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has harmonized the residue level with 

established Codex MRLs on cherry and 

peach, but notes that it is not possible 

to harmonize the tolerance expression at 

this time as the Codex MRL includes 

parent only. Additionally, it is not 

possible to harmonize with the codex 

MRL for plums as the established Codex 

MRL of 0.2 ppm is too low to cover 

residues that could result from the use 

of hexythiazox in the U.S. 

V. Conclusion 

Therefore, the tolerance for residues 

of hexythiazox, in or on plum, prune, 

dried is revised from 0.4 ppm to 1.3 

ppm; and the tolerance for fruit, stone, 

group 12, except plum is revised to read 

fruit, stone, group 12. The established 

tolerances for plum and for plum, 

prune, fresh can be removed as these 

commodities are addressed by the stone 

fruit group tolerance. 

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 

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. 

■ 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. In § 180.448, the table in paragraph 

(a) is amended as follows: 

i. Remove the entry for plum at 0.10 

ppm and for plum, prune, fresh at 0.10 

ppm; 

ii. Revise the entry for Fruit, stone, 

group 12, except plum; and 

iii. Revise the entry for plum, prune, 

dried. 

The revisions read as follows: 

§ 180.448 Hexythiazox; tolerances for 

residues. 

Commodity Parts per million 

* * * * * 

Fruit, stone, group 12 ..... 1.0 

* * * * * 

Plum, prune, dried .......... 1.3 

* * * * * 

* * * * * 

[FR Doc. 2010–17034 Filed 7–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

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 http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 


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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 Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://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: 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. 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)-1Himidazole-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, http:// 

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, 


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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-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 

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 http:// 

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

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk 

Assessment Study and Toxicological Effects 

Acute dietary (General population 

including infants and children) 

No adverse effects were observed which could be attributed to a single dose exposure for the general 

population. 

Acute dietary (Females 13–49 

years of age) 

NOAEL = 100 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 1.0 mg/kg/day 

aPAD = 1.0 mg/kg/day 

Rat Prenatal Developmental Toxicity Study 

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 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.948 mg/ 

kg/day 

cPAD = 0.948 mg/kg/day 

18-Month Mouse Oral Carcinogenicity Study 

LOAEL = 985 mg/kg/day based on increased skin lesions. 

Incidental oral, short-term 

(1 to 30 days) and intermediateterm (1-6 months) 

NOAEL= 30 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day Rat Oral Toxicity Study 

LOAEL = 295 mg/kg/day based on increased 

number of basophilic tubules of the kidneys, increased urinary volume, pH, and 

protein. 

Dermal, short-term (1 to 30 days) 

and intermediate-term (1-6 

months) 

For Children: No toxicity was found at 1,000 mg/kg/day in a 28–day dermal toxicity study; therefore, in 

the absence of hazard identified for this population, a dermal risk assessment is not necessary. 


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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CYAZOFAMID FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk 

Assessment Study and Toxicological Effects 

For Adults: Dermal (or 

oral) study 

NOAEL = 100 mg/kg/day 

(dermal absorption rate 

= 37 %) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Rat Prenatal Developmental Toxicity Study 

LOAEL = 1,000 mg/kg/day based on developmental toxicity findings of increased incidence of 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 

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 

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 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 intermediateterm 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 http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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. Shortterm, intermediate-term and chronicterm 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 


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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 intermediateterm 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 intermediateterm 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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 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)-1Himidazole-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 


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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Rules and Regulations 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. 

■ 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 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: 

§ 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)-1Himidazole-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)-1Himidazole-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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0231; FRL–8834–4] 

Castor Oil, Ethoxylated, Oleate; 

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 castor oil, 

ethoxylated, oleate (CAS Reg. No. 

220037–02–5) with a minimum number 

average molecular weight (in amu) of 

1,600 when used as an inert ingredient 

in a pesticide chemical formulation 

under 40 CFR 180.960. SciReg. Inc. on 

behalf of Rhodia, Inc, 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 castor oil, ethoxylated, 

oleate on food or feed commodities. 

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–2010–0231. 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 


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