[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 [www.gpo.gov]
[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 
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. For the latest 
status information on EPA/DC services, docket access, visit 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) 566-2875; 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 Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/current/title-40.

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:
     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. 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, https://www.regulations.gov. 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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.
 
                              * * * * * * *
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[FR Doc. 2023-04806 Filed 3-8-23; 8:45 am]
BILLING CODE 6560-50-P


