Orthosulfamuron; Pesticide Tolerances, 9869-9872 [2021-03181]
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Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Rules and Regulations
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
A. Does this action apply to me?
[EPA–HQ–OPP–2019–0580; FRL–10018–53]
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).
Orthosulfamuron; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of
orthosulfamuron (1-(4,6dimethoxypyrimidin-2-yl)-3-{[2(dimethylcarbamoyl)phenyl]
csulfamoyl}urea) in or on Almond,
hulls; Fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13–07F; Nut,
tree, group 14–12. Nichino America,
Inc. requested tolerances for these
commodities under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 17, 2021. Objections and
requests for hearings must be received
on or before April 19, 2021, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0580, 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
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.
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SUMMARY:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Publishing Office’s eCFR site at https://www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2019–0580 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 April
19, 2021. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2019–0580, by one of the following
methods:
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9869
• 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 March 3,
2020 (85 FR 12454) (FRL–10005–58),
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 9F8776) by
Nichino America, Inc., 4550 Linden Hill
Road, Suite 501, Wilmington, DE 19808.
The petition requested that 40 CFR
180.625 be amended by establishing
tolerances for residues of the herbicide
orthosulfamuron in or on almond hulls
at 0.03 parts per million (ppm), small
fruit vine climbing subgroup, except
fuzzy kiwifruit (crop subgroup 13–07F)
at 0.01 ppm, and tree nuts (crop group
14–12) at 0.01 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.
There were no comments received in
response to the notice of filing. Based
upon review of the data supporting the
petition, EPA has corrected the
commodity definitions to reflect current
Agency terminology.
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 the 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
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occupational exposure. Section
408(b)(2)(C) of the 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
orthosulfamuron including exposure
resulting from the tolerances established
by this action. EPA’s assessment of
exposures and risks associated with
orthosulfamuron 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.
Orthosulfamuron is included in a
group of herbicides referred to as
sulfonylureas that control weeds
through inhibition of the enzyme
acetolactate synthase (ALS). The
toxicological database for
orthosulfamuron is complete and no
additional data are required.
Orthosulfamuron showed low acute
toxicity by all routes and no dermal
irritation or sensitization (Category IV)
and was a mild eye irritant (Category
III). The major target organs of
orthosulfamuron are the liver, kidneys
and thyroid gland, with effects generally
observed at high doses following
chronic oral exposure. No evidence of
pre- and/or post-natal quantitative or
qualitative susceptibility was observed,
and the database overall did not show
evidence of neurotoxicity.
Thyroid follicular cell tumors were
observed at high doses in only one sex
and one species, and there was no
evidence of genotoxicity. Therefore, in
accordance with the EPA Final
Guidelines for Carcinogen Risk
Assessment (March 2005),
orthosulfamuron is classified as
‘‘Suggestive Evidence of
Carcinogenicity.’’
Specific information on the studies
received and the nature of the adverse
effects caused by orthosulfamuron as
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well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Orthosulfamuron. Human Health Risk
Assessment for Proposed New Uses on
Small Fruit Vine Climbing Subgroup,
Except Fuzzy Kiwifruit (13–07F), Tree
Nuts (14–12), Non-Bearing Citrus Fruit
(10–10), and Non-Bearing Stone Fruit
(12–12)’’ (hereinafter ‘‘Orthosulfamuron
Human Health Risk Assessment’’) on
page numbers 25–35 in docket ID
number EPA–HQ–OPP–2019–0580.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for orthosulfamuron used for
human risk assessment can be found on
page 13 in the Orthosulfamuron Human
Health Risk Assessment.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to orthosulfamuron, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing orthosulfamuron tolerances in
40 CFR 180.625. EPA assessed dietary
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exposures from orthosulfamuron 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
orthosulfamuron; therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used 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 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.
Based on the available data for
orthosulfamuron, which is summarized
in Unit III.A., EPA has concluded that
a nonlinear approach is appropriate for
assessing cancer risk to
orthosulfamuron. The chronic dietary
reference dose (cRfD) is significantly
lower than the dose that caused thyroid
tumors in male rats, and therefore is
protective of potential carcinogenicity.
Cancer risk was assessed using the same
exposure estimates as discussed in Unit
III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue or PCT
information in the dietary assessment
for orthosulfamuron. Tolerance-level
residues and 100 PCT were assumed for
all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for orthosulfamuron in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
orthosulfamuron. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www2.epa.gov/
pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide.
Screening groundwater-sourced
drinking water exposure estimates were
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generated with the Pesticide Root Zone
Model for GroundWater (PRZM–GW,
version 1.07) for use in sulfonylurea
dietary risk assessments. Rather than
using chemical-specific estimated
drinking water concentrations (EDWCs)
following the usual assessment
procedures, these coarse-screen
estimates should exceed upper-bound,
chemical-specific EDWCs for any
sulfonylurea (SU). This was achieved by
using model inputs that represent the
use pattern of highest exposure from
any SU, the highest soil mobility of any
SU residue of concern, and the highest
persistence to any route of degradation
over time. The resulting coarse-screen
EDWC from PRZM–GW was used as the
conservative estimate of exposure. The
chronic dietary assessment for
orthosulfamuron used the coarse-screen
maximum daily concentration of 0.751
ppm.
3. 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). Orthosulfamuron is not
registered for any specific use patterns
that would result in residential
exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the 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.’’
The Agency has assessed
orthosulfamuron, and its chemical class,
sulfonylureas, and determined that the
SUs do not share a common mechanism
of toxicity (EPA–HQ–OPP–2011–04538–
0024). The SUs share a core chemical
structure with varying degrees of
structural similarity based on individual
substituents on either side of the
molecule. In addition, the SUs share a
pesticidal mode of action (MOA)
(inhibition of acetolactate synthase
(ALS)), although the function of ALS in
humans is unknown and the relevance
of this MOA in humans in unclear.
Based on toxicity studies, the SUs do
not share a common toxicological
profile; instead the target organs vary
among the class and are often nonspecific, such as changes in body weight
or general effects on the liver. Further
dividing the SUs into subclasses based
on the urea substituent did not result in
a clear association of a target organ with
any particular substructure.
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Based on the weight of the evidence,
which includes the lack of a common
toxicological profile, the uncertainty in
the human relevance of ALS inhibition,
and the lack of mammalian MOA data,
a testable hypothesis for a common
mechanism of action cannot be
identified. Therefore, the Agency
concludes that no common mechanism
of toxicity exists among these pesticides
and a cumulative risk assessment
approach is not appropriate for this
class of pesticides.
D. Safety Factor for Infants and
Children
Section 408(b)(2)(C) of the FFDCA
provides that EPA shall apply an
additional tenfold (10X) margin of safety
for infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
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. The
rationale for that decision remains the
same as in the February 28, 2007 final
rule establishing tolerances for a use on
rice. See 72 FR 8928 (FRL–8113–4) for
the full rationale in Unit III.D.
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). 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, orthosulfamuron 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
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that chronic exposure to
orthosulfamuron from food and water
will utilize 81% of the cPAD for all
infants less than 1 year old, the
population group receiving the greatest
exposure. There are no residential uses
for orthosulfamuron.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
short-term or intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Short-term and intermediate-term
adverse effects were identified in the
toxicity database (e.g., kidney and liver
effects); however, orthosulfamuron is
not registered for any use patterns that
would result in short-term or
intermediate-term residential exposure.
Short-term risk is assessed based on
short-term residential exposure plus
chronic dietary exposure. Intermediateterm risk is assessed based on
intermediate-term residential exposure
plus chronic dietary exposure. Because
there is no short-term or intermediateterm 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 or intermediate-term risk), no
further assessment of short-term or
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating short-term
and intermediate-term risk for
orthosulfamuron.
4. Aggregate cancer risk for U.S.
population. As stated in Unit III.C.1.iii,
EPA has concluded that the chronic
reference dose (RfD) will adequately
account for all repeated exposure/
chronic toxicity, including
carcinogenicity, which could result
from exposure to orthosulfamuron. As
there is no chronic risk of concern, EPA
concludes that exposure to
orthosulfamuron 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
orthosulfamuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
utilizing high-performance liquid
chromatography with tandem mass
spectrometric detection (LC/MS/MS) is
available to enforce the tolerance
expression.
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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).
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.
Although EPA may establish a tolerance
that is different from a Codex MRL,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established an
MRL for orthosulfamuron in any
commodity.
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V. Conclusion
Therefore, tolerances are established
for residues of orthosulfamuron in or on
Almond, hulls at 0.03 ppm; Fruit, small,
vine climbing, except fuzzy kiwifruit,
subgroup 13–07F at 0.01 ppm; and Nut,
tree, group 14–12 at 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under the 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), nor is it considered a
regulatory action under Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
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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 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 the
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).
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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 4, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended 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 § 180.625,
a. Revise paragraph (a) introductory
text;
■ b. Designate the table in paragraph (a)
and add alphabetically the commodities
‘‘Almond, hulls’’; ‘‘Fruit, small, vine
climbing, except fuzzy kiwifruit,
subgroup 13–07F’’; and ‘‘Nut, tree,
group 14–12’’.
The revision and additions read as
follows:
■
■
§ 180.625 Orthosulfamuron; tolerances for
residues.
(a) General. Tolerances are
established for residues of the herbicide
orthosulfamuron, including its
metabolites and degradates, in or on the
commodities in the table, below.
Compliance with the tolerance levels
specified in the following table is to be
determined by measuring only
orthosulfamuron, 1-(4,6dimethoxypyrimidin-2-yl)-3-{[2(dimethylcarbamoyl)phenyl]
sulfamoyl}urea, in or on the following
commodities:
TABLE TO PARAGRAPH (a)
Parts per
million
Commodity
Almond, hulls ..............................
Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13–07F ....................................
Nut, tree, group 14–12 ...............
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[FR Doc. 2021–03181 Filed 2–16–21; 8:45 am]
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Agencies
[Federal Register Volume 86, Number 30 (Wednesday, February 17, 2021)]
[Rules and Regulations]
[Pages 9869-9872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03181]
[[Page 9869]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0580; FRL-10018-53]
Orthosulfamuron; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
orthosulfamuron (1-(4,6-dimethoxypyrimidin-2-yl)-3-{[2-
(dimethylcarbamoyl)phenyl]csulfamoyl{time} urea) in or on Almond,
hulls; Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup
13-07F; Nut, tree, group 14-12. Nichino America, Inc. requested
tolerances for these commodities under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective February 17, 2021. Objections and
requests for hearings must be received on or before April 19, 2021, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0580, 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
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:
RDFRNo[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0580 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
April 19, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0580, 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 March 3, 2020 (85 FR 12454) (FRL-10005-
58), 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
9F8776) by Nichino America, Inc., 4550 Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180.625 be
amended by establishing tolerances for residues of the herbicide
orthosulfamuron in or on almond hulls at 0.03 parts per million (ppm),
small fruit vine climbing subgroup, except fuzzy kiwifruit (crop
subgroup 13-07F) at 0.01 ppm, and tree nuts (crop group 14-12) at 0.01
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. There were no comments received in
response to the notice of filing. Based upon review of the data
supporting the petition, EPA has corrected the commodity definitions to
reflect current Agency terminology.
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 the 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
[[Page 9870]]
occupational exposure. Section 408(b)(2)(C) of the 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 orthosulfamuron including exposure resulting
from the tolerances established by this action. EPA's assessment of
exposures and risks associated with orthosulfamuron 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.
Orthosulfamuron is included in a group of herbicides referred to as
sulfonylureas that control weeds through inhibition of the enzyme
acetolactate synthase (ALS). The toxicological database for
orthosulfamuron is complete and no additional data are required.
Orthosulfamuron showed low acute toxicity by all routes and no dermal
irritation or sensitization (Category IV) and was a mild eye irritant
(Category III). The major target organs of orthosulfamuron are the
liver, kidneys and thyroid gland, with effects generally observed at
high doses following chronic oral exposure. No evidence of pre- and/or
post-natal quantitative or qualitative susceptibility was observed, and
the database overall did not show evidence of neurotoxicity.
Thyroid follicular cell tumors were observed at high doses in only
one sex and one species, and there was no evidence of genotoxicity.
Therefore, in accordance with the EPA Final Guidelines for Carcinogen
Risk Assessment (March 2005), orthosulfamuron is classified as
``Suggestive Evidence of Carcinogenicity.''
Specific information on the studies received and the nature of the
adverse effects caused by orthosulfamuron 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 ``Orthosulfamuron. Human Health Risk
Assessment for Proposed New Uses on Small Fruit Vine Climbing Subgroup,
Except Fuzzy Kiwifruit (13-07F), Tree Nuts (14-12), Non-Bearing Citrus
Fruit (10-10), and Non-Bearing Stone Fruit (12-12)'' (hereinafter
``Orthosulfamuron Human Health Risk Assessment'') on page numbers 25-35
in docket ID number EPA-HQ-OPP-2019-0580.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for orthosulfamuron used
for human risk assessment can be found on page 13 in the
Orthosulfamuron Human Health Risk Assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to orthosulfamuron, EPA considered exposure under the
petitioned-for tolerances as well as all existing orthosulfamuron
tolerances in 40 CFR 180.625. EPA assessed dietary exposures from
orthosulfamuron 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
orthosulfamuron; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used 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 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. Based
on the available data for orthosulfamuron, which is summarized in Unit
III.A., EPA has concluded that a nonlinear approach is appropriate for
assessing cancer risk to orthosulfamuron. The chronic dietary reference
dose (cRfD) is significantly lower than the dose that caused thyroid
tumors in male rats, and therefore is protective of potential
carcinogenicity. Cancer risk was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for orthosulfamuron. Tolerance-level residues and 100 PCT
were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for orthosulfamuron in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of orthosulfamuron. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Screening groundwater-sourced drinking water exposure estimates
were
[[Page 9871]]
generated with the Pesticide Root Zone Model for GroundWater (PRZM-GW,
version 1.07) for use in sulfonylurea dietary risk assessments. Rather
than using chemical-specific estimated drinking water concentrations
(EDWCs) following the usual assessment procedures, these coarse-screen
estimates should exceed upper-bound, chemical-specific EDWCs for any
sulfonylurea (SU). This was achieved by using model inputs that
represent the use pattern of highest exposure from any SU, the highest
soil mobility of any SU residue of concern, and the highest persistence
to any route of degradation over time. The resulting coarse-screen EDWC
from PRZM-GW was used as the conservative estimate of exposure. The
chronic dietary assessment for orthosulfamuron used the coarse-screen
maximum daily concentration of 0.751 ppm.
3. 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). Orthosulfamuron is
not registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
The Agency has assessed orthosulfamuron, and its chemical class,
sulfonylureas, and determined that the SUs do not share a common
mechanism of toxicity (EPA-HQ-OPP-2011-04538-0024). The SUs share a
core chemical structure with varying degrees of structural similarity
based on individual substituents on either side of the molecule. In
addition, the SUs share a pesticidal mode of action (MOA) (inhibition
of acetolactate synthase (ALS)), although the function of ALS in humans
is unknown and the relevance of this MOA in humans in unclear. Based on
toxicity studies, the SUs do not share a common toxicological profile;
instead the target organs vary among the class and are often non-
specific, such as changes in body weight or general effects on the
liver. Further dividing the SUs into subclasses based on the urea
substituent did not result in a clear association of a target organ
with any particular substructure.
Based on the weight of the evidence, which includes the lack of a
common toxicological profile, the uncertainty in the human relevance of
ALS inhibition, and the lack of mammalian MOA data, a testable
hypothesis for a common mechanism of action cannot be identified.
Therefore, the Agency concludes that no common mechanism of toxicity
exists among these pesticides and a cumulative risk assessment approach
is not appropriate for this class of pesticides.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of the FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
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. The rationale for that decision remains the same as in the
February 28, 2007 final rule establishing tolerances for a use on rice.
See 72 FR 8928 (FRL-8113-4) for the full rationale in Unit III.D.
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). 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,
orthosulfamuron 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
orthosulfamuron from food and water will utilize 81% of the cPAD for
all infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for orthosulfamuron.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term or
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Short-term and intermediate-term adverse effects were identified in
the toxicity database (e.g., kidney and liver effects); however,
orthosulfamuron is not registered for any use patterns that would
result in short-term or intermediate-term residential exposure. Short-
term risk is assessed based on short-term residential exposure plus
chronic dietary exposure. Intermediate-term risk is assessed based on
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short-term 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 or intermediate-term risk), no
further assessment of short-term or intermediate-term risk is
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short-term and intermediate-term risk for orthosulfamuron.
4. Aggregate cancer risk for U.S. population. As stated in Unit
III.C.1.iii, EPA has concluded that the chronic reference dose (RfD)
will adequately account for all repeated exposure/chronic toxicity,
including carcinogenicity, which could result from exposure to
orthosulfamuron. As there is no chronic risk of concern, EPA concludes
that exposure to orthosulfamuron 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 orthosulfamuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology utilizing high-performance liquid
chromatography with tandem mass spectrometric detection (LC/MS/MS) is
available to enforce the tolerance expression.
[[Page 9872]]
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). 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.
Although EPA may establish a tolerance that is different from a Codex
MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for
departing from the Codex level.
The Codex has not established an MRL for orthosulfamuron in any
commodity.
V. Conclusion
Therefore, tolerances are established for residues of
orthosulfamuron in or on Almond, hulls at 0.03 ppm; Fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; and Nut,
tree, group 14-12 at 0.01 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under the 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 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 the 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: January 4, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended 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. 180.625,
0
a. Revise paragraph (a) introductory text;
0
b. Designate the table in paragraph (a) and add alphabetically the
commodities ``Almond, hulls''; ``Fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13-07F''; and ``Nut, tree, group 14-12''.
The revision and additions read as follows:
Sec. 180.625 Orthosulfamuron; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide orthosulfamuron, including its metabolites and degradates, in
or on the commodities in the table, below. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only orthosulfamuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-
{[2-(dimethylcarbamoyl)phenyl]sulfamoyl{time} urea, in or on the
following commodities:
Table to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls............................................... 0.03
Fruit, small, vine climbing, except fuzzy kiwifruit, 0.01
subgroup 13-07F............................................
Nut, tree, group 14-12...................................... 0.01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2021-03181 Filed 2-16-21; 8:45 am]
BILLING CODE 6560-50-P