Mefentrifluconazole; Pesticide Tolerances, 70997-71001 [2020-24467]
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Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0068; FRL–10015–56]
Mefentrifluconazole; Pesticide
Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of
mefentrifluconazole in or on multiple
commodities that are identified and
discussed later in this document. BASF
Corporation requested these tolerances
under section 346a of the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
November 6, 2020. Objections and
requests for hearings must be received
on or before January 5, 2021 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0068, 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. Please note
that due to the public health crisis,
visitor access to the Public Reading
Room and OPP Docket are subject to
restrictions. Please review the visitor
instructions and additional information
about the docket available at 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–
8578; 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
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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 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–2020–0068 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
January 5, 2021. Addresses for mail and
hand delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2020–0068, 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.
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70997
• 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/where-sendcomments-epa-dockets.
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.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of April 15,
2020 (85 FR 20910) (FRL–10006–54),
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 9F8796) by BASF
Corporation, 26 Davis Drive, P.O. Box
13528, Research Triangle Park, North
Carolina 27709–3528. The petition
requested that 40 CFR 180.705 be
amended by establishing tolerances for
residues of the fungicide
mefentrifluconazole, a-[4-(4chlorophenoxy)-2(trifluoromethyl)phenyl]-a-methyl-1H1,2,4-triazole-1-ethanol, in or on berry,
low growing, subgroup 13–07G at 2
parts per million (ppm); bushberry,
subgroup 13–07B at 5 ppm; caneberry,
subgroup 13–07A at 3 ppm; cattle, fat at
0.8 ppm; cattle, kidney at 0.6 ppm;
cattle, liver at 1.5 ppm; cattle, meat at
0.07 ppm; cattle, meat byproducts at 1.5
ppm; cotton, gin byproducts at 10 ppm;
cottonseed subgroup 20C at 0.2 ppm;
egg at 0.01 ppm; goat, fat at 0.8 ppm;
goat, kidney at 0.6 ppm; goat, liver at 1.5
ppm; goat, meat at 0.07 ppm; goat, meat
byproducts at 1.5 ppm; grass, crop
group 17, forage at 50 ppm; grass, crop
group 17, hay at 100 ppm; hog, fat at
0.02 ppm; hog, kidney at 0.03 ppm; hog,
liver at 0.03 ppm; hog, meat at 0.01
ppm; hog, meat byproducts at 0.03 ppm;
horse, fat at 0.8 ppm; horse, kidney at
0.6 ppm; horse, liver at 1.5 ppm; horse,
meat at 0.07 ppm; horse, meat
byproducts at 1.5 ppm; melon subgroup
9A at 0.5 ppm; milk at 0.09 ppm; milk
fat at 2.4 ppm; non-grass animal feed,
forage, crop group 18 at 15 ppm; nongrass animal feed, hay, crop group 18 at
40 ppm; onion, bulb, subgroup 3–07A at
0.2 ppm; onion, green, subgroup 3–07B
at 4 ppm; poultry, fat at 0.015 ppm;
poultry, liver at 0.01 ppm; poultry, meat
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at 0.015 ppm; poultry, meat byproducts
at 0.015 ppm; sheep, fat at 0.8 ppm;
sheep, kidney at 0.6 ppm; sheep, liver
at 1.5 ppm; sheep, meat at 0.07 ppm;
sheep, meat byproducts at 1.5 ppm;
squash/cucumber subgroup 9B at 0.15
ppm; sugarcane, cane at 1.5 ppm;
sunflower subgroup 20B at 0.15 ppm;
tomato, dried at 5 ppm; vegetable, leafy,
except brassica, crop group 4–16 at 30
ppm; vegetables, fruiting, crop group 8–
10 at 0.9 ppm; vegetable, leaves of root
and tuber, crop group 2 at 20 ppm; and
vegetable, root, except sugar beet,
subgroup 1B at 0.7 ppm. That document
referenced a summary of the petition
prepared by BASF Corporation, 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 is
establishing several tolerances at
different levels than the petitioned-for
tolerances and revised some commodity
definitions. In addition, EPA is not
establishing several tolerances that were
petitioned-for. The reasons for these
changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for
mefentrifluconazole including exposure
resulting from the tolerances established
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by this action. EPA’s assessment of
exposures and risks associated with
mefentrifluconazole follows.
On June 28, 2019, EPA published in
the Federal Register a final rule
establishing tolerances for residues of
mefentrifluconazole in or on many
animal, corn, fruit, grain, nut and
vegetable commodities based on the
Agency’s conclusion that aggregate
exposure to mefentrifluconazole is safe
for the general population, including
infants and children. See (84 FR 30939)
(FRL–9994–51). EPA is incorporating
the following portions of that document
by reference here, as they have not
changed in the Agency’s current
assessment of mefentrifluconazole
tolerances: The toxicological profile and
points of departure, the cancer
assessment, the conclusions about
cumulative risk, and the Agency’s
determination regarding the children’s
safety factor. Additionally, EPA is
incorporating the assumptions for
exposure assessment from the June 28,
2019 final rule including the estimated
drinking water concentrations, which
have not changed except as explained in
the following paragraph.
EPA’s dietary (food and drinking
water) exposure assessments have been
updated to include the additional
exposure from the new uses of
mefentrifluconazole on root and tuber
vegetables (crop group 1B), leaves of
root and tuber vegetables (crop group 2),
leafy vegetables (crop group 4–16),
fruiting vegetables (crop group 8–10),
cucurbit vegetables (crop group 9),
berries (subgroups 13–07A, 13–07B, and
13–07G), grasses (crop group 17), nongrass animal feeds (crop group 18),
sunflower (crop group 20B), and cotton
(crop group 20C). EPA conducted an
unrefined acute dietary (food and
drinking water) exposure and risk
assessment that incorporates tolerancelevel residue values, 100% crop treated,
and EPA’s 2018 default processing
factors. EPA conducted a partially
refined chronic dietary (food and
drinking water) exposure and risk
assessment that incorporates 100% crop
treated, empirical processing factors
(when available), and average field trial
residues for some commodities. As
required under FFDCA 408(b)(2)(E),
when EPA relies on anticipated residue
data for supporting tolerances, EPA will
require submission of data to
demonstrate that the levels in food are
not above the levels anticipated no later
than 5 years from the date of issuance
of these tolerances.
Acute dietary (food and drinking
water) risks are below the Agency’s
level of concern of 100% of the acute
population-adjusted dose (aPAD): They
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are less than 5.4% of the aPAD for
females 13 to 49 years old, the only
population group of concern. Chronic
dietary risks are below the Agency’s
level of concern of 100% of the chronic
population-adjusted dose (cPAD): They
are less than 73% of the cPAD for
children 1 to 2 years old, the population
subgroup with the highest exposure
estimate.
There are no handler or postapplication residential exposures
anticipated from the new uses of
mefentrifluconazole. However, the
currently registered use on golf courses
will result in short-term (1 to 30 days)
residential post-application dermal
exposures to adults, youth 11 to less
than 16 years old, and children 6 to less
than 11 years old.
For aggregate risk assessment, the
acute and chronic aggregate risk
assessments include dietary (food and
drinking water) exposures only;
therefore, the acute and chronic
aggregate assessments are equivalent to
the acute and chronic dietary
assessments, respectively, and are not of
concern. The short-term aggregate risk
assessment includes residential
exposures (golfing activities on
previously treated turf) and average
dietary exposures. The short-term
aggregate margins of exposure (MOEs)
for adults (830) and children (6 to less
than 11 years old, 640) are not of
concern because they exceed EPA’s
level of concern (MOEs less than 100).
Therefore, there are no acute, chronic,
or short-term aggregate risk estimates of
concern for mefentrifluconazole.
Based on the information summarized
in this unit and in the supporting risk
assessment, 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 mefentrifluconazole
residues. More detailed information can
be found in the document titled
‘‘Mefentrifluconazole. Human Health
Risk Assessment in Support of the
Petition for the Establishment of
Permanent Tolerances and Registration
for Use on Root and Tuber Vegetables
(Crop Group 1B); Leaves of Root and
Tuber Vegetables (Crop Group 2); Leafy
Vegetables (Crop Group 4–16); Fruiting
Vegetables (Crop Group 8–10); Cucurbit
Vegetables (Crop Group 9); Berries
(Subgroups 13–07A, 13–07B, and 13–
07G), Grasses (Crop Group 17); NonGrass Animal Feeds (Crop Group 18);
Sunflower (Crop Group 20B); and
Cotton (Crop Group 20C),’’ dated
October 9, 2020 in docket ID EPA–HQ–
OPP–2020–0068.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
are available to enforce the tolerance
expression. Multi-residue method
QuEChERS (BASF method L0295/01) is
the enforcement method for the
determination of mefentrifluconazole
residues in plant matrices. BASF
Analytical Method No. L0272/01 is the
enforcement method for the
determination of residues of
mefentrifluconazole in livestock
commodities by liquid chromatography
with tandem mass spectroscopy (LC–
MS/MS).
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex has not established MRLs for
mefentrifluconazole.
C. Revisions to Petitioned-For
Tolerances
EPA revised the commodity
definitions for animal feed, nongrass,
group 18, forage; animal feed, nongrass,
group 18, hay; grass, forage, fodder and
hay, group 17, forage; grass, forage,
fodder and hay, group 17, hay; milk, fat;
vegetable, leafy, group 4–16; vegetable,
fruiting, group 8–10; and vegetable,
leaves of root and tuber, group 2. In
addition, EPA determined that separate
tolerances were not needed for the
petitioned-for commodities for cattle,
kidney at 0.6 ppm; cattle, liver at 1.5
ppm; goat, kidney at 0.6 ppm; goat, liver
at 1.5 ppm; hog, kidney at 0.03 ppm;
hog, liver at 0.03 ppm; horse; kidney at
0.6 ppm; horse, liver at 1.5 ppm;
poultry, liver at 0.01 ppm; sheep,
kidney at 0.6 ppm; and sheep, liver at
1.5 ppm because they are covered under
their respective petitioned-for meat
byproducts commodities.
Both the petitioner and EPA used the
Organization for Economic Co-operation
and Development (OECD) maximum
residue limit (MRL) calculation
procedures; however, differences were
noted in the process for inputting the
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data. The petitioner appears to have
inputted individual sample values,
whereas EPA used the field trial average
values per the OECD standard operating
procedure (SOP). The petitioner also
appears to have combined the results of
residue data from the individual crops
in a crop group for calculation of the
crop group tolerance, whereas EPA
calculated values for each crop
individually. Based on these
differences, EPA is establishing the
tolerances for animal feed, nongrass,
group 18, hay at 30 ppm (instead of 40
ppm) and for squash/cucumber
subgroup 9B at 0.2 ppm (instead of 0.15
ppm).
For livestock commodities, both the
petitioner and EPA used the Langmuir
Model (ver. 1.4) to calculate all
tolerance levels. In some cases, the
values determined by EPA were higher
than those determined by the petitioner.
It is possible that the petitioner used
average values from the livestock
feeding studies, while the EPA used
maximum values. Therefore, EPA
determined the tolerances should be set
at different levels for the following
commodities (with the petitioned-for
level in parentheses): Cattle, goat, horse
and sheep, fat at 1 ppm (0.8 ppm);
cattle, goat, horse and sheep, meat at
0.15 ppm (0.07 ppm); hog, fat at 0.015
ppm (0.02 ppm); milk at 0.15 ppm (0.09
ppm); and milk, fat at 4 ppm (2.4 ppm).
In addition, the tolerance for tomato,
dried is being established at 4 ppm
because EPA used the median
processing factor while the petitioner
proposed 5 ppm based on the average
processing factor. Finally, EPA is setting
a separate tolerance for lettuce, head at
5 ppm because it is more than 5 times
less than the tolerance for vegetable,
leafy, group 4–16 at 30 ppm.
V. Conclusion
Therefore, tolerances are established
for residues of mefentrifluconazole, a[4-(4-chlorophenoxy)-2(trifluoromethyl)phenyl]-a-methyl-1H1,2,4-triazole-1-ethanol, in or on Animal
feed, nongrass, group 18, forage at 15
ppm; Animal feed, nongrass, group 18,
hay at 30 ppm; Berry, low growing,
subgroup 13–07G at 2 ppm; Bushberry,
subgroup 13–07B at 5 ppm; Caneberry,
subgroup 13–07A at 3 ppm; Cotton, gin
byproducts at 10 ppm; Cottonseed
subgroup 20C at 0.2 ppm; Grass, forage,
fodder and hay, group 17, forage at 50
ppm; Grass, forage, fodder and hay,
group 17, hay at 100 ppm; Lettuce, head
at 5 ppm; Melon subgroup 9A at 0.5
ppm; Onion, bulb, subgroup 3–07A at
0.2 ppm; Onion, green, subgroup 3–07B
at 4 ppm; Squash/cucumber subgroup
9B at 0.2 ppm, Sugarcane, cane at 1.5
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ppm; Sunflower subgroup 20B at 0.15
ppm; Tomato, dried at 4 ppm;
Vegetable, fruiting, group 8–10 at 0.9
ppm; Vegetable, leafy, group 4–16,
except head lettuce at 30 ppm;
Vegetable, leaves of root and tuber,
group 2 at 20 ppm; Vegetable, root,
except sugar beet, subgroup 1B at 0.7
ppm.
In addition, EPA is revising the
tolerances for residues of
mefentrifluconazole, a-[4-(4chlorophenoxy)-2(trifluoromethyl)phenyl]-a-methyl-1H1,2,4-triazole-1-ethanol, in or on Cattle,
fat at 1 ppm; Cattle, meat at 0.15 ppm;
Cattle, meat byproducts at 1.5 ppm; Egg
at 0.01 ppm; Goat, fat at 1 ppm; Goat,
meat at 0.15 ppm; Goat, meat
byproducts at 1.5 ppm; Hog, fat at 0.015
ppm; Hog, meat at 0.01 ppm; Hog, meat
byproducts at 0.03 ppm; Horse, fat at 1
ppm; Horse, meat at 0.15 ppm; Horse,
meat byproducts at 1.5 ppm; Milk at
0.15 ppm; Milk, fat at 4 ppm; Poultry,
fat at 0.015 ppm; Poultry, meat at 0.015
ppm; Poultry, meat byproducts at 0.015
ppm; Sheep, fat at 1 ppm; Sheep, meat
at 0.15 ppm; and Sheep, meat
byproducts at 1.5 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to petitions 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).
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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 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: October 28, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.705, amend paragraph (a)
by:
■ a. In the introductory text, removing
‘‘the table below’’ and ‘‘specified
below’’ and adding ‘‘Table 1 to this
paragraph (a)’’ and ‘‘specified in Table
1 to this paragraph (a)’’, respectively, in
their places;
■ b. Designating the table as Table 1 to
paragraph (a); and
■ c. In newly designated Table 1 to
paragraph (a):
■ i. Adding entries for ‘‘Animal feed,
nongrass, group 18, forage’’, ‘‘Animal
feed, nongrass, group 18, hay’’, ‘‘Berry,
■
low growing, subgroup 13–07G’’,
‘‘Bushberry, subgroup 13–07B’’ and
‘‘Caneberry, subgroup 13–07A’’ in
alphabetical order;
■ ii. Revising the entries for ‘‘Cattle,
fat’’, ‘‘Cattle, meat’’ and ‘‘Cattle, meat
byproducts’’;
■ iii. Adding entries for ‘‘Cotton, gin
byproducts’’ and ‘‘Cottonseed subgroup
20C’’ in alphabetical order;
■ iv. Revising the entries for ‘‘Egg’’,
‘‘Goat, fat’’, ‘‘Goat, meat’’ and ‘‘Goat,
meat byproducts’’;
■ v. Adding entries for ‘‘Grass, forage,
fodder and hay, group 17, forage’’ and
‘‘Grass, forage, fodder and hay, group
17, hay’’ in alphabetical order;
■ vi. Revising the entries for ‘‘Hog, fat’’,
‘‘Hog, meat’’, ‘‘Hog, meat byproducts’’,
‘‘Horse, fat’’, ‘‘Horse, meat’’ and ‘‘Horse,
meat byproducts’’;
■ vii. Adding entries for ‘‘Lettuce, head’’
and ‘‘Melon subgroup 9A’’ in
alphabetical order;
■ viii. Revising the entries for ‘‘Milk’’
and ‘‘Milk, fat’’;
■ ix. Adding entries for ‘‘Onion, bulb,
subgroup 3–07A’’ and ‘‘Onion, green,
subgroup 3–07B’’ in alphabetical order;
■ x. Revising the entries for ‘‘Poultry,
fat’’, ‘‘Poultry, meat’’, ‘‘Poultry, meat
byproducts’’, ‘‘Sheep, fat’’, ‘‘Sheep,
meat’’ and ‘‘Sheep, meat byproducts’’;
and
■ xi. Adding entries for ‘‘Squash/
cucumber subgroup 9B’’, ‘‘Sugarcane,
cane’’, ‘‘Sunflower subgroup 20B’’,
‘‘Tomato, dried’’, ‘‘Vegetable, fruiting,
group 8–10’’, ‘‘Vegetable, leafy, group 4–
16, except head lettuce’’, ‘‘Vegetable,
leaves of root and tuber, group 2’’ and
‘‘Vegetable, root, except sugar beet,
subgroup 1B’’ in alphabetical order.
The additions read as follows:
§ 180.705 Mefentrifluconazole; tolerances
for residues.
(a) * * *
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
*
*
Animal feed, nongrass, group 18, forage ............................................................................................................................................
Animal feed, nongrass, group 18, hay ................................................................................................................................................
*
*
*
*
*
*
*
Berry, low growing, subgroup 13–07G ................................................................................................................................................
Bushberry, subgroup 13–07B ..............................................................................................................................................................
Caneberry, subgroup 13–07A .............................................................................................................................................................
Cattle, fat .............................................................................................................................................................................................
Cattle, meat .........................................................................................................................................................................................
Cattle, meat byproducts .......................................................................................................................................................................
*
*
*
*
*
*
*
Cotton, gin byproducts .........................................................................................................................................................................
Cottonseed subgroup 20C ...................................................................................................................................................................
*
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Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Rules and Regulations
TABLE 1 TO PARAGRAPH (a)—Continued
Parts per
million
Commodity
Egg .......................................................................................................................................................................................................
0.01
*
*
*
*
*
*
Goat, fat ...............................................................................................................................................................................................
Goat, meat ...........................................................................................................................................................................................
Goat, meat byproducts ........................................................................................................................................................................
*
*
*
*
*
*
*
Grass, forage, fodder and hay, group 17, forage ...............................................................................................................................
Grass, forage, fodder and hay, group 17, hay ....................................................................................................................................
Hog, fat ................................................................................................................................................................................................
Hog, meat ............................................................................................................................................................................................
Hog, meat byproducts .........................................................................................................................................................................
Horse, fat .............................................................................................................................................................................................
Horse, meat .........................................................................................................................................................................................
Horse, meat byproducts ......................................................................................................................................................................
*
*
*
*
*
*
*
Lettuce, head .......................................................................................................................................................................................
Melon subgroup 9A .............................................................................................................................................................................
Milk .......................................................................................................................................................................................................
Milk, fat ................................................................................................................................................................................................
*
*
*
*
*
*
*
Onion, bulb, subgroup 3–07A ..............................................................................................................................................................
Onion, green, subgroup 3–07B ...........................................................................................................................................................
*
*
*
*
*
*
*
Poultry, fat ............................................................................................................................................................................................
Poultry, meat ........................................................................................................................................................................................
Poultry, meat byproducts .....................................................................................................................................................................
*
*
*
*
*
*
*
Sheep, fat ............................................................................................................................................................................................
Sheep, meat ........................................................................................................................................................................................
Sheep, meat byproducts ......................................................................................................................................................................
*
*
*
*
*
*
*
Squash/cucumber subgroup 9B ..........................................................................................................................................................
Sugarcane, cane ..................................................................................................................................................................................
Sunflower subgroup 20B .....................................................................................................................................................................
Tomato, dried .......................................................................................................................................................................................
*
*
*
*
*
*
*
Vegetable, fruiting, group 8–10 ...........................................................................................................................................................
Vegetable, leafy, group 4–16, except head lettuce .............................................................................................................................
Vegetable, leaves of root and tuber, group 2 .....................................................................................................................................
*
*
*
*
*
*
*
Vegetable, root, except sugar beet, subgroup 1B ..............................................................................................................................
*
*
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2020–24467 Filed 11–5–20; 8:45 am]
BILLING CODE 6560–50–P
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0.015
0.01
0.03
1
0.15
1.5
5
0.5
0.15
4
0.2
4
0.015
0.015
0.015
1
0.15
1.5
0.2
1.5
0.15
4
0.9
30
20
0.7
*
Agencies
[Federal Register Volume 85, Number 216 (Friday, November 6, 2020)]
[Rules and Regulations]
[Pages 70997-71001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24467]
[[Page 70997]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0068; FRL-10015-56]
Mefentrifluconazole; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
mefentrifluconazole in or on multiple commodities that are identified
and discussed later in this document. BASF Corporation requested these
tolerances under section 346a of the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective November 6, 2020. Objections and
requests for hearings must be received on or before January 5, 2021 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0068, 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. Please note that due to the public health
crisis, visitor access to the Public Reading Room and OPP Docket are
subject to restrictions. Please review the visitor instructions and
additional information about the docket available at 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) 305-8578; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at 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-2020-0068 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
January 5, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0068, 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/where-send-comments-epa-dockets.
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.
II. Summary of Petitioned-For Tolerance
In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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
9F8796) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, North Carolina 27709-3528. The petition requested that
40 CFR 180.705 be amended by establishing tolerances for residues of
the fungicide mefentrifluconazole, [alpha]-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-[alpha]-methyl-1H-1,2,4-triazole-1-ethanol, in
or on berry, low growing, subgroup 13-07G at 2 parts per million (ppm);
bushberry, subgroup 13-07B at 5 ppm; caneberry, subgroup 13-07A at 3
ppm; cattle, fat at 0.8 ppm; cattle, kidney at 0.6 ppm; cattle, liver
at 1.5 ppm; cattle, meat at 0.07 ppm; cattle, meat byproducts at 1.5
ppm; cotton, gin byproducts at 10 ppm; cottonseed subgroup 20C at 0.2
ppm; egg at 0.01 ppm; goat, fat at 0.8 ppm; goat, kidney at 0.6 ppm;
goat, liver at 1.5 ppm; goat, meat at 0.07 ppm; goat, meat byproducts
at 1.5 ppm; grass, crop group 17, forage at 50 ppm; grass, crop group
17, hay at 100 ppm; hog, fat at 0.02 ppm; hog, kidney at 0.03 ppm; hog,
liver at 0.03 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.03
ppm; horse, fat at 0.8 ppm; horse, kidney at 0.6 ppm; horse, liver at
1.5 ppm; horse, meat at 0.07 ppm; horse, meat byproducts at 1.5 ppm;
melon subgroup 9A at 0.5 ppm; milk at 0.09 ppm; milk fat at 2.4 ppm;
non-grass animal feed, forage, crop group 18 at 15 ppm; non-grass
animal feed, hay, crop group 18 at 40 ppm; onion, bulb, subgroup 3-07A
at 0.2 ppm; onion, green, subgroup 3-07B at 4 ppm; poultry, fat at
0.015 ppm; poultry, liver at 0.01 ppm; poultry, meat
[[Page 70998]]
at 0.015 ppm; poultry, meat byproducts at 0.015 ppm; sheep, fat at 0.8
ppm; sheep, kidney at 0.6 ppm; sheep, liver at 1.5 ppm; sheep, meat at
0.07 ppm; sheep, meat byproducts at 1.5 ppm; squash/cucumber subgroup
9B at 0.15 ppm; sugarcane, cane at 1.5 ppm; sunflower subgroup 20B at
0.15 ppm; tomato, dried at 5 ppm; vegetable, leafy, except brassica,
crop group 4-16 at 30 ppm; vegetables, fruiting, crop group 8-10 at 0.9
ppm; vegetable, leaves of root and tuber, crop group 2 at 20 ppm; and
vegetable, root, except sugar beet, subgroup 1B at 0.7 ppm. That
document referenced a summary of the petition prepared by BASF
Corporation, 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 is
establishing several tolerances at different levels than the
petitioned-for tolerances and revised some commodity definitions. In
addition, EPA is not establishing several tolerances that were
petitioned-for. The reasons for these changes are explained in Unit
IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for mefentrifluconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with
mefentrifluconazole follows.
On June 28, 2019, EPA published in the Federal Register a final
rule establishing tolerances for residues of mefentrifluconazole in or
on many animal, corn, fruit, grain, nut and vegetable commodities based
on the Agency's conclusion that aggregate exposure to
mefentrifluconazole is safe for the general population, including
infants and children. See (84 FR 30939) (FRL-9994-51). EPA is
incorporating the following portions of that document by reference
here, as they have not changed in the Agency's current assessment of
mefentrifluconazole tolerances: The toxicological profile and points of
departure, the cancer assessment, the conclusions about cumulative
risk, and the Agency's determination regarding the children's safety
factor. Additionally, EPA is incorporating the assumptions for exposure
assessment from the June 28, 2019 final rule including the estimated
drinking water concentrations, which have not changed except as
explained in the following paragraph.
EPA's dietary (food and drinking water) exposure assessments have
been updated to include the additional exposure from the new uses of
mefentrifluconazole on root and tuber vegetables (crop group 1B),
leaves of root and tuber vegetables (crop group 2), leafy vegetables
(crop group 4-16), fruiting vegetables (crop group 8-10), cucurbit
vegetables (crop group 9), berries (subgroups 13-07A, 13-07B, and 13-
07G), grasses (crop group 17), non-grass animal feeds (crop group 18),
sunflower (crop group 20B), and cotton (crop group 20C). EPA conducted
an unrefined acute dietary (food and drinking water) exposure and risk
assessment that incorporates tolerance-level residue values, 100% crop
treated, and EPA's 2018 default processing factors. EPA conducted a
partially refined chronic dietary (food and drinking water) exposure
and risk assessment that incorporates 100% crop treated, empirical
processing factors (when available), and average field trial residues
for some commodities. As required under FFDCA 408(b)(2)(E), when EPA
relies on anticipated residue data for supporting tolerances, EPA will
require submission of data to demonstrate that the levels in food are
not above the levels anticipated no later than 5 years from the date of
issuance of these tolerances.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the acute population-adjusted dose
(aPAD): They are less than 5.4% of the aPAD for females 13 to 49 years
old, the only population group of concern. Chronic dietary risks are
below the Agency's level of concern of 100% of the chronic population-
adjusted dose (cPAD): They are less than 73% of the cPAD for children 1
to 2 years old, the population subgroup with the highest exposure
estimate.
There are no handler or post-application residential exposures
anticipated from the new uses of mefentrifluconazole. However, the
currently registered use on golf courses will result in short-term (1
to 30 days) residential post-application dermal exposures to adults,
youth 11 to less than 16 years old, and children 6 to less than 11
years old.
For aggregate risk assessment, the acute and chronic aggregate risk
assessments include dietary (food and drinking water) exposures only;
therefore, the acute and chronic aggregate assessments are equivalent
to the acute and chronic dietary assessments, respectively, and are not
of concern. The short-term aggregate risk assessment includes
residential exposures (golfing activities on previously treated turf)
and average dietary exposures. The short-term aggregate margins of
exposure (MOEs) for adults (830) and children (6 to less than 11 years
old, 640) are not of concern because they exceed EPA's level of concern
(MOEs less than 100). Therefore, there are no acute, chronic, or short-
term aggregate risk estimates of concern for mefentrifluconazole.
Based on the information summarized in this unit and in the
supporting risk assessment, 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 mefentrifluconazole
residues. More detailed information can be found in the document titled
``Mefentrifluconazole. Human Health Risk Assessment in Support of the
Petition for the Establishment of Permanent Tolerances and Registration
for Use on Root and Tuber Vegetables (Crop Group 1B); Leaves of Root
and Tuber Vegetables (Crop Group 2); Leafy Vegetables (Crop Group 4-
16); Fruiting Vegetables (Crop Group 8-10); Cucurbit Vegetables (Crop
Group 9); Berries (Subgroups 13-07A, 13-07B, and 13-07G), Grasses (Crop
Group 17); Non-Grass Animal Feeds (Crop Group 18); Sunflower (Crop
Group 20B); and Cotton (Crop Group 20C),'' dated October 9, 2020 in
docket ID EPA-HQ-OPP-2020-0068.
[[Page 70999]]
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies are available to enforce the
tolerance expression. Multi-residue method QuEChERS (BASF method L0295/
01) is the enforcement method for the determination of
mefentrifluconazole residues in plant matrices. BASF Analytical Method
No. L0272/01 is the enforcement method for the determination of
residues of mefentrifluconazole in livestock commodities by liquid
chromatography with tandem mass spectroscopy (LC-MS/MS).
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex has not established MRLs for
mefentrifluconazole.
C. Revisions to Petitioned-For Tolerances
EPA revised the commodity definitions for animal feed, nongrass,
group 18, forage; animal feed, nongrass, group 18, hay; grass, forage,
fodder and hay, group 17, forage; grass, forage, fodder and hay, group
17, hay; milk, fat; vegetable, leafy, group 4-16; vegetable, fruiting,
group 8-10; and vegetable, leaves of root and tuber, group 2. In
addition, EPA determined that separate tolerances were not needed for
the petitioned-for commodities for cattle, kidney at 0.6 ppm; cattle,
liver at 1.5 ppm; goat, kidney at 0.6 ppm; goat, liver at 1.5 ppm; hog,
kidney at 0.03 ppm; hog, liver at 0.03 ppm; horse; kidney at 0.6 ppm;
horse, liver at 1.5 ppm; poultry, liver at 0.01 ppm; sheep, kidney at
0.6 ppm; and sheep, liver at 1.5 ppm because they are covered under
their respective petitioned-for meat byproducts commodities.
Both the petitioner and EPA used the Organization for Economic Co-
operation and Development (OECD) maximum residue limit (MRL)
calculation procedures; however, differences were noted in the process
for inputting the data. The petitioner appears to have inputted
individual sample values, whereas EPA used the field trial average
values per the OECD standard operating procedure (SOP). The petitioner
also appears to have combined the results of residue data from the
individual crops in a crop group for calculation of the crop group
tolerance, whereas EPA calculated values for each crop individually.
Based on these differences, EPA is establishing the tolerances for
animal feed, nongrass, group 18, hay at 30 ppm (instead of 40 ppm) and
for squash/cucumber subgroup 9B at 0.2 ppm (instead of 0.15 ppm).
For livestock commodities, both the petitioner and EPA used the
Langmuir Model (ver. 1.4) to calculate all tolerance levels. In some
cases, the values determined by EPA were higher than those determined
by the petitioner. It is possible that the petitioner used average
values from the livestock feeding studies, while the EPA used maximum
values. Therefore, EPA determined the tolerances should be set at
different levels for the following commodities (with the petitioned-for
level in parentheses): Cattle, goat, horse and sheep, fat at 1 ppm (0.8
ppm); cattle, goat, horse and sheep, meat at 0.15 ppm (0.07 ppm); hog,
fat at 0.015 ppm (0.02 ppm); milk at 0.15 ppm (0.09 ppm); and milk, fat
at 4 ppm (2.4 ppm).
In addition, the tolerance for tomato, dried is being established
at 4 ppm because EPA used the median processing factor while the
petitioner proposed 5 ppm based on the average processing factor.
Finally, EPA is setting a separate tolerance for lettuce, head at 5 ppm
because it is more than 5 times less than the tolerance for vegetable,
leafy, group 4-16 at 30 ppm.
V. Conclusion
Therefore, tolerances are established for residues of
mefentrifluconazole, [alpha]-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-[alpha]-methyl-1H-1,2,4-triazole-1-ethanol, in
or on Animal feed, nongrass, group 18, forage at 15 ppm; Animal feed,
nongrass, group 18, hay at 30 ppm; Berry, low growing, subgroup 13-07G
at 2 ppm; Bushberry, subgroup 13-07B at 5 ppm; Caneberry, subgroup 13-
07A at 3 ppm; Cotton, gin byproducts at 10 ppm; Cottonseed subgroup 20C
at 0.2 ppm; Grass, forage, fodder and hay, group 17, forage at 50 ppm;
Grass, forage, fodder and hay, group 17, hay at 100 ppm; Lettuce, head
at 5 ppm; Melon subgroup 9A at 0.5 ppm; Onion, bulb, subgroup 3-07A at
0.2 ppm; Onion, green, subgroup 3-07B at 4 ppm; Squash/cucumber
subgroup 9B at 0.2 ppm, Sugarcane, cane at 1.5 ppm; Sunflower subgroup
20B at 0.15 ppm; Tomato, dried at 4 ppm; Vegetable, fruiting, group 8-
10 at 0.9 ppm; Vegetable, leafy, group 4-16, except head lettuce at 30
ppm; Vegetable, leaves of root and tuber, group 2 at 20 ppm; Vegetable,
root, except sugar beet, subgroup 1B at 0.7 ppm.
In addition, EPA is revising the tolerances for residues of
mefentrifluconazole, [alpha]-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-[alpha]-methyl-1H-1,2,4-triazole-1-ethanol, in
or on Cattle, fat at 1 ppm; Cattle, meat at 0.15 ppm; Cattle, meat
byproducts at 1.5 ppm; Egg at 0.01 ppm; Goat, fat at 1 ppm; Goat, meat
at 0.15 ppm; Goat, meat byproducts at 1.5 ppm; Hog, fat at 0.015 ppm;
Hog, meat at 0.01 ppm; Hog, meat byproducts at 0.03 ppm; Horse, fat at
1 ppm; Horse, meat at 0.15 ppm; Horse, meat byproducts at 1.5 ppm; Milk
at 0.15 ppm; Milk, fat at 4 ppm; Poultry, fat at 0.015 ppm; Poultry,
meat at 0.015 ppm; Poultry, meat byproducts at 0.015 ppm; Sheep, fat at
1 ppm; Sheep, meat at 0.15 ppm; and Sheep, meat byproducts at 1.5 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to petitions 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).
[[Page 71000]]
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 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: October 28, 2020.
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. 180.705, amend paragraph (a) by:
0
a. In the introductory text, removing ``the table below'' and
``specified below'' and adding ``Table 1 to this paragraph (a)'' and
``specified in Table 1 to this paragraph (a)'', respectively, in their
places;
0
b. Designating the table as Table 1 to paragraph (a); and
0
c. In newly designated Table 1 to paragraph (a):
0
i. Adding entries for ``Animal feed, nongrass, group 18, forage'',
``Animal feed, nongrass, group 18, hay'', ``Berry, low growing,
subgroup 13-07G'', ``Bushberry, subgroup 13-07B'' and ``Caneberry,
subgroup 13-07A'' in alphabetical order;
0
ii. Revising the entries for ``Cattle, fat'', ``Cattle, meat'' and
``Cattle, meat byproducts'';
0
iii. Adding entries for ``Cotton, gin byproducts'' and ``Cottonseed
subgroup 20C'' in alphabetical order;
0
iv. Revising the entries for ``Egg'', ``Goat, fat'', ``Goat, meat'' and
``Goat, meat byproducts'';
0
v. Adding entries for ``Grass, forage, fodder and hay, group 17,
forage'' and ``Grass, forage, fodder and hay, group 17, hay'' in
alphabetical order;
0
vi. Revising the entries for ``Hog, fat'', ``Hog, meat'', ``Hog, meat
byproducts'', ``Horse, fat'', ``Horse, meat'' and ``Horse, meat
byproducts'';
0
vii. Adding entries for ``Lettuce, head'' and ``Melon subgroup 9A'' in
alphabetical order;
0
viii. Revising the entries for ``Milk'' and ``Milk, fat'';
0
ix. Adding entries for ``Onion, bulb, subgroup 3-07A'' and ``Onion,
green, subgroup 3-07B'' in alphabetical order;
0
x. Revising the entries for ``Poultry, fat'', ``Poultry, meat'',
``Poultry, meat byproducts'', ``Sheep, fat'', ``Sheep, meat'' and
``Sheep, meat byproducts''; and
0
xi. Adding entries for ``Squash/cucumber subgroup 9B'', ``Sugarcane,
cane'', ``Sunflower subgroup 20B'', ``Tomato, dried'', ``Vegetable,
fruiting, group 8-10'', ``Vegetable, leafy, group 4-16, except head
lettuce'', ``Vegetable, leaves of root and tuber, group 2'' and
``Vegetable, root, except sugar beet, subgroup 1B'' in alphabetical
order.
The additions read as follows:
Sec. 180.705 Mefentrifluconazole; tolerances for residues.
(a) * * *
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Animal feed, nongrass, group 18, forage................. 15
Animal feed, nongrass, group 18, hay.................... 30
* * * * * * *
Berry, low growing, subgroup 13-07G..................... 2
Bushberry, subgroup 13-07B.............................. 5
Caneberry, subgroup 13-07A.............................. 3
Cattle, fat............................................. 1
Cattle, meat............................................ 0.15
Cattle, meat byproducts................................. 1.5
* * * * * * *
Cotton, gin byproducts.................................. 10
Cottonseed subgroup 20C................................. 0.2
[[Page 71001]]
Egg..................................................... 0.01
* * * * * * *
Goat, fat............................................... 1
Goat, meat.............................................. 0.15
Goat, meat byproducts................................... 1.5
* * * * * * *
Grass, forage, fodder and hay, group 17, forage......... 50
Grass, forage, fodder and hay, group 17, hay............ 100
Hog, fat................................................ 0.015
Hog, meat............................................... 0.01
Hog, meat byproducts.................................... 0.03
Horse, fat.............................................. 1
Horse, meat............................................. 0.15
Horse, meat byproducts.................................. 1.5
* * * * * * *
Lettuce, head........................................... 5
Melon subgroup 9A....................................... 0.5
Milk.................................................... 0.15
Milk, fat............................................... 4
* * * * * * *
Onion, bulb, subgroup 3-07A............................. 0.2
Onion, green, subgroup 3-07B............................ 4
* * * * * * *
Poultry, fat............................................ 0.015
Poultry, meat........................................... 0.015
Poultry, meat byproducts................................ 0.015
* * * * * * *
Sheep, fat.............................................. 1
Sheep, meat............................................. 0.15
Sheep, meat byproducts.................................. 1.5
* * * * * * *
Squash/cucumber subgroup 9B............................. 0.2
Sugarcane, cane......................................... 1.5
Sunflower subgroup 20B.................................. 0.15
Tomato, dried........................................... 4
* * * * * * *
Vegetable, fruiting, group 8-10......................... 0.9
Vegetable, leafy, group 4-16, except head lettuce....... 30
Vegetable, leaves of root and tuber, group 2............ 20
* * * * * * *
Vegetable, root, except sugar beet, subgroup 1B......... 0.7
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-24467 Filed 11-5-20; 8:45 am]
BILLING CODE 6560-50-P