Autographa Californica Multiple Nucleopolyhedrovirus Strain R3; Exemption From the Requirement of a Tolerance, 20185-20187 [2020-07043]
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20185
Federal Register / Vol. 85, No. 70 / Friday, April 10, 2020 / Rules and Regulations
EPA APPROVED STATUTES IN THE OKLAHOMA SIP—Continued
Title/subject
51 O.S. 24A.3 .......
Oklahoma Open Records Act;
Definitions.
Administrative Procedures Act;
Promulgation of certain rules—
Public inspection of rules, orders, decision and opinions—
Rulemaking record—Prohibited
actions—Violations.
Administrative Procedures Act;
Adoption, amendment or revocation of rule.
75 O.S. 302(B) ......
75 O.S. 303 ...........
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3. In § 52.1922 revise paragraph (b)
and remove paragraph (c).
The revision reads as follows:
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§ 52.1922
Approval status.
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(b) The EPA is disapproving the
following severable portions of the
February 6, 2012, Oklahoma SIP
submittal:
(1) Revisions establishing Minor New
Source Review Greenhouse Gas (GHG)
permitting requirements at OAC
252:100–7–2.1 as submitted on February
6, 2012.
(2) [Reserved].
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[FR Doc. 2020–06160 Filed 4–9–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0266; FRL–10005–93]
Autographa Californica Multiple
Nucleopolyhedrovirus Strain R3;
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 Autographa
californica multiple
nucleopolyhedrovirus strain R3 in or on
all food commodities when used in
accordance with label directions and
good agricultural practices. AgBiTech
Pty Ltd. 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
SUMMARY:
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11/1/1998
11/1/2013
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State effective
date
State citation
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EPA approval date
Explanation
4/10/2020, [Insert Federal Register citation].
4/10/2020, [Insert Federal Register citation].
SIP only includes the definition of
‘‘Record’’.
SIP only includes the requirement to maintain, and the description of the contents of the
rulemaking record.
4/10/2020, [Insert Federal Register citation].
SIP only includes the process for
adoption, amendment or revocation of a rule.
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need to establish a maximum
permissible level for residues of
Autographa californica multiple
nucleopolyhedrovirus strain R3 in or on
all food commodities under FFDCA.
DATES: This regulation is effective April
10, 2020. Objections and requests for
hearings must be received on or before
June 9, 2020 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–2019–0266, 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:
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
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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 Publishing
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–2019–0266 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 June
9, 2020. 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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20186
Federal Register / Vol. 85, No. 70 / Friday, April 10, 2020 / 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–
2019–0266, 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 June 7, 2019
(84 FR 26630) (FRL–9993–93), 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 exemption petition (PP
8F8697) by AgBiTech Pty Ltd., 8 Rocla
Ct., Glenvale, Queensland 4350,
Australia (c/o V.A. Forster Consulting,
Inc., P.O. Box 4097, Wilmington, DE
19807). 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 Autographa
californica multiple
nucleopolyhedrovirus strain R3 in or on
all food commodities. That notice
referenced a summary of the petition
prepared by the petitioner AgBiTech Pty
Ltd. and available in the docket via
https://www.regulations.gov. No relevant
comments were received.
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.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
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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
Autographa californica multiple
nucleopolyhedrovirus strain R3 and
considered their validity, completeness,
and reliability, as well as the
relationship of this information to
human risk. A summary of the data
upon which EPA relied and its risk
assessment based on those data can be
found within the document entitled
‘‘Federal Food, Drug, and Cosmetic Act
(FFDCA) Safety Determination for
Autographa californica Multiple
Nucleopolyhedrovirus strain R3’’
(‘‘Safety Determination Document’’).
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, Autographa
californica multiple
nucleopolyhedrovirus strain R3 is not
toxic, pathogenic, or infective via any
reasonably foreseeable route of exposure
and when used in accordance with label
directions and good agricultural
practices. Baculoviruses, such as
Autographa californica multiple
nucleopolyhedrovirus strain R3, are
ubiquitous in the environment and have
been extensively studied with no
adverse effects in mammals observed or
known. Although there may be dietary
and non-occupational exposure to
residues when Autographa californica
multiple nucleopolyhedrovirus strain
R3 is used on food commodities, there
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is not a concern due to the lack of
potential for adverse effects when used
in accordance with label directions and
good agricultural practices. EPA also
determined that retention of the Food
Quality Protection Act safety factor was
not necessary as part of the qualitative
assessment conducted for Autographa
californica multiple
nucleopolyhedrovirus strain R3.
Based upon its evaluation in the
Safety Determination Document, 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 Autographa californica
multiple nucleopolyhedrovirus strain
R3 when used in accordance with label
directions and good agricultural
practices. Therefore, an exemption from
the requirement of a tolerance is
established for residues of Autographa
californica multiple
nucleopolyhedrovirus strain R3 in or on
all food commodities when used in
accordance with label directions and
good agricultural practices.
B. Analytical Enforcement Methodology
An analytical method for enforcement
purposes is not required because EPA
has determined that reasonably
foreseeable exposure to residues of
Autographa californica multiple
nucleopolyhedrovirus strain R3 from
use of the pesticide will be safe, due to
lack of toxicity, pathogenicity, and
infectivity. Under those circumstances,
it is unnecessary to have an analytical
method to monitor for residues.
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
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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
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).
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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
and pests, Reporting and recordkeeping
requirements.
Dated: March 4, 2020.
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 § 180.1374 to subpart D to read
as follows:
■
§ 180.1374 Autographa californica multiple
nucleopolyhedrovirus strain R3; exemption
from the requirement of a tolerance.
Residues of Autographa californica
multiple nucleopolyhedrovirus strain
R3 are exempt from the requirement of
a tolerance in or on all food
commodities when used in accordance
with label directions and good
agricultural practices.
[FR Doc. 2020–07043 Filed 4–9–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 272
[EPA–R06–RCRA–2016–0549; FRL–10004–
22–Region 6]
Texas: Final Authorization of StateInitiated Changes and Incorporation by
Reference of State Hazardous Waste
Management Program
Environmental Protection
Agency (EPA).
ACTION: Final rule and response to
comments.
AGENCY:
In this rule, the
Environmental Protection Agency (EPA)
is approving state-initiated changes and
incorporation by reference of the State
of Texas hazardous waste program
under the Resource Conservation and
Recovery Act. The EPA also addresses
comments it received after issuing two
proposed rules on the Texas revisions.
EPA is confirming the program revisions
to the State of Texas hazardous waste
program satisfy all requirements needed
to qualify for final authorization. No
further opportunity for comment will be
provided. This final rule also codifies
and incorporates by reference the
authorized provisions of the Texas
SUMMARY:
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20187
statutes and regulations in the Code of
Federal Regulations.
DATES: This final rule is effective April
10, 2020. The incorporation by reference
of authorized provisions in the Texas
statutes and regulations contained in
this rule is approved by the Director of
the Federal Register as of April 10, 2020,
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R06–RCRA–2016–0549. All
documents in the docket are listed in
www.regulations.gov index. Although
listed in the index, some of the
information is not publicly available.
e.g., Confidential Business Information
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically through
www.regulations.gov or in hard copy.
You can view and copy the documents
that form the basis for the codification
and associated publicly available
materials from 8:30 a.m. to 4:00 p.m.,
Monday through Friday, at the
following location: EPA Region 6, 1201
Elm Street, Suite 500, Dallas, Texas,
75270, phone number (214) 665–8533.
Interested persons wanting to examine
these documents should make an
appointment with the office.
FOR FURTHER INFORMATION CONTACT:
Alima Patterson, Region 6, Regional
Authorization/Codification Coordinator,
Permit Section (LCR–RP), Land,
Chemicals and Redevelopment Division,
EPA Region 6, 1201 Elm Street, Suite
500, Dallas, Texas 75270, and Email
address patterson.alima@epa.gov.
SUPPLEMENTARY INFORMATION:
A. What were the comments and
responses to EPA’s proposal?
During the initial public comment
period that ended on November 23,
2018, EPA received comments from
three sources regarding EPA’s proposal
to (1) authorize State-initiated changes
to Texas’ hazardous waste regulations in
accordance with 40 CFR part 271 and
(2) codify in 40 CFR part 272, the prior
approval of Texas’ hazardous waste
management program and incorporate
by reference authorized provisions of
the State’s statutes and regulations. For
the public comment period ending
August 9, 2019, EPA received one
comment from one of the initial
commenters which reiterated concerns
about the Texas authorized program.
The full set of comments can be found
in the docket for this action.
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]]>Agencies
[Federal Register Volume 85, Number 70 (Friday, April 10, 2020)]
[Rules and Regulations]
[Pages 20185-20187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07043]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0266; FRL-10005-93]
Autographa Californica Multiple Nucleopolyhedrovirus Strain R3;
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 Autographa californica multiple
nucleopolyhedrovirus strain R3 in or on all food commodities when used
in accordance with label directions and good agricultural practices.
AgBiTech Pty Ltd. 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 Autographa
californica multiple nucleopolyhedrovirus strain R3 in or on all food
commodities under FFDCA.
DATES: This regulation is effective April 10, 2020. Objections and
requests for hearings must be received on or before June 9, 2020 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-2019-0266, 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 Publishing 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-2019-0266 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
June 9, 2020. 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 20186]]
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-2019-
0266, 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 June 7, 2019 (84 FR 26630) (FRL-9993-
93), 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 exemption
petition (PP 8F8697) by AgBiTech Pty Ltd., 8 Rocla Ct., Glenvale,
Queensland 4350, Australia (c/o V.A. Forster Consulting, Inc., P.O. Box
4097, Wilmington, DE 19807). 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 Autographa californica
multiple nucleopolyhedrovirus strain R3 in or on all food commodities.
That notice referenced a summary of the petition prepared by the
petitioner AgBiTech Pty Ltd. and available in the docket via https://www.regulations.gov. No relevant comments were received.
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
Autographa californica multiple nucleopolyhedrovirus strain R3 and
considered their validity, completeness, and reliability, as well as
the relationship of this information to human risk. A summary of the
data upon which EPA relied and its risk assessment based on those data
can be found within the document entitled ``Federal Food, Drug, and
Cosmetic Act (FFDCA) Safety Determination for Autographa californica
Multiple Nucleopolyhedrovirus strain R3'' (``Safety Determination
Document''). 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,
Autographa californica multiple nucleopolyhedrovirus strain R3 is not
toxic, pathogenic, or infective via any reasonably foreseeable route of
exposure and when used in accordance with label directions and good
agricultural practices. Baculoviruses, such as Autographa californica
multiple nucleopolyhedrovirus strain R3, are ubiquitous in the
environment and have been extensively studied with no adverse effects
in mammals observed or known. Although there may be dietary and non-
occupational exposure to residues when Autographa californica multiple
nucleopolyhedrovirus strain R3 is used on food commodities, there is
not a concern due to the lack of potential for adverse effects when
used in accordance with label directions and good agricultural
practices. EPA also determined that retention of the Food Quality
Protection Act safety factor was not necessary as part of the
qualitative assessment conducted for Autographa californica multiple
nucleopolyhedrovirus strain R3.
Based upon its evaluation in the Safety Determination Document, 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 Autographa californica multiple
nucleopolyhedrovirus strain R3 when used in accordance with label
directions and good agricultural practices. Therefore, an exemption
from the requirement of a tolerance is established for residues of
Autographa californica multiple nucleopolyhedrovirus strain R3 in or on
all food commodities when used in accordance with label directions and
good agricultural practices.
B. Analytical Enforcement Methodology
An analytical method for enforcement purposes is not required
because EPA has determined that reasonably foreseeable exposure to
residues of Autographa californica multiple nucleopolyhedrovirus strain
R3 from use of the pesticide will be safe, due to lack of toxicity,
pathogenicity, and infectivity. Under those circumstances, it is
unnecessary to have an analytical method to monitor for residues.
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
[[Page 20187]]
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
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: March 4, 2020.
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. 180.1374 to subpart D to read as follows:
Sec. 180.1374 Autographa californica multiple nucleopolyhedrovirus
strain R3; exemption from the requirement of a tolerance.
Residues of Autographa californica multiple nucleopolyhedrovirus
strain R3 are exempt from the requirement of a tolerance in or on all
food commodities when used in accordance with label directions and good
agricultural practices.
[FR Doc. 2020-07043 Filed 4-9-20; 8:45 am]
BILLING CODE 6560-50-P
