Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 5691 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 24, 2011. 

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 the table to § 180.910 add 

alphabetically a new inert ingredient to 

read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Isobutane (CAS Reg. No. 75–28–5) ....................................................................... None ...................... Propellant. 

* * * * * * * 

■ 3. In the table to § 180.930, add 

alphabetically a new inert ingredient to 

read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Isobutane (CAS Reg. No. 75–28–5) ....................................................................... None ...................... Propellant. 

* * * * * * * 

[FR Doc. 2011–2265 Filed 2–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0385; FRL–8860–3] 

Cyprodinil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of cyprodinil in 

or on fruit, pome, group 11 and apple 

wet pomace. This regulation also 

establishes tolerances for meat 

byproducts of cattle, goats, horses and 

sheep. Syngenta Crop Protection 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 2, 2011. Objections and 

requests for hearings must be received 

on or before April 4, 2011, 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–2010–0385. 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: Lisa 

Jones, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9424; e-mail address: 

jones.lisa@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. 


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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–2010–0385 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 April 4, 2011. 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–2010–0385, 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 

Tolerance 

In the Federal Register of June 8, 2010 

(75 FR 32466) (FRL–8827–5), 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 0F7696) by 

Syngenta Crop Protection, P.O. Box 

18300, Greensboro, NC 27409. The 

petition requested that 40 CFR 180.532 

be amended by raising tolerances for 

residues of the fungicide cyprodinil, in 

or on fruit, pome, group 11 from 0.1 

parts per million (ppm) to 1.7 ppm. That 

notice referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, the registrant, which is 

available 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 

increased the tolerance for apple, wet 

pomace from 0.15 ppm to 4.6 ppm. EPA 

has also established tolerances for meat 

byproducts of cattle, goats, horses, and 

sheep at 0.02 ppm. 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 cyprodinil 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with cyprodinil 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. 

Cyprodinil has low acute toxicity via 

the oral, dermal, and inhalation routes. 

Cyprodinil is mildly irritating to the 

eyes and negligibly irritating to the skin. 

It is a dermal sensitizer. The major 

target organs of cyprodinil are the liver 

in both rats and mice and the kidney in 

rats. Liver effects observed consistently 

in subchronic and chronic studies in 

rats and mice include increased liver 

weights, increases in serum clinical 

chemistry parameters associated with 

adverse effects on liver function, 

hepatocyte hypertrophy, and 

hepatocellular necrosis. Adverse kidney 

effects include tubular lesions and 

inflammation following subchronic 

exposure of male rats. The 

hematopoietic system also appeared to 

be a target of cyprodinil, causing mild 

anemia in rats exposed subchronically. 

Chronic effects in dogs were limited to 

decreased body-weight gain, decreased 

food consumption and decreased food 

efficiency. There was no evidence of 

increased susceptibility in the 

developmental rat or rabbit study 

following in utero exposure or in the 2- 

generation reproduction study following 

prenatal or postnatal exposure. There 

was no evidence of neuropathological or 

other neurological effects in the 

available subchronic neurotoxicity 

study. The results of a preliminary 

immunotoxicity study provided no 

evidence for immunotoxicity. There was 

no evidence of carcinogenic potential in 

either the rat chronic toxicity/ 

carcinogenicity or mouse 

carcinogenicity studies. 

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 (LOC) 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 


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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 cyprodinil used for 

human risk assessment is discussed in 

Unit III.A of the final rule published in 

the Federal Register of April 28, 2010 

(75 FR 22242) (FRL–8818–8). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to cyprodinil, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

cyprodinil tolerances in 40 CFR 

180.532. EPA assessed dietary 

exposures from cyprodinil 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. Such effects were identified 

for cyprodinil. In estimating acute 

dietary exposure, EPA used the Dietary 

Exposure Evaluation Model–Food 

Consumption Intake Database (DEEM– 

FCIDTM, Version 2.03), which uses food 

consumption data from the U. S. 

Department of Agriculture (USDA) 

Continuing Surveys of Food Intakes by 

Individuals (CSFII) from 1994–1996 and 

1998. As to residue levels in food, EPA 

performed a screening level acute 

dietary exposure analysis for the 

population subgroup females 13 to 49 

only. No acute endpoint was identified 

for the remaining population subgroups. 

Tolerance level residues and 100 

percent crop treated (PCT) assumptions 

were used. DEEM default and empirical 

processing factors were used to modify 

the tolerance values. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the DEEM– 

FCIDTM, Version 2.03, which uses food 

consumption data from the USDA 1994– 

1996 and 1998 CSFII. A moderately 

refined chronic dietary exposure 

analysis was performed for the general 

U.S. population and various population 

subgroups. Average field trial residues 

for pome fruit, tolerance level residues 

for the remaining commodities, and 100 

PCT assumptions were used. DEEM 

default and empirical processing factors 

were used. 

iii. Cancer. EPA determines whether 

quantitative cancer exposure and risk 

assessments are appropriate for a fooduse pesticide based on the weight of the 

evidence from cancer studies and other 

relevant data. If quantitative cancer risk 

assessment is appropriate, cancer risk 

may be quantified using a linear or nonlinear approach. If sufficient 

information on the carcinogenic mode 

of action is available, a threshold or 

non-linear approach is used and a 

cancer RfD is calculated based on an 

earlier non-cancer key event. If 

carcinogenic mode of action data are not 

available, or if the mode of action data 

determine a mutagenic mode of action, 

a default linear cancer slope factor 

approach is utilized. Data summarized 

in Table 2 of the document ‘‘Human 

Health Risk—Cyprodinil Increased 

Pome Fruit Tolerance’’, pp. 24 through 

29, in docket ID number EPA–HQ–OPP– 

2010–0385 at http:// 

www.regulations.gov, showed no 

evidence of carcinogenic potential in 

either the rat chronic toxicity/ 

carcinogenicity or mouse 

carcinogenicity studies. EPA therefore 

concluded that cyprodinil 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 percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cyprodinil in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of cyprodinil. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of 

cyprodinil for acute exposures are 34.79 

parts per billion (ppb) for surface water 

and 0.0861 ppb for ground water and for 

chronic exposures for non-cancer 

assessments are estimated to be 24.65 

ppb for surface water and 0.0861 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 34.79 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration 

value of 24.65 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). 

Cyprodinil is not registered for any 

specific use patterns that would result 

in residential exposure. 

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 cyprodinil to share 

a common mechanism of toxicity with 

any other substances, and cyprodinil 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cyprodinil does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 


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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 database is considered adequate for 

selection of study endpoints and 

determination of a dose/response to 

characterize the potential prenatal or 

postnatal toxicity of cyprodinil to 

infants and children. No increase in 

susceptibility was seen in 

developmental toxicity studies in rat 

and rabbit or reproductive toxicity 

studies in the rat. Toxicity to offspring 

was observed at dose levels the same or 

greater than those causing maternal or 

parental toxicity. Based on the results of 

developmental and reproductive 

toxicity studies, there is not a concern 

for increased qualitative and/or 

quantitative susceptibility following in 

utero exposure to cyprodinil. 

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 toxicology database for 

cyprodinil is largely complete, missing 

only the recently-required acute 

neurotoxicity study and the functional 

immunotoxicity study. EPA has 

determined that an additional 

uncertainty factor is not needed to 

account for the lack of these studies for 

the following reasons: 

The functional immunotoxicity study 

for cyprodinil is not expected to alter 

the RfD. A preliminary immunotoxicity 

study was submitted. The study did not 

meet all requirements, but is considered 

Upgradeable/Guideline. The registrant 

must either submit a required Natural 

Killer cell activity assay or provide 

justification that it is not needed. 

Otherwise, the results of the preliminary 

study provided no evidence of 

immunotoxicity. Specifically, there 

were no treatment-related effects on 

absolute, adjusted, or relative spleen or 

thymus weights; no effects on specific 

activity or total activity of splenic IgM 

antibody-forming cells to the T celldependent antigen sRBC. There is no 

evidence in the other existing studies 

that cyprodinil targets the immune 

system. No other immunotoxicity 

studies have been submitted. 

The acute neurotoxicity study is not 

expected to alter the RfD for cyprodinil 

because the available data show no 

evidence of neurotoxic potential for 

cyprodinil. The NOAEL from an acute 

study is unlikely to be appreciably 

lower than the NOAEL of 600 mg/kg/ 

day from the subchronic neurotoxicity 

study. Neurotoxicity was not observed 

in subchronic neurotoxicity study or the 

prenatal developmental toxicity studies 

in rats and rabbits. 

ii. A developmental neurotoxicity 

study is not required. As noted, the 

available data show no evidence of 

neurotoxic potential for cyprodinil. 

iii. There is no evidence that 

cyprodinil 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. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary food exposure 

assessments were performed based on 

100 PCT and tolerance-level residues. 

The chronic dietary food exposure 

assessments were performed based on 

average field trial residues for pome 

fruit, tolerance level residues for the 

remaining commodities, and 100 PCT 

assumptions. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to cyprodinil in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by cyprodinil. 

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 population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-, intermediate-, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

cyprodinil will occupy 4% of the aPAD 

for females 13 to 49 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to cyprodinil 

from food and water will utilize 86% of 

the cPAD for children 1 to 2 years old 

the population group receiving the 

greatest exposure. 

3. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

cyprodinil is not expected to pose a 

cancer risk to humans. 

4. 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 cyprodinil 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate High Performance Liquid 

Chromatography, using ultra-violet 

detection (HPLC/UV) methods with 

column switching (Syngenta Methods 

AG–631 and AG–631B) are available for 

enforcing tolerances of cyprodinil on 

plant commodities. The level of 

quantitation (LOQs) for these methods 

range from 0.01 to 0.05 ppm depending 

on the plant commodities. Method AG– 

631B also contains procedures for 

confirmatory analysis by gas 

chromatography with nitrogen 

phosphorus detection (GC/NPD). 

An adequate HPLC/mass spectrometry 

method (GRM010.01A) is also available 

for enforcing tolerances in livestock 

commodities. This method determines 

residues of both parent and the 

metabolite CGA–304075 (free and 

conjugated), expressed as parent. The 

LOQ is 0.01 ppm for each analyte for a 

combined LOQ of 0.02 ppm. 

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 

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 


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Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 5695 

(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. 

The Codex has established MRLs for 

residues of cyprodinil in/on apple (0.05 

mg/kg, the LOQ) and pear (1 mg/kg). 

There is also a currently established 

Canadian MRL for residues of 

cyprodinil in/on pome fruit (0.1 ppm); 

but none is established in Mexico. It is 

not possible to harmonize with Codex 

and Canadian MRLs for residues of 

cyprodinil in/on pome fruit 

commodities because the proposed use 

in the United States results in residue 

levels greater than the Codex and 

Canadian MRLs due to the shorter 

preharvest interval in the United States. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the submitted apple field 

trial and available apple processing 

data, the currently established tolerance 

for residues of cyprodinil in apple wet 

pomace will need to be increased from 

0.15 ppm to 4.6 ppm to cover the 

proposed amended uses of cyprodinil 

on pome fruit. Additionally, the Agency 

has determined the currently 

established 0.02 ppm tolerance level for 

meat byproducts of cattle, goats, horses, 

and sheep are adequate but the 

currently established tolerance 

expression for livestock commodities 

should be changed to reflect 

measurements of both parent and 

metabolite CGA–304075. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cyprodinil, in or on pome 

fruit at 1.7 ppm and in apple wet 

pomace at 4.6 ppm. Tolerances are also 

established for cyprodinil and (free and 

conjugated) CGA–304075, expressed in 

parent equivalents on meat byproducts 

of cattle, goats, horses, and sheep at 0.02 

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) (Pub. L. 

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: January 24, 2011. 

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 180.532 is amended by 

revising paragraph (a) to read: 

§ 180.532 Cyprodinil; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

cyprodinil, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only cyprodinil 4- 

cyclopropyl-6-methyl-N-phenyl-2- 

pyrimidinamine. 

Commodity Parts per 

million 

Almond ...................................... 0 .02 

Almond, hulls ............................ 8 .0 

Apple, wet pomace ................... 4 .6 

Avocado .................................... 1 .2 

Bean, dry .................................. 0 .6 

Bean, succulent ........................ 0 .6 

Brassica, head and stem, subgroup 5A ............................... 1 .0 

Brassica, leafy greens, subgroup 5B ............................... 10 .0 


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5696 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 

Commodity Parts per 

million 

Bushberry subgroup 13B .......... 3 .0 

Caneberry subgroup 13A ......... 10 

Canistel ..................................... 1 .2 

Canola, seed 1 .......................... 0 .03 

Citrus, dried pulp ...................... 8 .0 

Citrus, oil ................................... 340 

Fruit, pome ............................... 1 .7 

Fruit, stone ................................ 2 .0 

Grape ........................................ 2 .0 

Grape, raisin ............................. 3 .0 

Herb subgroup 19A, dried, except parsley ........................... 15 .0 

Herb subgroup 19A, fresh, except parsley ........................... 3 .0 

Juneberry .................................. 3 .0 

Kiwifruit ..................................... 1 .8 

Leafy greens subgroup 4A, except spinach 35 ..................... 30 

Lemon ....................................... 0 .60 

Lime .......................................... 0 .60 

Lingonberry ............................... 3 .0 

Longan ...................................... 2 .0 

Lychee ...................................... 2 .0 

Mango ....................................... 1 .2 

Onion, bulb ............................... 0 .60 

Onion, green ............................. 4 .0 

Papaya ...................................... 1 .2 

Parsley, dried leaves ................ 170 

Parsley, leaves ......................... 35 

Pistachio ................................... 0 .10 

Pulasan ..................................... 2 .0 

Rambutan ................................. 2 .0 

Salal .......................................... 3 .0 

Sapodilla ................................... 1 .2 

Sapote, black ............................ 1 .2 

Sapote, mamey ........................ 1 .2 

Spanish lime ............................. 2 .0 

Star apple ................................. 1 .2 

Strawberry ................................ 5 .0 

Tomatillo ................................... 0 .45 

Tomato ...................................... 0 .45 

Tomato, paste ........................... 1 .0 

Turnip, greens .......................... 10 .0 

Vegetable, cucurbit, group 9 .... 0 .70 

Vegetable, leaves of root and 

tuber, group 2 ....................... 10 

Vegetable, root, except sugarbeet, subgroup 1B 41 ........... 0 .75 

Watercress ................................ 20 

1 Import only. 

(2) Tolerances are established for 

residues of the fungicide cyprodinil, 

including its metabolites and 

degradates, in the commodities in the 

table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of cyprodinil 4-cyclopropyl-6-methyl-Nphenyl-2-pyrimidinamine and free and 

conjugated CGA–304075 4-(4- 

cyclopropyl-6-methyl-pyrimidin-2- 

ylamino)-phenol, calculated as the 

stoichiometric equivalent of cyprodinil. 

Commodity Parts per 

million 

Cattle, meat byproducts ............. 0.02 

Goat, meat byproducts ............... 0.02 

Horse, meat byproducts ............. 0.02 

Commodity Parts per 

million 

Sheep, meat byproducts ............ 0.02 

* * * * * 

[FR Doc. 2011–2157 Filed 2–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0980; FRL–8861–1] 

Fluazifop-P-butyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluazifop-Pbutyl in or on multiple commodities 

which are identified and discussed later 

in this document. Syngenta Crop 

Protection, Inc., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 2, 2011. Objections and 

requests for hearings must be received 

on or before April 4, 2011, 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–2009–0980. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0980 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 


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