Federal Register, Volume 77 Issue 158 (Wednesday, August 15, 2012)

[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Rules and Regulations]
[Pages 48907-48915]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19988]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0395; FRL-9357-5]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fludioxonil in or on multiple commodities which are identified and
discussed later in this document, associated with pesticide petition
(PP) 1E7853 and PP 1E7870. This regulation additionally revises several
established tolerances, and removes several established permanent and
time-limited tolerances. Interregional Research Project Number 4 (IR-4)
and Syngenta Crop Protection, LLC, requested the tolerances associated
with PP 1E7853 and PP 1E7870, respectively, under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 15, 2012. Objections and
requests for hearings must be received on or before October 15, 2012,
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-2011-0395, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, 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 review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; email address: nollen.laura@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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0395 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 15, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0395, by one of the following methods:

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0395 by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), Mail Code: 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 http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition, PP 1E7853,
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.516 be amended by establishing
tolerances for residues of the fungicide fludioxonil, (4-(2,2-difluoro-
1,3-benzodioxol-4-yl)-1-H -pyrrole-3-carbonitrile), in or on acerola at
5.0 parts per million (ppm); atemoya at 20 ppm; biriba at 20 ppm;
cherimoya at 20 ppm; custard apple at 20 ppm; feijoa at 5.0 ppm; guava
at 5.0 ppm; ilama at 20 ppm; jaboticaba at 5.0 ppm; passionfruit at 5.0
ppm; soursop at 20 ppm; starfruit at 5.0 ppm; sugar apple at

[[Page 48908]]

20 ppm; wax jambu at 5.0 ppm; ginseng at 3.0 ppm; onion, bulb subgroup
3-07A at 0.2 ppm; onion, green subgroup 3-07B at 7.0 ppm; caneberry
subgroup 13-07A at 5.0 ppm; bushberry subgroup 13-07B at 2.0 ppm;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
1.0 ppm; berry, low growing, subgroup 13-07G, except cranberry at 2.0
ppm; vegetable, fruiting, group 8-10, except tomato at 0.7 ppm; fruit,
citrus, group 10-10 at 10 ppm; fruit, pome, group 11-10 at 5.0 ppm;
leafy greens subgroup 4A at 30 ppm; potato at 6.0 ppm; pineapple at 8.0
ppm; and dragon fruit at 1.0 ppm.
That notice additionally requested to amend established tolerances
of fludioxonil in or on avocado from 0.45 ppm to 5.0 ppm; sapote, black
from 0.45 ppm to 5.0 ppm; canistel from 0.45 ppm to 5.0 ppm; sapote,
mamey from 0.45 ppm to 5.0 ppm; mango from 0.45 ppm to 5.0 ppm; papaya
from 0.45 ppm to 5.0 ppm; sapodilla from 0.45 ppm to 5.0 ppm; star
apple from 0.45 ppm to 5.0 ppm; longan from 1.0 ppm to 20 ppm; lychee
from 1.0 ppm to 20 ppm; pulasan from 1.0 ppm to 20 ppm; rambutan from
1.0 ppm to 20 ppm; Spanish lime from 1.0 ppm to 20 ppm; and tomato from
0.50 ppm to 3.0 ppm. Upon approval of the aforementioned tolerances,
the petition finally requested to amend 40 CFR 180.516 by removing the
established tolerances for residues of fludioxonil in or on the
following raw agricultural commodities: Onion, bulb at 0.2 ppm; onion,
green at 7.0 ppm; caneberry subgroup 13A at 5.0 ppm; bushberry subgroup
13B at 2.0 ppm; Juneberry at 2.0 ppm; lingonberry at 2.0 ppm; salal at
2.0 ppm; grape at 1.0 ppm; strawberry at 2.0 ppm; vegetable, fruiting,
group 8 at 0.01 ppm; tomatillo at 0.50 ppm; fruit, citrus, group 10 at
10 ppm; fruit, pome, group 11 at 5.0 ppm; and leafy greens subgroup 4A,
except spinach at 30 ppm. That notice referenced a summary of the
petition prepared on behalf of IR-4 by Syngenta Crop Protection, LLC,
the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1),
EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7853)
by IR-4, that requested that 40 CFR 180.516 be amended by establishing
tolerances for residues of the fungicide fludioxonil, (4-(2,2-difluoro-
1,3-benzodioxol-4-yl)-1-H -pyrrole-3-carbonitrile), in or on the
commodities requested in the Federal Register of July 20, 2011, with
one change. This petition requested to establish a tolerance for
residues of fludioxonil in or on vegetable, tuberous and corm, subgroup
1C at 6.0 ppm. This request superseded the previous request to
establish a tolerance in or on potato at 6.0 ppm, as potato is the
representative commodity of crop subgroup 1C. The May 2, 2012 petition
additionally requested that EPA remove the established tolerance in or
on vegetable, tuberous and corm, subgroup 1D at 3.5 ppm, as the
tolerance will be superseded by the vegetable, tuberous and corm,
subgroup 1C tolerance. That notice referenced a summary of the petition
prepared on behalf of IR-4 by Syngenta Crop Protection, LLC, the
registrant, which is available in the docket, http://www.regulations.gov. One comment was received to this notice of filing.
EPA's response to this comment is discussed in Unit IV.C.
Additionally, in the Federal Register of April 4, 2012 (77 FR
20334) (FRL-9340-4), EPA issued a notice pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346(d)(3), announcing the filing of PP 1E7870 by
Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27409.
The petition requested that 40 CFR 180.516 be amended by establishing a
tolerance for residues of the fungicide fludioxonil in or on leafy
petioles subgroup 04B at 14 ppm. That notice referenced a summary of
the petition prepared by Syngenta Crop Protection, LLC, the registrant,
which is available in the docket, http://www.regulations.gov. One
comment was received to this notice of filing. EPA's response to this
comment is discussed in Unit IV.C.
Based upon review of the data supporting the petitions, EPA has
revised the proposed tolerance levels and/or has revised the commodity
definitions for several commodities. Additionally, EPA has removed
several established tolerances and has determined that tolerances
should be established in or on several livestock commodities. Finally,
the Agency has revised the tolerance expression for all established
commodities to be consistent with current Agency policy. The reasons
for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fludioxonil including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fludioxonil follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Fludioxonil is of low acute toxicity and is not a dermal
sensitizer. For subchronic and chronic toxicity, the primary effects in
the mouse and rat were similar and included decreased body weight and
food consumption associated with clinical pathological and
histopathological effects in the liver and kidney. In the subchronic
dog study, diarrhea was the most sensitive indicator of toxicity. In
contrast, in the chronic toxicity study in dogs, decreased body-weight
gain in females was the most sensitive indicator of toxicity. Liver
toxicity was observed in both dog studies at higher doses.
Fludioxonil is not developmentally toxic in rabbits. In a rat
developmental toxicity study at the highest dose tested (HDT),
fludioxonil caused an increase in fetal incidence and litter incidence
of dilated renal pelvis in the presence of maternal toxicity. There was
no quantitative or qualitative evidence of increased susceptibility to
rats and rabbits following in utero exposure. There was also no
quantitative or

[[Page 48909]]

qualitative evidence of increased susceptibility to rats following
postnatal exposure and there was no evidence of immunotoxicity when
tested up to including the limit dose.
EPA determined that fludioxonil poses a negligible cancer risk.
This conclusion was based on the fact that cancer studies with
fludioxonil only showed marginal evidence of cancer in one sex of one
species. There was no evidence of carcinogenicity in mice when tested
up to the limited dose 7,000 ppm. There was no evidence of
carcinogenicity in male rats, but there was a statistically significant
increase, both trend and pairwise, of combined hepatocellular tumors in
female rats. The pairwise increase for combined tumors was significant
at p = 0.03, which is not a strong indication of a positive effect.
Further, statistical significance was only found when liver adenomas
were combined with liver carcinomas. Finally, the increase in these
tumors was within, but at the high end, of the historical controls.
Fludioxonil was not mutagenic in the tests for gene mutations. However,
based on the induction of polyploidy in the in vitro Chinese hamster
ovary cell cytogenetic assay and the suggestive evidence of micronuclei
induction in rat hepatocytes in vivo, additional mutagenicity testing
was performed in three studies specifically designed to address the
concerns regarding aneuploidy. The results of these assays were
negative for aneuploidy activity.
Specific information on the studies received and the nature of the
adverse effects caused by fludioxonil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: ``Fludioxonil. Tolerance Petitions for
Residues in/on Ginseng, Leafy Petioles Crop Subgroup 4B, Pineapple
(post-harvest treatment), Tuberous and Corm Vegetable Subgroup 1C,
Tropical Fruit (post-harvest treatment), Bulb Onion Subgroup 3-07A,
Green Onion subgroup 3-07B, Caneberry Subgroup 13-07A, Bushberry
Subgroup 13-07B, Small Fruit Vine Climbing Subgroup 13-07F (except
fuzzy kiwifruit), Low-Growing Berry Subgroup 13-07G (except cranberry),
Fruiting Vegetable Group 8-10 (except tomato), Citrus Fruit Group 10-
10, Pome Fruit Group 11-10, Leafy Vegetable (except Brassica) Subgroup
04A, Dragon Fruit, and Tomato (post-harvest treatment). Human-Health
Risk Assessment.'' pp. 40-42 in docket ID number EPA-HQ-OPP-2011-0395.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for fludioxonil used for human risk assessment is shown in
the Table of this unit.

Table--Summary of Toxicological Doses and Endpoints for Fludioxonil for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Females 13-49 NOAEL = 100 mg/kg/ Acute RfD = 1 mg/kg/ Prenatal developmental toxicity in
years of age). day. day. rats
UFA = 10X........... aPAD = 1 mg/kg/day. LOAEL = 1,000 mg/kg/day based on
UFH = 10X........... the increased incidence of
FQPA SF = 1X........ fetuses and litters with dilated
renal pelvis and dilated ureter
in rat developmental study.
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Acute dietary (General population There were no appropriate toxicological effects attributable to a single
including infants and children). exposure (dose) observed in available oral toxicity studies, including
maternal toxicity in the developmental toxicity studies. Therefore, a dose
and endpoint were not identified for this risk assessment.
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Chronic dietary (All populations) NOAEL= 3.3 mg/kg/day Chronic RfD = 0.033 Chronic toxicity in dogs
UFA = 10X........... mg/kg/day. LOAEL = 35.5 mg/kg/day based on
UFH = 10X........... cPAD = 0.033 mg/kg/ decreased weight gain in female
FQPA SF = 1X........ day. dogs during weeks 1-52 of one-
year dog feeding study.

[[Page 48910]]

Incidental oral short-term (1 to NOAEL= 10 mg/kg/day. LOC for MOE = 100.. Rabbit developmental study
30 days). UFA = 10X........... LOAEL = 100 mg/kg/day based on
UFH = 10X........... decreased weight gain during
FQPA SF = 1X........ dosing period.
Incidental oral intermediate-term NOAEL= 3.3 mg/kg/day LOC for MOE = 100.. Chronic toxicity in dogs
(1 to 6 months). UFA= 10X............ LOAEL = 35.5 mg/kg/day based on
UFH= 10X............ decreased weight gain in female
FQPA SF = 1X........ dogs during weeks 1-52 of one-
year dog feeding study.
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 1000. Rabbit developmental study
days). study NOAEL = 10 mg/ LOAEL = 100 mg/kg/day based on
kg/day (inhalation decreased weight gain during
absorption rate = dosing period.
100%).
UFA = 10X...........
UFH = 10X...........
FQPA SF = 10X.......
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Cancer (Oral, dermal, inhalation) Poses no greater than a negligible cancer risk.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population
(intraspecies).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fludioxonil, EPA considered exposure under the petitioned-
for tolerances as well as all existing fludioxonil tolerances in 40 CFR
180.516. EPA assessed dietary exposures from fludioxonil in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for fludioxonil for females 13-49 years old (i.e., females of child-
bearing age). In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
assumed tolerance-level residues, 100 percent crop treated (PCT)
estimates, and DEEM^TM ver. 7.81 default processing factors.
There were no appropriate toxicological effects attributable to a
single exposure for the general population; therefore, these population
subgroups were not included in this assessment.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues for most commodities, with the exception of the
following commodities for which anticipated residues were used: Celery,
pineapple, potato, spinach, apple, grapefruit, lemon, lime, orange,
pear, tomato, head lettuce, leaf lettuce, fresh parsley, brassica leafy
vegetables group 5, grape, cherry, peach, and plum. The anticipated
residues were estimated from field trial and processing study data for
the chronic analysis. The chronic dietary exposure assessment also
incorporated 100 PCT estimates and DEEM^TM ver. 7.81 default
processing factors, with the exception of citrus fruit juice (1X),
apple juice (1X), grape juice (0.42X), raisin (1.65X), potato
commodities (1X), and tomato commodities (1X), except dried tomato
(14.3X). These processing factors are based upon crop-specific
processing study data.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fludioxonil poses a negligible cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.

[[Page 48911]]

2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fludioxonil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fludioxonil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
fludioxonil for surface water are expected to be 83.8 parts per billion
(ppb) for acute exposures and 38.5 ppb for chronic exposures. The EDWCs
of fludioxonil for ground water are expected to be 0.2 ppb for acute
and chronic exposures.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 83.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 38.5 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Fludioxonil is
currently registered for the following uses that could result in
residential exposures: Parks, golf courses, athletic fields,
residential lawns, ornamentals, and greenhouses. In addition to the
conventional uses of fludioxonil in residential areas, there are also
antimicrobial uses. However, residential turf uses of fludioxonil are
expected to result in the highest potential exposure of all registered
residential uses of fludioxonil and, therefore, were assessed.
EPA assessed residential exposure using the following assumptions:
Short-term inhalation for residential handler exposure scenarios,
including mixing/loading/applying fludioxonil. Residential handler
exposures were considered to be short-term only due to the infrequent
use patterns associated with homeowner products. Additionally, EPA
assessed potential short- and intermediate-term postapplication
exposures to toddlers (children 1-2 years old) resulting from physical
activities on turf. These included incidental oral exposures from hand-
to-mouth, object-to-mouth, and incidental soil ingestion. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
fludioxonil to share a common mechanism of toxicity with 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 assumed that fludioxonil does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The fludioxonil toxicity
database includes developmental toxicity studies in rats and rabbits
and a 2-generation reproduction study in rats. In the rat developmental
study, there was an increase in the number of fetuses and litters with
dilated renal pelvis and dilated ureter at the limit dose (1,000 mg/kg/
day); maternal toxicity occurred at the same dose and was manifested as
a reduction in corrected body-weight gain, indicating that there is no
quantitative susceptibility for these fetal effects. In the rabbit
developmental study, no developmental toxicity was seen up to the HDT.
Maternal toxicity was demonstrated at that dose. In the 2-generation
rat reproduction study, offspring toxicity was seen at the same dose
that produced parental toxicity. The parental toxicity was manifested
as increased clinical signs, decreased body weight, body weight gain
and food consumption. Offspring toxicity was manifested as decreased
weight gain in pups. Parental and offspring toxicity were comparable;
therefore, it was concluded that there is no increased susceptibility
in the 2-generation reproduction study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for risks other than those related to
inhalation exposure. EPA is retaining the 10X FQPA safety factor for
risks from inhalation exposure. That decision is based on the following
findings:
i. The toxicity database for fludioxonil is complete except for a
90-day inhalation study. The point of departure for assessing risk from
inhalation exposure is being extrapolated from an oral study. The
uncertainty associated with this extrapolation requires the retention
of the 10X FQPA SF for these exposures.
ii. The only potential indicator of neurotoxicity in the
fludioxonil toxicity database was convulsions noted in mice following
handling at high doses. The convulsions were considered to be agonal in
nature. Therefore, EPA has determined that there is no need for a
developmental neurotoxicity study or an additional safety factor to
account for neurotoxicity.
iii. There is no evidence that fludioxonil results in increased
susceptibility in in utero rabbits in the prenatal developmental study
or in young rats in the 2-generation reproduction study. In the rat
developmental toxicity study, fetal effects were noted at the limit
dose in the presence of maternal toxicity. However, EPA determined that
the degree of concern is low for the noted fetal effects because the
effects were observed at the same doses as maternal effects, and there
is a clear NOAEL established which was used in endpoint selection.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary assessment for females 13-49 years old was
unrefined, assuming 100 PCT and tolerance-level

[[Page 48912]]

residues, and the chronic dietary exposure assessment assumed 100 PCT
and used tolerance-level residues or made use of average residues
derived from crop field trial studies. The chronic assessment also
assumed DEEM default or other processing factors based on reliable
processing data. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
fludioxonil in drinking water. EPA used similarly conservative
assumptions to assess short- and intermediate-term postapplication
exposure resulting from incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
fludioxonil.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
fludioxonil will occupy 16% of the aPAD for females 13-49 years old,
the population group identified as having a potential acute exposure to
fludioxonil.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fludioxonil from food and water will utilize 68% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fludioxonil is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fludioxonil
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to fludioxonil.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 310 for
children 1-2 years old. Because EPA's level of concern for fludioxonil
is a MOE of 100 or below, this MOE is not of concern.
Because the short-term oral and inhalation risks were estimated
using the same oral POD, these routes of exposure could be combined for
the adult short-term exposure assessment. However, because the level of
concern for oral and inhalation routes of exposure are not the same (an
MOE of <100 defines the level of concern for incidental oral risk while
inhalation risk is defined by an MOE of <1,000) an aggregate risk index
(ARI) was required to estimate aggregate risk for adults. Only adults
are assumed to be exposed to a combination of oral and inhalation
exposures because inhalation exposures for fludioxonil may occur only
as to those who apply the pesticide. EPA identifies ARIs at or below
one as a risk estimate of concern. The short-term aggregate ARI
exposure estimates to fludioxonil residues for adults are 9.5 for the
general population and 11 for adults 50 years and older.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Fludioxonil is currently registered for uses that could result
in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with intermediate-term residential exposures to
fludioxonil.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 105 for children 1-2 years old. Because EPA's level of
concern for fludioxonil is a MOE of 100 or below, this MOE is not of
concern.
5. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., EPA has concluded that fludioxonil poses a
negligible cancer risk to humans. Therefore, fludioxonil is not
expected to pose a cancer risk to humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fludioxonil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate high-performance liquid chromatography/ultraviolet light
detector (HPLC/UV) methods (Syngenta Methods AG-597 and AG-597B) are
available for enforcing tolerances for residues of fludioxonil in or on
plant commodities. An adequate liquid chromatography, tandem mass
spectrometry (LC-MS/MS) method (Analytical Method GRM025.03A) is
available for enforcing tolerances for residues of fludioxonil in or on
livestock commodities.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex 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.
There are no Codex MRLs established for the following tolerances
associated with these petitions: Ginseng; tropical fruit commodities;
onion, green, subgroup 3-07B; leaf petioles crop subgroup 4B; and fat
of cattle, goat, horse, and sheep. The following United States
tolerances being established by this action are harmonized with
comparable Codex MRLs: Caneberry subgroup 13-07A at 5.0 ppm; bushberry
subgroup 13-07B at 2.0 ppm; and fruit, pome, group 11-10 at 5.0 ppm;
onion, bulb, subgroup 3-07A at 0.50 ppm; fruit, small vine climbing,
except fuzzy

[[Page 48913]]

kiwifruit, subgroup 13-07F at 2.0 ppm; and berry, low growing, subgroup
13-07G, except cranberry at 3.0 ppm.
The following United States tolerances being established by this
action cannot be harmonized with the comparable Codex MRL: Tomato;
leafy greens subgroup 4A; vegetable, tuberous and corm, subgroup 1C;
fruit, citrus, group 10-10; and fruit, pome, group 11-10. The residue
data and use patterns in the United States for these commodities
support a higher tolerance value than what is established by Codex. The
Codex has proposed, though has not yet approved, MRLs on citrus fruits
at 10 ppm and pome fruits at 5.0 ppm that would result in harmonization
with the United States for these commodities.
Finally, EPA is establishing a tolerance on vegetable, fruiting,
group 8-10, except tomato that is not harmonized with Codex MRLs on
eggplant at 0.3 ppm or sweet peppers at 1 ppm, which are members of the
fruiting vegetable crop group. The United States tolerance was
established as the result of a joint review of residue field trial data
with Canada's Pest Management Regulatory Agency (PMRA). Based on the
EPA and PMRA review of the data supporting the petition, the resulting
tolerance for vegetable, fruiting, group 8-10, except tomato is 0.5
ppm. This tolerance cannot be harmonized with the Codex MRLs on
eggplant at 0.3 ppm and sweet peppers at 1 ppm since the MRLs are
established for two individual members of the fruiting vegetable crop
group at different levels.

C. Response to Comments

EPA received one comment to the notice of filing for PP 1E7870,
which requested additional information about the nature of the residue
and the adverse effects noted from exposure to fludioxonil. A summary
of information about the nature of the residue and the adverse effects
from fludioxonil was available to the commenter in the docket at the
time of the notice of filing. That information, as well as specific
information on the nature of the residue, including physical and
chemical characteristics, and the adverse effects caused by fludioxonil
from the toxicity studies can be found in the supporting and related
material at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2011-0395.
Additionally, the Agency received one comment to the May 2, 2012
notice of filing for PP 1E7853. The commenter raised concerns about the
proposal to increase an existing tolerance for fludioxonil 5-10 times
the current level and further stated that EPA would need to amend the
protocol and develop a completely new method. In response to these
concerns, EPA notes that the appropriate residue field trial data to
support the amended use pattern for a post-harvest use was submitted to
the Agency. From the risk assessment for the action, which included
review of the field trial data supporting petitioned-for tolerance
amendments, EPA has determined that the tolerance levels to be
established by the Agency are appropriate and safe.

D. Revisions to Petitioned-For Tolerances

Based on the data supporting the petitions, EPA revised the
proposed tolerances on several commodities, as follows: Ginseng from
3.0 ppm to 4.0 ppm; vegetable, fruiting, group 8-10, except tomato from
0.7 ppm to 0.50 ppm; tomato from 3.0 ppm to 5.0 ppm; pineapple from 8.0
ppm to 20 ppm; and leaf petioles crop subgroup 4B from 14 ppm to 15
ppm. Upon review of the data supporting the petitions, EPA also
determined that several tolerances should be established on livestock
commodities, as follows: Milk at 0.01 ppm; cattle, goat, horse, and
sheep meat at 0.01 ppm; meat byproducts of cattle, goat, horse, and
sheep at 0.05 ppm; and fat of cattle, goat, horse, and sheep at 0.05
ppm. The Agency revised these tolerance levels based on analysis of the
residue field trial data using the Organization for Economic
Cooperation and Development (OECD) tolerance calculation procedures.
Additionally, EPA revised the onion, bulb, subgroup 3-07A from 0.20
ppm to 0.50 ppm; fruit, small vine climbing, except fuzzy kiwifruit,
subgroup 13-07F from 1.0 ppm to 2.0 ppm; and berry, low growing,
subgroup 13-07G, except cranberry from 2.0 ppm to 3.0 ppm, in order to
align with the Codex MRLs associated with these tolerances.
EPA also removed the established tolerance in or on vegetable,
leafy, except brassica, group 4 at 0.01 ppm, as it will be superseded
by tolerances on leafy greens subgroup 4A at 30 ppm and leaf petioles
subgroup 4B at 15 ppm. Similarly, EPA removed the established tolerance
on vegetable, bulb, group 3 at 0.02 ppm, as the tolerance will be
superseded by tolerances on bulb onion subgroup 3-07A at 0.50 ppm and
green onion subgroup 3-07B at 7.0 ppm. In order to clarify the
established vegetable, root and tuber, group 1 tolerance at 0.02 ppm,
the Agency revised the entry to beet, sugar at 0.02 ppm. This change
has been made because all other commodity members currently in crop
group 1 will be superseded by tolerances in or on vegetable, root,
except sugar beet, subgroup 1B at 0.75 ppm and vegetable, tuberous and
corm, subgroup 1C at 6.0 ppm. EPA also revised the proposed commodity
definitions to reflect the correct designation for fruit, small, vine
climbing, except fuzzy kiwifruit, subgroup 13-07F and dragon fruit.
Finally, the Agency has revised the tolerance expression to
clarify:
1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of fludioxonil not specifically
mentioned; and
2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

Therefore, tolerances are established for residues of fludioxonil,
(4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3-carbonitrile), in
or on guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit,
and acerola at 5.0 ppm; sugar apple, atemoya, custard apple, cherimoya,
ilama, soursop and biriba at 20 ppm; ginseng at 4.0 ppm; onion, bulb,
subgroup 3-07A at 0.50 ppm; onion, green, subgroup 3-07B at 7.0 ppm;
caneberry subgroup 13-07A at 5.0 ppm; bushberry subgroup 13-07B at 2.0
ppm; fruit, small, vine climbing, subgroup 13-07F, except fuzzy
kiwifruit at 2.0 ppm; berry, low growing, subgroup 13-07G, except
cranberry at 3.0 ppm; vegetable, fruiting, group 8-10, except tomato at
0.50 ppm; fruit, citrus, group 10-10 at 10 ppm; fruit, pome, group 11-
10 at 5.0 ppm; leafy greens subgroup 4A at 30 ppm; vegetable, tuberous
and corm, subgroup 1C at 6.0 ppm; pineapple at 20; dragon fruit at 1.0
ppm; and leaf petioles subgroup 4B at 15 ppm. This regulation
additionally amends established tolerances of fludioxonil in or on
avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla
and star apple from 0.45 ppm to 5.0 ppm; longan, lychee, pulasan,
rambutan, and Spanish lime from 1.0 ppm to 20 ppm; and tomato from 0.50
ppm to 5.0 ppm.
Tolerances are established for residues of fludioxonil, (4-(2,2-
difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-carbonitrile), and its
metabolites converted to 2,2-difluoro-1,3-benzodioxole-4-carboxylic
acid, calculated as the stoichiometric equivalent of fludioxonil, in or
on milk at 0.01 ppm; cattle, meat byproducts at 0.05 ppm; cattle, meat
at 0.01 ppm; cattle, fat at 0.05 ppm; goat, meat byproducts at 0.05
ppm; goat, meat at 0.01 ppm; goat, fat at 0.05 ppm; horse, meat
byproducts at 0.05 ppm; horse,

[[Page 48914]]

meat at 0.01 ppm; horse, fat at 0.05 ppm; sheep, meat byproducts at
0.05 ppm; sheep, meat at 0.01 ppm; and sheep, fat at 0.05 ppm.
This regulation additionally removes established tolerances in or
on onion, bulb; onion, green; caneberry subgroup 13A; bushberry
subgroup 13B; Juneberry; lingonberry; salal; grape; strawberry;
vegetable, fruiting group 8; tomatillo; fruit, citrus, group 10; fruit,
pome, group 11; leafy green subgroup 4A, except spinach; vegetable,
tuberous and corm, except potato, subgroup 1D; vegetable, leafy, except
brassica, group 4; and vegetable, bulb, group 3. This regulation also
removes the time-limited tolerances in or on starfruit and pineapple.
Finally, this regulation revises the established tolerance on
vegetable, root and tuber, group 1 at 0.02 ppm to beet, sugar at 0.02
ppm.

VI. Statutory and Executive Order Reviews

This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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). This final rule 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 tolerance 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: August 3, 2012.
Lois Rossi,
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. Section 180.516 is amended by revising paragraphs (a) and (b) to
read as follows:

Sec. 180.516 Fludioxonil; tolerances for residues.

(a) General. (1) Tolerances are established for residues of the
fungicide fludioxonil, including its metabolites and degradates, in or
on the commodities in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-
H-pyrrole-3-carbonitrile).

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Acerola...................................................... 5.0
Animal feed, nongrass, group 18.............................. 0.01
Atemoya...................................................... 20
Avocado...................................................... 5.0
Bean, dry.................................................... 0.4
Bean, succulent.............................................. 0.4
Beet, sugar, roots........................................... 0.02
Berry, low growing, subgroup 13-07G, except cranberry........ 3.0
Biriba....................................................... 20
Brassica, head and stem, subgroup 5A......................... 2.0
Brassica, leafy greens, subgroup 5B.......................... 10
Bushberry subgroup 13-07B.................................... 2.0
Caneberry subgroup 13-07A.................................... 5.0
Canistel..................................................... 5.0
Cherimoya.................................................... 20
Citrus, oil.................................................. 500
Cotton, gin byproducts....................................... 0.05
Cotton, undelinted seed...................................... 0.05
Custard apple................................................ 20
Dragon fruit................................................. 1.0
Feijoa....................................................... 5.0
Flax, seed................................................... 0.05
Fruit, citrus, group 10-10................................... 10
Fruit, pome, group 11-10..................................... 5.0
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 2.0
13-07F......................................................
Fruit, stone, group 12....................................... 5.0
Ginseng...................................................... 4.0
Grain, cereal, group 15...................................... 0.02
Grain, cereal, forage, fodder, and straw, group 16........... 0.01
Grass, forage, fodder and hay, group 17...................... 0.01
Guava........................................................ 5.0
Herb subgroup 19A, dried leaves.............................. 65
Herb subgroup 19A, fresh leaves.............................. 10
Ilama........................................................ 20
Jaboticaba................................................... 5.0
Kiwifruit, fuzzy............................................. 20
Leaf petioles subgroup 4B.................................... 15
Leafy greens subgroup 4A..................................... 30
Longan....................................................... 20
Lychee....................................................... 20
Mango........................................................ 5.0
Melon subgroup 9A............................................ 0.03
Onion, bulb, subgroup 3-07A.................................. 0.50
Onion, green, subgroup 3-07B................................. 7.0
Papaya....................................................... 5.0

[[Page 48915]]

Passionfruit................................................. 5.0
Peanut....................................................... 0.01
Peanut, hay.................................................. 0.01
Pineapple.................................................... 20
Pistachio.................................................... 0.10
Pomegranate.................................................. 5.0
Pulasan...................................................... 20
Rambutan..................................................... 20
Rapeseed, forage............................................. 0.01
Rapeseed, seed............................................... 0.01
Safflower, seed.............................................. 0.01
Sapodilla.................................................... 5.0
Sapote, black................................................ 5.0
Sapote, mamey................................................ 5.0
Soursop...................................................... 20
Spanish lime................................................. 20
Spice subgroup 19B........................................... 0.02
Star apple................................................... 5.0
Starfruit.................................................... 5.0
Sugar apple.................................................. 20
Sunflower, seed.............................................. 0.01
Tomato....................................................... 5.0
Turnip, greens............................................... 10
Vegetable, cucurbit, group 9................................. 0.45
Vegetable, foliage of legume, group 7........................ 0.01
Vegetable, fruiting, group 8-10, except tomato............... 0.50
Vegetable, leaves of root and tuber, group 2................. 30
Vegetable, legume, group 6................................... 0.01
Vegetable, root, except sugar beet, subgroup 1B.............. 0.75
Vegetable, tuberous and corm, subgroup 1C.................... 6.0
Watercress................................................... 7.0
Wax jambu.................................................... 5.0
Yam, true, tuber............................................. 8.0
------------------------------------------------------------------------

(2) Tolerances are established for residues of the fungicide
fludioxonil, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only the sum of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-
4-yl)-1-H-pyrrole-3-carbonitrile), and its metabolites converted to
2,2-difluoro-l,3-benzodioxole-4-carboxylic acid, calculated as the
stoichiometric equivalent of fludioxonil.

(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2012-19988 Filed 8-14-12; 8:45 am]
BILLING CODE 6560-50-P