[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Rules and Regulations]
[Pages 60368-60372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23836]



40 CFR Part 180

[EPA-HQ-OPP-2020-0391; FRL-8991-01-OCSPP]

Benzobicyclon; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation increases a tolerance for residues of 
benzobicyclon in or on rice grain and removes any restriction on 
regional use. Gowan Company requested this tolerance increase under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 2, 2021. Objections and 
requests for hearings must be received on or before January 3, 2022, 
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-2020-0391, is available at http://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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health emergency, the EPA Docket Center (EPA/DC) 
and Reading Room is closed to visitors with limited exceptions. The 
staff continues to provide customer service via email, phone, and 
webform. For the latest status information on EPA/DC services, docket 
access, visit http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director, 
Registration Division (7505P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (703) 305-7090; email address: 
[email protected].


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 EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2020-0391 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 
January 3, 2022. 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-2020-0391, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://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 http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 22, 2021 (86 FR 21317) (FRL-10022-
59) EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0F8831) by

[[Page 60369]]

Gowan Company, P.O. Box 5569, Yuma, AZ 85364. The petition requested to 
amend the tolerance in 40 CFR 180.693 for residues of the herbicide 
benzobicyclon in or on rice to 0.15 parts per million (ppm). That 
document referenced a summary of the petition prepared by Gowan, the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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. 
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 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 . . 
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified therein, 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 benzobicyclon, including exposure resulting from 
the tolerance established by this action. EPA's assessment of exposures 
and risks associated with benzobicyclon follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemaking of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking, and EPA considers referral back to those sections 
as sufficient to provide an explanation of the information EPA 
considered in making its safety determination for the new rulemaking.
    EPA has previously published a tolerance rulemaking for 
benzobicyclon, in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to benzobicyclon and established a 
tolerance for residues of that chemical. See the benzobicyclon 
tolerance rulemaking published in the Federal Register of April 25, 
2017 (82 FR 18995) (FRL-9961-02). EPA is incorporating previously 
published sections from that rulemaking that remain unchanged, as 
described further in this rulemaking.
    Toxicological profile. There have been updates to the toxicological 
profile from the previous assessment. The parent compound, 
benzobicyclon, is a pro-pesticide, which means it requires hydrolysis 
of the thiophenyl group to generate the anticipated pesticidal active 
moiety, metabolite B (also referred to as 1315P-070). The toxicological 
database is considered complete for risk assessment purposes for both 
the parent, benzobicyclon, and metabolite B. The enzyme 4-
hydroxyphenylpyruvate dioxygenase (HPPD) is involved in the catabolism 
of tyrosine, an essential amino acid for mammals. While benzobicyclon 
may be referred to as an HPPD inhibitor, typical HPPD-inhibiting 
effects are not observed in its toxicological database. However, 
metabolite B does exhibit HPPD-inhibiting effects and is therefore 
considered an HPPD-inhibiting chemical. The initiating event in the 
mode-of-action (MOA)/adverse-outcome pathway (AOP) for HPPD-inhibiting 
chemicals, including metabolite B, involves binding of the chemical to 
the HPPD enzyme causing complete or virtually complete enzyme 
inhibition, which leads to a build-up of systemic tyrosine levels 
(tyrosinemia) and a spectrum of tyrosine-mediated effects. In 
laboratory animals, these have been identified as ocular and skeletal 
developmental effects. Species differences exist in laboratory animals 
related to the ability of a species to clear excess tyrosine from its 
system, which can impact its sensitivity to HPPD-inhibiting chemicals 
and its relevance for human health risk assessment. In this risk 
assessment, endpoints were selected for both benzobicyclon and 
metabolite B. Taking into account species differences, endpoints for 
human health risk assessment of HPPD inhibitors, including metabolite 
B, were selected from studies available in mice and dogs. Studies from 
other HPPD inhibitors were used for bridging to metabolite B as needed. 
Since benzobicyclon does not exhibit HPPD-inhibiting properties, 
endpoints were selected from the most sensitive species and effects in 
its database (not restricted to mice and dogs).
    Benzobicyclon: An acute dietary endpoint was not selected for 
benzobicyclon, as there were no effects attributable to a single dose 
identified in the database. The chronic dietary, incidental oral, and 
inhalation endpoints were based on increased incidence of hydropic 
degeneration (basophilic cells) in the pituitary observed in the two-
generation reproduction toxicity study in rats. A dermal endpoint was 
not selected since no hazard was identified in the dermal toxicity 
study and there was no evidence of increased quantitative 
susceptibility in the database. Benzobicyclon is classified as ``Not 
Likely to be Carcinogenic to Humans'' based on the absence of 
treatment-related tumors in two adequate rodent carcinogenicity 
    Metabolite B: There were no effects attributable to a single dose 
available in the metabolite B database or in studies from other HPPD 
inhibitors; therefore, an acute dietary endpoint was not selected for 
metabolite B. The chronic dietary endpoint is based on gallstones, 
eosinophilic cytoplasmic alteration, subepithelial mixed cell 
infiltrate, and dilatation in/of the gallbladder; hepatocellular 
vacuolation, hepatocellular hypertrophy, and increased liver weight in 
males and females; and papillary mineralization of the kidney and 
changes in hematological parameters indicative of anemia in females 
observed in the chronic/carcinogenicity study in mice from another HPPD 
chemical available for bridging (tembotrione). Since the only 
anticipated exposure is through drinking water, no additional points of 
departure (PODs) were selected for metabolite B. There are no 
carcinogenicity studies available for metabolite B; however, 
carcinogenicity studies are available for bridging for all of the other 
currently registered HPPD inhibitors. Overall, potential 
carcinogenicity is not a concern for the HPPD inhibitors, and the 
chronic dietary endpoint and POD for metabolite B is considered 
protective of any potential carcinogenicity.
    Additional information is available in the docket for this action 
in the document titled ``Benzobicyclon: Section 3 Risk Assessment for 
Proposed New Formulation, Increase to the Established Tolerance, and 
National Use Expansion on Rice'' (hereafter, the ``Benzobicyclon Human 
Health Risk Assessment'').

[[Page 60370]]

    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
benzobicyclon and metabolite B used for human health risk assessment, 
please reference section 4.6.3 on pages 25-27 of the ``Benzobicyclon 
Human Health Risk Assessment''.
    Exposure assessment. EPA's dietary exposure assessments have been 
updated to include the additional exposure from the tolerance increase 
on rice grain and national use expansion.
    No effects attributable to a single dose were observed for 
benzobicyclon or metabolite B; therefore, acute dietary exposure 
assessments were not conducted.
    Based on the toxicological effects of benzobicyclon and metabolite 
B, separate chronic dietary exposure and risk assessments were 
conducted. The assessments were conducted using Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCID) Version 3.16, which uses food consumption data from the 
U.S. Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). This 
dietary survey was conducted from 2003 to 2008.
    The benzobicyclon chronic dietary exposure assessment assumed 
tolerance-level residues for rice, 100 percent crop treated (PCT), and 
a modeled estimated drinking water concentration (EDWC) of 0.199 parts 
per billion (ppb). The DEEM default processing factor of 1.25 was used 
for both rice flour and rice bran.
    There is no anticipated exposure in food to metabolite B. As 
metabolite B is only a residue of concern in drinking water, the 
chronic dietary exposure assessment was conducted for drinking water 
only. The chronic analysis used a modeled EDWC of 4.27 ppb and assumed 
100 PCT.
    There are no residential (non-occupational) exposures associated 
with benzobicyclon or metabolite B.
    Cumulative exposure. The Agency is required to consider the 
cumulative risks of chemicals sharing a common mechanism of toxicity. 
The Agency has determined that the (p-hydroxyphenyl-pyruvate 
dioxygenase) HPPD inhibitors share a common mechanism of toxicity as 
discussed in the document titled ``HPPD Inhibiting Herbicides: State of 
the Science,'' which is available in the docket for this action. As 
explained in that document, the members of this group of chemicals 
share the ability to bind to and inhibit the HPPD enzyme resulting in 
elevated systemic tyrosine levels and common apical outcomes that are 
mediated by tyrosine, including ocular and developmental effects. In 
2021, after establishing a common mechanism grouping for the HPPD 
inhibitors, the Agency conducted the ``P-Hydroxyphenyl-Pyruvate 
Dioxygenase (HPPD) Inhibitors Cumulative Risk Assessment: 
Benzobicyclon, Bicyclopyrone, Isoxaflutole, Mesotrione, Pyrasulfotole, 
Tembotrione, Tolpyralate, and Topramezone,'' which is available in the 
docket for the action, and concluded that cumulative exposures to HPPD 
inhibitors (based on proposed and registered pesticidal uses at the 
time the assessment was conducted) did not present risks of concern.
    Safety Factor (SF) for Infants and Children. The Food Quality 
Protection Act (FQPA) section has been updated since the last 
assessment. EPA has determined that the required FQPA SF of 10X for the 
protection of infants and children be reduced to 1X for all exposure 
scenarios for benzobicyclon (parent). For metabolite B, since the 
chronic dietary endpoint is based on a study with no No-Observed-
Adverse-Effect Level (NOAEL), a 10X FQPA SF/Uncertainty Factor 
(UFL) has been retained for extrapolation from a Lowest-
Observed-Adverse-Effect Level (LOAEL) to a NOAEL.
    Completeness of the Toxicology Database: The existing toxicological 
database for benzobicyclon is adequate for FQPA evaluation. 
Developmental and two-generation reproduction studies in rats are 
available for benzobicyclon. However, the active moiety of 
benzobicyclon, metabolite B, has been shown to be more toxic than the 
parent compound. Therefore, studies were conducted with metabolite B, 
including a developmental toxicity study in mice. Additionally, 2-
generation reproduction toxicity studies are available from other HPPD 
inhibitors for bridging.
    Evidence of Neurotoxicity: There was no neurotoxicity observed 
throughout the database for benzobicyclon or metabolite B. The 
subchronic neurotoxicity study with benzobicyclon tested up to 1,290 
mg/kg with no adverse effects observed, nor was there evidence of 
neurotoxicity in any of the guideline studies in the databases for 
either chemical.
    Evidence of Sensitivity/Susceptibility in the Developing or Young 
Animal: For benzobicyclon, there was no increased qualitative or 
quantitative susceptibility observed in the two-generation reproduction 
or developmental toxicity studies in rats. A developmental study in 
rabbits was submitted but was considered unacceptable and subsequently 
waived by EPA.
    For metabolite B, a developmental toxicity study in mice did not 
show any increased qualitative or quantitative susceptibility. A 2-
generation reproduction study is not available for metabolite B; 
however, there are 2-generation reproduction studies from other HPPDs 
inhibitors that can be used for bridging. In one of the 2-generation 
studies in mice for another HPPD inhibitor (mesotrione), quantitative 
susceptibility was observed in offspring. However, concern is low 
because there are clear NOAEL/LOAEL values for the observed effects, 
the offspring LOAEL of 300 mg/kg/day from the mesotrione 2-generation 
reproduction toxicity study was set conservatively based on a low 
incidence of opaque/cloudy eyes, and the selected endpoints used in 
this risk assessment are protective of any potential sensitivity 
observed in mice.
    Residual Uncertainty in the Exposure Database: The exposure 
databases are complete or are estimated based on data that reasonably 
account for potential exposures. There are no registered or proposed 
residential uses and/or commercial uses at residential sites for 
benzobicyclon at this time. Therefore, a residential exposure 
assessment is not required. The dietary exposure assessments (food and 
drinking water) are considered to be conservative estimates of 
exposure. Tolerance-level residues for rice and 100 PCT were assumed 
for the food exposure assessment. Drinking water exposure estimates 
(for both benzobicyclon and metabolite B) are based on conservative 
models assuming maximum use rates and are not expected to underestimate 
the exposure. The Agency is confident that the assessments do not 
underestimate risk from dietary exposure to benzobicyclon or metabolite 
    Aggregate risks and Determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
aggregate exposure estimates to the acute population-adjusted dose 
(aPAD) and the chronic population-adjusted dose (cPAD). Short-, 
intermediate-, and chronic term risks are evaluated by comparing the 
estimated aggregate food, water, and residential exposure to the 
appropriate points of departure to ensure that an adequate margin of 
exposure (MOE) exists. For linear cancer risks, EPA calculates the 
lifetime probability of acquiring cancer given the estimated aggregate 
    There are no acute dietary endpoints for benzobicyclon or 
metabolite B; therefore, an acute risk assessment is

[[Page 60371]]

unnecessary. Chronic dietary risks are below the Agency's level of 
concern of 100% of the cPAD for both benzobicyclon and metabolite B. It 
is less than 1% of the cPAD for benzobicyclon for all population 
subgroups and 5.8% of the cPAD for metabolite B for all infants less 
than 1-year old, the population subgroup with the highest exposure 
estimate for both benzobicyclon and metabolite B.
    As noted earlier, there are no residential uses associated with 
benzobicyclon. Because there is no short- or intermediate-term 
residential exposure and chronic dietary exposure has been assessed 
under the appropriately protective cPAD, EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for benzobicyclon and metabolite B.
    Based on the lack of evidence of carcinogenicity in two adequate 
rodent carcinogenicity studies, benzobicyclon is not expected to pose a 
cancer risk to humans. For metabolite B, potential carcinogenicity is 
not a concern for the HPPD inhibitors and the chronic dietary endpoint 
and POD for metabolite B is considered protective of any potential 
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is reasonable certainty that no harm will 
result to the general population, or to infants and children, from 
aggregate exposure to benzobicyclon or metabolite B residues. More 
detailed information can be found at http://www.regulations.gov in the 
Benzobicyclon Human Health Risk Assessment in docket ID number EPA-HQ-

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the April 25, 2017 rulemaking (82 FR 18995) (FRL-

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4).
    The Codex has not established an MRL for residues of benzobicyclon 
in or on rice grain.

V. Conclusion

    Therefore, the tolerance for residues of benzobicyclon on rice, 
grain is increased from 0.01 ppm to 0.15 ppm and is no longer a 
tolerance with regional restrictions.

VI. Statutory and Executive Order Reviews

    This action increases 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 to 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, 
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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).

VII. 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: October 27, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter 1 as follows:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. Revise Sec.  180.693 to read as follows:

Sec.  180.693   Benzobicyclon; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide benzobicyclon, including its metabolites and degradates, in 
or on the commodity in the table below. Compliance with the tolerance 
level specified below is to be determined by measuring only 
benzobicyclon, 3-[2-chloro-4-(methylsulfonyl)benzoyl]-4-
(phenylthio)bicyclo-[3.2.1]oct-3-en-2-one), in or on the following raw 
agricultural commodity:

[[Page 60372]]

                      Table 1 to Sec.   180.693(a)
                                                             Parts per
                        Commodity                             million
Rice, grain.............................................            0.15

    (b)-(d) [Reserved]

[FR Doc. 2021-23836 Filed 11-1-21; 8:45 am]