Fludioxonil; Pesticide Tolerances, 7388-7393 [2022-02560]
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Federal Register / Vol. 87, No. 27 / Wednesday, February 9, 2022 / Rules and Regulations
application of those requirements would
be inconsistent with the CAA; and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where EPA or an
Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications and will not impose
substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
This action is subject to the
Congressional Review Act, and EPA will
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. This action
is not a ‘‘major rule’’ as defined by 5
U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by April 11, 2022. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Sulfur oxides.
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
2. In § 52.1170, the table in paragraph
(e) is amended by adding an entry for
‘‘2010 SO2 Nonattainment New Source
Review Certification’’ immediately after
the entry for ‘‘2010 Sulfur Dioxide Clean
Data Determination’’ and adding an
entry under the subheading ‘‘Emissions
Inventories’’ for ‘‘2010 SO2 Standard
2014 base year’’ after the entry for ‘‘2010
SO2 Standard 2012 base year’’ to read as
follows:
■
§ 52.1170
*
Dated: February 2, 2022.
Debra Shore,
Regional Administrator, Region 5.
Identification of plan.
*
*
(e) * * *
*
*
For the reasons stated in the
preamble, EPA amends 40 CFR part 52
as follows:
EPA-APPROVED MICHIGAN NONREGULATORY AND QUASI-REGULATORY PROVISIONS
State
submittal
date
Name of nonregulatory SIP
provision
Applicable geographic or
nonattainment area
*
*
2010 SO2 Nonattainment New
Source Review Certification.
*
*
St. Clair County (part) ...................
*
*
*
6/30/2021
*
EPA approval date
*
*
2/9/2022, [INSERT Federal Register CITATION].
*
*
Comments
*
*
Emissions Inventories
*
*
2010 SO2 Standard 2014 base
year.
*
*
*
St. Clair County (part) ...................
*
*
[FR Doc. 2022–02676 Filed 2–8–22; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
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[EPA–HQ–OPP–2020–0419 and EPA–HQ–
OPP–2021–0020; FRL–9482–01–OCSPP]
Fludioxonil; Pesticide Tolerances
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
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6/30/2021
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*
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2/9/2022, [INSERT Federal Register CITATION].
*
This regulation establishes or
amends tolerances for residues of
fludioxonil in or on multiple crops that
are referenced later in this document.
The Interregional Project Number 4 (IR–
4) and Syngenta Crop Protection, LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective
February 9, 2022. Objections and
requests for hearings must be received
on or before April 11, 2022, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
DATES:
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*
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The dockets for this action,
identified by docket identification (ID)
numbers EPA–HQ–OPP–2020–0419 and
EPA–HQ–OPP–2021–0020, are available
online at https://www.regulations.gov or
in-person 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.
Due to the public health emergency,
the EPA Docket Center (EPA/DC) and
Reading Room is open to visitors by
appointment only. For the latest status
information on EPA/DC services, docket
ADDRESSES:
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access, visit https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: RDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/
current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID numbers EPA–HQ–
OPP–2020–0419 and EPA–HQ–OPP–
2021–0020 in the subject line on the
first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before April
11, 2022. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
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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 numbers EPA–HQ–OPP–
2020–0419 and EPA–HQ–OPP–2021–
0020, 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 June 28,
2021 (86 FR 33922) (FRL–10025–08)
and in the Federal Register of February
25, 2021 (86 FR 11488) (FRL–10020–47),
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 0E8847) by IR–4,
North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210,
Raleigh, NC 27606. The February 25,
2021, notice erroneously identified
Syngenta as the petitioner. The petition
requested that 40 CFR 180.516 be
amended by establishing tolerances for
residues of fludioxonil, [4-(2, 2-difluoro1,3-benzodioxol-4-yl)-1H-pyrrole-3carbonitrile] in or on the raw
agricultural commodities: Carrot, roots
at 7 parts per million (ppm); Celtuce at
15 ppm; Cottonseed subgroup 20C at
0.05 ppm; Dragon fruit at 20 ppm;
Durian at 20 ppm; Fennel, Florence,
fresh leaves and stalk at 15 ppm;
Jackfruit at 20 ppm; Leaf petiole
vegetable subgroup 22B at 15 ppm;
Leafy greens subgroup 4–16A at 30
ppm; Mangosteen at 5 ppm; Persimmon,
Japanese at 5 ppm; Sunflower subgroup
20B at 0.01 ppm; Tropical and
subtropical, small fruit, inedible peel,
subgroup 24A at 20 ppm; Vegetable,
legume, group 6, except bean, dry and
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bean, succulent at 0.01 ppm; Vegetable,
root, except sugar beet, subgroup 1B,
except carrot and ginseng at 0.75 ppm;
and Vegetable, tuberous and corm,
subgroup 1C, except yam, true, tuber at
6 ppm. The petition also requested to
remove established tolerances for
residues of fludioxonil, [4-(2, 2-difluoro1,3- benzodioxol-4-yl)-1H-pyrrole-3carbonitrile] in or on the raw
agricultural commodities: Carrots at 7.0
ppm; Cotton, undelinted seed at 0.05
ppm; Dragon fruit at 1.0 ppm; Leaf
petioles subgroup 4B at 15 ppm; Leafy
greens subgroup 4A at 30 ppm; Longan
at 20 ppm; Lychee at 20 ppm; Melon
subgroup 9A at 0.03 ppm; Safflower,
seed at 0.01 ppm; Spanish lime at 20
ppm; Sunflower, seed at 0.01 ppm;
Vegetable, legume, group 6 at 0.01 ppm;
Vegetable, root, except sugar beet,
subgroup 1B at 0.75 ppm; and
Vegetable, tuberous and corm, subgroup
1C at 6.0 ppm. That document
referenced a summary of the petition
prepared by Syngenta Crop Protection,
the registrant, which is available in
docket ID number EPA–HQ–OPP–2020–
0419 at https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Also, in the Federal Register of
February 25, 2021 (86 FR 11488) (FRL–
10020–47) 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 0F8858) by
Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419. The
petition requested that 40 CFR 180.516
be amended by establishing tolerances
for residues of fludioxonil, [4-(2, 2difluoro-1,3-benzodioxol-4-yl)-1Hpyrrole-3-carbonitrile] in or on the raw
agricultural commodities tree nut crop
group 14–12, except pistachios at 0.2
ppm and almond hulls at 15 ppm. That
document referenced a summary of the
petition prepared by Syngenta Crop
Protection, the registrant, which is
available in docket ID number EPA–
HQ–OPP–2021–0020 at 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 one tolerance at a different
level than petitioned for, has modified
the nut tolerances, and has modified
some of the commodity definitions. A
discussion of these modifications can be
found in unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
FFDCA Section 408(b)(2)(A)(i) allows
EPA to establish a tolerance (the legal
limit for a pesticide chemical residue in
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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 fludioxonil
including exposure resulting from the
tolerance established by this action.
EPA’s assessment of exposures and risks
associated with fludioxonil follows.
In an effort to streamline its
publications in the Federal Register,
EPA is not reprinting sections that
repeat what has been previously
published for tolerance rulemaking of
the same pesticide chemical. Where
scientific information concerning a
particular chemical remains unchanged,
the content of those sections would not
vary between tolerance rulemaking and
republishing the same sections is
unnecessary. EPA considers referral
back to those sections as sufficient to
provide an explanation of the
information EPA considered in making
its safety determination for the new
rulemaking.
EPA has previously published a
number of tolerance rulemakings for
fludioxonil in which EPA concluded,
based on the available information, that
there is a reasonable certainty that no
harm would result from aggregate
exposure to fludioxonil and established
tolerances for residues of that chemical.
EPA is incorporating previously
published sections from those
rulemakings as described further in this
rulemaking, as they remain unchanged.
Toxicological profile. For a discussion
of the Toxicological Profile of
fludioxonil, see Unit III.A. of the
November 6, 2018, final rulemaking (83
FR 55491) (FRL–9982–75).
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Toxicological points of departure/
Levels of concern. For a summary of the
Toxicological Points of Departure/
Levels of Concern for fludioxonil used
for human risk assessment, please
reference Unit III.B. of the August 14,
2015, rulemaking (80 FR 48743) (FRL–
9931–06).
Exposure assessment. Much of the
exposure assessment remains the same
although updates have occurred to
accommodate exposures from the
petitioned-for tolerances. These updates
are discussed in this section; for a
description of the rest of the EPA
approach to and assumptions for the
exposure assessment, please reference
Unit III.C. of the November 6, 2018,
rulemaking.
EPA’s dietary exposure assessments
have been updated to include the
additional exposure from the new uses
of fludioxonil on the crops and the crop
group conversions and expansions
requested in these actions. The dietary
exposure assessment used the same
assumptions as the November 6, 2018,
final rule, including tolerance level
residues and 100 percent crop treated
(PCT).
Drinking water exposure. The new
uses do not result in an increase in the
estimated residue levels in drinking
water, so the estimated drinking water
concentrations used in 2018 final rule
are the same as those used in this
assessment.
Non-occupational exposure. The
assessment used the same assumptions
as the November 6, 2018, final rule. The
residential exposures used in the
aggregate assessment are inhalation
exposures from handlers applying
paints with airless sprayers for adults
and incidental oral exposures (hand-tomouth) from post-application exposure
to outdoor treated turf for children 1 to
<2 years old.
Cumulative exposure. Unlike other
pesticides for which EPA has followed
a cumulative risk approach based on a
common mechanism of toxicity, EPA
has not made a common mechanism of
toxicity finding as to fludioxonil and
any other substances and fludioxonil
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has not
assumed that fludioxonil has a common
mechanism of toxicity with other
substances.
Safety factor for infants and children.
EPA continues to conclude that there
are reliable data to support the
reduction of the Food Quality Protection
Act (FQPA) safety factor. See Unit III.D.
of the November 6, 2018, rulemaking for
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a discussion of the Agency’s rationale
for that determination.
Aggregate risks and determination of
safety. EPA determines whether acute
and chronic dietary pesticide exposures
are safe by comparing aggregate
exposure estimates to the acute
population adjusted dose (aPAD) and
chronic population adjusted dose
(cPAD). Short-, intermediate-, and
chronic-term risks are evaluated by
comparing the estimated aggregate food,
water, and residential exposure to the
appropriate points of departure to
ensure that an adequate margin of
exposure (MOE) exists. For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure.
An acute dietary exposure assessment
was not performed as there were no
appropriate toxicological effects
attributable to a single exposure (dose)
observed in available oral toxicity
studies, including maternal toxicity in
the developmental toxicity studies.
Fludioxonil is not expected to pose an
acute risk. Chronic dietary risks are
below the Agency’s level of concern of
100% of the cPAD: They are 52% of the
cPAD for children 1 to 2 years old, the
group with the highest exposure. EPA
has concluded the combined short-term
food, water, and residential exposures
result in margins of exposure above the
level of concern of 100 for all scenarios
assessed and are not of concern.
Intermediate- and long-term aggregate
risk assessments were not performed
because there are no registered or
proposed uses of fludioxonil that result
in intermediate- or long-term residential
exposures. A cancer dietary exposure
and risk assessment was not conducted
for fludioxonil as it is a Group D
chemical—not classifiable as to human
carcinogenicity.
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 fludioxonil residues. More
detailed information on this action can
be found in the document titled
‘‘Fludioxonil. Human Health Risk
Assessment for Section 3 Registration
for Crop Group Conversions/Expansions
for Cottonseed subgroup 20C, Fennel,
Florence, Fresh Leaves and Stalk; Leaf
Petiole Vegetable Subgroup 22B; Leafy
Greens Subgroup 4–16A; Sunflower
Subgroup 20B, Tropical and
Subtropical, Small Fruit, Inedible Peel,
Subgroup 24A and to Establish an
Individual Tolerance for Residues in/on
Tree Nuts Crop Group 14–12, Dragon
Fruit, Durian, Japanese Persimmon,
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Jackfruit, and Mangosteen.’’ (hereafter
‘‘the Fludioxonil Human Health Risk
Assessment’’) in docket ID numbers
EPA–HQ–OPP–2020–0419 and EPA–
HQ–OPP–2021–0020.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available
analytical enforcement method, see Unit
IV.A. of the November 6, 2018,
rulemaking.
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B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The U.S. tolerances for cottonseed
subgroup 20C; leaf petiole vegetable
subgroup 22B; and persimmon, Japanese
are harmonized with Codex MRLs.
There are no Codex MRLs for many of
the commodities included in this action,
including almond; almond, hulls;
celtuce; dragon fruit; durian; jackfruit;
mangosteen; pecan; sugar apple;
sunflower subgroup 20B; and tropical
and subtropical, small fruit, inedible
peel, subgroup 24A.
Several U.S. tolerances are higher
than the corresponding Codex MRLs.
The following U.S. tolerances cannot be
harmonized with Codex because U.S.
growers could have violative residues
despite legal use of fludioxonil: Carrot,
roots at 7 ppm (Codex MRL is 1 ppm)
and fennel, Florence, fresh leaves and
stalk at 15 ppm (Codex MRL is 9 ppm).
The U.S. tolerance for vegetable,
legume group 6 at 0.01 ppm reflects
seed treatment use. It is not appropriate
to harmonize with the significantly
higher Codex MRL of 0.6 ppm because
the tolerance would not be effective for
determining misuse. For a few other
U.S. subgroup tolerances, EPA is not
harmonizing with relevant Codex MRLs,
which are established for individual
commodities and vary widely among
those commodities. The available
representative commodity data support
the crop subgroup and EPA’s general
approach is to establish a crop group or
subgroup tolerance when supported by
available representative commodity
data, rather than break up the group or
subgroup for harmonization purposes.
The U.S. tolerance for leafy greens
subgroup 4–16A at 30 ppm is not
harmonized with all relevant Codex
MRLs for commodities in that group
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(e.g., head lettuce at 10 ppm and leaf
lettuce at 40 ppm), although it is
harmonized with the tolerance for
spinach. The registrant requested that
the leafy greens subgroup 4–16A
tolerance be harmonized with the
Canadian MRL of 30 ppm because
Canada is a major trading partner with
the U.S. for these crops. For vegetable,
root, except sugar beet, subgroup 1B, the
U.S. tolerance is harmonized with the
Canadian MRL at 0.75 ppm, rather than
splitting the group and harmonizing
individually with the Codex MRLs of 4
ppm for ginseng, root and 0.3 ppm for
radish, root. Finally, the U.S. tolerance
for vegetable, tuberous and corm,
subgroup 1C is harmonized with the
Canadian MRL at 6 ppm, rather than
splitting the group and harmonizing
individually with the Codex MRLs of 5
ppm for potato and 10 ppm for sweet
potato. Finally, EPA is not harmonizing
the U.S. tolerance for vegetable,
cucurbit, group 9 with the Codex MRL
of 0.5 ppm because the registrant
requested that EPA harmonize this
tolerance group with the Canadian MRL
of 0.45 ppm instead because Canada is
a major trading partner for these crops.
C. Revisions to Petitioned-For
Tolerances
One petitioner requested an exception
for carrot and ginseng from vegetable,
root, except sugar beet, subgroup 1B;
and yam, true, tuber from vegetable,
tuberous and corm, subgroup 1C. EPA is
not excepting carrot and yam from their
respective subgroups because
representative crops may not be
excepted from a crop subgroup under 40
CFR 180.40(h). Although an individual
tolerance has been established for
ginseng, EPA does not believe it is
necessary to exclude ginseng from the
vegetable, root, except sugar beet,
subgroup 1B tolerance, as residues will
be enforced according to the higher
tolerance. EPA is adjusting the tolerance
level for vegetable, tuberous and corm,
subgroup 1C to be consistent with
Agency rounding class practice. For tree
nut crop group 14–12, maximum
fludioxonil residues in representative
crops were not within a factor of five of
each other. Based on the residue data,
the recommended tolerance for residues
in/on almond is 0.2 ppm and the
recommended tolerance for residues in/
on pecan is 0.01 ppm. In those
circumstances, the Agency will
normally establish individual crop
tolerances, if supported by the available
residue data. EPA has determined that
the available data supports individual
nut tolerance levels, based on
translation from the representative
commodities to the various nut
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commodities as specified in the 2010
EPA analysis of IR–4’s petition to
amend crop group. See U.S. EPA,
Memorandum re: ‘‘Crop Grouping—Part
IX: Analysis of the USDA IR–4 Petition
to Amend the Crop Group Regulation 40
CFR 180.41(c)(16) and Commodity
Definitions (40 CFR 180.1(g)) Related to
the Crop Group 14 Tree Nuts. Part I.
Analysis.’’ at 134–136 (Sept. 30, 2010).
Specifically, EPA is establishing
tolerances of 0.2 ppm for the nut
commodities that identified almond as
the representative commodity and
tolerances of 0.01 ppm for the nut
commodities that identified pecan as
the representative commodity.
V. Conclusion
Therefore, tolerances are established
for residues of fludioxonil in or on
African Tree Nut at 0.01 ppm; Almond
at 0.2 ppm; Almond, hulls at 15 ppm;
Beechnut at 0.2 ppm; Brazil nut at 0.01
ppm; Brazilian pine at 0.2 ppm; Bunya
at 0.2 ppm; Bur oak at 0.01 ppm;
Butternut at 0.01 ppm; Cajou at 0.01
ppm; Candlenut at 0.2 ppm; Carrot,
roots at 7 ppm; Cashew at 0.01 ppm;
Celtuce at 15 ppm; Chestnut at 0.2 ppm;
Chinquapin at 0.2 ppm; Coconut at 0.01
ppm; Coquito nut at 0.01 ppm;
Cottonseed subgroup 20C at 0.05 ppm;
Dika nut at 0.01 ppm; Durian at 20 ppm;
Fennel, Florence, fresh leaves and stalk
at 15 ppm; Ginkgo at 0.2 ppm; Guiana
chestnut at 0.01 ppm; Hazelnut at 0.01
ppm; Heartnut at 0.01 ppm; Hickory nut
at 0.01 ppm; Jackfruit at 20 ppm;
Japanese horse-chestnut at 0.01 ppm;
Leaf petiole vegetable subgroup 22B at
15 ppm; Leafy greens subgroup 4–16A
at 30 ppm; Macadamia nut at 0.01 ppm;
Mangosteen at 5 ppm; Mongongo nut at
0.01 ppm; Monkey puzzle at 0.2 ppm;
Monkey-pot at 0.01 ppm; Okari nut at
0.2 ppm; Pachira nut at 0.01 ppm; Peach
palm nut at 0.2 ppm; Pecan at 0.01 ppm;
Pequi at 0.2 ppm; Persimmon, Japanese
at 5 ppm; Pili nut at 0.2 ppm; Pine nut
at 0.2 ppm; Sapucaia nut at 0.01 ppm;
Sunflower subgroup 20B at 0.01 ppm;
Tropical almond at 0.2 ppm; Tropical
and subtropical, small fruit, inedible
peel, subgroup 24A at 20 ppm; Walnut,
black at 0.01 ppm; Walnut, English at
0.01 ppm; and Yellowhorn at 0.01 ppm.
EPA is amending the tolerance for
Dragon fruit from 1.0 ppm to 20 ppm,
the tolerance for Pistachio from 0.10
ppm to 0.1 ppm, and the tolerance for
Vegetable, tuberous and corm, subgroup
1C from 6.0 ppm to 6 ppm. The
commodity definition for Vegetable,
legume, group 6 is amended to
Vegetable, legume, group 6, except bean
while maintaining the tolerance at 0.01
ppm.
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Additionally, the following tolerances
are removed as unnecessary due to the
establishment of the above tolerances:
Carrots at 7.0 ppm; Cotton, undelinted
seed at 0.05 ppm; Leaf petioles
subgroup 4B at 15 ppm; Leafy greens
subgroup 4A at 30 ppm; Longan at 20
ppm; Lychee at 20 ppm; Safflower, seed
at 0.01 ppm; Spanish lime at 20 ppm;
and Sunflower, seed at 0.01 ppm. In
addition, EPA is removing the tolerance
for the Melon subgroup, since it is
unnecessary due to the tolerance for
cucurbit vegetables, group 9 at 0.45
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 to
Executive Order 13045, entitled
‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997).
This action does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the 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
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16:18 Feb 08, 2022
Jkt 256001
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 (CRA)
Pursuant to the CRA (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: February 2, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter 1 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 § 180.516, amend the table in
paragraph (a) (1) by:
■ a. Adding in alphabetical order the
entries ‘‘African Tree Nut’’; ‘‘Almond’’;
‘‘Almond, hulls’’; ‘‘Beechnut’’; ‘‘Brazil
nut’’; ‘‘Brazilian pine’’; ‘‘Bunya’’; ‘‘Bur
oak’’; ‘‘Butternut’’; ‘‘Cajou’’; and
‘‘Candlenut’’.
■
PO 00000
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b. Removing the entry for ‘‘Carrots’’.
c. Adding in alphabetical order the
entries ‘‘Carrot, roots’’; ‘‘Cashew’’;
‘‘Celtuce’’; ‘‘Chestnut’’; ‘‘Chinquapin’’;
‘‘Coconut’’; ‘‘Coquito nut’’; and
‘‘Cottonseed subgroup 20C’’.
■ d. Removing the entry for ‘‘Cotton,
undelinted seed’’.
■ e. Adding in alphabetical order the
entry ‘‘Dika nut’’.
■ f. Revising the entry for ‘‘‘‘Dragon
fruit’’.
■ g. Adding in alphabetical order the
entries ‘‘Durian’’; ‘‘Fennel, Florence,
fresh leaves and stalk’’; ‘‘Ginkgo’’;
‘‘Guiana chestnut’’; ‘‘Hazelnut’’;
‘‘Heartnut’’; ‘‘Hickory nut’’; ‘‘Jackfruit’’;
and ‘‘Japanese horse-chestnut’’.
■ h. Removing the entry for ‘‘Leaf
petioles subgroup 4B’’.
■ i. Adding in alphabetical order the
entry ‘‘Leaf petiole vegetable subgroup
22B’’.
■ j. Removing the entry for ‘‘Leafy
greens subgroup 4A’’.
■ k. Adding in alphabetical order the
entry ‘‘Leafy greens subgroup 4–16A’’.
■ l. Removing the entries for ‘‘Longan’’;
and ‘‘Lychee’’.
■ m. Adding in alphabetical order the
entries ‘‘Macadamia nut’’; and
‘‘Mangosteen’’.
■ n. Removing the entry for ‘‘Melon
subgroup 9A’’.
■ o. Adding in alphabetical order the
entries ‘‘Mongongo nut’’; ‘‘Monkey
puzzle’’; ‘‘Monkey-pot’’; ‘‘Okari nut’’;
‘‘Pachira nut’’; ‘‘Peach palm nut’’;
‘‘Pecan’’; ‘‘Pequi’’; ‘‘Persimmon,
Japanese’’; ‘‘Pili nut’’; and ‘‘Pine nut’’.
■ p. Revising the entry for ‘‘Pistachio’’.
■ q. Removing the entry for ‘‘Safflower,
seed’’.
■ r. Adding in alphabetical order the
entry ‘‘Sapucaia nut’’.
■ s. Removing the entries for ‘‘Spanish
lime’’; and ‘‘Sunflower, seed’’.
■ t. Adding in alphabetical order the
entries ‘‘Sunflower subgroup 20B’’;
‘‘Tropical almond’’; and ‘‘Tropical and
subtropical, small fruit, inedible peel,
subgroup 24A’’.
■ u. Removing the entry for ‘‘Vegetable,
legume, group 6’’.
■ v. Adding in alphabetical order the
entry ‘‘Vegetable, legume, group 6,
except bean’’.
■ w. Revising the entry for ‘‘Vegetable,
tuberous and corm, subgroup 1C’’.
■ x. Adding in alphabetical order the
entries ‘‘Walnut, black’’; ‘‘Walnut,
English’’; and ‘‘Yellowhorn’’.
The additions and revisions read as
follows:
■
■
§ 180.516 Fludioxonil; tolerances for
residues.
(a) * * *
(1) * * *
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TABLE 1 TO PARAGRAPH (a)(1)
TABLE 1 TO PARAGRAPH (a)(1)—
Continued
Parts per
million
Commodity
Parts per
million
Commodity
*
*
*
*
African Tree Nut ....................................
Almond ..................................................
Almond, hulls .........................................
*
*
*
*
*
Beechnut ...............................................
*
*
*
*
*
Brazil nut ...............................................
Brazilian pine .........................................
Bunya ....................................................
Bur oak ..................................................
*
*
*
*
*
Butternut ................................................
Cajou .....................................................
Candlenut ..............................................
*
*
*
*
*
Carrot, roots ..........................................
Cashew ..................................................
Celtuce ..................................................
*
*
*
*
*
Chestnut ................................................
Chinquapin ............................................
*
*
*
*
*
Coconut .................................................
Coquito nut ............................................
*
*
*
*
*
Cottonseed subgroup 20C ....................
*
0.01
0.2
15
Pequi .....................................................
Persimmon, Japanese ...........................
Pili nut ....................................................
Pine nut .................................................
0.2
*
*
*
*
Pistachio ................................................
*
*
*
*
*
Sapucaia nut .........................................
*
*
*
*
*
Sunflower subgroup 20B .......................
*
*
*
*
*
Tropical almond .....................................
Tropical and subtropical, small fruit, inedible peel, subgroup 24A .................
*
*
*
*
*
Vegetable, legume, group 6, except
bean ...................................................
*
*
*
*
*
Vegetable, tuberous and corm, subgroup 1C ............................................
Walnut, black .........................................
Walnut, English .....................................
*
0.2
0.2
0.01
0.01
*
*
*
*
Yellowhorn .............................................
*
0.01
0.2
0.2
0.01
0.01
0.01
0.2
7
0.01
15
1 There
0.05
*
*
*
*
Dika nut .................................................
Dragon fruit ............................................
Durian ....................................................
*
*
*
*
*
Fennel, Florence, fresh leaves and
stalk ....................................................
*
*
*
*
*
Ginkgo ...................................................
*
*
*
*
*
Guiana chestnut ....................................
Hazelnut ................................................
Heartnut .................................................
*
*
*
*
*
Hickory nut ............................................
*
*
*
*
*
Jackfruit .................................................
Japanese horse-chestnut ......................
*
15
0.2
0.01
0.01
0.01
0.01
20
0.01
*
*
*
*
Leaf petiole vegetable subgroup 22B ...
Leafy greens subgroup 4–16A ..............
Macadamia nut ......................................
*
*
*
*
*
Mangosteen ...........................................
Mongongo nut .......................................
Monkey puzzle ......................................
Monkey-pot ............................................
Okari nut ................................................
*
*
*
*
*
Pachira nut ............................................
*
*
*
*
*
Peach palm nut .....................................
*
*
*
*
*
Pecan ....................................................
*
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0.01
0.2
20
0.01
6
0.01
0.01
0.01
*
*
*
*
[FR Doc. 2022–02560 Filed 2–8–22; 8:45 am]
BILLING CODE 6560–50–P
GENERAL SERVICES
ADMINISTRATION
48 CFR Parts 501, 502, 511, 539, 552,
and 570
[GSAR Case 2016–G511 Docket No. 2021–
0018; Sequence No. 1]
RIN 3090–AJ84
General Services Acquisition
Regulation (GSAR); Contract
Requirements for GSA Information
Systems
Office of Acquisition Policy,
General Services Administration (GSA).
ACTION: Final rule.
AGENCY:
15
30
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are no U.S. registrations as of July 28,
GSA is amending the General
Services Administration Acquisition
Regulation (GSAR) to streamline and
update requirements for contracts that
involve GSA information systems. The
revision of GSA’s cybersecurity and
other information technology
requirements will lead to the
elimination of a duplicative and
outdated provision and clause from the
GSAR. The final rule will replace the
outdated text with existing policies of
the GSA Office of the Chief Information
SUMMARY:
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7393
Officer (OCIO) and provide centralized
guidance to ensure consistent
application across the organization. The
updated GSA policy will align
cybersecurity requirements based on the
items being procured by ensuring
contract requirements are coordinated
with GSA’s Chief Information Security
Officer and included in all applicable
solicitations and contracts.
DATES: Effective March 11, 2022.
FOR FURTHER INFORMATION CONTACT: Ms.
Johnnie McDowell, Procurement
Analyst, at 202–718–6112 or
gsarpolicy@gsa.gov, for clarification of
content. For information pertaining to
status or publication schedules, contact
the Regulatory Secretariat Division at
202–501–4755 or gsaregsec@gsa.gov.
Please cite GSAR Case 2016–G511.
SUPPLEMENTARY INFORMATION:
I. Background
GSA published a proposed rule in the
Federal Register at 86 FR 50689 on
September 10, 2021, to amend the
General Services Administration
Regulations (GSAR) to revise GSAR part
511, Describing Agency Needs, part 539,
Acquisition Information Technology,
and other related parts; to maintain
consistency with the Federal
Acquisition Regulation (FAR); and to
incorporate and consolidate existing
cybersecurity and other information
technology requirements previously
implemented through various Office of
the Chief Information Officer (OCIO) or
agency policies.
In general, the changes are necessary
to bring long-standing GSA information
system practices into the GSAR,
consolidating policy into one area.
Because of that consolidation,
contractors may need less time and
fewer resources to read and understand
all the requirements relevant to their
contract.
II. Authority for This Rulemaking
Title 40 of the United States Code
(U.S.C.) Section 121 authorizes GSA to
issue regulations, including the GSAR,
to control the relationship between GSA
and contractors.
III. Discussion and Analysis
The proposed rule received one
comment. The General Services
Administration has reviewed the
comment in the development of the
final rule. The comment was
determined to be irrelevant. Therefore,
no changes were made between the
proposed rule and this final rule as a
result of the comment. GSA for clarity
of internal procedures made editorial
changes to GSAR 511.171 Requirements
E:\FR\FM\09FER1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 27 (Wednesday, February 9, 2022)]
[Rules and Regulations]
[Pages 7388-7393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02560]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0419 and EPA-HQ-OPP-2021-0020; FRL-9482-01-OCSPP]
Fludioxonil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes or amends tolerances for residues
of fludioxonil in or on multiple crops that are referenced later in
this document. The Interregional Project Number 4 (IR-4) and Syngenta
Crop Protection, LLC requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 9, 2022. Objections and
requests for hearings must be received on or before April 11, 2022, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2020-0419 and EPA-HQ-OPP-2021-
0020, are available online at https://www.regulations.gov or in-person
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.
Due to the public health emergency, the EPA Docket Center (EPA/DC)
and Reading Room is open to visitors by appointment only. For the
latest status information on EPA/DC services, docket
[[Page 7389]]
access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Acting Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (703) 305-7090; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Office of the
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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 numbers EPA-HQ-OPP-2020-0419 and EPA-HQ-OPP-2021-0020 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing and must be received by the
Hearing Clerk on or before April 11, 2022. Addresses for mail and hand
delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID numbers EPA-HQ-OPP-2020-0419 and EPA-
HQ-OPP-2021-0020, 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 June 28, 2021 (86 FR 33922) (FRL-10025-
08) and in the Federal Register of February 25, 2021 (86 FR 11488)
(FRL-10020-47), 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 0E8847) by IR-4, North Carolina State University, 1730
Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The February
25, 2021, notice erroneously identified Syngenta as the petitioner. The
petition requested that 40 CFR 180.516 be amended by establishing
tolerances for residues of fludioxonil, [4-(2, 2-difluoro-1,3-
benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] in or on the raw
agricultural commodities: Carrot, roots at 7 parts per million (ppm);
Celtuce at 15 ppm; Cottonseed subgroup 20C at 0.05 ppm; Dragon fruit at
20 ppm; Durian at 20 ppm; Fennel, Florence, fresh leaves and stalk at
15 ppm; Jackfruit at 20 ppm; Leaf petiole vegetable subgroup 22B at 15
ppm; Leafy greens subgroup 4-16A at 30 ppm; Mangosteen at 5 ppm;
Persimmon, Japanese at 5 ppm; Sunflower subgroup 20B at 0.01 ppm;
Tropical and subtropical, small fruit, inedible peel, subgroup 24A at
20 ppm; Vegetable, legume, group 6, except bean, dry and bean,
succulent at 0.01 ppm; Vegetable, root, except sugar beet, subgroup 1B,
except carrot and ginseng at 0.75 ppm; and Vegetable, tuberous and
corm, subgroup 1C, except yam, true, tuber at 6 ppm. The petition also
requested to remove established tolerances for residues of fludioxonil,
[4-(2, 2-difluoro-1,3- benzodioxol-4-yl)-1H-pyrrole-3- carbonitrile] in
or on the raw agricultural commodities: Carrots at 7.0 ppm; Cotton,
undelinted seed at 0.05 ppm; Dragon fruit at 1.0 ppm; Leaf petioles
subgroup 4B at 15 ppm; Leafy greens subgroup 4A at 30 ppm; Longan at 20
ppm; Lychee at 20 ppm; Melon subgroup 9A at 0.03 ppm; Safflower, seed
at 0.01 ppm; Spanish lime at 20 ppm; Sunflower, seed at 0.01 ppm;
Vegetable, legume, group 6 at 0.01 ppm; Vegetable, root, except sugar
beet, subgroup 1B at 0.75 ppm; and Vegetable, tuberous and corm,
subgroup 1C at 6.0 ppm. That document referenced a summary of the
petition prepared by Syngenta Crop Protection, the registrant, which is
available in docket ID number EPA-HQ-OPP-2020-0419 at https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Also, in the Federal Register of February 25, 2021 (86 FR 11488)
(FRL-10020-47) 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 0F8858) by Syngenta Crop Protection, LLC, P.O. Box 18300,
Greensboro, NC 27419. The petition requested that 40 CFR 180.516 be
amended by establishing tolerances for residues of fludioxonil, [4-(2,
2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] in or on
the raw agricultural commodities tree nut crop group 14-12, except
pistachios at 0.2 ppm and almond hulls at 15 ppm. That document
referenced a summary of the petition prepared by Syngenta Crop
Protection, the registrant, which is available in docket ID number EPA-
HQ-OPP-2021-0020 at 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 one tolerance at a different level than petitioned for,
has modified the nut tolerances, and has modified some of the commodity
definitions. A discussion of these modifications can be found in unit
IV.C.
III. Aggregate Risk Assessment and Determination of Safety
FFDCA Section 408(b)(2)(A)(i) allows EPA to establish a tolerance
(the legal limit for a pesticide chemical residue in
[[Page 7390]]
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 fludioxonil including exposure
resulting from the tolerance established by this action. EPA's
assessment of exposures and risks associated with fludioxonil follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemaking of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemaking and republishing the same sections is unnecessary.
EPA considers referral back to those sections as sufficient to provide
an explanation of the information EPA considered in making its safety
determination for the new rulemaking.
EPA has previously published a number of tolerance rulemakings for
fludioxonil in which EPA concluded, based on the available information,
that there is a reasonable certainty that no harm would result from
aggregate exposure to fludioxonil and established tolerances for
residues of that chemical. EPA is incorporating previously published
sections from those rulemakings as described further in this
rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the Toxicological
Profile of fludioxonil, see Unit III.A. of the November 6, 2018, final
rulemaking (83 FR 55491) (FRL-9982-75).
Toxicological points of departure/Levels of concern. For a summary
of the Toxicological Points of Departure/Levels of Concern for
fludioxonil used for human risk assessment, please reference Unit
III.B. of the August 14, 2015, rulemaking (80 FR 48743) (FRL-9931-06).
Exposure assessment. Much of the exposure assessment remains the
same although updates have occurred to accommodate exposures from the
petitioned-for tolerances. These updates are discussed in this section;
for a description of the rest of the EPA approach to and assumptions
for the exposure assessment, please reference Unit III.C. of the
November 6, 2018, rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the new uses of fludioxonil on the crops and
the crop group conversions and expansions requested in these actions.
The dietary exposure assessment used the same assumptions as the
November 6, 2018, final rule, including tolerance level residues and
100 percent crop treated (PCT).
Drinking water exposure. The new uses do not result in an increase
in the estimated residue levels in drinking water, so the estimated
drinking water concentrations used in 2018 final rule are the same as
those used in this assessment.
Non-occupational exposure. The assessment used the same assumptions
as the November 6, 2018, final rule. The residential exposures used in
the aggregate assessment are inhalation exposures from handlers
applying paints with airless sprayers for adults and incidental oral
exposures (hand-to-mouth) from post-application exposure to outdoor
treated turf for children 1 to <2 years old.
Cumulative exposure. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
fludioxonil and any other substances and fludioxonil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
fludioxonil has a common mechanism of toxicity with other substances.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit III.D. of the
November 6, 2018, rulemaking for a discussion of the Agency's rationale
for that determination.
Aggregate risks and determination of safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic population adjusted dose (cPAD). Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and residential exposure to the
appropriate points of departure to ensure that an adequate margin of
exposure (MOE) exists. For linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer given the estimated aggregate
exposure.
An acute dietary exposure assessment was not performed as there
were no appropriate toxicological effects attributable to a single
exposure (dose) observed in available oral toxicity studies, including
maternal toxicity in the developmental toxicity studies. Fludioxonil is
not expected to pose an acute risk. Chronic dietary risks are below the
Agency's level of concern of 100% of the cPAD: They are 52% of the cPAD
for children 1 to 2 years old, the group with the highest exposure. EPA
has concluded the combined short-term food, water, and residential
exposures result in margins of exposure above the level of concern of
100 for all scenarios assessed and are not of concern. Intermediate-
and long-term aggregate risk assessments were not performed because
there are no registered or proposed uses of fludioxonil that result in
intermediate- or long-term residential exposures. A cancer dietary
exposure and risk assessment was not conducted for fludioxonil as it is
a Group D chemical--not classifiable as to human carcinogenicity.
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 fludioxonil residues. More detailed information
on this action can be found in the document titled ``Fludioxonil. Human
Health Risk Assessment for Section 3 Registration for Crop Group
Conversions/Expansions for Cottonseed subgroup 20C, Fennel, Florence,
Fresh Leaves and Stalk; Leaf Petiole Vegetable Subgroup 22B; Leafy
Greens Subgroup 4-16A; Sunflower Subgroup 20B, Tropical and
Subtropical, Small Fruit, Inedible Peel, Subgroup 24A and to Establish
an Individual Tolerance for Residues in/on Tree Nuts Crop Group 14-12,
Dragon Fruit, Durian, Japanese Persimmon,
[[Page 7391]]
Jackfruit, and Mangosteen.'' (hereafter ``the Fludioxonil Human Health
Risk Assessment'') in docket ID numbers EPA-HQ-OPP-2020-0419 and EPA-
HQ-OPP-2021-0020.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method,
see Unit IV.A. of the November 6, 2018, rulemaking.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4).
The U.S. tolerances for cottonseed subgroup 20C; leaf petiole
vegetable subgroup 22B; and persimmon, Japanese are harmonized with
Codex MRLs. There are no Codex MRLs for many of the commodities
included in this action, including almond; almond, hulls; celtuce;
dragon fruit; durian; jackfruit; mangosteen; pecan; sugar apple;
sunflower subgroup 20B; and tropical and subtropical, small fruit,
inedible peel, subgroup 24A.
Several U.S. tolerances are higher than the corresponding Codex
MRLs. The following U.S. tolerances cannot be harmonized with Codex
because U.S. growers could have violative residues despite legal use of
fludioxonil: Carrot, roots at 7 ppm (Codex MRL is 1 ppm) and fennel,
Florence, fresh leaves and stalk at 15 ppm (Codex MRL is 9 ppm).
The U.S. tolerance for vegetable, legume group 6 at 0.01 ppm
reflects seed treatment use. It is not appropriate to harmonize with
the significantly higher Codex MRL of 0.6 ppm because the tolerance
would not be effective for determining misuse. For a few other U.S.
subgroup tolerances, EPA is not harmonizing with relevant Codex MRLs,
which are established for individual commodities and vary widely among
those commodities. The available representative commodity data support
the crop subgroup and EPA's general approach is to establish a crop
group or subgroup tolerance when supported by available representative
commodity data, rather than break up the group or subgroup for
harmonization purposes. The U.S. tolerance for leafy greens subgroup 4-
16A at 30 ppm is not harmonized with all relevant Codex MRLs for
commodities in that group (e.g., head lettuce at 10 ppm and leaf
lettuce at 40 ppm), although it is harmonized with the tolerance for
spinach. The registrant requested that the leafy greens subgroup 4-16A
tolerance be harmonized with the Canadian MRL of 30 ppm because Canada
is a major trading partner with the U.S. for these crops. For
vegetable, root, except sugar beet, subgroup 1B, the U.S. tolerance is
harmonized with the Canadian MRL at 0.75 ppm, rather than splitting the
group and harmonizing individually with the Codex MRLs of 4 ppm for
ginseng, root and 0.3 ppm for radish, root. Finally, the U.S. tolerance
for vegetable, tuberous and corm, subgroup 1C is harmonized with the
Canadian MRL at 6 ppm, rather than splitting the group and harmonizing
individually with the Codex MRLs of 5 ppm for potato and 10 ppm for
sweet potato. Finally, EPA is not harmonizing the U.S. tolerance for
vegetable, cucurbit, group 9 with the Codex MRL of 0.5 ppm because the
registrant requested that EPA harmonize this tolerance group with the
Canadian MRL of 0.45 ppm instead because Canada is a major trading
partner for these crops.
C. Revisions to Petitioned-For Tolerances
One petitioner requested an exception for carrot and ginseng from
vegetable, root, except sugar beet, subgroup 1B; and yam, true, tuber
from vegetable, tuberous and corm, subgroup 1C. EPA is not excepting
carrot and yam from their respective subgroups because representative
crops may not be excepted from a crop subgroup under 40 CFR 180.40(h).
Although an individual tolerance has been established for ginseng, EPA
does not believe it is necessary to exclude ginseng from the vegetable,
root, except sugar beet, subgroup 1B tolerance, as residues will be
enforced according to the higher tolerance. EPA is adjusting the
tolerance level for vegetable, tuberous and corm, subgroup 1C to be
consistent with Agency rounding class practice. For tree nut crop group
14-12, maximum fludioxonil residues in representative crops were not
within a factor of five of each other. Based on the residue data, the
recommended tolerance for residues in/on almond is 0.2 ppm and the
recommended tolerance for residues in/on pecan is 0.01 ppm. In those
circumstances, the Agency will normally establish individual crop
tolerances, if supported by the available residue data. EPA has
determined that the available data supports individual nut tolerance
levels, based on translation from the representative commodities to the
various nut commodities as specified in the 2010 EPA analysis of IR-4's
petition to amend crop group. See U.S. EPA, Memorandum re: ``Crop
Grouping--Part IX: Analysis of the USDA IR-4 Petition to Amend the Crop
Group Regulation 40 CFR 180.41(c)(16) and Commodity Definitions (40 CFR
180.1(g)) Related to the Crop Group 14 Tree Nuts. Part I. Analysis.''
at 134-136 (Sept. 30, 2010). Specifically, EPA is establishing
tolerances of 0.2 ppm for the nut commodities that identified almond as
the representative commodity and tolerances of 0.01 ppm for the nut
commodities that identified pecan as the representative commodity.
V. Conclusion
Therefore, tolerances are established for residues of fludioxonil
in or on African Tree Nut at 0.01 ppm; Almond at 0.2 ppm; Almond, hulls
at 15 ppm; Beechnut at 0.2 ppm; Brazil nut at 0.01 ppm; Brazilian pine
at 0.2 ppm; Bunya at 0.2 ppm; Bur oak at 0.01 ppm; Butternut at 0.01
ppm; Cajou at 0.01 ppm; Candlenut at 0.2 ppm; Carrot, roots at 7 ppm;
Cashew at 0.01 ppm; Celtuce at 15 ppm; Chestnut at 0.2 ppm; Chinquapin
at 0.2 ppm; Coconut at 0.01 ppm; Coquito nut at 0.01 ppm; Cottonseed
subgroup 20C at 0.05 ppm; Dika nut at 0.01 ppm; Durian at 20 ppm;
Fennel, Florence, fresh leaves and stalk at 15 ppm; Ginkgo at 0.2 ppm;
Guiana chestnut at 0.01 ppm; Hazelnut at 0.01 ppm; Heartnut at 0.01
ppm; Hickory nut at 0.01 ppm; Jackfruit at 20 ppm; Japanese horse-
chestnut at 0.01 ppm; Leaf petiole vegetable subgroup 22B at 15 ppm;
Leafy greens subgroup 4-16A at 30 ppm; Macadamia nut at 0.01 ppm;
Mangosteen at 5 ppm; Mongongo nut at 0.01 ppm; Monkey puzzle at 0.2
ppm; Monkey-pot at 0.01 ppm; Okari nut at 0.2 ppm; Pachira nut at 0.01
ppm; Peach palm nut at 0.2 ppm; Pecan at 0.01 ppm; Pequi at 0.2 ppm;
Persimmon, Japanese at 5 ppm; Pili nut at 0.2 ppm; Pine nut at 0.2 ppm;
Sapucaia nut at 0.01 ppm; Sunflower subgroup 20B at 0.01 ppm; Tropical
almond at 0.2 ppm; Tropical and subtropical, small fruit, inedible
peel, subgroup 24A at 20 ppm; Walnut, black at 0.01 ppm; Walnut,
English at 0.01 ppm; and Yellowhorn at 0.01 ppm.
EPA is amending the tolerance for Dragon fruit from 1.0 ppm to 20
ppm, the tolerance for Pistachio from 0.10 ppm to 0.1 ppm, and the
tolerance for Vegetable, tuberous and corm, subgroup 1C from 6.0 ppm to
6 ppm. The commodity definition for Vegetable, legume, group 6 is
amended to Vegetable, legume, group 6, except bean while maintaining
the tolerance at 0.01 ppm.
[[Page 7392]]
Additionally, the following tolerances are removed as unnecessary
due to the establishment of the above tolerances: Carrots at 7.0 ppm;
Cotton, undelinted seed at 0.05 ppm; Leaf petioles subgroup 4B at 15
ppm; Leafy greens subgroup 4A at 30 ppm; Longan at 20 ppm; Lychee at 20
ppm; Safflower, seed at 0.01 ppm; Spanish lime at 20 ppm; and
Sunflower, seed at 0.01 ppm. In addition, EPA is removing the tolerance
for the Melon subgroup, since it is unnecessary due to the tolerance
for cucurbit vegetables, group 9 at 0.45 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 to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 (CRA)
Pursuant to the CRA (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: February 2, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter 1 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. 180.516, amend the table in paragraph (a) (1) by:
0
a. Adding in alphabetical order the entries ``African Tree Nut'';
``Almond''; ``Almond, hulls''; ``Beechnut''; ``Brazil nut'';
``Brazilian pine''; ``Bunya''; ``Bur oak''; ``Butternut''; ``Cajou'';
and ``Candlenut''.
0
b. Removing the entry for ``Carrots''.
0
c. Adding in alphabetical order the entries ``Carrot, roots'';
``Cashew''; ``Celtuce''; ``Chestnut''; ``Chinquapin''; ``Coconut'';
``Coquito nut''; and ``Cottonseed subgroup 20C''.
0
d. Removing the entry for ``Cotton, undelinted seed''.
0
e. Adding in alphabetical order the entry ``Dika nut''.
0
f. Revising the entry for ````Dragon fruit''.
0
g. Adding in alphabetical order the entries ``Durian''; ``Fennel,
Florence, fresh leaves and stalk''; ``Ginkgo''; ``Guiana chestnut'';
``Hazelnut''; ``Heartnut''; ``Hickory nut''; ``Jackfruit''; and
``Japanese horse-chestnut''.
0
h. Removing the entry for ``Leaf petioles subgroup 4B''.
0
i. Adding in alphabetical order the entry ``Leaf petiole vegetable
subgroup 22B''.
0
j. Removing the entry for ``Leafy greens subgroup 4A''.
0
k. Adding in alphabetical order the entry ``Leafy greens subgroup 4-
16A''.
0
l. Removing the entries for ``Longan''; and ``Lychee''.
0
m. Adding in alphabetical order the entries ``Macadamia nut''; and
``Mangosteen''.
0
n. Removing the entry for ``Melon subgroup 9A''.
0
o. Adding in alphabetical order the entries ``Mongongo nut''; ``Monkey
puzzle''; ``Monkey-pot''; ``Okari nut''; ``Pachira nut''; ``Peach palm
nut''; ``Pecan''; ``Pequi''; ``Persimmon, Japanese''; ``Pili nut''; and
``Pine nut''.
0
p. Revising the entry for ``Pistachio''.
0
q. Removing the entry for ``Safflower, seed''.
0
r. Adding in alphabetical order the entry ``Sapucaia nut''.
0
s. Removing the entries for ``Spanish lime''; and ``Sunflower, seed''.
0
t. Adding in alphabetical order the entries ``Sunflower subgroup 20B'';
``Tropical almond''; and ``Tropical and subtropical, small fruit,
inedible peel, subgroup 24A''.
0
u. Removing the entry for ``Vegetable, legume, group 6''.
0
v. Adding in alphabetical order the entry ``Vegetable, legume, group 6,
except bean''.
0
w. Revising the entry for ``Vegetable, tuberous and corm, subgroup
1C''.
0
x. Adding in alphabetical order the entries ``Walnut, black'';
``Walnut, English''; and ``Yellowhorn''.
The additions and revisions read as follows:
Sec. 180.516 Fludioxonil; tolerances for residues.
(a) * * *
(1) * * *
[[Page 7393]]
Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
African Tree Nut............................................ 0.01
Almond...................................................... 0.2
Almond, hulls............................................... 15
* * * * *
Beechnut.................................................... 0.2
* * * * *
Brazil nut.................................................. 0.01
Brazilian pine.............................................. 0.2
Bunya....................................................... 0.2
Bur oak..................................................... 0.01
* * * * *
Butternut................................................... 0.01
Cajou....................................................... 0.01
Candlenut................................................... 0.2
* * * * *
Carrot, roots............................................... 7
Cashew...................................................... 0.01
Celtuce..................................................... 15
* * * * *
Chestnut.................................................... 0.2
Chinquapin.................................................. 0.2
* * * * *
Coconut..................................................... 0.01
Coquito nut................................................. 0.01
* * * * *
Cottonseed subgroup 20C..................................... 0.05
* * * * *
Dika nut.................................................... 0.01
Dragon fruit................................................ 20
Durian...................................................... 20
* * * * *
Fennel, Florence, fresh leaves and stalk.................... 15
* * * * *
Ginkgo...................................................... 0.2
* * * * *
Guiana chestnut............................................. 0.01
Hazelnut.................................................... 0.01
Heartnut.................................................... 0.01
* * * * *
Hickory nut................................................. 0.01
* * * * *
Jackfruit................................................... 20
Japanese horse-chestnut..................................... 0.01
* * * * *
Leaf petiole vegetable subgroup 22B......................... 15
Leafy greens subgroup 4-16A................................. 30
Macadamia nut............................................... 0.01
* * * * *
Mangosteen.................................................. 5
Mongongo nut................................................ 0.01
Monkey puzzle............................................... 0.2
Monkey-pot.................................................. 0.01
Okari nut................................................... 0.2
* * * * *
Pachira nut................................................. 0.01
* * * * *
Peach palm nut.............................................. 0.2
* * * * *
Pecan....................................................... 0.01
Pequi....................................................... 0.2
Persimmon, Japanese......................................... 5
Pili nut.................................................... 0.2
Pine nut.................................................... 0.2
* * * * *
Pistachio................................................... 0.1
* * * * *
Sapucaia nut................................................ 0.01
* * * * *
Sunflower subgroup 20B...................................... 0.01
* * * * *
Tropical almond............................................. 0.2
Tropical and subtropical, small fruit, inedible peel, 20
subgroup 24A...............................................
* * * * *
Vegetable, legume, group 6, except bean..................... 0.01
* * * * *
Vegetable, tuberous and corm, subgroup 1C................... 6
Walnut, black............................................... 0.01
Walnut, English............................................. 0.01
* * * * *
Yellowhorn.................................................. 0.01
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 28, 2021.
* * * * *
[FR Doc. 2022-02560 Filed 2-8-22; 8:45 am]
BILLING CODE 6560-50-P
