Rule2026-02933
Afidopyropen; Pesticide 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
February 13, 2026
Effective
February 13, 2026
Issuing agencies
Environmental Protection Agency
Abstract
This regulation amends the current tolerance for residues of the insecticide afidopyropen in or on the food and feed commodities of raw agricultural commodity of strawberry by increasing it from 0.15 parts per million (ppm) to 0.3 ppm and removes the established time- limited tolerance in or on strawberry at 0.3 ppm. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), BASF Corporation submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodity.
Full Text
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<title>Federal Register, Volume 91 Issue 30 (Friday, February 13, 2026)</title>
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[Federal Register Volume 91, Number 30 (Friday, February 13, 2026)]
[Rules and Regulations]
[Pages 6785-6789]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02933]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0509; FRL-13127-01-OCSPP]
Afidopyropen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the current tolerance for residues of
the insecticide afidopyropen in or on the food and feed commodities of
raw agricultural commodity of strawberry by increasing it from 0.15
parts per million (ppm) to 0.3 ppm and removes the established time-
limited tolerance in or on strawberry at 0.3 ppm. Under the Federal
Food, Drug, and Cosmetic Act (FFDCA), BASF Corporation submitted a
petition to EPA requesting that EPA establish a maximum permissible
level for residues of this pesticide in or on the identified commodity.
DATES: This rule is effective on February 13, 2026. Objections and
requests for hearings must be received on or before April 14, 2026 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.D. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2024-0509, is available online 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: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460-
0001; telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#b9ebfdffebf7d6cdd0dadccaf9dcc9d897ded6cf"><span class="__cf_email__" data-cfemail="e5b7a1a3b7ab8a918c868096a5809584cb828a93">[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 might apply to
them:
<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(b)(2)(A)(i) allows EPA to establish a tolerance (the legal limit
for a pesticide chemical residue in or on a food) only if EPA
determines that the tolerance is ``safe.'' FFDCA section
408(b)(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. FFDCA section 408(b)(2)(C)
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
[[Page 6786]]
infants and children from aggregate exposure to the pesticide chemical
residue . . .''
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-2024-0509 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 April 14, 2026.
The 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 the EPA's regulations require submission via U.S. Mail or hand
delivery, the EPA intends to treat submissions filed via electronic
means as properly filed submissions; therefore, the 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 Tolerance
In the Federal Register of December 9, 2024 (89 FR 97577) (FRL-
11682-10-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 4F9153) by BASF Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709-3528. The pesticide petition requested that 40
CFR 180.700 be amended by increasing the current tolerance for residues
of the insecticide afidopyropen in or on the raw agricultural commodity
of strawberry at 0.15 ppm to 0.3 ppm. That document referenced a
summary of the petition that was prepared by the petitioner and has
been included in the docket.
There were no comments received in response to the notice of
filing.
III. Final Tolerance Action
A. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for afidopyropen including exposure resulting from
the tolerances established by this action. EPA's assessment of
exposures and risks associated with afidopyropen is summarized in this
unit.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings for the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published tolerance rulemakings for afidopyropen
in which EPA concluded, based on the available information, that there
is a reasonable certainty that no harm would result from aggregate
exposure to afidopyropen and established tolerances for residues of the
chemical. Most recently, in the Federal Register of July 23, 2025 (90
FR 34602) (FRL-12842-01-OCSPP). As a result, EPA is not incorporating
previously published sections from these rulemakings as described
further in this rulemaking, as they remain unchanged.
B. Toxicological Profile
For a detailed discussion of the toxicological profile of
afidopyropen, see Section A.2. of the document entitled ``Afidopyropen.
Human Health Risk Assessment for the Petition for Amendment of
Tolerances in/on Field Grown Strawberries.'', dated January 29, 2026,
in docket ID EPA-HQ-OPP-2024-0509 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
C. Toxicological Points of Departure/Levels of Concern
All points of departure (POD), toxicity endpoints, and levels of
concern (LOC) for afidopyropen remain unchanged from the previous human
health risk assessment in support of the use of afidopyropen on leaf
lettuce grown in greenhouses, dated June 24, 2025. In addition, the
hazard characterization also remains unchanged. For a summary of the
toxicological points of departure/levels of concern for afidopyropen
used for human health risk assessment, see Tables 4.5.4.1 and 4.5.4.2.
of the document entitled ``Afidopyropen. Human Health Risk Assessment
for the Petition for Amendment of Tolerances in/on Field Grown
Strawberries.'', dated January 29, 2026, in docket ID EPA-HQ-OPP-2024-
0509 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
D. Exposure Assessment
An aggregate dietary (food + drinking water) exposure and risk
assessment was previously conducted using the Dietary Exposure
Evaluation Model software with the Food Commodity Intake Database
Version 4.02. This software uses 2005-2010 food consumption data from
the U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, What We Eat in America. An unrefined acute dietary
assessment was conducted in support of the use of afidopyropen on leaf
lettuce grown in greenhouses and included the current proposed
tolerance of 0.3 ppm for strawberry. The assessment was based on
tolerance-level residues and the recommended tolerance for leaf
lettuce, 100% crop treated (PCT) assumptions, and default and empirical
processing factors. At the 95th percentile of exposure, the estimated
risk is 4.2% of the acute population-adjusted dose (aPAD) for females
13-49 years old. Since an acute toxicological endpoint was only
identified for the population
[[Page 6787]]
subgroup females 13-49, an acute dietary exposure assessment was not
conducted for any of the other population subgroups. In addition, an
unrefined chronic dietary assessment was conducted in support of use of
afidopyropen on leaf lettuce grown in greenhouses and included the
current proposed tolerance of 0.3 ppm for strawberry. The assessment
was based on tolerance-level residues and the recommended tolerance for
leaf lettuce, 100 PCT assumptions, and default and empirical processing
factors. The estimated risk is 2.7% of the chronic population-adjusted
dose (cPAD) for the general U.S. population and the population subgroup
with the highest estimated risk is children 1-2 years old at 6.3% of
the cPAD.
Drinking water and non-occupational exposures. Strawberry is not a
significant feed commodity, and the most recent EDWCs remain unchanged
from the most recent risk assessment conducted in support of the use of
afidopyropen on leaf lettuce grown in greenhouses, which accounted for
afidopyropen residue levels in/on strawberry at 0.3 ppm. As such, these
EDWCs remain current and protective of the proposed amended use on
field-grown strawberries.
The proposed amended tolerance is not expected to result in
residential exposure; therefore, a residential assessment was not
conducted. There are existing residential ornamental uses that were
assessed previously and were not found to be of concern. The
residential risk estimates for use in the aggregate assessment for
afidopyropen remain unchanged from the most recent risk assessment
conducted in support of the use of afidopyropen on leaf lettuce grown
in greenhouses, which can be found in docket ID EPA-HQ-OPP-2024-0020 at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires
that, when considering whether to establish, modify, or revoke a
tolerance, the Agency considers ``available information'' concerning
the cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to afidopyropen and any other substances. For
the purposes of this tolerance action, therefore, EPA has not assumed
that afidopyropen has a common mechanism of toxicity with other
substances. Afidopyropen and another pesticide, aminocyclopyrachlor,
both produce the common toxic metabolite cyclopropanecarboxylic acid
(CPCA). Drinking water is the only expected exposure pathway for CPCA
for either pesticide. The likelihood of having ground water residues of
both afidopyropen and aminocyclopyrachlor at the EDWC predicted in the
screening ground water modeling in the same location is miniscule for
the following reasons: ground water modeling assumes application of a
chemical at the maximum rate, and the maximum number of applications,
every year for up to 100 years, and because lateral flow of chemicals
away from the application site is relatively slow, both chemicals would
have to be applied in approximately the same location every year at the
maximum application rates and maximum numbers of applications for each,
for the exposures to be additive. This is not a feasible scenario.
E. Safety Factor for Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) Safety Factor (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor.
EPA has determined that reliable data support the reduction of the
Food Quality Protection Act (FQPA) safety factor for afidopyropen from
10X to 1X for all exposure scenarios since the toxicology database is
complete and exposure analyses are unlikely to underestimate risk of
exposure from afidopyropen. Although there is evidence of increased
fetal and offspring susceptibility, the effects are well-characterized
with clearly established no-observed-adverse-effect level (NOAEL)
values and selected endpoints that are protective for the observed
effects.
F. Aggregate Risks and Determination of Safety
In accordance with the FQPA, HED must consider and aggregate (add)
pesticide exposures and risks from three major sources: food, drinking
water, and residential exposures. In an aggregate assessment, exposures
from relevant sources are added together and compared to quantitative
estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can
be aggregated. When aggregating exposures and risks from various
sources, EPA considers both the route and duration of exposure. The
acute and chronic aggregate risk assessments include food and drinking
water only. There are no acute or chronic aggregate risk estimates of
concern for afidopyropen or CPCA. The short-term aggregate risk
assessment applies only to residues of afidopyropen and combines
residential exposures (contacting previously treated ornamentals) and
average dietary (food and drinking water) exposures. The short-term
aggregate assessment results in MOEs of 1,900 for adults and 2,100 for
children (LOC = 100). There are no short-term aggregate risk estimates
of concern for afidopyropen. CPCA is not a residue of concern for
residential exposures.
Afidopyropen is classified as ``Suggestive Evidence of Carcinogenic
Potential.'' Quantification of risk using a non-linear approach (i.e.,
a cPAD) will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to afidopyropen. As a
result, a quantitative cancer dietary assessment was not performed.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the U.S. general population, or to infants and children, from
aggregate exposure to afidopyropen residues. More detailed information
on this action can be found in the document entitled ``Afidopyropen.
Human Health Risk Assessment for the Petition for Amendment of
Tolerances in/on Field Grown Strawberries'', dated January 29, 2026, in
docket ID EPA-HQ-OPP-2024-0509 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology as described in the supporting
documents is available to enforce the tolerance expressions.
Residues of afidopyropen can be measured in samples of strawberry
using liquid chromatography-tandem mass spectrometry (LC/MS/MS), BASF
Method No. D1103/01. This quick, easy, cheap, effective, rugged, and
safe (QuEChERS)-based method was previously deemed acceptable for
tolerance enforcement. The limit of quantitation (LOQ; determined as
the
[[Page 6788]]
lowest level of method validation) for afidopyropen is 0.01 ppm.
Acceptable method validation and concurrent recoveries within the range
of 70-120% were obtained from samples of strawberry fruit fortified
with afidopyropen at 0.010-1 ppm, thus the method.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The recommended
tolerance for afidopyropen residues in/on strawberry were obtained
using the Organization for Economic Co-operation and Development (OECD)
maximum residue limit (MRL) calculation procedures. The recommended
strawberry tolerance would change the harmonization status with Codex
since Codex currently has an MRL for strawberry at the U.S. existing
tolerance level of 0.15 ppm.
There are no Canadian MRLs established for residues of afidopyropen
in/on strawberry.
C. Effective and Expiration Date(s)
In general, a tolerance action is effective on the date of
publication of the final rule in the Federal Register. For actions in
the final rule that lower or revoke existing tolerances, EPA will set
an expiration date for the existing tolerance of six months after the
date of publication of the final rule in the Federal Register, in order
to allow a reasonable interval for producers in exporting members of
the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS)
Measures Agreement to adapt to the requirements.
V. Conclusion
Therefore, the existing strawberry tolerance established under 40
CFR 180.700 will be increased from 0.15 ppm to 0.3 ppm. EPA will also
remove the existing time-limited tolerance established for residues of
afidopyropen in or on strawberry at 0.3 ppm.
VI. 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)
Since tolerance actions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this
action.
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 on 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 tolerance actions like this one are exempt from
review under Executive Order 12866. 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 summarized in
Unit III.E.I.
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).
[[Page 6789]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 10, 2026.
Charles Smith,
Director, Registration Division, 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. In Sec. 180.700 amend paragraph (a) in table 1 by revising the
entry for ``Strawberry'' to read as follows:
Sec. 180.700 Afidopyropen; tolerances for residues.
(a) * * *
(1) * * *
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Strawberry................................................. 0.3
* * * * *
------------------------------------------------------------------------
* * * * *
Sec. 180.700 [Amended]
0
3. Amend Sec. 180.700 by removing and reserving paragraph (b).
[FR Doc. 2026-02933 Filed 2-12-26; 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.