[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:
[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 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