Rule2023-10349
D-Glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts; Exemptions 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
May 18, 2023
Effective
May 18, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes exemptions from the requirement of a tolerance for residues of D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts when used as inert ingredients (surfactants) pre- and post-harvest. Lamberti USA, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of D-glucopyranose, oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl glycosides, sulfonated, potassium salts, when used in accordance with the terms of these exemptions.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 96 (Thursday, May 18, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Rules and Regulations]
[Pages 31625-31629]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10349]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2021-0612; FRL-10972-01-OCSPP]
D-Glucopyranose, oligomeric, maleates, decyl octyl glycosides,
sulfonated, potassium salts; D-glucopyranose, oligomeric, maleates,
C10-16-alkyl glycosides, sulfonated, potassium salts; and D-
glucopyranose, oligomeric, maleates, C9-11-branched and linear alkyl
glycosides, sulfonated, potassium salts; Exemptions From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of D-glucopyranose, oligomeric, maleates,
decyl octyl glycosides, sulfonated, potassium salts; D-glucopyranose,
oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium
salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and
linear alkyl glycosides, sulfonated, potassium salts when used as inert
ingredients (surfactants) pre- and post-harvest. Lamberti USA, Inc.
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of exemptions from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of D-glucopyranose,
oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium
salts; D-glucopyranose, oligomeric, maleates, C10-16-alkyl glycosides,
sulfonated, potassium salts; and D-glucopyranose, oligomeric, maleates,
C9-11-branched and linear alkyl glycosides, sulfonated, potassium
salts, when used in accordance with the terms of these exemptions.
DATES: This regulation is effective May 18, 2023. Objections and
requests for hearings must be received on or before July 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 dockets for these actions, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0612, are 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. Please review the
visitor instructions and additional information about the docket
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 Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#e9bbadafbba7869d808a8c9aa98c9988c78e869f"><span class="__cf_email__" data-cfemail="74263032263a1b001d171107341104155a131b02">[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).
[[Page 31626]]
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 Federal Register Office's e-CFR site at <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1">https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180?toc=1</a>.
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. 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-2021-0612, 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
July 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-2021-0612, 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.
<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/dockets/where-send-comments-epa-dockets#express">https://www.epa.gov/dockets/where-send-comments-epa-dockets#express</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. Petition for Exemption
In the Federal Register of June 22, 2022 (87 FR 37287) (FRL-9410-
02-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11613) by Spring Regulatory Sciences, on behalf of Lamberti-USA, Inc.
(Lamberti), 161 Washington Street, Conshohocken, PA 19428. The petition
requested that 40 CFR 180.910 be amended by establishing exemptions
from the requirement of a tolerance for residues of D-glucopyranose,
oligomeric, maleates, decyl octyl glycosides, sulfonated, potassium
salts (CAS Reg. No. 2585031-35-0); D-glucopyranose, oligomeric,
maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS
Reg. No. 2587364-77-8); and D-glucopyranose, oligomeric, maleates, C9-
11-branched and linear alkyl glycosides, sulfonated, potassium salts
(CAS Reg. No, 1228577-37-4) when used as inert ingredients
(surfactants) in pesticide formulations pre- and post-harvest. That
document referenced a summary of the petition prepared by Lamberti,
which is available in the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There
were no comments received in response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
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 tolerance 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 in residential settings but does not include
occupational exposure. When making a safety determination for an
exemption from the requirement of a tolerance, FFDCA section
408(c)(2)(B) directs EPA to take into account the considerations in
section 408(b)(2)(C) and (D). 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 a tolerance or
exemption 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 . . . .'' Section 408(b)(2)(D) lists other
factors for EPA's consideration in making safety determinations, e.g.,
the validity, completeness, and reliability of available data, nature
of toxic effects, available information concerning the cumulative
effects of the pesticide chemical and other substances with a common
mechanism of toxicity, and available information concerning aggregate
exposure levels to the pesticide chemical and other related substances,
among other factors.
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm 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(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of these
actions. EPA has sufficient data to assess the hazards of and to make a
determination on
[[Page 31627]]
aggregate exposure for D-glucopyranose, oligomeric, maleates, decyl
octyl glycosides, sulfonated, potassium salts; D-glucopyranose,
oligomeric, maleates, C10-16-alkyl glycosides, sulfonated, potassium
salts; and D-glucopyranose, oligomeric, maleates, C9-11-branched and
linear alkyl glycosides, sulfonated, potassium salts, including
exposure resulting from the exemptions established by this action.
These three chemicals are potassium salts of alkyl (C8-C20)
polyglucoside esters (AGEs) and are herein referred to as the AGE
potassium salts. EPA's assessment of exposures and risks associated
with the AGE potassium salts follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused by the AGE potassium salts as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies are discussed in
this unit.
The toxicological database of the AGE potassium salts is supported
by data used for the Agency's 2015 evaluation of two AGE sodium salts
and one AGE lactate (80 FR 31481, June 3, 2015). When EPA previously
reviewed those AGEs, limited data were available, and the Agency
determined that it would be appropriate to bridge to data for similar
chemicals. EPA has determined that a similar approach is appropriate
for the three AGE potassium salts because of the similarities in the
manufacturing processes, functional groups/structure, composition,
physical/chemical properties, and expected toxicity of these chemicals
to those previously reviewed.
The AGEs are reaction products of glucose and fatty acids in which
the alcohol moiety is attached to the polyglucoside by a [beta]-
glucosides linkage. Alkyl polyglucoside is the first degradation
product in the biodegradation pathway of the AGEs, and toxicity data
for alkyl polyglucoside are very similar for the different alcohol
chain lengths in the range C8-C20. The toxicity profile of the AGE
potassium salts is therefore based upon data considered in the previous
risk assessment for AGE sodium salts and AGE lactate where the alcohol
component of the AGE substances is in the same C8-C20 range and is
considered appropriate for read across purposes.
Specifically, EPA considered data for D-glucopyranose, oligomeric,
6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alky)
ethers, sodium salts (CAS No. 151911-51-2); D-glucopyranose,
oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ethers,
sodium salts (CAS No. 151911-53-4); D-glucopyranose, oligomeric, 6-
[hydrogen (2R, 3R)-2,3-dihydroxybutanedioate], 1-(coco alkyl) ethers,
sodium salts (CAS No. 151911-52-3); and D-Glucopyranose, oligomeric,
maleates, C9-11-branched and linear alkyl glycosides, sulfonated,
sodium salts (CAS No. 1228577-41-0), as well as the metabolites
disodium sulfosuccinate and other sulfosuccinates.
In acute studies, the oral lethal dose, LD<INF>50</INF> for the
AGEs was >5,000 milligrams/kilogram (mg/kg). There is no available data
regarding acute exposure via the dermal, eye or inhalation routes.
Repeat dose studies were conducted with alkyl polyglucosides and
organic acids (metabolites) in which no toxicity was seen at doses as
high as 1,000 mg/kg/day. No fetal, parental, or reproductive toxicity
was seen in a reproduction/developmental toxicity screening test up to
1,000 mg/kg/day. In addition, no evidence of neurotoxicity was seen in
the database. Ames studies conducted with various AGE sodium salts were
negative for mutagenicity, and there was no indication of
carcinogenicity when the Agency evaluated the carcinogenic potential of
AGEs by conducting a qualitative structure activity relationship (SAR)
using the database, DEREK Nexus Version 2.0. No structural alerts were
identified for carcinogenicity.
Specific information on the studies reviewed and the nature of the
adverse effects caused by the AGEs can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the documents ``IN-11613; Alkyl (C8-C20)
polyglucoside esters (AGEs) potassium salts. Human Health Risk
Assessment and Ecological Effects Assessment to Support Inert
Ingredient Approval for use in Pesticide Formulations'' in docket ID
number EPA-HQ-OPP-2021-0612, and ``PC Codes 911028, 911029, 911030:
Alkyl (C8-C20) polyglucoside Esters (AGEs); Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2014-0678.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
The hazard profile of the AGE potassium salts is adequately
defined. These salts are rapidly hydrolyzed in intestine and liver. The
cleavage products, sugars, and long-chain alcohols enter the pathways
of lipid and carbohydrate metabolism. Based on the low acute,
subchronic, and developmental toxicity of AGEs, the body's ability to
rapidly metabolize these substances, the expected metabolites being
fatty acids and carbohydrates (which are normal constituents of the
body), and the lack of observed adverse effects for repeat dose studies
at the limit dose (1,000 mg/kg/day), no toxicological endpoint of
concern or PODs were identified. Therefore, a qualitative risk
assessment for the AGE potassium salts can be performed.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to the AGE potassium salts, EPA considered exposure under the
proposed exemptions from the
[[Page 31628]]
requirement of a tolerance. There are no other known food uses for
these chemicals; therefore, EPA assessed the proposed dietary exposures
from the AGE potassium salts in food as follows:
Dietary exposure (food and drinking water) to the AGE potassium
salts may occur following ingestion of foods with residues from their
use in accordance with these exemptions. However, a quantitative
dietary exposure assessment was not conducted since a toxicological
endpoint for risk assessment was not identified.
2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). AGE
potassium salts may be present in pesticide and non-pesticide products
that may be used in and around the home, including personal care
products such as antiperspirants, shampoos, conditioners, and
moisturizers. However, a quantitative residential exposure assessment
was not conducted since a toxicological endpoint for risk assessment
was not identified.
3. 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.''
Based on the lack of toxicity in the available database, EPA has
not found the AGE potassium salts to share a common mechanism of
toxicity with any other substances, and the AGE potassium salts do not
appear to produce a toxic metabolite produced by other substances. For
the purposes of these tolerance exemptions, therefore, EPA has assumed
that AGE potassium salts do 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>.
D. 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
safety factor. 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.
Based on an assessment of surrogate data for the AGE potassium
salts, EPA has concluded that there are no toxicological endpoints of
concern for the U.S. population, including infants and children.
Because there are no threshold effects associated with the AGE
potassium salts, EPA conducted a qualitative assessment. As part of
that assessment, the Agency did not use safety factors for assessing
risk, and no additional safety factor is needed for assessing risk to
infants and children.
E. Aggregate Risks and Determination of Safety
Because no toxicological endpoints of concern were identified, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to the AGE potassium salt residues.
V. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing exemptions from the requirement of a
tolerance without any numerical limitation.
VI. Conclusions
Therefore, exemptions from the requirement of a tolerance are
established for residues of D-glucopyranose, oligomeric, maleates,
decyl octyl glycosides, sulfonated, potassium salts (CAS Reg. No.
2585031-35-0); D-glucopyranose, oligomeric, maleates, C10-16-alkyl
glycosides, sulfonated, potassium salts (CAS Reg. No. 2587364-77-8);
and D-glucopyranose, oligomeric, maleates, C9-11-branched and linear
alkyl glycosides, sulfonated, potassium salts (CAS Reg. No. 1228577-37-
4) when used as inert ingredients (surfactants) in pesticide
formulations applied pre- and post-harvest under 40 CFR 180.910.
VII. Statutory and Executive Order Reviews
This action establishes exemptions from the requirement of a
tolerance 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 exemptions 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
[[Page 31629]]
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).
VIII. 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: May 10, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, the EPA amends
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. 180.910, amend Table 1 to 180.910 by adding, in
alphabetical order, entries for ``D-glucopyranose, oligomeric,
maleates, C10-16-alkyl glycosides, sulfonated, potassium salts (CAS
Reg. No. 2587364-77-8)'', ``D-glucopyranose, oligomeric, maleates, C9-
11-branched and linear alkyl glycosides, sulfonated, potassium salts
(CAS Reg. No. 1228577-37-4)'', and ``D-glucopyranose, oligomeric,
maleates, decyl octyl glycosides, sulfonated, potassium salts (CAS Reg.
No. 2585031-35-0)'' to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
Table 1 to 180.910
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
D-glucopyranose, oligomeric, .............. Surfactant.
maleates, C10-16-alkyl
glycosides, sulfonated,
potassium salts (CAS Reg. No.
2587364-77-8).
D-glucopyranose, oligomeric, .............. Surfactant.
maleates, C9-11-branched and
linear alkyl glycosides,
sulfonated, potassium salts
(CAS Reg. No. 1228577-37-4).
D-glucopyranose, oligomeric, .............. Surfactant.
maleates, decyl octyl
glycosides, sulfonated,
potassium salts (CAS Reg. No.
2585031-35-0).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2023-10349 Filed 5-17-23; 8:45 am]
BILLING CODE 6560-50-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 18, 2023.
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.