[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35791-35792]
[FR Doc No: 2021-14476]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC21-18-000]

Commission Information Collection Activities (FERC-725Y); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on a renewal of currently approved
information collection FERC-725Y, Mandatory Reliability Standard
(Personnel Performance, Training, and Qualifications), which will be
submitted to the Office of Management and Budget (OMB) for review.

DATES: Comments on the collection of information are due August 6,
2021.

ADDRESSES: Send written comments on FERC-725Y to OMB through
www.reginfo.gov/public/do/PRAMain. Attention: Federal Energy Regulatory
Commission Desk Officer. Please identify the OMB Control Number (1902-
0279) in the subject line of your comments. Comments should be sent
within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain.
    Please submit copies of your comments to the Commission. You may
submit copies of your comments (identified by Docket No. IC21-18-000)
by one of the following methods:
    Electronic filing through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery.
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Hand (including courier) Delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: OMB submissions must be formatted and filed in
accordance with submission guidelines at www.reginfo.gov/public/do/PRAMain. Using the search function under the ``Currently Under Review''
field, select Federal Energy Regulatory Commission; click ``submit,''
and select ``comment'' to the right of the subject collection. FERC
submissions must be formatted and filed in accordance with submission
guidelines at: http://www.ferc.gov. For user assistance, contact FERC
Online Support by email at<EMAIL_ADDRESS>or by phone at:
(866) 208-3676 (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at https://www.ferc.gov/ferc-online/overview.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725Y, Mandatory Reliability Standard (Personnel
Performance, Training, and Qualifications).
    OMB Control No.: 1902-0279.
    Type of Request: Three-year extension of the FERC-725Y information
collection requirements with no changes to the reporting requirements.
    Abstract: The FERC-725Y information collection is intended to help
ensure the safe and reliable operation of the interconnected grid
through the retention of suitably trained and qualified personnel in
positions that can impact the reliable operation of the Bulk-Power
System. The Commission uses the FERC-725Y to implement the
Congressional mandate of the Energy Policy Act of 2005 to develop
mandatory and enforceable Reliability Standards to better ensure the
reliability of the nation's Bulk-Power System. FERC-725Y ensures that
personnel performing or supporting real-time operations on the Bulk
Electric System (BES) are trained using a systematic approach. The
Reliability Standard requires entities to maintain records subject to
review by the Commission and North American Electric Reliability
Corporation (NERC) to ensure compliance with the Reliability Standard.
    Reliability Standard PER-005-2 (Operations Personnel Training)
requires entities to maintain records subject to review by the
Commission and NERC to ensure compliance with the Reliability Standard.
This Reliability Standard contains of six Requirements:

 R1 requires reliability coordinators, balancing authorities,
and transmission operators to develop and implement a training program
for system operators
 R2 requires transmission owners to develop and implement a
training program for system operators
 R3 requires reliability coordinators, balancing authorities,
transmission operators and transmission owners to verify the
capabilities of their identified personnel
 R4 requires reliability coordinators, balancing authorities,
transmission operators and transmission owners to provide those
personnel with emergency operations training using simulation
technology
 R5 requires reliability coordinators, balancing authorities,
and transmission operators develop and implement training for system
operators whose job functions can impact BES real-time reliability
tasks
 R6 requires applicable generator operators to develop and
implement training for certain of their dispatch personnel at a
centrally located dispatch center

    Reliability Standard PER-006-1 (Specific Training for personnel)
ensures that personnel are trained on specific topics essential to
reliability to perform or support Real-Time operations of the Bulk
Electric System.
     R1 identifies generator operator plant personnel
responsible for Real-time control and carrying out Operating
instructions are trained on the operational functionality of Protection
Systems and Remedial Action Schemes that affect the output of
generating facility(ies) it operates.

    The 60-day Federal Register Notice \1\ published on April 21, 2021
and no comments were received during the comment period.
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    \1\ 86 FR 20685.
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    Type of Respondents: Transmission owners and generator owners.
    Estimate of Annual Burden: \2\ Our estimate below regarding the
number of respondents is based on the NERC compliance registry as of
February 5, 2021.
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    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 Code of Federal Regulations 1320.3.
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    The Commission estimates the additional annual reporting burden and
cost as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number                                          Total annual burden      Cost per
                                       Number and type of    of  responses   Total number   Average burden & cost   hours & total annual    respondent
                                        respondents \3\     per respondent   of responses      per response \4\          cost  ($)              ($)
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           FERC-725Y in Docket No. IC21-18-000
                                                             Reliability Standard PER-005-2
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Annual Evaluation and Update of      (RC, BA, TOP, TO,                   1           1,148  8 hrs.; $561.52......  9,184 hrs.;                   $561.52
 Training Program (Reporting for      GOP) 1,148.                                                                   $644,624.96.
 all Req.).
Retention of Records...............  (RC, BA, TOP, TO,                   1           1,148  10 hrs.; $433.80.....  11,480 hrs.;                  $433.80
                                      GOP) 1,148.                                                                   $498,002.40.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       FERC-725Y (Reliability Standard PER-006-1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
GOP; Reporting Req. R1.............  937 \5\..............               1             937  5 hrs.; $350.95......  4,685 hrs.;                   $350.95
                                                                                $328,840.15.
GOP; Recordkeeping Req. R1.........  937..................               1             937  10 hrs. $433.80......  9,370 hrs.;                   $433.80
                                                                                $406,470.60.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  .....................  ..............  ..............  .....................  34,719 hrs.;           ..............
                                                                                $1,877,938.11.
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \3\ For PER-005-2 and PER-006-1: RC=Reliability Coordinator;
BA=Balancing Authority; TOP=Transmission Operator; TO=Transmission
Owner; GOP=Generator Operator. To eliminate counting the same number
multiple times the figure reflects the number of US unique entities
(1,148) accounts for overlaps between RC, BA, TOP, TO and GOP. The
NERC compliance registry table February 5, 2021 was used preform
analysis.
    \4\ The estimates for cost per response are loaded hourly wage
figure (includes benefits) is based on two occupational categories
for 2020 found on the Bureau of Labor Statistics website (http://www.bls.gov/oes/current/naics2_22.htm):
     Electrical Engineer (Occupation Code: 17-2071): $70.19
(to calculate the reporting requirements).
     Office and Administrative Support (Occupation Code: 43-
0000): $43.38 (to calculate the recordkeeping requirements).
    \5\ The number of US unique GOPs is 937 taken from the NERC
compliance registry information of February 5, 2021.

    Dated: June 30, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-14476 Filed 7-6-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Rules and Regulations]
[Pages 60327-60329]
[FR Doc No: 2014-23559]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0438; Directorate Identifier 2014-CE-015-AD;
Amendment 39-17985; AD 2014-20-12]
RIN 2120-AA64

Airworthiness Directives; Alexandria Aircraft LLC Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 75-20-06 for
certain Alexandria Aircraft LLC (type certificate previously held by
Bellanca Aircraft Corp., Viking Aviation, Inc., and Bellanca, Inc.)
Models 14-19-3A, 17-30, 17-30A, 17-31, 17-31A, 17-31ATC, and 17-31TC
airplanes. AD 75-20-06 required repetitively inspecting the aft
fuselage structure near the top of the vertical side tubing, which
connects the horizontal stabilizer carry-through to the upper fuselage
longeron, for cracks and installing the manufacturer's service repair
kit as a terminating action for the repetitive inspections to repair
any cracks found. Since we issued AD 75-20-06, we have determined that
installing the service kit has not prevented cracks from occurring. We
have also determined that all affected airplane serial numbers should
be included in the Applicability section. This AD requires continued
repetitive inspections of the aft fuselage structure near the top of
the vertical side tubing for cracks and making all necessary
replacements of cracked parts. This AD also adds additional serial
number airplanes to the Applicability section. We are issuing this AD
to correct the unsafe condition on these products.

DATES: This AD is effective November 12, 2014 November 12, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 12,
2014.

ADDRESSES: For service information identified in this AD, contact
Alexandria Aircraft LLC, 2504 Aga Drive, Alexandria, MN 5630; phone:
(320) 763-4088; fax:<PHONE_NUMBER>; Internet: www.bellanca-
aircraft.com; email<EMAIL_ADDRESS>You may view this
referenced service information at the FAA, Small Airplane Directorate,
901 Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0438; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Steven Rosenfeld, Aerospace Engineer,
FAA, Chicago Aircraft Certification Office, 2300 East Devon Avenue,
Room 107, Des Plaines, IL 60018; phone:<PHONE_NUMBER>; fax: (847) 294-
7834; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 75-20-06, Amendment 39-2372 (40 FR 43484,
September 22, 1975, (``AD 75-20-06''). AD 75-20-06 applied to certain
Alexandria Aircraft LLC (type certificate previously held by Bellanca
Aircraft Corp., Viking Aviation, Inc., and Bellanca, Inc.) Models 14-
19-3A, 17-30, 17-30A, 17-31, 17-31A, 17-31ATC, and 17-31TC airplanes.
The NPRM published in the Federal Register on July 2, 2014 (79 FR
37679). The NPRM was prompted by reports that cracks are still being
found in the vertical side fuselage tube (F.S. 7) in the area near the
upper fuselage longeron on airplanes that have had Bellanca Kit
SK1234789-0004 installed, which is a terminating action for the
repetitive inspections required in AD 75-20-06. The NPRM proposed to
retain the inspection requirements of AD 75-20-06, remove the
terminating action allowed in AD 75-20-06, and change the applicability
to include all serial numbers. We are issuing this AD to correct the
unsafe condition on these products.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 37679, July 2,
2014) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 37679, July 2, 2014) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 37679, July 2, 2014).

Costs of Compliance

    We estimate that this AD affects 847 airplanes of U.S. registry.

    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
             Action                  Labor cost               Parts cost              product        operators
----------------------------------------------------------------------------------------------------------------
Inspecting the horizontal        1 work-hour x $85   Not applicable.............             $85         $71,995
 stabilizer fuselage attachment   per hour = $85.
 tube and carry-thru tube
 support bracket (retained
 actions from AD 75-20-06).
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that will be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of the horizontal stabilizer        30 work-hours x $85 per hour =              $575          $3,125
 fuselage attachment tube and carry-thru tube    $2,550.
 support bracket.
----------------------------------------------------------------------------------------------------------------

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.
    We are 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

    We have determined that 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,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of 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 removing Airworthiness Directive (AD)
75-20-06, Amendment 39-2372 (40 FR 43484, September 22, 1975), and
adding the following new AD:

2014-20-12 Alexandria Aircraft LLC: Amendment 39-17985; Docket No.
FAA-2014-0438; Directorate Identifier 2014-CE-015-AD.

(a) Effective Date

    This AD is effective November 12, 2014.

(b) Affected ADs

    This AD supersedes AD 75-20-06, Amendment 39-2372 (40 FR 43484,
September 22, 1975, (``AD 75-20-06'')).

(c) Applicability

    This AD applies to Alexandria Aircraft LLC (type certificate
previously held by Bellanca Aircraft Corp., Viking Aviation, Inc.,
and Bellanca, Inc.) Models 14-19-3A, 17-30, 17-30A, 17-31, 17-31A,
17-31ATC, and 17-31TC airplanes, all serial numbers (S/Ns),
certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports that cracks are still being
found in the vertical side fuselage tube (fuselage station 7) in the
area near the upper fuselage longeron on airplanes that have had
Bellanca Kit SK1234789-0004 installed, which is a terminating action
for the repetitive inspections required in AD 75-20-06. We are
issuing this AD to detect and correct cracks in either vertical side
fuselage tube (F.S. 7), which is adjacent to the horizontal
stabilizer carry-through, in the area near the upper fuselage
longeron to prevent failure of the horizontal stabilizer. This
failure could cause reduced structural integrity of the fuselage and
result in loss of control.

(f) Compliance

    Comply with this AD within the compliance times specified in
paragraphs (g) through (h) of this AD, unless already done.

(g) Inspection

    (1) Models 14-19-3A and 17-31A, S/Ns 32-15 through 76-32-163;
Models 17-30 and 17-30A, S/Ns 30263 through 76-30811; and Models 17-
31, 17-31TC, and 17-31ATC, S/Ns 30004, and 31004 through 76-31124
(airplanes previously affected by AD 75-20-06): Within the next 100
hours time-in-service (TIS) after the last inspection completed by
AD 75-20-06 or within the next 25 hours TIS after November 12, 2014
(the effective date of this AD), whichever occurs later, and
repetitively thereafter at intervals not to exceed 100 hours TIS,
visually inspect the aft fuselage truss for cracks as specified in
paragraph 4. INSPECTION of Alexandria Aircraft LLC

Bellanca Service Letter 85, Revision B, dated April 8, 2004.
    (2) Models 14-19-3A, 17-30, 17-30A, 17-31, 17-31A, 17-31ATC, and
17-31TC airplanes, all S/Ns not referenced in paragraph (g)(1) of
this AD (airplanes not previously affected by AD 75-20-06): Before
or upon the accumulation of 300 hours TIS or within the next 25
hours TIS after November 12, 2014 (the effective date of this AD),
whichever occurs later, and repetitively thereafter at intervals not
to exceed 100 hours TIS, visually inspect the aft fuselage truss for
cracks as specified in paragraph 4. INSPECTION of Alexandria
Aircraft LLC Bellanca Service Letter 85, Revision B, dated April 8,
2004.

(h) Replacement

    If cracks are found during any inspection required by paragraphs
(g)(1) and (g)(2) of this AD, before further flight, replace the
cracked parts with FAA-approved zero-time parts as specified in
paragraph 5. REPAIR of Alexandria Aircraft LLC Bellanca Service
Letter 85, Revision B, dated April 8, 2004.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Chicago Aircraft Certification Office (ACO),
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 local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) AMOCs approved for AD 75-20-06, Amendment 39-2372 (40 FR
43484, September 22, 1975) are not approved as AMOCs for the
corresponding provisions of this AD.

(j) Related Information

    For more information about this AD, Steven Rosenfeld, Aerospace
Engineer, FAA, Chicago ACO, 2300 East Devon Avenue, Room 107, Des
Plaines, IL 60018; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(k) 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 the AD specifies otherwise.
    (i) Alexandria Aircraft LLC Bellanca Service Letter 85, Revision
B, dated April 8, 2004.
    (ii) Reserved.
    (3) For Alexandria Aircraft LLC service information identified
in this AD, contact Alexandria Aircraft LLC, 2504 Aga Drive,
Alexandria, MN 5630; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
Internet: www.bellanca-aircraft.com; email<EMAIL_ADDRESS>    (4) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) 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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on September 26, 2014.
Kelly A. Broadway,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-23559 Filed 10-6-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 36002-36005]
[FR Doc No: 2013-14112]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69723; File No. SR-OCC-2013-08]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Proposed Rule Change To Reflect Enhancements in
OCC's System for Theoretical Analysis and Numerical Simulations as
Applied to Longer-Tenor Options

June 10, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 30, 2013, The Options Clearing Corporation (``OCC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the clearing agency.\3\ The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ OCC also filed the proposed rule change as an advance notice
under Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street
Reform and Consumer Protection Act entitled the Payment, Clearing,
and Settlement Supervision Act of 2010 (``Clearing Supervision
Act''). 12 U.S.C. 5465(e)(1). See SR-OCC-2013-803.
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change would provide for enhancements in OCC's
margin model for longer-tenor options (i.e., those options with at
least three years of residual tenor) and would reflect those
enhancements in the description of OCC's margin model in OCC's Rules.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, OCC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. OCC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.\4\
---------------------------------------------------------------------------

    \4\ The Commission has modified the text of the summaries
prepared by OCC.
---------------------------------------------------------------------------

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    The purpose of this proposed rule change is to provide for
enhancements in OCC's margin model for longer-tenor options (i.e.,
those options with at least three years of residual tenor) and to
reflect those enhancements in the description of OCC's margin model in
OCC's Rules. OCC also proposes to make changes to the description of
OCC's margin model to clarify that description.
1. Background
    On August 30, 2012, OCC submitted a rule change with respect to
OCC's proposal to clear certain over-the-counter options on the S&P 500
Index (``OTC Options'').\5\ The OTC Options Rule Filing, as amended,
added a statement appearing before Section 6 of Article XVII of OCC's
By-Laws that ``THE BY-LAWS IN THIS SECTION (OTC INDEX OPTIONS) ARE

INOPERATIVE UNTIL FURTHER NOTICE BY THE CORPORATION'' to clarify that
OCC would not commence clearing OTC Options until the changes being
made to OCC's margin model for longer-tenor options, as provided in
this rule change, were put in place, notwithstanding whether the OTC
Options Rule Filing had already been approved. OCC is now proposing to
remove this statement from Section 6, which will allow OCC to commence
clearing of OTC Options on the S&P 500 Index.
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    \5\ See Release No. 34-67835; File No. SR-OCC-2012-14 (``OTC
Options Rule Filing''); published September 18, 2012 at 77 FR 57602.
SR-OCC-2012-14 replaced SR-OCC-2011-19, which was withdrawn on March
9, 2012. The OTC Options Rule Filing was subsequently amended to add
a statement to Section 6 of Article XVII of OCC's By-Laws providing
that the OTC Index Options By-Laws were to be inoperative until
further notice by OCC. See File No. SR-OCC-2012-14 Amendment No.1.
---------------------------------------------------------------------------

    Additional information concerning OCC's proposal to clear OTC
Options is included in the OTC Options Rule Filing. As described in the
OTC Options Rule Filing, OCC intends to use its STANS margin system to
calculate margin requirements for OTC Options on the same basis as for
exchange-listed options cleared by OCC. However, OCC is proposing to
implement enhancements to its risk models for all longer-tenor options
(including OTC Options) in order to better reflect certain risks of
longer-tenor options. The changes described herein would apply to all
longer-tenor options cleared by OCC and would be implemented before OCC
begins clearing OTC Options.
2. Description of Proposed Rule Changes
    OCC states that the proposed rule change includes daily OTC quotes,
variations in implied volatility, and valuation adjustments in the
modeling of all longer-tenor options under STANS, thereby enhancing
OCC's ability to set margin requirements through the use of risk-based
models and parameters and encouraging clearing members to have
sufficient financial resources to meet their obligations to OCC. OCC
believes the proposed rule change would not affect OCC's safeguarding
of securities and funds in its custody or control because, though it
may change margin requirements in respect of certain longer-tenor
options, it does not change the manner in which margin assets are
pledged. In addition, OCC believes the proposed rule change allows OCC
to enhance its risk management procedures and controls related to
longer-tenor options.
    OCC states that it calculates clearing-level margin using STANS,
which determines the minimum expected liquidating value of each account
using a large number of projected price scenarios created by large-
scale Monte Carlo simulations. OCC is proposing to implement
enhancements to the STANS margin calculation methodology with respect
to longer-tenor options and to amend Rule 601 to reflect these
enhancements as well as to make certain clarifying changes in the
description of STANS in Rule 601. The specific details of the
calculations performed by STANS are maintained in OCC's proprietary
procedures for the calculation of margin and coded into the computer
systems used by OCC to calculate daily margin requirements.
    OCC has proposed at this time to clear only OTC Options on the S&P
500 index and only such options with tenors of up to five years.
However, OCC currently clears FLEX Options with tenors of up to fifteen
years. While OCC believes that its current risk management practices
are adequate for current clearing activity, OCC proposes to implement
risk modeling enhancements with respect to all longer-tenor options.
Daily OTC Indicative Quotes
    OCC states that, in general, the market for listed longer-tenor
options is less liquid that the market for other options, with less
volume and therefore less price information. In order to supplement
OCC's pricing data derived from the listed markets, and to improve the
price discovery process for longer-tenor options, OCC proposes to
include in the daily dataset of market prices used by STANS to value
each portfolio indicative daily quotations obtained through a third-
party service provider that obtains these quotations through a daily
poll of OTC derivatives dealers. A third-party service provider was
selected to provide this data in lieu of having the data provided
directly by the OTC derivatives dealers in order to avoid unnecessarily
duplicating reporting that is already done in the OTC markets.
Variations in Implied Volatility
    OCC states that, to date, the STANS methodology has assumed that
implied volatilities of option contracts do not change during the two-
day risk horizon used by OCC in the STANS methodology. According to
OCC, back testing of its margin models has identified few instances in
which this assumption would have, as a result of sudden changes in
implied volatility, resulted in margin deposits insufficient to
liquidate clearing member accounts without loss. However, as OCC
expects to begin clearing more substantial volumes of longer-tenor
options, including OTC Options, OCC believes that implied volatility
shocks may become more relevant due to the greater sensitivity of
longer-tenor options to implied volatility. OCC therefore proposes to
introduce variations in implied volatility in the modeling of all
longer-tenor options under STANS. OCC states that this will be achieved
by incorporating, into the set of risk factors whose behavior is
included in the econometric models underlying STANS, time series of
proportional changes in implied volatilities for a range of tenors and
in-the-money and out-of-the-money amounts representative of the dataset
provided by OCC's third-party service provider.
    OCC states that it has reviewed individual S&P 500 Index put and
call options positions with varying in-the-money amounts and with four
to nine years of residual tenor and that such review indicates that the
inclusion of modeled implied volatilities tends to result in less
margin being held against short call positions and more margin being
held against short put positions. OCC believes these results are
consistent with what would be expected given the strong negative
correlation that exists between changes in implied volatility and
market returns.
    OCC states that the description of the Monte Carlo simulations
performed within STANS in Rule 601 references revaluations of assets
and liabilities in an account under numerous price scenarios for
``underlying interests.'' In order to accommodate the proposed implied
volatility enhancements, OCC is proposing to amend this portion of Rule
601 to provide that the scenarios used may also involve projected
levels of other variables influencing prices of cleared contracts and
modeled collateral. Accordingly, the references to ``underlying
interests'' are proposed to be deleted.
Valuation Adjustment
    OCC states that historically it has not cleared a significant
volume of longer-tenor options, but that it anticipates that there will
be growth in volume of longer-tenor options, including OTC Options,
being cleared with three to five year tenors. Longer-tenor options may
represent a larger portion of any clearing member's portfolio in the
future, and OCC has therefore identified a need to model anticipated
changes in the value of longer-tenor options on a portfolio basis in
order to address OCC's exposure to longer-tenor options that may have
illiquid characteristics. OCC proposes to introduce a valuation
adjustment into the portfolio net asset value used by STANS based upon
the aggregate sensitivity of any longer-tenor options in a portfolio to
the overall level of implied volatilities at three years and five years
and to the relationship between implied volatility and exercise prices
at both the three- and five-year tenors in order to allow for the
anticipated market impact of unwinding

a portfolio of longer-tenor options, as well as for any differences in
the quality of data in OCC's third party service provider's dataset,
given that month-end data may be subjected to more extensive validation
by the service provider than daily data. In order to accommodate the
planned valuation adjustment for longer-tenor options, OCC proposes to
add language to Rule 601 to indicate that the projected portfolio
values under the Monte Carlo simulations may be adjusted to account for
bid-ask spreads, illiquidity, or other factors.
Clarification of Pricing Model Reference in Rule 601
    Rule 601 currently refers to the use of ``options pricing models''
to predict the impact of changes in values on positions in OCC-cleared
contracts. OCC is proposing to amend this description to reflect that
OCC currently uses non-options related models to price certain
instruments, such as futures contracts and U.S. Treasury securities.
OCC states that this change is not intended to be substantive and
simply clarifies the description in Rule 601.
Effect on Clearing Members
    OCC believes that the proposed rule change will affect clearing
members who engage in transactions in longer-tenor options, and
indirectly their customers, by enhancing the STANS margin calculation
methodology for these options. The STANS enhancements could increase
margin requirements with respect to these positions. However, OCC
states that it does not believe that the enhancements will result in
significantly increased margin requirements for any particular clearing
member, and therefore that it is not aware of any significant problems
that clearing members are likely to have in complying with the proposed
rule change.
    OCC believes the proposed rule change is consistent with the
purposes and requirements of Section 17A(b)(3)(F) of the Act \6\ and
the rules and regulations thereunder, including Rules 17Ad-22(b)(2) and
(d)(2), because, by providing additional clarity to clearing members
and others concerning the current calculation of margin requirements
under OCC's Rules, while also enhancing the calculation of margin with
respect to longer-tenor options, the proposed modifications would help
remove impediments to and perfect the mechanism of a national system
for the prompt and accurate clearance and settlement of securities
transactions,\7\ ensure that OCC's rules are reasonably designed to
have participation requirements that are objective and publicly
disclosed and permit fair and open access,\8\ and provide for a well-
founded, transparent, and enforceable legal framework.\9\ OCC states
that the proposed rule change is not inconsistent with any rules of
OCC, including any other rules proposed to be amended.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1.
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
    \8\ 17 CFR 240.17Ad-22(d)(2).
    \9\ 17 CFR 240.17Ad-22(d)(1).
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(B) Clearing Agency's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would impose a
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. With respect to a burden on
competition among clearing agencies, OCC does not believe that the
proposed rule change would have any impact because OCC is the only
registered clearing agency that issues options and provides central
counterparty services to the options markets.
    OCC does not believe that enhancing OCC's margin model for longer-
tenor options would inhibit access to any of OCC's services or
disadvantage or favor any user of OCC's services in relationship to any
other such user because the model enhancements would apply equally to
all clearing members clearing longer-tenor options. Moreover, OCC
believes that the proposed rule change would also promote competition
among participants in the longer-tenor options markets. The rule change
would enhance OCC's ability to manage risk within OCC's existing
structure, and improve OCC's ability to reduce systemic risk to the
longer-tenor options market in general as well as reduce inter-dealer
counterparty risk in the OTC Options market, allowing for increased
participation in this market.
    For the foregoing reasons, OCC believes that the proposed rule
change is in the public interest, would be consistent with the
requirements of the Act applicable to clearing agencies, and would not
impose a burden on competition that is unnecessary or inappropriate in
furtherance of the purposes of the Act because the changes would
enhance OCC's margin methodology for longer-tenor options in ways that
help to promote the purposes of the Act and Rule 17Ad-22 thereunder as
described above.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments were not and are not intended to be solicited by
OCC with respect to the proposed rule change and none have been
received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.
    The proposal shall not take effect until all regulatory actions
required with respect to the proposal are completed.\10\
---------------------------------------------------------------------------

    \10\ OCC also filed the proposed rule change as an advance
notice under Section 806(e)(1) of the Clearing Supervision Act. See
supra note 3.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2013-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-OCC-2013-08. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the

submission, all subsequent amendments, all written statements with
respect to the proposed rule change that are filed with the Commission,
and all written communications relating to the proposed rule change
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of OCC and on OCC's Web site
(http://www.theocc.com/about/publications/bylaws.jsp). All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-OCC-2013-08 and should be
submitted on or before July 5, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-14112 Filed 6-13-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 2, 2010 (Volume 75, Number 105)]
[Notices]
[Page 30838-30839]
[DOCID:fr02jn10-84]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-N-0196] (formerly Docket No. 2003N-0233)

Drometrizole Trisiloxane Eligibility for Potential Inclusion in
Sunscreen Monograph; Over-the-Counter Sunscreen Drug Products for Human
Use; Request for Safety, Effectiveness, and Environmental Data

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of eligibility; request for data and information.

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SUMMARY:  As part of our ongoing review of over-the-counter (OTC) drug
products, we (Food and Drug Administration, FDA) are announcing a call-
for-data for safety, effectiveness, and environmental information for
drometrizole trisiloxane, in concentrations up to 15 percent, as a
sunscreen single active ingredient and in combination with generally
recognized as safe and effective (GRASE) sunscreen active ingredients
found in the sunscreen monograph. We reviewed a time and extent
application (TEA) for drometrizole trisiloxane and determined that it
is eligible to be considered for inclusion in our OTC drug monograph
system. We will evaluate the submitted safety and effectiveness data
and information to determine whether drometrizole trisiloxane can be
GRASE for its proposed OTC use. We also request data and information to
assess the projected environmental effects of a potential GRASE
determination in order to assist us in complying with the requirements
of the National Environmental Policy Act of 1969 (NEPA).

DATES:  Submit data, information, and general comments by August 31,
2010.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2003-
N-0196, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and docket number. All comments received may be posted without change
to http://www.regulations.gov, including any personal information
provided.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Anita Kumar, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5445, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Eligibility of Drometrizole Trisiloxane

    In January 2009, we received a TEA (Ref. 1) requesting that
drometrizole trisiloxane be found eligible for review and potential
inclusion in our OTC sunscreen drug monograph (part 352 (21 CFR part
352)). After reviewing the TEA, we believe that it includes adequate
data demonstrating that drometrizole trisiloxane has been marketed for
the prevention of sunburn for a material time and to a material extent
as required by Sec.  330.14 (21 CFR 330.14) (Ref. 2). Drometrizole
trisiloxane-containing sunscreen products indicated for the prevention
of sunburn have been marketed directly to consumers for over 5
continuous years in 40 countries, with over 177 million dosage units
marketed in 54 countries. Therefore, we conclude that drometrizole
trisiloxane, in concentrations up to 15 percent, is eligible to be
considered for potential inclusion in the OTC sunscreen drug monograph
as a single active ingredient and in combination with GRASE sunscreen
active ingredients found in Sec.  352.10.

II. Request for Data and Information

    We invite all interested persons to submit data and information, as
described in Sec.  330.14(f), on the safety and effectiveness of
drometrizole trisiloxane for use as an active ingredient in OTC
sunscreen products. The data should be sufficient so that we can
determine whether the ingredient can be GRASE and not misbranded under
recommended conditions of OTC use. Interested parties may refer to 21
CFR 330.10(a)(4) regarding the evidence necessary for establishing
general recognition of safety and effectiveness.
    Because the TEA that we reviewed did not include an official or
proposed United States Pharmacopeia-National Formulary (USP-NF) drug
monograph for drometrizole trisiloxane, we are asking interested
parties to provide such a monograph to us. An active ingredient must be
recognized in an official USP-NF drug monograph that sets forth its
standards of identity, strength, quality, and purity in order to be
included in a final OTC monograph (Sec.  330.14(i)).
    In addition, as stated in 21 CFR 25.1, FDA regulations must comply
with NEPA. To comply with NEPA, an environmental assessment (EA) of
agency actions is required unless we determine that a categorical
exclusion is warranted. Therefore, we also invite all interested
persons to either submit data and information that would support a
determination that the potential inclusion of drometrizole trisiloxane
in the OTC monograph for sunscreen meets the requirements for any
categorical exclusion found in 21 CFR 25.31, or to prepare an EA, if
necessary. For additional information on the types of information that
would support our environmental assessment, please refer to section IV
(pages 9 through 27) of the Center for Drug Evaluation and Research
Guidance on Environmental Assessment of Human Drug and Biologic
Applications. The guidance document can be viewed at http://
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm070561.pdf.
    For all data and information submitted, we request that a submitter
segregate any data or information that the submitter believes is
protected from disclosure by 5 U.S.C. 552(b), 18 U.S.C. 1905, or 21
U.S.C. 331(j) or 360j(c). If such data or information is included in
the submission, we request that the submitter summarize the
confidential information, to the extent possible, so that the summary
can be publicly disclosed (see 21 CFR 25.50 and 25.51(a); Sec.
330.14(f)).

III. Marketing Policy

    Under Sec.  330.14(h), any sunscreen product containing
drometrizole trisiloxane may not be marketed as an OTC drug in the
United States at this time unless it is the subject of an approved new
drug application or abbreviated new drug application.

IV. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) under Docket No. FDA-2003-N-0196 and may be
seen by interested persons between 9 a.m. and 4 p.m., Monday through
Friday.
    1. Redacted TEA for drometrizole trisiloxane submitted by L'Oreal
USA Products, Inc., dated January 21, 2009.
    2. FDA's evaluation of the TEA for drometrizole trisiloxane.

    Dated: May 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13001 Filed 6-1-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Rules and Regulations]
[Pages 41911-41915]
[FR Doc No: 2014-16807]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0644; FRL-9913-35]

Zoxamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
zoxamide in or on onion, bulb, subgroup 3-07A. Gowan Company requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective July 18, 2014. Objections and
requests for hearings must be received on or before September 16, 2014,
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-2013-0644, 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: Lois Rossi, 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-2013-0644 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
September 16, 2014. 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-2013-0644, 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 May 23, 2014 (79 FR 29731) (FRL-9910-
29), 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
3F8164) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition
requested that 40 CFR 180.567 be amended by establishing tolerances for
residues of the fungicide zoxamide, 3, 5-dichloro-N-(3-chloro-1-ethyl-
1-methyl-2-oxopropyl)-4-methylbenzamide, and its metabolites 3,5-
dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-
dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated
as the stoichiometric equivalent of zoxamide, in or on onion, bulb,
subgroup 3-07A at 0.7 parts per million (ppm). That document referenced
a summary of the petition prepared by Gowan Company, the registrant,
which is available in the docket, http://www.regulations.gov. Comments
were received on the notice of filing. EPA's response to these comments
is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is
establishing the tolerance as requested but revising the tolerance
expressions for zoxamide. The reason for these changes are explained in
Unit IV.D.

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 zoxamide including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with zoxamide 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.
    The toxicity data of zoxamide indicate that the primary target
organ is the liver. Liver and thyroid weights increased along with
liver histopathological change and increases in alkaline phosphatase.
Systemic toxicity was not observed in the 28-day rat dermal toxicity
study up to the limit dose (1,000 milligram/kilogram/day (mg/kg/day)).
There are no concerns for neurotoxicity, immunotoxicity, developmental
toxicity, or reproductive toxicity. There was no evidence of increased
susceptibility (quantitative or qualitative) for the offspring in the
reproduction studies or for fetuses following in utero exposure in the
developmental studies. Zoxamide is classified as ``not likely to be
carcinogenic to humans'' based on the lack of treatment-related tumors
in acceptable/guideline carcinogenicity studies in rats and mice.
    Specific information on the studies received and the nature of the
adverse effects caused by zoxamide as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Zoxamide. Health Risk Assessment for
the Proposed New Use on Bulb Onions (Crop Subgroup 3-07A) in docket ID
number EPA-HQ-OPP-2013-0644.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for zoxamide used for
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Zoxamide for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)..  There is no indication of an adverse effect attributable to a single dose.
                                    Additionally, developmental, neurotoxicity, and reproductive effects were
                                    not observed in the database. An aRfD was not established.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)  NOAEL= 48 mg/kg/day.  Chronic RfD = 0.48   Chronic Toxicity--Dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 255 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.48 mg/kg/    body weight changes, increases in
                                   FQPA SF = 1x........   day.                 liver and thyroid weights, and
                                                                               increases in alkaline
                                                                               phosphatase.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  There were no systemic or dermal toxicity findings in a 28-day dermal
                                    toxicity study in the rat up to the limit dose (1000 mg/kg/day) and there
                                    were no developmental, reproductive, or neurotoxicity concerns observed in
                                    the database.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  Chronic Toxicity--Dog.
 days) and Inhalation               study NOAEL= 48 mg/                       LOAEL = 255 mg/kg/day based on
 Intermediate-term (1 to 6          kg/day.                                    body weight changes, increases in
 months).                          UFA = 10x...........                        liver and thyroid weights, and
                                   UFH = 10x...........                        increases in alkaline
                                   FQPA SF = 1x........                        phosphatase.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to zoxamide, EPA considered exposure under the petitioned-for
tolerances as well as all existing zoxamide tolerances in 40 CFR
180.567. EPA assessed dietary exposures from zoxamide 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.
    No such effects were identified in the toxicological studies for
zoxamide; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA assumed
tolerance-level residues, 100% crop treated (CT), and default
processing factors from the Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEM-FCID) Version 7.81
(except for grape, raisin and potato granules/flakes).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that zoxamide does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for zoxamide in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of zoxamide. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM
GW), the estimated drinking water concentrations (EDWCs) of zoxamide
for chronic exposures (non-cancer) are estimated to be 0.81 parts per
billion (ppb) for surface water and 65.8 ppb for ground water,
respectively.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 65.8 ppb was used to
assess the contribution to drinking water.
    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).
    Zoxamide is not registered for any specific use patterns that would
result in residential exposure.
    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 zoxamide to share a common mechanism of toxicity
with any other substances, and zoxamide does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that zoxamide 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://www.epa.gov/pesticides/cumulative.

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. The prenatal and postnatal
toxicity studies include rat and rabbit prenatal developmental studies
in addition to a reproduction and fertility effects study in rats; and
the highest doses used in these studies are at or above the limit dose.
In the developmental studies, maternal and fetal toxicity was not
observed up to the limit dose (1,000 mg/kg/day). In the rat
reproduction and fertility effects study, decreased body weights and
body weight gains was observed in only the parental females at the
highest dose tested. Therefore, EPA has concluded that there was no
evidence of increased susceptibility (quantitative or qualitative) for
the offspring in the reproduction studies or for fetuses following in
utero exposure in the developmental studies.
    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 zoxamide is complete.
    ii. There is no indication that zoxamide 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 zoxamide 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 dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to zoxamide in drinking water. These assessments
will not underestimate the exposure and risks posed by zoxamide.

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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
zoxamide is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
zoxamide from food and water will utilize 4.8% of the cPAD for children
1 to 2 years old, the population group receiving the greatest

exposure. There are no residential uses for zoxamide.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate risk takes into account short-term and
intermediate-term residential exposure, respectively, plus chronic
exposure to food and water (considered to be a background exposure
level).
    Zoxamide is currently not registered for any use patterns that
could result in short-term or intermediate-term residential exposure.
Because short- or intermediate-term residential exposure and chronic
dietary exposure have already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short-term risk), further assessment of short- and intermediate-
term risk is not necessary. EPA relies on the chronic dietary risk
assessment for evaluating short- and intermediate-term risk for
zoxamide.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, zoxamide is not expected to pose a cancer risk to humans.
    5. 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 zoxamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron
capture detection (GC/ECD) and GC with mass selective detection (GC/
MSD)) is available to enforce the tolerance expression.
    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.
    Neither Codex, Canada, nor Mexico has not established a MRL for
zoxamide in/on bulb onions, so there will be no need to harmonize the
international standards.

C. Response to Comments

    One comment was received in response to the notice of filing of
Gowan Company's application. The commenter objected to the increase of
chemical residues generally and expressed concerns about the
carcinogenic effects of chemicals in general on humans. The Agency
understands the commenter's concerns regarding toxic chemicals and
their potential effects on humans. Pursuant to its authority under the
FFDCA, and as discussed further in this preamble, EPA conducted a
comprehensive assessment of zoxamide, which included an assessment on
the carcinogenic potential of zoxamide. Based on its assessment of the
available data, the Agency has concluded that zoxamide is not likely to
be a carcinogen and that there is a reasonable certainty that no harm
will result from aggregate exposure to residues of zoxamide.

D. Revisions to Petitioned-For Tolerances

    EPA is revising the tolerance expressions to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of Zoxamide not specifically
mentioned; and
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

 V. Conclusion

    Therefore, tolerances are established for residues of zoxamide, 3,
5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide
and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455
and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452
and RH-141452) calculated as the stoichiometric equivalent of zoxamide,
in or on onion, bulb, subgroup 3-07A at 0.7 ppm.
    In addition, EPA is revising the tolerance expressions for zoxamide
contained in paragraphs (a)(1) and (a)(2), and in paragraph (b),
removing the commodity ginseng, and reserving paragraph (b).

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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: July 10, 2014.
Lois Rossi,
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. Section 180.567 is amended as follows:
0
a. Revise the introductory text of paragraph (a)(1);
0
b. Revise the introductory text of paragraph (a)(2);
0
c. Alphabetically add ``Onion, bulb, subgroup 3-07A'' to the table in
paragraph (a)(2); and
0
d. Remove and reserve paragraph (b) to read as follows:

Sec.  180.567  Zoxamide; tolerance for residues.

    (a) General. (1) Tolerances are established for residues of
zoxamide including metabolites and degradates, in or on the commodities
in the table below. Compliance with the tolerance levels specified
below is to be determined by measuring only zoxamide (3,5-dichloro-N-
(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide).
* * * * *
    (2) Tolerances are established for residues of zoxamide including
metabolites and degradates, in or on the commodities in the table
below. Compliance with the tolerance levels specified below is to be
determined by measuring only the sum of zoxamide (3,5-dichloro-N-(3-
chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) and its
metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 and RH-
141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and RH-
141452) calculated as the stoichiometric equivalent of zoxamide.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Onion, bulb, subgroup 3-07A................................          0.7

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

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2014-16807 Filed 7-17-14; 8:45 am]
BILLING CODE 6560-50-P


HIGH LOW Commodities 149,075 91,279 91,279 91,279 Cucurbits 1,391,558 1,197,818 807,728 533,556 Eggplants 161529 160,374 120,471 88,544 Forest Seedlings 355,166 152,629 152,629 152,629 Ham 169,670 40,854 40,854 40,854 Orchard Replant 1,315,190 1,046,003 523,002 366,101 Fruit, Nut, & Flower Nursery 120,094 11,178 11,178 11,178 Ornamentals 283,495 145,905 145,905 145,905 Peppers 2,153,749 1,883,560 1,473,364 1,049,237 Strawberry Fruit 2,391,026 2,231,908 1,878,384 1,686,410 Strawberry Nursery 180,756 4,029 4,029 4,029 Structures Food Facilities 586,721 454,766 401,889 401,889 Tomatoes 4,722,340 4,535,675 2,716,336 2,209,420 Turf 680,388 246,468 112,143 65,043 Post Harvest Use ( NPMA) 189,050 171,664 147,320 147,320 TOTAL 14,849,807 12,374,110 8,626,512 6,993,395 PERCENT (%) OF 1991 BASELINE 58% 48% 34% 27%

1991 BASELINE 25,527,550 KILOGRAMS Conversion Units: 1 Pound = 0.453592 Kilograms Last Update: Methyl Bromide Critical Use Exemp 2007 Bromide Usage Numerical I ALL SECTOR COMPREHE SECTOR 2007 APPLICANT REQUEST ( KGS) INCLUDING SUBTRACTIONS FROM REQUEST ( KGS) COMBINED IMPACTS ADJUSTMENT ( KGS) INCLUDING ADOPTION / TRANSITION ADJUSTMENT 91,279 20 91,299 597,986 941 598,927 96,047 433 96,480 152,629  152,629 40,854  40,854 402,973 1,658 404,631 11,178 1,506 12,684 145,905 4,060 149,965 1,148,907 2,844 1,151,751 1,731,524 2,377 1,733,901 4,029 454 4,483 401,889  401,889 2,328,546 5,501 2,334,047 76,112 1,928 78,040 147,320  147,320 7,377,178 21,722 7,398,900 29% 0% 29%

1/ 28/ 05 low 76.5% RESEARCH AMOUNT ( KGS) 2007 NOMINATION OPTION mption Process l Index ( BUNI)  HENSIVE MOST LIKELY IMPACT VALUE ( KGS)