Document ID: EPA-HQ-OPP-2011-0394-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Cyprodinil
Posted Date: 2012-08-17T04:00Z

[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Rules and Regulations]
[Pages 49732-49738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20235]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0394; FRL-9359-7]

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 which are identified and 
discussed later in this document, associated with Pesticide Petition 
(PP) 1E7854, and establishes a tolerance in or on leaf petioles 
subgroup 4B, associated with PP 1E7869. Interregional Research Project 
Number 4 (IR-4) and Syngenta Crop Protection requested the tolerances 
associated with PP 1E7854 and 1E7869, respectively, under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 17, 2012. Objections and 
requests for hearings must be received on or before October 16, 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-2011-0394, 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

[[Page 49733]]

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).

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-2011-0394 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 16, 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-2011-0394, 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 Tolerance

    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 PP 1E7854 by IR-4, 500 College 
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 
40 CFR 180.532 be amended by establishing tolerances for residues of 
the fungicide cyprodinil, 4-cyclopropyl-6-methyl-N-phenyl-2-
pyrimidinamine, in or on onion, bulb, subgroup 3-07A at 0.6 parts per 
million (ppm); onion, green, subgroup 3-07B at 4.0 ppm; caneberry 
subgroup 13-07A at 10.0 ppm; bushberry subgroup 13-07B at 3.0 ppm; 
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 
2.0 ppm; berry, low growing, subgroup 13-07G, except cranberry at 5.0 
ppm; dragon fruit at 2.0 ppm; fruit, pome, group 11-10 at 1.7 ppm; 
vegetable, fruiting, group 8-10 at 1.3 ppm; and leafy greens subgroup 
4A at 40 ppm.
    Upon approval of the aforementioned tolerances, the petition 
additionally requested amendment of 40 CFR 180.532 by removing the 
established tolerances for the residues of cyprodinil in or on onion, 
bulb at 0.60 ppm; onion, green at 4.0 ppm; caneberry subgroup 13A at 10 
ppm; bushberry subgroup 13B at 3.0 ppm; Juneberry at 3.0 ppm; 
lingonberry at 3.0 ppm; salal at 3.0 ppm; grape at 2.0 ppm; strawberry 
at 5.0 ppm; fruit, pome at 1.7 ppm; tomatillo at 0.45 ppm; tomato at 
0.45 ppm; and leafy greens subgroup 4A, except spinach at 30 ppm. The 
published notice of the petition referenced a summary of the petition 
prepared on behalf of IR-4 by Syngenta Crop Protection, Inc., the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to 
this notice of filing.
    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. 
346a(d)(3), announcing the filing of PP 1E7869 by Syngenta Crop 
Protection, P.O. Box 18300, Greensboro, NC 27409. The petition 
requested that 40 CFR 180.532 be amended by establishing tolerances for 
residues of the fungicide cyprodinil in or on leafy petioles subgroup 
4B at 30 parts per million. That notice referenced a summary of the 
petition prepared by Syngenta Crop Protection, Inc., 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 the 
comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petitions, EPA has 
revised the proposed tolerance levels for several commodities. 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 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

[[Page 49734]]

subgroups of consumers, including infants and children.
    Cyprodinil has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. Cyprodinil is mildly irritating to the 
eyes and negligibly irritating to the skin. It is a dermal sensitizer. 
The major target organs of cyprodinil are the liver in both rats and 
mice and the kidney in rats. Liver effects observed consistently in 
subchronic and chronic studies in rats and mice included increased 
liver weights and increases in serum clinical chemistry parameters 
associated with adverse effects on liver function, hepatocyte 
hypertrophy, and hepatocellular necrosis. Adverse kidney effects 
included tubular lesions and inflammation following subchronic exposure 
of male rats. The hematopoietic system also appeared to be a target of 
cyprodinil, causing mild anemia following subchronic exposure to 
cyprodinil in rats. Chronic effects in dogs were limited to decreased 
body weight gain, decreased food consumption and decreased food 
efficiency.
    Fetal toxicity reported in developmental toxicity studies in the 
rat included significantly lower fetal weights and an increased 
incidence of delayed ossification in the rat and showed a slight 
increase in litters showing extra ribs in the rabbit. In a rat 2-
generation reproduction study, significantly lower pup weights were 
observed in F1 and F2 offspring. However, each of 
these fetal and neonatal effects occurred at the same dose levels at 
which maternal toxicity (decreased body weight gain) was observed, and 
the effects were considered to be secondary to maternal toxicity.
    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, 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 3 to 4. The subchronic 
neurotoxicity study in rats, showed no treatment-related effects 
related to neurotoxicity. An immunotoxicity study in mice resulted in 
no apparent suppression of the humoral component of the immune system. 
There was no evidence of carcinogenic potential in either the rat 
chronic toxicity/carcinogenicity or mouse carcinogenicity studies.
    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: Expansions of Existing 
Crop Group/Representative Commodity Uses to Numerous Crop Subgroups, 
Adding Use on Leafy Petiole Subgroup 4B, and Adding Use on the 
Remaining Crops in Fruiting Vegetables Group 8-10.'' pp 34-38 in docket 
ID number EPA-HQ-OPP-2011-0394.''

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 (LOC) 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 (U/SF) 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 shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Cyprodinil for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk  assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary All populations)...  NOAEL = 200 mg/kg/    Acute RfD = 2.0 mg/  Acute Neurotoxicity--Rat LOAEL =
                                    day.                  kg/day.              600 mg/kg/day based on clinical
                                   UFA = 10x...........  aPAD = 2.0 mg/kg/     signs of toxicity (hunched
                                   UFH = 10x...........   day.                 posture, piloerection, and
                                   FQPA SF = 1x........                        reduced responsiveness to sensory
                                                                               stimuli, reduced motor activity
                                                                               and hypothermia).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 2.7 mg/kg/    Chronic RfD = 0.027  2-Year Chronic Toxicity/
                                    day.                  mg/kg/day.           Carcinogenicity--rat LOAEL = 35.6
                                   UFA = 10x...........  cPAD = 0.027 mg/kg/   mg/kg/day based on degenerative
                                   UFH = 10x...........   day.                 liver lesions (spongiosis
                                   FQPA SF = 1x........                        hepatitis) in males.
----------------------------------------------------------------------------------------------------------------

[[Page 49735]]

 
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 1,000  28-Day Feeding/Range-Finding--Rat
 days).                             study NOAEL= 62 mg/                        LOAEL = 299 mg/kg/day based on
                                    kg/day (inhalation                         decreased body-weight gain,
                                    absorption rate =                          increased cholesterol and
                                    100%).                                     phospholipid levels,
                                   UFA = 10x...........                        microcytosis, and hepatocyte
                                   UFH = 10x...........                        hypertrophy.
                                   FQPA SF = 10x.......
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                     Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
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 cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR 
180.532.
    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) 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 Dietary Exposure Evaluation Model (DEEMTM 
(ver. 7.81)) default processing factors.
    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; average field trial residues for 
pome fruit, head lettuce, leaf lettuce, and grapes; and 100 PCT 
estimates. DEEMTM (ver. 7.81) default and empirical 
processing factors for tomato paste/puree (1x) and lemon/lime juice 
(1x) were 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 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 Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cyprodinil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyprodinil. 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 
cyprodinil for surface water are expected to be 34.79 parts per billion 
(ppb) for acute exposures and 24.65 ppb for chronic exposures. The 
EDWCs of cyprodinil for ground water are expected to be 0.0861 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 34.79 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 24.65 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). 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 residential handlers are expected from application to 
ornamental landscapes. Dermal exposures were not assessed, since there 
is no dermal POD. Residential handler exposure scenarios are considered 
to be short-term only, due to the infrequent use patterns associated 
with homeowner products. Postapplication exposures are not expected. 
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

[[Page 49736]]

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 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 cyprodinil toxicity 
database is adequate to evaluate potential increased susceptibility of 
infants and children, and includes developmental toxicity studies in 
rats and rabbits and a 2-generation reproduction study in rats. 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/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 inhalation data, 
EPA is relying on an oral study for estimating risk from inhalation 
exposures. EPA evaluation of use of oral studies to extrapolate an 
inhalation endpoint has shown that such extrapolation may understate 
risk. Accordingly, to address the uncertainty caused by extrapolating 
an inhalation endpoint from an oral study for cyprodinil, EPA has 
concluded that the 10X FQPA SF should be retained for risk assessments 
involving inhalation exposure.
    ii. In the subchronic neurotoxicity study in rats, there was no 
indication that cyprodinil is a neurotoxic chemical. 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 3 to 4. Based on this evidence, there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. In the prenatal developmental toxicity studies in rats and 
rabbits and the 2-generation reproduction study in rats, toxicity to 
the fetuses and/or offspring, when observed, occurred at the same doses 
at which effects were observed in maternal/parental animals. 
Additionally, the skeletal anomalies/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 
2-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food exposure assessment was performed 
based on 100 PCT and tolerance-level residues. The chronic dietary food 
exposure assessment was partially refined, assuming average field trial 
residues and empirical processing factors for some commodities, and 
tolerance level residues and DEEM\TM\ (ver. 7.81) default for the 
remaining commodities. 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 
aPAD and 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 
cyprodinil will occupy 8.2% of the aPAD for children 1-2 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 75% 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 
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

[[Page 49737]]

short-term residential exposure to adults, 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 9,000. 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 method 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 cyprodinil in or on several 
commodities that are not harmonized with the tolerances being 
established in the United States, as follows: Codex MRL on eggplant at 
0.2 ppm, pepper at 0.5 ppm, and tomato at 0.5 ppm and U.S. tolerance on 
vegetable, fruiting, group 8-10 at 1.5 ppm; Codex MRL on onion, bulb at 
0.3 ppm and U. S. tolerance on onion, bulb, subgroup 3-07A at 0.6 ppm; 
Codex MRL on black and red raspberry at 0.5 ppm and U.S. tolerance on 
caneberry subgroup 13-07A at 10 ppm; Codex MRL on head and leaf lettuce 
at 10 ppm and U. S. tolerance on leafy greens subgroup 4A at 50 ppm; 
and Codex MRLs on apple at 0.05 ppm and pear at 1 ppm and U. S. 
tolerance on fruit, pome, group 11-10 at 1.7 ppm. The United States 
tolerance recommendations cannot be harmonized with the Codex MRLs 
established for cyprodinil because the residue data supporting the 
tolerance necessitate a higher value.
    Additionally, Codex has an established MRL on grape at 3 ppm and 
dried grapes at 5 ppm. The EPA is establishing the tolerance for fruit, 
small vine climbing, except fuzzy kiwifruit, subgroup 13-07F (for which 
grape is the representative commodity) at 3 ppm and grape, raisin at 5 
ppm in order to harmonize with the Codex MRLs. Codex has not 
established MRLs on the other commodities associated with these 
petitions.

C. Response to Comments

    One comment was received to the Notice of Filing for PP 1E7869, 
which requested additional information about the nature of the residue 
and the adverse effects noted from exposure to cyprodinil. Specific 
information on the nature of the residue, including physical and 
chemical characteristics, as well as the adverse effects caused by 
cyprodinil 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-2011-0394.

D. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petitions, EPA has revised the 
proposed tolerance on vegetable, fruiting, group 8-10 from 1.3 ppm to 
1.5 ppm; and leafy greens subgroup 4A from 40 ppm to 50 ppm. The Agency 
revised these tolerance levels based on analysis of the residue field 
trial data using the Organization for Economic Co-operation and 
Development (OECD) tolerance calculation procedures.
    Additionally, the Agency revised the proposed tolerance in or on 
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F 
from 2.0 ppm to 3.0 ppm in order to harmonize with the established 
Codex MRL on grape at 3 ppm. The Agency has also revised the 
established tolerance in or on grape, raisin from 3.0 ppm to 5.0 ppm in 
order to align with the Codex MRL on dried grapes at 5 ppm.
    EPA determined that the established tolerance on tomato, paste at 
1.0 ppm should be removed, as it will be superseded by the tolerance in 
or on fruiting vegetable group 8-10 tolerance at 1.5 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of cyprodinil, 
4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine, in or on onion, 
bulb, subgroup 3-07A at 0.6 ppm; onion, green, subgroup 3-07B at 4.0 
ppm; caneberry subgroup 13-07A at 10 ppm; bushberry subgroup 13-07B at 
3.0 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 
13-07F at 3.0 ppm; grape, raisin at 5.0 ppm; berry, low growing, 
subgroup 13-07G, except cranberry at 5.0 ppm; vegetable, fruiting, 
group 8-10 at 1.5 ppm; leafy greens subgroup 4A at 50 ppm; fruit, pome, 
group 11-10 at 1.7 ppm; dragon fruit at 2.0 ppm; and leaf petioles 
subgroup 4B at 30 ppm. Additionally, the established tolerance on 
citrus, oil is amended from 340 ppm to 60 ppm. Finally, this regulation 
removes tolerances of cyprodinil in or on onion, bulb at 0.60 ppm; 
onion, green at 4.0 ppm; caneberry subgroup 13A at 10 ppm; bushberry 
subgroup 13B at 3.0 ppm; grape at 2.0 ppm; strawberry at 5.0 ppm; 
tomato at 0.45 ppm; Juneberry at 3.0 ppm;

[[Page 49738]]

lingonberry at 3.0 ppm; salal at 3.0 ppm; tomatillo at 0.45 ppm; fruit, 
pome at 1.7 ppm; leafy greens subgroup 4A, except spinach at 30 ppm; 
and tomato, paste at 1.0 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 10, 2012.
Daniel J. Rosenblatt,
Acting 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, the table in paragraph (a)(1) is revised to read 
as follows:

Sec.  180.532  Cyprodinil; tolerances for residues.

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

------------------------------------------------------------------------
                                                                 Parts
                          Commodity                               per
                                                                million
------------------------------------------------------------------------
Almond.......................................................       0.02
Almond, hulls................................................       8.0
Apple, wet pomace............................................       4.6
Avocado......................................................       1.2
Bean, dry....................................................       0.6
Bean, succulent..............................................       0.6
Berry, low growing, subgroup 13-07G, except cranberry........       5.0
Brassica, head and stem, subgroup 5A.........................       1.0
Brassica, leafy greens, subgroup 5B..........................      10.0
Bushberry subgroup 13-07B....................................       3.0
Caneberry subgroup 13-07A....................................      10
Canistel.....................................................       1.2
Canola, seed \1\.............................................       0.03
Citrus, dried pulp...........................................       8.0
Citrus, oil..................................................      60
Dragon fruit.................................................       2.0
Fruit, pome, group 11-10.....................................       1.7
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        3.0
 13-07F......................................................
Fruit, stone, group 12.......................................       2.0
Grape, raisin................................................       5.0
Herb subgroup 19A, dried, except parsley.....................      15.0
Herb subgroup 19A, fresh, except parsley.....................       3.0
Kiwifruit....................................................       1.8
Leaf petioles subgroup 4B....................................      30
Leafy greens subgroup 4A.....................................      50
Lemon........................................................       0.60
Lime.........................................................       0.60
Longan.......................................................       2.0
Lychee.......................................................       2.0
Mango........................................................       1.2
Onion, bulb, subgroup 3-07A..................................       0.6
Onion, green, subgroup 3-07B.................................       4.0
Papaya.......................................................       1.2
Parsley, dried leaves........................................     170
Parsley, leaves..............................................      35
Pistachio....................................................       0.10
Pulasan......................................................       2.0
Rambutan.....................................................       2.0
Sapodilla....................................................       1.2
Sapote, black................................................       1.2
Sapote, mamey................................................       1.2
Spanish lime.................................................       2.0
Star apple...................................................       1.2
Turnip, greens...............................................      10.0
Vegetable, cucurbit, group 9.................................       0.70
Vegetable, fruiting, group 8-10..............................       1.5
Vegetable, leaves of root and tuber, group 2.................      10
Vegetable, root, except sugarbeet, subgroup 1B...............       0.75
Watercress...................................................      20
------------------------------------------------------------------------
\1\ Import only.

* * * * *
[FR Doc. 2012-20235 Filed 8-16-12; 8:45 am]
BILLING CODE 6560-50-P