Isoprothiolane; Pesticide Tolerances, 68921-68926 [2021-26369]
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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Rules and Regulations
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).
XI. 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: December 1, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.960, amend the table by
adding a table heading and in
alphabetical order an entry for ‘‘2,5Furandione, polymer with
ethenylbenzene, octyl imide, imide with
polyethylene-polypropylene glycol 2aminopropyl Me ether, minimum
number average molecular weight (in
amu), 11,000’’ to read as follows:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
*
TABLE 1 TO § 180.960
Polymer
CAS No.
*
*
*
*
*
*
2,5-Furandione, polymer with ethenylbenzene, octyl imide, imide with polyethylene-polypropylene glycol 2-aminopropyl Me
ether, minimum number average molecular weight (in amu), 11,000 .......................................................................................
*
*
*
*
[FR Doc. 2021–26412 Filed 12–3–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0424; FRL–9063–01–
OCSPP]
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Isoprothiolane; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of isoprothiolane
in or on banana; rice, bran; rice, husked;
and rice, polished rice. Nichino
SUMMARY:
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*
*
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
PO 00000
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1812871–29–6
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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
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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 Office of the Federal Register’s eCFR site at https://www.ecfr.gov/
current/title-40.
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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
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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 1,3dithiolan-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
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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.
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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 nonlinear 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-observedadverse-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.
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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-
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pesticide-risks/assessing-human-healthrisk-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 fooduse 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.
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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 nonoccupational, 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-andassessing-pesticide-risks/pesticidecumulative-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
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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
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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
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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 intermediateterm 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: residuemethods@
epa.gov.
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
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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.
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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,
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15:44 Dec 03, 2021
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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
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Fmt 4700
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68925
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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Add § 180.721 to subpart C to read
as follows:
■
§ 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:
E:\FR\FM\06DER1.SGM
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68926
Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Rules and Regulations
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
Banana 1 .....................................
Rice, bran 1 .................................
Rice, husked 1 .............................
Rice, polished rice 1 ....................
0.9
15
6
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
SURFACE TRANSPORTATION BOARD
49 CFR Part 1180
[Docket No. EP 282 (Sub-No. 21)]
Petition for Rulemaking—Railroad
Consolidation Procedures—Exemption
for Emergency Temporary Trackage
Rights
Surface Transportation Board.
Final rule.
AGENCY:
ACTION:
The Surface Transportation
Board (Board) is adopting a final rule
establishing a new class exemption for
emergency temporary trackage rights.
The final rule also makes certain other
related changes to the class exemptions
for trackage rights and temporary
trackage rights.
DATES: The rule is effective December
30, 2021.
FOR FURTHER INFORMATION CONTACT:
Nathaniel Bawcombe at (202) 245–0376.
Assistance for the hearing impaired is
available through the Federal Relay
Service at (800) 877–8339.
SUPPLEMENTARY INFORMATION: In 2003,
the Board adopted a class exemption at
49 CFR 1180.2(d)(8) for temporary
overhead trackage rights of not more
than one year in duration. See R.R.
Consolidation Procs.—Exemption for
Temp. Trackage Rts., EP 282 (Sub-No.
20) (STB served May 23, 2003),
modified (STB served May 17, 2004).
Under 49 CFR 1180.4(g)(1), exemptions
sought under 49 CFR 1180.2(d)(8) (and
various other class exemptions under 49
CFR 1180.2(d)) cannot become effective
until at least 30 days after a railroad
files a verified notice of exemption for
the transaction. As a result, when a
railroad seeks to have a temporary
trackage rights exemption become
effective in less than 30 days, the
railroad must petition the Board for
waiver of the 30-day period. In such
cases, in addition to serving and
publishing notice of the exemption in
the Federal Register, the Board also
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SUMMARY:
VerDate Sep<11>2014
15:44 Dec 03, 2021
Jkt 256001
issues a separate decision acting on the
waiver request and setting the effective
date of the exemption. See, e.g., Union
Pac. R.R.—Temp. Trackage Rts.
Exemption—BNSF Ry., FD 36424 et al.
(STB served Aug. 10, 2020) (granting a
waiver of the 30-day notice period for a
trackage rights exemption under 49 CFR
1180.2(d)(8) and setting effective date);
Ala. & Gulf Coast Ry.—Temp. Trackage
Rts. Exemption—Kan. City S. Ry., FD
36418 (STB served July 2, 2020) (same).
In this final rule, the Board creates a
new class exemption at 49 CFR
1180.2(d)(9) for emergency temporary
trackage rights that eliminates the 30day notice period in certain
circumstances. The final rule also makes
certain other related changes to the
existing class exemptions for trackage
rights and temporary trackage rights.
Background
On October 9, 2020, the Association
of American Railroads (AAR) filed a
petition requesting that the Board
initiate a rulemaking proceeding to
establish a new emergency temporary
trackage rights class exemption for
specific limited situations that would
allow emergency temporary trackage
rights to take effect within five days of
a carrier filing a verified notice of
exemption without requiring waiver of
the 30-day notice requirement under 49
CFR 1180.4(g)(1). On November 4, 2020,
Samuel J. Nasca, for and on behalf of
SMART-Transportation Division-New
York State Legislative Board (SMART/
TD–NY), filed a reply in opposition to
AAR’s petition. SMART/TD–NY argued
that the Board should decline to
institute a rulemaking proceeding
because AAR’s proposed emergency
temporary trackage rights exemption is
unwarranted given the existing trackage
rights exemptions and because the
proposed exemption would threaten rail
safety by allowing operation by carrier
personnel unfamiliar with the line over
which the trackage rights would be
granted. (SMART/TD–NY Reply 3–4,
Nov. 4, 2020.)
On May 28, 2021, after considering
the petition and the responsive
comment, the Board issued a Notice of
Proposed Rulemaking. Pet. for
Rulemaking—R.R. Consolidation
Procs.—Exemption for Emergency
Temporary Trackage Rts. (NPRM), EP
282 (Sub-No. 21) (STB served May 28,
2021). In the NPRM, the Board
explained that SMART/TD–NY’s
arguments were unpersuasive because
the proposed class exemption would
make the process of obtaining temporary
trackage rights in an emergency more
efficient and predictable, and the
proposed rule would not affect rail
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
safety because it would not impact the
existing Federal Railroad
Administration (FRA) safety regulations,
such as the regulation governing
operations of more than one railroad
over the same track, as in a trackage
rights arrangement. NPRM, EP 282 (SubNo. 21), slip op. at 4.
As explained in the NPRM, the
proposed rule differed in some respects
from AAR’s petition request. The
proposed exemption would be available
only for ‘‘unforeseen’’ track outages
expected to last more than seven days
where there is no reasonable alternative
to maintain pre-outage levels of service.
Id. at 5. The Board also proposed a
requirement that the verified notice
provide a description of the situation
that includes, to the extent possible, the
following information: The nature of the
event that caused the unforeseen outage;
the location of the outage, the date that
the emergency situation occurred; the
date the track outage was discovered;
and the expected duration of the outage.
Id.
The proposed rule limited the
emergency temporary trackage rights to
an initial period not to exceed three
months, with the option to request a
renewal for an additional three months.
Id. Under the proposed rule, the
exemption would become effective not
upon publication in the Federal
Register but rather upon service of the
Board’s notice, which would occur
within five days after the railroad’s
verified notice of exemption is filed. Id.
at 6. The Board’s notice would be
published in the Federal Register
concurrently with service if possible, or
as soon thereafter as practicable. Id.
Additionally, the Board proposed that,
should the track outage be resolved and
use of the trackage rights become
unnecessary prior to the expiration of
the exemption period, carriers be
required to file a notice stating that the
outage has been resolved and that
trackage rights are no longer needed, as
well as the date on which use of the
trackage rights ceased. Id. at 6.
The Board proposed not requiring a
caption summary for exemptions under
49 CFR 1180.2(d)(9) and to eliminate the
existing caption summary requirements
for exemptions under 49 CFR
1180.2(d)(7) and 49 CFR 1180.2(d)(8).
NPRM, EP 282 (Sub-No. 21), slip op. at
7. Under the proposed rule, the caption
summary requirements would be
replaced by a requirement that the
parties provide in their verified notices
the same information currently required
in caption summaries. Id.
The proposed rule would also clarify
that the Board’s regulation at 49 CFR
1180.4(g)(4), pertaining to interchange
E:\FR\FM\06DER1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
