Rule2025-19712
ASFBIOF01-02 Polypeptide; Exemption From the Requirement of a Pesticide 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
October 30, 2025
Effective
October 30, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of ASFBIOF01-02 polypeptide in or on all food and feed commodities if used according to the label and good agricultural practices. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Biotalys NV submitted a petition to EPA requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of this pesticide when used in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 90 Issue 208 (Thursday, October 30, 2025)</title>
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[Federal Register Volume 90, Number 208 (Thursday, October 30, 2025)]
[Rules and Regulations]
[Pages 48822-48824]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19712]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0157; FRL-13031-01-OCSPP]
ASFBIOF01-02 Polypeptide; Exemption From the Requirement of a
Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ASFBIOF01-02 polypeptide in or on all
food and feed commodities if used according to the label and good
agricultural practices. Under the Federal Food, Drug, and Cosmetic Act
(FFDCA), Biotalys NV submitted a petition to EPA requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of this pesticide when used in accordance with the terms of
the exemption.
DATES: This regulation is effective October 30, 2025. Objections and
requests for hearings must be received on or before December 29, 2025,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0157, is available at <a href="http://www.regulations.gov">http://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) 566-1200; email address:
<a href="/cdn-cgi/l/email-protection#8dcfddddc9cbdfc3e2f9e4eee8fecde8fdeca3eae2fb"><span class="__cf_email__" data-cfemail="80c2d0d0c4c6d2ceeff4e9e3e5f3c0e5f0e1aee7eff6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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. 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 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 EPA, you must identify the docket ID number EPA-HQ-
OPP-2021-0157 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 December 29, 2025.
EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing
[[Page 48823]]
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 at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://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 Confidential Business Information (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 March 22, 2021 (86 FR 15162) (FRL-10021-
44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
1F8895) by Biotalys NV (Technologiepark 94, 9052 Ghent, Belgium, 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
ASFBIOF01-02 polypeptide in or on all food commodities. That document
referenced a summary of the petition prepared by the petitioner
Biotalys NV, which is available in the docket.
There were no comments received in response to the notice of
filing.
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data on
ASFBIOF01-02 polypeptide (hereafter ASFBIOF01-02) 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 the EPA relied and its risk assessment based on those data can be
found within the document entitled ``Product Characterization and Human
Health Risk Assessment for a FIFRA Section 3 Registration Request for
the New Active Ingredient ASFBIOF01-02, the Manufacturing Use Product
`ASFBIOF01-02 AGROBODY biofungicide,' and the End Use Product `EVOCA,'
as well as an Associated Petition to Exempt Residues of ASFBIOF01-02
from the Requirement of a Tolerance per FFDCA Section 408'' (Human
Health Risk Assessment). This document, as well as other relevant
information, are available in docket number EPA-HQ-OPP-2021-0157.
Products formulated with ASFBIOF01-02 are intended for use as
fungicides to control or suppress pre-harvest and post-harvest crop
diseases on food and non-food crops. The active ingredient ASFBIOF01-02
is an antigen binding fragment of an antibody (i.e., protein) that
recognizes specific components in the fungal cell membrane. Binding of
sufficient amounts of ASFBIOF01-02 to the cell membrane of the growing
fungus results in the disruption of the cell integrity, leading to
lysis and fungal death.
Dietary exposure to ASFBIOF01-02 may result from the consumption of
treated crops, although such exposure is likely to be limited by the
expected lability of the protein in the environment. The sole end-use
product currently proposed for registration is a broad-spectrum
sprayable fungicide proposed for the control/suppression of pre-harvest
plant and post-harvest crop diseases on both food and non-food crops.
ASFBIOF01-02 is a protein, which is a biological substance that is
subject to the processes of biodegradation and decay through mechanisms
such as photodegradation, hydrolysis, and active degradation through
microbial activity in the environment. As such, ASFBIOF01-02 is not
expected to accumulate in the environment but rather be converted into
its amino acid constituent through the aforementioned biotic and
abiotic processes. Similarly, the likelihood of ASFBIOF01-02 exposure
through drinking water is expected to be low given the protein's
environmental lability. Furthermore, stability in aquatic environments,
including municipal water treatment plants, is not expected.
Based on a weight-of-evidence approach, considering all available
hazard and exposure data for ASFBIOF01-02, the agency conducted a
qualitative dietary risk assessment. Dietary risk from ASFBIOF01-02 is
considered negligible for the following reasons: (1) submitted acute
oral toxicity (EPA Toxicity Category IV) and subchronic oral toxicity
studies demonstrate a low toxicity profile for ASFBIOF01-02; (2) the
protein is readily digested in simulated gastric and intestinal fluids,
indicating a low likelihood of allergenicity; (3) bioinformatic (in
silico) analysis with the ASFBIOF01-02 amino acid sequence showed that
there is a low likelihood that the antibody fragment exhibits cross-
reactivity with known or putative allergens; and (4) the expected
lability of the ASFBIOF01-02 protein in the environment. There are no
proposed residential uses for the product formulated with ASFBIOF01-02;
therefore, a residential handler and post-application exposure and risk
assessment has not been conducted.
Although FFDCA section 408(b)(2)(C) provides for an additional
tenfold margin of safety for infants and children in the case of
threshold effects, EPA has determined that there are no such effects
due to the lack of toxicity of ASFBIOF01-02. As a result, an additional
margin of safety for the protection of infants and children is
unnecessary.
B. Analytical Enforcement Methodology
An analytical method is not required for ASFBIOF01-02 since the
Agency is establishing an exemption from the requirement of a tolerance
without any numerical limitation.
C. Conclusion
Based upon its evaluation in the Human Health Risk Assessment, EPA
concludes that use of ASFBIOF01-02 will not result in unreasonable
adverse health effects to humans and 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 ASFBIOF01-
02. Therefore, EPA is finalizing the tolerance exemption that was
petitioned for by Biotalys NV (PP 1F8895). An exemption is established
for residues of ASFBIOF01-02 in or on all food commodities.
[[Page 48824]]
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/and-executive-orders">https://www.epa.gov/laws-regulations/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 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, 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 tolerance actions 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 the pesticide-specific review documents,
located in the applicable docket at <a href="https://www.regulations.gov">https://www.regulations.gov</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 Congress and to the
Comptroller General of the United States. 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: October 15, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
For the reasons set forth 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. 180.1421 to subpart D to read as follows:
Sec. 180.1421 ASFBIOF01-02 polypeptide; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of ASFBIOF01-02 polypeptide in or on all food commodities when
used in accordance with label directions and good agricultural
practices.
[FR Doc. 2025-19712 Filed 10-29-25; 8:45 am]
BILLING CODE 6560-50-P
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