BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0608; FRL-12022-01-OCSPP]
Poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol,
hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
in Pesticide Formulations; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement of a
tolerance for residues of poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2methyl-1,3-propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3benzenedicarboxylic acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2(hydroxymethyl)-1,3-propanediol, with a minimum number average molecular weight (in
amu) of 1400, (No CAS Reg. No.), when used as an inert ingredient in a pesticide
chemical formulation. Pyxis Regulatory Consulting Inc., on behalf of Tessara PTY Ltd.,
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 poly(oxy-1,2ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol, hexanedioic acid,
1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′-methylenebis[4isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol on food or feed
commodities when used in accordance with these exemptions.
DATES: This regulation is effective [INSERT DATE OF PUBLICATION IN THE
FEDERAL REGISTER]. Objections and requests for hearings must be received on or
before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE

FEDERAL REGISTER] 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-2023-0608, 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 Constitution Ave., NW., Washington, DC 20460-0001.
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 the
OPP Docket is (202) 566-1744. Please review the visitor instructions and additional
information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW, Washington, DC 20460-0001; main telephone number: (202)
566-1030; email address: RDFRNotices@epa.gov.
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. 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-2023-0608 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 [INSERT DATE
60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].
Addresses for mail and hand delivery of objections and hearing requests are provided in
40 CFR 178.25(b), although the Office of the Administrative Law Judges, which houses
the Hearing Clerk, encourages parties to file objections and hearing requests
electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-0410_-_order_urging_electronic_service_and_filing.pdf.
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-2023-0608, 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/wheresend-comments-epa-dockets#express.
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 and Statutory Findings
In the Federal Register of March 22, 2024 (89 FR 20410) (FRL-11682-02OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the receipt of a pesticide petition (PP IN-11735) filed by poly(oxy-1,2ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol, hexanedioic acid,
1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′-methylenebis[4isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol with a minimum
number average molecular weight (in amu) of 1400, (No CAS Reg. No.), Pyxis
Regulatory Consulting Inc., 4110 136th St., Ct., NW., Gig Harbor, WA 98332, on behalf
of Tessara PTY Ltd., 35 Kimball Avenue Epping 2 Cape Town 7460 S. Africa. The
petition requested that 40 CFR 180.960 be amended by establishing an exemption from
the requirement of a tolerance for residues of poly(oxy-1,2-ethanediyl), polymer with 1,2ethandiol, 2-methyl-1,3-propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid,
1,3-benzenedicarboxylic acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2(hydroxymethyl)-1,3-propanediol with a minimum number average molecular weight (in
amu) of 1400, (No CAS Reg. No.). That document included a summary of the petition

prepared by the petitioner and solicited comments on the petitioner’s request. The
Agency did not receive any comments.
Section 408(c)(2)(A)(i) of FFDCA 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.” 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 use in residential settings but does not
include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give
special consideration to exposure of infants and children to the pesticide chemical residue
in establishing an exemption from the requirement of 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...” and specifies factors EPA is to consider in
establishing an exemption.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only in those
cases where it can be shown that the risks from aggregate exposure to pesticide chemical
residues under reasonably foreseeable circumstances will pose no appreciable risks to
human health. In order to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in conjunction with possible
exposure to residues of the inert ingredient through food, drinking water, and through
other exposures that occur as a result of pesticide use in residential settings. If EPA is
able to determine that a finite tolerance is not necessary to ensure that there is a
reasonable certainty that no harm will result from aggregate exposure to the inert
ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this action and considered its
validity, completeness and reliability and the relationship of this information to human
risk. EPA has also considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including infants and children.
In the case of certain chemical substances that are defined as polymers, the Agency has
established a set of criteria to identify categories of polymers expected to present minimal
or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion
criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d).
Poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol,
hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol,
conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably anticipated to
become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition at least two of
the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
3. The polymer does not contain as an integral part of its composition, except as
impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to
substantially degrade, decompose, or depolymerize. An available biodegradation study
supports that poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic
acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3propanediol with a minimum number average molecular weight (in amu) of 1400, (No

CAS Reg. No.), is not readily biodegradable (MRID: 52034702).
5. The polymer is manufactured or imported from monomers and/or reactants
that are already included on the TSCA Chemical Substance Inventory or manufactured
under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average
molecular weight (MW) greater than or equal to 10,000 Daltons.
7. The polymer does not contain certain perfluoroalkyl moieties consisting of a
CF3- or longer chain length as listed in 40 CFR 723.250(d)(6). Additionally, the polymer
also meets as required the following exemption criteria: specified in 40 CFR 723.250(e):
The polymer's number average MW of 1400 Daltons is greater than 1,000, and less than
10,000 Daltons. However, the polymer contains less than 10% oligomeric material
below MW 500, and less than 25% oligomeric material below MW 1,000, and the
polymer has a combined (total) reactive group equivalent weight greater than or equal to
1,000 for the reactive functional groups listed in 40 CFR 723.250(e)(1)(ii)(B).
Thus, poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic
acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3propanediol, meets the criteria for a polymer to be considered low risk under 40 CFR
723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to poly(oxy-1,2-ethanediyl),
polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol, hexanedioic acid, 1,4benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′-methylenebis[4isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this exemption, EPA
considered that poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3-

propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic
acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3propanediol could be present in all raw and processed agricultural commodities and
drinking water, and that non-occupational non-dietary exposure was possible. The
number average MW of poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl1,3-propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3benzenedicarboxylic acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2(hydroxymethyl)-1,3-propanediol is 1400 Daltons. Generally, a polymer of this size
would be poorly absorbed through the intact gastrointestinal tract or through intact human
skin. Since poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic
acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3propanediol conforms to the criteria that identify a low-risk polymer, there are no
concerns for risks associated with any potential exposure scenarios that are reasonably
foreseeable. The Agency has determined that a tolerance is not necessary to protect the
public health.
V. Cumulative Effects from Substances with a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider “available information”
concerning the cumulative effects of a particular pesticide's residues and “other
substances that have a common mechanism of toxicity.”
EPA has not found poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2methyl-1,3-propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3benzenedicarboxylic acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2(hydroxymethyl)-1,3-propanediol to share a common mechanism of toxicity with any
other substances, and poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-

1,3-propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3benzenedicarboxylic acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2(hydroxymethyl)-1,3-propanediol does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance exemption, therefore, EPA has
assumed that poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic
acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3propanediol does not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticiderisks/cumulative-assessment-risk-pesticides.
VI. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA 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. Due to the expected low toxicity of
poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol,
hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol,
EPA has not used a safety factor analysis to assess the risk. For the same reasons no
additional safety factor is needed for assessing risk to infants and children.
VII. Determination of Safety
Based on the conformance to the criteria used to identify a low-risk polymer, EPA
concludes that there is a reasonable certainty of no harm to the U.S. population, including

infants and children, from aggregate exposure to residues of poly(oxy-1,2-ethanediyl),
polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol, hexanedioic acid, 1,4benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′-methylenebis[4isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol.
VIII. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since the Agency
is establishing an exemption from the requirement of a tolerance without any numerical
limitation.
IX. Conclusion
Accordingly, EPA finds that exempting residues of poly(oxy-1,2-ethanediyl),
polymer with 1,2-ethandiol, 2-methyl-1,3-propanediol, hexanedioic acid, 1,4benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′-methylenebis[4isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol from the
requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews
This action establishes a tolerance exemption under FFDCA section 408(d) 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,
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

(PRA) (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 exemption in this final rule, do not
require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (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, nor does this action alter the relationships or distribution of
power and responsibilities established by Congress in the preemption provisions of
FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 (UMRA) (2
U.S.C. 1501 et seq.).
This action does not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
XI. 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: June 12, 2024.
Charles Smith,
Director, Registration Division, 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
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In §180.960, amend table 1 to §180.960 by adding, in alphabetical order, the
polymer “Poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2-methyl-1,3propanediol, hexanedioic acid, 1,4-benzenedicarboxylic acid, 1,3-benzenedicarboxylic
acid, 1,1′-methylenebis[4-isocyanatobenzene] and 2-ethyl-2-(hydroxymethyl)-1,3propanediol, with a minimum number average molecular weight (in amu) of 1400” to
read as follows:
§ 180.960 Polymers; exemptions from the requirement of a tolerance.
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Table 1 to § 180.960
Polymer
CAS No.
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Poly(oxy-1,2-ethanediyl), polymer with 1,2-ethandiol, 2None
methyl-1,3-propanediol, hexanedioic acid, 1,4benzenedicarboxylic acid, 1,3-benzenedicarboxylic acid, 1,1′methylenebis[4-isocyanatobenzene] and 2-ethyl-2(hydroxymethyl)-1,3-propanediol, with a minimum number
average molecular weight (in amu) of 1400.
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[FR Doc. 2024-13588 Filed: 6/20/2024 8:45 am; Publication Date: 6/21/2024]

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