81_FR_72740 81 FR 72537 - Fluridone; Pesticide Tolerances

81 FR 72537 - Fluridone; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 203 (October 20, 2016)

Page Range72537-72539
FR Document2016-25291

This regulation establishes a tolerance for residues of fluridone in or on cotton gin byproducts. SePRO Corporation requested the tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 81 Issue 203 (Thursday, October 20, 2016)
[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Rules and Regulations]
[Pages 72537-72539]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25291]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0325; FRL-9951-81]


Fluridone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
fluridone in or on cotton gin byproducts. SePRO Corporation requested 
the tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 20, 2016. Objections and 
requests for hearings must be received on or before December 19, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0325, 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

[[Page 72538]]

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-2016-0325 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 December 19, 2016. Addresses for mail and 
hand delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0325, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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# 
6F8451) by SePRO Corporation, 11550 North Meridian Street, Suite 600, 
Carmel, IN 46032. The petition requested that 40 CFR part 180 be 
amended by establishing a tolerance for residues of the herbicide 
fluridone in or on cotton, gin byproducts at 0.1 ppm. That document 
referenced a summary of the petition prepared SePRO, the registrant, 
which is available in the docket EPA-HQ-OPP-2016-0325 at http://www.regulations.gov. No comments were 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), 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 fluridone in or on 
cotton gin byproducts, consistent with FFDCA section 408(b)(2).
    In the Federal Register of February 17, 2016 (81 FR 7982) (FRL-
9941-69), EPA established a tolerance for residues of fluridone in or 
on cotton, undelinted seed. EPA is relying upon the risk assessments 
that supported the findings made in the February 17, 2016 Federal 
Register document in support of this action. The toxicity profile of 
fluridone has not changed, and the previous risk assessments that 
supported the establishment of that tolerance remain valid.
    For the February 17, 2016 action, the petitioner did not propose a 
tolerance for residues of fluridone on cotton gin byproducts, however, 
the Agency determined that a cotton gin byproduct tolerance was needed 
to cover the cotton raw agricultural commodities (RAC). The commodity 
``cotton gin byproducts'' was included in the risk assessments that 
supported the February 17, 2016 Final Rule, but because they were not 
proposed by the registrant, they could not be established at that time. 
The registrant has subsequently proposed the cotton gin byproducts 
tolerance and therefore, the tolerance can now be established.
    EPA concludes that the aggregate exposure and risk estimates 
presented in the most recent human health risk assessment document, 
which were not of concern to the Agency, adequately account for 
exposures and risk resulting from all fluridone uses including cotton 
gin byproducts.
    Therefore, EPA relies upon the findings made in the February 17, 
2016, Federal Register document in support of this rule. EPA concludes 
that there is a reasonable certainty that no harm will result to the 
general population, or to infants and children from aggregate exposure 
to fluridone residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer to the 
February 17, 2016, Federal Register document and its supporting 
documents, available at http://www.regulations.gov in docket ID number 
EPA-HQ-OPP-2014-0913.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high performance liquid 
chromatography (HPLC) method (originally submitted as method AM-AA-CA-
RO52-AA-755) is available in the Pesticide Analytical Manual (PAM) 
Volume II for residues of fluridone in plant commodities.

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.
    There is no Codex MRL for fluridone residues in or on cotton.

V. Conclusion

    Therefore, a tolerance is established for residues of fluridone, 1-
methyl-3-

[[Page 72539]]

phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, in or on cotton, 
gin byproducts at 0.1 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances 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: October 7, 2016.
Daniel J. Rosenblatt,
Acting 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.  180.420, in paragraph (a)(2) add an entry ``Cotton, gin 
byproducts'' in alphabetical order to read as follows:


Sec.  180.420  Fluridone; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cotton, gin byproducts..................................             0.1
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-25291 Filed 10-19-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                                      Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Rules and Regulations                                                              72537

                                                  PART 52—APPROVAL AND                                                 Authority: 42 U.S.C. 7401 et seq.                       Review’’ by revising the entry for
                                                  PROMULGATION OF                                                                                                              ‘‘Section 2.0’’ to read as follows:
                                                                                                                   Subpart I—Delaware
                                                  IMPLEMENTATION PLANS
                                                                                                                                                                               § 52.420    Identification of plan.
                                                                                                                   ■ 2. In § 52.420, the table in paragraph
                                                  ■ 1. The authority citation for part 52                                                                                      *       *    *        *       *
                                                                                                                   (c) is amended under the heading ‘‘1125
                                                  continues to read as follows:                                    Requirements for Preconstruction                                (c) * * *

                                                                                            EPA-APPROVED REGULATIONS AND STATUTES IN THE DELAWARE SIP
                                                                                                                                            State
                                                            State regulation                                 Title/subject                 effective                 EPA approval date                   Additional explanation
                                                           (7 DNREC 1100)                                                                    date


                                                              *                            *                           *                          *                       *                      *                      *

                                                                                                                1125       Requirements for Preconstruction Review


                                                           *                               *                      *                           *                          *                      *                  *
                                                  Section 2.0 ...............................    Emission Offset Provisions                   2/11/12         10/2/12, 77 FR 60053 ............ Added Section 2.2.5, 2.4.3.3
                                                                                                   (EOP) including sections                                                                       and 2.5.7.
                                                                                                   1.0 through 3.16.4.
                                                                                                 Sections 2.5.5 and 2.5.6 ........          9/11/2013         10/20/2016 [Insert Federal         Disapproval. See 40 CFR
                                                                                                                                                                Register citation].                52.433(a).

                                                              *                            *                           *                          *                       *                      *                      *



                                                  *       *    *    *      *                                       ACTION:     Final rule.                                     DC 20460–0001; main telephone
                                                  ■   3. Add § 52.433 to read as follows:                                                                                      number: (703) 305–7090; email address:
                                                                                                                   SUMMARY:   This regulation establishes a                    RDFRNotices@epa.gov.
                                                  § 52.433        Nonattainment new source                         tolerance for residues of fluridone in or
                                                                                                                                                                               SUPPLEMENTARY INFORMATION:
                                                  review.                                                          on cotton gin byproducts. SePRO
                                                    (a) Disapproval. EPA is disapproving                           Corporation requested the tolerance                         I. General Information
                                                  Delaware’s October 15, 2013 submittal                            under the Federal Food, Drug, and
                                                                                                                   Cosmetic Act (FFDCA).                                       A. Does this action apply to me?
                                                  of revisions to 7 DNREC 1125, sections
                                                  2.5.5 and 2.5.6 because it does not meet                         DATES: This regulation is effective                            You may be potentially affected by
                                                  Clean Air Act (CAA) requirements                                 October 20, 2016. Objections and                            this action if you are an agricultural
                                                  which establish the criteria under which                         requests for hearings must be received                      producer, food manufacturer, or
                                                  the owner or operator of a new or                                on or before December 19, 2016, and                         pesticide manufacturer. The following
                                                  modified major stationary source must                            must be filed in accordance with the                        list of North American Industrial
                                                  obtain the required emission offsets for                         instructions provided in 40 CFR part                        Classification System (NAICS) codes is
                                                  the nonattainment new source review                              178 (see also Unit I.C. of the                              not intended to be exhaustive, but rather
                                                  (NSR) preconstruction permitting                                 SUPPLEMENTARY INFORMATION).                                 provides a guide to help readers
                                                  program and because Delaware                                     ADDRESSES: The docket for this action,                      determine whether this document
                                                  exercises authorities that are reserved                          identified by docket identification (ID)                    applies to them. Potentially affected
                                                  for EPA under section 107 of the CAA.                            number EPA–HQ–OPP–2016–0325, is                             entities may include:
                                                                                                                   available at http://www.regulations.gov                        • Crop production (NAICS code 111).
                                                  Delaware’s Federally-approved                                                                                                   • Animal production (NAICS code
                                                  nonattainment NSR preconstruction                                or at the Office of Pesticide Programs
                                                                                                                   Regulatory Public Docket (OPP Docket)                       112).
                                                  program in 7 DNREC 1125, sections 1.0                                                                                           • Food manufacturing (NAICS code
                                                  through 3.16.4, effective in Delaware on                         in the Environmental Protection Agency
                                                                                                                                                                               311).
                                                  February 11, 2012, was fully-approved                            Docket Center (EPA/DC), West William
                                                                                                                                                                                  • Pesticide manufacturing (NAICS
                                                  by EPA on October 2, 2012 and                                    Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                                                                               code 32532).
                                                  continues to apply.                                              Constitution Ave. NW., Washington, DC
                                                    (b) [Reserved]                                                 20460–0001. The Public Reading Room                         B. How can I get electronic access to
                                                  [FR Doc. 2016–24657 Filed 10–19–16; 8:45 am]
                                                                                                                   is open from 8:30 a.m. to 4:30 p.m.,                        other related information?
                                                                                                                   Monday through Friday, excluding legal                         You may access a frequently updated
                                                  BILLING CODE 6560–50–P
                                                                                                                   holidays. The telephone number for the                      electronic version of EPA’s tolerance
                                                                                                                   Public Reading Room is (202) 566–1744,                      regulations at 40 CFR part 180 through
                                                  ENVIRONMENTAL PROTECTION                                         and the telephone number for the OPP                        the Government Printing Office’s e-CFR
                                                  AGENCY                                                           Docket is (703) 305–5805. Please review                     site at http://www.ecfr.gov/cgi-bin/text-
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                                                                                   the visitor instructions and additional                     idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                  40 CFR Part 180                                                  information about the docket available                      40tab_02.tpl.
                                                                                                                   at http://www.epa.gov/dockets.
                                                  [EPA–HQ–OPP–2016–0325; FRL–9951–81]                              FOR FURTHER INFORMATION CONTACT:                            C. How can I file an objection or hearing
                                                                                                                   Michael Goodis, Registration Division                       request?
                                                  Fluridone; Pesticide Tolerances
                                                                                                                   (7505P), Office of Pesticide Programs,                        Under FFDCA section 408(g), 21
                                                  AGENCY: Environmental Protection                                 Environmental Protection Agency, 1200                       U.S.C. 346a, any person may file an
                                                  Agency (EPA).                                                    Pennsylvania Ave. NW., Washington,                          objection to any aspect of this regulation


                                             VerDate Sep<11>2014      15:55 Oct 19, 2016        Jkt 241001   PO 00000      Frm 00057   Fmt 4700       Sfmt 4700   E:\FR\FM\20OCR1.SGM   20OCR1


                                                  72538            Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Rules and Regulations

                                                  and may also request a hearing on those                 HQ–OPP–2016–0325 at http://                           proposed the cotton gin byproducts
                                                  objections. You must file your objection                www.regulations.gov. No comments                      tolerance and therefore, the tolerance
                                                  or request a hearing on this regulation                 were received in response to the notice               can now be established.
                                                  in accordance with the instructions                     of filing.                                               EPA concludes that the aggregate
                                                  provided in 40 CFR part 178. To ensure                                                                        exposure and risk estimates presented
                                                                                                          III. Aggregate Risk Assessment and                    in the most recent human health risk
                                                  proper receipt by EPA, you must
                                                                                                          Determination of Safety                               assessment document, which were not
                                                  identify docket ID number EPA–HQ–
                                                  OPP–2016–0325 in the subject line on                       Section 408(b)(2)(A)(i) of FFDCA                   of concern to the Agency, adequately
                                                  the first page of your submission. All                  allows EPA to establish a tolerance (the              account for exposures and risk resulting
                                                  objections and requests for a hearing                   legal limit for a pesticide chemical                  from all fluridone uses including cotton
                                                  must be in writing, and must be                         residue in or on a food) only if EPA                  gin byproducts.
                                                  received by the Hearing Clerk on or                     determines that the tolerance is ‘‘safe.’’               Therefore, EPA relies upon the
                                                  before December 19, 2016. Addresses for                 Section 408(b)(2)(A)(ii) of FFDCA                     findings made in the February 17, 2016,
                                                  mail and hand delivery of objections                    defines ‘‘safe’’ to mean that ‘‘there is a            Federal Register document in support
                                                  and hearing requests are provided in 40                 reasonable certainty that no harm will                of this rule. EPA concludes that there is
                                                  CFR 178.25(b).                                          result from aggregate exposure to the                 a reasonable certainty that no harm will
                                                    In addition to filing an objection or                 pesticide chemical residue, including                 result to the general population, or to
                                                  hearing request with the Hearing Clerk                  all anticipated dietary exposures and all             infants and children from aggregate
                                                  as described in 40 CFR part 178, please                 other exposures for which there is                    exposure to fluridone residues.
                                                  submit a copy of the filing (excluding                  reliable information.’’ This includes                    For a detailed discussion of the
                                                  any Confidential Business Information                   exposure through drinking water and in                aggregate risk assessments and
                                                  (CBI)) for inclusion in the public docket.              residential settings, but does not include            determination of safety for these
                                                  Information not marked confidential                     occupational exposure. Section                        tolerances, please refer to the February
                                                  pursuant to 40 CFR part 2 may be                        408(b)(2)(C) of FFDCA requires EPA to                 17, 2016, Federal Register document
                                                  disclosed publicly by EPA without prior                 give special consideration to exposure                and its supporting documents, available
                                                  notice. Submit the non-CBI copy of your                 of infants and children to the pesticide              at http://www.regulations.gov in docket
                                                  objection or hearing request, identified                chemical residue in establishing a                    ID number EPA–HQ–OPP–2014–0913.
                                                  by docket ID number EPA–HQ–OPP–                         tolerance and to ‘‘ensure that there is a             IV. Other Considerations
                                                  2016–0325, by one of the following                      reasonable certainty that no harm will
                                                  methods:                                                result to infants and children from                   A. Analytical Enforcement Methodology
                                                    • Federal eRulemaking Portal: http://                 aggregate exposure to the pesticide                     Adequate enforcement methodology
                                                  www.regulations.gov. Follow the online                  chemical residue. . . .’’                             high performance liquid
                                                  instructions for submitting comments.                      Consistent with FFDCA section                      chromatography (HPLC) method
                                                  Do not submit electronically any                        408(b)(2)(D), EPA has reviewed the                    (originally submitted as method AM–
                                                  information you consider to be CBI or                   available scientific data and other                   AA–CA–RO52–AA–755) is available in
                                                  other information whose disclosure is                   relevant information in support of this               the Pesticide Analytical Manual (PAM)
                                                  restricted by statute.                                  action. EPA has sufficient data to assess             Volume II for residues of fluridone in
                                                    • Mail: OPP Docket, Environmental                     the hazards of and to make a                          plant commodities.
                                                  Protection Agency Docket Center (EPA/                   determination on aggregate exposure for
                                                  DC), (28221T), 1200 Pennsylvania Ave.                   fluridone in or on cotton gin                         B. International Residue Limits
                                                  NW., Washington, DC 20460–0001.                         byproducts, consistent with FFDCA                        In making its tolerance decisions, EPA
                                                    • Hand Delivery: To make special                      section 408(b)(2).                                    seeks to harmonize U.S. tolerances with
                                                  arrangements for hand delivery or                          In the Federal Register of February                international standards whenever
                                                  delivery of boxed information, please                   17, 2016 (81 FR 7982) (FRL–9941–69),                  possible, consistent with U.S. food
                                                  follow the instructions at http://                      EPA established a tolerance for residues              safety standards and agricultural
                                                  www.epa.gov/dockets/contacts.html.                      of fluridone in or on cotton, undelinted              practices. EPA considers the
                                                    Additional instructions on                            seed. EPA is relying upon the risk                    international maximum residue limits
                                                  commenting or visiting the docket,                      assessments that supported the findings               (MRLs) established by the Codex
                                                  along with more information about                       made in the February 17, 2016 Federal                 Alimentarius Commission (Codex), as
                                                  dockets generally, is available at http://              Register document in support of this                  required by FFDCA section 408(b)(4).
                                                  www.epa.gov/dockets.                                    action. The toxicity profile of fluridone             The Codex Alimentarius is a joint
                                                                                                          has not changed, and the previous risk                United Nations Food and Agriculture
                                                  II. Summary of Petitioned-for Tolerance                 assessments that supported the                        Organization/World Health
                                                     In the Federal Register of July 20,                  establishment of that tolerance remain                Organization food standards program,
                                                  2016 (81 FR 47150) (FRL–9948–45),                       valid.                                                and it is recognized as an international
                                                  EPA issued a document pursuant to                          For the February 17, 2016 action, the              food safety standards-setting
                                                  FFDCA section 408(d)(3), 21 U.S.C.                      petitioner did not propose a tolerance                organization in trade agreements to
                                                  346a(d)(3), announcing the filing of a                  for residues of fluridone on cotton gin               which the United States is a party. EPA
                                                  pesticide petition (PP# 6F8451) by                      byproducts, however, the Agency                       may establish a tolerance that is
                                                  SePRO Corporation, 11550 North                          determined that a cotton gin byproduct                different from a Codex MRL; however,
                                                  Meridian Street, Suite 600, Carmel, IN                  tolerance was needed to cover the                     FFDCA section 408(b)(4) requires that
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  46032. The petition requested that 40                   cotton raw agricultural commodities                   EPA explain the reasons for departing
                                                  CFR part 180 be amended by                              (RAC). The commodity ‘‘cotton gin                     from the Codex level.
                                                  establishing a tolerance for residues of                byproducts’’ was included in the risk                    There is no Codex MRL for fluridone
                                                  the herbicide fluridone in or on cotton,                assessments that supported the February               residues in or on cotton.
                                                  gin byproducts at 0.1 ppm. That                         17, 2016 Final Rule, but because they
                                                  document referenced a summary of the                    were not proposed by the registrant,                  V. Conclusion
                                                  petition prepared SePRO, the registrant,                they could not be established at that                   Therefore, a tolerance is established
                                                  which is available in the docket EPA–                   time. The registrant has subsequently                 for residues of fluridone, 1-methyl-3-


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                                                                   Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Rules and Regulations                                                               72539

                                                  phenyl-5-(3-(trifluoromethyl)phenyl)-                   to this action. In addition, this action                              SURFACE TRANSPORTATION BOARD
                                                  4(1H)-pyridinone, in or on cotton, gin                  does not impose any enforceable duty or
                                                  byproducts at 0.1 ppm.                                  contain any unfunded mandate as                                       49 CFR Part 1022
                                                                                                          described under Title II of the Unfunded                              [Docket No. EP 716 (Sub-No. 1)]
                                                  VI. Statutory and Executive Order
                                                                                                          Mandates Reform Act (UMRA) (2 U.S.C.
                                                  Reviews
                                                                                                          1501 et seq.).                                                        Civil Monetary Penalty Inflation
                                                     This action establishes tolerances                                                                                         Adjustment Rule
                                                  under FFDCA section 408(d) in                             This action does not involve any
                                                  response to a petition submitted to the                 technical standards that would require                                AGENCY:    Surface Transportation Board.
                                                  Agency. The Office of Management and                    Agency consideration of voluntary
                                                                                                                                                                                ACTION:   Interim final rule.
                                                  Budget (OMB) has exempted these types                   consensus standards pursuant to section
                                                  of actions from review under Executive                  12(d) of the National Technology                                      SUMMARY:   The Surface Transportation
                                                  Order 12866, entitled ‘‘Regulatory                      Transfer and Advancement Act                                          Board (Board) is issuing an interim final
                                                  Planning and Review’’ (58 FR 51735,                     (NTTAA) (15 U.S.C. 272 note).                                         rule to adjust the Board’s civil monetary
                                                  October 4, 1993). Because this action                   VII. Congressional Review Act                                         penalties for inflation pursuant to the
                                                  has been exempted from review under                                                                                           Federal Civil Penalties Inflation
                                                  Executive Order 12866, this action is                     Pursuant to the Congressional Review                                Adjustment Act Improvements Act of
                                                  not subject to Executive Order 13211,                   Act (5 U.S.C. 801 et seq.), EPA will                                  2015. As mandated by that act, the
                                                  entitled ‘‘Actions Concerning                           submit a report containing this rule and                              Board is issuing a ‘‘catch-up
                                                  Regulations That Significantly Affect                   other required information to the U.S.                                adjustment’’ for its penalties and will
                                                  Energy Supply, Distribution, or Use’’ (66               Senate, the U.S. House of                                             thereafter make annual inflation
                                                  FR 28355, May 22, 2001) or Executive                    Representatives, and the Comptroller                                  adjustments according to a specified
                                                  Order 13045, entitled ‘‘Protection of                   General of the United States prior to                                 formula.
                                                  Children from Environmental Health                      publication of the rule in the Federal                                DATES:  This interim final rule is
                                                  Risks and Safety Risks’’ (62 FR 19885,                  Register. This action is not a ‘‘major                                effective on October 20, 2016.
                                                  April 23, 1997). This action does not                   rule’’ as defined by 5 U.S.C. 804(2).
                                                                                                                                                                                FOR FURTHER INFORMATION CONTACT:
                                                  contain any information collections
                                                                                                          List of Subjects in 40 CFR Part 180                                   Allison Davis: (202) 245–0378. Federal
                                                  subject to OMB approval under the
                                                                                                                                                                                Information Relay Service (FIRS) for the
                                                  Paperwork Reduction Act (PRA) (44                         Environmental protection,                                           hearing impaired: 1–800–877–8339.
                                                  U.S.C. 3501 et seq.), nor does it require               Administrative practice and procedure,
                                                  any special considerations under                                                                                              SUPPLEMENTARY INFORMATION:
                                                                                                          Agricultural commodities, Pesticides
                                                  Executive Order 12898, entitled                         and pests, Reporting and recordkeeping                                I. Background
                                                  ‘‘Federal Actions to Address                            requirements.
                                                  Environmental Justice in Minority                                                                                               On November 2, 2015, the President
                                                  Populations and Low-Income                                 Dated: October 7, 2016.                                            signed the Federal Civil Penalties
                                                  Populations’’ (59 FR 7629, February 16,                 Daniel J. Rosenblatt,                                                 Inflation Adjustment Act Improvements
                                                  1994).                                                  Acting Director, Registration Division, Office
                                                                                                                                                                                Act of 2015 (2015 Act), passed as part
                                                     Since tolerances and exemptions that                 of Pesticide Programs.                                                of the Bipartisan Budget Act of 2015,
                                                  are established on the basis of a petition                                                                                    Public Law 114–74, 129 Stat. 599. The
                                                  under FFDCA section 408(d), such as                       Therefore, 40 CFR chapter I is                                      2015 Act further amended the Federal
                                                  the tolerances in this final rule, do not               amended as follows:                                                   Civil Penalties Inflation Adjustment Act
                                                  require the issuance of a proposed rule,                                                                                      of 1990 (1990 Act), Public Law 101–410,
                                                  the requirements of the Regulatory                      PART 180—[AMENDED]                                                    104 Stat. 890 (codified as amended at 28
                                                  Flexibility Act (RFA) (5 U.S.C. 601 et                                                                                        U.S.C. 2461 note), as previously
                                                  seq.), do not apply.                                    ■ 1. The authority citation for part 180                              amended by the Debt Collection
                                                     This action directly regulates growers,              continues to read as follows:                                         Improvement Act of 1996 (1996 Act),
                                                  food processors, food handlers, and food                                                                                      Public Law 104–134, 110 Stat. 1321, in
                                                                                                              Authority: 21 U.S.C. 321(q), 346a and 371.
                                                  retailers, not States or tribes, nor does                                                                                     order to improve the effectiveness of
                                                  this action alter the relationships or                  ■ 2. In § 180.420, in paragraph (a)(2) add                            civil monetary penalties and to maintain
                                                  distribution of power and                               an entry ‘‘Cotton, gin byproducts’’ in                                their deterrent effect.1
                                                  responsibilities established by Congress                alphabetical order to read as follows:                                  The 1996 Act required each federal
                                                  in the preemption provisions of FFDCA                                                                                         agency to adopt regulations at least once
                                                  section 408(n)(4). As such, the Agency                  § 180.420 Fluridone; tolerances for                                   every four years that adjust for inflation
                                                  has determined that this action will not                residues.                                                             the maximum amount of civil monetary
                                                  have a substantial direct effect on States                                                                                    penalties under the statutes
                                                                                                                (a) * * *
                                                  or tribal governments, on the                                                                                                 administered by the agency. In
                                                  relationship between the national                             (2) * * *                                                       accordance with the 1996 Act, the Board
                                                  government and the States or tribal                                                                                           increased its existing civil monetary
                                                                                                                                                               Parts per        penalties, which had not been adjusted
                                                  governments, or on the distribution of                                  Commodity                             million
                                                  power and responsibilities among the                                                                                          for inflation since they were prescribed
                                                  various levels of government or between
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                                                                                                                                                  1 A ‘‘civil monetary penalty’’ is defined by the
                                                  the Federal Government and Indian                          *         *        *                          *          *
                                                                                                                                                                                1990 Act as: ‘‘any penalty, fine, or other sanction
                                                  tribes. Thus, the Agency has determined                 Cotton, gin byproducts .........                                0.1   that—(A)(i) is for a specific monetary amount as
                                                  that Executive Order 13132, entitled                                                                                          provided by Federal law; or (ii) has a maximum
                                                  ‘‘Federalism’’ (64 FR 43255, August 10,                       *               *              *           *          *         amount provided for by Federal law; and (B) is
                                                  1999) and Executive Order 13175,                                                                                              assessed or enforced by an agency pursuant to
                                                                                                          *           *     *           *          *                            Federal law; and (C) is assessed or enforced
                                                  entitled ‘‘Consultation and Coordination                                                                                      pursuant to an administrative proceeding or a civil
                                                  with Indian Tribal Governments’’ (65 FR                 [FR Doc. 2016–25291 Filed 10–19–16; 8:45 am]
                                                                                                                                                                                action in the Federal courts.’’ See also 49 CFR
                                                  67249, November 9, 2000) do not apply                   BILLING CODE 6560–50–P                                                1022.2(b).



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Document Created: 2016-10-21 09:59:16
Document Modified: 2016-10-21 09:59:16
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 October 20, 2016. Objections and requests for hearings must be received on or before December 19, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 72537 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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