82_FR_22036 82 FR 21946 - Fluazinam; Pesticide Tolerances

82 FR 21946 - Fluazinam; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 90 (May 11, 2017)

Page Range21946-21948
FR Document2017-09590

This regulation establishes a tolerance for residues of fluazinam in or on tea, dried. ISK Biosciences Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 82 Issue 90 (Thursday, May 11, 2017)
[Federal Register Volume 82, Number 90 (Thursday, May 11, 2017)]
[Rules and Regulations]
[Pages 21946-21948]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09590]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0160; FRL-9960-50]


Fluazinam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
fluazinam in or on tea, dried. ISK Biosciences Corporation requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 11, 2017. Objections and 
requests for hearings must be received on or before July 10, 2017, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0160, 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 Divison 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0160 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 
July 10, 2017. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0160, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 19, 2016 (81 FR 31583) (FRL-9946-
02), 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 
6E8449) by ISK Biosciences Corporation, 7470 Auburn RD, Suite A, 
Concord, OH 44077. The petition requested that 40 CFR 180.574 be 
amended by establishing tolerances for residues of the fungicide 
fluazinam, in or on dried tea at 5.0 parts per million (ppm). That 
document referenced a summary of the petition prepared by ISK 
Biosciences Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov. One comment was received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance from 5.0 ppm to 6.0 ppm. The reason for 
these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including

[[Page 21947]]

all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue . . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for fluazinam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fluazinam follows.
    In the Federal Register of April 8, 2016 (81 FR 20545) (FRL 9942-
99), EPA established tolerances for residues of fluazinam in or on 
cabbage at 3.0 parts per million (ppm), mayhaw at 2.0 ppm, the cucurbit 
vegetable crop group 9 at 0.07 ppm, and the tuberous and corm vegetable 
subgroup 1C at 0.02 ppm, and amended the commodity definition for the 
existing tolerance in vegetable, Brassica leafy, group 5 to vegetable, 
Brassica leafy, group 5, except cabbage. Fluazinam is also registered 
for use in other plant commodities at levels ranging from 0.01 ppm to 
7.0 ppm. A tolerance (without US registration) has been established for 
residues of fluazinam and its metabolite AMGT in/on wine grapes at 3.0 
ppm, and tolerances of 0.05 ppm have been established for residues of 
fluazinam and its metabolites AMPA and DAPA and their sulfamate 
conjugates in/on the fat and meat byproducts of cattle, goats, horses, 
and sheep.
    ISK Biosciences submitted 5 field trials for fluazinam on dried 
tea. The Agency finds these data are acceptable and sufficient to 
support the requested tolerance. The Agency also determined that 
establishing this tolerance would not result in any change in the 
exposure estimates from the previous risk assessment for fluazinam. 
Since the publication of the April 8, 2016 final rule, the toxicity 
profile of fluazinam has not changed, and the risk assessments that 
supported the establishment of those tolerances published in the 
Federal Register remain valid. The dietary risks for fluazinam are 
based on the parent compound for bulb vegetables and in root and tuber 
vegetables. For all other plant commodities, the residues of concern in 
plants for risk assessment are fluazinam and its metabolite AMGT. In 
drinking water, the degradates of concern are parent fluazinam and its 
transformation products. In livestock commodities, the residues of 
concern are fluazinam, the metabolites AMPA, DAPA, and their sulfamate 
conjugates.
    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 fluazinam residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for the proposed tolerances, please refer to 
the April 8, 2016 Federal Register document and its supporting 
documents, available at http://www.regulations.gov in docket ID number 
EPA-HQ-OPP-2015-0197.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a gas chromatographic method with 
electron capture detection (GC/ECD)) is available to enforce the 
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for fluazinam in any 
commodities.

C. Response to Comments

    EPA received one comment to the published Notice of Filing. This 
comment stated, in part and without any supporting information, that 
EPA should deny this petition because it is a harmful and toxic 
chemical with no benefits. The Agency recognizes that some individuals 
believe that pesticides should be banned on agricultural crops. The 
existing legal framework provided by section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), however, states that tolerances may be 
set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. EPA has assessed the effects of this chemical on human 
health and determined that aggregate exposure to it will be safe. This 
comment provides no information to support an alternative conclusion.

D. Revisions to Petitioned-For Tolerances

    The petitioner proposed tolerances for fluazinam in or on dried tea 
at 5.0 ppm. When mean residues from each of the tea field trials were 
entered into the Organization for Economic Cooperation and Development 
(OECD) MRL/Tolerance Calculation Procedure, the resulting tolerance was 
6.0 ppm. Therefore, EPA is establishing a tolerance of 6.0 ppm rather 
than the requested tolerance of 5.0 ppm.

V. Conclusion

    Therefore, a tolerance is established for residues of fluazinam, 3-
chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine, in or on tea, dried at 6.0 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

[[Page 21948]]

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 
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: March 28, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.


0
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.  180.574, add alphabetically the entry ``Tea, dried \1\'' 
and footnote 1 to the table in paragraph (a)(1) to read as follows:


Sec.  180.574  Fluazinam; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Tea, dried \1\..............................................         6.0
 
                                * * * * *
------------------------------------------------------------------------
\1\ There is no U.S. registration as of January 19, 2017.

* * * * *
[FR Doc. 2017-09590 Filed 5-10-17; 8:45 am]
BILLING CODE 6560-50-P



                                             21946                      Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations

                                                                                                  Parts per      (7505P), Office of Pesticide Programs,                   disclosed publicly by EPA without prior
                                                             Commodity                             million       Environmental Protection Agency, 1200                    notice. Submit the non-CBI copy of your
                                                                                                                 Pennsylvania Ave. NW., Washington,                       objection or hearing request, identified
                                                *            *              *               *              *     DC 20460–0001; main telephone                            by docket ID number EPA–HQ–OPP–
                                             Pepper/Eggplant, subgroup 8–                                        number: (703) 305–7090; email address:                   2016–0160, by one of the following
                                               10B ..........................................                3.0
                                                                                                                 RDFRNotices@epa.gov.                                     methods:
                                                *              *              *               *            *     SUPPLEMENTARY INFORMATION:                                 • Federal eRulemaking Portal: http://
                                              Tea1 ............................................                40                                                         www.regulations.gov. Follow the online
                                                                                                                     I. General Information                               instructions for submitting comments.
                                               *        *        *            *                            *         A. Does this action apply to me?                     Do not submit electronically any
                                             Tomato subgroup 8–10A ............                                0.4                                                        information you consider to be CBI or
                                                                                                                        You may be potentially affected by                other information whose disclosure is
                                                  *             *              *             *             *         this action if you are an agricultural               restricted by statute.
                                               1 There are no U.S. registrations for tea as
                                                                                                                     producer, food manufacturer, or                        • Mail: OPP Docket, Environmental
                                                                                                                     pesticide manufacturer. The following                Protection Agency Docket Center (EPA/
                                             of May 11, 2017.
                                                                                                                     list of North American Industrial                    DC), (28221T), 1200 Pennsylvania Ave.
                                             *        *         *        *         *                                 Classification System (NAICS) codes is               NW., Washington, DC 20460–0001.
                                             [FR Doc. 2017–09592 Filed 5–10–17; 8:45 am]                             not intended to be exhaustive, but rather              • Hand Delivery: To make special
                                             BILLING CODE 6560–50–P                                                  provides a guide to help readers                     arrangements for hand delivery or
                                                                                                                     determine whether this document                      delivery of boxed information, please
                                                                                                                     applies to them. Potentially affected                follow the instructions at http://
                                             ENVIRONMENTAL PROTECTION                                                entities may include:                                www.epa.gov/dockets/contacts.html.
                                             AGENCY                                                                     • Crop production (NAICS code 111).                 Additional instructions on
                                                                                                                        • Animal production (NAICS code                   commenting or visiting the docket,
                                             40 CFR Part 180
                                                                                                                     112).                                                along with more information about
                                             [EPA–HQ–OPP–2016–0160; FRL–9960–50]                                        • Food manufacturing (NAICS code                  dockets generally, is available at http://
                                                                                                                     311).                                                www.epa.gov/dockets.
                                             Fluazinam; Pesticide Tolerances                                            • Pesticide manufacturing (NAICS
                                                                                                                     code 32532).                                         II. Summary of Petitioned-For
                                             AGENCY:  Environmental Protection                                                                                            Tolerance
                                             Agency (EPA).                                                           B. How can I get electronic access to
                                             ACTION: Final rule.
                                                                                                                                                                             In the Federal Register of May 19,
                                                                                                                     other related information?
                                                                                                                                                                          2016 (81 FR 31583) (FRL–9946–02),
                                             SUMMARY:   This regulation establishes a                                   You may access a frequently updated               EPA issued a document pursuant to
                                             tolerance for residues of fluazinam in or                               electronic version of EPA’s tolerance                FFDCA section 408(d)(3), 21 U.S.C.
                                             on tea, dried. ISK Biosciences                                          regulations at 40 CFR part 180 through               346a(d)(3), announcing the filing of a
                                             Corporation requested this tolerance                                    the Government Printing Office’s e-CFR               pesticide petition (PP 6E8449) by ISK
                                             under the Federal Food, Drug, and                                       site at http://www.ecfr.gov/cgi-bin/text-            Biosciences Corporation, 7470 Auburn
                                             Cosmetic Act (FFDCA).                                                   idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                 RD, Suite A, Concord, OH 44077. The
                                             DATES: This regulation is effective May                                 40tab_02.tpl.                                        petition requested that 40 CFR 180.574
                                             11, 2017. Objections and requests for                                   C. How can I file an objection or hearing            be amended by establishing tolerances
                                             hearings must be received on or before                                  request?                                             for residues of the fungicide fluazinam,
                                             July 10, 2017, and must be filed in                                                                                          in or on dried tea at 5.0 parts per
                                                                                                                       Under FFDCA section 408(g), 21                     million (ppm). That document
                                             accordance with the instructions
                                                                                                                     U.S.C. 346a, any person may file an                  referenced a summary of the petition
                                             provided in 40 CFR part 178 (see also
                                                                                                                     objection to any aspect of this regulation           prepared by ISK Biosciences
                                             Unit I.C. of the SUPPLEMENTARY
                                                                                                                     and may also request a hearing on those              Corporation, the registrant, which is
                                             INFORMATION).
                                                                                                                     objections. You must file your objection             available in the docket, http://
                                             ADDRESSES: The docket for this action,                                  or request a hearing on this regulation              www.regulations.gov. One comment was
                                             identified by docket identification (ID)                                in accordance with the instructions                  received on the notice of filing. EPA’s
                                             number EPA–HQ–OPP–2016–0160, is                                         provided in 40 CFR part 178. To ensure               response to these comments is
                                             available at http://www.regulations.gov                                 proper receipt by EPA, you must                      discussed in Unit IV.C.
                                             or at the Office of Pesticide Programs                                  identify docket ID number EPA–HQ–                       Based upon review of the data
                                             Regulatory Public Docket (OPP Docket)                                   OPP–2016–0160 in the subject line on                 supporting the petition, EPA has revised
                                             in the Environmental Protection Agency                                  the first page of your submission. All               the proposed tolerance from 5.0 ppm to
                                             Docket Center (EPA/DC), West William                                    objections and requests for a hearing                6.0 ppm. The reason for these changes
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                                 must be in writing, and must be                      are explained in Unit IV.D.
                                             Constitution Ave. NW., Washington, DC                                   received by the Hearing Clerk on or
                                             20460–0001. The Public Reading Room                                     before July 10, 2017. Addresses for mail             III. Aggregate Risk Assessment and
                                             is open from 8:30 a.m. to 4:30 p.m.,                                    and hand delivery of objections and                  Determination of Safety
                                             Monday through Friday, excluding legal                                  hearing requests are provided in 40 CFR                 Section 408(b)(2)(A)(i) of FFDCA
                                             holidays. The telephone number for the                                  178.25(b).                                           allows EPA to establish a tolerance (the
                                             Public Reading Room is (202) 566–1744,                                    In addition to filing an objection or              legal limit for a pesticide chemical
pmangrum on DSK3GDR082PROD with RULES




                                             and the telephone number for the OPP                                    hearing request with the Hearing Clerk               residue in or on a food) only if EPA
                                             Docket is (703) 305–5805. Please review                                 as described in 40 CFR part 178, please              determines that the tolerance is ‘‘safe.’’
                                             the visitor instructions and additional                                 submit a copy of the filing (excluding               Section 408(b)(2)(A)(ii) of FFDCA
                                             information about the docket available                                  any Confidential Business Information                defines ‘‘safe’’ to mean that ‘‘there is a
                                             at http://www.epa.gov/dockets.                                          (CBI)) for inclusion in the public docket.           reasonable certainty that no harm will
                                             FOR FURTHER INFORMATION CONTACT:                                        Information not marked confidential                  result from aggregate exposure to the
                                             Michael Goodis, Registration Divison                                    pursuant to 40 CFR part 2 may be                     pesticide chemical residue, including


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                                                                 Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations                                        21947

                                             all anticipated dietary exposures and all               fluazinam are based on the parent                     C. Response to Comments
                                             other exposures for which there is                      compound for bulb vegetables and in                     EPA received one comment to the
                                             reliable information.’’ This includes                   root and tuber vegetables. For all other              published Notice of Filing. This
                                             exposure through drinking water and in                  plant commodities, the residues of                    comment stated, in part and without
                                             residential settings, but does not include              concern in plants for risk assessment are             any supporting information, that EPA
                                             occupational exposure. Section                          fluazinam and its metabolite AMGT. In                 should deny this petition because it is
                                             408(b)(2)(C) of FFDCA requires EPA to                   drinking water, the degradates of                     a harmful and toxic chemical with no
                                             give special consideration to exposure                  concern are parent fluazinam and its                  benefits. The Agency recognizes that
                                             of infants and children to the pesticide                transformation products. In livestock                 some individuals believe that pesticides
                                             chemical residue in establishing a                      commodities, the residues of concern                  should be banned on agricultural crops.
                                             tolerance and to ‘‘ensure that there is a               are fluazinam, the metabolites AMPA,                  The existing legal framework provided
                                             reasonable certainty that no harm will                  DAPA, and their sulfamate conjugates.                 by section 408 of the Federal Food,
                                             result to infants and children from                        EPA concludes that there is a                      Drug, and Cosmetic Act (FFDCA),
                                             aggregate exposure to the pesticide                     reasonable certainty that no harm will                however, states that tolerances may be
                                             chemical residue . . . .’’                              result to the general population, or to               set when persons seeking such
                                                Consistent with FFDCA section                        infants and children from aggregate                   tolerances or exemptions have
                                             408(b)(2)(D), and the factors specified in              exposure to fluazinam residues.                       demonstrated that the pesticide meets
                                             FFDCA section 408(b)(2)(D), EPA has                                                                           the safety standard imposed by that
                                                                                                        For a detailed discussion of the
                                             reviewed the available scientific data                                                                        statute. EPA has assessed the effects of
                                             and other relevant information in                       aggregate risk assessments and
                                                                                                     determination of safety for the proposed              this chemical on human health and
                                             support of this action. EPA has                                                                               determined that aggregate exposure to it
                                             sufficient data to assess the hazards of                tolerances, please refer to the April 8,
                                                                                                     2016 Federal Register document and its                will be safe. This comment provides no
                                             and to make a determination on                                                                                information to support an alternative
                                             aggregate exposure for fluazinam                        supporting documents, available at
                                                                                                     http://www.regulations.gov in docket ID               conclusion.
                                             including exposure resulting from the
                                             tolerances established by this action.                  number EPA–HQ–OPP–2015–0197.                          D. Revisions to Petitioned-For
                                             EPA’s assessment of exposures and risks                 IV. Other Considerations                              Tolerances
                                             associated with fluazinam follows.                                                                               The petitioner proposed tolerances for
                                                In the Federal Register of April 8,                  A. Analytical Enforcement Methodology
                                                                                                                                                           fluazinam in or on dried tea at 5.0 ppm.
                                             2016 (81 FR 20545) (FRL 9942–99), EPA                      Adequate enforcement methodology                   When mean residues from each of the
                                             established tolerances for residues of                  (a gas chromatographic method with                    tea field trials were entered into the
                                             fluazinam in or on cabbage at 3.0 parts                 electron capture detection (GC/ECD)) is               Organization for Economic Cooperation
                                             per million (ppm), mayhaw at 2.0 ppm,                   available to enforce the tolerance                    and Development (OECD) MRL/
                                             the cucurbit vegetable crop group 9 at                  expression.                                           Tolerance Calculation Procedure, the
                                             0.07 ppm, and the tuberous and corm                                                                           resulting tolerance was 6.0 ppm.
                                                                                                        The method may be requested from:
                                             vegetable subgroup 1C at 0.02 ppm, and                                                                        Therefore, EPA is establishing a
                                                                                                     Chief, Analytical Chemistry Branch,
                                             amended the commodity definition for                                                                          tolerance of 6.0 ppm rather than the
                                                                                                     Environmental Science Center, 701
                                             the existing tolerance in vegetable,                                                                          requested tolerance of 5.0 ppm.
                                                                                                     Mapes Rd., Ft. Meade, MD 20755–5350;
                                             Brassica leafy, group 5 to vegetable,
                                                                                                     telephone number: (410) 305–2905;                     V. Conclusion
                                             Brassica leafy, group 5, except cabbage.
                                                                                                     email address: residuemethods@
                                             Fluazinam is also registered for use in                                                                          Therefore, a tolerance is established
                                                                                                     epa.gov.
                                             other plant commodities at levels                                                                             for residues of fluazinam, 3-chloro-N-[3-
                                             ranging from 0.01 ppm to 7.0 ppm. A                     B. International Residue Limits                       chloro-2,6-dinitro-4-
                                             tolerance (without US registration) has                                                                       (trifluoromethyl)phenyl]-5-
                                             been established for residues of                           In making its tolerance decisions, EPA
                                                                                                                                                           (trifluoromethyl)-2-pyridinamine, in or
                                             fluazinam and its metabolite AMGT                       seeks to harmonize U.S. tolerances with
                                                                                                                                                           on tea, dried at 6.0 ppm.
                                             in/on wine grapes at 3.0 ppm, and                       international standards whenever
                                             tolerances of 0.05 ppm have been                        possible, consistent with U.S. food                   VI. Statutory and Executive Order
                                             established for residues of fluazinam                   safety standards and agricultural                     Reviews
                                             and its metabolites AMPA and DAPA                       practices. EPA considers the                            This action establishes tolerances
                                             and their sulfamate conjugates in/on the                international maximum residue limits                  under FFDCA section 408(d) in
                                             fat and meat byproducts of cattle, goats,               (MRLs) established by the Codex                       response to a petition submitted to the
                                             horses, and sheep.                                      Alimentarius Commission (Codex), as                   Agency. The Office of Management and
                                                ISK Biosciences submitted 5 field                    required by FFDCA section 408(b)(4).                  Budget (OMB) has exempted these types
                                             trials for fluazinam on dried tea. The                  The Codex Alimentarius is a joint                     of actions from review under Executive
                                             Agency finds these data are acceptable                  United Nations Food and Agriculture                   Order 12866, entitled ‘‘Regulatory
                                             and sufficient to support the requested                 Organization/World Health                             Planning and Review’’ (58 FR 51735,
                                             tolerance. The Agency also determined                   Organization food standards program,                  October 4, 1993). Because this action
                                             that establishing this tolerance would                  and it is recognized as an international              has been exempted from review under
                                             not result in any change in the exposure                food safety standards-setting                         Executive Order 12866, this action is
                                             estimates from the previous risk                        organization in trade agreements to                   not subject to Executive Order 13211,
                                             assessment for fluazinam. Since the                     which the United States is a party. EPA               entitled ‘‘Actions Concerning
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                                             publication of the April 8, 2016 final                  may establish a tolerance that is                     Regulations That Significantly Affect
                                             rule, the toxicity profile of fluazinam                 different from a Codex MRL; however,                  Energy Supply, Distribution, or Use’’ (66
                                             has not changed, and the risk                           FFDCA section 408(b)(4) requires that                 FR 28355, May 22, 2001) or Executive
                                             assessments that supported the                          EPA explain the reasons for departing                 Order 13045, entitled ‘‘Protection of
                                             establishment of those tolerances                       from the Codex level.                                 Children from Environmental Health
                                             published in the Federal Register                          The Codex has not established an                   Risks and Safety Risks’’ (62 FR 19885,
                                             remain valid. The dietary risks for                     MRL for fluazinam in any commodities.                 April 23, 1997). This action does not


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                                             21948               Federal Register / Vol. 82, No. 90 / Thursday, May 11, 2017 / Rules and Regulations

                                             contain any information collections                     List of Subjects in 40 CFR Part 180                   SUMMARY:   This final rule announces
                                             subject to OMB approval under the                         Environmental protection,                           inseason changes to management
                                             Paperwork Reduction Act (PRA) (44                       Administrative practice and procedure,                measures in the Pacific Coast groundfish
                                             U.S.C. 3501 et seq.), nor does it require               Agricultural commodities, Pesticides                  fishery. This action implements an
                                             any special considerations under                        and pests, Reporting and recordkeeping                increase in the incidental Pacific halibut
                                             Executive Order 12898, entitled                         requirements.                                         retention ratio in the sablefish primary
                                             ‘‘Federal Actions to Address                                                                                  fishery, and changes to recreational
                                             Environmental Justice in Minority                         Dated: March 28, 2017.                              fisheries management measures that
                                             Populations and Low-Income                              Michael Goodis,                                       will reduce recreational groundfish and
                                             Populations’’ (59 FR 7629, February 16,                 Director, Registration Division, Office of            rockfish bag limits and eliminate length
                                             1994).                                                  Pesticide Programs.                                   requirements for recreationally caught
                                                Since tolerances and exemptions that                 ■Therefore, 40 CFR chapter I is                       lingcod in all areas.
                                             are established on the basis of a petition              amended as follows:                                   DATES: This final rule is effective May
                                             under FFDCA section 408(d), such as                                                                           11, 2017.
                                             the tolerance in this final rule, do not                PART 180—[AMENDED]                                    FOR FURTHER INFORMATION CONTACT:
                                             require the issuance of a proposed rule,                                                                      Benjamin Mann phone: 206–526–6117,
                                             the requirements of the Regulatory                      ■ 1. The authority citation for part 180
                                                                                                     continues to read as follows:                         fax: 206–526–6736, or email:
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                                                                        Benjamin.mann@noaa.gov.
                                             seq.), do not apply.                                        Authority: 21 U.S.C. 321(q), 346a and 371.
                                                                                                                                                           SUPPLEMENTARY INFORMATION:
                                                This action directly regulates growers,              ■ 2. In § 180.574, add alphabetically the
                                             food processors, food handlers, and food                entry ‘‘Tea, dried 1’’ and footnote 1 to              Electronic Access
                                             retailers, not States or tribes, nor does               the table in paragraph (a)(1) to read as                 This rule is accessible via the Internet
                                             this action alter the relationships or                  follows:                                              at the Office of the Federal Register Web
                                             distribution of power and                                                                                     site at https://www.federalregister.gov.
                                             responsibilities established by Congress                § 180.574 Fluazinam; tolerances for
                                                                                                     residues.                                             Background information and documents
                                             in the preemption provisions of FFDCA                                                                         are available at the Pacific Fishery
                                             section 408(n)(4). As such, the Agency                      (a) * * *
                                                                                                         (1) * * *                                         Management Council’s Web site at
                                             has determined that this action will not                                                                      http://www.pcouncil.org/.
                                             have a substantial direct effect on States
                                             or tribal governments, on the                                                                     Parts per  Background
                                                                                                                 Commodity                      million
                                             relationship between the national                                                                               The Pacific Fishery Management
                                             government and the States or tribal                                                                          Council (Council)—in coordination with
                                             governments, or on the distribution of                       *        *              *               * *     the International Pacific Halibut
                                             power and responsibilities among the                    Tea, dried 1 .................................   6.0 Commission (IPHC) and the States of
                                             various levels of government or between                                                                      Washington, Oregon, and California—
                                             the Federal Government and Indian                            *        *              *               * *
                                                                                                                                                          recommended changes to groundfish
                                             tribes. Thus, the Agency has determined                    1 There is no U.S. registration as of January     management measures at its March 7–
                                             that Executive Order 13132, entitled                    19, 2017.                                            13, 2017, meeting. Specifically, the
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                 *      *      *        *         *                   Council recommended (1) an increase in
                                             1999) and Executive Order 13175,                        [FR Doc. 2017–09590 Filed 5–10–17; 8:45 am]          incidental halibut retention allocation
                                             entitled ‘‘Consultation and Coordination                BILLING CODE 6560–50–P                               in the primary sablefish fishery from
                                             with Indian Tribal Governments’’ (65 FR                                                                      110 lbs dressed weight halibut per 1,000
                                             67249, November 9, 2000) do not apply                                                                        lbs dressed weight sablefish, to 140 lbs
                                             to this action. In addition, this action                                                                     halibut to 1,000 lbs sablefish to improve
                                             does not impose any enforceable duty or                 DEPARTMENT OF COMMERCE                               opportunity for industry to harvest more
                                             contain any unfunded mandate as                                                                              of the sablefish allocation without
                                             described under Title II of the Unfunded                National Oceanic and Atmospheric
                                                                                                     Administration                                       exceeding it or the incidental halibut
                                             Mandates Reform Act (UMRA) (2 U.S.C.                                                                         allocation ACLs, and (2) a reduction in
                                             1501 et seq.).                                                                                               rockfish bag limits in the Washington
                                                                                                     50 CFR Part 660
                                                This action does not involve any                                                                          recreational groundfish fishery (all
                                             technical standards that would require                  [Docket No. 160808696–7010–02]                       areas) from 10 to 7 rockfish per angler,
                                             Agency consideration of voluntary                                                                            a reduction in the aggregated groundfish
                                             consensus standards pursuant to section                 RIN 0648–BG76                                        daily bag limit from 12 to 9 fish per
                                             12(d) of the National Technology                                                                             angler, and finally, removal of the 22-
                                             Transfer and Advancement Act                            Magnuson-Stevens Act Provisions;
                                                                                                                                                          inch minimum size limit for lingcod
                                             (NTTAA) (15 U.S.C. 272 note).                           Fisheries Off West Coast States;
                                                                                                                                                          retention.
                                                                                                     Pacific Coast Groundfish Fishery;
                                             VII. Congressional Review Act                           2017–2018 Biennial Specifications and Increased Incidental Halibut Retention
                                               Pursuant to the Congressional Review                  Management Measures; Inseason                        in the Limited Entry Fixed Gear
                                             Act (5 U.S.C. 801 et seq.), EPA will                    Adjustments                                          Sablefish Primary Fishery
                                             submit a report containing this rule and                AGENCY: National Marine Fisheries                       The IPHC establishes total allowable
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                                             other required information to the U.S.                  Service (NMFS), National Oceanic and                 catch (TAC) amounts for Pacific halibut
                                             Senate, the U.S. House of                               Atmospheric Administration (NOAA),                   each year in January. Under the
                                             Representatives, and the Comptroller                    Commerce.                                            authority of the Northern Pacific Halibut
                                             General of the United States prior to                   ACTION: Final rule; inseason adjustments
                                                                                                                                                          Act, and implementing regulations at 50
                                             publication of the rule in the Federal                  to biennial groundfish management                    CFR 300.63, a Catch Sharing Plan for
                                             Register. This action is not a ‘‘major                  measures.                                            IPHC Area 2A (waters off the U.S. West
                                             rule’’ as defined by 5 U.S.C. 804(2).                                                                        Coast), developed by the Council and


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Document Created: 2017-05-11 00:14:48
Document Modified: 2017-05-11 00:14:48
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 May 11, 2017. Objections and requests for hearings must be received on or before July 10, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael Goodis, Registration Divison (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 21946 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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