Document ID: EPA-HQ-OPP-2011-0395-0007
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fludioxonil
Posted Date: 2012-08-15T04:00Z

[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.
                                  ------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 DEEMTM 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 DEEMTM 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.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.05
Cattle, meat...............................................         0.01
Cattle, meat byproducts....................................         0.05
Goat, fat..................................................         0.05
Goat, meat.................................................         0.01
Goat, meat byproducts......................................         0.05
Horse, fat.................................................         0.05
Horse, meat................................................         0.01
Horse, meat byproducts.....................................         0.05
Milk.......................................................         0.01
Sheep, fat.................................................         0.05
Sheep, meat................................................         0.01
Sheep, meat byproducts.....................................         0.05
------------------------------------------------------------------------

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