Rule2023-02976
Glycerides, Soya Mono- and Di-, Ethoxylated; 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
February 14, 2023
Effective
February 14, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of glycerides, soya mono- and di-, ethoxylated (CAS Reg. No. 68553-06-0) when used as an inert ingredient in a pesticide chemical formulation. Spring Regulatory Sciences on behalf of Nouryon Chemicals LLC (USA), 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 glycerides, soya mono- and di-, ethoxylated on food or feed commodities when used in accordance with the terms of those exemptions.
Full Text
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<title>Federal Register, Volume 88 Issue 30 (Tuesday, February 14, 2023)</title>
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[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Rules and Regulations]
[Pages 9403-9406]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02976]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0320; FRL-10599-01-OCSPP]
Glycerides, Soya Mono- and Di-, Ethoxylated; 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 tolerance for residues of glycerides, soya mono- and di-,
ethoxylated (CAS Reg. No. 68553-06-0) when used as an inert ingredient
in a pesticide chemical formulation. Spring Regulatory Sciences on
behalf of Nouryon Chemicals LLC (USA), 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 glycerides, soya mono- and di-, ethoxylated on food or feed
commodities when used in accordance with the terms of those exemptions.
DATES: This regulation is effective February 14, 2023. Objections and
requests for hearings must be received on or before April 17, 2023 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-2021-0320, is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. For the latest
status information on EPA/DC services, docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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) 566-2875; email address:
<a href="/cdn-cgi/l/email-protection#297b6d6f7b67465d404a4c5a694c5948074e465f"><span class="__cf_email__" data-cfemail="2b796f6d7965445f42484e586b4e5b4a054c445d">[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).
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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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-2021-0320 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 17, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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-2021-0320, by one of
the following methods:
<bullet> Federal eRulemaking Portal: <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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
[[Page 9404]]
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/send-comments-epa-dockets">https://www.epa.gov/send-comments-epa-dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Background and Statutory Findings
In the Federal Register of June 1, 2021, (86 FR 29231) (FRL-10023-
95), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP IN-11514)
filed by Spring Regulatory Sciences on behalf of Nouryon Chemicals LLC
(USA), 131 S Dearborn, Suite 1000, Chicago, IL 60603-5566. The petition
requested that the existing exemption from the requirement of a
tolerance for residues of polyoxyalkylated glycerol fatty acid esters
under 40 CFR 180.960 be amended by adding glycerides, soya mono- and
di-, ethoxylated (CAS Reg. No. 68553-06-0). 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). Glycerides, soya mono- and di-,
ethoxylated (CAS Reg. No. 68553-06-0) 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 glycerides, soya mono- and
di-, ethoxylated is not readily biodegradable (MRID: 51796501).
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 CF<INF>3</INF>- 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 1,500 Daltons is greater than
1,000 and less than 10,000 Daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
Thus, glycerides, soya mono- and di-, ethoxylated meets the
criteria for a polymer to be considered low risk under 40 CFR 723.250.
Additionally, no soy protein is present as an impurity. Based on its
conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to glycerides,
soya mono- and di-, ethoxylated.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that glycerides, soya mono- and di-,
ethoxylated 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 glycerides, soya mono-
and di-, ethoxylated is 1,500 Daltons. Generally, a polymer of this
size would be poorly absorbed through the intact gastrointestinal tract
or through intact human skin. Since glycerides, soya mono- and di-,
ethoxylated conform 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
[[Page 9405]]
pesticide's residues and ``other substances that have a common
mechanism of toxicity.''
EPA has not found glycerides, soya mono- and di-, ethoxylated to
share a common mechanism of toxicity with any other substances, and
glycerides, soya mono- and di-, ethoxylated does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance exemption, therefore, EPA has assumed that glycerides,
soya mono- and di-, ethoxylated 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
<a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
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 glycerides, soya mono- and di-, ethoxylated, 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 glycerides, soya mono- and di-,
ethoxylated.
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 glycerides, soya
mono- and di-, ethoxylated 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: February 7, 2023.
Daniel Rosenblatt,
Acting 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 180.960 by revising the entry for
``Polyoxyalkylated glycerol fatty acid esters; the mono-, di-, or
triglyceride mixtures of C<INF>8</INF> through C<INF>22</INF>,
primarily C<INF>8</INF> through C<INF>18</INF> saturated and
unsaturated, fatty acids containing up to 15% water by weight reacted
with a minimum of three moles of either ethylene oxide or propylene
oxide; the resulting polyoxyalkylated glycerol ester polymer minimum
number average molecular weight (in amu), 1,500'' to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
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[[Page 9406]]
Table 1 to 180.960
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Polymer CAS No.
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* * * * * * *
Polyoxyalkylated glycerol fatty acid esters; the 61791-23-9, 68201-46-
mono-, di-, or triglyceride mixtures of C8 7, 68440-49-3, 68458-
through C22, primarily C8 through C18 saturated 88-8, 68553-06-0,
and unsaturated, fatty acids containing up to 68606-12-2, 68648-38-
15% water by weight reacted with a minimum of 4, 70377-91-2, 70914-
three moles of either ethylene oxide or 02-2, 72245-12-6,
propylene oxide; the resulting polyoxyalkylated 72698-41-3, 180254-52-
glycerol ester polymer minimum number average 8, 248273-72-5,
molecular weight (in amu), 1,500. 308063-50-5, 952722-
33-7.
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[FR Doc. 2023-02976 Filed 2-13-23; 8:45 am]
BILLING CODE 6560-50-P
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