[Federal Register Volume 77, Number 187 (Wednesday, September 26, 2012)]
[Rules and Regulations]
[Pages 59114-59120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23355]



[[Page 59114]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0906; FRL-9361-8]


Cyazofamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyazofamid in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally removes 
several established tolerances that are superseded by tolerances 
established by this regulation. Interregional Research Project Number 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 26, 2012 Objections and 
requests for hearings must be received on or before November 26, 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-2011-0906, 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), EPA West 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: 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: [email protected].

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
Office of Chemical Safety and Pollution Prevention (OCSPP) test 
guidelines referenced in this document electronically, please go to 
http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2011-0906 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 26, 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 (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-2011-0906, 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.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 December 8, 2011 (76 FR 76674) (FRL-
9328-8), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E7929) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 
08540. The petition requested that 40 CFR 180.601 be amended by 
establishing tolerances for residues of the fungicide cyazofamid, 4-
chloro-2-cyano-N, N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide, and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile (CA), expressed as cyazofamid, in or on basil, 
dried leaves at 80.0 parts per million (ppm); basil, fresh leaves at 
30.0 ppm; bean, succulent at 0.4 ppm; bean, succulent, shelled at 0.07 
ppm; leafy greens, subgroup 4A at 9.0 ppm; vegetable, fruiting, group 
8-10 at 0.40 ppm; and vegetable, tuberous and corm, subgroup 1C at 0.02 
ppm. Additionally, the notice requested that EPA remove the tolerances 
in 40 CFR 180.601 for residues of the fungicide cyazofamid and its 
metabolite CCIM, expressed as cyazofamid, in or on okra at 0.40 ppm; 
potato at 0.02 ppm; spinach at 9.0 ppm; and vegetable, fruiting, group 
8 at 0.40 ppm, as they will be superseded by inclusion in crop group or 
subgroup tolerances. That notice referenced a summary of the petition 
prepared on behalf of IR-4 by ISK Biosciences, 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 levels for several commodities. The 
Agency has also determined that the time-limited tolerance on basil, 
fresh should be

[[Page 59115]]

removed. 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 cyazofamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with cyazofamid 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.
    Cyazofamid has a low order of acute toxicity via the oral, dermal, 
and inhalation routes of exposure. It produces minimal but reversible 
eye irritation, is a slight dermal irritant, and is a weak dermal 
sensitizer. In subchronic toxicity studies in rats, the kidney appeared 
to be the primary target organ, with kidney effects including an 
increased number of basophilic kidney tubules and mild increases in 
urinary volume, pH, and protein. However, no adverse kidney effects 
were noted in chronic toxicity studies in rats. There were no toxicity 
findings up to the limit dose in a subchronic toxicity study in dogs; 
in the chronic dog toxicity study, increased cysts in parathyroids were 
observed in males at the limit dose for chronic toxicity testing.
    There were no maternal or developmental effects observed in the 
prenatal developmental toxicity study in rabbits and no maternal, 
reproductive, or offspring effects in the 2-generation reproductive 
toxicity study in rats. There was evidence of increased susceptibility 
following in utero exposure of rats in the prenatal developmental 
toxicity study at the highest dose tested; developmental effects, 
including an increased incidence of bent ribs, were observed in the 
absence of maternal toxicity.
    There was no evidence of neurotoxicity or evidence of biologically 
relevant structural effects on the immune system in any study in the 
exposure database for cyazofamid. Skin lesions, which may be due to a 
systemic allergy, were observed in male mice in a carcinogenicity 
study. There was no evidence of carcinogenicity in the rat or mouse 
carcinogenicity studies and no evidence that cyazofamid is mutagenic in 
several in vivo and in vitro studies. Based on the results of these 
studies, EPA has classified cyazofamid as ``not likely to be 
carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by cyazofamid 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, ``Cyazofamid. Human Health Risk 
Assessment for Proposed New Uses on Leafy Greens (Crop Subgroup 4A), 
Succulent-Podded and Succulent-Shelled Beans, Basil, Tuberous and Corm 
Vegetables (Subgroup 1C), and Fruiting Vegetables (Crop Group 8-10) 
with Updated Residential Risk Estimates of All Existing Residential 
Uses'' at pp. 32-36 in docket ID number EPA-HQ-OPP-2011-0906.

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 cyazofamid used for 
human risk assessment is shown in Table 1 of this unit. EPA notes that 
the last final rule for cyazofamid, published in the Federal Register 
of July 14, 2010 (75 FR 40745) (FRL-8833-1), included endpoints and 
points of departure for intermediate-term residential scenarios, 
including postapplication incidental oral exposure for children and 
dermal exposures for adults. However, the Agency has reevaluated these 
scenarios and has determined that residential exposure to turf and 
ornamentals is not likely to occur over an intermediate-term duration 
(i.e., 1 month to 6 months) for cyazofamid. Additionally, the Agency 
notes that the last final rule did not include an assessment of adult 
residential handler exposures. While the label for cyazofamid includes 
a statement that application by homeowners to residential turf is 
prohibited, it does not identify the product as a restricted use; 
therefore, a residential handler exposure assessment for short-term 
dermal and inhalation exposures was performed to be protective of 
potential residential handler exposures.

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  Table 1--Summary of Toxicological Doses and Endpoints for Cyazofamid 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 (General population     An appropriate endpoint for a single exposure was not identified for the
 including infants and children).                                general population.
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 100 mg/kg/    Acute RfD = 1.0 mg/  Rat Prenatal Developmental
 years of age).                     day.                  kg/day.              Toxicity Study. LOAEL = 1,000 mg/
                                   UFA = 10x...........  aPAD = 1.0 mg/kg/     kg/day based on developmental
                                   UFH = 10x...........   day.                 toxicity findings of increased
                                   FQPA SF = 1x........                        incidence of bent ribs.
Chronic dietary (All populations)  NOAEL= 94.8 mg/kg/    Chronic RfD = 0.948  18-Month Mouse Oral
                                    day.                  mg/kg/day.           Carcinogenicity Study. LOAEL =
                                   UFA = 10x...........  cPAD = 0.948 mg/kg/   985 mg/kg/day based on increased
                                   UFH = 10x...........   day.                 skin lesions.
                                   FQPA SF = 1x........
Incidental oral, short-term (1 to  NOAEL= 30 mg/kg/day.  LOC for MOE = 100..  90-Day Rat Oral Toxicity Study.
 30 days).                         UFA = 10x...........                        LOAEL = 295 mg/kg/day based on
                                   UFH = 10x...........                        increased number of basophilic
                                   FQPA SF = 1x........                        tubules of the kidneys, increased
                                                                               urinary volume, pH, and protein.
                                                                               This toxicity endpoint is also
                                                                               supported by the results of a 28-
                                                                               Day Oral Dose Range-Finding Study
                                                                               in rats. In this study, at 370 mg/
                                                                               kg/day or above increased
                                                                               incidence of basophilic tubules
                                                                               in the kidneys was found.
----------------------------------------------------------------------------------------------------------------
Dermal, short-term (1 to 30 days)  For children: No toxicity was found at 1,000 mg/kg/day in a 28-Day Dermal
                                    Toxicity Study; therefore, in the absence of hazard identified for this
                                    population, a dermal risk assessment is not necessary.
----------------------------------------------------------------------------------------------------------------
                                   For adults: Dermal    LOC for MOE = 100..  Rat Prenatal Developmental
                                    (or oral) study                            Toxicity Study. LOAEL = 1,000 mg/
                                    NOAEL = 100 mg/kg/                         kg/day based on developmental
                                    day (dermal                                toxicity findings of increased
                                    absorption rate =                          incidence of bent ribs.
                                    37%).
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
Inhalation, short-term (1 to 30    Inhalation (or oral)  LOC for MOE = 100..  Rat Prenatal Developmental
 days).                             study NOAEL= 100 mg/                       Toxicity Study. LOAEL = 1,000 mg/
                                    kg/day.                                    kg/day based on developmental
                                   UFA = 10x...........                        toxicity findings of increased
                                   UFH = 10x...........                        incidence of bent ribs.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Not likely to be carcinogenic to humans'' based on the
                                    absence of significant tumor increases in two adequate rodent
                                    carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
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 cyazofamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyazofamid tolerances in 40 CFR 
180.601. EPA assessed dietary exposures from cyazofamid 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. EPA identified such an 
effect (increased incidence of bent ribs in the rat prenatal 
developmental toxicity study) for the population subgroup females 13 to 
49 years old; however, no such effect was identified for the general 
population, including infants and children.
    In estimating acute dietary exposure for females 13 to 49 years 
old, EPA used food consumption information from the United States 
Department of Agriculture (USDA) 1994 to 1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA assumed tolerance-level residues, DEEMTM 
ver. 7.81 default processing factors and 100 percent crop treated (PCT) 
for all existing and proposed commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994 to 
1996 and 1998 CSFII. As to residue levels in food, EPA assumed 
tolerance-level residues, DEEMTM ver. 7.81 default 
processing factors and 100 PCT for all existing and proposed 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cyazofamid does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the

[[Page 59117]]

purpose of assessing cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for cyazofamid. Tolerance level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. Available environmental 
fate studies suggest cyazofamid is not very mobile and quickly degrades 
into a number of degradation products under different environmental 
conditions. Among the three major degradates for cyazofamid (CCIM, 
CCIM-AM, and CTCA), the two terminal degradates are CCIM and CTCA. The 
highest estimated drinking water concentrations resulted from modeling 
which assumed application of 100% molar conversion of the parent into 
the terminal degradate CTCA. EPA used these estimates of CTCA in its 
dietary exposure assessments, a conservative approach that likely 
overestimates the exposure contribution from drinking water.
    The Agency used screening level water exposure models in the 
dietary exposure analysis and risk assessment for cyazofamid and its 
degradates in drinking water. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
cyazofamid and its degradates. 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) model for surface water and the Screening 
Concentration in Ground Water (SCI-GROW) model for ground water, the 
estimated drinking water concentrations (EDWCs) of CTCA for acute 
exposures are estimated to be 136 parts per billion (ppb) for surface 
water and 2.18 ppb for ground water. Chronic exposures for noncancer 
assessments are estimated to be 133 ppb for surface water and 2.18 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 136 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 133 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).
    Cyazofamid is currently registered for use on turf at golf courses, 
sod farms, seed farms, college and professional sports fields, 
residential and commercial lawns, and on ornamental plants in 
landscapes and those grown in commercial greenhouses and nurseries. EPA 
assessed residential exposure using the following assumptions: For 
adult handlers, short-term dermal and inhalation exposures from mixing, 
loading, and applying cyazofamid in residential areas; for adults, 
short-term postapplication dermal exposure from contact with treated 
turf and ornamentals; and for children, short-term postapplication 
incidental oral exposure to treated turf, including hand-to-mouth 
activity, object-to-mouth activity, and soil ingestion. No POD was 
identified for dermal exposures to treated turf for children, since no 
toxicity was seen in the 28-day dermal toxicity study at the highest 
dose tested (1,000 milligrams/kilograms/day (mg/kg/day)); therefore, 
dermal postapplication exposure scenarios were not assessed for 
children. Based on the residential use profile, adult handler and adult 
and child postapplication exposures to cyazofamid are expected to be 
short-term only. Further information regarding EPA standard assumptions 
and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found cyazofamid to share a common mechanism of 
toxicity with any other substances, and cyazofamid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyazofamid 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 Food Quality 
Protection Act Safety Factor (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 prenatal and postnatal 
toxicology database for cyazofamid includes rat and rabbit 
developmental toxicity studies and a 2-generation reproductive toxicity 
study in rats. There was no indication of increased susceptibility, as 
compared to adults, of rabbit fetuses to in utero exposure in a 
developmental study or of rat pups in the 2-generation reproduction 
study. There is evidence of increased quantitative susceptibility 
following in utero exposure of rats to cyazofamid in the prenatal 
developmental study; an increased incidence of bent ribs in fetuses at 
the highest dose tested was noted in the absence of maternal effects.
    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 cyazofamid is complete except for 
immunotoxicity and subchronic neurotoxicity testing. Recent changes to 
40 CFR part 158 imposed new data requirements for immunotoxicity 
testing (OCSPP Test Guideline 870.7800) and subchronic neurotoxicity 
testing (OCSPP Test Guideline 870.6200) for pesticide registration. 
However, the available data for cyazofamid do not show potential for 
immunotoxicity. Further, there is no evidence of neurotoxicity in any 
study in the toxicity database for cyazofamid. EPA does not believe 
that conducting neurotoxicity and immunotoxicity studies will result in 
a NOAEL lower than the regulatory dose for risk assessment. 
Consequently, the EPA believes the existing data are sufficient for 
endpoint selection for exposure/risk assessment scenarios and for 
evaluation

[[Page 59118]]

of the requirements under the FQPA, and an additional database 
uncertainty factor does not need to be applied.
    ii. There is no indication that cyazofamid is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. Although there is evidence of increased quantitative 
susceptibility in the prenatal developmental study in rats, the Agency 
determined that concern is low because the developmental effect 
(increased bent ribs) is well identified with a clear NOAEL and LOAEL. 
In addition, other considerations indicating a low concern include the 
following: Increased bent ribs are considered a reversible variation 
rather than a malformation; the effect was noted only at the limit dose 
of 1,000 mg/kg/day and this endpoint was used to establish the RfD for 
females 13-49; and the overall toxicity profile indicates that 
cyazofamid is not a very toxic compound. Therefore, there are no 
residual concerns regarding developmental effects in the young.
    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 cyazofamid in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by cyazofamid.

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, 
cyazofamid is not expected to pose an acute risk. Using the exposure 
assumptions discussed in this unit for acute exposure, the acute 
dietary exposure from food and water to cyazofamid will occupy 2.5% of 
the aPAD for females 13 to 49 years old, the population group of 
concern for acute effects.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyazofamid from food and water will utilize 1.5% 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 
cyazofamid 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). Cyazofamid 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 cyazofamid.
    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 2,200 for 
children 1-2 years old and 390 for adults. Because EPA's level of 
concern for cyazofamid 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, 
cyazofamid 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 
cyazofamid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyazofamid 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 cyazofamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical methodology is available to enforce the 
proposed tolerances. Cyazofamid and the metabolite CCIM are completely 
recovered (>80% recovery) using the Food and Drug Administration's 
(FDA) Multi-Residue Protocol D (without cleanup). In addition, a high 
performance liquid chromatography/ultraviolet detector (HPLC/UV) method 
is available for use as a single analyte confirmatory method.
    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: 
[email protected].

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 not 
established a MRL for cyazofamid.

C. Response to Comments

    EPA received comments from a private citizen to the notice of 
filing for cyazofamid, PP 1E7929, objecting to the 
establishment of tolerances associated with the petition. In addition, 
the commenter noted several adverse effects seen in animal toxicology 
studies

[[Page 59119]]

for cyazofamid and claims because of these effects no tolerance should 
be approved.
    EPA has found, however, that there is a reasonable certainty of no 
harm to humans after considering these toxicological studies and the 
exposure levels of humans to cyazofamid. The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
certain pesticide chemicals should not be permitted in our food. 
However, the existing legal framework provided by FFDCA section 408 
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.

D. Revisions to Petitioned-for Tolerances

    Based on the data supporting the petition, EPA revised the proposed 
tolerances on several commodities, as follows: Basil, dried leaves from 
80 ppm to 90 ppm; bean, succulent from 0.4 ppm to 0.5 ppm; bean, 
succulent shelled from 0.07 ppm to 0.08 ppm; leafy greens subgroup 4A 
from 9.0 ppm to 10 ppm; and vegetable, fruiting, group 8-10 from 0.40 
ppm to 0.9 ppm. The Agency revised these tolerance levels based on 
analysis of the residue field trial data using the Organization for 
Economic Cooperation and Development (OECD) tolerance calculation 
procedures. Additionally, the Agency has determined that the time-
limited tolerance on basil, fresh at 12 ppm should be removed, as it 
will be superseded by the permanent tolerance on basil, fresh leaves.

 V. Conclusion

    Therefore, tolerances are established for residues of cyazofamid, 
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1 H-imidazole-1-
sulfonamide, and its metabolite, 4-chloro-5-(4-methylphenyl)-1H -
imidazole-2-carbonitrile, calculated as the stoichiometric equivalent 
of cyazofamid, in or on basil, dried leaves at 90 ppm; basil, fresh 
leaves at 30 ppm; bean, succulent at 0.5 ppm; bean, succulent shelled 
at 0.08 ppm; leafy greens subgroup 4A at 10 ppm; vegetable, fruiting, 
group 8-10 at 0.9 ppm; and vegetable, tuberous and corm, subgroup 1C at 
0.02 ppm. This regulation additionally removes the established 
permanent tolerances on okra, potato, spinach, and fruiting vegetable 
group 8, and the time-limited tolerance on basil, fresh because these 
tolerances are superseded by new crop group or subgroup tolerances 
established by this action.

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) (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 of 1995 (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: September 12, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.601:
0
a. Remove the commodities ``Okra'', ``Potato'', ``Spinach'', and 
``Vegetable, fruiting, group 8'' from the table in paragraph (a).
0
b. Add alphabetically the following commodities to the table in 
paragraph (a).
0
c. Remove the commodity ``Basil, fresh'' from the table in paragraph 
(b).
    The additions read as follows:


Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Basil, dried leaves.......................................         90
Basil, fresh leaves.......................................         30
Bean, succulent...........................................          0.5

[[Page 59120]]

 
Bean, succulent shelled...................................          0.08
 
                                * * * * *
Leafy greens subgroup 4A..................................         10
 
                                * * * * *
Vegetable, fruiting, group 8-10...........................          0.9
Vegetable, tuberous and corm, subgroup 1C.................          0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-23355 Filed 9-25-12; 8:45 am]
BILLING CODE 6560-50-P