Document ID: EPA-HQ-OPP-2020-0424-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Isoprothiolane
Posted Date: 2021-12-06T05:00Z

[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Rules and Regulations]
[Pages 68921-68926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26369]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0424; FRL-9063-01-OCSPP]

Isoprothiolane; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
isoprothiolane in or on banana; rice, bran; rice, husked; and rice, 
polished rice. Nichino America, Inc. requested these tolerances under 
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 6, 2021. Objections and 
requests for hearings must be received on or before February 4, 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-2020-0424, 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration

[[Page 68922]]

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].

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 EPA's 
tolerance regulations at 40 CFR part 180 through the Office of the 
Federal Register'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, 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-2020-0424 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 
February 4, 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-2020-0424, 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/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 21, 2020 (85 FR 82998) (FRL-
10016-93), 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 
9E8820) by Nichino America, Inc., 4550 Linden Hill Road, Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the fungicide 
isoprothiolane, Diisopropyl 1,3-dithiolan-2-ylidenemalonate, in or on 
raw agricultural commodities banana at 1 part per million (ppm); rice, 
bran, at 30 ppm; rice, husked, at 6 ppm; and rice, polished at 1.5 ppm. 
That document referenced a summary of the petition prepared by Nichino 
America, Inc., the registrant, which is available in the docket, 
https://www.regulations.gov. One comment was received on the notice of 
filing. EPA's response to the comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised one commodity definition and is establishing several tolerances 
at different levels than requested by the registrant. The reasons for 
these changes are explained in Unit IV.D.

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. 
Neither of these exposures are relevant to this action, however. 
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 in FFDCA section 408(b)(2)(D), 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 isoprothiolane. EPA's 
assessment of exposures and risks associated with isoprothiolane 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
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.
    The primary target organ for isoprothiolane is the liver in rats 
and mice. Consistent decreases in body weight were also observed at the 
same or lower doses than the liver effects throughout the database. 
Adverse liver effects included increases in liver enzymes, increased 
liver weight (absolute and relative), hepatocellular hypertrophy, 
eosinophilic foci of cellular alterations, eosinophilic cytoplasmic 
inclusions, and spongiosis hepatis in rats. In mice, following chronic 
dosing, amyloidosis was observed across several organs at the highest-
tested dose. There is no evidence of increased qualitative or 
quantitative susceptibility in the rat and rabbit developmental 
toxicity studies or the 2-generation rat reproduction study.
    There was no evidence of immunotoxicity, or neurotoxicity observed 
in any species in the submitted toxicity database.

[[Page 68923]]

    Isoprothiolane is classified as ``Suggestive Evidence of 
Carcinogenic Potential'' based upon increases of skin keratoacanthomas 
and keratoacanthomas, papillomas, basal cell epitheliomas and/or 
squamous cell carcinomas combined in male rats. Isoprothiolane is not 
considered to be genotoxic. The Agency has determined that 
quantification of risk using a non-linear approach (i.e., chronic 
reference dose (cRfD)) will adequately account for all chronic 
toxicity, including any potential carcinogenicity, that could result 
from exposure to isoprothiolane.
    Specific information on the studies received and the nature of the 
adverse effects caused by isoprothiolane as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document Isoprothiolane. Human Health Risk 
Assessment for Isoprothiolane Tolerances for Banana and Rice without a 
U.S. Registration (First Food Use) hereinafter ``Isoprothiolane Human 
Health Risk Assessment'' at pages 23-44 in docket ID number EPA-HQ-OPP-
2020-0424.

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 information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for isoprothiolane used 
for human risk assessment can be found in the Isoprothiolane Human 
Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isoprothiolane, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
isoprothiolane in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for isoprothiolane; therefore, 
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 2003-2008 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). As to 
residue levels in food, EPA assumed tolerance-level residues or 
tolerance level residues adjusted to account for the residue of concern 
for risk assessment; default and empirical processing factors; and 100 
percent crop treated (PCT).
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on its review of available data, EPA 
has concluded that a nonlinear RfD approach will adequately account for 
all chronic toxicity, including any potential carcinogenicity, that 
could result from exposure to isoprothiolane. Cancer risk was assessed 
using the same exposure estimates as discussed in Unit III.C.1.ii., 
chronic exposure.
    iv. Percent crop treated (PCT) information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for isoprothiolane. Tolerance level residues and/or 100% CT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. Residues are not expected 
in drinking water as the products will not be used in the U.S.
    3. From non-dietary 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, 
termiticides, and flea and tick control on pets).
    Isoprothiolane is not registered for any use patterns; therefore, 
there is no residential exposure.
    4. 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 other 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 isoprothiolane and any 
other substances and isoprothiolane does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
action, therefore, EPA has not assumed that isoprothiolane has 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/pesticide-cumulative-risk-assessment-framework.

D. Safety Factor for Infants and Children

    1. In general. 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 FQPA Safety 
Factor (SF). In applying

[[Page 68924]]

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.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased qualitative or quantitative susceptibility in the rat and 
rabbit developmental toxicity studies or the 2-generation rat 
reproduction study. In the rat developmental study, developmental 
effects (decrease fetal weights, increased incidence of small fetuses, 
and increased incidence of a skeletal variation (un-ossification of 
thoracic vertebral body)) were observed in the presence of maternal 
toxicity (decreased maternal body weight). In the rabbit developmental 
toxicity study, no significant developmental or maternal effects were 
seen. In the 2-generation reproductive toxicity study in rats, parental 
toxicity was manifested as decreases in body weights and food 
consumption in P and F1 parents; increases in liver weights and spleen 
weights (P and F1 parents); decreases in thymus weights (P and F1 
females); and increased incidences of microscopic findings in the liver 
(centrilobular hepatic hypertrophy), thymus (thymic atrophy) of P and 
F1 females. Offspring toxicity (decreased body weights and delayed 
physical development (delayed eye opening)) and reproductive toxicity 
(decreased ovary and uterus weights, atrophy of the endometrium and 
myometrium in the uterus, and atrophy of the ovaries) were observed in 
the presence of parental toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for isoprothiolane is complete at this 
time.
    ii. Although acute (ACN) and subchronic (SCN) neurotoxicity studies 
were not available, neurobehavior (functional observation battery (FOB) 
and motor activity) was assessed in two 13-week oral studies in rats 
and mice on isoprothiolane; no changes in FOB and motor activity were 
observed. There was no evidence of neurotoxicity in the isoprothiolane 
database including subchronic studies or in the routine clinical 
observations of the chronic studies. EPA's Hazard and Science Policy 
Council recommended waiving the acute and subchronic neurotoxicity 
studies at this time. There is no indication that isoprothiolane is a 
neurotoxic chemical and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that isoprothiolane results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. Tolerance-level residues or adjusted tolerance level 
residues (adjusted to account for the residue of concern), were used 
for the commodities. An assumption of 100% crop treated was also used 
for the chronic dietary analysis. There are no residual uncertainties 
in the exposure database. The residue database is adequate. The Human 
Health Risk Assessment will not underestimate the exposure and risks 
posed by isoprothiolane.

E. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
isoprothiolane is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
isoprothiolane from food and water will utilize 5.8% of the cPAD for 
all infants (<1 year old), the population group receiving the greatest 
exposure. There are no residential uses for isoprothiolane.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because isoprothiolane 
is not registered in the United States, the only exposures will be 
dietary, from residues in or on imported rice commodities or banana; 
therefore, no short-term or intermediate-term residential exposure is 
expected.
    Because there is no short- or intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess short-term risk), no further assessment of 
short- or intermediate-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short or intermediate-
term risk for isoprothiolane.
    4. Aggregate cancer risk for U.S. population. As stated in Unit 
III.A., EPA has concluded that the chronic reference dose will 
adequately account for all repeated exposure/chronic toxicity, 
including carcinogenicity, that could result from exposure to 
isoprothiolane. Based on the lack of chronic risk at regulated levels 
of exposure, EPA concludes that isoprothiolane will not pose an 
aggregate cancer risk.
    5. Determination of safety. Based on these risk assessments, 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 isoprothiolane residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology 88449-M is available to enforce 
the tolerance expression in/on banana. Method No. 88449-M includes 
analysis by liquid chromatography with tandem mass spectroscopy (LC/MS/
MS). For rice, the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) 
review indicated that the QuEChERS (quick, easy, cheap, effective, 
rugged, and safe) method is adequate for the determination of 
isoprothiolane.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

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 Alimentarius is a joint

[[Page 68925]]

United Nations Food and Agriculture Organization/World Health 
Organization food standards program, and it is recognized as an 
international food safety standards-setting organization in trade 
agreements to which the United States is a party. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain the reasons for departing from the 
Codex level.
    The Codex has established MRLs for isoprothiolane in or on rice, 
husked at 6 ppm and rice, polished at 1.5 ppm. These MRLs are the same 
as the tolerances established for isoprothiolane in the United States. 
There are currently no Codex MRLs for banana or rice, bran.

C. Response to Comments

    EPA received one comment in response to the December 21, 2020 
Notice of Filing, which recommended that the use of pesticides on food 
should be banned. Although the Agency recognizes that some individuals 
believe that pesticides should be banned on agricultural crops, the 
existing legal framework provided by section 408 of the FFDCA 
authorizes EPA to establish tolerances when it determines that the 
tolerance is safe. Upon consideration of the validity, completeness, 
and reliability of the available data as well as other factors the 
FFDCA requires EPA to consider, EPA has determined that the quizalofop 
ethyl tolerances are safe. The commenter has provided no information 
indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing two tolerances at different levels than 
requested by the petitioner. Specifically, EPA is establishing the 
tolerance for banana at 0.9 ppm rather than 1 based on the Organization 
for Economic Co-operation and Development (OECD) tolerance calculation 
procedure. The proposed ``rice, bran'' tolerance was 30 ppm. EPA is 
establishing the ``rice, bran'' tolerance at 15 ppm rather than 30 ppm 
based on the field trial and processing data. In addition, EPA revised 
the commodity definition from the proposed ``rice, polished'' to 
``rice, polished rice'' to conform to current practices.

V. Conclusion

    Therefore, tolerances are established for residues of 
isoprothiolane, including its metabolites and degradates, as determined 
by measuring only isoprothiolane (bis(1-methylethyl) 2-(1,3-dithiolan-
2-ylidene)propanedioate), in or on banana at 0.9 ppm; rice, bran, at 15 
ppm; rice, husked, at 6 ppm; and rice, polished rice at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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: November 23, 2021.
Edward Messina,
Director, 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. Add Sec.  180.721 to subpart C to read as follows:

Sec.  180.721  Isoprothiolane; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide isoprothiolane, including its metabolites and degradates, in 
or on the commodities in Table 1 to this paragraph (a). Compliance with 
the tolerance levels specified in Table 1 to this paragraph (a) is to 
be determined by measuring only residues of isoprothiolane (bis(1-
methylethyl) 2-(1,3-dithiolan-2-ylidene)propanedioate) in or on the 
commodities:

[[Page 68926]]

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana \1\..................................................         0.9
Rice, bran \1\..............................................          15
Rice, husked \1\............................................           6
Rice, polished rice \1\.....................................         1.5
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of December 6, 2021.

    (b)-(d) [Reserved]

[FR Doc. 2021-26369 Filed 12-3-21; 8:45 am]
BILLING CODE 6560-50-P