82_FR_35018 82 FR 34875 - Ametoctradin; Pesticide Tolerance

82 FR 34875 - Ametoctradin; Pesticide Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 143 (July 27, 2017)

Page Range34875-34877
FR Document2017-15762

This regulation amends a tolerance for residues of ametoctradin in or on hops. BASF Corporation requested this tolerance amendment under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 82 Issue 143 (Thursday, July 27, 2017)
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)]
[Rules and Regulations]
[Pages 34875-34877]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-15762]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0518; FRL-9963-04]


Ametoctradin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends a tolerance for residues of 
ametoctradin in or on hops. BASF Corporation requested this tolerance 
amendment under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 27, 2017. Objections and 
requests for hearings must be received on or before September 25, 2017, 
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-2016-0518, 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 (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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

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-2016-0518 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 25, 2017. 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-2016-0518, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online

[[Page 34876]]

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 November 30, 2016 (81 FR 86312) (FRL-
9954-06), 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 
6E8500) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.663 be amended by 
modifying the tolerance for residues of the fungicide ametoctradin in 
or on hop, dried cone from 10 parts per million (ppm) to 100 ppm. That 
document referenced a summary of the petition prepared by BASF 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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 ametoctradin including exposure 
resulting from the tolerance amended by this action, consistent with 
FFDCA section 408(b)(2).
    In the Federal Register of May 9, 2012 (77 FR 27130) (FRL-9339-6), 
EPA established tolerances for residues of ametoctradin in or on 
several commodities, including hop, dried cones at 10 ppm. EPA is 
relying upon the findings made in the May 9, 2012, Federal Register 
document, as well as the supporting risk assessments, in support of 
this action. The toxicity profile of ametoctradin has not changed since 
2012, and as discussed in the 2012 rule, no toxicological endpoints 
were identified for ametoctradin. The Agency evaluated the request to 
increase the existing tolerance on hop, dried cones and based on the 
lack of toxicity, has concluded that there is a reasonable certainty 
that no harm will result to the general population, or to infants and 
children from aggregate exposure to ametoctradin residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer to the May 
9, 2012, Federal Register document and its supporting documents, 
available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2010-0261. Additionally, the risk assessment for this action is 
available in docket ID number EPA-HQ-OPP-2016-0518.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using liquid chromatography tandem 
mass spectrometry (LC/MS/MS) 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: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established an MRL for ametoctradin in or on hop, 
dried cones at 30 ppm. This MRL is different than the tolerance 
established for ametoctradin in the United States, however, the 
tolerance increase addressed by this document was requested to 
accommodate the importation of hops grown in the European Union into 
the United States. It is the Agency's understanding that Codex intends 
to raise the MRL for ametoctradin on hop, dried cones to 100 ppm.

V. Conclusion

    Therefore, the existing tolerance for residues of ametoctradin, 
including its metabolites and degradates in or on hop, dried cones is 
increased from 10 ppm to 100 ppm.

VI. Statutory and Executive Order Reviews

    This action amends 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 action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority

[[Page 34877]]

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 22, 2017.
Michael Goodis,
Director Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.663, revise the entry for ``Hop, dried cones'' in the 
table in paragraph (a) to read as follows:


Sec.  180.663  Ametoctradin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts  per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Hop, dried cones............................................         100
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-15762 Filed 7-26-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                                         Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations                                                               34875

                                                tribes. Thus, the Agency has determined                                                                                    Parts per       I. General Information
                                                                                                                                  Commodity
                                                that Executive Order 13132, entitled                                                                                        million
                                                                                                                                                                                           A. Does this action apply to me?
                                                ‘‘Federalism’’ (64 FR 43255, August 10,
                                                1999) and Executive Order 13175,                                         *           *        *            *                     *            You may be potentially affected by
                                                entitled ‘‘Consultation and Coordination                              Fruit, citrus, group 10–10 ...........                         1.0   this action if you are an agricultural
                                                with Indian Tribal Governments’’ (65 FR                                                                                                    producer, food manufacturer, or
                                                                                                                          *           *              *               *           *
                                                67249, November 9, 2000) do not apply                                                                                                      pesticide manufacturer. The following
                                                to this action. In addition, this action                                                                                                   list of North American Industrial
                                                                                                                      *       *       *       *           *
                                                does not impose any enforceable duty or                               [FR Doc. 2017–15728 Filed 7–26–17; 8:45 am]
                                                                                                                                                                                           Classification System (NAICS) codes is
                                                contain any unfunded mandate as                                                                                                            not intended to be exhaustive, but rather
                                                                                                                      BILLING CODE 6560–50–P
                                                described under Title II of the Unfunded                                                                                                   provides a guide to help readers
                                                Mandates Reform Act (UMRA) (2 U.S.C.                                                                                                       determine whether this document
                                                1501 et seq.).                                                        ENVIRONMENTAL PROTECTION                                             applies to them. Potentially affected
                                                   This action does not involve any                                   AGENCY                                                               entities may include:
                                                technical standards that would require                                                                                                        • Crop production (NAICS code 111).
                                                Agency consideration of voluntary                                     40 CFR Part 180                                                         • Animal production (NAICS code
                                                consensus standards pursuant to section                                                                                                    112).
                                                12(d) of the National Technology                                      [EPA–HQ–OPP–2016–0518; FRL–9963–04]                                     • Food manufacturing (NAICS code
                                                Transfer and Advancement Act                                                                                                               311).
                                                (NTTAA) (15 U.S.C. 272 note).
                                                                                                                      Ametoctradin; Pesticide Tolerance                                       • Pesticide manufacturing (NAICS
                                                                                                                      AGENCY:  Environmental Protection                                    code 32532).
                                                VII. Congressional Review Act
                                                                                                                      Agency (EPA).                                                        B. How can I get electronic access to
                                                  Pursuant to the Congressional Review                                ACTION: Final rule.                                                  other related information?
                                                Act (5 U.S.C. 801 et seq.), EPA will
                                                submit a report containing this rule and                                                                                                      You may access a frequently updated
                                                                                                                      SUMMARY:   This regulation amends a
                                                other required information to the U.S.                                                                                                     electronic version of EPA’s tolerance
                                                                                                                      tolerance for residues of ametoctradin in
                                                Senate, the U.S. House of                                                                                                                  regulations at 40 CFR part 180 through
                                                                                                                      or on hops. BASF Corporation requested
                                                Representatives, and the Comptroller                                                                                                       the Government Printing Office’s e-CFR
                                                                                                                      this tolerance amendment under the
                                                General of the United States prior to                                                                                                      site at http://www.ecfr.gov/cgi-bin/text-
                                                                                                                      Federal Food, Drug, and Cosmetic Act
                                                publication of the rule in the Federal                                                                                                     idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                                                                                      (FFDCA).
                                                Register. This action is not a ‘‘major                                                                                                     40tab_02.tpl.
                                                rule’’ as defined by 5 U.S.C. 804(2).                                 DATES:  This regulation is effective July
                                                                                                                      27, 2017. Objections and requests for                                C. How can I file an objection or hearing
                                                List of Subjects in 40 CFR Part 180                                   hearings must be received on or before                               request?
                                                  Environmental protection,                                           September 25, 2017, and must be filed                                  Under FFDCA section 408(g), 21
                                                Administrative practice and procedure,                                in accordance with the instructions                                  U.S.C. 346a, any person may file an
                                                Agricultural commodities, Pesticides                                  provided in 40 CFR part 178 (see also                                objection to any aspect of this regulation
                                                and pests, Reporting and recordkeeping                                Unit I.C. of the SUPPLEMENTARY                                       and may also request a hearing on those
                                                requirements.                                                         INFORMATION).                                                        objections. You must file your objection
                                                                                                                                                                                           or request a hearing on this regulation
                                                  Dated: June 22, 2017.                                               ADDRESSES:    The docket for this action,
                                                                                                                                                                                           in accordance with the instructions
                                                Michael L. Goodis,                                                    identified by docket identification (ID)
                                                                                                                                                                                           provided in 40 CFR part 178. To ensure
                                                Director, Registration Division, Office of                            number EPA–HQ–OPP–2016–0518, is
                                                                                                                                                                                           proper receipt by EPA, you must
                                                Pesticide Programs.                                                   available at http://www.regulations.gov
                                                                                                                                                                                           identify docket ID number EPA–HQ–
                                                                                                                      or at the Office of Pesticide Programs
                                                  Therefore, 40 CFR chapter I is                                                                                                           OPP–2016–0518 in the subject line on
                                                                                                                      Regulatory Public Docket (OPP Docket)
                                                amended as follows:                                                                                                                        the first page of your submission. All
                                                                                                                      in the Environmental Protection Agency
                                                                                                                                                                                           objections and requests for a hearing
                                                PART 180—[AMENDED]                                                    Docket Center (EPA/DC), West William
                                                                                                                                                                                           must be in writing, and must be
                                                                                                                      Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                                                                                           received by the Hearing Clerk on or
                                                ■ 1. The authority citation for part 180                              Constitution Ave. NW., Washington, DC
                                                                                                                                                                                           before September 25, 2017. Addresses
                                                continues to read as follows:                                         20460–0001. The Public Reading Room
                                                                                                                                                                                           for mail and hand delivery of objections
                                                    Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                                      is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                                                                                                           and hearing requests are provided in 40
                                                                                                                      Monday through Friday, excluding legal
                                                ■  2. In § 180.566, revise the entries for                                                                                                 CFR 178.25(b).
                                                                                                                      holidays. The telephone number for the
                                                ‘‘Citrus, dried pulp’’, ‘‘Citrus, oil’’, and                                                                                                 In addition to filing an objection or
                                                                                                                      Public Reading Room is (202) 566–1744,
                                                ‘‘Fruit, citrus, group 10–10’’ in the table                                                                                                hearing request with the Hearing Clerk
                                                                                                                      and the telephone number for the OPP
                                                in paragraph (a)(1) to read as follows:                                                                                                    as described in 40 CFR part 178, please
                                                                                                                      Docket is (703) 305–5805. Please review
                                                                                                                                                                                           submit a copy of the filing (excluding
                                                § 180.566 Fenpyroximate; tolerances for                               the visitor instructions and additional
                                                                                                                                                                                           any Confidential Business Information
                                                residues.                                                             information about the docket available
                                                                                                                                                                                           (CBI)) for inclusion in the public docket.
                                                    (a) * * *                                                         at http://www.epa.gov/dockets.
                                                                                                                                                                                           Information not marked confidential
                                                    (1) * * *                                                         FOR FURTHER INFORMATION CONTACT:                                     pursuant to 40 CFR part 2 may be
                                                                                                                      Michael Goodis, Registration Division                                disclosed publicly by EPA without prior
                                                                                                                      (7505P), Office of Pesticide Programs,
mstockstill on DSK30JT082PROD with RULES




                                                                                                    Parts per                                                                              notice. Submit the non-CBI copy of your
                                                               Commodity                             million          Environmental Protection Agency, 1200                                objection or hearing request, identified
                                                                                                                      Pennsylvania Ave. NW., Washington,                                   by docket ID number EPA–HQ–OPP–
                                                                                                                      DC 20460–0001; main telephone                                        2016–0518, by one of the following
                                                    *            *              *               *           *
                                                Citrus, dried pulp ........................                     4.0
                                                                                                                      number: (703) 305–7090; email address:                               methods:
                                                Citrus, oil .....................................                15   RDFRNotices@epa.gov.                                                   • Federal eRulemaking Portal: http://
                                                                                                                      SUPPLEMENTARY INFORMATION:                                           www.regulations.gov. Follow the online


                                           VerDate Sep<11>2014        17:07 Jul 26, 2017       Jkt 241001   PO 00000      Frm 00041       Fmt 4700       Sfmt 4700       E:\FR\FM\27JYR1.SGM    27JYR1


                                                34876              Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations

                                                instructions for submitting comments.                      Consistent with FFDCA section                       international maximum residue limits
                                                Do not submit electronically any                         408(b)(2)(D), and the factors specified in            (MRLs) established by the Codex
                                                information you consider to be CBI or                    FFDCA section 408(b)(2)(D), EPA has                   Alimentarius Commission (Codex), as
                                                other information whose disclosure is                    reviewed the available scientific data                required by FFDCA section 408(b)(4).
                                                restricted by statute.                                   and other relevant information in                     The Codex Alimentarius is a joint
                                                  • Mail: OPP Docket, Environmental                      support of this action. EPA has                       United Nations Food and Agriculture
                                                Protection Agency Docket Center (EPA/                    sufficient data to assess the hazards of              Organization/World Health
                                                DC), (28221T), 1200 Pennsylvania Ave.                    and to make a determination on                        Organization food standards program,
                                                NW., Washington, DC 20460–0001.                          aggregate exposure for ametoctradin                   and it is recognized as an international
                                                  • Hand Delivery: To make special                       including exposure resulting from the                 food safety standards-setting
                                                arrangements for hand delivery or                        tolerance amended by this action,                     organization in trade agreements to
                                                delivery of boxed information, please                    consistent with FFDCA section                         which the United States is a party. EPA
                                                follow the instructions at http://                       408(b)(2).                                            may establish a tolerance that is
                                                www.epa.gov/dockets/contacts.html.                         In the Federal Register of May 9, 2012              different from a Codex MRL; however,
                                                  Additional instructions on                             (77 FR 27130) (FRL–9339–6), EPA                       FFDCA section 408(b)(4) requires that
                                                commenting or visiting the docket,                       established tolerances for residues of                EPA explain the reasons for departing
                                                along with more information about                        ametoctradin in or on several                         from the Codex level.
                                                dockets generally, is available at http://               commodities, including hop, dried                        The Codex has established an MRL for
                                                www.epa.gov/dockets.                                     cones at 10 ppm. EPA is relying upon                  ametoctradin in or on hop, dried cones
                                                II. Summary of Petitioned-For                            the findings made in the May 9, 2012,                 at 30 ppm. This MRL is different than
                                                Tolerance                                                Federal Register document, as well as                 the tolerance established for
                                                                                                         the supporting risk assessments, in                   ametoctradin in the United States,
                                                   In the Federal Register of November                                                                         however, the tolerance increase
                                                30, 2016 (81 FR 86312) (FRL–9954–06),                    support of this action. The toxicity
                                                                                                         profile of ametoctradin has not changed               addressed by this document was
                                                EPA issued a document pursuant to                                                                              requested to accommodate the
                                                FFDCA section 408(d)(3), 21 U.S.C.                       since 2012, and as discussed in the 2012
                                                                                                         rule, no toxicological endpoints were                 importation of hops grown in the
                                                346a(d)(3), announcing the filing of a                                                                         European Union into the United States.
                                                pesticide petition (PP 6E8500) by BASF                   identified for ametoctradin. The Agency
                                                                                                         evaluated the request to increase the                 It is the Agency’s understanding that
                                                Corporation, P.O. Box 13528, Research                                                                          Codex intends to raise the MRL for
                                                Triangle Park, NC 27709. The petition                    existing tolerance on hop, dried cones
                                                                                                         and based on the lack of toxicity, has                ametoctradin on hop, dried cones to 100
                                                requested that 40 CFR 180.663 be                                                                               ppm.
                                                amended by modifying the tolerance for                   concluded that there is a reasonable
                                                residues of the fungicide ametoctradin                   certainty that no harm will result to the             V. Conclusion
                                                in or on hop, dried cone from 10 parts                   general population, or to infants and
                                                                                                                                                                 Therefore, the existing tolerance for
                                                per million (ppm) to 100 ppm. That                       children from aggregate exposure to                   residues of ametoctradin, including its
                                                document referenced a summary of the                     ametoctradin residues.                                metabolites and degradates in or on hop,
                                                                                                           For a detailed discussion of the
                                                petition prepared by BASF Corporation,                                                                         dried cones is increased from 10 ppm to
                                                                                                         aggregate risk assessments and
                                                the registrant, which is available in the                                                                      100 ppm.
                                                                                                         determination of safety for these
                                                docket, http://www.regulations.gov.
                                                                                                         tolerances, please refer to the May 9,                VI. Statutory and Executive Order
                                                There were no comments received in
                                                                                                         2012, Federal Register document and its               Reviews
                                                response to the notice of filing.
                                                                                                         supporting documents, available at                       This action amends a tolerance under
                                                III. Aggregate Risk Assessment and                       http://www.regulations.gov in docket ID               FFDCA section 408(d) in response to a
                                                Determination of Safety                                  number EPA–HQ–OPP–2010–0261.                          petition submitted to the Agency. The
                                                   Section 408(b)(2)(A)(i) of FFDCA                      Additionally, the risk assessment for                 Office of Management and Budget
                                                allows EPA to establish a tolerance (the                 this action is available in docket ID                 (OMB) has exempted these types of
                                                legal limit for a pesticide chemical                     number EPA–HQ–OPP–2016–0518.                          actions from review under Executive
                                                residue in or on a food) only if EPA                     IV. Other Considerations                              Order 12866, entitled ‘‘Regulatory
                                                determines that the tolerance is ‘‘safe.’’                                                                     Planning and Review’’ (58 FR 51735,
                                                Section 408(b)(2)(A)(ii) of FFDCA                        A. Analytical Enforcement Methodology                 October 4, 1993). Because this action
                                                defines ‘‘safe’’ to mean that ‘‘there is a                 Adequate enforcement methodology                    has been exempted from review under
                                                reasonable certainty that no harm will                   using liquid chromatography tandem                    Executive Order 12866, this action is
                                                result from aggregate exposure to the                    mass spectrometry (LC/MS/MS) is                       not subject to Executive Order 13211,
                                                pesticide chemical residue, including                    available to enforce the tolerance                    entitled ‘‘Actions Concerning
                                                all anticipated dietary exposures and all                expression. The method may be                         Regulations That Significantly Affect
                                                other exposures for which there is                       requested from: Chief, Analytical                     Energy Supply, Distribution, or Use’’ (66
                                                reliable information.’’ This includes                    Chemistry Branch, Environmental                       FR 28355, May 22, 2001) or Executive
                                                exposure through drinking water and in                   Science Center, 701 Mapes Rd., Ft.                    Order 13045, entitled ‘‘Protection of
                                                residential settings, but does not include               Meade, MD 20755–5350; telephone                       Children from Environmental Health
                                                occupational exposure. Section                           number: (410) 305–2905; email address:                Risks and Safety Risks’’ (62 FR 19885,
                                                408(b)(2)(C) of FFDCA requires EPA to                    residuemethods@epa.gov.                               April 23, 1997). This action does not
                                                give special consideration to exposure                                                                         contain any information collections
                                                                                                         B. International Residue Limits
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                                                of infants and children to the pesticide                                                                       subject to OMB approval under the
                                                chemical residue in establishing a                         In making its tolerance decisions, EPA              Paperwork Reduction Act (PRA) (44
                                                tolerance and to ‘‘ensure that there is a                seeks to harmonize U.S. tolerances with               U.S.C. 3501 et seq.), nor does it require
                                                reasonable certainty that no harm will                   international standards whenever                      any special considerations under
                                                result to infants and children from                      possible, consistent with U.S. food                   Executive Order 12898, entitled
                                                aggregate exposure to the pesticide                      safety standards and agricultural                     ‘‘Federal Actions to Address
                                                chemical residue. . . .’’                                practices. EPA considers the                          Environmental Justice in Minority


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                                                                   Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations                                                       34877

                                                Populations and Low-Income                                 Dated: June 22, 2017.                                             Docket Center (EPA/DC), West William
                                                Populations’’ (59 FR 7629, February 16,                  Michael Goodis,                                                     Jefferson Clinton Bldg., Rm. 3334, 1301
                                                1994).                                                   Director Registration Division, Office of                           Constitution Ave. NW., Washington, DC
                                                   Since tolerances and exemptions that                  Pesticide Programs.                                                 20460–0001. The Public Reading Room
                                                are established on the basis of a petition                 Therefore, 40 CFR chapter I is                                    is open from 8:30 a.m. to 4:30 p.m.,
                                                under FFDCA section 408(d), such as                      amended as follows:                                                 Monday through Friday, excluding legal
                                                the tolerance in this final rule, do not                                                                                     holidays. The telephone number for the
                                                require the issuance of a proposed rule,                 PART 180—[AMENDED]                                                  Public Reading Room is (202) 566–1744,
                                                the requirements of the Regulatory                                                                                           and the telephone number for the OPP
                                                Flexibility Act (RFA) (5 U.S.C. 601 et                   ■ 1. The authority citation for part 180                            Docket is (703) 305–5805. Please review
                                                seq.), do not apply.                                     continues to read as follows:                                       the visitor instructions and additional
                                                                                                              Authority: 21 U.S.C. 321(q), 346a and 371.                     information about the docket available
                                                   This action directly regulates growers,                                                                                   at http://www.epa.gov/dockets.
                                                food processors, food handlers, and food                 ■ 2. In § 180.663, revise the entry for
                                                                                                                                                                             FOR FURTHER INFORMATION CONTACT:
                                                retailers, not States or tribes, nor does                ‘‘Hop, dried cones’’ in the table in
                                                this action alter the relationships or                   paragraph (a) to read as follows:                                   Michael Goodis, Registration Division
                                                distribution of power and                                                                                                    (7505P), Office of Pesticide Programs,
                                                responsibilities established by Congress                 § 180.663 Ametoctradin; tolerances for                              Environmental Protection Agency, 1200
                                                                                                         residues.                                                           Pennsylvania Ave. NW., Washington,
                                                in the preemption provisions of FFDCA
                                                section 408(n)(4). As such, the Agency                        (a) * * *                                                      DC 20460–0001; main telephone
                                                has determined that this action will not                                                                                     number: (703) 305–7090; email address:
                                                have a substantial direct effect on States                                                                       Parts       RDFRNotices@epa.gov.
                                                                                                                       Commodity                                  per        SUPPLEMENTARY INFORMATION:
                                                or tribal governments, on the                                                                                    million
                                                relationship between the national                                                                                            I. General Information
                                                government and the States or tribal
                                                governments, or on the distribution of                     *          *          *               *                    *      A. Does this action apply to me?
                                                power and responsibilities among the                     Hop, dried cones ........................                     100
                                                                                                                                                                                You may be potentially affected by
                                                various levels of government or between                                                                                      this action if you are an agricultural
                                                                                                               *           *              *               *           *
                                                the Federal Government and Indian                                                                                            producer, food manufacturer, or
                                                tribes. Thus, the Agency has determined                                                                                      pesticide manufacturer. The following
                                                                                                         *         *       *       *           *
                                                that Executive Order 13132, entitled                     [FR Doc. 2017–15762 Filed 7–26–17; 8:45 am]                         list of North American Industrial
                                                ‘‘Federalism’’ (64 FR 43255, August 10,                                                                                      Classification System (NAICS) codes is
                                                                                                         BILLING CODE 6560–50–P
                                                1999) and Executive Order 13175,                                                                                             not intended to be exhaustive, but rather
                                                entitled ‘‘Consultation and Coordination                                                                                     provides a guide to help readers
                                                with Indian Tribal Governments’’ (65 FR                  ENVIRONMENTAL PROTECTION                                            determine whether this document
                                                67249, November 9, 2000) do not apply                    AGENCY                                                              applies to them. Potentially affected
                                                to this action. In addition, this action                                                                                     entities may include:
                                                does not impose any enforceable duty or                  40 CFR Part 180                                                        • Crop production (NAICS code 111).
                                                contain any unfunded mandate as                                                                                                 • Animal production (NAICS code
                                                                                                         [EPA–HQ–OPP–2015–0405; FRL–9964–15]
                                                described under Title II of the Unfunded                                                                                     112).
                                                Mandates Reform Act (UMRA) (2 U.S.C.                     Tolpyralate; Pesticide Tolerances                                      • Food manufacturing (NAICS code
                                                1501 et seq.).                                                                                                               311).
                                                   This action does not involve any                      AGENCY:  Environmental Protection                                      • Pesticide manufacturing (NAICS
                                                technical standards that would require                   Agency (EPA).                                                       code 32532).
                                                Agency consideration of voluntary                        ACTION: Final rule.                                                 B. How can I get electronic access to
                                                consensus standards pursuant to section                                                                                      other related information?
                                                                                                         SUMMARY:   This regulation establishes
                                                12(d) of the National Technology
                                                                                                         tolerances for residues of tolpyralate in                              You may access a frequently updated
                                                Transfer and Advancement Act
                                                                                                         or on field corn, popcorn, and sweet                                electronic version of EPA’s tolerance
                                                (NTTAA) (15 U.S.C. 272 note).
                                                                                                         corn. ISK Biosciences Corporation                                   regulations at 40 CFR part 180 through
                                                VII. Congressional Review Act                            requested these tolerances under the                                the Government Printing Office’s e-CFR
                                                                                                         Federal Food, Drug, and Cosmetic Act                                site at http://www.ecfr.gov/cgi-bin/text-
                                                  Pursuant to the Congressional Review                   (FFDCA).                                                            idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                Act (5 U.S.C. 801 et seq.), EPA will                                                                                         40tab_02.tpl.
                                                submit a report containing this rule and                 DATES:  This regulation is effective July
                                                other required information to the U.S.                   27, 2017. Objections and requests for                               C. How can I file an objection or hearing
                                                Senate, the U.S. House of                                hearings must be received on or before                              request?
                                                Representatives, and the Comptroller                     September 25, 2017, and must be filed                                 Under FFDCA section 408(g), 21
                                                General of the United States prior to                    in accordance with the instructions                                 U.S.C. 346a, any person may file an
                                                publication of the rule in the Federal                   provided in 40 CFR part 178 (see also                               objection to any aspect of this regulation
                                                Register. This action is not a ‘‘major                   Unit I.C. of the SUPPLEMENTARY                                      and may also request a hearing on those
                                                rule’’ as defined by 5 U.S.C. 804(2).                    INFORMATION).
                                                                                                                                                                             objections. You must file your objection
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                                                List of Subjects in 40 CFR Part 180                      ADDRESSES:   The docket for this action,                            or request a hearing on this regulation
                                                                                                         identified by docket identification (ID)                            in accordance with the instructions
                                                  Environmental protection,                              number EPA–HQ–OPP–2015–0405, is                                     provided in 40 CFR part 178. To ensure
                                                Administrative practice and procedure,                   available at http://www.regulations.gov                             proper receipt by EPA, you must
                                                Agricultural commodities, Pesticides                     or at the Office of Pesticide Programs                              identify docket ID number EPA–HQ–
                                                and pests, Reporting and recordkeeping                   Regulatory Public Docket (OPP Docket)                               OPP–2015–0405 in the subject line on
                                                requirements.                                            in the Environmental Protection Agency                              the first page of your submission. All


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Document Created: 2017-07-27 02:07:16
Document Modified: 2017-07-27 02:07:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective July 27, 2017. Objections and requests for hearings must be received on or before September 25, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 34875 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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