83_FR_47255 83 FR 47074 - Beauveria bassiana Strain PPRI 5339; Exemption From the Requirement of a Tolerance

83 FR 47074 - Beauveria bassiana Strain PPRI 5339; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 181 (September 18, 2018)

Page Range47074-47076
FR Document2018-20285

This regulation establishes an exemption from the requirement of a tolerance for residues of Beauveria bassiana strain PPRI 5339 in or on all food commodities when this pesticide chemical is used in accordance with label directions and good agricultural practices. BASF Corporation 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 Beauveria bassiana strain PPRI 5339 in or on all food commodities under FFDCA.

Federal Register, Volume 83 Issue 181 (Tuesday, September 18, 2018)
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Rules and Regulations]
[Pages 47074-47076]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20285]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0608; FRL-9983-67]


Beauveria bassiana Strain PPRI 5339; 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 Beauveria bassiana strain PPRI 5339 in 
or on all food commodities when this pesticide chemical is used in 
accordance with label directions and good agricultural practices. BASF 
Corporation 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 Beauveria bassiana strain 
PPRI 5339 in or on all food commodities under FFDCA.

DATES: This regulation is effective September 18, 2018. Objections and 
requests for hearings must be received on or before November 19, 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) number EPA-HQ-OPP-2016-0608, 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: 
[email protected].

[[Page 47075]]


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-2016-0608 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 19, 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-2016-0608, 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 December 20, 2016 (81 FR 92758) (FRL-
9956-04), 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 6F8485) by BASF Corporation, 26 Davis Dr., Research 
Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of the insecticide Beauveria bassiana strain 
PPRI 5339 in or on all food commodities. That document referenced a 
summary of the petition prepared by the petitioner BASF Corporation 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 
Beauveria bassiana strain PPRI 5339 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 Beauveria bassiana strain PPRI 5339'' 
(Safety Determination). 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 Beauveria bassiana strain PPRI 
5339 is not toxic, pathogenic, or infective through most of the routes 
of exposure, except through inhalation where it is highly toxic by 
itself (100% active ingredient). When Beauveria bassiana strain PPRI 
5339 is combined with an oil and its concentration is decreased (8% 
active ingredient), however, data demonstrated it is not toxic through 
inhalation. Although there may be some exposure to residues when 
Beauveria bassiana strain PPRI 5339 is used on food commodities in 
accordance with label directions and good agricultural practices, there 
is a lack of concern due to the lack of toxicity from dietary exposure 
to Beauveria bassiana strain PPRI 5339. There are no residential uses 
currently associated with Beauveria bassiana strain PPRI 5339. In the 
event residential uses may be sought in the future, those exposures 
would not be aggregated with the dietary exposure due to the difference 
in toxic effects. Moreover, EPA intends to mitigate the potential for 
inhalation risk through terms on any associated registration(s). EPA 
also determined in the Safety Determination that retention of the Food 
Quality Protection Act (FQPA) safety factor was not necessary as part 
of the qualitative assessment conducted for Beauveria bassiana strain 
PPRI 5339.
    Based upon its evaluation in the Safety Determination, EPA 
concludes that there is a reasonable certainty that

[[Page 47076]]

no harm will result to the U.S. population, including infants and 
children, from aggregate exposure to residues of Beauveria bassiana 
strain PPRI 5339. Therefore, an exemption from the requirement of a 
tolerance is established for residues of Beauveria bassiana strain PPRI 
5339 in or on all food commodities when this pesticide chemical is 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 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: September 7, 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.  180.1362 to subpart D to read as follows:


Sec.  180.1362  Beauveria bassiana strain PPRI 5339; exemption from the 
requirement of a tolerance.

    Residues of Beauveria bassiana strain PPRI 5339 are exempt from the 
requirement of a tolerance in or on all food commodities when this 
pesticide chemical is used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2018-20285 Filed 9-17-18; 8:45 am]
 BILLING CODE 6560-50-P



                                             47074            Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations

                                             of Management and Budget under                          U.S. Senate, the U.S. House of                        ENVIRONMENTAL PROTECTION
                                             Executive Orders 12866 (58 FR 51735,                    Representatives, and the Comptroller                  AGENCY
                                             October 4, 1993) and 13563 (76 FR 3821,                 General of the United States prior to
                                             January 21, 2011);                                      publication of the rule in the Federal                40 CFR Part 180
                                                • is not an Executive Order 13771 (82                Register. A major rule cannot take effect             [EPA–HQ–OPP–2016–0608; FRL–9983–67]
                                             FR 9339, February 2, 2017) regulatory                   until 60 days after it is published in the
                                             action because actions such as SIP                      Federal Register. This action is not a                Beauveria bassiana Strain PPRI 5339;
                                             approvals are exempted under                            ‘‘major rule’’ as defined by 5 U.S.C.                 Exemption From the Requirement of a
                                             Executive Order 12866;                                  804(2).                                               Tolerance
                                                • does not impose an information
                                                                                                       Under section 307(b)(1) of the Clean                AGENCY:  Environmental Protection
                                             collection burden under the provisions
                                                                                                     Air Act, petitions for judicial review of             Agency (EPA).
                                             of the Paperwork Reduction Act (44
                                                                                                     this action must be filed in the United
                                             U.S.C. 3501 et seq.);                                                                                         ACTION: Final rule.
                                                • is certified as not having a                       States Court of Appeals for the
                                             significant economic impact on a                        appropriate circuit by November 19,                   SUMMARY:   This regulation establishes an
                                             substantial number of small entities                    2018. Filing a petition for                           exemption from the requirement of a
                                             under the Regulatory Flexibility Act (5                 reconsideration by the Administrator of               tolerance for residues of Beauveria
                                             U.S.C. 601 et seq.);                                    this final rule does not affect the finality          bassiana strain PPRI 5339 in or on all
                                                • does not contain any unfunded                      of this action for the purposes of judicial           food commodities when this pesticide
                                             mandate or significantly or uniquely                    review nor does it extend the time                    chemical is used in accordance with
                                             affect small governments, as described                  within which a petition for judicial                  label directions and good agricultural
                                             in the Unfunded Mandates Reform Act                     review may be filed, and shall not                    practices. BASF Corporation submitted
                                             of 1995 (Pub. L. 104–4);                                postpone the effectiveness of such rule               a petition to EPA under the Federal
                                                • does not have Federalism                           or action. This action may not be                     Food, Drug, and Cosmetic Act (FFDCA),
                                             implications as specified in Executive                  challenged later in proceedings to                    requesting an exemption from the
                                             Order 13132 (64 FR 43255, August 10,                    enforce its requirements (See section                 requirement of a tolerance. This
                                             1999);                                                  307(b)(2)).                                           regulation eliminates the need to
                                                • is not an economically significant                 List of Subjects in 40 CFR Part 52                    establish a maximum permissible level
                                             regulatory action based on health or                                                                          for residues of Beauveria bassiana strain
                                             safety risks subject to Executive Order                   Environmental protection, Air                       PPRI 5339 in or on all food commodities
                                             13045 (62 FR 19885, April 23, 1997);                    pollution control, Carbon monoxide,                   under FFDCA.
                                                • is not a significant regulatory action             Incorporation by reference,                           DATES: This regulation is effective
                                             subject to Executive Order 13211 (66 FR                 Intergovernmental relations, Lead,                    September 18, 2018. Objections and
                                             28355, May 22, 2001);                                   Nitrogen dioxide, Ozone, Particulate                  requests for hearings must be received
                                                • is not subject to requirements of                  matter, Reporting and recordkeeping                   on or before November 19, 2018, and
                                             Section 12(d) of the National                           requirements, Sulfur oxides, Volatile                 must be filed in accordance with the
                                             Technology Transfer and Advancement                     organic compounds.                                    instructions provided in 40 CFR part
                                             Act of 1995 (15 U.S.C. 272 note) because                                                                      178 (see also Unit I.C. of the
                                                                                                         Authority: 42 U.S.C. 7401 et seq.
                                             this action does not involve technical                                                                        SUPPLEMENTARY INFORMATION).
                                             standards; and                                            Dated: September 5, 2018.
                                                • does not provide the EPA with the                                                                        ADDRESSES: The docket for this action,
                                                                                                     Chris Hladick,
                                             discretionary authority to address, as                                                                        identified by docket identification (ID)
                                                                                                     Regional Administrator, Region 10.
                                             appropriate, disproportionate human                                                                           number EPA–HQ–OPP–2016–0608, is
                                             health or environmental effects, using                      40 CFR part 52 is amended as follows:             available at http://www.regulations.gov
                                             practicable and legally permissible                                                                           or at the Office of Pesticide Programs
                                             methods, under Executive Order 12898                    PART 52—APPROVAL AND                                  Regulatory Public Docket (OPP Docket)
                                             (59 FR 7629, February 16, 1994).                        PROMULGATION OF                                       in the Environmental Protection Agency
                                                The SIP is not approved to apply on                  IMPLEMENTATION PLANS                                  Docket Center (EPA/DC), West William
                                             any Indian reservation land and is also                                                                       Jefferson Clinton Bldg., Rm. 3334, 1301
                                             not approved to apply in any other area                 ■ 1. The authority citation for Part 52               Constitution Ave. NW, Washington, DC
                                             where the EPA or an Indian tribe has                    continues to read as follows:                         20460–0001. The Public Reading Room
                                             demonstrated that a tribe has                                                                                 is open from 8:30 a.m. to 4:30 p.m.,
                                                                                                         Authority: 42 U.S.C. 7401 et seq.
                                             jurisdiction. In those areas of Indian                                                                        Monday through Friday, excluding legal
                                             country, the rule does not have tribal                  Subpart MM—Oregon                                     holidays. The telephone number for the
                                             implications as specified by Executive                                                                        Public Reading Room is (202) 566–1744,
                                             Order 13175 (65 FR 67249, November 9,                                                                         and the telephone number for the OPP
                                                                                                     ■ 2. Section 52.1992 is added to read as
                                             2000).                                                                                                        Docket is (703) 305–5805. Please review
                                                                                                     follows:
                                                The Congressional Review Act, 5                                                                            the visitor instructions and additional
                                             U.S.C. 801 et seq., as added by the Small               § 52.1992 Interstate Transport for the 2012           information about the docket available
                                             Business Regulatory Enforcement                         PM2.5 NAAQS.                                          at http://www.epa.gov/dockets.
                                             Fairness Act of 1996, generally provides                  (a) The EPA approves Oregon’s SIP                   FOR FURTHER INFORMATION CONTACT:
                                             that before a rule may take effect, the                 revision submitted on October 20, 2015,               Robert McNally, Biopesticides and
                                             agency promulgating the rule must                                                                             Pollution Prevention Division (7511P),
daltland on DSKBBV9HB2PROD with RULES




                                                                                                     addressing the requirements of CAA
                                             submit a rule report, which includes a                  section 110(a)(2)(D)(i)(I) for the 2012               Office of Pesticide Programs,
                                             copy of the rule, to each House of the                  PM2.5 NAAQS.                                          Environmental Protection Agency, 1200
                                             Congress and to the Comptroller General                                                                       Pennsylvania Ave. NW, Washington, DC
                                             of the United States. The EPA will                        (b) [Reserved]                                      20460–0001; main telephone number:
                                             submit a report containing this action                  [FR Doc. 2018–20172 Filed 9–17–18; 8:45 am]           (703) 305–7090; email address:
                                             and other required information to the                   BILLING CODE 6560–50–P                                BPPDFRNotices@epa.gov.


                                        VerDate Sep<11>2014   18:11 Sep 17, 2018   Jkt 244001   PO 00000   Frm 00048   Fmt 4700   Sfmt 4700   E:\FR\FM\18SER1.SGM   18SER1


                                                              Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations                                      47075

                                             SUPPLEMENTARY INFORMATION:                              instructions for submitting comments.                 infants and children to the pesticide
                                                                                                     Do not submit electronically any                      chemical residue in establishing a
                                             I. General Information
                                                                                                     information you consider to be CBI or                 tolerance or tolerance exemption and to
                                             A. Does this action apply to me?                        other information whose disclosure is                 ‘‘ensure that there is a reasonable
                                                You may be potentially affected by                   restricted by statute.                                certainty that no harm will result to
                                             this action if you are an agricultural                    • Mail: OPP Docket, Environmental                   infants and children from aggregate
                                             producer, food manufacturer, or                         Protection Agency Docket Center (EPA/                 exposure to the pesticide chemical
                                             pesticide manufacturer. The following                   DC), (28221T), 1200 Pennsylvania Ave.                 residue. . . .’’ Additionally, FFDCA
                                             list of North American Industrial                       NW, Washington, DC 20460–0001.                        section 408(b)(2)(D) requires that EPA
                                             Classification System (NAICS) codes is                    • Hand Delivery: To make special                    consider ‘‘available information
                                             not intended to be exhaustive, but rather               arrangements for hand delivery or                     concerning the cumulative effects of [a
                                             provides a guide to help readers                        delivery of boxed information, please                 particular pesticide’s] . . . residues and
                                             determine whether this document                         follow the instructions at http://                    other substances that have a common
                                             applies to them. Potentially affected                   www.epa.gov/dockets/contacts.html.                    mechanism of toxicity.’’
                                             entities may include:                                   Additional instructions on commenting                    EPA evaluated the available
                                                • Crop production (NAICS code 111).                  or visiting the docket, along with more               toxicological and exposure data on
                                                • Animal production (NAICS code                      information about dockets generally, is               Beauveria bassiana strain PPRI 5339
                                             112).                                                   available at http://www.epa.gov/                      and considered their validity,
                                                • Food manufacturing (NAICS code                     dockets.                                              completeness, and reliability, as well as
                                             311).                                                                                                         the relationship of this information to
                                                • Pesticide manufacturing (NAICS                     II. Background                                        human risk. A full explanation of the
                                             code 32532).                                              In the Federal Register of December                 data upon which EPA relied and its risk
                                                                                                     20, 2016 (81 FR 92758) (FRL–9956–04),                 assessment based on those data can be
                                             B. How can I get electronic access to                                                                         found within the document entitled
                                                                                                     EPA issued a document pursuant to
                                             other related information?                                                                                    ‘‘Federal Food, Drug, and Cosmetic Act
                                                                                                     FFDCA section 408(d)(3), 21 U.S.C.
                                               You may access a frequently updated                   346a(d)(3), announcing the filing of a                (FFDCA) Safety Determination for
                                             electronic version of 40 CFR part 180                   pesticide tolerance petition (PP 6F8485)              Beauveria bassiana strain PPRI 5339’’
                                             through the Government Printing                         by BASF Corporation, 26 Davis Dr.,                    (Safety Determination). This document,
                                             Office’s e-CFR site at http://www.ecfr.                 Research Triangle Park, NC 27709. The                 as well as other relevant information, is
                                             gov/cgi-bin/text-idx?&c=ecfr&tpl=/                      petition requested that 40 CFR part 180               available in the docket for this action as
                                             ecfrbrowse/Title40/40tab_02.tpl.                        be amended by establishing an                         described under ADDRESSES.
                                                                                                     exemption from the requirement of a                      The available data demonstrated that
                                             C. How can I file an objection or hearing
                                                                                                     tolerance for residues of the insecticide             Beauveria bassiana strain PPRI 5339 is
                                             request?
                                                                                                     Beauveria bassiana strain PPRI 5339 in                not toxic, pathogenic, or infective
                                               Under FFDCA section 408(g), 21                                                                              through most of the routes of exposure,
                                                                                                     or on all food commodities. That
                                             U.S.C. 346a(g), any person may file an                                                                        except through inhalation where it is
                                                                                                     document referenced a summary of the
                                             objection to any aspect of this regulation                                                                    highly toxic by itself (100% active
                                                                                                     petition prepared by the petitioner
                                             and may also request a hearing on those                                                                       ingredient). When Beauveria bassiana
                                                                                                     BASF Corporation and available in the
                                             objections. You must file your objection                                                                      strain PPRI 5339 is combined with an
                                                                                                     docket via http://www.regulations.gov.
                                             or request a hearing on this regulation                                                                       oil and its concentration is decreased
                                                                                                     There were no comments received in
                                             in accordance with the instructions                                                                           (8% active ingredient), however, data
                                                                                                     response to the notice of filing.
                                             provided in 40 CFR part 178. To ensure                                                                        demonstrated it is not toxic through
                                             proper receipt by EPA, you must                         III. Final Rule                                       inhalation. Although there may be some
                                             identify docket ID number EPA–HQ–                                                                             exposure to residues when Beauveria
                                                                                                     A. EPA’s Safety Determination
                                             OPP–2016–0608 in the subject line on                                                                          bassiana strain PPRI 5339 is used on
                                             the first page of your submission. All                     Section 408(c)(2)(A)(i) of FFDCA                   food commodities in accordance with
                                             objections and requests for a hearing                   allows EPA to establish an exemption                  label directions and good agricultural
                                             must be in writing, and must be                         from the requirement of a tolerance (the              practices, there is a lack of concern due
                                             received by the Hearing Clerk on or                     legal limit for a pesticide chemical                  to the lack of toxicity from dietary
                                             before November 19, 2018. Addresses                     residue in or on a food) only if EPA                  exposure to Beauveria bassiana strain
                                             for mail and hand delivery of objections                determines that the exemption is ‘‘safe.’’            PPRI 5339. There are no residential uses
                                             and hearing requests are provided in 40                 Section 408(c)(2)(A)(ii) of FFDCA                     currently associated with Beauveria
                                             CFR 178.25(b).                                          defines ‘‘safe’’ to mean that ‘‘there is a            bassiana strain PPRI 5339. In the event
                                               In addition to filing an objection or                 reasonable certainty that no harm will                residential uses may be sought in the
                                             hearing request with the Hearing Clerk                  result from aggregate exposure to the                 future, those exposures would not be
                                             as described in 40 CFR part 178, please                 pesticide chemical residue, including                 aggregated with the dietary exposure
                                             submit a copy of the filing (excluding                  all anticipated dietary exposures and all             due to the difference in toxic effects.
                                             any Confidential Business Information                   other exposures for which there is                    Moreover, EPA intends to mitigate the
                                             (CBI)) for inclusion in the public docket.              reliable information.’’ This includes                 potential for inhalation risk through
                                             Information not marked confidential                     exposure through drinking water and in                terms on any associated registration(s).
                                             pursuant to 40 CFR part 2 may be                        residential settings but does not include             EPA also determined in the Safety
                                             disclosed publicly by EPA without prior                 occupational exposure. Pursuant to                    Determination that retention of the Food
                                                                                                     FFDCA section 408(c)(2)(B), in
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                                             notice. Submit the non-CBI copy of your                                                                       Quality Protection Act (FQPA) safety
                                             objection or hearing request, identified                establishing or maintaining in effect an              factor was not necessary as part of the
                                             by docket ID number EPA–HQ–OPP–                         exemption from the requirement of a                   qualitative assessment conducted for
                                             2016–0608, by one of the following                      tolerance, EPA must take into account                 Beauveria bassiana strain PPRI 5339.
                                             methods:                                                the factors set forth in FFDCA section                   Based upon its evaluation in the
                                               • Federal eRulemaking Portal: http://                 408(b)(2)(C), which require EPA to give               Safety Determination, EPA concludes
                                             www.regulations.gov. Follow the online                  special consideration to exposure of                  that there is a reasonable certainty that


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                                             47076            Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations

                                             no harm will result to the U.S.                         relationships or distribution of power                § 180.1362 Beauveria bassiana strain PPRI
                                             population, including infants and                       and responsibilities established by                   5339; exemption from the requirement of a
                                             children, from aggregate exposure to                    Congress in the preemption provisions                 tolerance.
                                             residues of Beauveria bassiana strain                   of FFDCA section 408(n)(4). As such,                    Residues of Beauveria bassiana strain
                                             PPRI 5339. Therefore, an exemption                      EPA has determined that this action will              PPRI 5339 are exempt from the
                                             from the requirement of a tolerance is                  not have a substantial direct effect on               requirement of a tolerance in or on all
                                             established for residues of Beauveria                   States or tribal governments, on the                  food commodities when this pesticide
                                             bassiana strain PPRI 5339 in or on all                  relationship between the national                     chemical is used in accordance with
                                             food commodities when this pesticide                    government and the States or tribal                   label directions and good agricultural
                                             chemical is used in accordance with                     governments, or on the distribution of                practices.
                                             label directions and good agricultural                  power and responsibilities among the                  [FR Doc. 2018–20285 Filed 9–17–18; 8:45 am]
                                             practices.                                              various levels of government or between               BILLING CODE 6560–50–P
                                             B. Analytical Enforcement Methodology                   the Federal Government and Indian
                                                                                                     tribes. Thus, EPA has determined that
                                               An analytical method is not required                  Executive Order 13132, entitled                       ENVIRONMENTAL PROTECTION
                                             because EPA is establishing an                          ‘‘Federalism’’ (64 FR 43255, August 10,               AGENCY
                                             exemption from the requirement of a                     1999), and Executive Order 13175,
                                             tolerance without any numerical                         entitled ‘‘Consultation and Coordination              40 CFR Part 300
                                             limitation.                                             with Indian Tribal Governments’’ (65 FR               [EPA–HQ–SFUND–1990–0011; FRL–9983–
                                             IV. Statutory and Executive Order                       67249, November 9, 2000), do not apply                84—Region 5]
                                             Reviews                                                 to this action. In addition, this action
                                                This action establishes a tolerance                  does not impose any enforceable duty or               National Oil and Hazardous
                                             exemption under FFDCA section 408(d)                    contain any unfunded mandate as                       Substances Pollution Contingency
                                             in response to a petition submitted to                  described under Title II of the Unfunded              Plan National Priorities List: Partial
                                             EPA. The Office of Management and                       Mandates Reform Act (UMRA) (2 U.S.C.                  Deletion of the Beloit Corporation
                                             Budget (OMB) has exempted these types                   1501 et seq.).                                        Superfund Site
                                             of actions from review under Executive                     This action does not involve any                   AGENCY: Environmental Protection
                                             Order 12866, entitled ‘‘Regulatory                      technical standards that would require                Agency (EPA).
                                             Planning and Review’’ (58 FR 51735,                     EPA’s consideration of voluntary
                                                                                                                                                           ACTION: Withdrawal of direct final rule.
                                             October 4, 1993). Because this action                   consensus standards pursuant to section
                                             has been exempted from review under                     12(d) of the National Technology                      SUMMARY:    On July 16, 2018, the
                                             Executive Order 12866, this action is                   Transfer and Advancement Act                          Environmental Protection Agency (EPA)
                                             not subject to Executive Order 13211,                   (NTTAA) (15 U.S.C. 272 note).                         published a Notice of Intent for Partial
                                             entitled ‘‘Actions Concerning                                                                                 Deletion and a direct final Notice of
                                                                                                     V. Congressional Review Act
                                             Regulations That Significantly Affect                                                                         Partial Deletion for the Research Center
                                             Energy Supply, Distribution, or Use’’ (66                 Pursuant to the Congressional Review                Property (RCP) of the Beloit Superfund
                                             FR 28355, May 22, 2001), or Executive                   Act (5 U.S.C. 801 et seq.), EPA will                  Site (Beloit Site) from the National
                                             Order 13045, entitled ‘‘Protection of                   submit a report containing this rule and              Priorities List (NPL). EPA is
                                             Children from Environmental Health                      other required information to the U.S.                withdrawing the direct final Notice of
                                             Risks and Safety Risks’’ (62 FR 19885,                  Senate, the U.S. House of                             Partial Deletion because EPA did not
                                             April 23, 1997), nor is it considered a                 Representatives, and the Comptroller                  provide timely notice of the publication
                                             regulatory action under Executive Order                 General of the United States prior to                 of this rulemaking through publication
                                             13771, entitled ‘‘Reducing Regulations                  publication of the rule in the Federal                of an advertisement in a local
                                             and Controlling Regulatory Costs’’ (82                  Register. This action is not a ‘‘major                newspaper as required by EPA policy.
                                             FR 9339, February 3, 2017). This action                 rule’’ as defined by 5 U.S.C. 804(2).                 DATES: This withdrawal of the direct
                                             does not contain any information                                                                              final action 83 FR 32798 (July 16, 2018)
                                             collections subject to OMB approval                     List of Subjects in 40 CFR Part 180
                                                                                                                                                           is effective as of September 14, 2018.
                                             under the Paperwork Reduction Act                         Environmental protection,
                                             (PRA), 44 U.S.C. 3501 et seq., nor does                                                                       FOR FURTHER INFORMATION CONTACT:
                                                                                                     Administrative practice and procedure,                Randolph Cano, NPL Deletion
                                             it require any special considerations                   Agricultural commodities, Pesticides
                                             under Executive Order 12898, entitled                                                                         Coordinator, U.S. Environmental
                                                                                                     and pests, Reporting and recordkeeping                Protection Agency Region 5 (SR–6J), 77
                                             ‘‘Federal Actions to Address                            requirements.
                                             Environmental Justice in Minority                                                                             West Jackson Boulevard, Chicago, IL
                                             Populations and Low-Income                                Dated: September 7, 2018.                           60604, (312) 886–6036, or via email at
                                             Populations’’ (59 FR 7629, February 16,                 Richard P. Keigwin, Jr.,                              cano.randolph@epa.gov.
                                             1994).                                                  Director, Office of Pesticide Programs.               SUPPLEMENTARY INFORMATION: On July
                                                Since tolerances and exemptions that                                                                       16, 2018, the EPA published a Notice of
                                             are established on the basis of a petition                Therefore, 40 CFR chapter I is                      Intent for Partial Deletion (83 FR 32825)
                                             under FFDCA section 408(d), such as                     amended as follows:                                   and a direct final Notice of Partial
                                             the tolerance exemption in this action,                                                                       Deletion (83 FR 32798) for the Research
                                             do not require the issuance of a                        PART 180—[AMENDED]                                    Center Property (RCP) of the Beloit
                                                                                                                                                           Superfund Site (Beloit Site) from the
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                                             proposed rule, the requirements of the
                                             Regulatory Flexibility Act (RFA) (5                     ■ 1. The authority citation for part 180              National Priorities List (NPL). After
                                             U.S.C. 601 et seq.) do not apply.                       continues to read as follows:                         consideration of the comments received,
                                                This action directly regulates growers,                  Authority: 21 U.S.C. 321(q), 346a and 371.        if appropriate, EPA will publish a
                                             food processors, food handlers, and food                                                                      Notice of Partial Deletion in the Federal
                                             retailers, not States or tribes. As a result,           ■ 2. Add § 180.1362 to subpart D to read              Register based on the parallel Notice of
                                             this action does not alter the                          as follows:                                           Intent for Partial Deletion and place a


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Document Created: 2018-09-18 01:18:21
Document Modified: 2018-09-18 01:18:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective September 18, 2018. Objections and requests for hearings must be received on or before November 19, 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 47074 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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