82_FR_31597 82 FR 31468 - Flonicamid; Pesticide Tolerances

82 FR 31468 - Flonicamid; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 129 (July 7, 2017)

Page Range31468-31471
FR Document2017-14339

This regulation establishes tolerances for residues of flonicamid in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 82 Issue 129 (Friday, July 7, 2017)
[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)]
[Rules and Regulations]
[Pages 31468-31471]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14339]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0013; FRL-9962-15]


Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
flonicamid in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 7, 2017. Objections and 
requests for hearings must be received on or before September 5, 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-2016-0013, 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 L. Goodis, Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

[[Page 31469]]

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-2016-0013 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 5, 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-2016-0013, 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 31581) (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) 
5E8428 submitted by IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requests that 40 CFR 180.613 be 
amended by establishing tolerances for residues of the fungicide 
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, 
and its metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM 
(4-trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric 
equivalent of flonicamid, in or on pea and bean, dried shelled, except 
soybean, subgroup 6C at 3.0 parts per million (ppm); Pea and bean, 
succulent shelled, subgroup 6B at 6.0 ppm; and Vegetable, legume, 
edible podded, subgroup 6A at 4.0 ppm. This petition contains an 
additional request to increase the existing tolerance on Vegetable, 
fruiting, group 8-10 from 0.4 to 1.50 ppm, but EPA has already taken 
action on that specific request, in a final tolerance rule published in 
the Federal Register on May 11, 2017 (82 FR 21941) (FRL-9959-91).
    A summary of the petition prepared by ISK Biosciences Corporation, 
the registrant, is available in the docket, http://www.regulations.gov, 
at docket #: EPA-HQ-OPP-2016-0013. One comment was received on the 
notice of filing. EPA's response to the comment is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing a tolerance for Pea and bean, succulent shelled, subgroup 
6B that varies slightly from what the petitioner requested. The reason 
for this change is 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 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 flonicamid including exposure 
resulting from the tolerances established by this action, consistent 
with FFDCA section 408(b)(2).
    In the Federal Register of May 11, 2017 (82 FR 21941) (FRL-9959-
91), EPA established tolerances for residues of flonicamid in or on 
several commodities. The risk assessments supporting that action 
aggregated dietary and non-occupational exposures from existing and 
proposed uses of flonicamid, including from the exposures associated 
with the tolerances requested in this action. That assessment, which 
included the tolerances in today's action, concluded that the 
tolerances are safe; therefore, EPA is relying upon that Federal 
Register document and the risk assessments supporting the findings in 
that document to support the safety finding for the tolerances that are 
the subject of this action.
    Specific information on the studies received and the nature of the 
adverse effects caused by flonicamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, ``Subject: Flonicamid. Human 
Health Risk Assessment for New Uses on Legume Vegetables, Subgroups 6A, 
6B, and 6C; Add Directions for use on Greenhouse Grown Peppers and 
Increase the Tolerance for Residues on Fruiting Vegetables, Group 8-10; 
New Use on Citrus Fruits, Group 10-10; and a Tolerance without U.S. 
Registration for residues in/on Dried Tea'' in docket ID number, EPA-
HQ-OPP-2016-0013.
    Based on the findings of the May 11, 2017 Federal Register document 
and the supporting documents, EPA concludes that there is a reasonable

[[Page 31470]]

certainty that no harm will result to the general population, or to 
infants and children from aggregate exposure to flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (FMC Method No. P-3561M, a liquid 
chromatography with tandem mass spectrometry (LC/MS/MS) method) is 
available to enforce the tolerance expression for flonicamid and its 
metabolites in or on plant commodities.
    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 a MRL for flonicamid.

C. Response to Comments

    Comment: One anonymous comment on the notice of filing of petition 
5E8428 was received. The commenter claims that flonicamid is a ``toxic 
pesticide'' and residues at any level in food commodities should not be 
allowed and requested that EPA deny setting tolerances for the 
petition-for new uses of flonicamid. The comment stated that the 
proposed flonicamid use would add to about 25,000 toxic chemicals 
currently in the environment and combine to create even more toxic 
chemical residues in food and drinking water further increasing harmful 
effects to humans and environment.
    Agency response: The Agency recognizes that some individuals 
believe that pesticides should be banned completely. However, under the 
existing legal framework provided by FFDCA section 408, EPA is 
authorized to establish pesticide tolerances or exemptions where 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute. In 
this instance, EPA has examined all the relevant and available data and 
concluded that the tolerances are safe. The commenter has not provided 
any information to support a conclusion by the Agency that the 
tolerances are not safe.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing a slightly higher tolerance for Pea and bean, 
succulent shelled, subgroup 6B at 7.0 ppm compared to the petitioner's 
request of a tolerance at 6.0 ppm. EPA's decision is based on the 
Organization for Economic Cooperation and Development (OECD) tolerance 
calculation procedures and available field trial data.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid, 
N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its 
metabolites, TFNA (4-trifluoromethylinicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric 
equivalent of flonicamid, in or on Pea and bean, succulent shelled, 
subgroup 6B at 7.0 ppm; Pea and bean, dried shelled, except soybean, 
subgroup 6C at 3.0 ppm; and Vegetable, legume, edible podded, subgroup 
6A at 4.0 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 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).

[[Page 31471]]

List of Subjects in 40 CFR Part 180

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

    Dated: June 2, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.613, add alphabetically the following commodities ``Pea 
and bean, succulent shelled, subgroup 6B''; ``Pea and bean, dried 
shelled, except soybean, subgroup 6C''; and ``Vegetable, legume, edible 
podded, subgroup 6A'' to the table in paragraph (a)(1) to read as 
follows:


Sec.  180.613  Flonicamid; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
 
                                * * * * *
Pea and bean, succulent shelled, subgroup 6B.................        7.0
Pea and bean, dried shelled, except soybean, subgroup 6C.....        3.0
 
                                * * * * *
Vegetable, legume, edible podded, subgroup 6A................        4.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-14339 Filed 7-6-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                  31468                 Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations

                                                  extend the time within which a petition                  List of Subjects in 40 CFR Part 52                              Authority: 42 U.S.C. 7401 et seq.
                                                  for judicial review may be filed, and                      Environmental protection, Air
                                                  shall not postpone the effectiveness of                                                                              Subpart NN—Pennsylvania
                                                                                                           pollution control, Incorporation by
                                                  such rule or action. Parties with                        reference, Intergovernmental relations,
                                                  objections to this direct final rule are                                                                             ■  2. In § 52.2020, the table in paragraph
                                                                                                           Ozone, Particulate matter, Reporting
                                                  encouraged to file a comment in                          and recordkeeping requirements,                             (e)(1) is amended by adding an entry for
                                                  response to the parallel notice of                       Volatile organic compounds.                                 ‘‘Reasonably Available Control
                                                  proposed rulemaking for this action                                                                                  Technology (RACT) for the 1997 ozone
                                                  published in the proposed rules section                    Dated: June 22, 2017.
                                                                                                                                                                       national ambient air quality standard
                                                  of today’s Federal Register, rather than                 Cecil Rodrigues,                                            (NAAQS)’’ at the end of the table to read
                                                  file an immediate petition for judicial                  Acting Regional Administrator, Region III.                  as follows:
                                                  review of this direct final rule, so that                     40 CFR part 52 is amended as follows:
                                                  EPA can withdraw this direct final rule                                                                              52.2020    Identification of plan.
                                                  and address the comment in the                           PART 52—APPROVAL AND                                        *       *    *      *      *
                                                  proposed rulemaking action.                              PROMULGATION OF
                                                     This action approving Pennsylvania’s                                                                                  (e) * * *
                                                                                                           IMPLEMENTATION PLANS
                                                  2006 RACT SIP may not be challenged                                                                                      (1) * * *
                                                  later in proceedings to enforce its                      ■ 1. The authority citation for part 52
                                                  requirements. (See section 307(b)(2).)                   continues to read as follows:

                                                                                                         Applicable geographic           State submittal
                                                       Name of non-regulatory SIP revision                                                                        EPA approval date            Additional explanation
                                                                                                                 area                         date


                                                            *                   *                            *                           *                        *                   *                      *
                                                  Reasonably Available Control Technology                Statewide ...................           9/25/2006    7/7/2017, [Insert Federal     Pertaining only to control
                                                    (RACT) for the 1997 ozone national ambi-                                                                    Register citation].           technique guideline
                                                    ent air quality standard (NAAQS).                                                                                                         (CTG) source cat-
                                                                                                                                                                                              egories and three non-
                                                                                                                                                                                              CTG volatile organic
                                                                                                                                                                                              compound (VOC)
                                                                                                                                                                                              source categories: Man-
                                                                                                                                                                                              ufacture of surface ac-
                                                                                                                                                                                              tive agents, mobile
                                                                                                                                                                                              equipment repair and
                                                                                                                                                                                              refinishing, and ethylene
                                                                                                                                                                                              production plants. Re-
                                                                                                                                                                                              mainder of submittal
                                                                                                                                                                                              withdrawn 6/27/2016.



                                                  *      *     *       *       *                           provided in 40 CFR part 178 (see also                       main telephone number: (703) 305–
                                                  [FR Doc. 2017–14204 Filed 7–6–17; 8:45 am]               Unit I.C. of the SUPPLEMENTARY                              7090; email address: RDFRNotices@
                                                  BILLING CODE 6560–50–P                                   INFORMATION).                                               epa.gov.
                                                                                                           ADDRESSES: The docket for this action,
                                                                                                                                                                       SUPPLEMENTARY INFORMATION:
                                                                                                           identified by docket identification (ID)
                                                  ENVIRONMENTAL PROTECTION
                                                                                                           number EPA–HQ–OPP–2016–0013, is                             I. General Information
                                                  AGENCY
                                                                                                           available at http://www.regulations.gov
                                                                                                           or at the Office of Pesticide Programs                      A. Does this action apply to me?
                                                  40 CFR Part 180
                                                                                                           Regulatory Public Docket (OPP Docket)                          You may be potentially affected by
                                                  [EPA–HQ–OPP–2016–0013; FRL–9962–15]                      in the Environmental Protection Agency
                                                                                                                                                                       this action if you are an agricultural
                                                                                                           Docket Center (EPA/DC), West William
                                                  Flonicamid; Pesticide Tolerances                                                                                     producer, food manufacturer, or
                                                                                                           Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                           Constitution Ave. NW., Washington, DC                       pesticide manufacturer. The following
                                                  AGENCY:  Environmental Protection
                                                                                                           20460–0001. The Public Reading Room                         list of North American Industrial
                                                  Agency (EPA).
                                                                                                           is open from 8:30 a.m. to 4:30 p.m.,                        Classification System (NAICS) codes is
                                                  ACTION: Final rule.
                                                                                                           Monday through Friday, excluding legal                      not intended to be exhaustive, but rather
                                                  SUMMARY:   This regulation establishes                   holidays. The telephone number for the                      provides a guide to help readers
                                                  tolerances for residues of flonicamid in                 Public Reading Room is (202) 566–1744,                      determine whether this document
                                                  or on multiple commodities which are                     and the telephone number for the OPP                        applies to them. Potentially affected
                                                  identified and discussed later in this                   Docket is (703) 305–5805. Please review                     entities may include:
                                                  document. Interregional Research                         the visitor instructions and additional                        • Crop production (NAICS code 111).
asabaliauskas on DSKBBXCHB2PROD with RULES




                                                  Project Number 4 (IR–4) requested these                  information about the docket available
                                                  tolerances under the Federal Food,                       at http://www.epa.gov/dockets.                                 • Animal production (NAICS code
                                                  Drug, and Cosmetic Act (FFDCA).                                                                                      112).
                                                                                                           FOR FURTHER INFORMATION CONTACT:
                                                  DATES: This regulation is effective July                 Michael L. Goodis, Director,                                   • Food manufacturing (NAICS code
                                                  7, 2017. Objections and requests for                     Registration Division (7505P), Office of                    311).
                                                  hearings must be received on or before                   Pesticide Programs, Environmental                              • Pesticide manufacturing (NAICS
                                                  September 5, 2017, and must be filed in                  Protection Agency, 1200 Pennsylvania                        code 32532).
                                                  accordance with the instructions                         Ave. NW., Washington, DC 20460–0001;


                                             VerDate Sep<11>2014   17:43 Jul 06, 2017   Jkt 241001   PO 00000    Frm 00036    Fmt 4700       Sfmt 4700   E:\FR\FM\07JYR1.SGM   07JYR1


                                                                        Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations                                         31469

                                                  B. How can I get electronic access to                    II. Summary of Petitioned-For                         reliable information.’’ This includes
                                                  other related information?                               Tolerance                                             exposure through drinking water and in
                                                                                                              In the Federal Register of May 19,                 residential settings, but does not include
                                                     You may access a frequently updated                                                                         occupational exposure. Section
                                                  electronic version of EPA’s tolerance                    2016 (81 FR 31581) (FRL–9946–02),
                                                                                                           EPA issued a document pursuant to                     408(b)(2)(C) of FFDCA requires EPA to
                                                  regulations at 40 CFR part 180 through                                                                         give special consideration to exposure
                                                  the Government Printing Office’s e-CFR                   FFDCA section 408(d)(3), 21 U.S.C.
                                                                                                           346a(d)(3), announcing the filing of a                of infants and children to the pesticide
                                                  site at http://www.ecfr.gov/cgi-bin/text-                                                                      chemical residue in establishing a
                                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                     pesticide petition (PP) 5E8428
                                                                                                                                                                 tolerance and to ‘‘ensure that there is a
                                                  40tab_02.tpl.                                            submitted by IR–4 Project Headquarters,
                                                                                                                                                                 reasonable certainty that no harm will
                                                                                                           Rutgers, The State University of New
                                                  C. How can I file an objection or hearing                                                                      result to infants and children from
                                                                                                           Jersey, 500 College Road East, Suite 201
                                                  request?                                                                                                       aggregate exposure to the pesticide
                                                                                                           W, Princeton, NJ 08540. The petition
                                                                                                                                                                 chemical residue. . . .’’
                                                                                                           requests that 40 CFR 180.613 be                          Consistent with FFDCA section
                                                    Under FFDCA section 408(g), 21
                                                                                                           amended by establishing tolerances for                408(b)(2)(D), and the factors specified in
                                                  U.S.C. 346a, any person may file an
                                                                                                           residues of the fungicide flonicamid, N-              FFDCA section 408(b)(2)(D), EPA has
                                                  objection to any aspect of this regulation
                                                                                                           (cyanomethyl)-4-(trifluoromethyl)-3-                  reviewed the available scientific data
                                                  and may also request a hearing on those
                                                                                                           pyridinecarboxamide, and its                          and other relevant information in
                                                  objections. You must file your objection
                                                                                                           metabolites, TFNA (4-                                 support of this action. EPA has
                                                  or request a hearing on this regulation
                                                                                                           trifluoromethylinicotinic acid), TFNA–                sufficient data to assess the hazards of
                                                  in accordance with the instructions
                                                                                                           AM (4-trifluoromethylnicotinamide),                   and to make a determination on
                                                  provided in 40 CFR part 178. To ensure
                                                                                                           and TFNG, N-(4-                                       aggregate exposure for flonicamid
                                                  proper receipt by EPA, you must
                                                                                                           trifluoromethylnicotinoyl)glycine,                    including exposure resulting from the
                                                  identify docket ID number EPA–HQ–
                                                                                                           calculated as the stoichiometric                      tolerances established by this action,
                                                  OPP–2016–0013 in the subject line on
                                                                                                           equivalent of flonicamid, in or on pea                consistent with FFDCA section
                                                  the first page of your submission. All
                                                                                                           and bean, dried shelled, except soybean,              408(b)(2).
                                                  objections and requests for a hearing
                                                                                                           subgroup 6C at 3.0 parts per million                     In the Federal Register of May 11,
                                                  must be in writing, and must be
                                                                                                           (ppm); Pea and bean, succulent shelled,               2017 (82 FR 21941) (FRL–9959–91),
                                                  received by the Hearing Clerk on or
                                                                                                           subgroup 6B at 6.0 ppm; and Vegetable,                EPA established tolerances for residues
                                                  before September 5, 2017. Addresses for
                                                                                                           legume, edible podded, subgroup 6A at                 of flonicamid in or on several
                                                  mail and hand delivery of objections
                                                                                                           4.0 ppm. This petition contains an                    commodities. The risk assessments
                                                  and hearing requests are provided in 40
                                                                                                           additional request to increase the                    supporting that action aggregated
                                                  CFR 178.25(b).
                                                                                                           existing tolerance on Vegetable, fruiting,            dietary and non-occupational exposures
                                                    In addition to filing an objection or                  group 8–10 from 0.4 to 1.50 ppm, but                  from existing and proposed uses of
                                                  hearing request with the Hearing Clerk                   EPA has already taken action on that                  flonicamid, including from the
                                                  as described in 40 CFR part 178, please                  specific request, in a final tolerance rule           exposures associated with the tolerances
                                                  submit a copy of the filing (excluding                   published in the Federal Register on                  requested in this action. That
                                                  any Confidential Business Information                    May 11, 2017 (82 FR 21941) (FRL–9959–                 assessment, which included the
                                                  (CBI)) for inclusion in the public docket.               91).                                                  tolerances in today’s action, concluded
                                                  Information not marked confidential                         A summary of the petition prepared                 that the tolerances are safe; therefore,
                                                  pursuant to 40 CFR part 2 may be                         by ISK Biosciences Corporation, the                   EPA is relying upon that Federal
                                                  disclosed publicly by EPA without prior                  registrant, is available in the docket,               Register document and the risk
                                                  notice. Submit the non-CBI copy of your                  http://www.regulations.gov, at docket #:              assessments supporting the findings in
                                                  objection or hearing request, identified                 EPA–HQ–OPP–2016–0013. One                             that document to support the safety
                                                  by docket ID number EPA–HQ–OPP–                          comment was received on the notice of                 finding for the tolerances that are the
                                                  2016–0013, by one of the following                       filing. EPA’s response to the comment is              subject of this action.
                                                  methods:                                                 discussed in Unit IV.C.                                  Specific information on the studies
                                                    • Federal eRulemaking Portal: http://                     Based upon review of the data                      received and the nature of the adverse
                                                  www.regulations.gov. Follow the online                   supporting the petition, EPA is                       effects caused by flonicamid as well as
                                                  instructions for submitting comments.                    establishing a tolerance for Pea and                  the no-observed-adverse-effect-level
                                                  Do not submit electronically any                         bean, succulent shelled, subgroup 6B                  (NOAEL) and the lowest-observed-
                                                  information you consider to be CBI or                    that varies slightly from what the                    adverse-effect-level (LOAEL) from the
                                                  other information whose disclosure is                    petitioner requested. The reason for this             toxicity studies can be found at http://
                                                  restricted by statute.                                   change is explained in Unit IV.D.                     www.regulations.gov in the document,
                                                    • Mail: OPP Docket, Environmental                                                                            ‘‘Subject: Flonicamid. Human Health
                                                                                                           III. Aggregate Risk Assessment and
                                                  Protection Agency Docket Center (EPA/                                                                          Risk Assessment for New Uses on
                                                                                                           Determination of Safety
                                                  DC), (28221T), 1200 Pennsylvania Ave.                                                                          Legume Vegetables, Subgroups 6A, 6B,
                                                                                                              Section 408(b)(2)(A)(i) of FFDCA                   and 6C; Add Directions for use on
                                                  NW., Washington, DC 20460–0001.
                                                                                                           allows EPA to establish a tolerance (the              Greenhouse Grown Peppers and
                                                    • Hand Delivery: To make special                       legal limit for a pesticide chemical                  Increase the Tolerance for Residues on
                                                  arrangements for hand delivery or                        residue in or on a food) only if EPA                  Fruiting Vegetables, Group 8–10; New
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                                                  delivery of boxed information, please                    determines that the tolerance is ‘‘safe.’’            Use on Citrus Fruits, Group 10–10; and
                                                  follow the instructions at http://                       Section 408(b)(2)(A)(ii) of FFDCA                     a Tolerance without U.S. Registration
                                                  www.epa.gov/dockets/contacts.html.                       defines ‘‘safe’’ to mean that ‘‘there is a            for residues in/on Dried Tea’’ in docket
                                                    Additional instructions on                             reasonable certainty that no harm will                ID number, EPA–HQ–OPP–2016–0013.
                                                  commenting or visiting the docket,                       result from aggregate exposure to the                    Based on the findings of the May 11,
                                                  along with more information about                        pesticide chemical residue, including                 2017 Federal Register document and
                                                  dockets generally, is available at http://               all anticipated dietary exposures and all             the supporting documents, EPA
                                                  www.epa.gov/dockets.                                     other exposures for which there is                    concludes that there is a reasonable


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                                                  31470                 Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations

                                                  certainty that no harm will result to the                that pesticides should be banned                      April 23, 1997). This action does not
                                                  general population, or to infants and                    completely. However, under the existing               contain any information collections
                                                  children from aggregate exposure to                      legal framework provided by FFDCA                     subject to OMB approval under the
                                                  flonicamid residues.                                     section 408, EPA is authorized to                     Paperwork Reduction Act (PRA) (44
                                                                                                           establish pesticide tolerances or                     U.S.C. 3501 et seq.), nor does it require
                                                  IV. Other Considerations                                 exemptions where persons seeking such                 any special considerations under
                                                  A. Analytical Enforcement Methodology                    tolerances or exemptions have                         Executive Order 12898, entitled
                                                                                                           demonstrated that the pesticide meets                 ‘‘Federal Actions to Address
                                                     Adequate enforcement methodology
                                                                                                           the safety standard imposed by that                   Environmental Justice in Minority
                                                  (FMC Method No. P–3561M, a liquid
                                                                                                           statute. In this instance, EPA has                    Populations and Low-Income
                                                  chromatography with tandem mass
                                                                                                           examined all the relevant and available               Populations’’ (59 FR 7629, February 16,
                                                  spectrometry (LC/MS/MS) method) is
                                                                                                           data and concluded that the tolerances                1994).
                                                  available to enforce the tolerance                                                                                Since tolerances and exemptions that
                                                                                                           are safe. The commenter has not
                                                  expression for flonicamid and its                                                                              are established on the basis of a petition
                                                                                                           provided any information to support a
                                                  metabolites in or on plant commodities.                                                                        under FFDCA section 408(d), such as
                                                                                                           conclusion by the Agency that the
                                                     The method may be requested from:                     tolerances are not safe.                              the tolerance in this final rule, do not
                                                  Chief, Analytical Chemistry Branch,                                                                            require the issuance of a proposed rule,
                                                  Environmental Science Center, 701                        D. Revisions to Petitioned-For                        the requirements of the Regulatory
                                                  Mapes Rd., Ft. Meade, MD 20755–5350;                     Tolerances                                            Flexibility Act (RFA) (5 U.S.C. 601 et
                                                  telephone number: (410) 305–2905;                           EPA is establishing a slightly higher              seq.), do not apply.
                                                  email address: residuemethods@                           tolerance for Pea and bean, succulent                    This action directly regulates growers,
                                                  epa.gov.                                                 shelled, subgroup 6B at 7.0 ppm                       food processors, food handlers, and food
                                                  B. International Residue Limits                          compared to the petitioner’s request of               retailers, not States or tribes, nor does
                                                                                                           a tolerance at 6.0 ppm. EPA’s decision                this action alter the relationships or
                                                     In making its tolerance decisions, EPA                is based on the Organization for                      distribution of power and
                                                  seeks to harmonize U.S. tolerances with                  Economic Cooperation and                              responsibilities established by Congress
                                                  international standards whenever                         Development (OECD) tolerance                          in the preemption provisions of FFDCA
                                                  possible, consistent with U.S. food                      calculation procedures and available                  section 408(n)(4). As such, the Agency
                                                  safety standards and agricultural                        field trial data.                                     has determined that this action will not
                                                  practices. EPA considers the                                                                                   have a substantial direct effect on States
                                                  international maximum residue limits                     V. Conclusion
                                                                                                                                                                 or tribal governments, on the
                                                  (MRLs) established by the Codex                             Therefore, tolerances are established              relationship between the national
                                                  Alimentarius Commission (Codex), as                      for residues of flonicamid, N-                        government and the States or tribal
                                                  required by FFDCA section 408(b)(4).                     (cyanomethyl)-4-(trifluoromethyl)-3-                  governments, or on the distribution of
                                                  The Codex Alimentarius is a joint                        pyridinecarboxamide, and its                          power and responsibilities among the
                                                  United Nations Food and Agriculture                      metabolites, TFNA (4-                                 various levels of government or between
                                                  Organization/World Health                                trifluoromethylinicotinic acid), TFNA–                the Federal Government and Indian
                                                  Organization food standards program,                     AM (4-trifluoromethylnicotinamide),                   tribes. Thus, the Agency has determined
                                                  and it is recognized as an international                 and TFNG, N-(4-                                       that Executive Order 13132, entitled
                                                  food safety standards-setting                            trifluoromethylnicotinoyl)glycine,                    ‘‘Federalism’’ (64 FR 43255, August 10,
                                                  organization in trade agreements to                      calculated as the stoichiometric                      1999) and Executive Order 13175,
                                                  which the United States is a party. EPA                  equivalent of flonicamid, in or on Pea                entitled ‘‘Consultation and Coordination
                                                  may establish a tolerance that is                        and bean, succulent shelled, subgroup                 with Indian Tribal Governments’’ (65 FR
                                                  different from a Codex MRL; however,                     6B at 7.0 ppm; Pea and bean, dried                    67249, November 9, 2000) do not apply
                                                  FFDCA section 408(b)(4) requires that                    shelled, except soybean, subgroup 6C at               to this action. In addition, this action
                                                  EPA explain the reasons for departing                    3.0 ppm; and Vegetable, legume, edible                does not impose any enforceable duty or
                                                  from the Codex level.                                    podded, subgroup 6A at 4.0 ppm.                       contain any unfunded mandate as
                                                     The Codex has not established a MRL                                                                         described under Title II of the Unfunded
                                                  for flonicamid.                                          VI. Statutory and Executive Order
                                                                                                           Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                                  C. Response to Comments                                                                                        1501 et seq.).
                                                                                                             This action establishes tolerances                     This action does not involve any
                                                    Comment: One anonymous comment                         under FFDCA section 408(d) in                         technical standards that would require
                                                  on the notice of filing of petition 5E8428               response to a petition submitted to the               Agency consideration of voluntary
                                                  was received. The commenter claims                       Agency. The Office of Management and                  consensus standards pursuant to section
                                                  that flonicamid is a ‘‘toxic pesticide’’                 Budget (OMB) has exempted these types                 12(d) of the National Technology
                                                  and residues at any level in food                        of actions from review under Executive                Transfer and Advancement Act
                                                  commodities should not be allowed and                    Order 12866, entitled ‘‘Regulatory                    (NTTAA) (15 U.S.C. 272 note).
                                                  requested that EPA deny setting                          Planning and Review’’ (58 FR 51735,
                                                  tolerances for the petition-for new uses                 October 4, 1993). Because this action                 VII. Congressional Review Act
                                                  of flonicamid. The comment stated that                   has been exempted from review under                     Pursuant to the Congressional Review
                                                  the proposed flonicamid use would add                    Executive Order 12866, this action is                 Act (5 U.S.C. 801 et seq.), EPA will
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                                                  to about 25,000 toxic chemicals                          not subject to Executive Order 13211,                 submit a report containing this rule and
                                                  currently in the environment and                         entitled ‘‘Actions Concerning                         other required information to the U.S.
                                                  combine to create even more toxic                        Regulations That Significantly Affect                 Senate, the U.S. House of
                                                  chemical residues in food and drinking                   Energy Supply, Distribution, or Use’’ (66             Representatives, and the Comptroller
                                                  water further increasing harmful effects                 FR 28355, May 22, 2001) or Executive                  General of the United States prior to
                                                  to humans and environment.                               Order 13045, entitled ‘‘Protection of                 publication of the rule in the Federal
                                                    Agency response: The Agency                            Children from Environmental Health                    Register. This action is not a ‘‘major
                                                  recognizes that some individuals believe                 Risks and Safety Risks’’ (62 FR 19885,                rule’’ as defined by 5 U.S.C. 804(2).


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                                                                         Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations                                         31471

                                                  List of Subjects in 40 CFR Part 180                       forage; grain, cereal, forage, fodder, and            B. How can I get electronic access to
                                                    Environmental protection,                               straw, group 16, hay; grain, cereal,                  other related information?
                                                  Administrative practice and procedure,                    forage, fodder, and straw, group 16,
                                                                                                            straw; and grain, cereal, group 15.                      You may access a frequently updated
                                                  Agricultural commodities, Pesticides                                                                            electronic version of EPA’s tolerance
                                                  and pests, Reporting and recordkeeping                    Syngenta Crop Protection, LLC
                                                                                                            requested these tolerances under the                  regulations at 40 CFR part 180 through
                                                  requirements.                                                                                                   the Government Printing Office’s e-CFR
                                                                                                            Federal Food, Drug, and Cosmetic Act
                                                    Dated: June 2, 2017.                                    (FFDCA).                                              site at http://www.ecfr.gov/cgi-bin/text-
                                                  Michael L. Goodis,                                                                                              idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                  Director, Registration Division, Office of                DATES:  This regulation is effective July             40tab_02.tpl.
                                                  Pesticide Programs.                                       7, 2017. Objections and requests for
                                                                                                            hearings must be received on or before                C. How can I file an objection or hearing
                                                    Therefore, 40 CFR chapter I is                          September 5, 2017, and must be filed in               request?
                                                  amended as follows:                                       accordance with the instructions                        Under FFDCA section 408(g), 21
                                                  PART 180—[AMENDED]                                        provided in 40 CFR part 178 (see also                 U.S.C. 346a, any person may file an
                                                                                                            Unit I.C. of the SUPPLEMENTARY                        objection to any aspect of this regulation
                                                  ■ 1. The authority citation for part 180                  INFORMATION).
                                                                                                                                                                  and may also request a hearing on those
                                                  continues to read as follows:                             ADDRESSES:    The docket for this action,             objections. You must file your objection
                                                      Authority: 21 U.S.C. 321(q), 346a and 371.            identified by docket identification (ID)              or request a hearing on this regulation
                                                  ■ 2. In § 180.613, add alphabetically the                 number EPA–HQ–OPP–2016–0218, is                       in accordance with the instructions
                                                  following commodities ‘‘Pea and bean,                     available at http://www.regulations.gov               provided in 40 CFR part 178. To ensure
                                                  succulent shelled, subgroup 6B’’; ‘‘Pea                   or at the Office of Pesticide Programs                proper receipt by EPA, you must
                                                  and bean, dried shelled, except soybean, Regulatory Public Docket (OPP Docket)                                  identify docket ID number EPA–HQ–
                                                  subgroup 6C’’; and ‘‘Vegetable, legume,                   in the Environmental Protection Agency                OPP–2016–0218 in the subject line on
                                                  edible podded, subgroup 6A’’ to the                       Docket Center (EPA/DC), West William                  the first page of your submission. All
                                                  table in paragraph (a)(1) to read as                      Jefferson Clinton Bldg., Rm. 3334, 1301               objections and requests for a hearing
                                                  follows:                                                  Constitution Ave. NW., Washington, DC                 must be in writing, and must be
                                                                                                            20460–0001. The Public Reading Room                   received by the Hearing Clerk on or
                                                  § 180.613 Flonicamid; tolerances for                      is open from 8:30 a.m. to 4:30 p.m.,                  before September 5, 2017. Addresses for
                                                  residues.                                                 Monday through Friday, excluding legal                mail and hand delivery of objections
                                                     (a) * * *                                              holidays. The telephone number for the                and hearing requests are provided in 40
                                                     (1) * * *                                              Public Reading Room is (202) 566–1744,                CFR 178.25(b).
                                                                                                            and the telephone number for the OPP                    In addition to filing an objection or
                                                                                                Parts per Docket is (703) 305–5805. Please review
                                                              Commodity                                                                                           hearing request with the Hearing Clerk
                                                                                                 million
                                                                                                            the visitor instructions and additional               as described in 40 CFR part 178, please
                                                                                                            information about the docket available                submit a copy of the filing (excluding
                                                      *        *            *               *         *     at http://www.epa.gov/dockets.                        any Confidential Business Information
                                                  Pea and bean, succulent shelled,                          FOR FURTHER INFORMATION CONTACT:                      (CBI)) for inclusion in the public docket.
                                                     subgroup 6B ..............................         7.0 Michael L. Goodis, Registration Division              Information not marked confidential
                                                  Pea and bean, dried shelled, ex-                                                                                pursuant to 40 CFR part 2 may be
                                                     cept soybean, subgroup 6C ......                   3.0
                                                                                                            (7505P), Office of Pesticide Programs,
                                                                                                            Environmental Protection Agency, 1200                 disclosed publicly by EPA without prior
                                                      *        *            *               *         *     Pennsylvania Ave. NW., Washington,                    notice. Submit the non-CBI copy of your
                                                  Vegetable, legume, edible pod-                            DC 20460–0001; main telephone                         objection or hearing request, identified
                                                     ded, subgroup 6A .....................             4.0 number: (703) 305–7090; email address:                by docket ID number EPA–HQ–OPP–
                                                                                                            RDFRNotices@epa.gov.                                  2016–0218, by one of the following
                                                      *        *            *               *         *
                                                                                                            SUPPLEMENTARY INFORMATION:                            methods:
                                                                                                                                                                    • Federal eRulemaking Portal: http://
                                                  *      *      *       *       *                           I. General Information                                www.regulations.gov. Follow the online
                                                  [FR Doc. 2017–14339 Filed 7–6–17; 8:45 am]
                                                                                                            A. Does this action apply to me?                      instructions for submitting comments.
                                                  BILLING CODE 6560–50–P
                                                                                                                                                                  Do not submit electronically any
                                                                                                               You may be potentially affected by                 information you consider to be CBI or
                                                                                                            this action if you are an agricultural                other information whose disclosure is
                                                  ENVIRONMENTAL PROTECTION                                  producer, food manufacturer, or
                                                  AGENCY                                                                                                          restricted by statute.
                                                                                                            pesticide manufacturer. The following
                                                                                                            list of North American Industrial                       • Mail: OPP Docket, Environmental
                                                  40 CFR Part 180                                           Classification System (NAICS) codes is                Protection Agency Docket Center (EPA/
                                                  [EPA–HQ–OPP–2016–0218; FRL–9962–97]                       not intended to be exhaustive, but rather             DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                            provides a guide to help readers                      NW., Washington, DC 20460–0001.
                                                  Prosulfuron; Pesticide Tolerances                         determine whether this document                         • Hand Delivery: To make special
                                                                                                            applies to them. Potentially affected                 arrangements for hand delivery or
                                                  AGENCY:  Environmental Protection
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                                                                                                            entities may include:                                 delivery of boxed information, please
                                                  Agency (EPA).
                                                                                                               • Crop production (NAICS code 111).                follow the instructions at http://
                                                  ACTION: Final rule.
                                                                                                               • Animal production (NAICS code                    www.epa.gov/dockets/contacts.html.
                                                  SUMMARY:   This regulation establishes                    112).                                                   Additional instructions on
                                                  tolerances for residues of prosulfuron in                    • Food manufacturing (NAICS code                   commenting or visiting the docket,
                                                  or on grain, cereal, forage, fodder, and                  311).                                                 along with more information about
                                                  straw, group 16, stover; grain, cereal,                      • Pesticide manufacturing (NAICS                   dockets generally, is available at http://
                                                  forage, fodder, and straw, group 16,                      code 32532).                                          www.epa.gov/dockets.


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Document Created: 2017-07-07 02:19:56
Document Modified: 2017-07-07 02:19:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective July 7, 2017. Objections and requests for hearings must be received on or before September 5, 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 L. Goodis, Director, 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
FR Citation82 FR 31468 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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