Cyazofamid; Pesticide Tolerances, 40745-40751 [2010-17025]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 134 (Wednesday, July 14, 2010)]
[Rules and Regulations]
[Pages 40745-40751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17025]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0801; FRL-8833-1]


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 Brassica, head and stem, subgroup 5A; Brassica, 
leafy greens, subgroup 5B; turnip, greens; spinach; and hop, dried 
cones. Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 14, 2010. Objections and 
requests for hearings must be received on or before September 13, 2010, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0801. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available,

[[Page 40746]]

e.g., Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP 
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The Docket Facility telephone number is (703) 305-5805.

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; e-mail address: nollen.laura@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr.

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-2009-0801 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 
September 13, 2010. 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-2009-0801, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of January 6, 2010 (75 FR 864) (FRL-8801-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7615) by IR-4, 500 College Road East, Suite 201 W., 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, expressed as cyazofamid, in or on Brassica, 
head and stem, subgroup 5A at 1.2 parts per million (ppm); Brassica, 
leafy greens, subgroup 5B at 12.0 ppm; turnip, greens at 12.0 ppm; 
spinach at 9.0 ppm; and hops at 10.0 ppm. 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, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    EPA has revised the tolerance expression for all established 
commodities to be consistent with current Agency policy. The reason for 
this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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,

[[Page 40747]]

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. 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 highest dose tested (HDT).
    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 HDT; developmental effects, including an 
increased incidence of bent ribs, were observed in the absence of 
maternal toxicity.
    There was no evidence of neurotoxicity 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 https://www.regulations.gov in document: ``Cyazofamid. Human Health Risk 
Assessment for Proposed Uses on Brassica (Cole) Leafy Vegetables Crop 
Group 5, Turnip Greens, Spinach, and Hops,'' pp 34-38 in docket ID 
number EPA-HQ-OPP-2009-0801.

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
     A summary of the toxicological endpoints for cyazofamid used for 
human risk assessment is shown in the following Table.

  Table 1.--Summary of Toxicological Doses and Endpoints for cyazofamid for Use in Human Health Risk Assessment
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                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population        No adverse effects were observed which could be attributed to a single
 including infants and children)                        dose exposure for the general population.
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of  NOAEL = 100 mg/kg/day    Acute RfD = 1.0 mg/kg/   Rat Prenatal
 age)                                  UFA = 10x..............   day                      Developmental Toxicity
                                       UFH = 10x..............  aPAD = 1.0 mg/kg/day...   Study
                                       FQPA SF = 1x...........                           LOAEL = 1,000 mg/kg/day
                                                                                          based on developmental
                                                                                          toxicity findings of
                                                                                          increased incidence of
                                                                                          bent ribs.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 94.8 mg/kg/day    Chronic RfD = 0.948 mg/  18-Month Mouse Oral
                                       UFA = 10x..............   kg/day                   Carcinogenicity Study
                                       UFH = 10x..............  cPAD = 0.948 mg/kg/day.   LOAEL = 985 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                          skin lesions.
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Incidental oral, short-term            NOAEL= 30 mg/kg/day      LOC for MOE = 100        90-day Rat Oral
(1 to 30 days) and intermediate-term   UFA = 10x..............                            Toxicity Study
 (1-6 months).                         UFH = 10x..............                           LOAEL = 295 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                          number of basophilic
                                                                                          tubules of the
                                                                                          kidneys, increased
                                                                                          urinary volume, pH,
                                                                                          and protein.
----------------------------------------------------------------------------------------------------------------
Dermal, short-term (1 to 30 days) and  For Children: No toxicity was found at 1,000 mg/kg/day in a 28-day dermal
 intermediate-term (1-6 months)          toxicity study; therefore, in the absence of hazard identified for this
                                                 population, a dermal risk assessment is not necessary.
----------------------------------------------------------------------------------------------------------------

[[Page 40748]]

 
                                       For Adults: Dermal (or   LOC for MOE = 100        Rat Prenatal
                                        oral) study                                       Developmental Toxicity
                                       NOAEL = 100 mg/kg/day                              Study
                                        (dermal absorption                               LOAEL = 1,000 mg/kg/day
                                        rate = 37 %).                                     based on developmental
                                       UFA = 10x..............                            toxicity findings of
                                       UFH = 10x..............                            increased incidence of
                                       FQPA SF = 1x...........                            bent ribs.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

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, Dietary Exposure 
Evaluation Model (DEEM) 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, DEEM 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 purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and 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. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cyazofamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyazofamid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    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. 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 non-cancer 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 residential turf and 
ornamentals and on professionally managed turf areas, such as golf 
courses and college/professional sports fields. For the use of 
cyazofamid on professionally managed turf areas, short-term and 
intermediate-term postapplication dermal exposure was assessed for 
adult and youth golfers and adult athletes. However, because it is 
unlikely for an individual to experience a co-occurrence of activities 
within a single day, the scenarios of golfing and/or using recreational 
fields were not aggregated with the residential turf and ornamental 
scenarios.
    For the use of cyazofamid on residential turf and ornamentals, 
application by homeowners is

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prohibited; therefore, residential handler exposure is not expected and 
was not assessed. However, short-term and intermediate-term 
postapplication exposure is possible for adults and children. Adults 
were assessed for short-term and intermediate-term postapplication 
dermal exposure from contact with treated turf and ornamentals. The 
adult population of concern for dermal risk assessment is females of 
childbearing age (13+), based on the developmental toxicity findings of 
increased incidence of bent ribs; thus, the estimated risk for this 
population is protective of all adult population subgroups. Children 
were assessed for short-term and intermediate-term postapplication 
incidental oral exposure to treated residential turf and ornamentals, 
including hand-to-mouth activity, object-to-mouth activity, and soil 
ingestion. No POD was identified for dermal exposures to treated turf 
or ornamentals for children, since no toxicity was seen in the 28-day 
dermal toxicity study at the HDT (1,000 mg/kg/day); therefore, dermal 
postapplication exposure scenarios for children were not assessed.
    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 website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The 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 reproductive 
toxicity 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 HDT 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 make immunotoxicity testing (OSCPP Harmonized Guideline 
870.7800) and subchronic neurotoxicity testing (OSCPP Harmonized 
Guideline 158.500) required 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 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 UFs to account for neurotoxicity.
    iii. There is no evidence that cyazofamid results in increased 
susceptibility in rabbits in the prenatal developmental study or in 
young rats in the 2-generation reproductive toxicity study. Although 
there is evidence of increased quantitative susceptibility in the 
prenatal developmental study in rats, the Agency determined that 
concern is low because:
    a. The developmental effect (increased bent ribs) is well 
identified with a clear NOAEL and LOAEL.
    b. Increased bent ribs are considered a reversible variation rather 
than a malformation.
    c. The effect was noted only at the limit dose of 1,000 mg/kg/day.
    d. This endpoint was used to establish the acute reference dose 
(aRfD) for females 13-49.
    e. 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-term, intermediate-term 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 cyazofamid will occupy 1.2% of the aPAD for females 13 to 49 years 
old, the population group of concern for acute effects. Cyazofamid is 
not expected to pose an acute risk to the general population, including 
infants and children.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyazofamid

[[Page 40750]]

from food and water will utilize 1.2% of the cPAD for infants less than 
1 year 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 and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-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 and 
intermediate-term postapplication residential exposure to adults and 
children. The Agency has determined that it is appropriate to aggregate 
chronic exposure through food and water with short-term and 
intermediate-term residential exposure to cyazofamid.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined 
short-term and intermediate-term food, water, and residential exposures 
(treated residential turf and ornamentals) aggregated result in MOEs of 
1,000 for the general U.S. population, 1,400 for children 3 to 5 years 
old, and 1,500 for children 6 to 12 years old. As the MOEs are greater 
than 100 for all population subgroups, short-term and intermediate-term 
aggregate exposure to cyazofamid is not of concern.
    4. 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.
    5. 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 FDA's 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. These 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; 
e-mail 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 U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
     There are currently no Codex or Canadian MRLs established for 
residues of cyazofamid in or on commodities associated with this 
petition.

C. Revisions to Petitioned-For Tolerances

    The EPA has revised the tolerance expression to clarify: 1. That, 
as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of cyazofamid not specifically mentioned; 2. 
That compliance with the specified tolerance levels is to be determined 
by measuring only the specific compounds mentioned in the tolerance 
expression.

V. Conclusion

    Therefore, tolerances are established for residues of cyazofamid, 
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-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 Brassica, head and stem, subgroup 5A at 1.2 
ppm; Brassica, leafy greens, subgroup 5B at 12.0 ppm; turnip, greens at 
12.0 ppm; spinach at 9.0 ppm; and hop, dried cones at 10.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 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

[[Page 40751]]

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: July 1, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. Section 180.601 is amended by:
    i. Revising the introductory text and alphabetically adding the 
following commodities to the table in paragraph (a):
    ii. Revising the introductory text in paragraph (c) to read as 
follows:


Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide cyazofamid, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only the sum of 4-chloro-2-cyano-N,N-dimethyl-5-(4-
methylphenyl)-1H-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 the following 
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.................                1.2
------------------------------------------------------------------------
Brassica, leafy greens, subgroup 5B..................               12.0
------------------------------------------------------------------------
 
                              * * * * * * *
Hop dried cones......................................               10.0
------------------------------------------------------------------------
 
                              * * * * * * *
Spinach..............................................                9.0
------------------------------------------------------------------------
Turnip, greens.......................................               12.0
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for residues of the fungicide 
cyazofamid, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only the sum of 4-chloro-2-cyano-N,N-dimethyl-5-(4-
methylphenyl)-1H-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 the following 
commodities:
* * * * *
[FR Doc. 2010-17025 Filed 7-13-10; 8:45 am]
BILLING CODE 6560-50-S