Trifloxystrobin; Pesticide Tolerance, 1363-1367 [2022-00311]
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2. In § 180.960, amend the table by
adding in alphabetical order an entry for
the polymer ‘‘Acetic acid ethenyl ester,
polymer with ethene, N(hydroxymethyl)-2-propenamide, and 2propenamide, (AM–E–NMA–VA)
minimum number average molecular
■
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.
weight (in amu), 5500’’ to read as
follows:
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
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TABLE 1 TO § 180.960
Polymer
CAS No.
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Acetic acid ethenyl ester, polymer with ethene, N-(hydroxymethyl)-2-propenamide, and 2-propenamide, (AM–E– CAS. Reg. No. 49603–78–3.
NMA–VA) minimum number average molecular weight (in amu), 5500.
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[FR Doc. 2022–00312 Filed 1–10–22; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0038; FRL–9086–01–
OCSPP]
Trifloxystrobin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of trifloxystrobin
in or on multiple commodities which
are identified and discussed later in this
document. Bayer CropScience requested
this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 11, 2022. Objections and
requests for hearings must be received
on or before March 14, 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–2020–0038, 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.
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SUMMARY:
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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, Acting Director,
Registration Division (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: 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 e-
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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(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2020–0038 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 March
14, 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–
2020–0038, 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.
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• 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.
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II. Summary of Petitioned-For
Tolerances
In the Federal Register of September
10, 2020 (85 FR 55810) (FRL–10013–78),
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 9E8792) by Bayer
CropScience, 800 N Lindbergh Blvd., St.
Louis, MO 63141. The petition
requested that 40 CFR 180.555 be
amended by establishing tolerances for
residues of the fungicide trifloxystrobin
in or on the following raw agricultural
commodities: Caneberry, Crop Subgroup
13–07A at 3.0 parts per million (ppm);
Currant, black and red, at 4.0 ppm;
Edible-Podded Legume Vegetables, Crop
Subgroup 6A, at 1.5 ppm; Oil, olive,
refined at 0.5 ppm; Pea, dry, seed at 0.2
ppm; Succulent shelled pea and bean,
Crop Subgroup 6B at 0.15 ppm; and
Tropical and Subtropical, Small fruit,
edible peel, Crop Subgroup 23A at 0.2
ppm. That document referenced a
summary of the petition prepared by
Bayer CropScience, the petitioner,
which is available in the docket for this
action, docket ID number EPA–HQ–
OPP–2020–0038, at https://
www.regulations.gov. Two comments
were received on the notice of filing.
EPA’s response to these comments is
discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA is
establishing tolerances for some
commodities at different levels than
requested by the petitioner and
correcting some of the commodity
definitions. Also, EPA is not
establishing tolerances for two
commodities. 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 the 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
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other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D) and the factors specified
therein, EPA has reviewed the available
scientific data and other relevant
information in support of this action.
EPA has sufficient data to assess the
hazards of and to make a determination
on aggregate exposure for
trifloxystrobin, including exposure
resulting from the tolerances established
by this action. EPA’s assessment of
exposures and risks associated with
trifloxystrobin follows.
In an effort to streamline its
publications in the Federal Register,
EPA is not reprinting sections that
repeat what has been previously
published for tolerance rulemakings of
the same pesticide chemical. Where
scientific information concerning a
particular chemical remains unchanged,
the content of those sections would not
vary between tolerance rulemakings,
and EPA considers referral back to those
sections as sufficient to provide an
explanation of the information EPA
considered in making its safety
determination for the new rulemaking.
EPA has previously published a
number of tolerance rulemakings for
trifloxystrobin, in which EPA
concluded, based on the available
information, that there is a reasonable
certainty that no harm would result
from aggregate exposure to
trifloxystrobin and established
tolerances for residues of that chemical.
EPA is incorporating previously
published sections of those rulemakings
that remain unchanged, as described
further in this rulemaking. Specific
information on the risk assessment
conducted in support of this action,
including on the studies received and
the nature of the adverse effects caused
by trifloxystrobin, can be found in the
document titled ‘‘Trifloxystrobin.
Human Health Aggregate Risk
Assessment for Use on Currant, Black
and Red; Edible-Podded Legume
Vegetables, Subgroup 6A; Succulent
Shelled Pea and Bean, Subgroup 6B;
Dried Shelled Pea; Caneberry, Subgroup
13–07A; Tropical and Subtropical,
Small Fruit, Edible Peel, Subgroup 23A
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without U.S. Registration.’’ dated
September 29, 2021, which is available
in the docket for this action at https://
www.regulations.gov.
Toxicological profile. For a discussion
of the Toxicological Profile of
trifloxystrobin, see Unit III.A. of the
trifloxystrobin tolerance rulemaking
published in the Federal Register of
February 15, 2019 (84 FR 4340) (FRL–
9985–23) (Docket number EPA–HQ–
OPP–2017–0530–0008).
Toxicological points of departure/
Levels of concern. For a summary of the
Toxicological Points of Departure/
Levels of Concern used for the safety
assessment, see Unit III.B. of the
February 15, 2019 rulemaking.
Exposure assessment. Much of the
exposure assessment remains the same
since the February 15, 2019 rulemaking,
although the new exposure assessment
incorporates additional dietary
exposures from the petitioned-for
tolerances and reevaluates residential
exposures based on approved label
amendments. These updates are
discussed in this section; for a
description of the rest of EPA’s
approach to and assumptions for the
exposure assessment, including with
respect to residue data, percent crop
treated (PCT), processing factors,
estimated drinking water
concentrations, and the Agency’s
conclusions about cumulative effects,
see Unit III.C. of the February 15, 2019
rulemaking.
EPA’s acute and chronic dietary (food
and drinking water) exposure
assessments have been updated to
include the additional exposure from
residues of trifloxystrobin on the
commodities identified in this action.
The acute dietary assessment used the
same assumptions described in the
February 15, 2019 rulemaking
concerning tolerance-level residues,
100% CT and default processing factors.
As described in the February 15, 2019
rulemaking, the assumptions for the
chronic dietary assessment included
average field trial residues for selected
crops, tolerance-level residues for all
other crop commodities, default and
empirical processing factors, and PCT
data when available. Tolerance-level
residues were used for the commodities
identified in this action.
In the new chronic dietary exposure
assessment, EPA assumed average field
trial residues for apples, rice and
commodities in subgroups 4A, 4B, 5A,
5B and 19A. The following average PCT
estimates were used in the chronic
dietary risk assessment for the crops for
which trifloxystrobin is currently
registered: Apples: 25%, apricots: 10%,
cantaloupes 5%, carrots 2.5%, cotton:
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10%, cherries: 25%, pop, sweet, and
field corn: <2.5%, cucumbers: <2.5%,
dry beans/peas: <1%, grapefruit: 30%,
grapes: 25%; hazelnuts: 65%, oranges:
5%, peaches: <2.5%, peanuts: 5%,
pears: 10%, pecans: 15%, peppers: 5%,
plums/prunes: <2.5%, potatoes: <1%,
pumpkins: 5%, rice: 15%, soybeans:
5%, squash: <2.5%, strawberries: 5%,
sugar beets: 5%, sweet corn: <2.5%,
tangerines: 5%, tomatoes: <2.5%,
watermelons: 5%, and wheat: <2.5%.
One hundred percent (100%) CT was
assumed for the remaining
commodities. Due to uncertainty in PCT
data from California, PCT for almonds,
walnuts, pistachio, celery, artichokes,
and nectarine were set to 100%.
Anticipated residue and percent crop
treated information. Section 408(b)(2)(F)
of FFDCA states that the Agency may
use data on the actual percent of food
treated for assessing chronic dietary risk
only if:
• Condition a: The data used are
reliable and provide a valid basis to
show what percentage of the food
derived from such crop is likely to
contain the pesticide residue.
• Condition b: The exposure estimate
does not underestimate exposure for any
significant subpopulation group.
• Condition c: Data are available on
pesticide use and food consumption in
a particular area, and the exposure
estimate does not understate exposure
for the population in such area.
In addition, the Agency must provide
for periodic evaluation of any estimates
used. To provide for the periodic
evaluation of the estimate of PCT as
required by FFDCA section 408(b)(2)(F),
EPA may require registrants to submit
data on PCT.
In most cases, EPA uses available data
from United States Department of
Agriculture/National Agricultural
Statistics Service (USDA/NASS),
proprietary market surveys, and the
National Pesticide Use Database for the
chemical/crop combination for the most
recent 6 to 7 years. EPA uses an average
PCT for chronic dietary risk analysis.
The average PCT figure for each existing
use is derived by combining available
public and private market survey data
for that use, averaging across all
observations, and rounding to the
nearest 5%, except for those situations
in which the average PCT is less than
one. In those cases, 1% is used as the
average PCT and 2.5% is used as the
maximum PCT. EPA uses a 100 PCT for
acute dietary risk analysis. The
maximum PCT figure is the highest
observed maximum value reported
within the recent 6 years of available
public and private market survey data
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for the existing use and rounded up to
the nearest multiple of 5%.
The Agency believes that Conditions
a, b, and c discussed above have been
met. With respect to Condition a, PCT
estimates are derived from Federal and
private market survey data, which are
reliable and have a valid basis. The
Agency is reasonably certain that the
percentage of the food treated is not
likely to be an underestimation. As to
Conditions b and c, regional
consumption information and
consumption information for significant
subpopulations is taken into account
through EPA’s computer-based model
for evaluating the exposure of
significant subpopulations including
several regional groups. Use of this
consumption information in EPA’s risk
assessment process ensures that EPA’s
exposure estimate does not understate
exposure for any significant
subpopulation group and allows the
Agency to be reasonably certain that no
regional population is exposed to
residue levels higher than those
estimated by the Agency. Other than the
data available through national food
consumption surveys, EPA does not
have available reliable information on
the regional consumption of food to
which trifloxystrobin may be applied in
a particular area.
Estimated drinking water
concentrations have not changed since
the February 15, 2019 rulemaking,
because there will be no U.S.
registrations for use of trifloxystrobin on
the commodities identified in this
action. The non-dietary (i.e., residential)
exposure assessment reevaluated
residential exposures and risk based on
approved label amendments reflecting a
lower representative single maximum
application rate of 0.34 lb ai/A for
products with residential turf use sites.
There was no adverse systemic hazard
via the dermal route of exposure. The
updated residential post-application
risk estimates for children 1 to less than
2 years old were not of concern.
Safety factor for infants and children.
EPA continues to conclude that there is
reliable data showing that the safety of
infants and children is adequately
protected if the Food Quality Protection
Act (FQPA) safety factor is reduced from
10X to 1X for all routes of exposure
other than inhalation. The FQPA safety
factor of 10X has been retained for
inhalation endpoints only to account for
the lack of the subchronic inhalation
toxicity study for trifloxystrobin at this
time. The reasons for this determination
are articulated in Unit III.D. of the
February 15, 2019 rulemaking.
Assessment of aggregate risks. EPA
determines whether acute and chronic
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dietary pesticide exposures are safe by
comparing aggregate exposure estimates
to the acute population adjusted dose
(aPAD) and chronic population adjusted
dose (cPAD). Short-, intermediate-, and
chronic-term risks are evaluated by
comparing the estimated aggregate food,
water, and residential exposure to the
appropriate points of departure (PODs)
to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure.
Acute dietary (food and drinking
water) risks are below the Agency’s
level of concern of 100% of the aPAD:
They are 3.4% of the aPAD at the 95th
percentile of exposure for females 13 to
49 years old, which is the population
subgroup with the highest exposure
estimate. No other subpopulations were
evaluated. Chronic dietary (food and
drinking water) risks are below the
Agency’s level of concern of 100% of
the cPAD: They are 58% of the cPAD for
infants less than 1 year old, which is the
population subgroup with the highest
exposure estimate. Moreover, the shortterm aggregate risk for the population
subgroup with the highest total
exposure (children 1 to less than 2 years
old) is represented by an aggregate MOE
of 120, which is not a risk of concern
because EPA considers MOEs of 100 or
less to be of concern; short-term
aggregate risk calculations are protective
of the intermediate-term duration of
exposure. Chronic aggregate risk is
equivalent to chronic dietary (food and
drinking water) risk estimates, which
are not of concern. Trifloxystrobin is
classified as ‘‘not likely to be
carcinogenic to humans’’ based on the
absence of significant tumor increases in
two adequate rodent carcinogenicity
studies; therefore, cancer exposure and
risk assessments were not conducted at
this time.
Determination of safety. Therefore,
based on the risk assessments and
information described above, EPA
concludes there is a reasonable certainty
that no harm will result to the general
population, or to infants and children,
from aggregate exposure to
trifloxystrobin residues. More detailed
information on the subject action to
establish tolerances in or on Caneberry,
subgroup 13–07A; Currant; Vegetable,
legume, edible podded, subgroup 6A;
Pea and bean, succulent shelled,
subgroup 6B; and Tropical and
subtropical, small fruit, edible peel,
subgroup 23A can be found in the
document entitled, ‘‘Trifloxystrobin.
Human Health Aggregate Risk
Assessment for Use on Currant, Black
and Red; Edible-Podded Legume
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Vegetables, Subgroup 6A; Succulent
Shelled Pea and Bean, Subgroup 6B;
Dried Shelled Pea; Caneberry, Subgroup
13–07A; Tropical and Subtropical,
Small Fruit, Edible Peel, Subgroup 23A
without U.S. Registration.’’ dated
September 29, 2021 at
www.regulations.gov, under docket ID
number EPA–HQ–OPP–2020–0038.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the February 15, 2019
rulemaking.
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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).
Codex is a joint United Nations Food
and Agriculture Organization/World
Health Organization food standards
program, and it is recognized as an
international food safety standardssetting 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 tolerances for trifloxystrobin are
not harmonized with Codex for every
commodity identified in this action. No
Codex MRLs have been established for
residues of trifloxystrobin in or on
Caneberry, subgroup 13–07A and
Currant. The U.S. tolerance level for
Vegetable, legume, edible-podded,
subgroup 6A (1.5 ppm), calculated using
the Organisation for Economic Cooperation and Development (OECD)
MRL procedure, is much higher than the
Codex MRL (0.01 ppm), and thus
harmonization is not possible.
Similarly, the U.S. tolerance level for
Pea and bean, succulent shelled,
subgroup 6B (0.2 ppm) is much higher
than the Codex MRL (0.01 ppm for lima
beans only), and thus harmonization is
not possible. The U.S. tolerance level for
Tropical and subtropical, small fruit,
edible peel, subgroup 23A, is
harmonized with the Codex MRL
established in or on olives, a member of
subgroup 23A, at 0.3 ppm.
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C. Response to Comments
V. Conclusion
We received two comments regarding
this import tolerance. A comment was
received on September 10, 2020
regarding the absence of an analytical
method and obtaining additional data.
Analytical enforcement methodology is
available for trifloxystrobin and is
described in Unit IV.A. of the February
15, 2019 rulemaking (84 FR 4340) (FRL–
9985–23). A risk assessment was
conducted by EPA based on the wellcharacterized toxicology database for
this active ingredient, and no risks of
concern were identified. Tolerances are
being set based on residue data and
calculations using the OECD MRL
calculation procedures.
An anonymous comment was
received October 13, 2020, supporting
the pesticide regulation. 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
trifloxystrobin tolerances are safe.
Therefore, tolerances are established
for residues of trifloxystrobin including
its metabolites and degradates in or on
Caneberry, subgroup 13–07A at 2 parts
per million (ppm); Currant at 3 ppm;
Pea and bean, succulent shelled,
subgroup 6B at 0.2 ppm; Tropical and
subtropical, small fruit, edible peel,
subgroup 23A at 0.3 ppm; and
Vegetable, legume, edible podded,
subgroup 6A at 1.5 ppm.
D. Revisions to Petitioned-For
Tolerances
The Agency is setting a tolerance for
residues of trifloxystrobin in or on
Caneberry, subgroup 13–07A at 2 ppm
rather than the requested 3.0 ppm; in or
on Currant at 3 ppm instead of the
requested 4.0 ppm; and in or on Pea and
bean, succulent shelled, subgroup 6B at
0.2 ppm rather than the requested 0.15
ppm based on values determined in
accordance with the OECD MRL
calculation procedures. A tolerance in
or on Currant is being set rather than the
petitioned-for ‘‘Currant, black and red’’
based on standard commodity
definitions. Based on crop group
revisions, the terminology Pea and bean,
succulent shelled, subgroup 6B is used
instead of the petitioned-for ‘‘Succulent
shelled pea and bean, subgroup 6B’’ and
Vegetable, legume, edible podded,
subgroup 6A is used instead of the
petitioned-for ‘‘Edible-podded legume
vegetables, subgroup 6A.’’ The
petitioned-for tolerance on ‘‘Pea, dry
seed’’ is not being set because this
commodity is covered by a tolerance
that is already established for Pea and
bean, dried shelled, except soybean,
subgroup 6C. The tolerance in or on
Tropical and subtropical, small fruit,
edible peel, subgroup 23A tolerance is
being set at 0.3 ppm rather than the
petitioned-for 0.2 ppm to harmonize
with the Codex MRL. The petitioned-for
tolerance in or on Olive, oil is not being
established because this commodity is
covered by the tolerance established in
this action for subgroup 23A.
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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). 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 for residues 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
E:\FR\FM\11JAR1.SGM
11JAR1
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Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations
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).
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).
Dated: January 5, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
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 § 180.555, amend the table in
paragraph (a) by:
■ a. Adding in alphabetical order the
entries for ‘‘Caneberry, subgroup 13–
07A’’; ‘‘Currant’’; ‘‘Pea and bean,
succulent shelled, subgroup 6B’’;
‘‘Tropical and subtropical, small fruit,
edible peel, subgroup 23A’’; and
‘‘Vegetable, legume, edible podded,
subgroup 6A’’.
■ b. Add footnote 4.
The additions read as follows:
■
§ 180.555 Trifloxystrobin; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
*
*
Caneberry, subgroup 13–07A 4 ...........................................................................................................................................................
*
*
*
*
*
*
*
Currant 4 ...............................................................................................................................................................................................
*
*
*
*
*
*
*
Pea and bean, succulent shelled, subgroup 6B 4 ...............................................................................................................................
*
*
*
*
*
*
*
Tropical and subtropical, small fruit, edible peel, subgroup 23A 4 ......................................................................................................
*
*
*
*
*
*
*
Vegetable, legume, edible podded, subgroup 6A 4 .............................................................................................................................
*
*
3
4 There
*
*
*
*
*
*
*
*
*
are no U.S. registrations on this commodity as of January 11, 2022.
*
*
*
ACTION:
[FR Doc. 2022–00311 Filed 1–10–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1008
Medicare and State Health Care
Programs: Fraud and Abuse;
Procedures Regarding the Submission
of Advisory Opinion Requests to, and
the Issuance of Advisory Opinions by,
OIG
Office of Inspector General
(OIG), Department of Health and Human
Services (HHS).
AGENCY:
VerDate Sep<11>2014
17:25 Jan 10, 2022
Jkt 256001
*
*
Final rule.
OIG is amending the
regulations governing the procedures for
the submission of advisory opinion
requests to, and the issuance of advisory
opinions by, OIG.
DATES: This final rule is effective
February 10, 2022.
FOR FURTHER INFORMATION CONTACT:
Christina Hinkle, Office of Counsel to
the Inspector General, (202) 465–6245.
SUPPLEMENTARY INFORMATION:
SUMMARY:
BILLING CODE 6560–50–P
khammond on DSKJM1Z7X2PROD with RULES
*
I. Background
Pursuant to section 1128D of the
Social Security Act (the Act),1 HHS,
through OIG, publishes advisory
opinions regarding the application of
*
PO 00000
U.S.C. 1320a–7d.
Frm 00051
Fmt 4700
Sfmt 4700
3
0.2
0.3
1.5
*
*
the Federal anti-kickback statute 2 and
the safe harbor provisions, as well as
OIG’s administrative sanction
authorities, to parties’ proposed or
existing arrangements. More
specifically, in consultation with the
Department of Justice (DOJ) OIG issues
written advisory opinions to requesting
parties with regard to: (1) What
constitutes prohibited remuneration
under the Federal anti-kickback statute;
(2) whether an arrangement or proposed
arrangement satisfies the criteria in
section 1128B(b)(3) of the Act, or
established by regulation (i.e., safe
harbors),3 for activities that do not result
in prohibited remuneration; (3) what
constitutes an inducement to reduce or
2 Section
1128B of the Act; 42 U.S.C. 1320a–7b(b).
safe harbor regulations are set forth at 42
CFR 1001.952.
3 The
1 42
2
E:\FR\FM\11JAR1.SGM
11JAR1
Agencies
[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Rules and Regulations]
[Pages 1363-1367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00311]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0038; FRL-9086-01-OCSPP]
Trifloxystrobin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
trifloxystrobin in or on multiple commodities which are identified and
discussed later in this document. Bayer CropScience requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 11, 2022. Objections and
requests for hearings must be received on or before March 14, 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-2020-0038, 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, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[email protected].
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(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2020-0038 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
March 14, 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-2020-0038, 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.
[[Page 1364]]
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 Tolerances
In the Federal Register of September 10, 2020 (85 FR 55810) (FRL-
10013-78), 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
9E8792) by Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO
63141. The petition requested that 40 CFR 180.555 be amended by
establishing tolerances for residues of the fungicide trifloxystrobin
in or on the following raw agricultural commodities: Caneberry, Crop
Subgroup 13-07A at 3.0 parts per million (ppm); Currant, black and red,
at 4.0 ppm; Edible-Podded Legume Vegetables, Crop Subgroup 6A, at 1.5
ppm; Oil, olive, refined at 0.5 ppm; Pea, dry, seed at 0.2 ppm;
Succulent shelled pea and bean, Crop Subgroup 6B at 0.15 ppm; and
Tropical and Subtropical, Small fruit, edible peel, Crop Subgroup 23A
at 0.2 ppm. That document referenced a summary of the petition prepared
by Bayer CropScience, the petitioner, which is available in the docket
for this action, docket ID number EPA-HQ-OPP-2020-0038, at https://www.regulations.gov. Two comments were received on the notice of
filing. EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA is
establishing tolerances for some commodities at different levels than
requested by the petitioner and correcting some of the commodity
definitions. Also, EPA is not establishing tolerances for two
commodities. 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 the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D) and the factors
specified therein, EPA has reviewed the available scientific data and
other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for trifloxystrobin, including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with trifloxystrobin follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings, and EPA considers referral back to those
sections as sufficient to provide an explanation of the information EPA
considered in making its safety determination for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for
trifloxystrobin, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to trifloxystrobin and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections of those rulemakings that remain
unchanged, as described further in this rulemaking. Specific
information on the risk assessment conducted in support of this action,
including on the studies received and the nature of the adverse effects
caused by trifloxystrobin, can be found in the document titled
``Trifloxystrobin. Human Health Aggregate Risk Assessment for Use on
Currant, Black and Red; Edible-Podded Legume Vegetables, Subgroup 6A;
Succulent Shelled Pea and Bean, Subgroup 6B; Dried Shelled Pea;
Caneberry, Subgroup 13-07A; Tropical and Subtropical, Small Fruit,
Edible Peel, Subgroup 23A without U.S. Registration.'' dated September
29, 2021, which is available in the docket for this action at https://www.regulations.gov.
Toxicological profile. For a discussion of the Toxicological
Profile of trifloxystrobin, see Unit III.A. of the trifloxystrobin
tolerance rulemaking published in the Federal Register of February 15,
2019 (84 FR 4340) (FRL-9985-23) (Docket number EPA-HQ-OPP-2017-0530-
0008).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
safety assessment, see Unit III.B. of the February 15, 2019 rulemaking.
Exposure assessment. Much of the exposure assessment remains the
same since the February 15, 2019 rulemaking, although the new exposure
assessment incorporates additional dietary exposures from the
petitioned-for tolerances and reevaluates residential exposures based
on approved label amendments. These updates are discussed in this
section; for a description of the rest of EPA's approach to and
assumptions for the exposure assessment, including with respect to
residue data, percent crop treated (PCT), processing factors, estimated
drinking water concentrations, and the Agency's conclusions about
cumulative effects, see Unit III.C. of the February 15, 2019
rulemaking.
EPA's acute and chronic dietary (food and drinking water) exposure
assessments have been updated to include the additional exposure from
residues of trifloxystrobin on the commodities identified in this
action. The acute dietary assessment used the same assumptions
described in the February 15, 2019 rulemaking concerning tolerance-
level residues, 100% CT and default processing factors. As described in
the February 15, 2019 rulemaking, the assumptions for the chronic
dietary assessment included average field trial residues for selected
crops, tolerance-level residues for all other crop commodities, default
and empirical processing factors, and PCT data when available.
Tolerance-level residues were used for the commodities identified in
this action.
In the new chronic dietary exposure assessment, EPA assumed average
field trial residues for apples, rice and commodities in subgroups 4A,
4B, 5A, 5B and 19A. The following average PCT estimates were used in
the chronic dietary risk assessment for the crops for which
trifloxystrobin is currently registered: Apples: 25%, apricots: 10%,
cantaloupes 5%, carrots 2.5%, cotton:
[[Page 1365]]
10%, cherries: 25%, pop, sweet, and field corn: <2.5%, cucumbers:
<2.5%, dry beans/peas: <1%, grapefruit: 30%, grapes: 25%; hazelnuts:
65%, oranges: 5%, peaches: <2.5%, peanuts: 5%, pears: 10%, pecans: 15%,
peppers: 5%, plums/prunes: <2.5%, potatoes: <1%, pumpkins: 5%, rice:
15%, soybeans: 5%, squash: <2.5%, strawberries: 5%, sugar beets: 5%,
sweet corn: <2.5%, tangerines: 5%, tomatoes: <2.5%, watermelons: 5%,
and wheat: <2.5%. One hundred percent (100%) CT was assumed for the
remaining commodities. Due to uncertainty in PCT data from California,
PCT for almonds, walnuts, pistachio, celery, artichokes, and nectarine
were set to 100%.
Anticipated residue and percent crop treated information. Section
408(b)(2)(F) of FFDCA states that the Agency may use data on the actual
percent of food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, and the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 to 7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a 100 PCT for acute dietary risk analysis. The maximum
PCT figure is the highest observed maximum value reported within the
recent 6 years of available public and private market survey data for
the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that Conditions a, b, and c discussed above
have been met. With respect to Condition a, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
reliable information on the regional consumption of food to which
trifloxystrobin may be applied in a particular area.
Estimated drinking water concentrations have not changed since the
February 15, 2019 rulemaking, because there will be no U.S.
registrations for use of trifloxystrobin on the commodities identified
in this action. The non-dietary (i.e., residential) exposure assessment
reevaluated residential exposures and risk based on approved label
amendments reflecting a lower representative single maximum application
rate of 0.34 lb ai/A for products with residential turf use sites.
There was no adverse systemic hazard via the dermal route of exposure.
The updated residential post-application risk estimates for children 1
to less than 2 years old were not of concern.
Safety factor for infants and children. EPA continues to conclude
that there is reliable data showing that the safety of infants and
children is adequately protected if the Food Quality Protection Act
(FQPA) safety factor is reduced from 10X to 1X for all routes of
exposure other than inhalation. The FQPA safety factor of 10X has been
retained for inhalation endpoints only to account for the lack of the
subchronic inhalation toxicity study for trifloxystrobin at this time.
The reasons for this determination are articulated in Unit III.D. of
the February 15, 2019 rulemaking.
Assessment of aggregate risks. EPA determines whether acute and
chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute population adjusted dose (aPAD) and
chronic population adjusted dose (cPAD). Short-, intermediate-, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the appropriate points of
departure (PODs) to ensure that an adequate margin of exposure (MOE)
exists. For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer given the estimated aggregate exposure.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the aPAD: They are 3.4% of the
aPAD at the 95th percentile of exposure for females 13 to 49 years old,
which is the population subgroup with the highest exposure estimate. No
other subpopulations were evaluated. Chronic dietary (food and drinking
water) risks are below the Agency's level of concern of 100% of the
cPAD: They are 58% of the cPAD for infants less than 1 year old, which
is the population subgroup with the highest exposure estimate.
Moreover, the short-term aggregate risk for the population subgroup
with the highest total exposure (children 1 to less than 2 years old)
is represented by an aggregate MOE of 120, which is not a risk of
concern because EPA considers MOEs of 100 or less to be of concern;
short-term aggregate risk calculations are protective of the
intermediate-term duration of exposure. Chronic aggregate risk is
equivalent to chronic dietary (food and drinking water) risk estimates,
which are not of concern. Trifloxystrobin is classified as ``not likely
to be carcinogenic to humans'' based on the absence of significant
tumor increases in two adequate rodent carcinogenicity studies;
therefore, cancer exposure and risk assessments were not conducted at
this time.
Determination of safety. Therefore, based on the risk assessments
and information described above, EPA concludes there is a reasonable
certainty that no harm will result to the general population, or to
infants and children, from aggregate exposure to trifloxystrobin
residues. More detailed information on the subject action to establish
tolerances in or on Caneberry, subgroup 13-07A; Currant; Vegetable,
legume, edible podded, subgroup 6A; Pea and bean, succulent shelled,
subgroup 6B; and Tropical and subtropical, small fruit, edible peel,
subgroup 23A can be found in the document entitled, ``Trifloxystrobin.
Human Health Aggregate Risk Assessment for Use on Currant, Black and
Red; Edible-Podded Legume
[[Page 1366]]
Vegetables, Subgroup 6A; Succulent Shelled Pea and Bean, Subgroup 6B;
Dried Shelled Pea; Caneberry, Subgroup 13-07A; Tropical and
Subtropical, Small Fruit, Edible Peel, Subgroup 23A without U.S.
Registration.'' dated September 29, 2021 at www.regulations.gov, under
docket ID number EPA-HQ-OPP-2020-0038.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the February 15, 2019 rulemaking.
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). Codex 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.
The tolerances for trifloxystrobin are not harmonized with Codex
for every commodity identified in this action. No Codex MRLs have been
established for residues of trifloxystrobin in or on Caneberry,
subgroup 13-07A and Currant. The U.S. tolerance level for Vegetable,
legume, edible-podded, subgroup 6A (1.5 ppm), calculated using the
Organisation for Economic Co-operation and Development (OECD) MRL
procedure, is much higher than the Codex MRL (0.01 ppm), and thus
harmonization is not possible. Similarly, the U.S. tolerance level for
Pea and bean, succulent shelled, subgroup 6B (0.2 ppm) is much higher
than the Codex MRL (0.01 ppm for lima beans only), and thus
harmonization is not possible. The U.S. tolerance level for Tropical
and subtropical, small fruit, edible peel, subgroup 23A, is harmonized
with the Codex MRL established in or on olives, a member of subgroup
23A, at 0.3 ppm.
C. Response to Comments
We received two comments regarding this import tolerance. A comment
was received on September 10, 2020 regarding the absence of an
analytical method and obtaining additional data. Analytical enforcement
methodology is available for trifloxystrobin and is described in Unit
IV.A. of the February 15, 2019 rulemaking (84 FR 4340) (FRL-9985-23). A
risk assessment was conducted by EPA based on the well-characterized
toxicology database for this active ingredient, and no risks of concern
were identified. Tolerances are being set based on residue data and
calculations using the OECD MRL calculation procedures.
An anonymous comment was received October 13, 2020, supporting the
pesticide regulation. 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
trifloxystrobin tolerances are safe.
D. Revisions to Petitioned-For Tolerances
The Agency is setting a tolerance for residues of trifloxystrobin
in or on Caneberry, subgroup 13-07A at 2 ppm rather than the requested
3.0 ppm; in or on Currant at 3 ppm instead of the requested 4.0 ppm;
and in or on Pea and bean, succulent shelled, subgroup 6B at 0.2 ppm
rather than the requested 0.15 ppm based on values determined in
accordance with the OECD MRL calculation procedures. A tolerance in or
on Currant is being set rather than the petitioned-for ``Currant, black
and red'' based on standard commodity definitions. Based on crop group
revisions, the terminology Pea and bean, succulent shelled, subgroup 6B
is used instead of the petitioned-for ``Succulent shelled pea and bean,
subgroup 6B'' and Vegetable, legume, edible podded, subgroup 6A is used
instead of the petitioned-for ``Edible-podded legume vegetables,
subgroup 6A.'' The petitioned-for tolerance on ``Pea, dry seed'' is not
being set because this commodity is covered by a tolerance that is
already established for Pea and bean, dried shelled, except soybean,
subgroup 6C. The tolerance in or on Tropical and subtropical, small
fruit, edible peel, subgroup 23A tolerance is being set at 0.3 ppm
rather than the petitioned-for 0.2 ppm to harmonize with the Codex MRL.
The petitioned-for tolerance in or on Olive, oil is not being
established because this commodity is covered by the tolerance
established in this action for subgroup 23A.
V. Conclusion
Therefore, tolerances are established for residues of
trifloxystrobin including its metabolites and degradates in or on
Caneberry, subgroup 13-07A at 2 parts per million (ppm); Currant at 3
ppm; Pea and bean, succulent shelled, subgroup 6B at 0.2 ppm; Tropical
and subtropical, small fruit, edible peel, subgroup 23A at 0.3 ppm; and
Vegetable, legume, edible podded, subgroup 6A 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). 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 for
residues 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
[[Page 1367]]
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: January 5, 2022.
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
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. 180.555, amend the table in paragraph (a) by:
0
a. Adding in alphabetical order the entries for ``Caneberry, subgroup
13-07A''; ``Currant''; ``Pea and bean, succulent shelled, subgroup
6B''; ``Tropical and subtropical, small fruit, edible peel, subgroup
23A''; and ``Vegetable, legume, edible podded, subgroup 6A''.
0
b. Add footnote 4.
The additions read as follows:
Sec. 180.555 Trifloxystrobin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Caneberry, subgroup 13-07A \4\.......................... 2
* * * * * * *
Currant \4\............................................. 3
* * * * * * *
Pea and bean, succulent shelled, subgroup 6B \4\........ 0.2
* * * * * * *
Tropical and subtropical, small fruit, edible peel, 0.3
subgroup 23A \4\.......................................
* * * * * * *
Vegetable, legume, edible podded, subgroup 6A \4\....... 1.5
* * * * * * *
------------------------------------------------------------------------
\3\ * * * * * * *
\4\ There are no U.S. registrations on this commodity as of January 11,
2022.
* * * * *
[FR Doc. 2022-00311 Filed 1-10-22; 8:45 am]
BILLING CODE 6560-50-P