Diglycerol in Pesticide Formulations; Tolerance Exemption
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Issuing agencies
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of diglycerol when used as an inert ingredient (plasticizer) on growing crops and raw agricultural commodities pre- and post-harvest. This regulation eliminates the need to establish a maximum permissible level for residues of diglycerol, when used in accordance with the terms of the exemption. This regulation also amends the tolerance exemption 2,6-pyridinedicarboxylic acid by correcting the CAS Reg. No.
Full Text
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<title>Federal Register, Volume 88 Issue 46 (Thursday, March 9, 2023)</title>
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[Federal Register Volume 88, Number 46 (Thursday, March 9, 2023)]
[Rules and Regulations]
[Pages 14491-14495]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04806]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0737; FRL-10688-01-OCSPP]
Diglycerol in Pesticide Formulations; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule and correction.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of diglycerol when used as an inert
ingredient (plasticizer) on growing crops and raw agricultural
commodities pre- and post-harvest. This regulation eliminates the need
to establish a maximum permissible level for residues of diglycerol,
when used in accordance with the terms of the exemption. This
regulation also amends the tolerance
[[Page 14492]]
exemption 2,6-pyridinedicarboxylic acid by correcting the CAS Reg. No.
DATES: This regulation is effective March 9, 2023. Objections and
requests for hearings must be received on or before May 8, 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-2022-0737, 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#03514745514d6c776a606670436673622d646c75"><span class="__cf_email__" data-cfemail="2a786e6c7864455e43494f596a4f5a4b044d455c">[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 Government Publishing Office's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</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-2022-0737 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
May 8, 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-2022-0737, 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">https://www.epa.gov/dockets/where-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. Petition for Exemption
In the Federal Register of September 23, 2022 (87 FR 58047) (FRL-
9410-05-OSCPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11673) by RRStewart Consulting, LLC, on behalf of Aicello America
Corporation, 182 Nassau Street, Princeton, NJ 08542. The petition
requested that 40 CFR 180.910 be amended by establishing an exemption
from the requirement of a tolerance for residues of diglycerol (CAS
Reg. No. 59113-36-9) when used as an inert ingredient (plasticizer) in
pesticide formulations applied to growing crops or raw agricultural
commodities pre- and post-harvest. That document referenced a summary
of the petition prepared by RRStewart Consulting, LLC, on behalf of
Aicello America Corporation, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no comments received in response to the
notice of filing.
On November 23, 2022, (87 FR 71523) (FRL-10400-01-OCSPP), the
exemption from the requirement of a tolerance was published for 2,6-
pyridinedicarboxylic acid; however, the rule inadvertently included an
error in the CAS Reg. No. This document also corrects (CAS Reg. No.
449-83-2) to read (CAS Reg. No. 499-83-2) under 40 CFR 180.910.
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
[[Page 14493]]
occupational exposure. When making a safety determination for an
exemption for 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 this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for diglycerol, including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with diglycerol 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 diglycerol 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 diglycerol is supported by data
regarding glycerol and polyglycerol. EPA has determined that it is
appropriate to bridge glycerol and polyglycerol data to assess
diglycerol due to similarities in functional groups/structure.
Diglycerol exhibits low levels of acute toxicity via the oral and
dermal routes of exposure, and it is anticipated to have low acute
inhalation toxicity. Diglycerol is not an acute skin or eye irritant
nor a skin sensitizer.
Portal-of-entry effects (squamous metaplasia of the epithelium
lining the base of the epiglottis) were observed in the available
subchronic inhalation toxicity study. There is no evidence of offspring
susceptibility in the available developmental toxicity study or in the
2-generation reproductive toxicity study with the surrogate chemical
glycerol. No effects on reproductive parameters were observed in the 2-
generation reproductive toxicity study with glycerol. Concern for
carcinogenicity is low, based on negative results in mutagenicity and
genotoxicity studies and lack of treatment-related neoplastic effects
in the available chronic toxicity study in rats. No evidence of
neurotoxicity or immunotoxicity was seen in the available studies.
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 diglycerol is adequately defined. No acute
dietary, chronic dietary, incidental oral, or dermal endpoints were
selected because no adverse effects were identified following dietary
exposure to diglycerol or related compounds. The short-term inhalation
endpoints are selected from the inhalation toxicity study in rats, with
a no observed adverse effect concentration (NOAEC) of 0.165 mg/L and a
lowest observed adverse effect concentration (LOAEC) of 0.66 mg/L,
based on squamous metaplasia of the epithelium lining the base of the
epiglottis.
C. Exposure Assessment
1. Dietary exposure. Dietary exposure (food and drinking water) may
occur from consuming food treated with pesticide formulations
containing this inert ingredient and from non-pesticidal uses (e.g.,
personal care products). However, no dietary endpoints of concern were
identified, and therefore, a quantitative dietary exposure assessment
for diglycerol was not conducted.
Based on the lack of treatment-related tumors in the
carcinogenicity study in rats and the lack of mutagenicity in the
available in vitro studies, diglycerol is considered not likely to be
carcinogenic. Therefore, a cancer dietary exposure assessment was not
performed.
2. Residential exposure. The term ``residential exposure'' is used
in this document to refer to non-occupational, non-dietary exposure
(e.g., for lawn and garden pest control, indoor pest control, etc.).
Diglycerol may be used as an inert ingredient in pesticide products
that are registered for specific uses that may result in residential
exposure, such as pesticides used in and around the home. For
residential handlers, the Agency assumed handlers may receive short-
term dermal and inhalation exposure to diglycerol from formulations
containing
[[Page 14494]]
the inert ingredient in outdoor and indoor scenarios. However, as
dermal endpoints were not selected, margins of exposure (MOEs) were
only calculated for inhalation exposure scenarios. For residential
handler short-term outdoor and indoor exposure scenarios, inhalation
MOEs ranged from 23,000 to 940,000 and are not of concern (i.e., the
level of concern (LOC) for inhalation exposure is for MOEs that are
less than 100). Residential handler intermediate-term and long-term
exposures are not calculated because applications are not expected to
occur daily or for more than 30 days.
Residential post-application scenarios include short- and
intermediate-term dermal (skin contact with treated surfaces) exposure
for adults and children as well as short- and intermediate-term
incidental oral exposure for children (hand-to-mouth exposure with
treated surfaces). However, no dermal or dietary endpoints were
selected for diglycerol and therefore, a post-application exposure
assessment was not performed.
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.''
Unlike pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to diglycerol and any other
substances, and diglycerol does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance exemption, therefore, EPA has assumed that diglycerol 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>.
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
(FQPA) 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 the evaluation of available toxicity studies, there is low
concern for pre- and postnatal susceptibility for infants and children
from exposure to diglycerol. The FQPA safety factor has been reduced to
1X because: (1) the toxicity database is adequate to characterize
potential pre- and postnatal risk for infants and children; (2) no
developmental or reproductive effects were observed in the available
reproduction toxicity and developmental studies; (3) no evidence of
neurotoxicity was observed in the database; and (4) the assumptions for
the exposure assessment are unlikely to underestimate risk.
E. Aggregate Risks and Determination of Safety
In an aggregate assessment, exposures from relevant sources are
added together and compared to quantitative estimates of hazard (e.g.,
a NOAEL or PAD), or the risks themselves can be aggregated. When
aggregating exposures and risks from various sources, EPA considers
both the route and duration of exposure.
1. Acute aggregate risk. An acute aggregate risk assessment takes
into account exposure estimates from acute dietary consumption of food
and drinking water. However, there was no hazard attributable to a
single exposure seen in the toxicity database for diglycerol.
Therefore, diglycerol is not expected to pose an acute aggregate risk.
2. Short-term aggregate risk. Short-term aggregate exposure takes
into account short-term residential (dermal and inhalation) exposure
plus chronic dietary exposure (food and drinking water). However, there
was no hazard attributable to chronic dietary or dermal exposure.
Therefore, the short-term aggregate risk is equal to the inhalation
exposure risk, which is not of concern.
3. Chronic aggregate risk. A chronic aggregate risk assessment
takes into account exposure estimates from chronic dietary consumption
of food and drinking water. However, there was no hazard attributable
to chronic dietary exposure. Therefore, diglycerol is not expected to
pose a chronic aggregate risk.
4. Cancer aggregate risk. EPA has not identified any concerns for
carcinogenicity relating to diglycerol. Therefore, diglycerol is not
expected to pose a cancer aggregate risk.
5. Determination of safety. Therefore, based on the risk
assessments and information described above, EPA concludes there is a
reasonable certainty that no harm will result to the general
population, or to infants and children, from aggregate exposure to
diglycerol residues. More detailed information on this action can be
found in the ``Diglycerol. Human Health Risk Assessment and Ecological
Effects Assessment to Support Inert Ingredient Approval for use in
Pesticide Formulations'' in docket ID EPA-HQ-OPP-2022-0737.
V. 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.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of diglycerol (CAS Reg. No. 59113-36-9) when
used as an inert ingredient (plasticizer) in pesticide formulations
applied to growing crops and raw agricultural commodities pre- and
post-harvest under 40 CFR 180.910.
VII. Statutory and Executive Order Reviews
This action establishes an exemption 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
[[Page 14495]]
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 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).
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: March 3, 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. 180.910, amend table 1 to 180.910 by:
0
a. Adding in alphabetical order an entry for ``diglycerol'' and
0
b. Revising the entry for ``2,6-Pyridinedicarboxylic acid''.
The addition and revision 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
------------------------------------------------------------------------
* * * * * * *
Diglycerol (CAS Reg. No. 59113- ................. Plasticizer.
36-9).
* * * * * * *
2,6-Pyridinedicarboxylic acid Not to exceed 2 Stabilizer.
(CAS Reg. No. 499-83-2). ppm.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2023-04806 Filed 3-8-23; 8:45 am]
BILLING CODE 6560-50-P
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</html>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.