Document ID: EPA-HQ-OPP-2014-0496-0021
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fludioxonil
Posted Date: 2015-08-14T04:00Z

[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Rules and Regulations]
[Pages 48743-48749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20019]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0496; FRL-9931-06]

Fludioxonil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
fludioxonil in or on carrots, the stone fruit group 12-12, and the 
rapeseed subgroup 20A, except flax seed. Interregional Research Project 
Number 4 (IR-4) requested the tolerances for carrots and the stone 
fruit group 12-12, and Syngenta Crop Protection requested the tolerance 
for the rapeseed subgroup 20A under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 14, 2015. Objections and 
requests for hearings must be received on or before October 13, 2015, 
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-2014-0496, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room

[[Page 48744]]

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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0496 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 13, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0496, 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 CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    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 Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4E8272) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide fludioxonil [4-
(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] in or on 
the raw agricultural commodity carrot at 7.0 ppm, and by changing the 
existing entry for ``fruit, stone, group 12 at 5.0 ppm'' to ``fruit, 
stone, group 12-12 at 5.0 ppm.'' That document referenced a summary of 
the petition prepared by Syngenta Crop Protection, the registrant, 
which is available in the docket, http://www.regulations.gov.
    In the Federal Register of October 24, 2014 (79 FR 63594) (FRL-
9916-03), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
4F8277) by Syngenta Crop Protection, LLC, 410 Swing Rd., Greensboro, NC 
27419. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide fludioxonil in or 
on the rapeseed subgroup 20A, except flax seed at 0.01 ppm. That 
document referenced a summary of the petition prepared by Syngenta Crop 
Protection, the registrant, which is available in the docket, http://www.regulations.gov.
    Comments were received on the notice of filing. EPA's response to 
these comments is discussed in Unit IV.C.

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.

[[Page 48745]]

    In all species tested, the effects in the fludioxonil database are 
indicative of toxicity to the liver and kidney. The hematopoietic 
system was also a target in dogs. There were also decreased body 
weights and clinical signs throughout the database. Fludioxonil was 
non-toxic through the dermal route, and there was no evidence of 
immunotoxicity when tested up to and including the limit dose. 
Fludioxonil was not mutagenic in the tests for gene mutations.
    In a rat developmental toxicity study, fludioxonil caused an 
increase in fetal incidence and litter incidence of dilated renal 
pelvis at the limit dose (1,000 mg/kg/day). These effects are known to 
occur spontaneously in the rat, in addition to being transient and 
reversible which is consistent with the fludioxonil hazard database 
(not seen in offspring in the 2-generation reproductive study). Under 
current policy, the agency considers classification of these effects as 
treatment-related but conservative and not indicative of increased 
fetal susceptibility. Maternal toxicity occurred at the same dose and 
manifested as body weight decrements. In the 2-generation reproduction 
study, parental and offspring effects occurred at the same dose and 
consisted of decreased body weights in parental and offspring animals, 
as well as increased clinical signs in parental animals.
    There was no evidence of carcinogenicity in male or female CD-1 
mice and male Sprague-Dawley rats following dietary administration at 
doses that were adequate for assessing the carcinogenic potential of 
fludioxonil. In female Sprague-Dawley rats, there was a statistically 
significant increase in tumor incidence only when hepatocellular 
adenomas and carcinomas were combined (not for individual tumor types). 
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. Based on 
these findings and in accordance with the Agency's 1986 ``Guidelines 
for Carcinogen Risk Assessment,'' fludioxonil was classified as a Group 
D carcinogen; therefore, there is no need for a quantitative cancer 
risk assessment.
    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 the document titled ``Fludioxonil. Section 3 
Registration for Use on Carrots, Stone Fruit, Group 12-12, and 
Rapeseed, Subgroup 20A. Human Health Risk Assessment'' at page 28 in 
docket ID number EPA-HQ-OPP-2014-0496.

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 Table 1 of this unit. Since the last 
assessment in 2012, (August 15, 2012) (77 FR 48907) (FRL-9357-5), the 
Agency has reevaluated the toxicological endpoints. Based upon current 
policy, it was determined that an acute dietary assessment was no 
longer necessary for fludioxonil. This decision was based upon the 
following weight of evidence: (1) After re-evaluation of the hazard 
database, it was determined that there were no effects that could be 
attributed to single dose and (2) the fetal effects in the 
developmental rat study occurred only at the limit dose (1,000 mg/kg/
day). Additionally, though the same study is being used to assess 
chronic dietary risk, the NOAEL and LOAEL have been reclassified. 
Further, the remaining endpoints for short-term incidental oral 
toxicity and short-term inhalation toxicity have changed as well.

  Table 1--Summary of Toxicological Doses and Endpoints for Fludioxonil for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
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.
                                    ----------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL= 33.1 mg/kg/day   Chronic RfD = 0.33 mg/  Chronic toxicity in dogs--
                                      UFA = 10x.              kg/day.                LOAEL = 297.8 mg/kg/day
                                     UFH = 10x.............  cPAD = 0.33 mg/kg/day.   based upon decreased
                                     FQPA SF = 1x..........                           absolute body weights,
                                                                                      increased platelets and
                                                                                      fibrin in both sexes,
                                                                                      cholesterol in males, and
                                                                                      increased alkaline
                                                                                      phosphatase release in
                                                                                      both sexes. Enlarged
                                                                                      livers in two females were
                                                                                      observed along with
                                                                                      biliary epithelial cell
                                                                                      proliferation in one
                                                                                      female.

[[Page 48746]]

 
Incidental oral short-term (1 to 30  NOAEL= 50 mg/kg/day     LOC for MOE = 100.....  Subchronic toxicity in
 days).                               UFA = 10x.                                      dogs--
                                     UFH = 10x.............                          LOAEL = 250 mg/kg/day based
                                     FQPA SF = 1x..........                           upon decreased absolute
                                                                                      body weights in both
                                                                                      sexes, diarrhea,
                                                                                      hematological alterations
                                                                                      (increased platelets and
                                                                                      fibrin, decreased red
                                                                                      cells, hemoglobin, and
                                                                                      packed cell volume),
                                                                                      clinical chemistry
                                                                                      alterations (increased
                                                                                      alpha-1 and alpha-2
                                                                                      globulin in females),
                                                                                      increased liver weights in
                                                                                      both sexes, increased
                                                                                      testes and ovary weights,
                                                                                      and an increased severity
                                                                                      (but not incidence) of
                                                                                      bile duct proliferation.
Inhalation short-term (1 to 30       Oral study NOAEL= 50    LOC for MOE = 100.....  Subchronic toxicity in
 days).                               mg/kg/day (inhalation                           dogs--
                                      absorption rate =                              LOAEL = 250 mg/kg/day based
                                      100%).                                          upon decreased absolute
                                     UFA = 10x.............                           body weights in both
                                     UFH = 10x.............                           sexes, diarrhea,
                                     FQPA SF = 1x..........                           hematological alterations
                                                                                      (increased platelets and
                                                                                      fibrin, decreased red
                                                                                      cells, hemoglobin, and
                                                                                      packed cell volume),
                                                                                      clinical chemistry
                                                                                      alterations (increased
                                                                                      alpha-1 and alpha-2
                                                                                      globulin in females),
                                                                                      increased liver weights in
                                                                                      both sexes, increased
                                                                                      testes and ovary weights,
                                                                                      and an increased severity
                                                                                      (but not incidence) of
                                                                                      bile duct proliferation.
                                    ----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  Classified as a Group D carcinogen; no cancer assessment is necessary.
----------------------------------------------------------------------------------------------------------------
 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). 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.
    No such effects were identified in the toxicological studies for 
fludioxonil; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the U.S. Department 
of Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, an unrefined chronic dietary exposure and risk assessment was 
performed assuming tolerance-level residues, 100 percent crop treated 
(PCT) estimates, and DEEM (ver. 7.81) default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
classified fludioxonil as a group D carcinogen. Therefore, a dietary 
exposure assessment for the purpose of assessing cancer risk is 
unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
fludioxonil. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    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 chronic exposures are estimated to be 38.5 parts per 
billion (ppb) for surface water and 0.2 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the 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. To assess 
residential handler exposure, the Agency used the short-term inhalation 
exposure to adults from mixing/loading/applying a wettable powder in 
water-soluble packaging with hose end sprayer (both for turf and 
gardens). To assess post-application exposure, the Agency used short-
term incidental oral exposures (hand-to-mouth) to children 1<2 years 
old from exposure to outdoor treated turf. 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.

[[Page 48747]]

    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. There was no quantitative or 
qualitative evidence of increased susceptibility following in utero 
exposure to rats and rabbits or following pre-/postnatal exposure. In a 
rat developmental toxicity study, fludioxonil caused an increase in 
fetal incidence and litter incidence of dilated renal pelvis at the 
limit dose (1,000 mg/kg/day). Maternal toxicity occurred at the same 
dose and manifested as body weight decrements. Fludioxonil was not 
developmentally toxic in rabbits. In the 2-generation reproduction 
study, parental and offspring effects occurred at the same dose and 
consisted of decreased body weights in parental and offspring animals, 
as well as increased clinical signs in parental animals.
    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. That decision is based on the following 
findings:
    i. The toxicity database for fludioxonil is complete.
    ii. The only potential indicator of neurotoxicity for fludioxonil 
was convulsions in mice following handling in the mouse carcinogenicity 
study at the mid- and high-doses. The concern is low however since 
there was no supportive neuropathology, the effect was not seen at 
similar doses in a second mouse carcinogenicity study, there were no 
other signs of potential neurotoxicity observed in the database, and 
selected endpoints are protective of the effect seen in mice. 
Therefore, there is no residual uncertainty concerning neurotoxicity 
and no need to retain the FQPA 10X safety factor.
    iii. There is no evidence that fludioxonil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. 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 post-application exposure of 
children as well as 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. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
fludioxonil is not expected to pose an acute risk.
    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 71% of the cPAD for 
children 1-2 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 aggregate MOEs of 81,000 for adults 
and 4,800 for children 1-2 years old. Because EPA's level of concern 
for fludioxonil is a MOE of 100 or below, these MOEs are not of 
concern.
    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).
    An intermediate-term adverse effect was identified; however, 
fludioxonil is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
fludioxonil.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion contained in Unit III.A., 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

[[Page 48748]]

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 (HPLC/
UV) methods (Methods AG-597 and AG-597B) are available for enforcing 
tolerances for fludioxonil 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.
    The Codex has established MRLs for fludioxonil in or on multiple 
stone fruit commodities (peaches, apricots, etc.) at 5.0 ppm. These 
MRLs are the same as the tolerances established for fludioxonil in the 
United States.
    The Codex has established an MRL for fludioxonil in or on carrot 
roots at 0.7 ppm. This MRL is different than the tolerance established 
for fludioxonil in the United States because it is based on a foliar 
use, whereas the U.S. use is based on a post-harvest use. Harmonization 
with the Codex MRL is likely to result in tolerance exceedances when 
fludioxonil is applied to carrots in accordance with the label.
    The Codex has established an MRL for fludioxonil in or on rape seed 
at 0.02 ppm. This MRL is different than the 0.01 ppm tolerance 
established for fludioxonil on the rapeseed subgroup 20A in the U.S., 
which is aligned with the existing Canadian MRL on rapeseed. In their 
petition, Syngenta requested to remain aligned with Canada at 0.01 ppm 
for rapeseed in order to prevent NAFTA trade barriers.

C. Response to Comments

    Several comments were received in response to the Notice of Filing 
regarding adverse impacts to bees but did not reference any specific 
active ingredient. The commenters by and large stated this action 
should be denied due to toxicity to bees and that all use of chemicals 
should be stopped. The comments primarily appear directed to the 
registration of the pesticide under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA). One comment referenced the establishment 
of a tolerance for an unnamed Syngenta pesticide, so to the extent that 
comment is directed at the present tolerance action, the Agency 
understands the commenters' concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, the existing legal framework provided by section 408 of 
the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances 
may be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. The comment appears to be directed at the underlying 
statute and not EPA's implementation of it; no contentions have been 
made that EPA has acted in violation of the statutory framework. As to 
bees the EPA considers impacts to the environment and non-target 
species under the authority of the (FIFRA).

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 carrots at 7.0 ppm; fruit, stone, group 12-12 at 5.0 ppm; and the 
rapeseed subgroup 20A, except flax seed at 0.01 ppm. In addition, upon 
establishment of these tolerances, the existing tolerance for rapeseed, 
seed is removed as unnecessary since it is part of the rapeseed 
subgroup 20A.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require

[[Page 48749]]

Agency consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
(NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 6, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.516:
0
a. Remove the entry in the table in paragraph (a) for ``Rapeseed, 
seed''.
0
b. Add alphabetically the entries for ``Carrots'' and ``Rapeseed 
subgroup 20A, except flax seed'' to the table in paragraph (a).
0
c. Revise the entry for ``Fruit, stone, group 12'' to read ``Fruit, 
stone, group 12-12'' in the table in paragraph (a).
    The additions and revisions read as follows:

Sec.  180.516  Fludioxonil; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Carrots.................................................             7.0
 
                                * * * * *
Fruit, stone, group 12-12...............................             5.0
 
                                * * * * *
Rapeseed subgroup 20A, except flax seed.................            0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-20019 Filed 8-13-15; 8:45 am]
BILLING CODE 6560-50-P