[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.

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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 
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

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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


