Bacteriophage Active Against Pseudomonas syringae pv. syringae; Bacteriophage Active Against Xanthomonas arboricola pv. corylina; Bacteriophage Active Against Xanthomonas arboricola pv. juglandis; and Bacteriophage Active Against Xanthomonas arboricola pv. pruni; Exemptions From the Requirement of Tolerances, 15616-15619 [2023-05003]
Download as PDF
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15616
Federal Register / Vol. 88, No. 49 / Tuesday, March 14, 2023 / Rules and Regulations
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001); Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997); or Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.) nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance exemption in this action,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes. As a result,
this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA has determined that this action will
not have a substantial direct effect on
States or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, EPA has determined that
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
EPA’s consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
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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).
List of Subjects in 40 CFR Part 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 6, 2023.
Charles Smith,
Director, Biopesticides and Pollution
Prevention Division.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 174—PROCEDURES AND
REQUIREMENTS FOR PLANTINCORPORATED PROTECTANTS
1. The authority citation for part 174
continues to read as follows:
■
Authority: 7 U.S.C. 136–136y; 21 U.S.C.
321(q), 346a and 371.
2. Add § 174.545 to subpart W to read
as follows:
■
§ 174.545 BLB2 and AMR3 proteins in
potato; temporary exemption from the
requirement of a tolerance.
Residues of BLB2 and AMR3 proteins
in potato are temporarily exempt from
the requirement of a tolerance when
used as a plant-incorporated protectant
in potato in accordance with the terms
of Experimental Use Permit No. 8917–
EUP–3. This temporary exemption from
the requirement of a tolerance expires
on March 31, 2024.
[FR Doc. 2023–05246 Filed 3–13–23; 8:45 am]
BILLING CODE 6560–50–P
PO 00000
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0519; FRL–10544–01–
OCSPP]
Bacteriophage Active Against
Pseudomonas syringae pv. syringae;
Bacteriophage Active Against
Xanthomonas arboricola pv. corylina;
Bacteriophage Active Against
Xanthomonas arboricola pv. juglandis;
and Bacteriophage Active Against
Xanthomonas arboricola pv. pruni;
Exemptions From the Requirement of
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
exemptions from the requirement of a
tolerance for residues of Bacteriophage
active against Pseudomonas syringae
pv. syringae, Bacteriophage active
against Xanthomonas arboricola pv.
corylina, Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni, in or
on all food commodities when used in
accordance with label directions and
good agricultural practices. OmniLytics,
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 Bacteriophage active
against Pseudomonas syringae pv.
syringae, Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni
under FFDCA when used in accordance
with this exemption.
DATES: This regulation is effective
March 14, 2023. Objections and requests
for hearings must be received on or
before May 15, 2023, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0519, 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
ADDRESSES:
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Federal Register / Vol. 88, No. 49 / Tuesday, March 14, 2023 / Rules and Regulations
Constitution Ave. NW, Washington, DC
20004. 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 and OPP Docket
is (202) 566–1744. For the latest status
information on EPA/DC services, docket
access, visit https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Biopesticides and
Pollution Prevention Division (7511M),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(202) 566–1400; 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).
ddrumheller on DSK120RN23PROD with RULES1
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 Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
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–2021–0519 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 May
15, 2023. Addresses for mail and hand
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delivery of objections and hearing
requests are provided in 40 CFR
178.25(b), although EPA strongly
encourages those interested in
submitting objections or a hearing
request to submit objections and hearing
requests electronically. See Order
Urging Electronic Service and Filing
(April 10, 2020), https://www.epa.gov/
sites/default/files/2020-05/documents/
2020-04-10_-_order_urging_electronic_
service_and_filing.pdf. At this time,
because of the COVID–19 pandemic, the
judges and staff of the Office of
Administrative Law Judges are working
remotely and not able to accept filings
or correspondence by courier, personal
delivery, or commercial delivery, and
the ability to receive filings or
correspondence by U.S. Mail is
similarly limited. When submitting
documents to the U.S. EPA Office of
Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing
system at https://yosemite.epa.gov/oa/
eab/eab-alj_upload.nsf.
Although EPA’s regulations require
submission via U.S. Mail or hand
delivery, EPA intends to treat
submissions filed via electronic means
as properly filed submissions during
this time that the Agency continues to
maximize telework due to the
pandemic; therefore, EPA believes the
preference for submission via electronic
means will not be prejudicial. If it is
impossible for a person to submit
documents electronically or receive
service electronically, e.g., the person
does not have any access to a computer,
the person shall so advise OALJ by
contacting the Hearing Clerk at (202)
564–6281. If a person is without access
to a computer and must file documents
by U.S. Mail, the person shall notify the
Hearing Clerk every time it files a
document in such a manner. The
address for mailing documents is U.S.
Environmental Protection Agency,
Office of Administrative Law Judges,
Mail Code 1900R, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
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–
2021–0519, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
PO 00000
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15617
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/where-sendcomments-epa-dockets.
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 September
22, 2021 (86 FR 52624) (FRL–8792–03–
OCSPP), 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 1F8907) by OmniLytics, Inc., 9075
S Sandy Parkway, Sandy, UT 84070.
The petition requested that 40 CFR part
180 be amended by establishing an
exemption from the requirement of a
tolerance for residues of Bacteriophage
active against Pseudomonas syringae
pv. syringae, Bacteriophage active
against Xanthomonas arboricola pv.
corylina, Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni in or
on all food commodities. That notice
referenced a summary of the petition
prepared by the petitioner OmniLyics,
Inc. and is available in the docket via
https://www.regulations.gov. EPA
received no comments in response to
the notice of filing.
III. Final Rule
A. EPA’s Safety Determination
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement of a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Pursuant to
FFDCA section 408(c)(2)(B), in
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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
Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni 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
‘‘Human Health Risk Assessment of
Bacteriophages active against
Pseudomonas syringae pv. syringae,
Xanthomonas arboricola pv. corylina,
Xanthomonas arboricola pv. juglandis,
and Xanthomonas arboricola pv. pruni,
New Active Ingredients, in 67986–RN
AgriPhage Nut & Stone Fruit Proposed
for Registration and an Associated
Petition Requesting a Tolerance
Exemption’’ (Bacteriophage active
against Pseudomonas syringae pv.
syringae, Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni,
Human Health Risk Assessment). This
document, as well as other relevant
information, is available in the docket
for this action as described under
ADDRESSES.
The available data and information
demonstrated that, with regard to
humans, Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
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Xanthomonas arboricola pv. pruni are
not anticipated to be toxic, pathogenic,
or infective via any route of exposure.
Significant dietary and nonoccupational exposures to residues of
Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni are
not expected due to the inability of
bacteriophage to persist when the
specific bacterial hosts are not present
and sensitivity to environmental
conditions (e.g., ultraviolet light and
heat). Even if dietary and nonoccupational exposures to residues of
Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni were
to occur, there is not a concern due to
the lack of potential for adverse effects
and lack of significant exposure since
bacteriophage populations are expected
to decrease rapidly when host bacteria
are not present, since bacteriophage
persist only in the presence of the
specific bacterial hosts and due to
environmental conditions (e.g.,
ultraviolet light and heat). Because there
are no threshold levels of concern with
the toxicity, pathogenicity, or infectivity
of Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni, EPA
determined that the additional margin
of safety referred to as the Food Quality
Protection Act Safety Factor is not
necessary to protect infants and
children as part of the qualitative
assessment conducted.
Based upon its evaluation in the
Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni
Human Health Risk Assessment, which
concludes that there are no potential
risks of concern from aggregate exposure
to Bacteriophage active against
Pseudomonas syringae pv. syringae,
PO 00000
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Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni, EPA
determines 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 Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni.
Therefore, exemptions from the
requirement of a tolerance are
established for residues of
Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni, 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
for Bacteriophage active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni
because EPA is establishing exemptions
from the requirement of a tolerance
without any numerical limitation.
C. Conclusion
Therefore, exemptions from the
requirement of a tolerance are
established for residues of
Bacteriophages active against
Pseudomonas syringae pv. syringae,
Bacteriophage active against
Xanthomonas arboricola pv. corylina,
Bacteriophage active against
Xanthomonas arboricola pv. juglandis,
and Bacteriophage active against
Xanthomonas arboricola pv. pruni in or
on all food commodities when used in
accordance with label directions and
good agricultural practices.
IV. Statutory and Executive Order
Reviews
This action establishes tolerance
exemptions under FFDCA section
408(d) in response to a petition
submitted to EPA. The Office of
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ddrumheller on DSK120RN23PROD with RULES1
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).
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
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 exemptions 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
VerDate Sep<11>2014
16:01 Mar 13, 2023
Jkt 259001
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 6, 2023.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add §§ 180.1399, 180.1400,
180.1401, and 180.1402 to subpart D to
read as follows:
*
*
*
*
*
■
Sec.
180.1399 Bacteriophage active against
Pseudomonas syringae pv. syringae;
exemption from the requirement of a
tolerance.
180.1400 Bacteriophage active against
Xanthomonas arboricola pv. corylina;
PO 00000
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15619
exemption from the requirement of a
tolerance.
180.1401 Bacteriophage active against
Xanthomonas arboricola pv. juglandis;
exemption from the requirement of a
tolerance.
180.1402 Bacteriophage active against
Xanthomonas arboricola pv. pruni;
exemption from the requirement of a
tolerance.
§ 180.1399 Bacteriophage active against
Pseudomonas syringae pv. syringae;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacteriophage active against
Pseudomonas syringae pv. syringae in
or on all food commodities when used
in accordance with label directions and
good agricultural practices.
§ 180.1400 Bacteriophage active against
Xanthomonas arboricola pv. corylina;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacteriophage active against
Xanthomonas arboricola pv. corylina in
or on all food commodities when used
in accordance with label directions and
good agricultural practices.
§ 180.1401 Bacteriophage active against
Xanthomonas arboricola pv. juglandis;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacteriophage active against
Xanthomonas arboricola pv. juglandi in
or on all food commodities when used
in accordance with label directions and
good agricultural practices.
§ 180.1402 Bacteriophage active against
Xanthomonas arboricola pv. pruni;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of Bacteriophage active against
Xanthomonas arboricola pv. pruni in or
on all food commodities when used in
accordance with label directions and
good agricultural practices.
[FR Doc. 2023–05003 Filed 3–13–23; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\14MRR1.SGM
14MRR1
]]>Agencies
[Federal Register Volume 88, Number 49 (Tuesday, March 14, 2023)]
[Rules and Regulations]
[Pages 15616-15619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05003]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0519; FRL-10544-01-OCSPP]
Bacteriophage Active Against Pseudomonas syringae pv. syringae;
Bacteriophage Active Against Xanthomonas arboricola pv. corylina;
Bacteriophage Active Against Xanthomonas arboricola pv. juglandis; and
Bacteriophage Active Against Xanthomonas arboricola pv. pruni;
Exemptions From the Requirement of Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of Bacteriophage active against Pseudomonas
syringae pv. syringae, Bacteriophage active against Xanthomonas
arboricola pv. corylina, Bacteriophage active against Xanthomonas
arboricola pv. juglandis, and Bacteriophage active against Xanthomonas
arboricola pv. pruni, in or on all food commodities when used in
accordance with label directions and good agricultural practices.
OmniLytics, 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 Bacteriophage
active against Pseudomonas syringae pv. syringae, Bacteriophage active
against Xanthomonas arboricola pv. corylina, Bacteriophage active
against Xanthomonas arboricola pv. juglandis, and Bacteriophage active
against Xanthomonas arboricola pv. pruni under FFDCA when used in
accordance with this exemption.
DATES: This regulation is effective March 14, 2023. Objections and
requests for hearings must be received on or before May 15, 2023, 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-2021-0519, 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
[[Page 15617]]
Constitution Ave. NW, Washington, DC 20004. 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 and
OPP Docket is (202) 566-1744. For the latest status information on EPA/
DC services, docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1400; 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 Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.
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-2021-0519 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
May 15, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. At this
time, because of the COVID-19 pandemic, the judges and staff of the
Office of Administrative Law Judges are working remotely and not able
to accept filings or correspondence by courier, personal delivery, or
commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at (202) 564-6281. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
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-2021-0519, 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/where-send-comments-epa-dockets.
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 September 22, 2021 (86 FR 52624) (FRL-
8792-03-OCSPP), 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 1F8907) by OmniLytics, Inc., 9075 S
Sandy Parkway, Sandy, UT 84070. The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of Bacteriophage active against Pseudomonas
syringae pv. syringae, Bacteriophage active against Xanthomonas
arboricola pv. corylina, Bacteriophage active against Xanthomonas
arboricola pv. juglandis, and Bacteriophage active against Xanthomonas
arboricola pv. pruni in or on all food commodities. That notice
referenced a summary of the petition prepared by the petitioner
OmniLyics, Inc. and is available in the docket via https://www.regulations.gov. EPA received no comments in response to the notice
of filing.
III. Final Rule
A. EPA's Safety Determination
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
[[Page 15618]]
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
Bacteriophage active against Pseudomonas syringae pv. syringae,
Bacteriophage active against Xanthomonas arboricola pv. corylina,
Bacteriophage active against Xanthomonas arboricola pv. juglandis, and
Bacteriophage active against Xanthomonas arboricola pv. pruni 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 ``Human Health
Risk Assessment of Bacteriophages active against Pseudomonas syringae
pv. syringae, Xanthomonas arboricola pv. corylina, Xanthomonas
arboricola pv. juglandis, and Xanthomonas arboricola pv. pruni, New
Active Ingredients, in 67986-RN AgriPhage Nut & Stone Fruit Proposed
for Registration and an Associated Petition Requesting a Tolerance
Exemption'' (Bacteriophage active against Pseudomonas syringae pv.
syringae, Bacteriophage active against Xanthomonas arboricola pv.
corylina, Bacteriophage active against Xanthomonas arboricola pv.
juglandis, and Bacteriophage active against Xanthomonas arboricola pv.
pruni, Human Health Risk Assessment). This document, as well as other
relevant information, is available in the docket for this action as
described under ADDRESSES.
The available data and information demonstrated that, with regard
to humans, Bacteriophage active against Pseudomonas syringae pv.
syringae, Bacteriophage active against Xanthomonas arboricola pv.
corylina, Bacteriophage active against Xanthomonas arboricola pv.
juglandis, and Bacteriophage active against Xanthomonas arboricola pv.
pruni are not anticipated to be toxic, pathogenic, or infective via any
route of exposure. Significant dietary and non-occupational exposures
to residues of Bacteriophage active against Pseudomonas syringae pv.
syringae, Bacteriophage active against Xanthomonas arboricola pv.
corylina, Bacteriophage active against Xanthomonas arboricola pv.
juglandis, and Bacteriophage active against Xanthomonas arboricola pv.
pruni are not expected due to the inability of bacteriophage to persist
when the specific bacterial hosts are not present and sensitivity to
environmental conditions (e.g., ultraviolet light and heat). Even if
dietary and non-occupational exposures to residues of Bacteriophage
active against Pseudomonas syringae pv. syringae, Bacteriophage active
against Xanthomonas arboricola pv. corylina, Bacteriophage active
against Xanthomonas arboricola pv. juglandis, and Bacteriophage active
against Xanthomonas arboricola pv. pruni were to occur, there is not a
concern due to the lack of potential for adverse effects and lack of
significant exposure since bacteriophage populations are expected to
decrease rapidly when host bacteria are not present, since
bacteriophage persist only in the presence of the specific bacterial
hosts and due to environmental conditions (e.g., ultraviolet light and
heat). Because there are no threshold levels of concern with the
toxicity, pathogenicity, or infectivity of Bacteriophage active against
Pseudomonas syringae pv. syringae, Bacteriophage active against
Xanthomonas arboricola pv. corylina, Bacteriophage active against
Xanthomonas arboricola pv. juglandis, and Bacteriophage active against
Xanthomonas arboricola pv. pruni, EPA determined that the additional
margin of safety referred to as the Food Quality Protection Act Safety
Factor is not necessary to protect infants and children as part of the
qualitative assessment conducted.
Based upon its evaluation in the Bacteriophage active against
Pseudomonas syringae pv. syringae, Bacteriophage active against
Xanthomonas arboricola pv. corylina, Bacteriophage active against
Xanthomonas arboricola pv. juglandis, and Bacteriophage active against
Xanthomonas arboricola pv. pruni Human Health Risk Assessment, which
concludes that there are no potential risks of concern from aggregate
exposure to Bacteriophage active against Pseudomonas syringae pv.
syringae, Bacteriophage active against Xanthomonas arboricola pv.
corylina, Bacteriophage active against Xanthomonas arboricola pv.
juglandis, and Bacteriophage active against Xanthomonas arboricola pv.
pruni, EPA determines 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 Bacteriophage active against
Pseudomonas syringae pv. syringae, Bacteriophage active against
Xanthomonas arboricola pv. corylina, Bacteriophage active against
Xanthomonas arboricola pv. juglandis, and Bacteriophage active against
Xanthomonas arboricola pv. pruni. Therefore, exemptions from the
requirement of a tolerance are established for residues of
Bacteriophage active against Pseudomonas syringae pv. syringae,
Bacteriophage active against Xanthomonas arboricola pv. corylina,
Bacteriophage active against Xanthomonas arboricola pv. juglandis, and
Bacteriophage active against Xanthomonas arboricola pv. pruni, 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 for Bacteriophage active
against Pseudomonas syringae pv. syringae, Bacteriophage active against
Xanthomonas arboricola pv. corylina, Bacteriophage active against
Xanthomonas arboricola pv. juglandis, and Bacteriophage active against
Xanthomonas arboricola pv. pruni because EPA is establishing exemptions
from the requirement of a tolerance without any numerical limitation.
C. Conclusion
Therefore, exemptions from the requirement of a tolerance are
established for residues of Bacteriophages active against Pseudomonas
syringae pv. syringae, Bacteriophage active against Xanthomonas
arboricola pv. corylina, Bacteriophage active against Xanthomonas
arboricola pv. juglandis, and Bacteriophage active against Xanthomonas
arboricola pv. pruni in or on all food commodities when used in
accordance with label directions and good agricultural practices.
IV. Statutory and Executive Order Reviews
This action establishes tolerance exemptions under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
[[Page 15619]]
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). 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
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
exemptions 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 6, 2023.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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. Sec. 180.1399, 180.1400, 180.1401, and 180.1402 to subpart
D to read as follows:
* * * * *
Sec.
180.1399 Bacteriophage active against Pseudomonas syringae pv.
syringae; exemption from the requirement of a tolerance.
180.1400 Bacteriophage active against Xanthomonas arboricola pv.
corylina; exemption from the requirement of a tolerance.
180.1401 Bacteriophage active against Xanthomonas arboricola pv.
juglandis; exemption from the requirement of a tolerance.
180.1402 Bacteriophage active against Xanthomonas arboricola pv.
pruni; exemption from the requirement of a tolerance.
Sec. 180.1399 Bacteriophage active against Pseudomonas syringae pv.
syringae; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacteriophage active against Pseudomonas syringae pv.
syringae in or on all food commodities when used in accordance with
label directions and good agricultural practices.
Sec. 180.1400 Bacteriophage active against Xanthomonas arboricola pv.
corylina; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacteriophage active against Xanthomonas arboricola pv.
corylina in or on all food commodities when used in accordance with
label directions and good agricultural practices.
Sec. 180.1401 Bacteriophage active against Xanthomonas arboricola pv.
juglandis; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacteriophage active against Xanthomonas arboricola pv.
juglandi in or on all food commodities when used in accordance with
label directions and good agricultural practices.
Sec. 180.1402 Bacteriophage active against Xanthomonas arboricola pv.
pruni; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of Bacteriophage active against Xanthomonas arboricola pv.
pruni in or on all food commodities when used in accordance with label
directions and good agricultural practices.
[FR Doc. 2023-05003 Filed 3-13-23; 8:45 am]
BILLING CODE 6560-50-P
