83_FR_46292 83 FR 46115 - Metschnikowia Fructicola Strain NRRLY-27328; Exemption From the Requirement of a Tolerance

83 FR 46115 - Metschnikowia Fructicola Strain NRRLY-27328; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 177 (September 12, 2018)

Page Range46115-46117
FR Document2018-19870

This regulation establishes an exemption from the requirement of a tolerance for residues of Metschnikowia fructicola strain NRRL Y- 27328 in or on the stone fruit group (group 12-12); the small fruit vine climbing subgroup, except fuzzy kiwifruit (subgroup 13-07F); and the low growing berry subgroup (subgroup 13-07G) when used in accordance with label directions and good agricultural practices. Interregional Research Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Metschnikowia fructicola strain NRRL Y-27328 under FFDCA.

Federal Register, Volume 83 Issue 177 (Wednesday, September 12, 2018)
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Rules and Regulations]
[Pages 46115-46117]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19870]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0705; FRL-9982-22]


Metschnikowia Fructicola Strain NRRLY-27328; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Metschnikowia fructicola strain NRRL Y-
27328 in or on the stone fruit group (group 12-12); the small fruit 
vine climbing subgroup, except fuzzy kiwifruit (subgroup 13-07F); and 
the low growing berry subgroup (subgroup 13-07G) when used in 
accordance with label directions and good agricultural practices. 
Interregional Research Project Number 4 (IR-4) submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Metschnikowia fructicola strain NRRL Y-27328 under FFDCA.

DATES: This regulation is effective September 12, 2018. Objections and 
requests for hearings must be received on or before November 13, 2018, 
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) EPA-HQ-OPP-2017-0705, 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: 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: 
BPPDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 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 EPA-HQ-OPP-2017-0705 in the subject line on the first page of 
your submission. All objections and requests for a hearing must be in 
writing, and must be received by the Hearing Clerk on or before 
November 13, 2018. 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-2017-0705, 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

[[Page 46116]]

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 March 21, 2018 (83 FR 12311) (FRL-9974-
76), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 7E8560) by IR-4, Rutgers, The State University of New 
Jersey, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The 
petition requested that 40 CFR part 180 be amended by establishing an 
exemption from the requirement of a tolerance for residues of the 
microbial pesticide Metschnikowia fructicola strain NRRL Y-27328 in or 
on stone fruit group 12-12; small fruit vine climbing, except fuzzy 
kiwifruit subgroup 13-07F; and low growing berry subgroup 13-07G. That 
document referenced a summary of the petition prepared by the 
petitioner IR-4 and available in the docket via http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, 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 
Metschnikowia fructicola strain NRRL Y-27328 and considered their 
validity, completeness, and reliability, as well as the relationship of 
this information to human risk. A full explanation of the data upon 
which EPA relied and its risk assessment based on those data can be 
found within the document entitled ``Federal Food, Drug, and Cosmetic 
Act (FFDCA) Safety Determination for Metschnikowia fructicola strain 
NRRL Y-27328.'' 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 Metschnikowia fructicola 
strain NRRL Y-27328 is not significantly toxic, pathogenic, or 
infective via any route of exposure. Although there may be some 
exposure to residues when Metschnikowia fructicola strain NRRL Y-27328 
is used on certain food commodities in accordance with label directions 
and good agricultural practices, there is a lack of concern due to the 
lack of potential for adverse effects. EPA also determined that 
retention of the Food Quality Protection Act (FQPA) safety factor was 
not necessary as part of the qualitative assessment conducted for 
Metschnikowia fructicola strain NRRL Y-27328.
    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 
Metschnikowia fructicola strain NRRL Y-27328. Therefore, an exemption 
from the requirement of a tolerance is established for residues of 
Metschnikowia fructicola strain NRRL Y-27328 in or on the stone fruit 
group (group 12-12); the small fruit vine climbing subgroup, except 
fuzzy kiwifruit (subgroup 13-07F); and the low growing berry subgroup 
(subgroup 13-07G) when used in accordance with label directions and 
good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required because EPA is establishing an 
exemption from the requirement of a tolerance without any numerical 
limitation.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption 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 
exemption 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 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

[[Page 46117]]

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: August 16, 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.  180.1358 to subpart D to read as follows:


Sec.  180.1358  Metschnikowia fructicola strain NRRL Y-27328; exemption 
from the requirement of a tolerance.

    Residues of Metschnikowia fructicola strain NRRL Y-27328 are exempt 
from the requirement of a tolerance in or on the food commodities 
included in the following crop groups and subgroups when this pesticide 
chemical is used in accordance with label directions and good 
agricultural practices: Fruit, stone group 12-12; Fruit, small fruit 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F; and Berry, low 
growing subgroup 13-07G.

[FR Doc. 2018-19870 Filed 9-11-18; 8:45 am]
 BILLING CODE 6560-50-P



                                                          Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Rules and Regulations                                        46115
                                               2 Program delegated to New Mexico Environment Department (NMED) for standards promulgated by the EPA, as amended in the Federal
                                             Register through January 15, 2017.
                                               3 Program delegated to Albuquerque-Bernalillo County Air Quality Control Board (ABCAQCB) for standards promulgated by the EPA, as
                                             amended in the Federal Register through September 13, 2013.
                                               4 The NMED was previously delegated this subpart on February 9, 2004 (68 FR 69036). The ABCAQCB has adopted the subpart unchanged
                                             and applied for delegation of the standard. The subpart was vacated and remanded to the EPA by the United States Court of Appeals for the
                                             District of Columbia Circuit. See Mossville Environmental Action Network v. EPA, 370 F. 3d 1232 (D.C. Cir. 2004). Because of the D.C. Court’s
                                             holding this subpart is not delegated to NMED or ABCAQCB at this time.
                                               5 This subpart was issued a partial vacatur by the United States Court of Appeals for the District of Columbia Circuit. See 72 FR 61060 (Octo-
                                             ber 29, 2007).
                                               6 Final Rule. See 76 FR (March 21, 2011), as amended at 78 FR 7138 (January 31, 2013); 80 FR 72807 (November 20, 2015). Note that the
                                             ABCAQCB has not yet applied for updated delegation of these standards.
                                               7 Final Promulgated Rule adopted by the EPA. See 80 FR 65470 (October 26, 2015). Note that Part 63 Subpart KKKKK was amended to cor-
                                             rect minor typographical errors. See 80 FR 75817 (December 4, 2015). Note that the ABCAQCB has not yet applied for updated delegation of
                                             these standards.
                                               8 Final Rule. See 77 FR 9304 (February 16, 2012), as amended 81 FR 20172 (April 6, 2016). Final Supplemental Finding that it is appropriate
                                             and necessary to regulate HAP emissions from Coal- and Oil-fired EUSGU Units. See 81 FR 24420 (April 25, 2016). Note that the ABCAQCB
                                             has not yet applied for updated delegation of these standards.


                                             *      *     *       *      *                           Environmental Protection Agency                       gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfr
                                             [FR Doc. 2018–19801 Filed 9–11–18; 8:45 am]             Docket Center (EPA/DC), West William                  browse/Title40/40tab_02.tpl.
                                             BILLING CODE 6560–50–P                                  Jefferson Clinton Bldg., Rm. 3334, 1301
                                                                                                                                                           C. How can I file an objection or hearing
                                                                                                     Constitution Ave. NW, Washington, DC
                                                                                                                                                           request?
                                                                                                     20460–0001. The Public Reading Room
                                             ENVIRONMENTAL PROTECTION                                is open from 8:30 a.m. to 4:30 p.m.,                    Under FFDCA section 408(g), 21
                                             AGENCY                                                  Monday through Friday, excluding legal                U.S.C. 346a(g), any person may file an
                                                                                                     holidays. The telephone number for the                objection to any aspect of this regulation
                                             40 CFR Part 180                                         Public Reading Room is (202) 566–1744,                and may also request a hearing on those
                                             [EPA–HQ–OPP–2017–0705; FRL–9982–22]                     and the telephone number for the OPP                  objections. You must file your objection
                                                                                                     Docket is (703) 305–5805. Please review               or request a hearing on this regulation
                                             Metschnikowia Fructicola Strain                         the visitor instructions and additional               in accordance with the instructions
                                             NRRLY–27328; Exemption From the                         information about the docket available                provided in 40 CFR part 178. To ensure
                                             Requirement of a Tolerance                              at http://www.epa.gov/dockets.                        proper receipt by EPA, you must
                                             AGENCY:  Environmental Protection                       FOR FURTHER INFORMATION CONTACT:                      identify docket ID EPA–HQ–OPP–2017–
                                             Agency (EPA).                                           Robert McNally, Biopesticides and                     0705 in the subject line on the first page
                                                                                                     Pollution Prevention Division (7511P),                of your submission. All objections and
                                             ACTION: Final rule.
                                                                                                     Office of Pesticide Programs,                         requests for a hearing must be in
                                             SUMMARY:   This regulation establishes an               Environmental Protection Agency, 1200                 writing, and must be received by the
                                             exemption from the requirement of a                     Pennsylvania Ave. NW, Washington, DC                  Hearing Clerk on or before November
                                             tolerance for residues of Metschnikowia                 20460–0001; main telephone number:                    13, 2018. Addresses for mail and hand
                                             fructicola strain NRRL Y–27328 in or on                 (703) 305–7090; email address:                        delivery of objections and hearing
                                             the stone fruit group (group 12–12); the                BPPDFRNotices@epa.gov.                                requests are provided in 40 CFR
                                             small fruit vine climbing subgroup,                     SUPPLEMENTARY INFORMATION:                            178.25(b).
                                             except fuzzy kiwifruit (subgroup 13–                                                                            In addition to filing an objection or
                                             07F); and the low growing berry                         I. General Information                                hearing request with the Hearing Clerk
                                             subgroup (subgroup 13–07G) when used                    A. Does this action apply to me?                      as described in 40 CFR part 178, please
                                             in accordance with label directions and                                                                       submit a copy of the filing (excluding
                                             good agricultural practices. Interregional                 You may be potentially affected by                 any Confidential Business Information
                                             Research Project Number 4 (IR–4)                        this action if you are an agricultural                (CBI)) for inclusion in the public docket.
                                             submitted a petition to EPA under the                   producer, food manufacturer, or                       Information not marked confidential
                                             Federal Food, Drug, and Cosmetic Act                    pesticide manufacturer. The following                 pursuant to 40 CFR part 2 may be
                                             (FFDCA), requesting an exemption from                   list of North American Industrial                     disclosed publicly by EPA without prior
                                             the requirement of a tolerance. This                    Classification System (NAICS) codes is                notice. Submit the non-CBI copy of your
                                             regulation eliminates the need to                       not intended to be exhaustive, but rather             objection or hearing request, identified
                                             establish a maximum permissible level                   provides a guide to help readers                      by docket ID number EPA–HQ–OPP–
                                             for residues of Metschnikowia fructicola                determine whether this document                       2017–0705, by one of the following
                                             strain NRRL Y–27328 under FFDCA.                        applies to them. Potentially affected                 methods:
                                             DATES: This regulation is effective
                                                                                                     entities may include:                                   • Federal eRulemaking Portal: http://
                                                                                                        • Crop production (NAICS code 111).
                                             September 12, 2018. Objections and                         • Animal production (NAICS code                    www.regulations.gov. Follow the online
                                             requests for hearings must be received                  112).                                                 instructions for submitting comments.
                                             on or before November 13, 2018, and                        • Food manufacturing (NAICS code                   Do not submit electronically any
                                             must be filed in accordance with the                    311).                                                 information you consider to be CBI or
                                             instructions provided in 40 CFR part                       • Pesticide manufacturing (NAICS                   other information whose disclosure is
                                             178 (see also Unit I.C. of the                          code 32532).                                          restricted by statute.
                                             SUPPLEMENTARY INFORMATION).                                                                                     • Mail: OPP Docket, Environmental
daltland on DSKBBV9HB2PROD with RULES




                                             ADDRESSES: The docket for this action,                  B. How can I get electronic access to                 Protection Agency Docket Center (EPA/
                                             identified by docket identification (ID)                other related information?                            DC), (28221T), 1200 Pennsylvania Ave.
                                             EPA–HQ–OPP–2017–0705, is available                        You may access a frequently updated                 NW, Washington, DC 20460–0001.
                                             at http://www.regulations.gov or at the                 electronic version of 40 CFR part 180                   • Hand Delivery: To make special
                                             Office of Pesticide Programs Regulatory                 through the Government Printing                       arrangements for hand delivery or
                                             Public Docket (OPP Docket) in the                       Office’s e-CFR site at http://www.ecfr.               delivery of boxed information, please


                                        VerDate Sep<11>2014   16:01 Sep 11, 2018   Jkt 244001   PO 00000   Frm 00047   Fmt 4700   Sfmt 4700   E:\FR\FM\12SER1.SGM   12SER1


                                             46116        Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Rules and Regulations

                                             follow the instructions at http://                      residue . . . .’’ Additionally, FFDCA                 IV. Statutory and Executive Order
                                             www.epa.gov/dockets/contacts.html.                      section 408(b)(2)(D) requires that EPA                Reviews
                                             Additional instructions on commenting                   consider ‘‘available information                         This action establishes a tolerance
                                             or visiting the docket, along with more                 concerning the cumulative effects of a                exemption under FFDCA section 408(d)
                                             information about dockets generally, is                 particular pesticide’s residues and other             in response to a petition submitted to
                                             available at http://www.epa.gov/                        substances that have a common                         EPA. The Office of Management and
                                             dockets.                                                mechanism of toxicity.’’                              Budget (OMB) has exempted these types
                                             II. Background                                             EPA evaluated the available                        of actions from review under Executive
                                                                                                     toxicological and exposure data on                    Order 12866, entitled ‘‘Regulatory
                                                In the Federal Register of March 21,                 Metschnikowia fructicola strain NRRL                  Planning and Review’’ (58 FR 51735,
                                             2018 (83 FR 12311) (FRL–9974–76),                       Y–27328 and considered their validity,                October 4, 1993). Because this action
                                             EPA issued a document pursuant to                       completeness, and reliability, as well as             has been exempted from review under
                                             FFDCA section 408(d)(3), 21 U.S.C.                      the relationship of this information to               Executive Order 12866, this action is
                                             346a(d)(3), announcing the filing of a                  human risk. A full explanation of the                 not subject to Executive Order 13211,
                                             pesticide tolerance petition (PP 7E8560)                data upon which EPA relied and its risk               entitled ‘‘Actions Concerning
                                             by IR–4, Rutgers, The State University of               assessment based on those data can be                 Regulations That Significantly Affect
                                             New Jersey, 500 College Rd. East, Suite                 found within the document entitled                    Energy Supply, Distribution, or Use’’ (66
                                             201 W, Princeton, NJ 08540. The                         ‘‘Federal Food, Drug, and Cosmetic Act                FR 28355, May 22, 2001), or Executive
                                             petition requested that 40 CFR part 180                 (FFDCA) Safety Determination for                      Order 13045, entitled ‘‘Protection of
                                             be amended by establishing an                           Metschnikowia fructicola strain NRRL                  Children from Environmental Health
                                             exemption from the requirement of a                     Y–27328.’’ This document, as well as                  Risks and Safety Risks’’ (62 FR 19885,
                                             tolerance for residues of the microbial                 other relevant information, is available              April 23, 1997) nor is it considered a
                                             pesticide Metschnikowia fructicola                      in the docket for this action as described            regulatory action under Executive Order
                                             strain NRRL Y–27328 in or on stone                      under ADDRESSES.                                      13771, entitled ‘‘Reducing Regulations
                                             fruit group 12–12; small fruit vine                        The available data demonstrated that               and Controlling Regulatory Costs’’ (82
                                             climbing, except fuzzy kiwifruit                        Metschnikowia fructicola strain NRRL                  FR 9339, February 3, 2017). This action
                                             subgroup 13–07F; and low growing                        Y–27328 is not significantly toxic,                   does not contain any information
                                             berry subgroup 13–07G. That document                    pathogenic, or infective via any route of             collections subject to OMB approval
                                             referenced a summary of the petition                    exposure. Although there may be some                  under the Paperwork Reduction Act
                                             prepared by the petitioner IR–4 and                     exposure to residues when                             (PRA), 44 U.S.C. 3501 et seq., nor does
                                             available in the docket via http://                     Metschnikowia fructicola strain NRRL                  it require any special considerations
                                             www.regulations.gov. There were no                      Y–27328 is used on certain food                       under Executive Order 12898, entitled
                                             comments received in response to the                    commodities in accordance with label                  ‘‘Federal Actions to Address
                                             notice of filing.                                       directions and good agricultural                      Environmental Justice in Minority
                                             III. Final Rule                                         practices, there is a lack of concern due             Populations and Low-Income
                                                                                                     to the lack of potential for adverse                  Populations’’ (59 FR 7629, February 16,
                                             A. EPA’s Safety Determination                           effects. EPA also determined that                     1994).
                                                Section 408(c)(2)(A)(i) of FFDCA                     retention of the Food Quality Protection                 Since tolerances and exemptions that
                                             allows EPA to establish an exemption                    Act (FQPA) safety factor was not                      are established on the basis of a petition
                                             from the requirement of a tolerance (the                necessary as part of the qualitative                  under FFDCA section 408(d), such as
                                             legal limit for a pesticide chemical                    assessment conducted for                              the tolerance exemption in this action,
                                             residue in or on a food) only if EPA                    Metschnikowia fructicola strain NRRL                  do not require the issuance of a
                                             determines that the exemption is ‘‘safe.’’              Y–27328.                                              proposed rule, the requirements of the
                                             Section 408(c)(2)(A)(ii) of FFDCA                          Based upon its evaluation, EPA                     Regulatory Flexibility Act (RFA) (5
                                             defines ‘‘safe’’ to mean that ‘‘there is a              concludes that there is a reasonable                  U.S.C. 601 et seq.) do not apply.
                                             reasonable certainty that no harm will                  certainty that no harm will result to the                This action directly regulates growers,
                                             result from aggregate exposure to the                   U.S. population, including infants and                food processors, food handlers, and food
                                             pesticide chemical residue, including                   children, from aggregate exposure to                  retailers, not States or tribes. As a result,
                                             all anticipated dietary exposures and all               residues of Metschnikowia fructicola                  this action does not alter the
                                             other exposures for which there is                      strain NRRL Y–27328. Therefore, an                    relationships or distribution of power
                                             reliable information.’’ This includes                   exemption from the requirement of a                   and responsibilities established by
                                             exposure through drinking water and in                  tolerance is established for residues of              Congress in the preemption provisions
                                             residential settings but does not include               Metschnikowia fructicola strain NRRL                  of FFDCA section 408(n)(4). As such,
                                             occupational exposure. Pursuant to                      Y–27328 in or on the stone fruit group                EPA has determined that this action will
                                             FFDCA section 408(c)(2)(B), in                          (group 12–12); the small fruit vine                   not have a substantial direct effect on
                                             establishing or maintaining in effect an                climbing subgroup, except fuzzy                       States or tribal governments, on the
                                             exemption from the requirement of a                     kiwifruit (subgroup 13–07F); and the                  relationship between the national
                                             tolerance, EPA must take into account                   low growing berry subgroup (subgroup                  government and the States or tribal
                                             the factors set forth in FFDCA section                  13–07G) when used in accordance with                  governments, or on the distribution of
                                             408(b)(2)(C), which require EPA to give                 label directions and good agricultural                power and responsibilities among the
                                             special consideration to exposure of                    practices.                                            various levels of government or between
                                             infants and children to the pesticide                                                                         the Federal Government and Indian
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                                                                                                     B. Analytical Enforcement Methodology
                                             chemical residue in establishing a                                                                            tribes. Thus, EPA has determined that
                                             tolerance or tolerance exemption and to                   An analytical method is not required                Executive Order 13132, entitled
                                             ‘‘ensure that there is a reasonable                     because EPA is establishing an                        ‘‘Federalism’’ (64 FR 43255, August 10,
                                             certainty that no harm will result to                   exemption from the requirement of a                   1999), and Executive Order 13175,
                                             infants and children from aggregate                     tolerance without any numerical                       entitled ‘‘Consultation and Coordination
                                             exposure to the pesticide chemical                      limitation.                                           with Indian Tribal Governments’’ (65 FR


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                                                          Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Rules and Regulations                                          46117

                                             67249, November 9, 2000), do not apply                  ENVIRONMENTAL PROTECTION                              Friday: 9:00 a.m.–5:00 p.m., Saturday
                                             to this action. In addition, this action                AGENCY                                                and Sunday—Closed.
                                             does not impose any enforceable duty or                                                                          Southington Public Library, 255 Main
                                             contain any unfunded mandate as                         40 CFR Part 300                                       Street, Southington, CT, Phone: 860–
                                             described under Title II of the Unfunded                                                                      628–0947, Hours: Monday–Thursday
                                                                                                     [EPA–HQ–SFUND–2005–0011; FRL–9983–                    9:00 a.m.–9:00 p.m., Friday–Saturday
                                             Mandates Reform Act (UMRA) (2 U.S.C.                    63—Region 1]
                                             1501 et seq.).                                                                                                9:00 a.m.–5:00 p.m., and Sunday
                                                                                                     National Oil and Hazardous                            Closed.
                                               This action does not involve any
                                             technical standards that would require                  Substances Pollution Contingency                      FOR FURTHER INFORMATION CONTACT:
                                             EPA’s consideration of voluntary                        Plan; National Priorities List: Deletion              Almerinda Silva, Remedial Project
                                             consensus standards pursuant to section                 of the Old Southington Landfill                       Manager, U.S. Environmental Protection
                                             12(d) of the National Technology                        Superfund Site                                        Agency, Region I, OSRR 07–4, 5 Post
                                             Transfer and Advancement Act                                                                                  Office Square, Boston, MA 02109–3912.
                                                                                                     AGENCY:  Environmental Protection                     Telephone (617) 918–1246, Email
                                             (NTTAA) (15 U.S.C. 272 note).                           Agency.                                               silva.almerinda@epa.gov.
                                             V. Congressional Review Act                             ACTION: Final rule.                                   SUPPLEMENTARY INFORMATION: The site to
                                               Pursuant to the Congressional Review                                                                        be deleted from the NPL is: the Old
                                                                                                     SUMMARY:    The Environmental Protection
                                             Act (5 U.S.C. 801 et seq.), EPA will                                                                          Southington Landfill Superfund Site
                                                                                                     Agency (EPA) Region 1 announces the
                                                                                                                                                           located at Old Turnpike Road,
                                             submit a report containing this rule and                deletion of the Old Southington Landfill
                                                                                                                                                           Southington, Connecticut. A Notice of
                                             other required information to the U.S.                  Superfund Site (Site) located in
                                                                                                                                                           Intent to Delete for this Site was
                                             Senate, the U.S. House of                               Southington, Connecticut, from the
                                                                                                                                                           published in the Federal Register (83
                                             Representatives, and the Comptroller                    National Priorities List (NPL). The NPL,
                                                                                                                                                           FR 34513) on July 20, 2018.
                                             General of the United States prior to                   promulgated pursuant to Section 105 of                   The closing date for comments on the
                                             publication of the rule in the Federal                  the Comprehensive Environmental                       Notice of Intent to Delete was August
                                             Register. This action is not a ‘‘major                  Response, Compensation, and Liability                 20, 2018. No public comments were
                                             rule’’ as defined by 5 U.S.C. 804(2).                   Act (CERCLA) of 1980, as amended, is                  received. Therefore, a responsiveness
                                                                                                     an appendix of the National Oil and                   summary was not prepared and not
                                             List of Subjects in 40 CFR Part 180                     Hazardous Substances Pollution                        placed in the docket, EPA–HQ–SFUND–
                                               Environmental protection,                             Contingency Plan (NCP). The EPA and                   2005–0011, on www.regulations.gov, nor
                                             Administrative practice and procedure,                  the State of Connecticut, through the                 in the local repositories listed above.
                                             Agricultural commodities, Pesticides                    Connecticut Department of Energy and                  EPA still believes the deletion action is
                                             and pests, Reporting and recordkeeping                  Environmental Protection (CTDEEP),                    still appropriate.
                                             requirements.                                           have determined that all appropriate                     EPA maintains the NPL as the list of
                                                                                                     response actions under CERCLA, other                  sites that appear to present a significant
                                               Dated: August 16, 2018.                               than operation and maintenance,                       risk to public health, welfare, or the
                                             Richard P. Keigwin, Jr.,                                monitoring, and five-year reviews, have               environment. Deletion from the NPL
                                             Director, Office of Pesticide Programs.                 been completed. However, this deletion                does not preclude further remedial
                                                                                                     does not preclude future actions under                action. Whenever there is a significant
                                               Therefore, 40 CFR chapter I is                        Superfund.                                            release from a site deleted from the NPL,
                                             amended as follows:                                     DATES: This action is effective                       the deleted site may be restored to the
                                                                                                     September 12, 2018.                                   NPL without application of the hazard
                                             PART 180—[AMENDED]
                                                                                                     ADDRESSES:                                            ranking system. Deletion of a site from
                                                                                                        Docket: EPA has established a docket               the NPL does not affect responsible
                                             ■ 1. The authority citation for part 180
                                                                                                     for this action under Docket                          party liability in the unlikely event that
                                             continues to read as follows:
                                                                                                     Identification No. EPA–HQ–SFUND–                      future conditions warrant further
                                                 Authority: 21 U.S.C. 321(q), 346a and 371.          2005–0011. All documents in the docket                actions.
                                                                                                     are listed on the http://                             List of Subjects in 40 CFR Part 300
                                             ■ 2. Add § 180.1358 to subpart D to read                www.regulations.gov website. Although
                                             as follows:                                             listed in the index, some information is                Environmental protection, Air
                                                                                                     not publicly available, i.e., Confidential            pollution control, Chemicals, Hazardous
                                             § 180.1358 Metschnikowia fructicola strain
                                             NRRL Y–27328; exemption from the                        Business Information or other                         substances, Hazardous waste,
                                             requirement of a tolerance.                             information whose disclosure is                       Intergovernmental relations, Penalties,
                                                                                                     restricted by statute. Certain other                  Reporting and recordkeeping
                                                Residues of Metschnikowia fructicola                 material, such as copyrighted material,               requirements, Superfund, Water
                                             strain NRRL Y–27328 are exempt from                     is not placed on the internet and will be             pollution control, and Water supply.
                                             the requirement of a tolerance in or on                 publicly available only in hard copy                    Dated: September 4, 2018.
                                             the food commodities included in the                    form. Publicly available docket                       Alexandra Dapolito Dunn,
                                             following crop groups and subgroups                     materials are available either                        Regional Administrator, Region 1.
                                             when this pesticide chemical is used in                 electronically through http://
                                             accordance with label directions and                                                                            For reasons set out in the preamble,
                                                                                                     www.regulations.gov or in hard copy at
                                             good agricultural practices: Fruit, stone                                                                     40 CFR part 300 is amended as follows:
                                                                                                     the Site information repositories.
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                                             group 12–12; Fruit, small fruit vine                    Locations, contacts, phone numbers and
                                             climbing, except fuzzy kiwifruit,                                                                             PART 300—NATIONAL OIL AND
                                                                                                     viewing hours are:                                    HAZARDOUS SUBSTANCES
                                             subgroup 13–07F; and Berry, low                            U.S. EPA Region 1—New England,
                                             growing subgroup 13–07G.                                                                                      POLLUTION CONTINGENCY PLAN
                                                                                                     Superfund Records Center, 5 Post Office
                                             [FR Doc. 2018–19870 Filed 9–11–18; 8:45 am]             Square, Suite 100, Boston, MA 02109,                  ■ 1. The authority citation for part 300
                                             BILLING CODE 6560–50–P                                  Phone: 617–918–1440, Hours: Monday–                   continues to read as follows:


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Document Created: 2018-09-12 02:06:20
Document Modified: 2018-09-12 02:06:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective September 12, 2018. Objections and requests for hearings must be received on or before November 13, 2018, 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 46115 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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