Document ID: EPA-HQ-OPP-2014-0506-0011
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Cyprodinil
Posted Date: 2015-09-09T04:00Z

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Rules and Regulations]
[Pages 54242-54248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22031]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0506; FRL-9930-04]

Cyprodinil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyprodinil in or on multiple commodities that are identified and 
discussed later in this document, and removes the established tolerance 
on fruit, stone, group 12. Interregional Research Project Number 4

[[Page 54243]]

(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 9, 2015. Objections and 
requests for hearings must be received on or before November 9, 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-2014-0506, 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 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-2014-0506 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 
November 9, 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-2014-0506, 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 September 5, 2014 (79 FR 53009) (FRL-
9914-98), 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 
4E8293) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide cyprodinil, 4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on acerola at 1.5 
parts per million (ppm); artichoke, globe at 4.0 ppm; feijoa at 1.5 
ppm; fruit, stone group 12-12 at 2.0 ppm; guava at 1.5 ppm; jaboticaba 
at 1.5 ppm; passionfruit at 1.5 ppm; pomegranate at 7.0 ppm; starfruit 
at 1.5 ppm; and wax jambu at 1.5 ppm. This petition additionally 
requested to remove the tolerance in 40 CFR 180.532 for residues of 
cyprodinil in or on fruit, stone, group 12 at 2.0 ppm. That document 
referenced a summary of the petition prepared on behalf of IR-4 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.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance on pomegranate, and has revised the 
commodity definition for artichoke to artichoke, globe. 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

[[Page 54244]]

aggregate exposure for cyprodinil including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with cyprodinil 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.
    The major target organs of cyprodinil are the liver and the kidney. 
Liver effects were consistent among rats and mice in both subchronic 
and chronic studies and typically included increased liver weights and 
increases in serum clinical chemistry parameters, associated with 
adverse effects on liver function (i.e., increased cholesterol and 
phospholipid levels). Microscopic lesions in rats and mice included 
hepatocyte hypertrophy and hepatocellular necrosis. In the kidneys, 
chronic tubular lesions and chronic kidney inflammation following 
subchronic exposure and increased kidney weights and progressive 
nephropathy following chronic exposures in male rats. Chronic effects 
in dogs were limited to decreased body-weight gain, decreased food 
consumption and decreased food efficiency. The hematopoietic system 
also appeared to be a target of cyprodinil, as mild anemia was seen 
following subchronic rat exposure (reductions in hematocrit and 
hemoglobin and microcytosis). Although increases in thyroid weight or 
hypertrophy of thyroid follicular cells were observed at higher doses 
in the 28-day and 90-day oral toxicity study in rats, treatment-related 
changes in thyroid weights or gross/microscopic observations were not 
observed in the chronic rat study or in other studies.
    A 28-day dietary immunotoxicity study in mice resulted in no 
apparent suppression of the humoral component of the immune system. The 
only effect attributed to cyprodinil treatment was higher liver weights 
at the highest dose tested. There were no treatment-related effects on 
spleen or thymus weights; no effects on specific activity or total 
activity of splenic immunoglobulin M (IgM) antibody-forming cells to 
the T cell-dependent antigen sheep red blood cells (sRBC).
    An acute neurotoxicity study indicated systemic toxicity with signs 
of induced hunched posture, pilorection, and reduced responsiveness to 
sensory stimuli and reduced motor activity. Clinical signs, 
hypothermia, and changes in motor activity were found to be reversible 
by day 8 and 15 investigations. A subchronic neurotoxicity study showed 
no treatment related effects on mortality, clinical signs, or gross or 
histological neuropathology. Functional observational battery (FOB) and 
motor activity testing revealed no treatment related effects up to the 
highest dose tested.
    There was no evidence of increased susceptibility in the 
developmental rat or rabbit study following in utero exposure or in the 
two-generation reproduction study following pre- and post-natal 
exposure. Fetal toxicity, manifested as significantly lower fetal 
weights and an increased incidence of delayed ossification in the rat 
and a slight increase in litters showing extra ribs in the rabbit, was 
reported in developmental toxicity studies. In a rat two-generation 
reproduction study, significantly lower pup weights for F1 
and F2 offspring were observed. Each of these fetal or 
neonatal effects occurred at the same dose levels at which maternal 
toxicity (decreased body weight gain) was observed and were considered 
to be secondary to maternal toxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyprodinil 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: Cyprodinil. Human Health Risk 
Assessment for the Expansion of Existing Crop Group/Representative 
Commodity Uses to Stone Fruit Group 12-12, and Adding New Uses on the 
Artichoke, Guava, Pomegranate, Passionfruit, Feijoa, Jaboticaba, Wax 
Jambu, Starfruit, and Acerola and Amended Uses on Greenhouse Cucumbers 
and Small Tomatoes at pages 36-40 in docket ID number EPA-HQ-OPP-2014-
0506.

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 cyprodinil used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of October 16, 2012 (77 FR 49732) 
(FRL-9359-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR 
180.532. EPA assessed dietary exposures from cyprodinil 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 cyprodinil. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA), from 2003 to 2008. As to 
residue levels in food, EPA utilized tolerance-level residues and 100 
percent crop treated (PCT) for all commodities. The acute assessment 
also incorporated Dietary Exposure Evaluation Model software with the 
Food Commodity Intake Database (DEEM-FCID) Version 3.18 default 
processing factors; and empirical processing factors for tomato paste/
tomato puree and lemon/lime juice, where 1X empirical processing 
factors were used to modify the tolerance values.

[[Page 54245]]

    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA utilized average field trial 
residues for pome fruit, head lettuce, leaf lettuce, spinach, tomato, 
and grape and tolerance-level residues for the remaining commodities. 
The Agency also assumed 100 PCT. The chronic assessment also 
incorporated DEEM default processing factors except for tomato paste/
tomato puree and lemon juice/lime juice, where a 1X empirical 
processing factor was used to modify the tolerance values.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cyprodinil does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT 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.
    2. Dietary exposure from drinking water. The residues of concern in 
drinking water for risk assessment purposes are cyprodinil and the 
degradate CGA 249287. The estimated drinking water concentrations 
(EDWCs) for each of these was calculated using a molecular weight 
conversion and then combined for each modeled scenario. The Agency used 
screening level water exposure models in the dietary exposure analysis 
and risk assessment for cyprodinil and CGA 249287 in drinking water. 
These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of cyprodinil and CGA 
249287. 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), Screening Concentration in Ground Water (SCI-
GROW), and Pesticide Root Zone Model for Groundwater (PRZM-GW) models, 
the EDWCs of cyprodinil and CGA 249287 for acute exposures are 
estimated to be 34.8 parts per billion (ppb) for surface water and 2.05 
ppb for ground water. EDWCs for chronic exposures for non-cancer 
assessments are estimated to be 24.7 ppb for surface water and 1.80 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. The water concentration values 
of 34.8 ppb and 24.7 ppb were used to assess the contribution to 
drinking water for the acute and chronic dietary risk assessments, 
respectively.
    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).
    Cyprodinil is currently registered for the following uses that 
could result in residential exposures: Ornamental landscapes. EPA 
assessed residential exposure using the following assumptions: Short-
term inhalation exposures to adult residential handlers from the 
application of cyprodinil to ornamental landscapes. The residential 
handler exposure scenarios were considered to be short-term only, due 
to the infrequent use patterns associated with homeowner products. 
Dermal exposures were not assessed since there was no dermal endpoint 
identified for cyprodinil. Postapplication exposures to adults or 
children were not expected and were not assessed. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 cyprodinil to share a common mechanism of 
toxicity with any other substances, and cyprodinil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyprodinil 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. In a rat developmental 
toxicity study, there were significantly lower mean fetal weights in 
the high dose group compared to controls as well as a significant 
increase in skeletal anomalies in the high dose group due to abnormal 
ossification. The skeletal anomalies or variations were considered to 
be a transient developmental delay that occurred secondary to the 
maternal toxicity noted in the high dose group. In the rabbit study, 
the only treatment-related developmental effect was the indication of 
an increased incidence of a 13th rib at maternally toxic doses. Signs 
of fetal effects in the reproductive toxicity study included 
significantly lower F1 and F2 pup weights in the high dose group during 
lactation, which continued to be lower than controls post-weaning and 
after the pre-mating period in the F1 generation. Reproductive effects 
were seen only at doses that also caused parental toxicity.
    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 non-inhalation exposure scenarios. For 
inhalation exposure scenarios for all population groups, EPA is 
retaining a 10X FQPA SF. That decision is based on the following 
findings:
    i. The toxicity database for cyprodinil is complete, except for a 
90-day inhalation toxicity study. In the absence of a route-specific 
inhalation study, EPA is relying on the 28-day feeding/range-

[[Page 54246]]

finding rat oral study to estimate risk from inhalation exposures. EPA 
has determined that the use of this study to extrapolate an inhalation 
endpoint may understate risk. Accordingly, to address this uncertainty, 
EPA has concluded that the 10X FQPA SF should be retained for risk 
assessments involving inhalation exposure.
    ii. As to evidence of neurotoxicity, in an acute neurotoxicity 
study in rats clinical signs, hypothermia, and changes in motor 
activity were all found to be reversible and no longer seen at day 8 
and 15 investigations. There were no treatment-related effects on 
mortality or gross or histological neuropathology. Reduced motor 
activity, induced hunched posture, piloerection and reduced 
responsiveness to sensory stimuli were observed and disappeared in all 
animals by day three to four. For the subchronic neurotoxicity study in 
rats, there was no indication that cyprodinil is a neurotoxic chemical. 
Based on this evidence, there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. When toxicity was observed in the prenatal developmental 
toxicity studies in rats and rabbits and the two-generation 
reproduction study in rats, toxicity to the fetuses or offspring 
occurred at the same doses at which effects were observed in maternal/
parental animals. Additionally, the skeletal anomalies or variations 
were considered to be a transient developmental delay that occurred 
secondary to the maternal toxicity noted in the high dose group. 
Therefore, there is no evidence that cyprodinil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary assessment was conservative and based upon 
100 PCT and tolerance-level residues, as well as DEEM default and 
empirical processing factors. The chronic dietary assessment was 
partially refined with average field trial residues for some 
commodities and tolerance-level residues for the remaining commodities. 
DEEM default and empirical processing factors were also incorporated 
into the chronic dietary assessment. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to cyprodinil in drinking water. Based on the discussion in 
Unit III.C.3, postapplication exposure of children as well as 
incidental oral exposure of toddlers is not expected. These assessments 
will not underestimate the exposure and risks posed by cyprodinil.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cyprodinil will occupy 8.6% of the aPAD for children one to two 
years old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyprodinil from food and water will utilize 85% of the cPAD for 
children one to two 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 
cyprodinil 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). Cyprodinil 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 cyprodinil.
    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 7,900. Because 
EPA's level of concern for cyprodinil is a MOE of 1,000 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, 
cyprodinil 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 
cyprodinil.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyprodinil 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 cyprodinil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate high performance liquid chromatography, using ultra-violet 
detection (HPLC/UV) methods (Methods AG-631 and AG-631B) are available 
to enforce the tolerance expression of cyprodinil in/on plant 
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,

[[Page 54247]]

FFDCA section 408(b)(4) requires that EPA explain the reasons for 
departing from the Codex level.
    The Codex has established MRLs for cyprodinil in or on stone fruit 
at 2.0 ppm. This MRL is the same as the tolerance established for 
cyprodinil in the United States for fruit, stone, group 12-12. The 
Codex has not established a MRL for cyprodinil in or on the other 
commodities associated with this action.

C. Response to Comments

    Several comments were received in response to the notice of filing. 
All but one were concerned with potential environmental impacts, and 
were not specifically related to the cyprodinil action. EPA notes that 
these comments address potential environmental concerns; however, the 
safety standard for approving tolerances under section 408 of the FFDCA 
focuses on potential harms to human health and does not permit 
consideration of effects on the environment.
    One additional comment was received that did not specifically 
address the cyprodinil action, but that raised concerns about the 
toxicity of pesticides and requested that no tolerance be established. 
The Agency understands the commenter's 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 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. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework. EPA has found 
that there is a reasonable certainty of no harm to humans after 
considering the toxicological studies and the exposure levels of humans 
to cyprodinil.

D. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA has determined 
that the proposed tolerance in or on pomegranate at 7.0 ppm should be 
established at 10 ppm. This tolerance level was determined by the 
Organization for Economic Cooperation and Development tolerance 
calculation procedures. Additionally, the Agency is establishing a 
tolerance in or on artichoke, globe, rather than the petitioned-for 
commodity artichoke in order to provide the correct commodity 
definition.

 V. Conclusion

    Therefore, tolerances are established for residues of cyprodinil, 
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on acerola at 
1.5 ppm; artichoke, globe at 4.0 ppm; feijoa at 1.5 ppm; fruit, stone, 
group 12-12 at 2.0 ppm; guava at 1.5 ppm; jaboticaba at 1.5 ppm; 
passionfruit at 1.5 ppm; pomegranate at 10 ppm; starfruit at 1.5 ppm; 
and wax jambu at 1.5 ppm. Additionally, this action removes the 
tolerance established in or on fruit, stone, group 12 at 2.0 ppm as 
that crop group tolerance is superseded by the tolerance being 
established in this action for crop group 12-12.

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 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 13, 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.  180.532, remove the entry, ``Fruit, stone, group 12'' and 
alphabetically add the following commodities to the table in paragraph 
(a) to read as follows:

[[Page 54248]]

Sec.  180.532  Cyprodinil; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................         1.5
 
                                * * * * *
Artichoke, globe............................................         4.0
 
                                * * * * *
Feijoa......................................................         1.5
 
                                * * * * *
Fruit, stone, group 12-12...................................         2.0
 
                                * * * * *
Guava.......................................................         1.5
 
                                * * * * *
Jaboticaba..................................................         1.5
 
                                * * * * *
Passionfruit................................................         1.5
 
                                * * * * *
Pomegranate.................................................          10
 
                                * * * * *
Starfruit...................................................         1.5
 
                                * * * * *
Wax jambu...................................................         1.5
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-22031 Filed 9-8-15; 8:45 am]
 BILLING CODE 6560-50-P