[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Rules and Regulations]
[Pages 48308-48315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18390]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0054; FRL-8750-02-OCSPP]


Thiabendazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
thiabendazole in or on multiple commodities that are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 30, 2021. Objections and 
requests for hearings must be received on or before October 29, 2021, 
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-2020-0054, 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,

[[Page 48309]]

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 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 
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: 
RDFRNotices@epa.gov.

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 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, 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-2020-0054 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 
October 29, 2021. 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-2020-0054, 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 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    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 June 28, 2021 (86 FR 33922) (FRL-10025-
08), 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 
9E8812) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201W, Princeton, 
NJ 08540. The petition requested EPA to establish tolerances in 40 CFR 
180.242 for residues of thiabendazole (2-(4-thiazolyl)benzimidazole), 
including its metabolites and degradates, in or on the following raw 
agricultural commodities: Animal feed, nongrass, group 18 at 0.01 parts 
per million (ppm); Beet, garden, leaves at 0.01 ppm; Brassica, leafy 
greens, subgroup 4-16B at 0.01 ppm; Burdock, edible, leaves at 0.01 
ppm; Carrot, leaves at 0.01 ppm; Carrot, roots at 10 ppm; Celeriac, 
leaves at 0.01 ppm; Chervil, turnip rooted, leaves at 0.01 ppm; 
Chicory, leaves at 0.01 ppm; Fruit, citrus, group 10-10 at 10 ppm; 
Fruit, pome, group 11-10 at 10 ppm; Kohlrabi at 0.01 ppm; Radish, 
oriental, leaves at 0.01 ppm; Rutabaga, leaves at 0.01 ppm; Salsify, 
black, leaves at 0.01 ppm; Sweet potato, tuber at 3 ppm; Vegetable, 
Brassica, head and stem, group 5-16 at 0.01 ppm; Vegetable, root, 
except sugar beet, subgroup 1B at 0.01 ppm; Vegetable, tuberous and 
corm, subgroup 1C, except sweet potato at 10 ppm.
    The petition also proposed to remove the established tolerances for 
residues of thiabendazole (2-(4-thiazolyl)benzimidazole), including its 
metabolites and degradates, in or on the following raw agricultural 
commodities: Potato, postharvest at 10.0 ppm; Sweet potato (postharvest 
to sweet potato intended only for use as seed) at 0.05 ppm; Alfalfa, 
forage at 0.02 ppm; Alfalfa, hay at 0.02 ppm; Radish, tops at 0.02 ppm; 
Brassica, head and stem, subgroup 5A at 0.02 ppm; Fruit, citrus, group 
10, postharvest at 10.0 ppm; Fruit, pome, group 11, postharvest at 5.0 
ppm; Vegetable, root (except sugarbeet), subgroup 1B at 0.02 ppm; 
Carrot, roots, postharvest at 10.0 ppm; and in paragraph (b) Sweet 
potato at 10 ppm.
    That document referenced a summary of the petition prepared by 
Syngenta Crop Protection, the registrant, which is available in the 
docket, http://www.regulations.gov. No comments were received in 
response to the notice of filing.
    A previous notice of filing was published in the Federal Register 
of April 15, 2020 (85 FR 20910) (FRL-10006-54). The April 15, 2020 
notice is superseded by the June 28, 2021 notice.

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. . . 
.''

[[Page 48310]]

    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 thiabendazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with thiabendazole 
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.
    Decreased body weight is the most sensitive effect of exposure to 
thiabendazole observed even in young rat pups during lactation. 
Histopathological changes in the spleen (congestion and pigmentation) 
and kidney (calculus and hyperplasia of transitional epithelium) were 
noted in a subchronic rat study, and splenic erythropoiesis and 
hemosiderosis were reported in a chronic dog study. Other target organs 
of thiabendazole toxicity are the liver and thyroid. Increased 
quantitative susceptibility was observed in the rat and rabbit 
developmental toxicity studies, in which developmental effects occurred 
in the absence of maternal toxicity. Increased quantitative 
susceptibility was not observed in the prenatal developmental toxicity 
study in mice and in the 2-generation reproduction study in rats. In an 
acute neurotoxicity rat study (ACN), reduced locomotor activity was 
identified, although no morphological or histopathological effects were 
noted in the brain. No signs of neurotoxicity were seen in the 
subchronic neurotoxicity study. Thiabendazole is classified as ``Likely 
to be carcinogenic to humans at doses high enough to cause a 
disturbance of the thyroid hormonal balance. It is not likely to be 
carcinogenic at doses lower than those which could cause a disturbance 
of this hormonal balance''.
    Additional information on the toxicological profile can be found at 
http://www.regulations.gov in the document titled ``Thiabendazole: 
Human Health Risk Assessment for the Establishment of Permanent 
Tolerances and Registration for Use on Animal feed, nongrass, group 18; 
Brassica, leafy greens, subgroup 4-16B; and Sweet Potato; and Crop 
Group Conversions/Expansions to Fruit, citrus, group 10-10; Fruit, 
pome, group 11-10; Kohlrabi; Vegetable, Brassica, head and stem, group 
5-16; Vegetable, root, except sugar beet, subgroup 1B; and Vegetable, 
tuberous and corm, subgroup 1C, except sweet potato'' (hereinafter 
``Thiabendazole Human Health Risk Assessment'') in docket ID number 
EPA-HQ-OPP-2020-0054.

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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for thiabendazole used for 
human risk assessment can be found in the Thiabendazole Human Health 
Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thiabendazole, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
thiabendazole 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.
    In conducting the acute dietary exposure assessment, EPA used the 
2003-2008 food consumption data from the U.S. Department of 
Agriculture's National Health and Nutrition Examination Survey, What We 
Eat in America (NHANES/WWEIA). The acute dietary exposure assessment is 
partially refined and incorporated established and recommended 
tolerance-level residues for some commodities, maximum field trial 
residues for the remaining commodities according to blending 
classification, 100 percent crop treated (PCT), and default processing 
factors (except for apple juice, grapefruit juice, lemon juice, lime 
juice, orange juice, pear juice, potato granules/flakes, and tangerine 
juice).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the 2003-2008 food consumption data from the 
USDA's NHANES/WWEIA. The chronic dietary exposure assessment is 
partially refined and incorporated established and recommended 
tolerance-level residues for some commodities, average field trial 
residues for the remaining commodities according to blending 
classification, 100 PCT, and default processing factors (except for 
apple juice, grapefruit juice, lemon juice, lime juice, orange juice, 
pear juice, potato granules/flakes, and tangerine juice).
    iii. Cancer. Thiabendazole is classified as ``Likely to be 
carcinogenic at doses high enough to cause a disturbance of the thyroid 
hormonal balance but not likely to be carcinogenic at doses lower than 
those which could cause a disturbance of this hormonal balance.'' EPA 
is regulating chronic exposure based on a reference dose that is lower 
than (and thus protective of) the level that would cause a disturbance 
in the thyroid hormonal balance, making tumor formation highly 
unlikely; therefore, a cancer dietary exposure assessment is not 
required. The current partially refined chronic dietary risk assessment 
is conservative and is protective for cancer effects.
    iv. Anticipated residue and PCT information. EPA used some 
tolerance-level residues and some anticipated residue data for 
assessing tolerances. Section 408(b)(2)(E) of FFDCA authorizes EPA to 
use available data and information on the anticipated residue levels of 
pesticide residues in food and the actual levels of pesticide residues 
that have been measured in food. If EPA relies on such information, EPA 
must require pursuant to FFDCA section 408(f)(1) that data be provided 
5 years

[[Page 48311]]

after the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    EPA did not use PCT estimates in the dietary assessment for 
thiabendazole; 100 PCT was assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for thiabendazole in drinking water. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the FQPA Index Reservoir Screening Tool (FIRST; surface 
water) model and the Pesticide Root Zone Model for Ground Water (PRZM-
GW; groundwater), EPA used an estimated drinking water concentration 
(EDWC) of 3.80 ppb for the acute dietary risk assessment and a value of 
0.47 ppb for the chronic dietary risk assessment.
    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).
    Thiabendazole is currently registered for uses that may result in 
residential handler and post-application exposures, including use in 
paints and textiles. As an initial matter in assessing aggregate risk 
of the pesticide chemical residues, the Agency takes into consideration 
those residential exposure scenarios that provide the most conservative 
estimate of residential exposures, including handler exposure and post-
application exposure or both.
    The residential handler exposure scenario used in the aggregate 
assessment is for adult handler inhalation exposures from applying 
thiabendazole-treated paint using airless sprayers. For this scenario, 
the Aggregate Risk Index (ARI) approach was used since the PODs/
endpoints were similar, but the levels of concern (LOCs) were 
different. An ARI greater than or equal to 1 is not of concern.
    The residential exposure scenario used for the post-application 
assessment is incidental oral exposures from children 1 to <2 years old 
mouthing preserved textiles (clothing) treated with thiabendazole.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 thiabendazole and any 
other substances and thiabendazole does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that thiabendazole has 
a common mechanism of toxicity with other substances.

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 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. The data submitted to the 
Agency, as well as those from published literature, demonstrated 
increased quantitative susceptibility in the rat and rabbit 
developmental toxicity studies, in which developmental effects 
(decreased fetal weights in rat and rabbit pups) were observed while 
maternal toxicity was not observed up to the highest doses tested. No 
increased susceptibility was observed in mice in utero and/or to rats 
following early postnatal exposure to thiabendazole.
    3. Conclusion. EPA has determined there is reliable data to support 
a conclusion that a FQPA Safety Factor (SF) of 1X will be protective 
for infants and children for all scenarios, with the exception of the 
assessment of inhalation exposure. The default FQPA 10X SF remains in 
place for assessing the non-occupational inhalation exposure due to the 
lack of a subchronic inhalation study with thyroid measurements. That 
decision is based on the following findings:
    i. The toxicology database for thiabendazole is complete with the 
exception of a subchronic inhalation toxicity study with thyroid 
measurements. Based on a weight of evidence approach considering all 
the available hazard and exposure information for thiabendazole, the 
Agency determined that a developmental thyroid toxicity study is not 
required at this time. Acceptable studies are available for 
developmental, reproduction, chronic, subchronic, subchronic 
neurotoxicity and immunotoxicity.
    ii. In an acute neurotoxicity rat study (ACN), reduced locomotor 
activity in males and females at time of peak effect (approximately 3 
hours post-dose) were seen without morphological or histopathological 
effects on the brain. Thiabendazole was not neurotoxic in rats in a 
subchronic neurotoxicity study at the highest dose tested (1,500 ppm 
equivalent to 95 mg/kg/day).
    iii. As noted above, there is some evidence of increased 
susceptibility in the developmental fetus from exposure to 
thiabendazole. Nevertheless, the Agency has sufficient data to 
understand and protect against the potential developmental effects. The 
data indicating the potential for developmental toxicity presented 
well-defined NOAELs and LOAELs, which the Agency took into account when 
identifying endpoints. The selected points of departure for regulating 
exposure are protective of both the potential for neurotoxicity and the 
increased susceptibility of infants and children. There is no residual 
uncertainty concerning the potential for prenatal or post-natal 
toxicity that precludes the reduction of the FPQA 10X SF.
    iv. There are no residual uncertainties in the exposure database. 
The dietary risk assessment is conservative and will not underestimate 
dietary and/or non-dietary occupational exposure to thiabendazole. The 
acute and chronic dietary assessments conducted were slightly refined 
analyses. The assessments utilized tolerance-level residues, maximum 
residue or average

[[Page 48312]]

residue values from field-trial data, empirical or EPA's 2018 default 
processing factors, and 100 PCT. The analysis also used Tier 1 drinking 
water estimates. For these reasons, it can be concluded that the 
analysis does not underestimate risk from acute or chronic exposure to 
thiabendazole. Similarly, EPA does not believe that the non-dietary 
exposures are underestimated because they are also based on 
conservative assumptions.

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. Using the exposure assumptions described in this unit 
for acute exposure, EPA has concluded that acute exposure to 
thiabendazole from food and water will utilize 50% of the aPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
thiabendazole from food and water will utilize 64% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Thiabendazole 
is registered for uses that could result in short-term residential 
exposure, and the Agency has determined that it is appropriate to 
aggregate chronic exposure through food and water with short-term 
residential exposures to thiabendazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate ARI of 1.88 for adults 
and an MOE of 200 for children 1 to 2 years old. Because EPA's level of 
concern for thiabendazole is an ARI of less than or equal to 1 or an 
MOE of 100 or below, these ARIs/MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
thiabendazole is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no 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 intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
thiabendazole.
    5. Aggregate cancer risk for U.S. population. As the risks 
estimated based on the chronic reference dose are protective of cancer 
effects, no separate cancer risk assessment is necessary. The chronic 
dietary aggregate risk assessment is below the Agency's level of 
concern; therefore, the Agency concludes that aggregate exposure to 
thiabendazole is not likely to pose a cancer risk.
    6. 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 thiabendazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate spectrophotofluorometric methods are available in the 
Pesticide Analytical Manual, Volume II (PAM II) for enforcement of 
thiabendazole tolerances.

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 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.
    Codex has established more restrictive (i.e., lower) MRLs for 
residues in/on citrus fruits and pome fruits (7 ppm and 3 ppm 
respectively, versus the existing U.S. tolerances for the old crop 
groups, which are 10.0 ppm for citrus and 5.0 ppm for pome fruit.) 
Therefore, harmonization with the Codex MRLs are not possible because 
U.S. growers would be at risk of violative residues of thiabendazole 
despite legal use according to the label. Instead, EPA is harmonizing 
the tolerance for fruit, pome, group 11-10 with the Canadian MRL of 10 
ppm in/on apples and pears. Additionally, Codex has established an MRL 
for residues in/on potato at 15 ppm, which is higher than the revised 
U.S. tolerance of 10 ppm. Per the registrant's request, the Agency is 
not harmonizing with the established Codex MRL for residues in/on 
potato. Instead, the U.S. tolerance is harmonized with the Canadian MRL 
for potatoes at 10 ppm because Canada is a major trading partner with 
the United States for potatoes.

C. Revisions to Petitioned-For Tolerances

    As mentioned in Unit II., the petitioner requested that the time-
limited tolerance in Sec.  180.242(b) at 10 ppm for residues of 
thiabendazole in/on sweet potato be removed upon the establishment of a 
permanent tolerance for residues of thiabendazole in/on sweet potato in 
Sec.  180.242(a). EPA is not removing the time-limited tolerance on 
sweet potato in Sec.  180.242(b) due to a difference between the 
section 18 use pattern and the proposed use pattern for the section 3 
registration. There is a potential that use under the current section 
18 could result in exceedances if this tolerance was revoked.

D. International Trade Considerations

    In this rule, EPA is establishing tolerances for thiabendazole 
residues in or on the Animal feed, nongrass, group 18; Vegetable, 
Brassica, head and stem, group 5-16; and the Vegetable, root, except 
sugar beet, subgroup 1B (all at 0.01 ppm) that are lower than the 
current tolerances of Alfalfa forage, Alfalfa hay, Brassica head and 
stem

[[Page 48313]]

subgroup 5A, and Vegetable, root (except sugarbeet), subgroup 1B (all 
0.02 ppm). For the reasons explained in the Thiabendazole Human Health 
Risk Assessment, the Agency believes these revised, lower tolerances 
are appropriate.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of the changes to these tolerances in order to satisfy its 
obligations under the Agreement. In addition, the SPS Agreement 
requires that Members provide a ``reasonable interval'' between the 
publication of a regulation subject to the Agreement and its entry into 
force to allow time for producers in exporting Member countries to 
adapt to the new requirement. Accordingly, EPA is establishing an 
expiration date for the existing tolerances to allow these tolerances 
to remain in effect for a period of six months after the effective date 
of this final rule. After the six-month period expires, these 
tolerances will be reduced or revoked, as indicated in the regulatory 
text, and allowable residues on alfalfa forage, alfalfa hay, Brassica 
head and stem subgroup 5A, and vegetable, root (except sugarbeet), 
subgroup 1B must conform to the tolerances for Animal feed, nongrass, 
group 18; Vegetable, Brassica, head and stem, group 5-16; and 
Vegetable, root, except sugar beet, subgroup 1B. This reduction in 
tolerance level is not discriminatory; the same food safety standard 
contained in the FFDCA applies equally to domestically produced and 
imported foods. The new tolerance levels are supported by available 
residue data.

V. Conclusion

    Therefore, tolerances are established for residues of thiabendazole 
in or on Animal feed, nongrass, group 18 at 0.01 ppm; Beet, garden, 
leaves at 0.01 ppm; Brassica, leafy greens, subgroup 4-16B at 0.01 ppm; 
Burdock, edible, leaves at 0.01 ppm; Carrot, leaves at 0.01 ppm; 
Carrot, roots at 10 ppm; Celeriac, leaves at 0.01 ppm; Chervil, turnip 
rooted, leaves at 0.01 ppm; Chicory, leaves at 0.01 ppm; Fruit, citrus, 
group 10-10 at 10 ppm; Fruit, pome, group 11-10 at 10 ppm; Kohlrabi at 
0.01 ppm; Radish, oriental, leaves at 0.01 ppm; Rutabaga, leaves at 
0.01 ppm; Salsify, black, leaves at 0.01 ppm; Sweet potato, tuber at 3 
ppm; Vegetable, Brassica, head and stem, group 5-16 at 0.01 ppm; 
Vegetable, root, except sugar beet, subgroup 1B at 0.01 ppm; and 
Vegetable, tuberous and corm, subgroup 1C, except sweet potato at 10 
ppm.
    Additionally, the following tolerances are removed as unnecessary 
due to the establishment of the above tolerances: Alfalfa, forage; 
Alfalfa, hay; Brassica, head and stem, subgroup 5A; Carrot, roots, 
postharvest; Fruit, citrus, group 10, postharvest; Fruit, pome, group 
11, postharvest; Potato, postharvest; Radish, tops; Sweet potato 
(postharvest to sweet potato intended only for use as seed); and 
Vegetable, root (except sugarbeet), subgroup 1B.
    Finally, EPA is revising the tolerance expression for thiabendazole 
in 40 CFR 180.242(a)(1) and (2) to clarify (1) that, as provided in 
FFDCA section 408(a)(3), the tolerance covers metabolites and 
degradates of thiabendazole not specifically mentioned; and (2) that 
compliance with the specified tolerance levels is to be determined by 
measuring only the specific compounds mentioned in the tolerance 
expression. EPA has determined that it is reasonable to make this 
change final without prior proposal and opportunity for comment, 
because public comment is not necessary, in that the change has no 
substantive effect on the tolerance, but rather is merely intended to 
clarify the existing tolerance expression.

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 tolerances and 
modifications 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: August 18, 2021.
Catherine Aubee,
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:

[[Page 48314]]

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.  180.242:
0
a. Amend paragraph (a)(1) by:
0
i. Revising the introductory text.
0
ii. In the table:
0
A. Adding the heading ``Table 1 to Paragraph (a)(1)'';
0
B. Removing the entries for ``Alfalfa, forage''; and ``Alfalfa, hay'';
0
C. Adding in alphabetical order the entries ``Animal feed, nongrass, 
group 18''; and ``Beet, garden, leaves'';
0
D. Removing the entry for ``Brassica, head and stem, subgroup 5A'';
0
E. Adding in alphabetical order the entries ``Brassica, leafy greens, 
subgroup 4-16B''; ``Burdock, edible, leaves''; ``Carrot, leaves''; and 
``Carrot, roots'';
0
F. Removing the entry for ``Carrot, roots, postharvest'';
0
G. Adding in alphabetical order the entries ``Celeriac, leaves''; 
``Chervil, turnip rooted, leaves''; ``Chicory, leaves''; and ``Fruit, 
citrus, group 10-10'';
0
H. Removing the entry for ``Fruit, citrus, group 10, postharvest'';
0
I. Adding the entry ``Fruit, pome, group 11-10'';
0
K. Removing the entry for ``Fruit, pome, group 11, postharvest'';
0
L. Adding in alphabetical order the entry ``Kohlrabi'';
0
M. Removing the entry for ``Potato, postharvest'';
0
N. Adding in alphabetical order the entry ``Radish, oriental, leaves'';
0
O. Removing the entry for ``Radish, tops'';
0
P. Adding in alphabetical order the entries ``Rutabaga, leaves''; and 
``Salsify, black, leaves'';
0
Q. Removing the entry for ``Sweet potato (postharvest to sweet potato 
intended only for use as seed)'';
0
R. Adding in alphabetical order the entries ``Sweet potato, tuber''; 
``Vegetable, Brassica, head and stem, group 5-16''; and ``Vegetable, 
root, except sugar beet, subgroup 1B'';
0
S. Removing the entry for ``Vegetable, root (except sugarbeet), 
subgroup 1B'';
0
T. Adding in alphabetical order the entry ``Vegetable, tuberous and 
corm, subgroup 1C, except sweet potato'' and
0
b. Amend paragraph (a)(2) by:
0
i. Revising the introductory text.
0
ii. In the table, adding the heading ``Table 2 to Paragraph (a)(2)''.
0
The additions and revisions read as follows:


Sec.  180.242   Thiabendazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
thiabendazole, including its metabolites and degradates, in or on the 
commodities in table 1 to paragraph (a)(1). Compliance with the 
tolerance levels specified to table 1 to paragraph (a)(1) is to be 
determined by measuring only thiabendazole in or on the commodity.

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage 1.......................................            0.02
Alfalfa, hay 1..........................................            0.02
Animal feed, nongrass, group 18.........................            0.01
 
                              * * * * * * *
Beet, garden, leaves....................................            0.01
Brassica, head and stem, subgroup 5A 1..................            0.02
Brassica, leafy greens, subgroup 4-16B..................            0.01
Burdock, edible, leaves.................................            0.01
 
                              * * * * * * *
Carrot, leaves..........................................            0.01
Carrot, roots...........................................              10
Celeriac, leaves........................................            0.01
Chervil, turnip rooted, leaves..........................            0.01
Chicory, leaves.........................................            0.01
 
                              * * * * * * *
Fruit, citrus, group 10-10..............................              10
Fruit, pome, group 11-10................................              10
Kohlrabi................................................            0.01
 
                              * * * * * * *
Radish, oriental, leaves................................            0.01
Rutabaga, leaves........................................            0.01
Salsify, black, leaves..................................            0.01
Sweet potato, tuber.....................................               3
 
                              * * * * * * *
Vegetable, Brassica, head and stem, group 5-16..........            0.01
 
                              * * * * * * *
Vegetable, root, except sugar beet, subgroup 1B.........            0.01
Vegetable, root, except sugar beet, subgroup 1B 1.......            0.02
Vegetable, tuberous and corm, subgroup 1C, except sweet               10
 potato.................................................
 
                              * * * * * * *
------------------------------------------------------------------------
1 This tolerance expires on February 28, 2022.


[[Page 48315]]

    (2) Tolerances are established for residues of thiabendazole, 
including its metabolites and degradates, in or on the commodities in 
table 2 to paragraph (a)(2). Compliance with the tolerance levels 
specified to table 2 to paragraph (a)(2) is to be determined by 
measuring only the sum of thiabendazole (2-(4-thiazolyl)benzimidazole) 
and its metabolite 5-hydroxythiabendazole (free and conjugated) 
calculated as the stoichiometric equivalent of thiabendazole, in or on 
the commodity.

                       Table 2 to Paragraph (a)(2)
 
 
 
 
 

* * * * *
[FR Doc. 2021-18390 Filed 8-27-21; 8:45 am]
BILLING CODE 6560-50-P


