Autographa Californica, 38561-38563 [2019-16707]
Download as PDF
<![CDATA[
38561
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Rules and Regulations
MAINE NON REGULATORY
Name of non regulatory SIP
provision
Applicable geographic or nonattainment area
State submittal date/effective
date
EPA approved date 3
*
*
*
Reasonably Available Control
Statewide ...............................
Technology (RACT) for the
2008 8-hour Ozone National Ambient Air Quality
Standard.
*
*
Submitted 9/4/2018 ................
*
8/7/2019 [Insert Federal Register citation].
Explanations
*
3 In order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for the particular provision.
[FR Doc. 2019–16203 Filed 8–6–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0727; FRL–9996–44]
Autographa Californica Multiple
Nucleopolyhedrovirus Strain FV#11;
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 FV#11 in
or on all food commodities when used
in accordance with label directions and
good agricultural practices. Andermatt
Biocontrol AG 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 FV#11 in
or on all food commodities under
FFDCA.
SUMMARY:
This regulation is effective
August 7, 2019. Objections and requests
for hearings must be received on or
before October 7, 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).
jspears on DSK3GMQ082PROD with RULES
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0727, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
ADDRESSES:
VerDate Sep<11>2014
17:55 Aug 06, 2019
Jkt 247001
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
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-
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
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–2017–0727 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
October 7, 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
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2017–0727, 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.
E:\FR\FM\07AUR1.SGM
07AUR1
38562
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Rules and Regulations
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 March 21,
2018 (83 FR 12311) (FRL–9974–76),
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
7F8621) 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 insecticide Autographa
californica multiple
nucleopolyhedrovirus (AcMNPV) strain
FV#11 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. One comment was
received on the notice of filing. EPA’s
response to this comment is discussed
in Unit III.C.
jspears on DSK3GMQ082PROD with RULES
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
VerDate Sep<11>2014
17:55 Aug 06, 2019
Jkt 247001
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 FV#11 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
Autographa californica Multiple
Nucleopolyhedrovirus strain FV#11’’
(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, Autographa
californica multiple
nucleopolyhedrovirus strain FV#11 is
not anticipated to be 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 FV#11, are
ubiquitous in the environment and have
been extensively studied with no
adverse effects in mammals observed or
known. Although there may be some
exposure to residues when Autographa
californica multiple
nucleopolyhedrovirus strain FV#11 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 FV#11.
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 Autographa californica
multiple nucleopolyhedrovirus strain
FV#11 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
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
nucleopolyhedrovirus strain FV#11 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
EPA received one comment on the
notice of filing. Generally, the
commenter acknowledged that
pesticides are essential for food
production and human exposure to
them is likely but emphasized that these
substances need to be regulated
appropriately to, among other things,
instill trust amongst the public with
regard to pesticide use and protect
human health. EPA agrees that
pesticides must be regulated
appropriately and therefore has
evaluated the available information on
Autographa californica multiple
nucleopolyhedrovirus strain FV#11,
including toxicological and potential
exposure information, and concluded,
in accordance with the statutory
requirements of FFDCA, that the
exemption would be safe. The
commenter provided no basis for a
different conclusion.
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
E:\FR\FM\07AUR1.SGM
07AUR1
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Rules and Regulations
‘‘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).
jspears on DSK3GMQ082PROD with RULES
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.
VerDate Sep<11>2014
17:55 Aug 06, 2019
Jkt 247001
Dated: July 24, 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 § 180.1369 to subpart D to read
as follows:
■
§ 180.1369 Autographa californica multiple
nucleopolyhedrovirus strain FV#11;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Autographa californica multiple
nucleopolyhedrovirus strain FV#11 in
or on all food commodities when used
in accordance with label directions and
good agricultural practices.
[FR Doc. 2019–16707 Filed 8–6–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2019–0003; Internal
Agency Docket No. FEMA–8591]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
SUMMARY:
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
38563
www.fema.gov/national-floodinsurance-program-community-statusbook.
DATES: Effective Dates: The effective
date of each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact Adrienne L.
Sheldon, PE, CFM, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 400 C
Street SW, Washington, DC 20472, (202)
212–3966.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
to be eligible for the sale of NFIP flood
insurance. A notice withdrawing the
suspension of such communities will be
published in the Federal Register.
In addition, FEMA publishes a Flood
Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard
Areas (SFHAs) in these communities.
The date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may be provided for construction
or acquisition of buildings in identified
SFHAs for communities not
E:\FR\FM\07AUR1.SGM
07AUR1
]]>Agencies
[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Rules and Regulations]
[Pages 38561-38563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16707]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0727; FRL-9996-44]
Autographa Californica Multiple Nucleopolyhedrovirus Strain
FV#11; 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 FV#11 in or on all food commodities when
used in accordance with label directions and good agricultural
practices. Andermatt Biocontrol AG 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
FV#11 in or on all food commodities under FFDCA.
DATES: This regulation is effective August 7, 2019. Objections and
requests for hearings must be received on or before October 7, 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-2017-0727, 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-2017-0727 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
October 7, 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 submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0727, 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.
[[Page 38562]]
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 March 21, 2018 (83 FR 12311) (FRL-9974-
76), 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 7F8621) 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 insecticide Autographa californica
multiple nucleopolyhedrovirus (AcMNPV) strain FV#11 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. One comment was received on the notice
of filing. EPA's response to this comment 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 toxicological and exposure data on
Autographa californica multiple nucleopolyhedrovirus strain FV#11 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 Autographa
californica Multiple Nucleopolyhedrovirus strain FV#11'' (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,
Autographa californica multiple nucleopolyhedrovirus strain FV#11 is
not anticipated to be 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
FV#11, are ubiquitous in the environment and have been extensively
studied with no adverse effects in mammals observed or known. Although
there may be some exposure to residues when Autographa californica
multiple nucleopolyhedrovirus strain FV#11 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 FV#11.
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 Autographa californica multiple
nucleopolyhedrovirus strain FV#11 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 FV#11 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
EPA received one comment on the notice of filing. Generally, the
commenter acknowledged that pesticides are essential for food
production and human exposure to them is likely but emphasized that
these substances need to be regulated appropriately to, among other
things, instill trust amongst the public with regard to pesticide use
and protect human health. EPA agrees that pesticides must be regulated
appropriately and therefore has evaluated the available information on
Autographa californica multiple nucleopolyhedrovirus strain FV#11,
including toxicological and potential exposure information, and
concluded, in accordance with the statutory requirements of FFDCA, that
the exemption would be safe. The commenter provided no basis for a
different conclusion.
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
[[Page 38563]]
``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: July 24, 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. 180.1369 to subpart D to read as follows:
Sec. 180.1369 Autographa californica multiple nucleopolyhedrovirus
strain FV#11; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Autographa californica multiple nucleopolyhedrovirus strain
FV#11 in or on all food commodities when used in accordance with label
directions and good agricultural practices.
[FR Doc. 2019-16707 Filed 8-6-19; 8:45 am]
BILLING CODE 6560-50-P
