[Federal Register Volume 89, Number 142 (Wednesday, July 24, 2024)]
[Rules and Regulations]
[Pages 59835-59838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16188]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2024-0103; FRL-12080-01-OCSPP]


Poly(oxy-1,2-ethanediyl), a-hydro-v-hydroxy-, Ether With N-[4-
[bis[4-[bis(2-hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-
ylidene]-2-hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate 
(6:1:1); Tolerance Exemption

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 poly(oxy-1,2-ethanediyl), a-hydro-
[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1) when 
used as an inert ingredient in a pesticide chemical formulation. Spring 
Regulatory Sciences, on behalf of Heubach Colorants USA LLC., 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-1,2-ethanediyl), a-hydro-[omega]-
hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1) on 
food or feed commodities when used in accordance with these exemptions.

DATES: This regulation is effective July 24, 2024. Objections and 
requests for hearings must be received on or before September 23, 2024 
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-2024-0103, 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: Daniel Rosenblatt, 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: 
[email protected].

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

[[Page 59836]]

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-2024-0103 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 
September 23, 2024. 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/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.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-2024-0103, 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/where-send-comments-epa-dockets.
    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-
02-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11843) filed by Spring Regulatory Sciences, 6620 Cypresswood Dr, Suite 
250, Spring, TX 77379 on behalf of Heubach Colorants USA LLC., 5500 77 
Center Drive, Suite 120/140, Charlotte, NC 28217-0160. 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), a-hydro-[omega]-hydroxy-, ether with N-[4-
[bis[4[bis(2hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-
ylidene]-2-hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate 
(6:1:1), (CAS# 1313600-46-2). 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), a-hydro-
[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1) 
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), 
a-hydro-[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)

[[Page 59837]]

ethanaminium, benzenesulfonate (6:1:1) is not readily biodegradable 
(MRID 52132902).
    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 1,370 Daltons is greater than 
1,000 and less than 10,000 Daltons. The polymer contains less than 10% 
oligomeric material below MW 500 (2.2%) and less than 25% oligomeric 
material below MW 1,000 (16.7%), 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), a-hydro-[omega]-hydroxy-, ether 
with N-[4-[bis[4-[bis(2-hydroxyethyl)amino]phenyl]methylene]-2,5-
cyclohexadien-1-ylidene]-2-hydroxy-N-(2-hydroxyethyl)ethanaminium, 
benzenesulfonate (6:1:1) 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), a-
hydro-[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1).

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that poly(oxy-1,2-ethanediyl), a-hydro-
[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1) 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), a-hydro-
[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1) is 
1,370 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), a-hydro-[omega]-hydroxy-, 
ether with N-[4-[bis[4-[bis(2-hydroxyethyl)amino]phenyl]methylene]-2,5-
cyclohexadien-1-ylidene]-2-hydroxy-N-(2-hydroxyethyl)ethanaminium, 
benzenesulfonate (6:1:1) 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), a-hydro-[omega]-
hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1) to 
share a common mechanism of toxicity with any other substances, and 
poly(oxy-1,2-ethanediyl), a-hydro-[omega]-hydroxy-, ether with N-[4-
[bis[4-[bis(2-hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-
ylidene]-2-hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate 
(6:1:1) 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), a-hydro-[omega]-hydroxy-
, ether with N-[4-[bis[4-[bis(2-hydroxyethyl)amino]phenyl]methylene]-
2,5-cyclohexadien-1-ylidene]-2-hydroxy-N-(2-hydroxyethyl)ethanaminium, 
benzenesulfonate (6:1:1) 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-pesticide-risks/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. 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. Due to the expected low toxicity of poly(oxy-1,2-
ethanediyl), a-hydro-[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1), 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), a-hydro-
[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1).

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), a-hydro-[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2 
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium,

[[Page 59838]]

benzenesulfonate (6:1:1) 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: July 18, 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

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.  180.960, amend table 1 to Sec.  180.960 by adding, in 
alphabetical order, the polymer ``Poly(oxy-1,2-ethanediyl), a-hydro-
[omega]-hydroxy-, ether with N-[4-[bis[4-[bis(2-
hydroxyethyl)amino]phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-2-
hydroxy-N-(2-hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1), 
minimum number average molecular weight (in amu) of 1,370'' to read as 
follows:


Sec.  180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
                       Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
Poly(oxy-1,2-ethanediyl), a-hydro-[omega]-hydroxy-,         1313600-46-2
 ether with N-[4-[bis[4-[bis(2-
 hydroxyethyl)amino]phenyl]methylene]-2,5-
 cyclohexadien-1-ylidene]-2-hydroxy-N-(2-
 hydroxyethyl)ethanaminium, benzenesulfonate (6:1:1),
 minimum number average molecular weight (in amu) of
 1,370...............................................
 
                              * * * * * * *
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[FR Doc. 2024-16188 Filed 7-23-24; 8:45 am]
BILLING CODE 6560-50-P