83_FR_64266 83 FR 64027 - [EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73] HEAD6-Benzyladenine; Pesticide Tolerances

83 FR 64027 - [EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73] HEAD6-Benzyladenine; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 239 (December 13, 2018)

Page Range64027-64030
FR Document2018-27047

This regulation establishes tolerances for residues of 6- benzyladenine in or on avocados, peppers, tomatoes, cucumbers, melons, and squash. Interregional Research Project Number 4 and Valent BioSciences LLC have requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 83 Issue 239 (Thursday, December 13, 2018)
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Rules and Regulations]
[Pages 64027-64030]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-27047]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180


[EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283; FRL-9986-73]

6-Benzyladenine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 6-
benzyladenine in or on avocados, peppers, tomatoes, cucumbers, melons, 
and squash. Interregional Research Project Number 4 and Valent 
BioSciences LLC have requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 13, 2018. Objections and 
requests for hearings must be received on or before February 11, 2019, 
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 dockets for this action, identified by docket 
identification (ID)

[[Page 64028]]

numbers EPA-HQ-OPP-2017-0288 and EPA-HQ-OPP-2017-0283, are 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: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), 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 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(g), 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-2017-0288 and EPA-HQ-OPP-2017-0283 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 February 11, 2019. 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 numbers EPA-HQ-OPP-2017-0288 and EPA-
HQ-OPP-2017-0283, 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. Background

    In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions: PP 
6E8526 by Interregional Research Project Number 4 (IR-4), Rutgers, 
State University of New Jersey, 681 U.S. Highway No. 1, S. North New 
Brunswick, NJ 08902; and PP 7F8548 by Valent BioSciences LLC (Valent), 
870 Technology Way, Libertyville, IL 60048. Petition 6E8526 requested 
that 40 CFR part 180 be amended by establishing a tolerance for 
residues of the plant growth regulator 6-benzyladenine, in or on 
avocados at 0.05 parts per million (ppm). Petition 7F8548 requested 
amendment of the current exemption from the requirement of tolerance 
for residues of 6-benzyladenine, 40 CFR 180.1150, to add fruiting 
vegetables (tomatoes and peppers) and cucurbit vegetables (cucumbers, 
melons, and squash). That document referenced summaries of the 
petitions prepared by Valent, the registrant, which are available in 
the respective dockets via, www.regulations.gov. Comments were received 
on the notice of filing, and the Agency's response can be found in Unit 
III.D.
    Based upon review of the data supporting each petition, EPA is 
establishing tolerance levels for 6-benzyladenine on avocados, 
tomatoes, peppers, cucumbers, melons and squash in one final rule. The 
reasons for these changes are explained in Part III.E. of this 
document.

III. Final Rule

A. EPA's Safety Determination

    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. EPA 
must take into account the factors set forth in FFDCA section 
408(b)(2)(C), which require EPA to give special consideration to 
exposure of infants and children to the pesticide chemical residue in 
establishing a tolerance or tolerance exemption 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 . . 
. .'' Additionally, FFDCA section 408(b)(2)(D) requires that EPA 
consider ``available information concerning the cumulative effects of a 
particular pesticide's residues and other substances that have a common 
mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on 6-
benzyladenine and considered their validity, completeness, and 
reliability, as well as the relationship of this information to human 
risk. A summary of the data upon which EPA relied and its risk 
assessment based on those data can be found within the document

[[Page 64029]]

entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Safety 
Assessment for Tolerances for Residues of 6-benzyladenine.'' This 
document, as well as other relevant information, is available in the 
docket for this action as described under ADDRESSES.
    The available data demonstrated that the predominant adverse effect 
from exposure to 6-benzyladenine was a significant reduction in body 
weight, including an increased susceptibility of body weight effects in 
fetuses and offspring. Despite these effects, EPA determined that 
reliable data show the safety of infants and children would be 
adequately protected if the Food Quality Protection Act (FQPA) safety 
factor was reduced to 1X. EPA conducted a quantitative aggregate risk 
assessment, taking into account chronic exposures to residues of 6-
benzyladenine in food and drinking water (no residential exposures are 
anticipated) and concluded that risks do not exceed EPA's level of 
concern.
    Based upon its evaluation, EPA concludes that there is a reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposure to residues of 6-
benzyladenine. Therefore, tolerances are established for residues of 6-
benzyladenine, in or on tomato, pepper, cucumber, melon, and squash at 
0.01 ppm and in or on avocado at 0.02 ppm.

B. Analytical Enforcement Methodology

    Adequate enforcement methodologies to quantitatively determine 6-
benzyladenine residues by liquid chromatography/mass spectrometer/mass 
spectrometer (LC/MS/MS) (Meth-209, Determination of 6-Benzyladenine (6-
BA) in Selected Fruiting Vegetable and Cucurbit Vegetable Raw 
Agricultural and Processed Commodities and Meth-210, Determination of 
6-Benzyladenine (6-BA) in Selected Oily Crop Raw Agricultural 
Commodities) are available to enforce the tolerance expression. The 
methods 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].

C. 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 6-benzyladenine; however, Canada and the 
European Union (EU) have set default MRLs at 0.1 ppm (Canada) and 0.01 
ppm (EU), respectively.

D. Response to Comments

    One comment was received in response to each of the petitions. Each 
comment generally opposed pesticide residues on food; only one 
mentioned 6-benzyladenine by name. Neither comment was accompanied by 
any substantiation or data supporting a conclusion that the tolerances 
being established in this action do not meet the FFDCA safety standard. 
Although EPA recognizes that some individuals would oppose any use of 
pesticides on food, section 408 of the FFDCA authorizes EPA to set 
tolerances for residues of pesticide chemicals in or on food when it 
determines that the tolerance meets the safety standard imposed by that 
statute. EPA has made that determination for the 6-benzyladenine 
tolerances established by this final rule.

E. Revisions to Petitioned-For Tolerance and Tolerance Exemption

    The applicant requested a tolerance for residues of 6-benzyladenine 
on avocado at 0.05 ppm. Based on available residue data and using the 
Organisation for Economic Co-operation and Development (OECD) 
calculator, EPA has determined that a tolerance for residues of 6-
benzyladenine on avocado at 0.02 ppm is appropriate. In addition, the 
applicant requested to amend the current exemption, 40 CFR 180.1150, 
for residues of 6-benzyladenine by adding fruiting vegetables (tomatoes 
and peppers) and cucurbit vegetables (cucumbers, melons, and squash) at 
20 parts per million (ppm) at a maximum of five applications (total 
18.8 grams of active ingredient per acre per season) with a seven-day 
interval between applications. Due to the toxicological profile of the 
chemical and the measurable residues, EPA has concluded that a 
tolerance is the appropriate regulatory mechanism for covering residues 
of 6-benzyladenine under the FFDCA. Based on the available residue data 
and using the OECD calculator, EPA has determined that tolerances for 
residues of 6-benzyladenine on tomato, pepper, cucumber, melon, and 
squash at 0.01 ppm are appropriate.

IV. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to EPA. 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) nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82 FR 9339, February 3, 2017). 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 
action, 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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

[[Page 64030]]

governments, or on the distribution of power and responsibilities among 
the various levels of government or between the Federal Government and 
Indian tribes. Thus, EPA 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 EPA's 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).

V. 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: November 28, 2018.
Richard P. Keigwin, Jr.,
Director, 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. Add Sec.  180.703 to subpart C to read as follows:


Sec.  180.703   6-benzyladenine; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant 
growth regulator, 6-benzyladenine in or on the commodities listed in 
the table below. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only 6-benzyladenine in or 
on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Avocado.....................................................        0.02
Cucumber....................................................        0.01
Melon.......................................................        0.01
Pepper......................................................        0.01
Squash......................................................        0.01
Tomato......................................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2018-27047 Filed 12-12-18; 8:45 am]
 BILLING CODE 6560-50-P



                                                            Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations                                            64027

                                           authorized in section 110(k)(3) of the                   methods, under Executive Order 12898                  November 16, 2017 by the Governor’s
                                           Act, the EPA is approving these                          (59 FR 7629, February 16, 1994).                      designee.
                                           certifications into the California SIP as                   In addition, the SIP is not approved                 (i) [Reserved]
                                           proposed.                                                to apply on any Indian reservation land                 (ii) Additional materials. (A) South
                                                                                                    or in any other area where the EPA or                 Coast Air Quality Management District.
                                           IV. Statutory and Executive Order                                                                                (1) ‘‘Nonattainment New Source
                                                                                                    an Indian tribe has demonstrated that a
                                           Reviews                                                                                                        Review (NSR) Compliance
                                                                                                    tribe has jurisdiction. In those areas of
                                              Under the CAA, the Administrator is                   Indian country, the rule does not have                Demonstration for the 2008 Ozone
                                           required to approve a SIP submission                     tribal implications and will not impose               National Ambient Air Quality Standard
                                           that complies with the provisions of the                 substantial direct costs on tribal                    (NAAQS),’’ adopted July 7, 2017.
                                           Act and applicable Federal regulations.                  governments or preempt tribal law as                    (2) [Reserved]
                                           42 U.S.C. 7410(k); 40 CFR 52.02(a).                      specified by Executive Order 13175 (65                  (511) New additional materials for the
                                           Thus, in reviewing SIP submissions, the                  FR 67249, November 9, 2000).                          following APCD’s were submitted on
                                           EPA’s role is to approve state choices,                                                                        June 19, 2018 by the Governor’s
                                                                                                       The Congressional Review Act, 5
                                           provided that they meet the criteria of                                                                        designee.
                                                                                                    U.S.C. 801 et seq., as added by the Small
                                           the CAA. Accordingly, this action                                                                                (i) [Reserved]
                                                                                                    Business Regulatory Enforcement                         (ii) Additional materials. (A) San
                                           merely approves state law as meeting                     Fairness Act of 1996, generally provides              Joaquin Valley Air Pollution Control
                                           Federal requirements and does not                        that before a rule may take effect, the               District.
                                           impose additional requirements beyond                    agency promulgating the rule must                       (1) ‘‘Certification that the San Joaquin
                                           those imposed by state law. For that                     submit a rule report, which includes a                Valley Unified Air Pollution Control
                                           reason, this action:                                     copy of the rule, to each House of the                District’s Current NNSR Program
                                              • Is not a significant regulatory action              Congress and to the Comptroller General               Addresses the 2008 Ozone NAAQS SIP
                                           subject to review by the Office of                       of the United States. The EPA will                    Requirements Rule,’’ adopted April 19,
                                           Management and Budget under                              submit a report containing this action                2018.
                                           Executive Orders 12866 (58 FR 51735,                     and other required information to the                   (2) [Reserved]
                                           October 4, 1993) and 13563 (76 FR 3821,                  U.S. Senate, the U.S. House of                          (B) Yolo-Solano Air Quality
                                           January 21, 2011);                                       Representatives, and the Comptroller                  Management District.
                                              • Is not an Executive Order 13771 (82                 General of the United States prior to                   (1) ‘‘Certification that Yolo-Solano’s
                                           FR 9339, February 2, 2017) regulatory                    publication of the rule in the Federal                Existing NNSR Program meets the 2008
                                           action because SIP approvals are                         Register. A major rule cannot take effect             Ozone NAAQS SIP Requirements Rule,’’
                                           exempted under Executive Order 12866;                    until 60 days after it is published in the            adopted March 14, 2018.
                                              • Does not impose an information                      Federal Register. This action is not a                  (2) [Reserved]
                                           collection burden under the provisions                   ‘‘major rule’’ as defined by 5 U.S.C.                 [FR Doc. 2018–26921 Filed 12–12–18; 8:45 am]
                                           of the Paperwork Reduction Act (44                       804(2).                                               BILLING CODE 6560–50–P
                                           U.S.C. 3501 et seq.);
                                                                                                    List of Subjects in 40 CFR Part 52
                                              • Is certified as not having a
                                           significant economic impact on a                           Environmental protection, Air                       ENVIRONMENTAL PROTECTION
                                           substantial number of small entities                     pollution control, Incorporation by                   AGENCY
                                           under the Regulatory Flexibility Act (5                  reference, Intergovernmental relations,
                                           U.S.C. 601 et seq.);                                     Nitrogen dioxide, Ozone, Reporting and                40 CFR Part 180
                                              • Does not contain any unfunded                       recordkeeping requirements, Volatile
                                           mandate or significantly or uniquely                     organic compounds.                                    [EPA–HQ–OPP–2017–0288 and EPA–
                                           affect small governments, as described                                                                         HQ–OPP–2017–0283; FRL–9986–73]
                                                                                                      Dated: October 24, 2018.
                                           in the Unfunded Mandates Reform Act                      Michael Stoker,
                                           of 1995 (Pub. L. 104–4);                                                                                       6-Benzyladenine; Pesticide Tolerances
                                                                                                    Regional Administrator, Region IX.
                                              • Does not have Federalism                                                                                  AGENCY:  Environmental Protection
                                           implications as specified in Executive                     Part 52, Chapter I, Title 40 of the Code            Agency (EPA).
                                           Order 13132 (64 FR 43255, August 10,                     of Federal Regulations is amended as
                                                                                                                                                          ACTION: Final rule.
                                           1999);                                                   follows:
                                              • Is not an economically significant                                                                        SUMMARY:   This regulation establishes
                                                                                                    PART 52—APPROVAL AND                                  tolerances for residues of 6-
                                           regulatory action based on health or
                                                                                                    PROMULGATION OF                                       benzyladenine in or on avocados,
                                           safety risks subject to Executive Order
                                                                                                    IMPLEMENTATION PLANS                                  peppers, tomatoes, cucumbers, melons,
                                           13045 (62 FR 19885, April 23, 1997);
                                              • Is not a significant regulatory action              ■ 1. The authority citation for Part 52
                                                                                                                                                          and squash. Interregional Research
                                           subject to Executive Order 13211 (66 FR                                                                        Project Number 4 and Valent
                                                                                                    continues to read as follows:
                                           28355, May 22, 2001);                                                                                          BioSciences LLC have requested these
                                                                                                        Authority: 42 U.S.C. 7401 et seq.
                                              • Is not subject to requirements of                                                                         tolerances under the Federal Food,
                                           Section 12(d) of the National                                                                                  Drug, and Cosmetic Act (FFDCA).
                                                                                                    Subpart F—California
                                           Technology Transfer and Advancement                                                                            DATES: This regulation is effective
                                           Act of 1995 (15 U.S.C. 272 note) because                 ■ 2. Section 52.220 is amended by                     December 13, 2018. Objections and
                                           application of those requirements would                  adding paragraphs (c)(510) and (511) to               requests for hearings must be received
                                           be inconsistent with the Clean Air Act;                  read as follows:                                      on or before February 11, 2019, and
amozie on DSK3GDR082PROD with RULES




                                           and                                                                                                            must be filed in accordance with the
                                              • Does not provide the EPA with the                   § 52.220    Identification of plan—in part.           instructions provided in 40 CFR part
                                           discretionary authority to address, as                   *     *    *   *     *                                178 (see also Unit I.C. of the
                                           appropriate, disproportionate human                        (c) * * *                                           SUPPLEMENTARY INFORMATION).
                                           health or environmental effects, using                     (510) New additional materials for the              ADDRESSES: The dockets for this action,
                                           practicable and legally permissible                      following APCD was submitted on                       identified by docket identification (ID)


                                      VerDate Sep<11>2014    16:44 Dec 12, 2018   Jkt 247001   PO 00000   Frm 00005   Fmt 4700   Sfmt 4700   E:\FR\FM\13DER1.SGM   13DER1


                                           64028            Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations

                                           numbers EPA–HQ–OPP–2017–0288 and                         in accordance with the instructions                   7F8548 requested amendment of the
                                           EPA–HQ–OPP–2017–0283, are available                      provided in 40 CFR part 178. To ensure                current exemption from the requirement
                                           at http://www.regulations.gov or at the                  proper receipt by EPA, you must                       of tolerance for residues of 6-
                                           Office of Pesticide Programs Regulatory                  identify docket ID number EPA–HQ–                     benzyladenine, 40 CFR 180.1150, to add
                                           Public Docket (OPP Docket) in the                        OPP–2017–0288 and EPA–HQ–OPP–                         fruiting vegetables (tomatoes and
                                           Environmental Protection Agency                          2017–0283 in the subject line on the                  peppers) and cucurbit vegetables
                                           Docket Center (EPA/DC), West William                     first page of your submission. All                    (cucumbers, melons, and squash). That
                                           Jefferson Clinton Bldg., Rm. 3334, 1301                  objections and requests for a hearing                 document referenced summaries of the
                                           Constitution Ave. NW, Washington, DC                     must be in writing, and must be                       petitions prepared by Valent, the
                                           20460–0001. The Public Reading Room                      received by the Hearing Clerk on or                   registrant, which are available in the
                                           is open from 8:30 a.m. to 4:30 p.m.,                     before February 11, 2019. Addresses for               respective dockets via,
                                           Monday through Friday, excluding legal                   mail and hand delivery of objections                  www.regulations.gov. Comments were
                                           holidays. The telephone number for the                   and hearing requests are provided in 40               received on the notice of filing, and the
                                           Public Reading Room is (202) 566–1744,                   CFR 178.25(b).                                        Agency’s response can be found in Unit
                                           and the telephone number for the OPP                        In addition to filing an objection or              III.D.
                                           Docket is (703) 305–5805. Please review                  hearing request with the Hearing Clerk                   Based upon review of the data
                                           the visitor instructions and additional                  as described in 40 CFR part 178, please               supporting each petition, EPA is
                                           information about the docket available                   submit a copy of the filing (excluding                establishing tolerance levels for 6-
                                           at http://www.epa.gov/dockets.                           any Confidential Business Information                 benzyladenine on avocados, tomatoes,
                                           FOR FURTHER INFORMATION CONTACT:
                                                                                                    (CBI)) for inclusion in the public docket.            peppers, cucumbers, melons and squash
                                           Robert McNally, Biopesticides and                        Information not marked confidential                   in one final rule. The reasons for these
                                           Pollution Prevention Division (7511P),                   pursuant to 40 CFR part 2 may be                      changes are explained in Part III.E. of
                                           Office of Pesticide Programs,                            disclosed publicly by EPA without prior               this document.
                                                                                                    notice. Submit the non-CBI copy of your
                                           Environmental Protection Agency, 1200                                                                          III. Final Rule
                                                                                                    objection or hearing request, identified
                                           Pennsylvania Ave. NW, Washington, DC
                                                                                                    by docket ID numbers EPA–HQ–OPP–                      A. EPA’s Safety Determination
                                           20460–0001; main telephone number:
                                                                                                    2017–0288 and EPA–HQ–OPP–2017–
                                           (703) 305–7090; email address:                                                                                    Section 408(b)(2)(A)(i) of FFDCA
                                                                                                    0283, by one of the following methods:
                                           BPPDFRNotices@epa.gov.                                      • Federal eRulemaking Portal: http://              allows EPA to establish a tolerance (the
                                           SUPPLEMENTARY INFORMATION:                               www.regulations.gov. Follow the online                legal limit for a pesticide chemical
                                                                                                    instructions for submitting comments.                 residue in or on a food) only if EPA
                                           I. General Information
                                                                                                    Do not submit electronically any                      determines that the tolerance is ‘‘safe.’’
                                           A. Does this action apply to me?                         information you consider to be CBI or                 Section 408(b)(2)(A)(ii) of FFDCA
                                              You may be potentially affected by                    other information whose disclosure is                 defines ‘‘safe’’ to mean that ‘‘there is a
                                           this action if you are an agricultural                   restricted by statute.                                reasonable certainty that no harm will
                                           producer, food manufacturer, or                             • Mail: OPP Docket, Environmental                  result from aggregate exposure to the
                                           pesticide manufacturer. The following                    Protection Agency Docket Center (EPA/                 pesticide chemical residue, including
                                           list of North American Industrial                        DC), (28221T), 1200 Pennsylvania Ave.                 all anticipated dietary exposures and all
                                           Classification System (NAICS) codes is                   NW, Washington, DC 20460–0001.                        other exposures for which there is
                                           not intended to be exhaustive, but rather                   • Hand Delivery: To make special                   reliable information.’’ This includes
                                           provides a guide to help readers                         arrangements for hand delivery or                     exposure through drinking water and in
                                           determine whether this document                          delivery of boxed information, please                 residential settings but does not include
                                           applies to them. Potentially affected                    follow the instructions at http://                    occupational exposure. EPA must take
                                           entities may include:                                    www.epa.gov/dockets/contacts.html.                    into account the factors set forth in
                                              • Crop production (NAICS code 111).                   Additional instructions on commenting                 FFDCA section 408(b)(2)(C), which
                                              • Animal production (NAICS code                       or visiting the docket, along with more               require EPA to give special
                                           112).                                                    information about dockets generally, is               consideration to exposure of infants and
                                              • Food manufacturing (NAICS code                      available at http://www.epa.gov/                      children to the pesticide chemical
                                           311).                                                    dockets.                                              residue in establishing a tolerance or
                                              • Pesticide manufacturing (NAICS                      II. Background
                                                                                                                                                          tolerance exemption and to ‘‘ensure that
                                           code 32532).                                                                                                   there is a reasonable certainty that no
                                                                                                       In the Federal Register of September               harm will result to infants and children
                                           B. How can I get electronic access to                    15, 2017 (82 FR 43352) (FRL–9965–43),                 from aggregate exposure to the pesticide
                                           other related information?                               EPA issued a document pursuant to                     chemical residue . . . .’’ Additionally,
                                             You may access a frequently updated                    FFDCA section 408(d)(3), 21 U.S.C.                    FFDCA section 408(b)(2)(D) requires
                                           electronic version of 40 CFR part 180                    346a(d)(3), announcing the filing of two              that EPA consider ‘‘available
                                           through the Government Printing                          pesticide petitions: PP 6E8526 by                     information concerning the cumulative
                                           Office’s e-CFR site at http://www.ecfr.                  Interregional Research Project Number 4               effects of a particular pesticide’s
                                           gov/cgi-bin/text-idx?&c=ecfr&tpl=/                       (IR–4), Rutgers, State University of New              residues and other substances that have
                                           ecfrbrowse/Title40/40tab_02.tpl.                         Jersey, 681 U.S. Highway No. 1, S. North              a common mechanism of toxicity.’’
                                                                                                    New Brunswick, NJ 08902; and PP                          EPA evaluated the available
                                           C. How can I file an objection or hearing                7F8548 by Valent BioSciences LLC                      toxicological and exposure data on 6-
                                           request?                                                 (Valent), 870 Technology Way,                         benzyladenine and considered their
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                                             Under FFDCA section 408(g), 21                         Libertyville, IL 60048. Petition 6E8526               validity, completeness, and reliability,
                                           U.S.C. 346a(g), any person may file an                   requested that 40 CFR part 180 be                     as well as the relationship of this
                                           objection to any aspect of this regulation               amended by establishing a tolerance for               information to human risk. A summary
                                           and may also request a hearing on those                  residues of the plant growth regulator 6-             of the data upon which EPA relied and
                                           objections. You must file your objection                 benzyladenine, in or on avocados at                   its risk assessment based on those data
                                           or request a hearing on this regulation                  0.05 parts per million (ppm). Petition                can be found within the document


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                                                            Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations                                         64029

                                           entitled ‘‘Federal Food, Drug, and                       (MRLs) established by the Codex                       concluded that a tolerance is the
                                           Cosmetic Act (FFDCA) Safety                              Alimentarius Commission (Codex), as                   appropriate regulatory mechanism for
                                           Assessment for Tolerances for Residues                   required by FFDCA section 408(b)(4).                  covering residues of 6-benzyladenine
                                           of 6-benzyladenine.’’ This document, as                  The Codex Alimentarius is a joint                     under the FFDCA. Based on the
                                           well as other relevant information, is                   United Nations Food and Agriculture                   available residue data and using the
                                           available in the docket for this action as               Organization/World Health                             OECD calculator, EPA has determined
                                           described under ADDRESSES.                               Organization food standards program,                  that tolerances for residues of 6-
                                              The available data demonstrated that                  and it is recognized as an international              benzyladenine on tomato, pepper,
                                           the predominant adverse effect from                      food safety standards-setting                         cucumber, melon, and squash at 0.01
                                           exposure to 6-benzyladenine was a                        organization in trade agreements to                   ppm are appropriate.
                                           significant reduction in body weight,                    which the United States is a party. EPA
                                           including an increased susceptibility of                                                                       IV. Statutory and Executive Order
                                                                                                    may establish a tolerance that is
                                           body weight effects in fetuses and                                                                             Reviews
                                                                                                    different from a Codex MRL; however,
                                           offspring. Despite these effects, EPA                    FFDCA section 408(b)(4) requires that                    This action establishes tolerances
                                           determined that reliable data show the                   EPA explain the reasons for departing                 under FFDCA section 408(d) in
                                           safety of infants and children would be                  from the Codex level. The Codex has not               response to a petition submitted to EPA.
                                           adequately protected if the Food Quality                 established an MRL for 6-                             The Office of Management and Budget
                                           Protection Act (FQPA) safety factor was                  benzyladenine; however, Canada and                    (OMB) has exempted these types of
                                           reduced to 1X. EPA conducted a                           the European Union (EU) have set                      actions from review under Executive
                                           quantitative aggregate risk assessment,                  default MRLs at 0.1 ppm (Canada) and                  Order 12866, entitled ‘‘Regulatory
                                           taking into account chronic exposures to                 0.01 ppm (EU), respectively.                          Planning and Review’’ (58 FR 51735,
                                           residues of 6-benzyladenine in food and                                                                        October 4, 1993). Because this action
                                           drinking water (no residential exposures                 D. Response to Comments                               has been exempted from review under
                                           are anticipated) and concluded that                        One comment was received in                         Executive Order 12866, this action is
                                           risks do not exceed EPA’s level of                       response to each of the petitions. Each               not subject to Executive Order 13211,
                                           concern.                                                 comment generally opposed pesticide                   entitled ‘‘Actions Concerning
                                              Based upon its evaluation, EPA                        residues on food; only one mentioned 6-               Regulations That Significantly Affect
                                           concludes that there is a reasonable                     benzyladenine by name. Neither                        Energy Supply, Distribution, or Use’’ (66
                                           certainty that no harm will result to the                comment was accompanied by any                        FR 28355, May 22, 2001), or Executive
                                           U.S. population, including infants and                   substantiation or data supporting a                   Order 13045, entitled ‘‘Protection of
                                           children, from aggregate exposure to                     conclusion that the tolerances being                  Children from Environmental Health
                                           residues of 6-benzyladenine. Therefore,                  established in this action do not meet                Risks and Safety Risks’’ (62 FR 19885,
                                           tolerances are established for residues of               the FFDCA safety standard. Although                   April 23, 1997) nor is it considered a
                                           6-benzyladenine, in or on tomato,                        EPA recognizes that some individuals                  regulatory action under Executive Order
                                           pepper, cucumber, melon, and squash at                   would oppose any use of pesticides on                 13771, entitled ‘‘Reducing Regulations
                                           0.01 ppm and in or on avocado at 0.02                    food, section 408 of the FFDCA                        and Controlling Regulatory Costs’’ (82
                                           ppm.                                                     authorizes EPA to set tolerances for                  FR 9339, February 3, 2017). This action
                                                                                                    residues of pesticide chemicals in or on              does not contain any information
                                           B. Analytical Enforcement Methodology                    food when it determines that the                      collections subject to OMB approval
                                              Adequate enforcement methodologies                    tolerance meets the safety standard                   under the Paperwork Reduction Act
                                           to quantitatively determine 6-                           imposed by that statute. EPA has made                 (PRA), 44 U.S.C. 3501 et seq., nor does
                                           benzyladenine residues by liquid                         that determination for the 6-                         it require any special considerations
                                           chromatography/mass spectrometer/                        benzyladenine tolerances established by               under Executive Order 12898, entitled
                                           mass spectrometer (LC/MS/MS) (Meth-                      this final rule.                                      ‘‘Federal Actions to Address
                                           209, Determination of 6-Benzyladenine                                                                          Environmental Justice in Minority
                                                                                                    E. Revisions to Petitioned-For Tolerance
                                           (6–BA) in Selected Fruiting Vegetable                                                                          Populations and Low-Income
                                                                                                    and Tolerance Exemption
                                           and Cucurbit Vegetable Raw                                                                                     Populations’’ (59 FR 7629, February 16,
                                           Agricultural and Processed                                  The applicant requested a tolerance                1994).
                                           Commodities and Meth-210,                                for residues of 6-benzyladenine on                       Since tolerances and exemptions that
                                           Determination of 6-Benzyladenine (6–                     avocado at 0.05 ppm. Based on available               are established on the basis of a petition
                                           BA) in Selected Oily Crop Raw                            residue data and using the Organisation               under FFDCA section 408(d), such as
                                           Agricultural Commodities) are available                  for Economic Co-operation and                         the tolerance in this action, do not
                                           to enforce the tolerance expression. The                 Development (OECD) calculator, EPA                    require the issuance of a proposed rule,
                                           methods may be requested from: Chief,                    has determined that a tolerance for                   the requirements of the Regulatory
                                           Analytical Chemistry Branch,                             residues of 6-benzyladenine on avocado                Flexibility Act (RFA) (5 U.S.C. 601 et
                                           Environmental Science Center, 701                        at 0.02 ppm is appropriate. In addition,              seq.) do not apply.
                                           Mapes Rd., Ft. Meade, MD 20755–5350;                     the applicant requested to amend the                     This action directly regulates growers,
                                           telephone number: (410) 305–2905;                        current exemption, 40 CFR 180.1150, for               food processors, food handlers, and food
                                           email address: residuemethods@                           residues of 6-benzyladenine by adding                 retailers, not States or tribes. As a result,
                                           epa.gov.                                                 fruiting vegetables (tomatoes and                     this action does not alter the
                                                                                                    peppers) and cucurbit vegetables                      relationships or distribution of power
                                           C. International Residue Limits                          (cucumbers, melons, and squash) at 20                 and responsibilities established by
                                             In making its tolerance decisions, EPA                 parts per million (ppm) at a maximum                  Congress in the preemption provisions
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                                           seeks to harmonize U.S. tolerances with                  of five applications (total 18.8 grams of             of FFDCA section 408(n)(4). As such,
                                           international standards whenever                         active ingredient per acre per season)                EPA has determined that this action will
                                           possible, consistent with U.S. food                      with a seven-day interval between                     not have a substantial direct effect on
                                           safety standards and agricultural                        applications. Due to the toxicological                States or tribal governments, on the
                                           practices. EPA considers the                             profile of the chemical and the                       relationship between the national
                                           international maximum residue limits                     measurable residues, EPA has                          government and the States or tribal


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                                           64030            Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Rules and Regulations

                                           governments, or on the distribution of                                                                       Parts per   particular community was suspended
                                                                                                                   Commodity
                                           power and responsibilities among the                                                                          million    on the suspension date or for further
                                           various levels of government or between                                                                                  information, contact Adrienne L.
                                           the Federal Government and Indian                        Avocado ......................................           0.02   Sheldon, PE, CFM, Federal Insurance
                                           tribes. Thus, EPA has determined that                    Cucumber ...................................             0.01   and Mitigation Administration, Federal
                                                                                                    Melon ..........................................         0.01
                                           Executive Order 13132, entitled                          Pepper ........................................          0.01
                                                                                                                                                                    Emergency Management Agency, 400 C
                                           ‘‘Federalism’’ (64 FR 43255, August 10,                  Squash ........................................          0.01   Street SW, Washington, DC 20472, (202)
                                           1999), and Executive Order 13175,                        Tomato ........................................          0.01   212–3966.
                                           entitled ‘‘Consultation and Coordination                                                                                 SUPPLEMENTARY INFORMATION: The NFIP
                                           with Indian Tribal Governments’’ (65 FR                    (b) Section 18 emergency exemptions.                          enables property owners to purchase
                                           67249, November 9, 2000), do not apply                   [Reserved]                                                      Federal flood insurance that is not
                                           to this action. In addition, this action                   (c) Tolerances with regional                                  otherwise generally available from
                                           does not impose any enforceable duty or                  registrations. [Reserved]                                       private insurers. In return, communities
                                           contain any unfunded mandate as                            (d) Indirect or inadvertent residues.                         agree to adopt and administer local
                                           described under Title II of the Unfunded                 [Reserved]                                                      floodplain management measures aimed
                                           Mandates Reform Act (UMRA) (2 U.S.C.                                                                                     at protecting lives and new construction
                                           1501 et seq.).                                           [FR Doc. 2018–27047 Filed 12–12–18; 8:45 am]
                                                                                                                                                                    from future flooding. Section 1315 of
                                                                                                    BILLING CODE 6560–50–P
                                              This action does not involve any                                                                                      the National Flood Insurance Act of
                                           technical standards that would require                                                                                   1968, as amended, 42 U.S.C. 4022,
                                           EPA’s consideration of voluntary                                                                                         prohibits the sale of NFIP flood
                                           consensus standards pursuant to section                  DEPARTMENT OF HOMELAND                                          insurance unless an appropriate public
                                           12(d) of the National Technology                         SECURITY                                                        body adopts adequate floodplain
                                           Transfer and Advancement Act                                                                                             management measures with effective
                                           (NTTAA) (15 U.S.C. 272 note).                            Federal Emergency Management                                    enforcement measures. The
                                                                                                    Agency                                                          communities listed in this document no
                                           V. Congressional Review Act
                                                                                                                                                                    longer meet that statutory requirement
                                             Pursuant to the Congressional Review                   44 CFR Part 64                                                  for compliance with program
                                           Act (5 U.S.C. 801 et seq.), EPA will                     [Docket ID FEMA–2018–0002; Internal                             regulations, 44 CFR part 59.
                                           submit a report containing this rule and                 Agency Docket No. FEMA–8559]                                    Accordingly, the communities will be
                                           other required information to the U.S.                                                                                   suspended on the effective date in the
                                           Senate, the U.S. House of                                Suspension of Community Eligibility                             third column. As of that date, flood
                                           Representatives, and the Comptroller                                                                                     insurance will no longer be available in
                                           General of the United States prior to                    AGENCY:  Federal Emergency
                                                                                                    Management Agency, DHS.                                         the community. We recognize that some
                                           publication of the rule in the Federal                                                                                   of these communities may adopt and
                                           Register. This action is not a ‘‘major                   ACTION: Final rule.                                             submit the required documentation of
                                           rule’’ as defined by 5 U.S.C. 804(2).                                                                                    legally enforceable floodplain
                                                                                                    SUMMARY:    This rule identifies
                                           List of Subjects in 40 CFR Part 180                      communities where the sale of flood                             management measures after this rule is
                                                                                                    insurance has been authorized under                             published but prior to the actual
                                             Environmental protection,                                                                                              suspension date. These communities
                                                                                                    the National Flood Insurance Program
                                           Administrative practice and procedure,                                                                                   will not be suspended and will continue
                                                                                                    (NFIP) that are scheduled for
                                           Agricultural commodities, Pesticides                                                                                     to be eligible for the sale of NFIP flood
                                                                                                    suspension on the effective dates listed
                                           and pests, Reporting and recordkeeping                                                                                   insurance. A notice withdrawing the
                                                                                                    within this rule because of
                                           requirements.                                                                                                            suspension of such communities will be
                                                                                                    noncompliance with the floodplain
                                             Dated: November 28, 2018.                              management requirements of the                                  published in the Federal Register.
                                           Richard P. Keigwin, Jr.,                                 program. If the Federal Emergency                                  In addition, FEMA publishes a Flood
                                           Director, Office of Pesticide Programs.                  Management Agency (FEMA) receives                               Insurance Rate Map (FIRM) that
                                                                                                    documentation that the community has                            identifies the Special Flood Hazard
                                             Therefore, 40 CFR chapter I is                                                                                         Areas (SFHAs) in these communities.
                                           amended as follows:                                      adopted the required floodplain
                                                                                                    management measures prior to the                                The date of the FIRM, if one has been
                                                                                                    effective suspension date given in this                         published, is indicated in the fourth
                                           PART 180—[AMENDED]                                                                                                       column of the table. No direct Federal
                                                                                                    rule, the suspension will not occur and
                                           ■ 1. The authority citation for part 180                 a notice of this will be provided by                            financial assistance (except assistance
                                           continues to read as follows:                            publication in the Federal Register on a                        pursuant to the Robert T. Stafford
                                                                                                    subsequent date. Also, information                              Disaster Relief and Emergency
                                               Authority: 21 U.S.C. 321(q), 346a and 371.                                                                           Assistance Act not in connection with a
                                                                                                    identifying the current participation
                                           ■ 2. Add § 180.703 to subpart C to read                  status of a community can be obtained                           flood) may be provided for construction
                                           as follows:                                              from FEMA’s Community Status Book                               or acquisition of buildings in identified
                                                                                                    (CSB). The CSB is available at https://                         SFHAs for communities not
                                           § 180.703 6-benzyladenine; tolerances for                                                                                participating in the NFIP and identified
                                           residues.                                                www.fema.gov/national-flood-
                                                                                                    insurance-program-community-status-                             for more than a year on FEMA’s initial
                                             (a) General. Tolerances are                            book.                                                           FIRM for the community as having
                                           established for residues of the plant                                                                                    flood-prone areas (section 202(a) of the
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                                           growth regulator, 6-benzyladenine in or                  DATES:  The effective date of each                              Flood Disaster Protection Act of 1973,
                                           on the commodities listed in the table                   community’s scheduled suspension is                             42 U.S.C. 4106(a), as amended). This
                                           below. Compliance with the tolerance                     the third date (‘‘Susp.’’) listed in the                        prohibition against certain types of
                                           levels specified in this paragraph is to                 third column of the following tables.                           Federal assistance becomes effective for
                                           be determined by measuring only 6-                       FOR FURTHER INFORMATION CONTACT: If                             the communities listed on the date
                                           benzyladenine in or on the commodity.                    you want to determine whether a                                 shown in the last column. The


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Document Created: 2018-12-13 01:15:55
Document Modified: 2018-12-13 01:15:55
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 December 13, 2018. Objections and requests for hearings must be received on or before February 11, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactRobert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
FR Citation83 FR 64027 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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