[Federal Register: October 1, 2010 (Volume 75, Number 190)]
[Proposed Rules]
[Page 60655-60658]
[DOCID:fr01oc10-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0952; Directorate Identifier 2010-NM-131-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A330-201, -202, -203, -
223, and -243 Airplanes; Airbus Model A330-300 Series Airplanes; and
Airbus Model A340-200 and -300 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    [T]he FAA published SFAR 88 (Special Federal Aviation Regulation
88).
    By mail referenced 04/00/02/07/01-L296 of March 4th, 2002 and
04/00/02/07/03-L024 of February 3rd, 2003 the JAA [Joint Aviation
Authorities] recommended to the National Aviation Authorities (NAA)
the application of a similar regulation.
    The aim of this regulation is to require * * * a definition
review against explosion hazards.
* * * * *

Failure of the auxiliary power unit (APU) bleed leak detection system
could result in overheat of the fuel tank located in the horizontal
stabilizer and ignition of the fuel vapors in that tank, which could
result in a fuel tank explosion and consequent loss of the airplane.
The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by November 15,
2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; e-mail<EMAIL_ADDRESS>Internet http://
www.airbus.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington. 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; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0952;
Directorate Identifier 2010-NM-131-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We have lengthened the 30-day comment period for proposed ADs that
address MCAI originated by aviation authorities of other countries to
provide adequate time for interested parties to submit comments. The
comment period for these proposed ADs is now typically 45 days, which
is consistent with the comment period for domestic transport ADs.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0089, dated May 10, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    [T]he FAA published SFAR 88 (Special Federal Aviation Regulation
88).
    By mail referenced 04/00/02/07/01-L296 of March 4th, 2002 and
04/00/02/07/03-L024 of February 3rd, 2003 the JAA [Joint Aviation
Authorities] recommended to the National Aviation Authorities (NAA)
the application of a similar regulation.
    The aim of this regulation is to require all holders of type
certificates for transport aircraft certified after 01 January 1958
with a capacity of 30 passengers or more, or a payload of 3,402 kg
or more, to carry out a definition review against explosion hazards.
    To be compliant with SFAR88/JAA INT/POL 25/12 requirements, this
AD requires the installation of the updated FWC [flight warning
computer] software standard which ensures correct operation of the
APU bleed leak detection system before each flight.

Failure of the auxiliary power unit (APU) bleed leak detection system
could result in overheat of the fuel tank located in the horizontal
stabilizer and ignition of the fuel vapors in that tank, which could
result in a fuel tank explosion and consequent loss of the airplane.
You may obtain further information by examining the MCAI in the AD
docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 requires certain type design (i.e.,
type certificate (TC) and supplemental type certificate (STC)) holders
to substantiate that their fuel tank systems can prevent ignition
sources in the fuel tanks. This requirement applies to type design
holders for large turbine-powered transport airplanes and for
subsequent modifications to those airplanes. It requires them to
perform design reviews and to develop design changes and maintenance
procedures if their designs do not meet the new fuel tank safety
standards. As explained in the preamble to the rule, we intended to
adopt airworthiness directives to mandate any changes found necessary
to address unsafe conditions identified as a result of these reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88. (The JAA is an associated body of the European
Civil Aviation Conference (ECAC) representing the civil aviation
regulatory authorities of a number of European states who have agreed
to co-operate in developing and implementing common safety regulatory
standards and procedures.) Under this regulation, the JAA stated that
all members of the ECAC that hold type certificates for transport
category airplanes are required to conduct a design review against
explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Airbus has issued the service information identified in the table
below.

                                          Relevant Service Information
----------------------------------------------------------------------------------------------------------------
        Airbus Service Bulletin--                   Revision--                           Dated--
----------------------------------------------------------------------------------------------------------------
A330-31-3125.............................  Original....................  December 31, 2008.
A330-31-3146, including Appendix 01......  01..........................  May 5, 2010.
A340-31-4111.............................  Original....................  February 5, 2007.
A340-31-4125.............................  01..........................  December 9, 2008.
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The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 53 products of U.S. registry. We also estimate that
it would take about 5 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $0 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $22,525, or $425 per product.

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 determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2010-0952; Directorate Identifier 2010-NM-
131-AD.

Comments Due Date

    (a) We must receive comments by November 15, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes identified in paragraphs
(c)(1) and (c)(2) of this AD.
    (1) Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -
303, -321, -322, -323, -341, -342 and -343 airplanes, all
manufacturer serial numbers except those on which Airbus
modification 51790 has been embodied in production or Airbus Service
Bulletin A330-31-3066, A330-31-3082, A330-31-3093, or A330-31-3105
has been embodied in service; certificated in any category.
    (2) Airbus Model A340-211, -212, -213, -311, -312, and -313
airplanes, all

manufacturer serial numbers; certificated in any category.

Subject

    (d) Air Transport Association (ATA) of America Code 31:
Instruments.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    [T]he FAA published SFAR 88 (Special Federal Aviation Regulation
88).
    By mail referenced 04/00/02/07/01-L296 of March 4th, 2002 and
04/00/02/07/03-L024 of February 3rd, 2003 the JAA [Joint Aviation
Authorities] recommended to the National Aviation Authorities (NAA)
the application of a similar regulation.
    The aim of this regulation is to require * * * a definition
review against explosion hazards.
* * * * *
Failure of the auxiliary power unit (APU) bleed leak detection
system could result in overheat of the fuel tank located in the
horizontal stabilizer and ignition of the fuel vapors in that tank,
which could result in a fuel tank explosion and consequent loss of
the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 6 months after the effective date of this AD, do the
applicable actions specified in paragraphs (g)(1) and (g)(2) of this
AD.
    (1) For Model A330-201, -202, -203, -223, -243, -301, -302, -
303, -321, -322, -323, -341, -342 and -343 airplanes: Install flight
warning computer (FWC) software standard T3 (part number (P/N)
LA2E20202T30000) on both FWCs, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-31-3146, including
Appendix 01, Revision 01, dated May 5, 2010.
    (2) For Model A340-211, -212, -213, -311, -312, and -313
airplanes: Install FWC software standard L11 (P/N LA2E0060D110000)
on both FWCs, in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A340-31-4125, Revision 01, dated December 9,
2008.
    (h) Prior to or concurrently with accomplishing the
corresponding requirements of paragraph (g) of this AD, install FWC
software standard T2-0 in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-31-3125, dated December
31, 2008 (for Model A330-201, -202, -203, -223, -243, -301, -302, -
303, -321, -322, -323, -341, -342 and -343 airplanes).
    (i) Prior to or concurrently with accomplishing the
corresponding requirements of paragraph (g) of this AD, install FWC
software standard L10-1 in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A340-31-4111, dated February
5, 2007 (for Model A340-211, -212, -213, -311, -312, and -313
airplanes).
    (j) Actions done before the effective date of this AD in
accordance with Airbus Service Bulletin A330-31-3146, dated February
2, 2010; or A340-31-4125, dated October 27, 2008; are acceptable for
compliance with the corresponding requirements of paragraph (g) of
this AD.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (k) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (l) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2010-0089, dated May 10, 2010, and the
service information identified in Table 1 of this AD, for related
information.

                                      Table 1--Related Service Information
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        Airbus Service Bulletin--                   Revision--                           Dated--
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A330-31-3125.............................  Original....................  December 31, 2008.
A330-31-3146, including Appendix 01......  01..........................  May 5, 2010.
A340-31-4111.............................  Original....................  February 5, 2007.
A340-31-4125.............................  01..........................  December 9, 2008.
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    Issued in Renton, Washington on September 23, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-24711 Filed 9-30-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 187 (Wednesday, September 26, 2012)]
[Rules and Regulations]
[Pages 59120-59128]
[FR Doc No: 2012-23712]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0171; FRL-9358-8]
RIN 2070-ZA16

Butylate, Clethodim, Dichlorvos, Dicofol, Isopropyl Carbanilate,
et al.; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking specific tolerances, in follow-up to canceled
uses or where a commodity is no longer a significant feed item, for
butylate, clethodim, dichlorvos, dicofol, isopropyl carbanilate,
methanearsonic acid, methomyl, naled, primisulfuron-methyl,
tralomethrin, and ziram, and the tolerance exemption for pine oil.
However, EPA will not revoke the dicofol tolerances on tea and
tolerance exemptions for rotenone, derris, or cube roots at this time.
Also, EPA is making minor revisions to the tolerance expressions for
dicofol, methanearsonic acid, methomyl, and tralomethrin, revising the
nomenclature of specific tolerances for butylate, methomyl, and
tralomethrin, and removing expired tolerances for certain pesticide
active ingredients, in accordance with current EPA practice. In
addition, EPA is reinstating popcorn tolerances for metolachlor to
remedy an inadvertent omission and cover existing registrations.

DATES: This regulation is effective March 25, 2013. Objections and
requests for hearings must be received on or before November 26, 2012,
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-2012-0171, 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), EPA West 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 (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; 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 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under the Federal Food, Drug, and Cosmetic Act (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-
2012-0171 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 November 26, 2012. 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 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-2012-0171, 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 Confidential Business
Information (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.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

A. What action is the agency taking?

    In the Federal Register of May 9, 2012 (77 FR 27164) (FRL-9345-2),
EPA issued a proposed rule, in follow-up to canceled uses or where a
commodity is no longer a significant feed item, to revoke specific
tolerances for butylate, clethodim, dichlorvos, dicofol, isopropyl
carbanilate, methanearsonic acid, methomyl, naled, primisulfuron-
methyl, tralomethrin, and ziram, and tolerance exemptions for rotenone,
derris, cube roots, and pine oil. Also, it proposed minor revisions to
the tolerance expressions for dicofol,

methanearsonic acid, methomyl, and tralomethrin, revisions to the
nomenclature of specific tolerances for butylate, methomyl, and
tralomethrin, and removal of expired tolerances for certain pesticide
active ingredients, in accordance with current EPA practice. In
addition, it proposed to reinstate popcorn tolerances for metolachlor
to remedy an inadvertent omission and cover existing registrations.
Also, the proposed rule of May 9, 2012 provided a 60-day comment period
which invited public comment for consideration and for support of
tolerance retention under FFDCA standards.
    In this final rule, EPA is finalizing these tolerance actions, with
the exception of the proposed revocations of tolerance exemptions for
rotenone, derris, and cube roots, revocation of the dicofol tolerances
on tea, and date of expiration/revocation proposed for the methomyl
tolerance on grape. EPA is revoking tolerances for butylate, clethodim,
dichlorvos, dicofol, isopropyl carbanilate, methanearsonic acid,
methomyl, naled, primisulfuron-methyl, tralomethrin, and ziram, and the
tolerance exemption for pine oil. The tolerance and tolerance exemption
revocations for dichlorvos, naled, and pine oil are consistent with the
recommendations in their individual Reregistration Eligibility
Decisions (REDs) of 2006.
    As part of the tolerance reassessment process, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of FFDCA. The safety finding determination of ``reasonable
certainty of no harm'' is discussed in detail in each RED for the
active ingredient. REDs recommend the implementation of certain
tolerance actions, including modifications, to reflect current use
patterns, to meet safety findings and change commodity names and
groupings in accordance with new EPA policy. Printed copies of many
REDs may be obtained from EPA's National Service Center for
Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH
45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-
8695; Internet at http://www.epa.gov/ncepihom and from the National
Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield,
VA 22161; telephone number: 1-800-553-6847 or<PHONE_NUMBER>; Internet
at http://www.ntis.gov. Electronic copies of REDs are available on the
Internet at http://www.regulations.gov and  http://www.epa.gov/pesticides/reregistration/status.htm.
    In this final rule, EPA is revoking certain tolerances and/or
tolerance exemptions because either they are no longer needed or are
associated with food uses that are no longer registered under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the
United States. Those instances where registrations were canceled were
because the registrant failed to pay the required maintenance fee and/
or the registrant voluntarily requested cancellation of one or more
registered uses of the pesticide active ingredient. The tolerances
revoked by this final rule are no longer necessary to cover residues of
the relevant pesticides in or on domestically treated commodities or
commodities treated outside but imported into the United States. It is
EPA's general practice to issue a final rule revoking those tolerances
and tolerance exemptions for residues of pesticide active ingredients
on crop uses for which there are no active registrations under FIFRA,
unless any person in comments on the proposal indicates a need for the
tolerance or tolerance exemption to cover residues in or on imported
commodities or legally treated domestic commodities.
    EPA has historically been concerned that retention of tolerances
that are not necessary to cover residues in or on legally treated foods
may encourage misuse of pesticides within the United States.
    Generally, EPA will proceed with the revocation of these tolerances
on the grounds discussed in Unit II.A. if one of the following
conditions applies:
    1. Prior to EPA's issuance of a FFDCA section 408(f) order
requesting additional data or issuance of a FFDCA section 408(d) or (e)
order revoking the tolerances on other grounds, commenters retract the
comment identifying a need for the tolerance to be retained.
    2. EPA independently verifies that the tolerance is no longer
needed.
    3. The tolerance is not supported by data that demonstrate that the
tolerance meets the requirements under Food Quality Protection Act
(FQPA).
    This final rule does not revoke those tolerances or tolerance
exemptions for which EPA received comments stating a need for the
tolerance or tolerance exemption to be retained. Among the comments
received by EPA, are the following:
    i. Dicofol--Comment by Tea Association of the U.S.A., Inc. The
commenter stated that dicofol is used in tea production in countries
such as India, China, and Argentina, and requested that EPA not revoke
the dicofol tolerances on tea but maintain them for importation
purposes.
    Agency response. EPA will not revoke the dicofol tolerances in 40
CFR 180.163(a)(1) on ``tea, dried'' and ``tea, plucked leaves'' at this
time. EPA will address the tea tolerances and the comment received on
them in a future document to be published in the Federal Register.
However, EPA is finalizing all other amendments (including all other
tolerance revocations) proposed concerning dicofol in the Federal
Register of May 9, 2012 (77 FR 27164).
    ii. Methomyl--Comments by DuPont Crop Protection and the California
Grape and Tree Fruit League (CGTFL). DuPont Crop Protection commented
that one year is not sufficient time to exhaust methomyl existing
stocks for use on grapes. DuPont requested that EPA extend the
expiration/revocation date for the methomyl tolerance on grape by a
minimum of 3 years (from June 8, 2013 to June 8, 2016). The CGTFL
represents California's table grape and deciduous tree fruit growers,
packers, and shippers. The CGTFL requested additional time to exhaust
existing stocks and suggested a more appropriate expiration/revocation
date for the methomyl tolerance on grape would be December 31, 2020.
    Agency response. Based upon the comments received by EPA regarding
requests for additional time to exhaust existing methomyl end-use
stocks for use in or on grapes, and on the Agency's review of methomyl
use, EPA is extending the expiration/revocation of the methomyl
tolerance in 40 CFR 180.253(a) on grape by more than 3 years from June
8, 2013 to December 31, 2016.
    iii. Rotenone--Comments by CERES GmbH, Frutban S.A., Dole Fresh
Fruit International, Ltd. (DFFI), and DFFI-Costa Rica. Multiple
comments from CERES GmbH (a company headquartered in Germany which
offers international certification for organic farming and food
processing), Frutban S.A. (an organic banana farm in Ecuador), DFFI,
and DFFI-Costa Rica, were received which expressed concerns with EPA's
proposal to revoke the U.S. tolerance exemptions for rotenone based
insecticides. The commenters stated that there are lots of farmers
(especially organic farmers) who rely on rotenone based insecticides on
various commodities imported into the United States.
    Agency response. Based on the multiple comments by CERES GmbH,
Frutban S.A., DFFI, and DFFI-Costa Rica, which stated a continued need
for the tolerance exemptions for rotenone for importation purposes into
the United States, EPA will not revoke the

tolerance exemptions in 40 CFR 180.905 (when applied to growing crops
in accordance with good agricultural practice) for rotenone or derris
or cube roots at this time. However, because there are no longer any
active food-use registrations in the United States and no comments were
received by EPA which expressed a need for more time to exhaust
existing stocks for domestic use, EPA is not changing its previous
determination (as stated in the proposed rule of May 9, 2012) that
existing stocks in the United States will be exhausted by August 11,
2012. EPA will note in 40 CFR 180.905 that the tolerance exemptions for
rotenone, derris, and cube roots have no U.S. registrations as of March
23, 2011. Also, retaining these tolerance exemptions may require
submission of data to demonstrate their safety. EPA believes that
residue data from foreign countries, and perhaps other data, may be
needed to support import tolerance exemptions for rotenone or derris or
cube roots. For example, domestic U.S. residue data are not likely to
be representative of growing conditions and use patterns in other
countries. EPA published guidances on pesticide import tolerances and
residue data for imported food in the Federal Register notices of April
5, 2006 (71 FR 17099) (FRL-7772-1) and June 1, 2000 (65 FR 35069) (FRL-
6559-3).
    EPA did not receive any specific comments, during the 60-day
comment period, on the following pesticide active ingredients:
Butylate, clethodim, dichlorvos, (dicofol with the exception of tea),
isopropyl carbanilate, naled, primisulfuron-methyl, tralomethrin, and
ziram, and pine oil, and any of the active ingredients associated with
the removal of expired tolerances. Therefore, with the exception of the
changes described in the Agency responses to comments in this final
rule, EPA is finalizing the amendments proposed concerning the
pesticide active ingredients in the Federal Register of May 9, 2012 (77
FR 27164) (FRL-9345-2). For a detailed discussion of the Agency's
rationale for the finalized tolerance actions, refer to the proposed
rule of May 9, 2012.

B. What is the agency's authority for taking this action?

    EPA may issue a regulation establishing, modifying, or revoking a
tolerance under FFDCA section 408(e). In this final rule, EPA is
revoking tolerances as follow-up on canceled uses of pesticides, which
is consistent with the tolerance recommendations made in certain REDs.

C. When do these actions become effective?

    As stated in the DATES section, this regulation is effective 180
days after the date of publication in the Federal Register. EPA is
delaying the effective date of these finalized actions to allow a
reasonable interval for producers in exporting members of the World
Trade Organization's Sanitary and Phytosanitary Measures Agreement to
adapt to the requirements of a final rule. With the exception of
butylate, dicofol, methanearsonic acid (and salts), methomyl,
tralomethrin, and ziram, EPA believes that existing stocks of the
canceled or amended pesticide products labeled for the uses associated
with the revoked tolerances and tolerance exemptions have been
completely exhausted and that treated commodities have had sufficient
time for passage through the channels of trade. EPA is revoking certain
tolerances for butylate, dicofol, methanearsonic acid (and salts),
methomyl, tralomethrin, and ziram with expiration/revocation dates. EPA
believes that these revocation dates allow users to exhaust stocks and
allow sufficient time for passage of treated commodities through the
channels of trade.
    Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this final rule, and that
are in the channels of trade following the tolerance revocations, shall
be subject to FFDCA section 408(1)(5), as established by FQPA. Under
this unit, any residues of these pesticides in or on such food shall
not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates that the
pesticide was applied to such food.

III. 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 not established a MRL for butylate, isopropyl
carbanilate (also called propham), methanearsonic acid (and salts),
metolachlor, naled, pine oil, primisulfuron-methyl, rotenone (or derris
or cube roots), tralomethrin, or MRL for clethodim in or on soybean
soapstock, or MRL for dichlorvos on tomato.
    The Codex has not established a MRL for ziram per se, but has MRLs
for total dithiocarbamates (which includes the dithiocarbamate ziram),
determined as carbon disulfide. However, there is no MRL for total
dithiocarbamates in or on blackberry.
    The Codex has established a MRL for methomyl in or on grapes at 5
milligrams/kilogram (mg/kg). This MRL is the same as the tolerance
established for methomyl on grapes in the United States.
    The Codex has established MRLs for dicofol in or on cattle meat at
3 mg/kg, eggs at 0.05 mg/kg, poultry meat and cottonseed at 0.1 mg/kg,
and cherries at 5 mg/kg. These MRLs and some others are the same as the
tolerances established for dicofol in the United States.
    The Codex has established MRLs for dicofol in or on various other
commodities, including beans, dry at 0.1 mg/kg, citrus fruits at 5 mg/
kg, hops, dry at 50 mg/kg, melons, except watermelon at 0.2 mg/kg,
pecans and walnuts at 0.01 mg/kg, and peppers and summer squash at 1
mg/kg. These MRLs are all covered by U.S. tolerances at higher levels.
These MRLs are different than the tolerances established for dicofol in
the United States because of differences in use patterns and/or good
agricultural practices.

IV. Statutory and Executive Order Reviews

    In this final rule, EPA revokes specific tolerances established
under FFDCA section 408. The Office of Management and Budget (OMB) has
exempted this type of action (i.e., a tolerance revocation for which
extraordinary circumstances do not exist) from review under Executive
Order 12866, entitled ``Regulatory Planning and Review'' (58

FR 51735, October 4, 1993). Because this rule has been exempted from
review under Executive Order 12866 due to its lack of significance,
this 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). 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.), or
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.). Nor does it require any special
considerations as required by Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994); or OMB review
or any other Agency action under Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.), the Agency previously assessed whether revocations of
tolerances might significantly impact a substantial number of small
entities and concluded that, as a general matter, these actions do not
impose a significant economic impact on a substantial number of small
entities. This analysis was published on December 17, 1997 (62 FR
66020) (FRL-5753-1), and was provided to the Chief Counsel for Advocacy
of the Small Business Administration. Taking into account this analysis
and available information concerning the pesticides listed in this
rule, the Agency hereby certifies that this final rule will not have a
significant economic impact on a substantial number of small entities.
In a memorandum dated May 25, 2001, EPA determined that eight
conditions must all be satisfied in order for an import tolerance or
tolerance exemption revocation to adversely affect a significant number
of small entity importers, and that there is a negligible joint
probability of all eight conditions holding simultaneously with respect
to any particular revocation. (This Agency document is available in the
docket of the proposed rule, as mentioned in Unit II.A.). Furthermore,
for the pesticides named in this final rule, the Agency knows of no
extraordinary circumstances that exist as to the present revocations
that would change EPA's previous analysis. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled ``Federalism'' (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule 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, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

V. 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: September 18, 2012.
Steven Bradbury,
Director, 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 180.116 is amended by revising the table in paragraph (a) to
read as follows:

Sec.  [emsp14]180.116  Ziram; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                      Parts per   Expiration/ revocation
             Commodity                 million              date
------------------------------------------------------------------------
Almond.............................      \1\ 0.1  None
Apple..............................      \1\ 7.0  None
Apricot............................      \1\ 7.0  None
Blackberry.........................      \1\ 7.0  5/11/13
Blueberry..........................      \1\ 7.0  None
Cherry, sweet......................      \1\ 7.0  None
Cherry, tart.......................      \1\ 7.0  None
Grape..............................          7.0  None
Huckleberry........................          7.0  None
Peach..............................          7.0  None
Pear...............................      \1\ 7.0  None
Pecan..............................          0.1  None
Quince.............................      \1\ 7.0  None
Strawberry.........................          7.0  None
Tomato.............................      \1\ 7.0  None
------------------------------------------------------------------------
\1\ Some of these tolerances were established on the basis of data
  acquired at the public hearings held in 1950 (formerly Sec.   180.101)
  and the remainder were established on the basis of pesticide petitions
  presented under the procedure specified in the amendment to the
  Federal Food, Drug, and Cosmetic Act by Public Law 518, 83d Congress
  (68 Stat. 511).

* * * * *

Sec. Sec.  180.133 and 180.144  [Removed]

0
3. Sections 180.133 and 180.144 are removed.

0
4. Section 180.163 is amended by revising the section heading and
paragraph (a) to read as follows:

Sec.  [emsp14]180.163  Dicofol; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide dicofol, including its metabolites and degradates, in or on
the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only dicofol as the sum of its p,p-dicofol and o,p-dicofol
isomers: 4-chloro-[alpha]-(4-chlorophenyl)-[alpha]-
(trichloromethyl)benzenemethanol and 2-chloro-[alpha]-(4-chlorophenyl)-
[alpha]-(trichloromethyl)benzenemethanol, in or on the commodity.

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     revocation
                                               million         date
------------------------------------------------------------------------
Apple, wet pomace..........................         38.0        10/31/16
Bean, dry, seed............................          0.5        10/31/16
Bean, succulent............................          3.0        10/31/16
Butternut..................................          0.1        10/31/16
Caneberry subgroup 13A.....................          5.0        10/31/16
Chestnut...................................          0.1        10/31/16
Citrus, dried pulp.........................         12.0        10/31/16
Citrus oil.................................        200.0        10/31/16
Cotton, refined oil........................          0.5        10/31/16
Cotton, undelinted seed....................          0.1        10/31/16
Fruit, citrus, group 10....................          6.0        10/31/16
Fruit, pome, group 11......................         10.0        10/31/16
Fruit, stone, group 12.....................          5.0        10/31/16
Grape......................................          5.0        10/31/16
Grape, raisin..............................         20.0        10/31/16
Hazelnut...................................          0.1        10/31/16
Hop, dried cones...........................         65.0        10/31/16
Nut, hickory...............................          0.1        10/31/16
Nut, macadamia.............................          0.1        10/31/16
Pecan......................................          0.1        10/31/16
Peppermint, oil............................         30.0        10/31/16
Peppermint, tops...........................         25.0        10/31/16
Spearmint, oil.............................         30.0        10/31/16
Spearmint, tops............................         25.0        10/31/16
Strawberry.................................         10.0        10/31/16
Tea, dried.................................         50.0            None
Tea, plucked leaves........................         30.0            None
Vegetable, cucurbit, group 9...............          2.0        10/31/16
Vegetable, fruiting, group 8...............          2.0        10/31/16
Walnut.....................................          0.1        10/31/16
------------------------------------------------------------------------

     (2) Tolerances are established for residues of the insecticide
dicofol, including its metabolites and degradates, in or on the
commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only the sum of p,p-dicofol, 4-chloro-[alpha]-(4-
chlorophenyl)-[alpha]-(trichloromethyl)benzenemethanol, its isomer o,p-
dicofol, 2-chloro-[alpha]-(4-chlorophenyl)-[alpha]-
(trichloromethyl)benzenemethanol, and its metabolites 4-chloro-[alpha]-
(4-chlorophenyl)-[alpha]-(dichloromethyl)benzenemethanol and 2-chloro-
[alpha]-(4-chlorophenyl)-[alpha]-(dichloromethyl)benzenemethanol,
calculated as the stoichiometric equivalent of p,p-dicofol, 4-chloro-
[alpha]-(4-chlorophenyl)-[alpha]-(trichloromethyl)benzenemethanol, in
or on the commodity.

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     Revocation
                                               million         Date
------------------------------------------------------------------------
Cattle, fat...............................         50.0         10/31/16
Cattle, liver.............................          5.0         10/31/16
Cattle, meat..............................          3.0         10/31/16
Cattle, meat byproducts, except liver.....          3.0         10/31/16
Egg.......................................          0.05        10/31/16
Goat, fat.................................         50.0         10/31/16
Goat, liver...............................          5.0         10/31/16
Goat, meat................................          3.0         10/31/16
Goat, meat byproducts, except liver.......          3.0         10/31/16
Hog, fat..................................         50.0         10/31/16
Hog, liver................................          5.0         10/31/16
Hog, meat.................................          3.0         10/31/16
Hog, meat byproducts, except liver........          3.0         10/31/16
Horse, fat................................         50.0         10/31/16
Horse, liver..............................          5.0         10/31/16
Horse, meat...............................          3.0         10/31/16
Horse, meat byproducts, except liver......          3.0         10/31/16
Milk, fat (reflecting 0.75 ppm in whole            22.0         10/31/16
 milk)....................................
Poultry, fat..............................          0.1         10/31/16
Poultry, meat.............................          0.1         10/31/16
Poultry, meat byproducts..................          0.1         10/31/16
Sheep, fat................................         50.0         10/31/16
Sheep, liver..............................          5.0         10/31/16
Sheep, meat...............................          3.0         10/31/16
Sheep, meat byproducts, except liver......          3.0         10/31/16
------------------------------------------------------------------------

* * * * *

Sec. Sec.  180.173, 180.180, and 180.214  [Removed]

0
5. Sections 180.173, 180.180, and 180.214 are removed.

Sec.  180.215  [Amended]

0
6. Section 180.215 is amended by removing the entry for ``Lettuce''
from the table in paragraph (a)(1).

Sec.  180.221  [Removed]

0
7. Section 180.221 is removed.

0
8. Section 180.232 is amended by revising the table in paragraph (a) to
read as follows:

Sec.  [emsp14]180.232  Butylate; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     revocation
                                               million         date
------------------------------------------------------------------------
Corn, field, forage.......................          0.1          3/23/13
Corn, field, grain........................          0.1          3/23/13
Corn, field, stover.......................          0.1          3/23/13
Corn, pop, grain..........................          0.1          3/23/13
Corn, pop, stover.........................          0.1          3/23/13
Corn, sweet, forage.......................          0.1          3/23/13
Corn, sweet, kernel plus cob with husks             0.1          3/23/13
 removed..................................
------------------------------------------------------------------------

* * * * *

Sec.  180.235  [Amended]

0
9. Section 180.235 is amended by removing the entry for ``Tomato,
postharvest (residues expressed as naled)'' from the table in paragraph
(a)(1).

Sec.  180.239  [Removed]

0
10. Section 180.239 is removed.

0
11. Section 180.253 is amended by revising paragraphs (a) and (c) to
read as follows:

Sec.  180.253  Methomyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide methomyl, including its metabolites and degradates, in or
on the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only methomyl, methyl N-
[[(methylamino)carbonyl]oxy]ethanimidothioate, in or on the commodity.

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     revocation
                                               million         date
------------------------------------------------------------------------
Alfalfa, forage...........................         10               None
Alfalfa, hay..............................         10               None
Apple.....................................          1               None
Asparagus.................................          2               None
Avocado...................................          2               None
Barley, grain.............................          1               None
Barley, hay...............................         10               None
Barley, straw.............................         10               None
Bean, dry, seed...........................          0.1             None
Bean, forage..............................         10               None
Bean, succulent...........................          2               None
Beet, garden, tops........................          6               None
Bermudagrass, forage......................         10               None
Bermudagrass, hay.........................         40               None
Blueberry.................................          6               None
Broccoli..................................          3               None
Brussels sprouts..........................          2               None
Cabbage...................................          5               None
Cabbage, Chinese, bok choy................          5               None
Cabbage, Chinese, napa....................          5               None
Cauliflower...............................          2               None
Celery....................................          3               None
Collards..................................          6               None
Corn, field, forage.......................         10               None
Corn, field, grain........................          0.1             None
Corn, field, stover.......................         10               None
Corn, pop, grain..........................          0.1             None
Corn, pop, stover.........................         10               None
Corn, sweet, forage.......................         10               None
Corn, sweet, kernel plus cob with husks             0.1             None
 removed..................................
Corn, sweet, stover.......................         10               None
Cotton, undelinted seed...................          0.1             None
Dandelion, leaves.........................          6               None
Endive....................................          5               None
Grape.....................................          5           12/31/16
Grapefruit................................          2               None
Hop, dried cones \1\......................         12               None
Kale......................................          6               None
Lemon.....................................          2               None
Lentil, seed..............................          0.1             None
Lettuce...................................          5               None
Mustard greens............................          6               None
Nectarine.................................          5               None

Oat, forage...............................         10               None
Oat, grain................................          1               None
Oat, hay..................................         10               None
Oat, straw................................         10               None
Onion, green..............................          3               None
Orange....................................          2               None
Parsley, leaves...........................          6               None
Pea.......................................          5               None
Pea, field, vines.........................         10               None
Peach.....................................          5               None
Peanut....................................          0.1             None
Pecan.....................................          0.1             None
Pepper, bell..............................          2               None
Pepper, nonbell...........................          2               None
Peppermint, tops..........................          2               None
Pomegranate...............................          0.2             None
Rye, forage...............................         10               None
Rye, grain................................          1               None
Rye, straw................................         10               None
Sorghum, grain, forage....................          1               None
Sorghum, grain, grain.....................          0.2             None
Soybean, forage...........................         10               None
Soybean, seed.............................          0.2             None
Spearmint, tops...........................          2               None
Spinach...................................          6               None
Swiss chard...............................          6               None
Tangerine.................................          2               None
Tomato....................................          1               None
Turnip, greens............................          6               None
Vegetable, brassica, leafy, group 5.......          6.0             None
Vegetable, cucurbit, group 9..............          0.2             None
Vegetable, fruiting, group 8..............          0.2             None
Vegetables, leafy \2\.....................          0.2             None
Vegetable, root and tuber, group 1........          0.2             None
Wheat, forage.............................         10               None
Wheat, grain..............................          1               None
Wheat, hay................................         10               None
Wheat, straw..............................         10               None
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of methomyl on hop, dried
  cone, as of February 14, 1990.
\2\ Except for Beet (tops), broccoli, Brussels sprouts, cabbage,
  cabbage, Chinese, cauliflower, celery, collards, dandelions, endive
  (escarole), kale, lettuce, mustard greens, parsley, spinach, Swiss
  chard, turnip, greens (tops), and watercress.

* * * * *
    (c) Tolerances with regional registrations. A tolerance with
regional registration, as defined in Sec.  180.1(l), is established for
residues of the insecticide methomyl, including its metabolites and
degradates, in or on the commodity in the table in this paragraph.
Compliance with the tolerance level specified in this paragraph is to
be determined by measuring only methomyl, methyl N-
[[(methylamino)carbonyl]oxy]ethanimidothioate, in or on the commodity.
* * * * *

0
12. Section 180.289 is amended by revising paragraph (a) to read as
follows:

Sec.  180.289  Methanearsonic acid; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide methanearsonic acid, including its metabolites and
degradates, in or on the commodities in the table in this paragraph.
Compliance with the tolerance levels specified in this paragraph is to
be determined by measuring only methanearsonic acid, from application
of the disodium and monosodium salts of methanearsonic acid, calculated
as the stoichiometric equivalent of As2O3, in or
on the commodity.

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     Revocation
                                               million         Date
------------------------------------------------------------------------
Cotton, undelinted seed...................          0.7             None
Cotton, hulls.............................          0.9             None
Fruit, citrus.............................          0.35        12/31/12
------------------------------------------------------------------------

* * * * *

0
13. Section 180.319 is revised to read as follows:

Sec.  180.319  Interim tolerances.

    (a) General. While petitions for tolerances for negligible residues
are pending and until action is completed on these petitions, interim
tolerances are established for residues of the listed pesticide
chemicals in or on the following raw agricultural commodities:

----------------------------------------------------------------------------------------------------------------
                                                                                Expiration/
           Substances                     Uses           Tolerance in parts   Raw  agricultural     revocation
                                                            per million           commodity            date
----------------------------------------------------------------------------------------------------------------
Coordination product of zinc ion  Fungicide...........  1.0 (Calculated as   Potato.............            None
 and maneb.                                              zinc ethylene-
                                                         bisdithio-
                                                         carbamate).
Endothall (7-oxabicyclo-          Herbicide...........  0.2................  Beet, sugar........            None
 (2,2,1)heptane 2,3-dicarboxylic
 acid.
Methyl parathion................  Herbicide...........  0.5................  Rye................        12/31/13
----------------------------------------------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

0
14. Section 180.368 is amended by alphabetically adding the following
entries to the table in paragraph (a)(1) to read as follows:

Sec.  180.368  Metolachlor; tolerances for residues.

    (a) * * * (1) * * *

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

                                * * * * *
Corn, pop, grain........................................            0.10
Corn, pop, stover.......................................            6.0

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

* * * * *

0
15. Section 180.422 is amended by revising paragraph (a) to read as
follows:

Sec.  180.422  Tralomethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
insecticide tralomethrin, including its metabolites and degradates, in
or on the commodities in the table in this paragraph. Compliance with
the tolerance levels specified in this paragraph is to be determined by
measuring only the sum of tralomethrin, (S)-cyano(3-
phenoxyphenyl)methyl (1R,3S)-2,2-dimethyl-3-(1,2,2,2-
tetrabromoethyl)cyclopropanecarboxylate, and its metabolites (S)-
cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-cyano(3-phenoxyphenyl)methyl
(1S,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate,
calculated as the stoichiometric equivalent of tralomethrin, in or on
the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                      Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Broccoli.....................................          0.5        7/9/13
Cotton, undelinted seed......................          0.02       7/9/13
Cotton, oil..................................          0.20       7/9/13
Lettuce, head................................          1.00       7/9/13
Lettuce, leaf................................          3.00       7/9/13
Soybean, seed................................          0.05       7/9/13
Sunflower, seed..............................          0.05       7/9/13
------------------------------------------------------------------------

     (2) A tolerance of 0.02 part per million with an expiration/
revocation date of July 9, 2013 is established for residues of the
insecticide tralomethrin, including its metabolites and degradates, in
or on food commodities (other than those covered by a higher tolerance
as a result of use on growing crops) in food-handling establishments.
Compliance with the tolerance level specified in this paragraph is to
be determined by measuring only the sum of tralomethrin, (S)-cyano(3-
phenoxyphenyl)methyl (1R,3S)-2,2-dimethyl-3-(1,2,2,2-
tetrabromoethyl)cyclopropanecarboxylate, and its metabolites (S)-
cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-cyano(3-phenoxyphenyl)methyl
(1S,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate,
calculated as the stoichiometric equivalent of tralomethrin, in or on
the commodity.
    (i) The insecticide may be present as a residue from application of
tralomethrin in food-handling establishments, including food service,
manufacturing, and processing establishments, such as restaurants,
cafeterias, supermarkets, bakeries, breweries, dairies, meat
slaughtering and packing plants, and canneries.
    (ii) The application shall be made in accordance with the following
prescribed conditions: Application shall be limited to a general
surface and spot and/or crack and crevice treatment in food-handling
establishments where food and food products are held, processed,
prepared, and served. General surface application may be used only when
the facility is not in operation provided exposed food has been covered
or removed from the area being treated. All food-contact surfaces and
equipment must be thoroughly cleaned after general surface
applications. Spot and/or crack and crevice application may be used
while the facility is in operation provided exposed food is covered or
removed from the area being treated prior to application. Spray
concentration shall be limited to a maximum of 0.06 percent active
ingredient. Contamination of food and food-contact surfaces shall be
avoided.
    (3) A tolerance of 0.02 part per million with an expiration/
revocation date of July 9, 2013 is established for residues of the
insecticide tralomethrin, including its metabolites and degradates, in
or on feed commodities (other than those covered by a higher tolerance
as a result of use on growing crops) in feed-handling establishments.
Compliance with the tolerance level specified in this paragraph is to
be determined by measuring only the sum of tralomethrin, (S)-cyano(3-
phenoxyphenyl)methyl (1R,3S)-2,2-dimethyl-3-(1,2,2,2-
tetrabromoethyl)cyclopropanecarboxylate, and its metabolites (S)-
cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-cyano(3-phenoxyphenyl)methyl
(1S,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate,
calculated as the stoichiometric equivalent of tralomethrin, in or on
the commodity.
    (i) The insecticide may be present as a residue from application of
tralomethrin in feed-handling establishments, including feed
manufacturing and processing establishments.
    (ii) The application shall be made in accordance with the following
prescribed conditions: Application shall be limited to a general
surface and spot and/or crack and crevice treatment in feed-handling
establishments where feed and feed products are held or processed.
General surface application may be used only when the facility is

not in operation provided exposed feed has been covered or removed from
the area being treated. All feed-contact surfaces and equipment must be
thoroughly cleaned after general surface applications. Spot and/or
crack and crevice application may be used while the facility is in
operation provided exposed feed is covered or removed from the area
being treated prior to application. Spray concentration shall be
limited to a maximum of 0.06 percent active ingredient. Contamination
of feed and feed-contact surfaces shall be avoided.
* * * * *

Sec.  180.452  [Amended]

0
16. Section 180.452 is amended by removing the entries for ``Corn,
sweet, forage'' and ``Corn, sweet, stover'' from the table in paragraph
(a).

Sec.  180.458  [Amended]

0
17. Section 180.458 is amended by removing the entry for ``Soybean,
soapstock'' from the table in paragraph (a).

Sec. Sec.  180.536 and 180.550  [Removed]

0
18. Sections 180.536 and 180.550 are removed.

0
19. Section 180.905 is revised to read as follows:

Sec.  [emsp14]180.905  Pesticide chemicals; exemptions from the
requirement of a tolerance.

    (a) When applied to growing crops, in accordance with good
agricultural practice, the following pesticide chemicals are exempt
from the requirement of a tolerance:
    (1) Petroleum oils.
    (2) Piperonyl butoxide.
    (3) Pyrethrins.
    (4) Sabadilla.
    (b) When applied to growing crops, in accordance with good
agricultural practice, the pesticides rotenone or derris or cube roots
are exempt from the requirement of a tolerance. There are no U.S.
registrations for use of rotenone, derris, or cube roots on food
commodities as of March 23, 2011.
    (c) These pesticides are not exempted from the requirement of a
tolerance when applied to a crop at the time of or after harvest.

Sec.  180.1035  [Removed]

0
20. Section 180.1035 is removed.

[FR Doc. 2012-23712 Filed 9-25-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56248-56250]
[FR Doc No: 2017-25632]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0384]

Pediatric Information for X-Ray Imaging Device Premarket
Notifications; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Pediatric Information for
X-ray Imaging Device Premarket Notifications.'' This guidance document
outlines FDA's current thinking on information that should be provided
in premarket notification submissions for x-ray imaging devices that
are indicated for pediatric populations or general use x-ray imaging
devices for which considerable pediatric application is anticipated.
FDA intends for this guidance to minimize uncertainty during the
premarket review process of premarket notification submissions for x-
ray imaging devices for pediatric use to encourage the inclusion of
pediatric indications for use for x-ray imaging device premarket
notification submissions and to provide recommendations on information
to support such indications. Both new devices and modifications of
existing x-ray imaging devices that require submission of a new
premarket notification are included within the scope of this guidance
document, regardless of whether the device is a complete x-ray imaging
system, a component part of an x-ray imaging device, or an accessory
(e.g., detectors and software).

DATES: The announcement of the guidance is published in the Federal
Register on November 28, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-

2012-D-0384 for ``Pediatric Information for X-ray Imaging Device
Premarket Notifications.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Pediatric Information for X-ray Imaging Device Premarket
Notifications'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Laurel Burk, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4268, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document outlines the current thinking of FDA
regarding information that should be provided in premarket notification
submissions (510(k)s) and device labeling for x-ray imaging devices
that are indicated for pediatric populations or general use x-ray
imaging devices for which considerable pediatric application is
anticipated. General use x-ray imaging devices typically neither
include nor exclude specific populations in the indications for use and
may be expected to be used in any population. Because a large
percentage of the hundreds of millions of x-ray examinations performed
annually in the United States are exams of pediatric patients, FDA
expects that most general use x-ray imaging devices will be used for a
considerable quantity of pediatric examinations unless a device's
design precludes use in smaller sized patients. This guidance is
intended to enhance clarity regarding the premarket review process of
510(k)s for x-ray imaging devices, to encourage the inclusion of
pediatric indications for use for x-ray imaging device 510(k)s, and to
provide recommendations regarding labeling, including the instructions
for use.
    In February 2010, FDA launched an ``Initiative to Reduce
Unnecessary Radiation Exposure from Medical Imaging'' (https://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm); and on March 30 and 31, 2010
(75 FR 8375, February 24, 2010), the Agency held a public meeting
entitled ``Device Improvements to Reduce Unnecessary Radiation Exposure
from Medical Imaging'' (https://www.federalregister.gov/documents/2010/02/24/2010-3674/device-improvements-to-reduce-unnecessary-radiation-exposure-from-medical-imaging-public-meeting). At the meeting, FDA
sought advice on ``steps that manufacturers of computerized tomography
(CT) and fluoroscopic devices could take to reduce unnecessary
radiation exposure through improved product design, enhanced labeling,
or improved instructions and training for equipment use and quality
assurance at medical imaging facilities.'' The Agency asked whether
manufacturers should incorporate special provisions for pediatric
patients, particularly with regard to hardware and software features.
Recommendations received by FDA, which apply to all general-use x-ray
imaging modalities, included making available pediatric protocols and
control settings, targeted instructions, and educational materials
emphasizing pediatric dose reduction, quality assurance tools for
facilities emphasizing radiation dose management, and dose information
applicable to pediatric patients. Many of the recommendations from
pediatric experts focused on expanding the flexibility or range of
features already available on x-ray imaging devices, which may also
improve adult imaging for nonstandard applications.
    In the Federal Register of May 10, 2012 (77 FR 27461), the Agency
announced the issuance of the draft guidance entitled ``Pediatric
Information for X-ray Imaging Device Premarket Notifications'' and
interested persons were invited to comment by September 7, 2012. On
July 16, 2012 (77 FR 27463, May 10, 2012), the Agency held a public
meeting entitled ``Device Improvements for Pediatric X-ray Imaging''
(https://www.regulations.gov/document?D=FDA-2012-N-0385-0002) where FDA
also solicited public feedback on the draft of this guidance. FDA has
considered the comments received and has incorporated changes suggested
by the comments, as appropriate. In addition, FDA requested help in
identifying issues relevant to radiation safety in pediatric x-ray
imaging that might benefit from standards development or further
research at this workshop. FDA requested specific comments on technical
device design and pediatric safety questions. Since the 2012 meeting,
many recommended device design improvements have been incorporated into
FDA-recognized consensus standards, and others are under consideration
for future revisions of such standards.
    In 2014, the Agency issued a revised general pediatric guidance
entitled ``Premarket Assessment of Pediatric Medical Devices.'' The
guidance, which applies to all devices, defines pediatric
subpopulations and the general information that should be provided for

different types of premarket submissions for devices intended for use
in pediatric populations.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on pediatric information for x-ray imaging
device 510(k)s. It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Pediatric
Information for X-ray Imaging Device Premarket Notifications'' may send
an email request to [email protected] to receive an electronic
copy of the document. Please use the document number 1771 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485; and the collections of
information in 21 CFR parts 1002, 1010, 1020, 1030, 1040, and 1050 have
been approved under OMB control number 0910-0025. The collections of
information in the guidance document ``Requests for Feedback on Medical
Device Submissions: The Pre-Submission Program and Meetings with Food
and Drug Administration Staff'' have been approved under OMB control
number 0910-0756. In addition, FDA concludes that the Indications for
Use warning label does not constitute a ``collection of information''
under the PRA. Rather, the labeling statements are ``public
disclosure(s) of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public.'' (5 CFR 1320.3(c)(2).)

    Dated: November 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25632 Filed 11-27-17; 8:45 am]
 BILLING CODE 4164-01-P