Bacillus amyloliquefaciens subspecies plantarum strain FZB42; Exemption From the Requirement of a Tolerance, 28235-28237 [2019-12748]
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Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Rules and Regulations
APPENDIX C TO PART 4—ALPHABETICAL INDEX OF DISABILITIES—Continued
Diagnostic code
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Nontuberculosis mycobacterium infection ...................................................................................................................................
Nontyphoid salmonella infection ..................................................................................................................................................
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Rickettsial, ehrlichia, and anaplasma Infections .........................................................................................................................
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Schistosomiasis ...........................................................................................................................................................................
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Shigella infections ........................................................................................................................................................................
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Vibriosis (Cholera, Non-cholera) .................................................................................................................................................
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West Nile virus infection ..............................................................................................................................................................
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[FR Doc. 2019–12682 Filed 6–17–19; 8:45 am]
Unit I.C. of the SUPPLEMENTARY
BILLING CODE 8320–01–P
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0560, 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.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0560; FRL–9994–90]
Bacillus amyloliquefaciens subspecies
plantarum strain FZB42; Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42 in or on all
food commodities when used in
accordance with label directions and
good agricultural practices. Andermatt
Biocontrol AG (c/o SciReg, Inc.)
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 Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42 in or on all
food commodities under FFDCA.
DATES: This regulation is effective June
18, 2019. Objections and requests for
hearings must be received on or before
August 19, 2019 and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
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16:08 Jun 17, 2019
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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
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6312
6333
6317
6326
6334
6300
6335
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/textidx?&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–2014–0560 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
August 19, 2019. Addresses for mail and
hand delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
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28236
Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Rules and Regulations
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–
2014–0560, 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 May 18,
2018 (83 FR 23247) (FRL–9976–87),
EPA issued a Notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 7F8620) by
Andermatt Biocontrol AG,
Stahlermatten 6, CH–6146 Grossdietwil,
Switzerland (c/o SciReg, Inc., 12733
Director’s Loop, Woodbridge, VA
22192). The petition requested that 40
CFR part 180 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of the fungicide Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42 in or on all
food commodities. That Notice
referenced a summary of the petition
prepared by the petitioner Andermatt
Biocontrol AG and available in the
docket via https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit III.C.
III. Final Rule
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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.’’
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16:08 Jun 17, 2019
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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 toxicity
and exposure data on Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42 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 Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42’’ (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,
with regard to humans, Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42 is not toxic,
pathogenic, or infective via any route of
exposure. Although there may be some
exposure to residues when Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42 is used on food
commodities in accordance with label
directions and good agricultural
practices, dietary exposure to such
residues presents no concern for adverse
effects. EPA also determined that a Food
Quality Protection Act (FQPA) safety
factor was not necessary as part of the
qualitative assessment conducted for
Bacillus amyloliquefaciens subspecies
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plantarum strain FZB42. These findings
are discussed in more detail in the
Safety Determination.
Based upon its evaluation in the
Safety Determination, EPA concludes
that there is a reasonable certainty that
no harm will result to the U.S.
population, including infants and
children, from aggregate exposure to
residues of Bacillus amyloliquefaciens
subspecies plantarum strain FZB42.
Therefore, an exemption from the
requirement of a tolerance is established
for residues of Bacillus
amyloliquefaciens subspecies
plantarum strain FZB42 in or on all
food commodities when used in
accordance with label directions and
good agricultural practices.
B. Analytical Enforcement Methodology
An analytical method is not required
because EPA is establishing an
exemption from the requirement of a
tolerance without any numerical
limitation.
C. Response to Comments
Three comments were received in
response to the notice of filing. EPA
reviewed the comments and determined
that they are irrelevant to the tolerance
exemption in this action.
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, 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
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Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Rules and Regulations
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 (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 (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 (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).
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List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
VerDate Sep<11>2014
16:08 Jun 17, 2019
Jkt 247001
and pests, Reporting and recordkeeping
requirements.
Dated: June 10, 2019.
Richard Keigwin,
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 § 180.1367 to subpart D to read
as follows:
■
§ 180.1367 Bacillus amyloliquefaciens
subspecies plantarum strain FZB42;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacillus amyloliquefaciens
subspecies plantarum strain FZB42 in
or on all food commodities when used
in accordance with label directions and
good agricultural practices.
[FR Doc. 2019–12748 Filed 6–17–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 180713633–9174–02]
RIN 0648–XH059
Fisheries of the Exclusive Economic
Zone Off Alaska; Reallocation of
Pollock in the Bering Sea and Aleutian
Islands
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule.
AGENCY:
SUMMARY: NMFS is reallocating the
projected unused amounts of the Aleut
Corporation’s pollock directed fishing
allowances from the Aleutian Islands
subarea to the Bering Sea subarea
directed fisheries. These actions are
necessary to provide opportunity for
harvest of the 2019 total allowable catch
of pollock, consistent with the goals and
objectives of the Fishery Management
Plan for Groundfish of the Bering Sea
and Aleutian Islands (BSAI)
Management Area.
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28237
Effective 1200 hrs, Alaska local
time (A.l.t.), June 13, 2019, until 2400
hrs, A.l.t., December 31, 2019.
DATES:
FOR FURTHER INFORMATION CONTACT:
Steve Whitney, 907–586–7228.
NMFS
manages the groundfish fishery in the
BSAI exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Bering Sea
and Aleutian Islands Management Area
(FMP) prepared by the North Pacific
Fishery Management Council (Council)
under authority of the MagnusonStevens Fishery Conservation and
Management Act. Regulations governing
fishing by U.S. vessels in accordance
with the FMP appear at subpart H of 50
CFR part 600 and 50 CFR part 679.
In the Aleutian Islands subarea, the
portion of the 2019 pollock total
allowable catch (TAC) allocated to the
Aleut Corporation’s directed fishing
allowance (DFA) is 14,700 metric tons
(mt) as established by the final 2019 and
2020 harvest specifications for
groundfish in the BSAI (84 FR 9000,
March 13, 2019).
As of June 12, 2019, the
Administrator, Alaska Region, NMFS,
(Regional Administrator) has
determined that 14,600 mt of Aleut
Corporation’s DFA in the Aleutian
Islands subarea will not be harvested.
Therefore, in accordance with
§ 679.20(a)(5)(iii)(B)(4), NMFS
reallocates 14,600 mt of Aleut
Corporation’s DFA from the Aleutian
Islands subarea to the 2019 Bering Sea
subarea allocations. The 14,600 mt of
pollock in the Bering Sea subarea is
apportioned to the AFA Inshore sector
(50 percent), AFA catcher/processor
sector (40 percent), and the AFA
mothership sector (10 percent). The
2019 Bering Sea subarea pollock
incidental catch allowance remains at
46,520 mt. As a result, the 2019 harvest
specifications for pollock in the
Aleutian Islands subarea included in the
final 2019 and 2020 harvest
specifications for groundfish in the
BSAI (84 FR 9000, March 13, 2019 and
84 FR 9976, March 19, 2019) are revised
as follows: 100 mt to Aleut
Corporation’s DFA. Furthermore,
pursuant to § 679.20(a)(5), Table 4 of the
final 2019 and 2020 harvest
specifications for groundfish in the
BSAI (84 FR 9000, March 13, 2019 and
84 FR 9976, March 19, 2019) is revised
to make 2019 pollock allocations
consistent with this reallocation.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Rules and Regulations]
[Pages 28235-28237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12748]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0560; FRL-9994-90]
Bacillus amyloliquefaciens subspecies plantarum strain FZB42;
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 Bacillus amyloliquefaciens subspecies
plantarum strain FZB42 in or on all food commodities when used in
accordance with label directions and good agricultural practices.
Andermatt Biocontrol AG (c/o SciReg, Inc.) 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 Bacillus amyloliquefaciens subspecies plantarum strain
FZB42 in or on all food commodities under FFDCA.
DATES: This regulation is effective June 18, 2019. Objections and
requests for hearings must be received on or before August 19, 2019 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0560, 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].
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-2014-0560 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
August 19, 2019. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please
[[Page 28236]]
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-2014-
0560, 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 May 18, 2018 (83 FR 23247) (FRL-9976-
87), EPA issued a Notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
7F8620) by Andermatt Biocontrol AG, Stahlermatten 6, CH-6146
Grossdietwil, Switzerland (c/o SciReg, Inc., 12733 Director's Loop,
Woodbridge, VA 22192). The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of the fungicide Bacillus amyloliquefaciens
subspecies plantarum strain FZB42 in or on all food commodities. That
Notice referenced a summary of the petition prepared by the petitioner
Andermatt Biocontrol AG and available in the docket via https://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit III.C.
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 toxicity and exposure data on Bacillus
amyloliquefaciens subspecies plantarum strain FZB42 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 Bacillus
amyloliquefaciens subspecies plantarum strain FZB42'' (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, with regard to humans,
Bacillus amyloliquefaciens subspecies plantarum strain FZB42 is not
toxic, pathogenic, or infective via any route of exposure. Although
there may be some exposure to residues when Bacillus amyloliquefaciens
subspecies plantarum strain FZB42 is used on food commodities in
accordance with label directions and good agricultural practices,
dietary exposure to such residues presents no concern for adverse
effects. EPA also determined that a Food Quality Protection Act (FQPA)
safety factor was not necessary as part of the qualitative assessment
conducted for Bacillus amyloliquefaciens subspecies plantarum strain
FZB42. These findings are discussed in more detail in the Safety
Determination.
Based upon its evaluation in the Safety Determination, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of Bacillus amyloliquefaciens subspecies plantarum
strain FZB42. Therefore, an exemption from the requirement of a
tolerance is established for residues of Bacillus amyloliquefaciens
subspecies plantarum strain FZB42 in or on all food commodities when
used in accordance with label directions and good agricultural
practices.
B. Analytical Enforcement Methodology
An analytical method is not required because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitation.
C. Response to Comments
Three comments were received in response to the notice of filing.
EPA reviewed the comments and determined that they are irrelevant to
the tolerance exemption in this action.
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, 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
[[Page 28237]]
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 (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 (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 (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: June 10, 2019.
Richard Keigwin,
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. 180.1367 to subpart D to read as follows:
Sec. 180.1367 Bacillus amyloliquefaciens subspecies plantarum strain
FZB42; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacillus amyloliquefaciens subspecies plantarum strain
FZB42 in or on all food commodities when used in accordance with label
directions and good agricultural practices.
[FR Doc. 2019-12748 Filed 6-17-19; 8:45 am]
BILLING CODE 6560-50-P
