80_FR_56574 80 FR 56393 - Fluensulfone; Pesticide Tolerances

80 FR 56393 - Fluensulfone; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 181 (September 18, 2015)

Page Range56393-56395
FR Document2015-23359

This regulation establishes a tolerance for residues of fluensulfone in or on tomato, paste. Makhteshim Agan of North America, Inc., doing business as ADAMA requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 181 (Friday, September 18, 2015)
[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Rules and Regulations]
[Pages 56393-56395]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23359]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0375; FRL-9933-02]


Fluensulfone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
fluensulfone in or on tomato, paste. Makhteshim Agan of North America, 
Inc., doing business as ADAMA requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 18, 2015. Objections and 
requests for hearings must be received on or before November 17, 2015, 
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-2015-0375, 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: Susan Lewis, 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: RDFRNotices@epa.gov.

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-2015-0375 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 17, 2015. 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-2015-0375, 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 17, 2015 (80 FR 42462) (FRL-9929-
13), 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 
5F8365) by Makhteshim Agan of North America, Inc., doing business as 
ADAMA, 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition 
requested that 40 CFR part 180 be amended by establishing tolerances 
for residues of the insecticide fluensulfone, 3,4,4-trifluoro-but-3-
ene-1-sulfonic acid, in or on tomato, paste at 1.0 parts per million 
(ppm). That document referenced a summary of the petition prepared by 
ADAMA, 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

[[Page 56394]]

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, consistent with FFDCA 
section 408(b)(2).
    In the Federal Register of September 24, 2014 (79 FR 56963) (FRL-
9914-35), EPA established tolerances for residues of fluensulfone in or 
on cucurbit vegetable crop group 9 and fruiting vegetable crop group 8-
10 at 0.50 parts per million (ppm). The information available to the 
Agency in support of the September 24, 2014 final rule showed no 
concentration of fluensulfone or the metabolite BSA in or on fruiting 
vegetable commodities and that separate tolerances for residues in or 
on processed tomato products were unnecessary. Therefore, EPA 
established a tolerance for residues of fluensulfone in or on fruiting 
vegetable crop group 8-10 at 0.50 ppm and determined that a separate 
tolerance for tomato, paste was not necessary.
    Since the time of the September 24, 2014 final rule, EPA received a 
new tomato processing study that demonstrates a concentration of BSA 
residues in tomato paste (3.5X). Based on this concentration factor and 
the highest average field trial (HAFT) residues in tomato (0.29 ppm), 
the Agency determined that the fruiting vegetable crop group 8-10 
tolerance at 0.5 ppm is insufficient to cover residues in tomato, paste 
and therefore a tolerance of 1.0 ppm in or on tomato, paste is 
necessary to cover residues of BSA.
    The Agency assessed the use of fluensulfone in or on tomato, paste 
at the tolerance of 1.0 ppm and determined that there would be no 
resulting change in the risk estimates from the previous risk 
assessment for the chemical. Since the publication of the September 24, 
2014 final rule, the toxicity profile of fluensulfone has not changed, 
and the risk assessments that supported the establishment of those 
tolerances published in the Federal Register remain valid. The dietary 
risk assessments for fluensulfone are based on residues of the parent 
compound only. Since residues of the parent did not concentrate in 
tomato paste, a new risk assessment is not necessary. Therefore, EPA 
relies upon those supporting risk assessments and the findings made in 
the September 24, 2014 Federal Register document, as well as the review 
of the additional tomato processing data 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 fluensulfone residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for the proposed tolerances, please refer to 
the September 24, 2014 Federal Register document and its supporting 
documents, available at http://www.regulations.gov in docket ID number 
EPA-HQ-OPP-2012-0593. Further information about EPA's determination 
that a separate tolerance should be established in or on tomato, paste 
may be found in the document, ``Fluensulfone--Revised Tolerance 
Recommendation for Tomato Paste.'' in docket ID number EPA-HQ-OPP-2015-
0375.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a reverse-phase high performance 
liquid chromatography with dual mass spectrometry/mass spectrometry 
(HPLC-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: 
residuemethods@epa.gov.

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 not established a MRL for fluensulfone.

V. Conclusion

    Therefore, tolerances are established for residues of fluensulfone, 
3,4,4-trifluoro-but-3-ene-1-sulfonic acid, in or on tomato, paste at 
1.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between

[[Page 56395]]

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: September 4, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.680, add alphabetically the following commodity to the 
table in paragraph (a) to read as follows:


Sec.  180.680  Fluensulfone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Tomato, paste...........................................             1.0
------------------------------------------------------------------------
 
                              * * * * * * *
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* * * * *
[FR Doc. 2015-23359 Filed 9-17-15; 8:45 am]
BILLING CODE 6560-50-P



                                                             Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Rules and Regulations                                       56393

                                            subpart DDDD of part 62, the                            Environmental Protection Agency, 1200                 notice. Submit the non-CBI copy of your
                                            Commercial and Industrial Solid Waste                   Pennsylvania Ave. NW., Washington,                    objection or hearing request, identified
                                            Incineration (CISWI) rule, 10 CSR 10–                   DC 20460–0001; main telephone                         by docket ID number EPA–HQ–OPP–
                                            6.161, which became effective on                        number: (703) 305–7090; email address:                2015–0375, by one of the following
                                            November 21, 2013. This revision was                    RDFRNotices@epa.gov.                                  methods:
                                            submitted on March 5, 2014.                             SUPPLEMENTARY INFORMATION:                              • Federal eRulemaking Portal: http://
                                              (b) Identification of sources. The plan                                                                     www.regulations.gov. Follow the online
                                            applies to existing commercial and                      I. General Information                                instructions for submitting comments.
                                            industrial solid waste incineration                     A. Does this action apply to me?                      Do not submit electronically any
                                            (CISWI) units that commenced                                                                                  information you consider to be CBI or
                                            construction on or before November 30,                     You may be potentially affected by                 other information whose disclosure is
                                            1999.                                                   this action if you are an agricultural                restricted by statute.
                                              (c) The effective date of the amended                 producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                            plan is November 17, 2015.                              pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                    list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                            [FR Doc. 2015–23390 Filed 9–17–15; 8:45 am]
                                                                                                    Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                            BILLING CODE 6560–50–P                                  not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                                                                                    provides a guide to help readers                      arrangements for hand delivery or
                                                                                                    determine whether this document                       delivery of boxed information, please
                                            ENVIRONMENTAL PROTECTION                                applies to them. Potentially affected
                                            AGENCY                                                                                                        follow the instructions at http://
                                                                                                    entities may include:                                 www.epa.gov/dockets/contacts.html.
                                            40 CFR Part 180                                            • Crop production (NAICS code 111).                  Additional instructions on
                                                                                                       • Animal production (NAICS code                    commenting or visiting the docket,
                                            [EPA–HQ–OPP–2015–0375; FRL–9933–02]                     112).                                                 along with more information about
                                                                                                       • Food manufacturing (NAICS code                   dockets generally, is available at
                                            Fluensulfone; Pesticide Tolerances                      311).                                                 http://www.epa.gov/dockets.
                                            AGENCY:  Environmental Protection                          • Pesticide manufacturing (NAICS
                                                                                                    code 32532).                                          II. Summary of Petitioned-For
                                            Agency (EPA).                                                                                                 Tolerance
                                            ACTION: Final rule.                                     B. How can I get electronic access to                    In the Federal Register of July 17,
                                                                                                    other related information?                            2015 (80 FR 42462) (FRL–9929–13),
                                            SUMMARY:   This regulation establishes a
                                            tolerance for residues of fluensulfone in                  You may access a frequently updated                EPA issued a document pursuant to
                                            or on tomato, paste. Makhteshim Agan                    electronic version of EPA’s tolerance                 FFDCA section 408(d)(3), 21 U.S.C.
                                            of North America, Inc., doing business                  regulations at 40 CFR part 180 through                346a(d)(3), announcing the filing of a
                                            as ADAMA requested these tolerances                     the Government Printing Office’s e-CFR                pesticide petition (PP 5F8365) by
                                            under the Federal Food, Drug, and                       site at http://www.ecfr.gov/cgi-bin/text-             Makhteshim Agan of North America,
                                            Cosmetic Act (FFDCA).                                   idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  Inc., doing business as ADAMA, 3120
                                                                                                    40tab_02.tpl.                                         Highwoods Blvd., Suite 100, Raleigh,
                                            DATES: This regulation is effective
                                            September 18, 2015. Objections and                      C. How can I file an objection or hearing             NC 27604. The petition requested that
                                            requests for hearings must be received                  request?                                              40 CFR part 180 be amended by
                                            on or before November 17, 2015, and                                                                           establishing tolerances for residues of
                                                                                                      Under FFDCA section 408(g), 21                      the insecticide fluensulfone, 3,4,4-
                                            must be filed in accordance with the                    U.S.C. 346a, any person may file an
                                            instructions provided in 40 CFR part                                                                          trifluoro-but-3-ene-1-sulfonic acid, in or
                                                                                                    objection to any aspect of this regulation            on tomato, paste at 1.0 parts per million
                                            178 (see also Unit I.C. of the                          and may also request a hearing on those
                                            SUPPLEMENTARY INFORMATION).
                                                                                                                                                          (ppm). That document referenced a
                                                                                                    objections. You must file your objection              summary of the petition prepared by
                                            ADDRESSES: The docket for this action,                  or request a hearing on this regulation               ADAMA, the registrant, which is
                                            identified by docket identification (ID)                in accordance with the instructions                   available in the docket, http://
                                            number EPA–HQ–OPP–2015–0375, is                         provided in 40 CFR part 178. To ensure                www.regulations.gov. There were no
                                            available at http://www.regulations.gov                 proper receipt by EPA, you must                       comments received in response to the
                                            or at the Office of Pesticide Programs                  identify docket ID number EPA–HQ–                     notice of filing.
                                            Regulatory Public Docket (OPP Docket)                   OPP–2015–0375 in the subject line on
                                            in the Environmental Protection Agency                  the first page of your submission. All                III. Aggregate Risk Assessment and
                                            Docket Center (EPA/DC), West William                    objections and requests for a hearing                 Determination of Safety
                                            Jefferson Clinton Bldg., Rm. 3334, 1301                 must be in writing, and must be                          Section 408(b)(2)(A)(i) of FFDCA
                                            Constitution Ave. NW., Washington, DC                   received by the Hearing Clerk on or                   allows EPA to establish a tolerance (the
                                            20460–0001. The Public Reading Room                     before November 17, 2015. Addresses                   legal limit for a pesticide chemical
                                            is open from 8:30 a.m. to 4:30 p.m.,                    for mail and hand delivery of objections              residue in or on a food) only if EPA
                                            Monday through Friday, excluding legal                  and hearing requests are provided in 40               determines that the tolerance is ‘‘safe.’’
                                            holidays. The telephone number for the                  CFR 178.25(b).                                        Section 408(b)(2)(A)(ii) of FFDCA
                                            Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               defines ‘‘safe’’ to mean that ‘‘there is a
                                            and the telephone number for the OPP                    hearing request with the Hearing Clerk                reasonable certainty that no harm will
                                            Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               result from aggregate exposure to the
tkelley on DSK3SPTVN1PROD with RULES




                                            the visitor instructions and additional                 submit a copy of the filing (excluding                pesticide chemical residue, including
                                            information about the docket available                  any Confidential Business Information                 all anticipated dietary exposures and all
                                            at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            other exposures for which there is
                                            FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   reliable information.’’ This includes
                                            Susan Lewis, Registration Division                      pursuant to 40 CFR part 2 may be                      exposure through drinking water and in
                                            (7505P), Office of Pesticide Programs,                  disclosed publicly by EPA without prior               residential settings, but does not include


                                       VerDate Sep<11>2014   16:42 Sep 17, 2015   Jkt 235001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700   E:\FR\FM\18SER1.SGM   18SER1


                                            56394            Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Rules and Regulations

                                            occupational exposure. Section                          only. Since residues of the parent did                FFDCA section 408(b)(4) requires that
                                            408(b)(2)(C) of FFDCA requires EPA to                   not concentrate in tomato paste, a new                EPA explain the reasons for departing
                                            give special consideration to exposure                  risk assessment is not necessary.                     from the Codex level.
                                            of infants and children to the pesticide                Therefore, EPA relies upon those                         The Codex has not established a MRL
                                            chemical residue in establishing a                      supporting risk assessments and the                   for fluensulfone.
                                            tolerance and to ‘‘ensure that there is a               findings made in the September 24,                    V. Conclusion
                                            reasonable certainty that no harm will                  2014 Federal Register document, as
                                            result to infants and children from                     well as the review of the additional                     Therefore, tolerances are established
                                            aggregate exposure to the pesticide                     tomato processing data in support of                  for residues of fluensulfone, 3,4,4-
                                            chemical residue. . . .’’                               this rule. EPA concludes that there is a              trifluoro-but-3-ene-1-sulfonic acid, in or
                                               Consistent with FFDCA section                        reasonable certainty that no harm will                on tomato, paste at 1.0 ppm.
                                            408(b)(2)(D), EPA has reviewed the                      result to the general population, or to               VI. Statutory and Executive Order
                                            available scientific data and other                     infants and children from aggregate                   Reviews
                                            relevant information in support of this                 exposure to fluensulfone residues.
                                            action. EPA has sufficient data to assess                                                                        This action establishes a tolerance
                                                                                                       For a detailed discussion of the
                                            the hazards of and to make a                                                                                  under FFDCA section 408(d) in
                                                                                                    aggregate risk assessments and
                                            determination on aggregate exposure,                                                                          response to a petition submitted to the
                                                                                                    determination of safety for the proposed              Agency. The Office of Management and
                                            consistent with FFDCA section                           tolerances, please refer to the September
                                            408(b)(2).                                                                                                    Budget (OMB) has exempted these types
                                                                                                    24, 2014 Federal Register document and                of actions from review under Executive
                                               In the Federal Register of September                 its supporting documents, available at
                                            24, 2014 (79 FR 56963) (FRL–9914–35),                                                                         Order 12866, entitled ‘‘Regulatory
                                                                                                    http://www.regulations.gov in docket ID               Planning and Review’’ (58 FR 51735,
                                            EPA established tolerances for residues                 number EPA–HQ–OPP–2012–0593.
                                            of fluensulfone in or on cucurbit                                                                             October 4, 1993). Because this action
                                                                                                    Further information about EPA’s                       has been exempted from review under
                                            vegetable crop group 9 and fruiting                     determination that a separate tolerance
                                            vegetable crop group 8–10 at 0.50 parts                                                                       Executive Order 12866, this action is
                                                                                                    should be established in or on tomato,                not subject to Executive Order 13211,
                                            per million (ppm). The information                      paste may be found in the document,
                                            available to the Agency in support of the                                                                     entitled ‘‘Actions Concerning
                                                                                                    ‘‘Fluensulfone—Revised Tolerance                      Regulations That Significantly Affect
                                            September 24, 2014 final rule showed                    Recommendation for Tomato Paste.’’ in
                                            no concentration of fluensulfone or the                                                                       Energy Supply, Distribution, or Use’’ (66
                                                                                                    docket ID number EPA–HQ–OPP–2015–                     FR 28355, May 22, 2001) or Executive
                                            metabolite BSA in or on fruiting                        0375.
                                            vegetable commodities and that separate                                                                       Order 13045, entitled ‘‘Protection of
                                            tolerances for residues in or on                        IV. Other Considerations                              Children from Environmental Health
                                            processed tomato products were                                                                                Risks and Safety Risks’’ (62 FR 19885,
                                                                                                    A. Analytical Enforcement Methodology                 April 23, 1997). This action does not
                                            unnecessary. Therefore, EPA established
                                            a tolerance for residues of fluensulfone                   Adequate enforcement methodology,                  contain any information collections
                                            in or on fruiting vegetable crop group 8–               a reverse-phase high performance liquid               subject to OMB approval under the
                                            10 at 0.50 ppm and determined that a                    chromatography with dual mass                         Paperwork Reduction Act (PRA) (44
                                            separate tolerance for tomato, paste was                spectrometry/mass spectrometry                        U.S.C. 3501 et seq.), nor does it require
                                            not necessary.                                          (HPLC–MS/MS), is available to enforce                 any special considerations under
                                               Since the time of the September 24,                  the tolerance expression.                             Executive Order 12898, entitled
                                            2014 final rule, EPA received a new                        The method may be requested from:                  ‘‘Federal Actions to Address
                                            tomato processing study that                            Chief, Analytical Chemistry Branch,                   Environmental Justice in Minority
                                            demonstrates a concentration of BSA                     Environmental Science Center, 701                     Populations and Low-Income
                                            residues in tomato paste (3.5X). Based                  Mapes Rd., Ft. Meade, MD 20755–5350;                  Populations’’ (59 FR 7629, February 16,
                                            on this concentration factor and the                    telephone number: (410) 305–2905;                     1994).
                                            highest average field trial (HAFT)                      email address:                                           Since tolerances and exemptions that
                                            residues in tomato (0.29 ppm), the                      residuemethods@epa.gov.                               are established on the basis of a petition
                                            Agency determined that the fruiting                                                                           under FFDCA section 408(d), such as
                                                                                                    B. International Residue Limits
                                            vegetable crop group 8–10 tolerance at                                                                        the tolerance in this final rule, do not
                                            0.5 ppm is insufficient to cover residues                 In making its tolerance decisions, EPA              require the issuance of a proposed rule,
                                            in tomato, paste and therefore a                        seeks to harmonize U.S. tolerances with               the requirements of the Regulatory
                                            tolerance of 1.0 ppm in or on tomato,                   international standards whenever                      Flexibility Act (RFA) (5 U.S.C. 601 et
                                            paste is necessary to cover residues of                 possible, consistent with U.S. food                   seq.), do not apply.
                                            BSA.                                                    safety standards and agricultural                        This action directly regulates growers,
                                               The Agency assessed the use of                       practices. EPA considers the                          food processors, food handlers, and food
                                            fluensulfone in or on tomato, paste at                  international maximum residue limits                  retailers, not States or tribes, nor does
                                            the tolerance of 1.0 ppm and                            (MRLs) established by the Codex                       this action alter the relationships or
                                            determined that there would be no                       Alimentarius Commission (Codex), as                   distribution of power and
                                            resulting change in the risk estimates                  required by FFDCA section 408(b)(4).                  responsibilities established by Congress
                                            from the previous risk assessment for                   The Codex Alimentarius is a joint                     in the preemption provisions of FFDCA
                                            the chemical. Since the publication of                  United Nations Food and Agriculture                   section 408(n)(4). As such, the Agency
                                            the September 24, 2014 final rule, the                  Organization/World Health                             has determined that this action will not
                                            toxicity profile of fluensulfone has not                Organization food standards program,                  have a substantial direct effect on States
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                                            changed, and the risk assessments that                  and it is recognized as an international              or tribal governments, on the
                                            supported the establishment of those                    food safety standards-setting                         relationship between the national
                                            tolerances published in the Federal                     organization in trade agreements to                   government and the States or tribal
                                            Register remain valid. The dietary risk                 which the United States is a party. EPA               governments, or on the distribution of
                                            assessments for fluensulfone are based                  may establish a tolerance that is                     power and responsibilities among the
                                            on residues of the parent compound                      different from a Codex MRL; however,                  various levels of government or between


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                                                             Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Rules and Regulations                                                  56395

                                            the Federal Government and Indian                                                                         Parts per    FOR FURTHER INFORMATION CONTACT:
                                                                                                                Commodity
                                            tribes. Thus, the Agency has determined                                                                    million    Jessica Franks, Ph.D., Marine and
                                            that Executive Order 13132, entitled                                                                                  Coastal Section (6WQ–EC),
                                            ‘‘Federalism’’ (64 FR 43255, August 10,                 Tomato, paste .......................                     1.0 Environmental Protection Agency,
                                            1999) and Executive Order 13175,                                                                                      Region 6, 1445 Ross Avenue, Suite
                                            entitled ‘‘Consultation and Coordination                        *      *      *       *       *       *       *       1200, Dallas, Texas 75202–2733,
                                            with Indian Tribal Governments’’ (65 FR                                                                               telephone (214) 665–8335, fax number
                                            67249, November 9, 2000) do not apply                   *      *       *          *       *                           (214) 665–6689; email address
                                            to this action. In addition, this action                [FR Doc. 2015–23359 Filed 9–17–15; 8:45 am]                   franks.jessica@epa.gov.
                                            does not impose any enforceable duty or                 BILLING CODE 6560–50–P
                                                                                                                                                                   SUPPLEMENTARY INFORMATION:
                                            contain any unfunded mandate as
                                            described under Title II of the Unfunded                                                                               Table of Contents
                                            Mandates Reform Act (UMRA) (2 U.S.C.                    ENVIRONMENTAL PROTECTION                                       A. Potentially Affected Persons
                                            1501 et seq.).                                          AGENCY                                                         B. Background
                                               This action does not involve any                                                                                    C. Final Action
                                                                                                    40 CFR Part 228                                                D. Responses to Comments
                                            technical standards that would require
                                            Agency consideration of voluntary                       [EPA–R06–OW–2015–0121; FRL–9934–25–                            E. Administrative Review
                                            consensus standards pursuant to section                 Region 6]                                                        1. Executive Order 12866
                                                                                                                                                                     2. Paperwork Reduction Act
                                            12(d) of the National Technology
                                                                                                    Ocean Dumping: Modification of Final                             3. Regulatory Flexibility Act, as Amended
                                            Transfer and Advancement Act                                                                                                by the Small Business Regulatory
                                            (NTTAA) (15 U.S.C. 272 note).                           Site Designation
                                                                                                                                                                        Enforcement Fairness Act of 1996
                                                                                                    AGENCY:  Environmental Protection                                4. Unfunded Mandates Reform Act
                                            VII. Congressional Review Act
                                                                                                    Agency (EPA).                                                    5. Executive Order 13132: Federalism
                                              Pursuant to the Congressional Review                  ACTION: Final rule.                                              6. Executive Order 13175: Consultation
                                            Act (5 U.S.C. 801 et seq.), EPA will                                                                                        and Coordination with Indian Tribal
                                                                                                    SUMMARY:    The Environmental Protection                            Governments
                                            submit a report containing this rule and
                                                                                                    Agency (EPA) today is modifying the                              7. Executive Order 13045: Protection of
                                            other required information to the U.S.                                                                                      Children from Environmental Health and
                                                                                                    use restrictions of the Galveston, TX
                                            Senate, the U.S. House of                                                                                                   Safety Risks
                                                                                                    Dredged Material Site, Freeport Harbor,
                                            Representatives, and the Comptroller                                                                                     8. Executive Order 13211: Actions That
                                                                                                    TX, New Work (45 Foot Project),
                                            General of the United States prior to                                                                                       Significantly Affect Energy Supply,
                                                                                                    Freeport Harbor, TX, Maintenance (45
                                            publication of the rule in the Federal                                                                                      Distribution, or Use Compliance with
                                                                                                    Foot Project), Matagorda Ship Channel,
                                            Register. This action is not a ‘‘major                                                                                      Administrative Procedure Act
                                                                                                    TX, Corpus Christi Ship Channel, TX,                             9. National Technology Transfer
                                            rule’’ as defined by 5 U.S.C. 804(2).
                                                                                                    Port Mansfield, TX, Brazos Island                                   Advancement Act
                                            List of Subjects in 40 CFR Part 180                     Harbor, TX and Brazos Island Harbor                              10. Executive Order 12898: Federal Actions
                                                                                                    (42-Foot Project), TX Ocean Dredged                                 to Address Environmental Justice in
                                              Environmental protection,                             Material Disposal Sites (ODMDSs)                                    Minority Populations and Low Income
                                            Administrative practice and procedure,                  located in the Gulf of Mexico offshore                              Populations
                                            Agricultural commodities, Pesticides                    of Galveston, Freeport, Matagorda,
                                            and pests, Reporting and recordkeeping                                                                                 A. Potentially Affected Persons
                                                                                                    Corpus Christi, Port Mansfield and
                                            requirements.                                           Brownsville, Texas, respectively. These                          Persons potentially affected by this
                                              Dated: September 4, 2015.                             sites are EPA designated ocean dumping                         action include those who seek or might
                                                                                                    sites for the disposal of suitable dredged                     seek permits or approval by EPA to
                                            Susan Lewis,
                                                                                                    material. This action is being taken at                        dispose of dredged material into ocean
                                            Director, Registration Division, Office of              the request of the United States Army
                                            Pesticide Programs.                                                                                                    waters pursuant to the Marine
                                                                                                    Corps of Engineers Galveston District to                       Protection Research and Sanctuaries
                                              Therefore, 40 CFR chapter I is                        allow disposal of suitable dredged                             Act, 33 U.S.C. 1401 et seq. EPA’s action
                                            amended as follows:                                     material from the vicinity of the federal                      would be relevant to persons, including
                                                                                                    navigation channels to alleviate                               organizations and government bodies
                                            PART 180—[AMENDED]                                      pressure on the capacity of their upland                       seeking to dispose of dredged material
                                                                                                    dredged material placement areas, when                         in ocean waters offshore of Galveston,
                                            ■ 1. The authority citation for part 180                necessary.                                                     Freeport, Matagorda, Corpus Christi,
                                            continues to read as follows:                           DATES: This document is effective on                           Port Mansfield and Brownsville, Texas.
                                                                                                    October 19, 2015.                                              Currently, the U.S. Army Corps of
                                                Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                    ADDRESSES: The EPA established a                               Engineers (Corps) and other persons
                                            ■ 2. In § 180.680, add alphabetically the               docket for this action under Docket No.                        with permits to use designated sites
                                            following commodity to the table in                     EPA–R06–OW–2015–0121. All                                      offshore of Galveston, Freeport,
                                            paragraph (a) to read as follows:                       documents in the docket are listed on                          Matagorda, Corpus Christi, Port
                                                                                                    the http://www.regulations.gov Web                             Mansfield, and Brownsville, Texas
                                            § 180.680 Fluensulfone; tolerances for                  site. Publicly available docket materials                      would be most impacted by this final
                                            residues.
                                                                                                    are available electronically through                           action. Potentially affected categories
                                                (a) * * *                                           http://www.regulations.gov.                                    and persons include:
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Document Created: 2015-12-15 09:27:44
Document Modified: 2015-12-15 09:27:44
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 September 18, 2015. Objections and requests for hearings must be received on or before November 17, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation80 FR 56393 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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