32448 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. The table in paragraph (a)(1) of 

§ 180.518 is amended by removing the 

commodities ‘‘Fruit, citrus, group 10 

postharvest’’ and ‘‘Fruit, stone, group 

12, except cherry’’ and alphabetically 

adding the following commodities to 

read as follows: 

§ 180.518 Pyrimethanil; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

*****

Fruit, citrus, group 10, except 

lemon, postharvest ................ 10 

*****

Fruit, stone, group 12 ............... 10 

*****

Lemon, preharvest and 

postharvest ............................ 11 

*****

* * * * * 

[FR Doc. E9–15942 Filed 7–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

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: 

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 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 


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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: 

• Federal eRulemaking Portal: http:// 

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. 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)-1Himidazole-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 § 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 


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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-observedadverse-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 


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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 nonoccupational, 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. Shortand 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 handto-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 


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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 intermediateterm 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; email address: residuemethods@epa.gov. 

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)-1Himidazole-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 


sroberts on DSKD5P82C1PROD with RULES
Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 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: 

§ 180.601 Cyazofamid; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

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)-1Himidazole-2-carbonitrile, expressed as 

cyazofamid, in or on the following 

commodities: 

Commodity Parts per 

million 

Grape ........................................ 1.5 

* * * * * 

[FR Doc. E9–15945 Filed 7–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0256; FRL–8422–3] 

2-Propenoic acid, 2-methyl-, polymers 

with Bu acrylate, Et acrylate, Me 

methacrylate and polyethylene glycol 

methacrylate C16-18-alkyl ethers; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 2-propenoic 

acid, 2-methyl-, polymers with Bu 

acrylate, Et acrylate, Me methacrylate 

and polyethylene glycol methacrylate 

C16-18-alkyl ethers; when used as an 

inert ingredient in a pesticide chemical 

formulation. BASF Corporation, 100 

Campus Drive, Florham Park, NJ 07932 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of 2-propenoic acid, 2- 

methyl-, polymers with Bu acrylate, Et 

acrylate, Me methacrylate and 

polyethylene glycol methacrylate C16-18- 

alkyl ethers on food or feed 

commodities. 

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–2009–0256. 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 


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