Rule2025-11590
Pepino Mosaic Virus, Strain LP, Isolate VX1 and Pepino Mosaic Virus, Strain CH2, Isolate VC1; Exemptions From the Requirement of a Tolerance
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
June 24, 2025
Effective
June 24, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes exemptions from the requirement of a tolerance for residues of Pepino mosaic virus, strain LP, isolate VX1 and Pepino mosaic virus, strain CH2, isolate VC1 in or on all food commodities when used in accordance with label directions and good agricultural practices. Valto BV submitted a petition to the EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Pepino mosaic virus, strain LP, isolate VX1 and Pepino mosaic virus, strain CH2, isolate VC1 under FFDCA when used in accordance with these exemptions.
Full Text
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<title>Federal Register, Volume 90 Issue 119 (Tuesday, June 24, 2025)</title>
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[Federal Register Volume 90, Number 119 (Tuesday, June 24, 2025)]
[Rules and Regulations]
[Pages 26766-26769]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11590]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0217; FRL-12767-01-OCSPP]
Pepino Mosaic Virus, Strain LP, Isolate VX1 and Pepino Mosaic
Virus, Strain CH2, Isolate VC1; Exemptions From the Requirement of a
Tolerance
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 Pepino mosaic virus, strain LP, isolate VX1
and Pepino mosaic virus, strain CH2, isolate VC1 in or on all food
commodities when used in accordance with label directions and good
agricultural practices. Valto BV submitted a petition to the EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these
exemptions from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Pepino mosaic virus, strain LP, isolate VX1 and Pepino
mosaic virus, strain CH2, isolate VC1 under FFDCA when used in
accordance with these exemptions.
DATES: This regulation is effective June 24, 2025. Objections and
requests for hearings must be received on or before August 25, 2025 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-2023-0217, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Shannon Borges, 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#723022223634203c1d061b111701321702135c151d04"><span class="__cf_email__" data-cfemail="7b392b2b3f3d2935140f12181e083b1e0b1a551c140d">[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).
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What is EPA's authority for taking this action?
EPA is issuing this rulemaking under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section
408(c)(2)(A)(i) allows EPA to establish an exemption from the
requirement for a tolerance (the legal limit for a pesticide chemical
residue in or on a food) only if EPA determines that the exemption is
``safe.'' FFDCA section 408(c)(2)(A)(ii) defines ``safe'' to mean that
``there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.'' This includes exposure through drinking
water and in residential settings but does not include occupational
exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from the requirement of a tolerance,
EPA must take into account the factors set forth in FFDCA section
408(b)(2)(C), which require EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will
[[Page 26767]]
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . . '' Additionally, FFDCA section 408(b)(2)(D)
requires that the Agency consider, among other things, ``available
information concerning the cumulative effects of a particular
pesticide's residues'' and ``other substances that have a common
mechanism of toxicity.''
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. If you fail to file an objection to the
final rule within the time period specified in the final rule, you will
have waived the right to raise any issues resolved in the final rule.
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 the EPA, you must identify docket ID number EPA-HQ-
OPP-2023-0503 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 August 25, 2025.
EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Filing and
Service,'' dated June 22, 2023, which can be found athttps://
<a href="http://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</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; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, 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>.
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 CBI) for inclusion in the public docket at
<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. If you wish to include CBI in your request, please follow
the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the information that you claim to be
CBI. Information not marked confidential pursuant to 40 CFR part 2 may
be disclosed publicly by EPA without prior notice.
II. Petitioned-For Exemption
In the Federal Register of May 18, 2023 (96 FR 31667) (FRL-10579-
04-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 2F9022 by Valto BV, Leehove 81, 2678 MB De Lier
Zuid-Holland, 2678-MB, Netherlands (c/o SciReg., Inc. 12733 Director's
Loop, Woodbridge, VA 22192). The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of the virucides Pepino mosaic virus, strain LP,
isolate VX1 and Pepino mosaic virus, strain CH2, isolate VC1 in or on
all food commodities. That notice referenced a summary of the petition
prepared by the petitioner Valto BV and available in the docket via
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. EPA received a comment on the notice of
filing. EPA's response to comment is discussed in Unit III.C.
EPA omitted the descriptor ``virucides'' from the tolerance
exemption. The reasons for this change are explained in Unit III.D.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data on
Pepino mosaic virus, strain LP, isolate VX1 and Pepino mosaic virus,
strain CH2, isolate VC1 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 Pepino mosaic virus
strain LP isolate VX1 and Pepino mosaic virus strain CH2 isolate VC1,
New Active Ingredients in (End-use Product) 100361-R V10 Proposed for
Registration and an Associated Petition Requesting a Tolerance
Exemption'' (Pepino mosaic viruses 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 active ingredients are naturally occurring isolates of Pepino
mosaic virus which have been found to colonize tomato plants without
causing disease. These active ingredients are proposed for use in
pesticide products to inoculate young tomato plants and elicit cross-
protection from other potentially more virulent strains of Pepino
mosaic virus. The active ingredients have no demonstrated infectivity
to humans and low acute toxicity based on the results of the submitted
data and information. In addition, Pepino mosaic viruses are unlikely
to cause harm to humans given their host range and inability to grow
and replicate within mammalian cells. Exposure to residues on food is
expected to be negligible due to the limited use pattern and
postharvest processing of food commodities. Drinking water exposure is
expected to be negligible since exposure is limited to greenhouse
application, and municipal drinking water processing should greatly
reduce residues of the active ingredients. Other residential or non-
occupational exposure is not expected due to the limited use pattern in
greenhouses. EPA determined that no additional margin of safety is
necessary to protect infants and children as part of the qualitative
assessment conducted, as data and rationale demonstrated that these
active ingredients are not toxic, pathogenic or infective.
Based upon its evaluation in the Pepino mosaic viruses human health
risk assessment, which concludes that there are no risks of concern
from aggregate exposure to Pepino mosaic virus, strain LP, isolate VX1
and Pepino mosaic virus, strain CH2, isolate VC1, EPA concludes that
there is a reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to
residues of Pepino mosaic virus, strain LP, isolate VX1 and Pepino
mosaic virus, strain CH2, isolate VC1.
B. Analytical Enforcement Methodology
An analytical method is not required for Pepino mosaic virus,
strain LP, isolate VX1 and Pepino mosaic virus, strain CH2, isolate VC1
because EPA is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
C. Response to Comments
One anonymous public comment was received and expressed concern
with a different active ingredient and was therefore not relevant to
this action.
[[Page 26768]]
D. Revisions to the Requested Tolerance Exemption
The Agency is omitting the descriptor, ``virucides,'' from the
tolerance exemption to conform with standard nomenclature and reduce
any possible future regulatory burden.
E. Conclusion
Therefore, exemptions from the requirement of a tolerance are
established for residues of Pepino mosaic virus, strain LP, isolate VX1
and Pepino mosaic virus, strain CH2, isolate VC1 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it establishes or modifies a
pesticide tolerance or a tolerance exemption under FFDCA section 408 in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance exemption under FFDCA
section 408 are exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA, 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA
applies only to rules subject to notice and comment rulemaking
requirements under the Administrative Procedure Act (APA), 5 U.S.C.
553, or any other statute. This rule is not subject to the APA but is
subject to FFDCA section 408(d), which does not require notice and
comment rulemaking to take this action in response to a petition.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
State, local or Tribal governments or the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not a significant regulatory action under
section 3(f)(1) of Executive Order 12866 (See Unit IV.A.), and because
EPA does not believe the environmental health or safety risks addressed
by this action present a disproportionate risk to children.
However, EPA's 2021 Policy on Children's Health applies to this
action. This rule finalizes an exemption from the requirement of a
tolerance under the FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance 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 . .
.'' (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in
Unit III.A.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action 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: June 20, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
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. 180.1480 to Subpart D to read as follows:
Sec. 180.1418 Pepino mosaic virus; exemptions from the requirement
of a tolerance.
(a) Pepino mosaic virus, strain LP, isolate VX1. An exemption from
the requirement of a tolerance is established for residues of pepino
mosaic virus, strain LP, isolate VX1 in or on all food commodities when
used in accordance with label directions and good agricultural
practices.
(b) Pepino mosaic virus, strain CH2, isolate VC1. An exemption from
the requirement of a tolerance is established for residues of Pepino
mosaic virus, strain CH2, isolate VC1 in or on all food commodities
when used in accordance
[[Page 26769]]
with label directions and good agricultural practices.
[FR Doc. 2025-11590 Filed 6-23-25; 8:45 am]
BILLING CODE 6560-50-P
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