[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Rules and Regulations]
[Pages 32448-32453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15945]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0731; FRL-8423-5]


Cyazofamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of cyazofamid and its metabolite, CCIM, expressed as cyazofamid in or 
on fruiting vegetable group 8 and okra. Additionally, it establishes a 
tolerance with regional restrictions in or on grape. Finally, this 
regulation removes the established grape import and tomato tolerances, 
as a regional tolerance on grape and fruiting vegetable group tolerance 
replaces them, respectively. 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 8, 2009. Objections and 
requests for hearings must be received on or before September 8, 2009, 
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-2008-0731. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, 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 http://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: <a href="/cdn-cgi/l/email-protection#4d23222121282363212c383f2c0d283d2c632a223b"><span class="__cf_email__" data-cfemail="c2acadaeaea7acecaea3b7b0a382a7b2a3eca5adb4">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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

[[Page 32449]]

identify docket ID number EPA-HQ-OPP-2008-0731 in the subject line on 
the first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk as required by 40 CFR 
part 178 on or before September 8, 2009.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0731, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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. Petition for Tolerance

    In the Federal Register of December 3, 2008 (73 FR 73644) (FRL-
8386-9), 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 
8E7427) 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 combined 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 fruiting vegetable group 8 and okra at 0.80 parts per million 
(ppm); and be further amended by establishing a tolerance with regional 
restrictions in or on grape at 1.5 ppm. Since data were submitted that 
only supports the use of cyazofamid on grapes grown east of the Rocky 
Mountains, the proposed tolerance for grape will be restricted to a 
regional tolerance under paragraph (c) of Sec.  180.601. This petition 
additionally requested the removal of the currently established grape 
import and tomato tolerances. That notice referenced a summary of the 
petition prepared on behalf of IR-4 by ISK Biosciences Corporation, the 
registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified some of the proposed tolerances. The reason for these changes 
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 the petitioned-for 
tolerances for combined residues of cyazofamid and its metabolite CCIM, 
expressed as cyazofamid, on fruiting vegetable, group 8 and okra at 
0.40 ppm and grape at 1.5 ppm. EPA's assessment of exposures and risks 
associated with establishing tolerances 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 cyazofamid exhibited 
mild or low toxicity with the kidney being the primary target organ. 
Kidney effects included an increased number of ``basophilic kidney 
tubules'' and mild increases in urinary volume, pH, and protein. No 
adverse kidney effects or any other toxicity findings were noted in 
chronic toxicity studies in rats. Similarly, the overall toxicity 
profile in dogs is unremarkable. In both the 13 week and 1-year dog 
studies, there were no major toxicity findings up to a dose of 1,000 
milligrams/kilograms/day (mg/kg/day). The only possible effect was 
increased cysts in parathyroids and the pituitary (females only) 
observed in the high-dose groups of the 1-year study.
    Skin lesions, which may be due to systemic allergy, were observed 
in the males of the 18 month mouse carcinogenicity study. At the high 
dose, approaching 1,000 mg/kg/day, male mice suffered hair loss due to 
scratching, which was confirmed at necropsy by increased incidence of 
body sores (head, neck, trunk, limb, and/or tail) and was correlated 
histologically with an increased incidence of acanthosis (hyperplasia), 
chronic active dermatitis, ulceration, and premature death. The 
sulfonamide moiety in the cyanoimidazole ring might have rendered 
cyazofamid an allergen, albeit a weak one. This is supported by the 
findings that cyazofamid is a moderate irritant in the primary rabbit 
skin test and is a positive weak sensitizer in the guinea pig skin 
maximization test. There were no skin allergies in the rat feeding 
study, which may be due possible species variation.
    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 reproduction 
study in rats. There was some evidence of increased susceptibility 
following in utero exposure of rats in the prenatal developmental 
toxicity study. At the highest dose tested (HDT) (1,000 mg/kg/day), 
developmental effects (increased incidence of bent ribs) were observed 
in the absence of maternal toxicity.
    There were no indications of treatment-related adverse 
neurotoxicity

[[Page 32450]]

findings. In the acute neurotoxicity study, there were no clinical 
signs indicating potential neurotoxic effects, no qualitative or 
quantitative neurobehavioral effects, no changes in brain weight, and 
no evidence of gross or microscopic pathology. There was no evidence of 
neurotoxicity in other available studies for cyazofamid as well.
    There was no evidence of carcinogenicity in the rat and 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 document Cyazofamid. Human Health Risk 
Assessment for Proposed Uses on Fruiting Vegetables and Okra, Grapes 
East of the Rocky Mountains, Vegetable Greenhouse Transplants, and 
Commercial Application on Residential Turf and Residential Ornamentals, 
pages 47-52 in docket ID number EPA-HQ-OPP-2008-0731.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in 
document Cyazofamid. Human Health Risk Assessment for Proposed Uses on 
Fruiting Vegetables and Okra, Grapes East of the Rocky Mountains, 
Vegetable Greenhouse Transplants, and Commercial Application on 
Residential Turf and Residential Ornamentals, pages 15-16 in docket ID 
number EPA-HQ-OPP-2008-0731.

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 13-49 years old, 
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, Dietary Exposure Evaulation Model 
(DEEM) default processing factors and 100 percent crop treated (PCT) 
for all existing and new uses of cyazofamid.
    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, DEEM default processing factors, and 100 PCT for all 
commodities.
    iii. Cancer. Based on the absence of significant tumor increases in 
two adequate rodent carcinogenicity studies, EPA has classified 
cyazofamid as ``not likely to be carcinogenic to humans;'' therefore, a 
quantitative exposure assessment to evaluate 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. 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 http://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

[[Page 32451]]

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 professionally 
managed turf areas, such as golf courses and college/professional 
sports fields and proposed for use on residential lawns and 
ornamentals. For the registered uses, short- and intermediate-term 
postapplication dermal exposure was previously assessed for adult and 
young golfers and adult athletes, and is not of concern to the EPA. 
Because it is unlikely for an individual to experience a co-occurrence 
of activities within a single day, the two scenarios of golfing or 
using recreational fields were not aggregated with the proposed 
residential lawn postapplication scenario.
    For the proposed use of cyazofamid on residential lawns and 
ornamentals, application by homeowners to residential turf is 
prohibited. Therefore, non-occupational (i.e., residential) handler 
exposure for residential lawns and ornamentals is not expected and was 
not assessed. A turf transferrable residue (TTR) study, which was 
submitted for use in assessing postapplication activities, was useful 
in determining residue dissipation. Short- and intermediate-term 
postapplication exposure is possible for adults and children in contact 
with residential lawns and ornamentals after application of cyazofamid. 
EPA determined there is no significant incidental oral exposure for 
adults; therefore, only dermal exposure from contact with treated turf 
and ornamentals was appropriate to analyze for short- and intermediate-
term risk for adults. 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. For children, postapplication exposure to treated 
residential turf was estimated for hand-to-mouth activity, object-to-
mouth activity, and soil ingestion. No point of departure was 
identified for dermal exposures to treated turf for children, since no 
toxicity was seen in the 28-day dermal toxicity study at the HDT (1,000 
mg/kg/day); therefore, dermal exposure scenarios for children were not 
assessed. The estimated exposure is believed to be a reasonable high-
end estimate based on observations from chemical-specific studies and 
professional judgment.
    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 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 of 1996 (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 reproduction toxicity 
study in rats. The toxicology data for cyazofamid provides no 
indication of increased susceptibility, as compared to adults, of 
rabbit fetuses to in utero exposure in a developmental study or of rats 
in the 2-generation reproduction study. There is evidence of increased 
quantitative susceptibility following in utero exposure to rats in the 
prenatal developmental study; an increased incidence of bent ribs in 
fetuses at the HDT was noted in the absence of maternal effects. 
However, the Agency determined that concern is low because:
    i. The developmental effect is well identified with clear NOAEL/
LOAEL.
    ii. The developmental effect (increased bent ribs) is a reversible 
variation rather than a malformation.
    iii. The developmental effect is seen only at the limit dose of 
1,000 mg/kg/day.
    iv. This endpoint is used to establish the acute reference dose for 
females 13-49.
    v. The overall toxicity profile indicates that cyazofamid is not a 
very toxic compound.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if 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. 40 CFR part 158 
makes immunotoxicity testing (OPPTS Guideline 870.7800) and subchronic 
neurotoxicity testing (OPPTS 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 
testing will result in a NOAEL lower than the regulatory dose for risk 
assessment. Consequently, EPA believes the existing data are sufficient 
for endpoint selection for exposure/risk assessment scenarios and for 
evaluation of the requirements under FQPA, and an additional database 
UF 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 in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. Although there is evidence of increased quantitative 
susceptibility in the prenatal developmental study in rats, the Agency 
did not identify any residual uncertainties after establishing toxicity

[[Page 32452]]

endpoints and traditional UFs to be used in the risk assessment of 
cyazofamid. 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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 
cyazofamid will occupy <1% of the aPAD for females 13-49 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 from food and water will utilize 1% 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- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Cyazofamid is currently 
proposed for uses that could result in short- 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- and intermediate-term residential 
exposure to cyazofamid.
    Using the exposure assumptions described in this unit for short- 
and intermediate-term exposures, EPA has concluded the combined short- 
and intermediate-term food, water, and residential exposures (treated 
residential turf and ornamentals) aggregated result in aggregate MOEs 
of 1,100 for the general U.S. population and 1,400 for children 1-2 
years old. As the aggregate MOEs are greater than 100 for the general 
U.S. population and children 1-2 years old, short- and intermediate-
term aggregate exposure to cyazofamid is not of concern to EPA.
    4. Aggregate cancer risk for U.S. population. As discussed in unit 
III.C.1.iii, EPA has classified cyazofamid as ``not likely to be 
carcinogenic to humans,'' and it 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

    Adequate analytical methodology is available to enforce the 
tolerances. Cyazofamid and the metabolite CCIM are completely recovered 
(>80% recovery) using the Food and Drug Administration's Multi-Residue 
Protocol D (without cleanup). In addition, an acceptable HPLC/UV method 
(high performance liquid chromatography method using an ultra violet 
detector) 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; e-mail address: 
<a href="/cdn-cgi/l/email-protection#2f5d4a5c464b5a4a424a5b47404b5c6f4a5f4e01484059"><span class="__cf_email__" data-cfemail="146671677d7061717971607c7b7067547164753a737b62">[email protected]</span></a>.

B. International Residue Limits

    There are currently no maximum residues limits (MRLs) established 
by Codex or Mexico for cyazofamid. A Canadian MRL has been established 
for residues of cyazofamid and CCIM at 0.20 ppm for tomatoes. The 
currently established U.S. MRL for tomato (0.20 ppm) will be replaced 
by inclusion in fruiting vegetable group 8 (0.40 ppm). At this time, 
the U.S. fruiting vegetable group tolerance cannot be harmonized with 
the Canadian tomato MRL because field trial data supporting the group 
tolerance are higher than 0.20 ppm.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerances on ``vegetable, fruiting, group 
8'' and ``okra'' should be decreased from 0.80 ppm to 0.40 ppm. EPA 
revised these tolerance levels based on analysis of the residue field 
trial data using the Agency's Tolerance Spreadsheet in accordance with 
the Agency's Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
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 vegetable, fruiting, group 8 at 0.40 ppm; and okra at 0.40 ppm. 
Additionally, a tolerance with regional restrictions is established in 
or on grape at 1.5 ppm. Finally, this regulation removes the 
established grape import and tomato tolerances, as a regional tolerance 
on grape and fruiting vegetable group tolerance replaces them, 
respectively.

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

[[Page 32453]]

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 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: June 26, 2009.
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 as follows:
    i. By removing the commodities ``Grape, wine,* import'' and 
``Tomato'' and the footnote in the table in paragraph (a).
    ii. By alphabetically adding the following commodities to the table 
in paragraph (a) and by revising paragraph (c) to read as follows:


Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Okra.......................................................         0.40
                                * * * * *
Vegetable, fruiting, group 8...............................         0.40
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations are established for the combined residues of 
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 the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grape......................................................          1.5
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-15945 Filed 7-7-09; 8:45 am]
BILLING CODE 6560-50-S


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