Beauveria bassiana Strain PPRI 5339; Exemption From the Requirement of a Tolerance, 47074-47076 [2018-20285]
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47074
Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations
of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• is not an Executive Order 13771 (82
FR 9339, February 2, 2017) regulatory
action because actions such as SIP
approvals are exempted under
Executive Order 12866;
• does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
this action does not involve technical
standards; and
• does not provide the EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
The SIP is not approved to apply on
any Indian reservation land and is also
not approved to apply in any other area
where the EPA or an Indian tribe has
demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications as specified by Executive
Order 13175 (65 FR 67249, November 9,
2000).
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. The EPA will
submit a report containing this action
and other required information to the
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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. A major rule cannot take effect
until 60 days after it is published in the
Federal Register. This action is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Under section 307(b)(1) of the Clean
Air Act, petitions for judicial review of
this action must be filed in the United
States Court of Appeals for the
appropriate circuit by November 19,
2018. Filing a petition for
reconsideration by the Administrator of
this final rule does not affect the finality
of this action for the purposes of judicial
review nor does it extend the time
within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements (See section
307(b)(2)).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Lead,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: September 5, 2018.
Chris Hladick,
Regional Administrator, Region 10.
40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for Part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart MM—Oregon
2. Section 52.1992 is added to read as
follows:
■
§ 52.1992 Interstate Transport for the 2012
PM2.5 NAAQS.
(a) The EPA approves Oregon’s SIP
revision submitted on October 20, 2015,
addressing the requirements of CAA
section 110(a)(2)(D)(i)(I) for the 2012
PM2.5 NAAQS.
(b) [Reserved]
[FR Doc. 2018–20172 Filed 9–17–18; 8:45 am]
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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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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 https://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 https://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.
SUMMARY:
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Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations
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).
daltland on DSKBBV9HB2PROD with RULES
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 https://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: https://
www.regulations.gov. Follow the online
VerDate Sep<11>2014
16:42 Sep 17, 2018
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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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://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 https://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
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47075
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
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Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations
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.
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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
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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]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.1362 to subpart D to read
as follows:
■
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§ 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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–1990–0011; FRL–9983–
84—Region 5]
National Oil and Hazardous
Substances Pollution Contingency
Plan National Priorities List: Partial
Deletion of the Beloit Corporation
Superfund Site
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of direct final rule.
AGENCY:
On July 16, 2018, the
Environmental Protection Agency (EPA)
published a Notice of Intent for Partial
Deletion and a direct final Notice of
Partial Deletion for the Research Center
Property (RCP) of the Beloit Superfund
Site (Beloit Site) from the National
Priorities List (NPL). EPA is
withdrawing the direct final Notice of
Partial Deletion because EPA did not
provide timely notice of the publication
of this rulemaking through publication
of an advertisement in a local
newspaper as required by EPA policy.
DATES: This withdrawal of the direct
final action 83 FR 32798 (July 16, 2018)
is effective as of September 14, 2018.
FOR FURTHER INFORMATION CONTACT:
Randolph Cano, NPL Deletion
Coordinator, U.S. Environmental
Protection Agency Region 5 (SR–6J), 77
West Jackson Boulevard, Chicago, IL
60604, (312) 886–6036, or via email at
cano.randolph@epa.gov.
SUPPLEMENTARY INFORMATION: On July
16, 2018, the EPA published a Notice of
Intent for Partial Deletion (83 FR 32825)
and a direct final Notice of Partial
Deletion (83 FR 32798) for the Research
Center Property (RCP) of the Beloit
Superfund Site (Beloit Site) from the
National Priorities List (NPL). After
consideration of the comments received,
if appropriate, EPA will publish a
Notice of Partial Deletion in the Federal
Register based on the parallel Notice of
Intent for Partial Deletion and place a
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Rules and Regulations]
[Pages 47074-47076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20285]
-----------------------------------------------------------------------
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 https://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 https://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 https://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: https://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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://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 https://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
