable,
tuberous and corm, subgroup 1C. small fruit vine climbing subgroup
(except fuzzy kiwifruit), subgroup 13-07F was changed to fruit, small
vine climbing, except fuzzy kiwifruit, subgroup 13-07F and low growing
berry, subgroup 13-07G was changed to berry, low growing, subgroup 13-
07G. Bayer requested a tolerance for spice (crop subgroup 19B), except
black pepper. As black pepper is the representative commodity for spice
subgroup 19B, it may not be excepted from a tolerance. 40 CFR
180.40(h). Without sufficient data to establish the subgroup tolerance,
the Agency is establishing an individual tolerance for the crop for
which data was submitted--dill, seed.

V. Conclusion

    Therefore, tolerances are established for residues of
trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene] amino]oxy]methyl]-,
methyl ester, and the free form of its acid metabolite CGA-321113,
(E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid, calculated as the
stoichiometric equivalent of trifloxystrobin, in or on Brassica, head
and stem, subgroup 5A at 2 ppm; Brassica, leafy greens, subgroup 5B at
30 ppm; herb subgroup 19A at 200 ppm; dill, seed at 30 ppm; vegetable,
tuberous and corm, subgroup 1C at 0.04 ppm; fruit, small vine climbing,
except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; berry, low growing,
subgroup 13-07G at 1.5 ppm; and leaf petioles, subgroup 4A at 30 ppm.
    The existing tolerance for leaf petioles subgroup 4B, is amended
from 3.5 ppm to 9 ppm based on new celery residue data at zero day
(pre-harvest interval) PHI. The existing tolerance for potato at 0.04
ppm is being removed because it is included with the new tolerance
being established for tuberous and corm vegetables (crop subgroup 1C)
at 0.04 ppm. Similarly, the current tolerances for grape at 2.0 ppm and
strawberry at 1.1 ppm are being removed as they are included in the new
tolerances for the small fruit vine climbing (subgroup 13-07F) at 2.0
ppm, and low growing berries (subgroup 13-07G) at 1.5 ppm,
respectively.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of

Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 11, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.555, is amended:
0
a. By alphabetically adding the commodities to the table in paragraph
(a);
0
b. By removing ``Grape'', ``Potato'', and ``Strawberry'' from the table
in paragraph (a);
0
c. By revising ``Leaf petioles subgroup 4B'' in the table in paragraph
(a).
    The additions and revision read as follows:

Sec.  180.555  Trifloxystrobin; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                              * * * * * * *
Berry, low growing subgroup 13-07G.........................          1.5
Brassica, head and stem, subgroup 5A.......................          2.0
Brassica, leafy greens, subgroup 5B........................           30

                              * * * * * * *
Dill, seed.................................................           30

                              * * * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit,                  2.0
 subgroup 13-07F...........................................

                              * * * * * * *
Herbs, subgroup 19A........................................          200

                              * * * * * * *
Leaf petioles subgroup 4B..................................          9.0
Leafy greens, subgroup 4A..................................           30

                              * * * * * * *
Vegetable, tuberous and corm, subgroup 1C..................         0.04

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

* * * * *
[FR Doc. 2016-04070 Filed 2-25-16; 8:45 am]
BILLING CODE 6560-50-P