Flupyradifurone; Pesticide Tolerances, 51668-51672 [2020-17153]
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Federal Register / Vol. 85, No. 163 / Friday, August 21, 2020 / Rules and Regulations
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 63
[EPA–HQ–OAR–2016–0243; FRL–10009–65–
OAR]
RIN 2060–AO66
National Emission Standards for
Hazardous Air Pollutants: Plywood and
Composite Wood Products Residual
Risk and Technology Review
Correction
In rule document 2020–12725
appearing on pages 49434–49469 in the
issue of August 13, 2020, make the
following correction:
§ 63.2282
[Corrected]
On page 49459, in § 63.2282, in the
third column, in the ninth line down,
‘‘August 13, 2021]’’ should read
‘‘August 13, 2020’’.
■
[FR Doc. C1–2020–12725 Filed 8–20–20; 8:45 am]
BILLING CODE 1300–01–D
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2019–0460; FRL–10010–98]
Flupyradifurone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of
flupyradifurone in or on multiple
commodities which are identified and
discussed later in this document. The
Interregional Project Number 4 (IR–4)
and the registrant, Bayer CropScience,
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
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SUMMARY:
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This regulation is effective
August 21, 2020. Objections and
requests for hearings must be received
on or before October 20, 2020 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–2019–0460, 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 emergency, the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
[FR Doc. 2020–16725 Filed 8–20–20; 8:45 am]
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
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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–2019–0460 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before October 20, 2020. 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
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objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2019–0460, 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-sendcomments-epa-dockets.
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 February
11, 2020 (85 FR 7708) (FRL–10005–02),
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 9E8771) by
Interregional Project Number 4 (IR–4),
Rutgers, the State University of New
Jersey, 500 College Road East, Suite 201
W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.679 be
amended by establishing tolerances for
residues of the insecticide
flupyradifurone, 4-[[(6-chloro-3pyridinyl)methyl](2,2difluoroethyl)amino]- 2(5H)-furanone,
in or on Brassica, leafy greens, subgroup
4–16B at 40 parts per million (ppm);
Celtuce at 9 ppm; Coffee, green bean at
1.5 ppm; Fennel, Florence, fresh leaves
and stalk at 9 ppm; Kohlrabi at 6 ppm;
Leaf petiole vegetable subgroup 22B at
9 ppm; Leafy greens subgroup 4–16A at
30 ppm; Pineapple at 0.3 ppm; Sesame,
seed at 3 ppm; Stalk and stem vegetable
subgroup 22A, except prickly pear,
pads, and prickly pear, Texas, pads at
0.01 ppm; Sunflower subgroup 20B at
0.7 ppm; Tropical and subtropical,
inedible peel, cactus, subgroup 24D at
0.3 ppm; Tropical and subtropical, palm
fruit, edible peel, subgroup 23C at 8
ppm; and Vegetable, Brassica, head and
stem, group 5–16 at 6 ppm.
In addition, the IR–4 petition
requested that 40 CFR 180.679(c) be
amended by establishing tolerances
with regional restrictions for residues of
the insecticide flupyradifurone, 4-[[(6chloro-3-pyridinyl)methyl](2,2-
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difluoroethyl)amino]- 2(5H)-furanone,
in or on Grass, forage, fodder and hay,
group 17 at 15 ppm.
Upon establishment of the above
tolerances, IR–4 requested the removal
of the existing tolerances in 40 CFR part
180.679 for residues of the insecticide
flupyradifurone, 4-[[(6-chloro-3pyridinyl)methyl](2,2difluoroethyl)amino]- 2(5H)-furanone,
in or on Brassica, head and stem
subgroup 5A at 6.0 ppm; Brassica, leafy
greens subgroup 5B at 40 ppm; Cactus,
fruit at 0.30 ppm; Cilantro, fresh leaves
at 30 ppm; Coffee, green been (import
tolerance) at 1.5 ppm; Leaf petioles,
subgroup 4B at 9.0 ppm; Leafy greens,
subgroup 4A at 30 ppm; Pitaya at 0.30
ppm; and Turnip greens at 40 ppm.
IR–4 also requested removal of the
section 18 emergency exemption
tolerances on sorghum, syrup at 90.0
ppm and sorghum, forage at 30 ppm.
Through inadvertent error however,
EPA failed to provide notice of this
petitioned-for request in its February 11,
2020 document.
In the Federal Register of October 28,
2019 (84 FR 57417) (FRL–10001–12),
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 9F8775) by Bayer
CropScience, 2 T.W. Alexander Drive,
Research Triangle Park, NC 27709, that
requested to establish a tolerance in in
40 CFR part 180.679 for residues of the
insecticide flupyradifurone 4-[[(6chloro-3-pyridinyl)methyl](2,2difluoroethyl)amino]- 2(5H)-furanone,
in or on Rapeseed subgroup (Crop
Subgroup 20A) at 0.03 ppm. This
document referenced a summary of the
petition prepared by Bayer CropScience,
the registrant, which is available in the
docket, https://www.regulations.gov.
One comment was submitted on each
notice of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA revised the
commodity definitions for two
commodities to be consistent with
EPA’s preferred terminology, changing
Fennel, Florence, fresh leaves and stalk
to Fennel, florence, fresh leaves and
stalk; and Vegetable, Brassica, head and
stem, group 5–16 to Vegetable, brassica,
head and stem, group 5–16. Finally, due
to the failure to provide timely notice of
the request to remove the section 18
emergency exemption tolerances for
sorghum commodities, EPA is not
removing those tolerances at this time.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
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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 flupyradifurone
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with flupyradifurone follows.
On September 23, 2016, EPA
published in the Federal Register a final
rule establishing tolerances for residues
of flupyradifurone in or on several
commodities based on the Agency’s
conclusion that aggregate exposure to
flupyradifurone is safe for the general
population, including infants and
children. See (81 FR 65552) (FRL–9951–
68). EPA is incorporating the following
portions of that document by reference
here, as they have not changed in the
Agency’s current assessment of
flupyradifurone tolerances—the
toxicological profile and points of
departure, the conclusions about
cumulative risk, and the Agency’s
rationale for reducing the children’s
safety factor.
EPA’s exposure assessments have
been updated to include the additional
exposure from use of flupyradifurone on
the Brassica, leafy greens, subgroup 4–
16B; Celtuce; Coffee, green bean;
Fennel, florence, fresh leaves and stalk;
Kohlrabi; Leaf petiole vegetable
subgroup 22B; Leafy greens subgroup 4–
16A; Pineapple; Rapeseed subgroup
20A; Sesame, seed; Stalk and stem
vegetable subgroup 22A, except prickly
pear, pads, and prickly pear, Texas,
pads; Sunflower subgroup 20B; Tropical
and subtropical, inedible peel, cactus,
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subgroup 24D; Tropical and subtropical,
palm fruit, edible peel, subgroup 23C;
and Vegetable, brassica, head and stem,
group 5–16. EPA has assumed tolerancelevel residues and 100 percent crop
treated (PCT) for the acute dietary
assessment. For the chronic dietary
assessment, EPA assumed average
residues, rather than tolerance-level
residues, for some commodities and 100
PCT. EPA’s aggregate exposure
assessment incorporated this dietary
exposure, as well as exposure in
drinking water and from residential
sources, although drinking water and
residential exposures are not impacted
by the new uses and thus have not
changed since the last assessment and
as reflected in the preamble to the
September 23, 2016 rule.
Acute dietary risks are below the
Agency’s level of concern of 100% of
the acute population adjusted dose
(aPAD); they are 38% of the aPAD for
children 1 to 2 years old, the most
highly exposed population group.
Chronic dietary risks are below the
Agency’s level of concern of 100% of
the chronic population adjusted dose
(cPAD); they are 64% of the cPAD for
children 1 to 2 years old, the group with
the highest exposure. As required by the
FFDCA, EPA considered aggregate
exposures to flupyradifurone, i.e.,
exposures from food, drinking water,
and residential uses, in its risk
assessment. There are no residential
uses expected to result in acute,
intermediate-term, or chronic
exposures; therefore, aggregate risks for
those exposure durations are equal to
the dietary risks for those exposure
durations and not of concern.
Aggregating short-term exposures to
adults and children with the chronic
(background) dietary exposures yields
margins of exposure (MOEs) of 300
(adults) and 220 (children). Both of
these exceed the Agency’s level of
concern, which is an MOE of 100 or
lower; therefore, short-term exposures
are not of concern.
Therefore, based on the risk
assessments and information described
above, EPA concludes there is a
reasonable certainty that no harm will
result to the general population, or to
infants and children from aggregate
exposure to flupyradifurone residues.
More detailed information about the
Agency’s analysis can be found in the
document entitled, ‘‘Flupyradifurone;
Human Health Risk Assessment for Uses
on Grass Forage Fodder and Hay Group
17, Pineapple, Rapeseed Subgroup 20A,
Sesame Seed, Stalk and Stem Vegetable
Subgroup 22A (except Prickly Pear Pads
and Prickly Pear Texas Pads), Sunflower
Subgroup 20B, Sweet Sorghum,
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Tropical and Subtropical Palm Fruit
Edible Peel Subgroup 23C, Crop Group
Expansions/Conversions of Tolerances
to Brassica Leafy Greens Subgroup 4–
16B, Leafy Greens Subgroup 4–16A,
Leaf Petiole Vegetable Subgroup 22B,
Tropical and Subtropical Inedible Peel
Cactus Subgroup 24D, Vegetable
Brassica Head and Stem Group 5–16
and Establish Individual Tolerances on
Celtuce, Fennel Florence, Kohlrabi; and
Coffee,’’ which is described under
ADDRESSES. Locate and click on the
hyperlink for docket ID number EPA–
HQ–OPP–2019–0460.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
Method RV–001–P10–03, which uses
high-performance liquid
chromatography with tandem mass
spectrometry (HPLC/MS/MS) to
quantitate residues of flupyradifurone
and its metabolite difluoroacetic acid
(DFA) in various crops is available for
enforcement. An HPLC/MS/MS method,
Method RV–004–A11–05 is adequate as
the enforcement method for
determination of residues of
flupyradifurone and its metabolite DFA
in livestock commodities.
The method may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
Codex MRLs have been established
for head cabbage at 1.5 ppm, cauliflower
at 6 ppm, and lettuce (head and leaf) at
4 ppm. For leafy greens subgroup 4–
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16A, harmonization with Codex is not
possible because the U.S. tolerance of 30
ppm is much higher than the Codex
MRLs for head lettuce and leaf lettuce.
Harmonizing with the Codex MRLs
would put U.S. growers at risk of having
violative residues despite legal use of
the pesticide. The U.S. tolerance on
Brassica head and stem group 5–16 is
harmonized with the Codex cauliflower
MRL (6 ppm). It is not possible to also
harmonize with head cabbage, which is
another commodity in crop group 5–16.
C. Response to Comments
One comment was received stating
that residues of pesticide chemicals on
various commodities are a serious
health hazard that needs to be regulated.
Another comment received stated that
this chemical should not be used on any
food products that Americans eat. The
existing legal framework provided by
section 408 of the FFDCA states that
tolerances may be set when persons
seeking such tolerances or exemptions
have demonstrated that the pesticide
meets the safety standard imposed by
that statute. These comments appear to
be directed at the underlying statute and
not EPA’s implementation of it; the
comments provide no information
relevant to the Agency’s safety
determination.
V. Conclusion
Therefore, tolerances are established
for residues of flupyradifurone, 4-[[(6chloro-3-pyridinyl)methyl](2,2difluoroethyl)amino]-2(5H)-furanone, in
or on Brassica, leafy greens, subgroup
4–16B at 40 ppm; Celtuce at 9 ppm;
Fennel, florence, fresh leaves and stalk
at 9 ppm; Kohlrabi at 6 ppm; Leaf
petiole vegetable subgroup 22B at 9
ppm; Leafy greens subgroup 4–16A at
30 ppm; Pineapple at 0.3 ppm;
Rapeseed subgroup 20A at 0.03 ppm;
Sesame, seed at 3 ppm; Stalk and stem
vegetable subgroup 22A, except prickly
pear, pads, and prickly pear, Texas,
pads at 0.01 ppm; Sunflower subgroup
20B at 0.7 ppm; Tropical and
subtropical, inedible peel, cactus,
subgroup 24D at 0.3 ppm; Tropical and
subtropical, palm fruit, edible peel,
subgroup 23C at 8 ppm; and Vegetable,
brassica, head and stem, group 5–16 at
6 ppm. A tolerance with regional
restrictions is established for residues of
the insecticide flupyradifurone, 4-[[(6chloro-3-pyridinyl)methyl](2,2difluoroethyl)amino]-2(5H)-furanone, in
or on Grass, forage, fodder and hay,
group 17 at 15 ppm. Additionally, the
existing tolerance for Coffee, green bean
is revised to remove the footnote.
In addition, the existing tolerances in
40 CFR part 180.679 for residues of the
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insecticide flupyradifurone, 4-[[(6chloro-3-pyridinyl)methyl](2,2difluoroethyl)amino]-2(5H)-furanone, in
or on the following commodities are
removed: Brassica, head and stem
subgroup 5A at 6.0 ppm; Brassica, leafy
greens subgroup 5B at 40 ppm; Cactus,
fruit at 0.30 ppm; Cilantro, fresh leaves
at 30 ppm; Leaf petioles, subgroup 4B at
9.0 ppm; Leafy greens, subgroup 4A at
30 ppm; Pitaya at 0.30 ppm; and Turnip
greens at 40 ppm.
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VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) 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
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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: June 26, 2020.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
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51671
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.679:
a. In paragraph (a):
■ i. Add a heading for the table.
■ ii. Remove the entries for ‘‘Brassica,
head and stem subgroup 5A’’ and
‘‘Brassica, leafy greens subgroup 5B’’.
■ iii. Add alphabetically the entry
‘‘Brassica, leafy greens, subgroup 4–
16B’’.
■ iv. Remove the entry for ‘‘Cactus,
fruit’’.
■ v. Add alphabetically the entry
‘‘Celtuce’’.
■ vi. Remove the entry for ‘‘Cilantro,
fresh leaves’’.
■ vii. Revise the entry for ‘‘Coffee, green
bean’’.
■ viii. Add alphabetically the entries
‘‘Fennel, florence, fresh leaves and
stalk’’; ‘‘Kohlrabi’’ and ‘‘Leaf petiole
vegetable subgroup 22B’’.
■ ix. Remove the entries for ‘‘Leaf
petioles, subgroup 4B’’ and ‘‘Leafy
greens, subgroup 4A’’.
■ x. Add alphabetically the entries
‘‘Leafy greens subgroup 4–16A’’ and
‘‘Pineapple’’.
■ xi. Remove the entry for ‘‘Pitaya’’.
■ xii. Add alphabetically the entries
‘‘Rapeseed subgroup 20A’’; ‘‘Sesame,
seed’’; ‘‘Stalk and stem vegetable
subgroup 22A, except prickly pear,
pads, and prickly pear, Texas, pads’’;
‘‘Sunflower subgroup 20B’’; ‘‘Tropical
and subtropical, inedible peel, cactus,
subgroup 24D’’ and ‘‘Tropical and
subtropical, palm fruit, edible peel,
subgroup 23C’’.
■ xiii. Remove the entry for ‘‘Turnip
greens’’.
■ xiv. Add alphabetically the entry
‘‘Vegetable, brassica, head and stem,
group 5–16’’.
■ b. In paragraph (c):
■ i. Add a heading for the table.
■ ii. Add alphabetically the entry
‘‘Grass, forage, fodder and hay, group
17’’.
■ The additions and revisions read as
follows:
■
■
§ 180.679 Flupyradifurone; tolerances for
residues.
(a) * * *
E:\FR\FM\21AUR1.SGM
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Federal Register / Vol. 85, No. 163 / Friday, August 21, 2020 / Rules and Regulations
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
*
*
Brassica, leafy greens, subgroup 4–16B ............................................................................................................................................
*
*
*
*
*
*
*
Celtuce .................................................................................................................................................................................................
Coffee, green bean ..............................................................................................................................................................................
*
*
*
*
*
*
*
Fennel, florence, fresh leaves and stalk .............................................................................................................................................
*
*
*
*
*
*
*
Kohlrabi ................................................................................................................................................................................................
Leaf petiole vegetable subgroup 22B ..................................................................................................................................................
Leafy greens subgroup 4–16A ............................................................................................................................................................
*
*
*
*
*
*
*
Pineapple .............................................................................................................................................................................................
*
*
*
*
*
*
*
Rapeseed subgroup 20A .....................................................................................................................................................................
Sesame, seed ......................................................................................................................................................................................
*
*
*
*
*
*
*
Stalk and stem vegetable subgroup 22A, except prickly pear, pads, and prickly pear, Texas, pads ................................................
Sunflower subgroup 20B .....................................................................................................................................................................
*
*
*
*
*
*
*
Tropical and subtropical, inedible peel, cactus, subgroup 24D ..........................................................................................................
*
*
*
*
*
*
*
Tropical and subtropical, palm fruit, edible peel, subgroup 23C .........................................................................................................
Vegetable, brassica, head and stem, group 5–16 ..............................................................................................................................
*
*
*
*
*
*
(c) * * *
*
*
*
*
*
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
TABLE 3 TO PARAGRAPH (c)
Parts per
million
Commodity
50 CFR Part 679
[Docket No. 200221–0062]
*
*
*
*
*
[FR Doc. 2020–17153 Filed 8–20–20; 8:45 am]
BILLING CODE 6560–50–P
*
15
Fisheries of the Exclusive Economic
Zone off Alaska; Sablefish in the
Central Regulatory Area of the Gulf of
Alaska
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS is prohibiting retention
of sablefish by vessels using trawl gear
and not participating in the cooperative
fishery of the Rockfish Program in the
Central Regulatory Area of the Gulf of
Alaska (GOA). This action is necessary
because the 2020 total allowable catch
of sablefish allocated to vessels using
trawl gear and not participating in the
cooperative fishery of the Rockfish
jbell on DSKJLSW7X2PROD with RULES
16:00 Aug 20, 2020
Jkt 250001
PO 00000
Frm 00040
Fmt 4700
9
6
9
30
0.3
0.03
3
0.01
0.7
0.3
8
6
*
Program in the Central Regulatory Area
of the GOA has been reached.
Effective 1200 hours, Alaska
local time (A.l.t.), August 18, 2020,
through 2400 hours, A.l.t., December 31,
2020.
DATES:
Obren Davis, 907–586–7228.
SUMMARY:
VerDate Sep<11>2014
9
1.5
FOR FURTHER INFORMATION CONTACT:
RTID 0648–XA414
*
*
*
*
Grass, forage, fodder and hay,
group 17 ................................
*
40
Sfmt 4700
NMFS
manages the groundfish fishery in the
GOA exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Gulf of
Alaska (FMP) prepared by the North
Pacific Fishery Management Council
under authority of the MagnusonStevens Fishery Conservation and
Management Act. Regulations governing
fishing by U.S. vessels in accordance
with the FMP appear at subpart H of 50
CFR part 600 and 50 CFR part 679.
The 2020 total allowable catch (TAC)
of sablefish allocated to vessels using
trawl gear and not participating in the
cooperative fishery of the Rockfish
Program in the Central Regulatory Area
of the GOA is 626 metric tons (mt) as
established by the final 2020 and 2021
SUPPLEMENTARY INFORMATION:
E:\FR\FM\21AUR1.SGM
21AUR1
]]>Agencies
[Federal Register Volume 85, Number 163 (Friday, August 21, 2020)]
[Rules and Regulations]
[Pages 51668-51672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17153]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2019-0460; FRL-10010-98]
Flupyradifurone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
flupyradifurone in or on multiple commodities which are identified and
discussed later in this document. The Interregional Project Number 4
(IR-4) and the registrant, Bayer CropScience, requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 21, 2020. Objections and
requests for hearings must be received on or before October 20, 2020
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-2019-0460, 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 emergency, the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at 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-2019-0460 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 20, 2020. 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
[[Page 51669]]
objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2019-0460, 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.
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 February 11, 2020 (85 FR 7708) (FRL-
10005-02), 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
9E8771) by Interregional Project Number 4 (IR-4), Rutgers, the State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.679 be
amended by establishing tolerances for residues of the insecticide
flupyradifurone, 4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]- 2(5H)-furanone, in or on Brassica, leafy greens,
subgroup 4-16B at 40 parts per million (ppm); Celtuce at 9 ppm; Coffee,
green bean at 1.5 ppm; Fennel, Florence, fresh leaves and stalk at 9
ppm; Kohlrabi at 6 ppm; Leaf petiole vegetable subgroup 22B at 9 ppm;
Leafy greens subgroup 4-16A at 30 ppm; Pineapple at 0.3 ppm; Sesame,
seed at 3 ppm; Stalk and stem vegetable subgroup 22A, except prickly
pear, pads, and prickly pear, Texas, pads at 0.01 ppm; Sunflower
subgroup 20B at 0.7 ppm; Tropical and subtropical, inedible peel,
cactus, subgroup 24D at 0.3 ppm; Tropical and subtropical, palm fruit,
edible peel, subgroup 23C at 8 ppm; and Vegetable, Brassica, head and
stem, group 5-16 at 6 ppm.
In addition, the IR-4 petition requested that 40 CFR 180.679(c) be
amended by establishing tolerances with regional restrictions for
residues of the insecticide flupyradifurone, 4-[[(6-chloro-3-
pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5H)-furanone, in or on
Grass, forage, fodder and hay, group 17 at 15 ppm.
Upon establishment of the above tolerances, IR-4 requested the
removal of the existing tolerances in 40 CFR part 180.679 for residues
of the insecticide flupyradifurone, 4-[[(6-chloro-3-
pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5H)-furanone, in or on
Brassica, head and stem subgroup 5A at 6.0 ppm; Brassica, leafy greens
subgroup 5B at 40 ppm; Cactus, fruit at 0.30 ppm; Cilantro, fresh
leaves at 30 ppm; Coffee, green been (import tolerance) at 1.5 ppm;
Leaf petioles, subgroup 4B at 9.0 ppm; Leafy greens, subgroup 4A at 30
ppm; Pitaya at 0.30 ppm; and Turnip greens at 40 ppm.
IR-4 also requested removal of the section 18 emergency exemption
tolerances on sorghum, syrup at 90.0 ppm and sorghum, forage at 30 ppm.
Through inadvertent error however, EPA failed to provide notice of this
petitioned-for request in its February 11, 2020 document.
In the Federal Register of October 28, 2019 (84 FR 57417) (FRL-
10001-12), 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
9F8775) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle
Park, NC 27709, that requested to establish a tolerance in in 40 CFR
part 180.679 for residues of the insecticide flupyradifurone 4-[[(6-
chloro-3-pyridinyl)methyl](2,2-difluoroethyl)amino]- 2(5H)-furanone, in
or on Rapeseed subgroup (Crop Subgroup 20A) at 0.03 ppm. This document
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, which is available in the docket, https://www.regulations.gov.
One comment was submitted on each notice of filing. EPA's response
to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA revised
the commodity definitions for two commodities to be consistent with
EPA's preferred terminology, changing Fennel, Florence, fresh leaves
and stalk to Fennel, florence, fresh leaves and stalk; and Vegetable,
Brassica, head and stem, group 5-16 to Vegetable, brassica, head and
stem, group 5-16. Finally, due to the failure to provide timely notice
of the request to remove the section 18 emergency exemption tolerances
for sorghum commodities, EPA is not removing those tolerances at this
time.
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 flupyradifurone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with flupyradifurone
follows.
On September 23, 2016, EPA published in the Federal Register a
final rule establishing tolerances for residues of flupyradifurone in
or on several commodities based on the Agency's conclusion that
aggregate exposure to flupyradifurone is safe for the general
population, including infants and children. See (81 FR 65552) (FRL-
9951-68). EPA is incorporating the following portions of that document
by reference here, as they have not changed in the Agency's current
assessment of flupyradifurone tolerances--the toxicological profile and
points of departure, the conclusions about cumulative risk, and the
Agency's rationale for reducing the children's safety factor.
EPA's exposure assessments have been updated to include the
additional exposure from use of flupyradifurone on the Brassica, leafy
greens, subgroup 4-16B; Celtuce; Coffee, green bean; Fennel, florence,
fresh leaves and stalk; Kohlrabi; Leaf petiole vegetable subgroup 22B;
Leafy greens subgroup 4-16A; Pineapple; Rapeseed subgroup 20A; Sesame,
seed; Stalk and stem vegetable subgroup 22A, except prickly pear, pads,
and prickly pear, Texas, pads; Sunflower subgroup 20B; Tropical and
subtropical, inedible peel, cactus,
[[Page 51670]]
subgroup 24D; Tropical and subtropical, palm fruit, edible peel,
subgroup 23C; and Vegetable, brassica, head and stem, group 5-16. EPA
has assumed tolerance-level residues and 100 percent crop treated (PCT)
for the acute dietary assessment. For the chronic dietary assessment,
EPA assumed average residues, rather than tolerance-level residues, for
some commodities and 100 PCT. EPA's aggregate exposure assessment
incorporated this dietary exposure, as well as exposure in drinking
water and from residential sources, although drinking water and
residential exposures are not impacted by the new uses and thus have
not changed since the last assessment and as reflected in the preamble
to the September 23, 2016 rule.
Acute dietary risks are below the Agency's level of concern of 100%
of the acute population adjusted dose (aPAD); they are 38% of the aPAD
for children 1 to 2 years old, the most highly exposed population
group. Chronic dietary risks are below the Agency's level of concern of
100% of the chronic population adjusted dose (cPAD); they are 64% of
the cPAD for children 1 to 2 years old, the group with the highest
exposure. As required by the FFDCA, EPA considered aggregate exposures
to flupyradifurone, i.e., exposures from food, drinking water, and
residential uses, in its risk assessment. There are no residential uses
expected to result in acute, intermediate-term, or chronic exposures;
therefore, aggregate risks for those exposure durations are equal to
the dietary risks for those exposure durations and not of concern.
Aggregating short-term exposures to adults and children with the
chronic (background) dietary exposures yields margins of exposure
(MOEs) of 300 (adults) and 220 (children). Both of these exceed the
Agency's level of concern, which is an MOE of 100 or lower; therefore,
short-term exposures are not of concern.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children from
aggregate exposure to flupyradifurone residues. More detailed
information about the Agency's analysis can be found in the document
entitled, ``Flupyradifurone; Human Health Risk Assessment for Uses on
Grass Forage Fodder and Hay Group 17, Pineapple, Rapeseed Subgroup 20A,
Sesame Seed, Stalk and Stem Vegetable Subgroup 22A (except Prickly Pear
Pads and Prickly Pear Texas Pads), Sunflower Subgroup 20B, Sweet
Sorghum, Tropical and Subtropical Palm Fruit Edible Peel Subgroup 23C,
Crop Group Expansions/Conversions of Tolerances to Brassica Leafy
Greens Subgroup 4-16B, Leafy Greens Subgroup 4-16A, Leaf Petiole
Vegetable Subgroup 22B, Tropical and Subtropical Inedible Peel Cactus
Subgroup 24D, Vegetable Brassica Head and Stem Group 5-16 and Establish
Individual Tolerances on Celtuce, Fennel Florence, Kohlrabi; and
Coffee,'' which is described under ADDRESSES. Locate and click on the
hyperlink for docket ID number EPA-HQ-OPP-2019-0460.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology Method RV-001-P10-03, which uses
high-performance liquid chromatography with tandem mass spectrometry
(HPLC/MS/MS) to quantitate residues of flupyradifurone and its
metabolite difluoroacetic acid (DFA) in various crops is available for
enforcement. An HPLC/MS/MS method, Method RV-004-A11-05 is adequate as
the enforcement method for determination of residues of flupyradifurone
and its metabolite DFA in livestock commodities.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
Codex MRLs have been established for head cabbage at 1.5 ppm,
cauliflower at 6 ppm, and lettuce (head and leaf) at 4 ppm. For leafy
greens subgroup 4-16A, harmonization with Codex is not possible because
the U.S. tolerance of 30 ppm is much higher than the Codex MRLs for
head lettuce and leaf lettuce. Harmonizing with the Codex MRLs would
put U.S. growers at risk of having violative residues despite legal use
of the pesticide. The U.S. tolerance on Brassica head and stem group 5-
16 is harmonized with the Codex cauliflower MRL (6 ppm). It is not
possible to also harmonize with head cabbage, which is another
commodity in crop group 5-16.
C. Response to Comments
One comment was received stating that residues of pesticide
chemicals on various commodities are a serious health hazard that needs
to be regulated. Another comment received stated that this chemical
should not be used on any food products that Americans eat. The
existing legal framework provided by section 408 of the FFDCA states
that tolerances may be set when persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute. These comments appear to be directed
at the underlying statute and not EPA's implementation of it; the
comments provide no information relevant to the Agency's safety
determination.
V. Conclusion
Therefore, tolerances are established for residues of
flupyradifurone, 4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]-2(5H)-furanone, in or on Brassica, leafy greens,
subgroup 4-16B at 40 ppm; Celtuce at 9 ppm; Fennel, florence, fresh
leaves and stalk at 9 ppm; Kohlrabi at 6 ppm; Leaf petiole vegetable
subgroup 22B at 9 ppm; Leafy greens subgroup 4-16A at 30 ppm; Pineapple
at 0.3 ppm; Rapeseed subgroup 20A at 0.03 ppm; Sesame, seed at 3 ppm;
Stalk and stem vegetable subgroup 22A, except prickly pear, pads, and
prickly pear, Texas, pads at 0.01 ppm; Sunflower subgroup 20B at 0.7
ppm; Tropical and subtropical, inedible peel, cactus, subgroup 24D at
0.3 ppm; Tropical and subtropical, palm fruit, edible peel, subgroup
23C at 8 ppm; and Vegetable, brassica, head and stem, group 5-16 at 6
ppm. A tolerance with regional restrictions is established for residues
of the insecticide flupyradifurone, 4-[[(6-chloro-3-
pyridinyl)methyl](2,2-difluoroethyl)amino]-2(5H)-furanone, in or on
Grass, forage, fodder and hay, group 17 at 15 ppm. Additionally, the
existing tolerance for Coffee, green bean is revised to remove the
footnote.
In addition, the existing tolerances in 40 CFR part 180.679 for
residues of the
[[Page 51671]]
insecticide flupyradifurone, 4-[[(6-chloro-3-pyridinyl)methyl](2,2-
difluoroethyl)amino]-2(5H)-furanone, in or on the following commodities
are removed: Brassica, head and stem subgroup 5A at 6.0 ppm; Brassica,
leafy greens subgroup 5B at 40 ppm; Cactus, fruit at 0.30 ppm;
Cilantro, fresh leaves at 30 ppm; Leaf petioles, subgroup 4B at 9.0
ppm; Leafy greens, subgroup 4A at 30 ppm; Pitaya at 0.30 ppm; and
Turnip greens at 40 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), 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 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: June 26, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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. 180.679:
0
a. In paragraph (a):
0
i. Add a heading for the table.
0
ii. Remove the entries for ``Brassica, head and stem subgroup 5A'' and
``Brassica, leafy greens subgroup 5B''.
0
iii. Add alphabetically the entry ``Brassica, leafy greens, subgroup 4-
16B''.
0
iv. Remove the entry for ``Cactus, fruit''.
0
v. Add alphabetically the entry ``Celtuce''.
0
vi. Remove the entry for ``Cilantro, fresh leaves''.
0
vii. Revise the entry for ``Coffee, green bean''.
0
viii. Add alphabetically the entries ``Fennel, florence, fresh leaves
and stalk''; ``Kohlrabi'' and ``Leaf petiole vegetable subgroup 22B''.
0
ix. Remove the entries for ``Leaf petioles, subgroup 4B'' and ``Leafy
greens, subgroup 4A''.
0
x. Add alphabetically the entries ``Leafy greens subgroup 4-16A'' and
``Pineapple''.
0
xi. Remove the entry for ``Pitaya''.
0
xii. Add alphabetically the entries ``Rapeseed subgroup 20A'';
``Sesame, seed''; ``Stalk and stem vegetable subgroup 22A, except
prickly pear, pads, and prickly pear, Texas, pads''; ``Sunflower
subgroup 20B''; ``Tropical and subtropical, inedible peel, cactus,
subgroup 24D'' and ``Tropical and subtropical, palm fruit, edible peel,
subgroup 23C''.
0
xiii. Remove the entry for ``Turnip greens''.
0
xiv. Add alphabetically the entry ``Vegetable, brassica, head and stem,
group 5-16''.
0
b. In paragraph (c):
0
i. Add a heading for the table.
0
ii. Add alphabetically the entry ``Grass, forage, fodder and hay, group
17''.
0
The additions and revisions read as follows:
Sec. 180.679 Flupyradifurone; tolerances for residues.
(a) * * *
[[Page 51672]]
Table 1 to Paragraph (a)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Brassica, leafy greens, subgroup 4-16B.................. 40
* * * * * * *
Celtuce................................................. 9
Coffee, green bean...................................... 1.5
* * * * * * *
Fennel, florence, fresh leaves and stalk................ 9
* * * * * * *
Kohlrabi................................................ 6
Leaf petiole vegetable subgroup 22B..................... 9
Leafy greens subgroup 4-16A............................. 30
* * * * * * *
Pineapple............................................... 0.3
* * * * * * *
Rapeseed subgroup 20A................................... 0.03
Sesame, seed............................................ 3
* * * * * * *
Stalk and stem vegetable subgroup 22A, except prickly 0.01
pear, pads, and prickly pear, Texas, pads..............
Sunflower subgroup 20B.................................. 0.7
* * * * * * *
Tropical and subtropical, inedible peel, cactus, 0.3
subgroup 24D...........................................
* * * * * * *
Tropical and subtropical, palm fruit, edible peel, 8
subgroup 23C...........................................
Vegetable, brassica, head and stem, group 5-16.......... 6
* * * * * * *
------------------------------------------------------------------------
* * * * *
(c) * * *
Table 3 to Paragraph (c)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Grass, forage, fodder and hay, group 17.................... 15
------------------------------------------------------------------------
* * * * *
[FR Doc. 2020-17153 Filed 8-20-20; 8:45 am]
BILLING CODE 6560-50-P
