Rule2026-01901
PDHP 68949; Exemption 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
January 30, 2026
Effective
January 30, 2026
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of PDHP 68949 in or on all food commodities if used according to the label and good agricultural practices. Plant Health Care, Inc. submitted a petition to the 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 PDHP 68949 under FFDCA when used in accordance with this exemption.
Full Text
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<title>Federal Register, Volume 91 Issue 20 (Friday, January 30, 2026)</title>
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[Federal Register Volume 91, Number 20 (Friday, January 30, 2026)]
[Rules and Regulations]
[Pages 4013-4016]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01901]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0157; FRL-13197-01-OCSPP]
PDHP 68949; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a
[[Page 4014]]
tolerance for residues of PDHP 68949 in or on all food commodities if
used according to the label and good agricultural practices. Plant
Health Care, Inc. submitted a petition to the 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 PDHP 68949 under
FFDCA when used in accordance with this exemption.
DATES: This regulation is effective January 30, 2026. Objections and
requests for hearings must be received on or before March 31, 2026 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-2024-0157, 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#baf8eaeafefce8f4d5ced3d9dfc9fadfcadb94ddd5cc"><span class="__cf_email__" data-cfemail="773527273331253918031e1412043712071659101801">[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 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-2024-0157 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 March 31, 2026.
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 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 May 3, 2024 (89 FR 36737) (FRL-11682-03-
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 3F9091) by Plant Health Care, Inc., 242 South
Main Street, Suite 216, Holly Springs, NC 27540. The petition requested
that 40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of the biochemical pesticide
PDHP 68949 in or on all food commodities. That notice referenced a
summary of the petition prepared by the petitioner Plant Health Care,
Inc., which is available in the docket. EPA did not receive any
comments in response to the notice of filing.
[[Page 4015]]
III. Final Tolerance Actions
A. EPA's Safety Determination
EPA evaluated the available toxicological and exposure data on PDHP
68949 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 ``Human Health Risk Assessment in Support of the Registration
of PHC 68949 End Use Product Containing the New Active Ingredient PDHP
68949 (1%) and Associated Petition to Establish a Permanent Tolerance
Exemption'' (Human Health Risk Assessment). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
PDHP 68949 is a modified peptide derived from a bacterial harpin
protein that acts as a plant growth regulator and activates resistance
to nematodes in treated plants (PDHP refers to peptide derived from
harpin protein). Harpins are naturally occurring proteins expressed by
certain phytopathogenic bacteria that stimulate the innate immune
response in plants, commonly referred to as systemic acquired
resistance (SAR), which increases the general ability of plants to
respond to infections and some soil-borne pests.
EPA used a weight-of-evidence approach, considering available
hazard and exposure data, to assess the risk to human health from the
use of products containing the active ingredient PDHP 68949. The active
ingredient is intended for direct applications to a wide range of
plants, including ornamentals, turf, conifers and trees in commercial
nurseries, plantation forests, landscapes and parks, as well as
agricultural crops as foliar, seed, and root treatments. Accordingly,
dietary exposure may result from consumption of treated foods. However,
any risks associated with dietary exposures are expected to be
negligible because PDHP 68949 is of low oral toxicity, does not exhibit
protein homology to putative or known allergens, and is readily
digested in both simulated gastric fluids and simulated intestinal
fluids containing only chymotrypsin. In addition, there is an
expectation of lability of PDHP 68949 in the environment. PDHP 68949 is
a protein, which is a biological substance that is subject to
biodegradation and decay through mechanisms such as photodegradation,
hydrolysis, and active degradation through microbial activity in the
environment. Further, food crops undergo a post-harvest washing process
to remove soil and surface residues, therefore reducing the amounts of
PDHP 68949 on the treated crops. Seed and root treatments are expected
to result in negligible exposures of above-ground plant parts to PDHP
68949. Exposure through drinking water is expected to be negligible
because the PDHP 68949 peptide is expected to be susceptible to
biodegradation, degradation due to environmental conditions, and water
treatment processes.
To assess hazard, an acute oral toxicity study was conducted on the
end-use product, PHC 68949, 1% active ingredient PDHP 68949, because
the product is manufactured using an integrated process, meaning that
the active ingredient is never isolated in the process. The acute oral
toxicity study found no toxicity or adverse effects from PHC 68949 and
was classified as EPA Toxicity Category IV, indicating minimal
toxicity.
One method of assessing allergenicity is to search for homologous
sequences (i.e., amino acid similarity) of a protein of interest to
known allergenic proteins in databases that contain peer-reviewed
protein sequences from allergenic proteins. Matches of greater than 35%
identity over 80 amino acids are considered to be indicative of a
potential for cross-reactivity. Sometimes a contiguous eight amino acid
sequence is also used as an indicator. An analysis of PDHP 68949 found
no alignments with greater than 35% identity over 80 contiguous amino
acids or eight amino acid exact matches. These data indicate that there
is negligible likelihood for cross reactivity of PDHP 68949 with any
known allergen sequences deposited in these databases.
To further address the potential allergenicity of PDHP 68949, a
gastrointestinal stability study of PHC 68949 was conducted. Proteins
are broken into their amino acid components upon ingestion and
subsequently used as a nutritional source. Some proteins are more
stable in the gastrointestinal tract than others, and it is thought
that this relative stability may increase the likelihood of
sensitization potential to the protein (i.e., its allergenic
potential). Therefore, peptide lability was simulated by incubating PHC
68949 peptide in simulated gastric fluids (pepsin) and simulated
intestinal fluids (chymotrypsin) to simulate digestion and assess
degradation. Pepsin began to digest PHC 68949 quickly within one minute
with a fraction present until 20 minutes. Chymotrypsin fully digested
PHC 68949 within five minutes, again with digestion starting at one
minute. Both enzymatic digestions were not conducted at the recommended
body temperature (37 [deg]C) to mimic real-world conditions, but rather
at suboptimal temperatures (between 0 [deg]C and 25 [deg]C) for both
pepsin and chymotrypsin activity, thus skewing the results towards
slower digestion in the assay compared to what would be expected to
occur upon ingestion of the peptide. Together, the data show that PDHP
68949 is expected to be labile in the gastric system, albeit at a
faster rate than indicated by the two assays.
Exposure of bystanders may occur with landscaping, turf, and in
field uses, especially when applied aerially. In those cases, exposure
may result from spray drift and are likely to be minimal as, per the
label instructions, application may only occur in low wind conditions
and medium and coarse droplet sizes are to be used. Additionally, both
the aerial application rate (0.5-3 ounces/acre) and frequency (every 2-
4 weeks) are low. Should significant non-occupational exposures occur,
the results of the mammalian inhalation and oral (and by extension
dermal) toxicology testing performed with the end-use product
demonstrated PDHP 68949 is of low toxicity. Therefore, a quantitative
non-occupational exposure assessment was not performed for PDHP 68949.
The proposed end-use product does not include residential (non-
occupational) uses of PDHP 68949; therefore, no exposure is expected,
and residential and post-application risk assessments have 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 negligible hazard of PDHP 68949. 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 PDHP 68949 because the EPA
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, the
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 PDHP 68949. Therefore, an exemption
from the requirement of a tolerance is established for residues of
[[Page 4016]]
PDHP 68949 in or on all food commodities.
IV. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/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 (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 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: January 26, 2026.
Edward Messina,
Director, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the 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. 180.1422 to subpart D to read as follows:
Sec. 180.1422 PDHP 68949; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of PDHP 68949 in or on all food commodities when used in
accordance with label directions and good agricultural practices.
[FR Doc. 2026-01901 Filed 1-29-26; 8:45 am]
BILLING CODE 6560-50-P
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