Rule2023-05003
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 14, 2023
Effective
March 14, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 49 (Tuesday, March 14, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#bbf9ebebfffde9f5d4cfd2d8dec8fbdecbda95dcd4cd"><span class="__cf_email__" data-cfemail="a0e2f0f0e4e6f2eecfd4c9c3c5d3e0c5d0c18ec7cfd6">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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), <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>. 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 <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.