50548 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 

Dated: August 18, 2008. 

Fred M. Rosa, Jr., 

Rear Admiral, U.S. Coast Guard Commander, 

Fifth Coast Guard District. 

[FR Doc. E8–19894 Filed 8–26–08; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1069; FRL–8377–8] 

Cyprodinil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyprodinil, 4- 

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

pyrimidinamine, in or on tomato; 

tomatillo; tomato, paste; avocado; 

sapote, black; canistel; sapote, mamey; 

mango; papaya; sapodilla; star apple; 

parsley, leaves; parsley, dried leaves; 

vegetable, leaves of root and tuber, 

group 2; vegetable, root, except 

sugarbeet, subgroup 1B; lemon; lime; 

citrus, dried pulp; citrus, oil; kiwifruit; 

onion, bulb; onion, green; strawberries; 

vegetable, cucurbit, group 9; and meat 

byproducts of cattle, goats, horses and 

sheep. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 27, 2008. Objections and 

requests for hearings must be received 

on or before October 27, 2008, 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–2007–1069. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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: 

Barbara Madden, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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 an electronic 

copy of this Federal Register document 

through the electronic docket 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 pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2007–1069 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 October 27, 2008. 

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–2007–1069, 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’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 January 23, 

2008 (73 FR 3964) (FRL–8345–7), 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 7E7235) by 

Interregional, Research Project Number 

4 (IR–4), 500 College Road East, Suite 

201W, Princeton, NJ 08540. The petition 

requested that 40 CFR 180.532 be 


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Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 50549 

amended by establishing tolerances for 

residues of the fungicide cyprodinil, 4- 

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

pyrimidinamine, in or on the food 

commodities tomato at 0.40 parts per 

million (ppm); tomatillo at 0.40 ppm; 

tomato, paste at 1.0 ppm; avocado at 1.2 

ppm; sapote, black at 1.2 ppm; canistel 

at 1.2 ppm; sapote, mamey at 1.2 ppm; 

mango at 1.2 ppm; papaya at 1.2 ppm; 

sapodilla at 1.2 ppm; star apple at 1.2 

ppm; herbs subgroup19A, fresh at 25 

ppm; herbs subgroup 19A, dried at 170 

ppm; vegetable, root and tuber, group, 

leaves at 9.0 ppm; vegetable, root, 

except sugarbeet subgroup at 0.60 ppm; 

lemon at 0.6 ppm; lime at 0.6 ppm; 

kiwifruit at 1.8 ppm; onion, dry bulb at 

0.50 ppm; onion, green at 1.2 ppm; 

strawberry at 7.0 ppm; and cucurbits at 

0.40 ppm. That notice referenced a 

summary of the petition prepared by IR4, the registrant, which is available to 

the public in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is revising 

some of the items as proposed in this 

Unit. The reason for these changes is 

explained in Unit IV.D. 

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 residues of cyprodinil, 4- 

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

pyrimidinamine on tomato; tomatillo; 

tomato, paste; avocado; sapote, black; 

canistel; sapote, mamey; mango; papaya; 

sapodilla; star apple; parsley, leaves; 

parsley, dried leaves; vegetable, leaves 

of root and tuber, group 2; vegetable, 

root, except sugarbeet, subgroup 1B; 

lemon; lime; citrus, dried pulp; citrus, 

oil; kiwifruit; onion, bulb; onion, green; 

strawberries; vegetable, cucurbit, group 

9; and meat byproducts of cattle, goats, 

horses and sheep. 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. 

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 were consistent among 

male and female rats and mice in both 

subchronic and chronic studies and 

typically included increased liver 

weights along with increases in serum 

clinical chemistry parameters associated 

with adverse effects on liver function 

(i.e., increased cholesterol and 

phospholipid levels). Microscopic 

lesions in rats and mice included 

hepatocyte hypertrophy and 

hepatocellular necrosis. In the kidneys, 

adverse effects were manifested as 

chronic tubular lesions and chronic 

kidney inflamation following 

subchronic exposure of male rats. 

Chronically, cyprodinil caused 

increased kidney weights and 

progressive nephropathy in male rats. 

Chronic effects in dogs were limited to 

decreased body-weight gain, decreased 

food consumption and decreased food 

efficiency. Liver toxicity was not seen in 

the dog. The hematopoietic system also 

appeared to be a target of cyprodinil, 

causing mild anemia in rats exposed 

subchronically. There was no evidence 

of carcinogenic potential in either the 

rat chronic toxicity/carcinogenicity or 

mouse carcinogenicity studies and no 

concern for mutagenicity. 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. No 

clinical signs of toxicity suggestive of 

neurobehavioral alterations nor 

evidence of neuropathological effects 

were observed in the available oraltoxicity studies. There was also no 

evidence of a neurodevelopmental effect 

in the rat or rabbit developmental 

toxicity studies or in the rat 2- 

generation reproductive-toxicity study. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by cyprodinil 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 

Cyprodinil Human Health Risk 

Assessment for the uses in/on tomato, 

avocado, herbs, root vegetables, leaves 

of root and tuber vegetables, lemon, 

lime, cucurbits, kiwifruit, green and dry 

bulb onions, and strawberries, page 16 

in docket ID number EPA–HQ–OPP–

2007–1069. 

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 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 

the LOAEL of concern are identified 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-term, 

intermediate-term, 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). 


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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 cyprodinil used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Cyprodinil Human Health Risk 

Assessment for the uses in/on tomato, 

avocado, herbs, root vegetables, leaves 

of root and tuber vegetables, lemon, 

lime, cucurbits, kiwifruit, green and dry 

bulb onions, and strawberries, page 22 

in docket ID number EPA–HQ–OPP–

2007–1069. 

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. 

In estimating acute dietary exposure, 

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 used tolerance-level 

residues, DEEM default processing 

factors and assumed 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 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance level residues, DEEM 

default processing factors, and assumed 

100 PCT for all existing and proposed 

commodities. 

iii. Cancer An aggregate exposure 

assessment for the purpose of assessing 

cancer risk was not performed because 

cyprodinil has been classified as ‘‘not 

likely to be carcinogenic to humans.’’

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for cyprodinil. Tolerance level residues 

and 100 PCT were assumed for all 

existing and proposed 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 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. 

For surface water the Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS) Tier 

2 aquatic models were used, and for 

ground water, the Tier 1 aquatic model 

Screening Concentration in Ground 

Water (SCI–GROW) was utilized. For 

the assessment, maximum application 

rates and minimum intervals between 

applications were used. The Agency has 

concluded that the transformation 

product CGA–249287 of cyprodinil is of 

potential concern for drinking water 

sources. Therefore, estimated drinking 

water concentrations (EDWCs) of CGA–

249287 were also simulated using the 

PRZM/EXAMS and SCI–GROW models. 

For surface water, this degradate was 

modeled individually, as opposed to the 

use of the total residue approach due to 

the fact that only one degradate was 

modeled and sufficient information was 

available for the modeling. 

Based on the Tier 2 PRZM/EXAMS 

and the Tier 1 SCI–GROW models, the 

EDWCs of cyprodinil and its 

transformation product CGA–249287 for 

acute exposures are estimated to be 

34.56 parts per billion (ppb) for surface 

water and 0.108 ppb for ground water. 

For chronic exposures for non-cancer 

assessments the concentrations are 

estimated to be 20.05 ppb for surface 

water and 0.108 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 34.56 ppb was 

used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 20.05 

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 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 (MOS) 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 MOS 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There are no concerns or residual 

uncertainties for prenatal and/or 

postnatal exposure. 

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 cyprodinil 

is complete. 

ii. There is no indication that 

cyprodinil is a neurotoxic chemical and 


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there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

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. 

EPA made conservative (protective) 

assumptions in the ground water and 

surface water modeling used to assess 

exposure to cyprodinil 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 cyprodinil. 

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. Shortterm, intermediate-term, and chronicterm 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. 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 13–49 years old, the only 

population group of concern. 

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 67% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for cyprodinil. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Cyprodinil is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

short-term aggregate risk is the sum of 

the risk from exposure to cyprodinil 

through food and water and will not be 

greater than the chronic aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Cyprodinil is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to cyprodinil through food and 

water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in mice and 

rats at doses that were judged to be 

adequate to assess the carcinogenic 

potential, cyprodinil was classified as 

‘‘not likely to be carcinogenic to 

humans.’’ Therefore, cyprodinil is not 

expected to pose a cancer risk to 

humans. 

6. 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 enforcement methodology 

(high performance liquid 

chromatography with ultraviolet 

detector (HPLC/UV)) is available to 

enforce the tolerance expression on 

plant commodities. In addition, a high 

performance liquid chromatography 

with mass spectrometry (HPLC/MS) 

method (Method No. GRM010.01A) is 

available for determining residues of 

cyprodinil and its metabolite CGA–

304075 (free+conjugated) in livestock 

commodities. These methods may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no established or proposed 

Canadian or Mexican MRLs for 

cyprodinil on any of the plant 

commodities of interest in these 

petitions. There are Codex MRLs for 

tomato, bulb onion, cucurbit, and 

summer squash. Tomato has a proposed 

tolerance of 0.45 ppm and a Codex MRL 

of 0.5 ppm, therefore no change in the 

tolerance is necessary for harmonization 

purposes. The Codex MRLs for bulb 

onion at 0.3 ppm (vs 4.0 ppm for green 

onion and 0.60 ppm for dry bulb onion), 

cucurbit at 0.2 ppm (vs 0.70 ppm for 

cucurbit vegetables), and summer 

squash at 0.2 ppm (vs 1.0 ppm for head 

and stem Brassica, 5A) were established 

based on application levels from 0.21 to 

0.26x the domestic rate. Harmonization 

of U.S. tolerances on these commodities 

is not possible at this time. 

Codex MRLs have been established 

for livestock commodities, and these 

MRLs are set at the method LOQ. For 

both the Canadian and Codex MRLs, the 

regulated residues include cyprodinil 

per se. As the U.S. definition for 

cyprodinil residues in livestock 

commodities is different than those 

established for Canada and Codex, 

harmonization of U.S. tolerances on 

livestock commodities is not possible at 

this time. 

C. Response to Comments 

EPA received one comment to the 

Notice of Filing that had a general 

objection to ‘‘this product being allowed 

on food.’’ The comment contained no 

scientific data or other substantive 

evidence to rebut this conclusion or the 

Agency’s finding that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

cyprodinil from the establishment of 

these tolerances. The Agency has 

received these same or similar 

comments from this commenter on 

numerous previous occasions. Refer to 

Federal Register 70 FR 37686 (June 30, 

2005), 70 FR 1354 (January 7, 2005), and 

69 FR 63096 (October 29, 2004) for the 

Agency’s previous responses to these 

objections. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petitions, EPA 

determined that separate tolerances are 

needed for fresh parsley at 35 ppm; 

dried parsley at 170 ppm; citrus, dry 

pulp at 8.0 ppm; citrus, oil at 340 ppm; 

and meat byproducts of cattle, goats, 

horses and sheep at 0.02 ppm. EPA is 

establishing those tolerances in this 

action. In addition, EPA revised the 

tolerances for tomato from 0.40 ppm to 

0.45 ppm; tomatillo from 0.40 ppm to 

0.45 ppm; herb subgroup 19A fresh from 

25 ppm to 3 ppm and re-naming herb 

subgroup 19A fresh, except parsley; 

herb subgroup 19A dried from 170 ppm 

to 15 ppm and re-naming herb subgroup 

19A, dried, except parsley; leaves of 

root and tuber vegetables from 9.0 ppm 

to 10 ppm; root vegetables, except sugar 


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50552 Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 

beet subgroup from 0.60 ppm to 0.75 

ppm; cucurbits from 0.40 to 0.70 ppm. 

EPA revised these tolerance levels based 

on analyses 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 residues of cyprodinil, 4- 

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

pyrimidinamine, in or on the food 

commodities tomato at 0.45 ppm; 

tomatillo at 0.45 ppm; tomato, paste at 

1.0 ppm; avocado at 1.2 ppm; sapote, 

black at 1.2 ppm; canistel at 1.2 ppm; 

sapote, mamey at 1.2 ppm; mango at 1.2 

ppm; papaya at 1.2 ppm; sapodilla at 1.2 

ppm; star apple at 1.2 ppm; parsley, 

leaves at 35 ppm; parsley, dried leaves 

at 170 ppm; vegetable, leaves of root and 

tuber, group 2 at 10 ppm; vegetable, 

root, except sugarbeet, subgroup 1B at 

0.75 ppm; lemon at 0.60 ppm; lime at 

0.60 ppm; citrus, dried pulp at 8.0 ppm; 

citrus, oil at 340 ppm; kiwifruit at 1.8 

ppm; onion, bulb at 0.60 ppm; onion, 

green at 4.0 ppm; strawberry at 5.0 ppm; 

vegetable, cucurbit, group 9 at 0.70 

ppm; and meat byproducts of cattle, 

goats, horses and sheep at 0.02 ppm. 

Also, the following entries in the table 

in paragraph (a)(1) are changed to read 

as follows: ‘‘herb subgroup 19A, fresh’’

is amended to ‘‘herb subgroup 19A, 

fresh, except parsley’’; ‘‘herb subgroup 

19A, dried’’ is amended to ‘‘herb 

subgroup 19 A, dried, except parsley’’.. 

Further, the following entry is 

removed from the table in paragraph 

(a)(1): ‘‘Carrot’’ because of the 

establishment of the vegetable, root 

tolerance by this action. 

And lastly, the following entries are 

removed from the table in paragraph 

(a)(2): ‘‘Onion, bulb’’ ‘‘onion, green’’, 

and ‘‘strawberry’’ because permanent 

tolerances are being established by this 

action. 

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, 

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: August 15, 2008. 

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 as 

follows: 

i. Paragraph (a)(2) is removed. 

ii. Paragraph (a)(1) is redesignated as 

paragraph (a). 

iii. Newly designated paragraph (a) is 

amended in the table by removing the 

commodity ‘‘Carrot’’; by revising the 

commodities ‘‘Herb subgroup 19A, 

dried’’ and ‘‘Herb subgroup 19A, fresh’’

to read ‘‘Herb, subgroup 19A, dried, 

except parsley’’ and ‘‘Herb, subgroup 

19A, fresh, except parsley’’ respectively; 

and by alphabetically adding 

commodities. 

The amendments read as follows: 

§ 180.532 Cyprodinil; tolerances for 

residues. 

(a) General. * * * 


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Federal Register / Vol. 73, No. 167 / Wednesday, August 27, 2008 / Rules and Regulations 50553 

Commodity Parts per million 

*****

Avocado ............................................................................................................................................................................... 1.2 

*****

Canistel ................................................................................................................................................................................ 1.2 

*****

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

Citrus, dried pulp ................................................................................................................................................................. 8.0 

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

*****

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

*****

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

*****

Kiwifruit ................................................................................................................................................................................ 1.8 

*****

Lemon .................................................................................................................................................................................. 0.60 

Lime ..................................................................................................................................................................................... 0.60 

*****

Mango .................................................................................................................................................................................. 1.2 

Onion, bulb .......................................................................................................................................................................... 0.60 

Onion, green ........................................................................................................................................................................ 4.0 

Papaya ................................................................................................................................................................................. 1.2 

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

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

*****

Sapodilla .............................................................................................................................................................................. 1.2 

Sapote, black ....................................................................................................................................................................... 1.2 

Sapote, mamey .................................................................................................................................................................... 1.2 

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

*****

Star apple ............................................................................................................................................................................ 1.2 

Strawberry ............................................................................................................................................................................ 5.0 

Tomatillo .............................................................................................................................................................................. 0.45 

Tomato ................................................................................................................................................................................. 0.45 

Tomato, paste ...................................................................................................................................................................... 1.0 

*****

Vegetable, cucurbit, group 9 ............................................................................................................................................... 0.70 

Vegetable, leaves of root and tuber, group 2 ..................................................................................................................... 10 

Vegetable, root, except sugarbeet, subgroup 1B ................................................................................................................ 0.75 

*****

* * * * * 

[FR Doc. E8–19747 Filed 8–26–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1020; FRL–8378–5] 

Bacillus subtilis GB03; Exemption 

from the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the microbial 

pesticide Bacillus subtilis GB03 in or on 

all raw agricultural commodities when 

applied in accordance with good 

agricultural practices. Growth Products 

Ltd. submitted a petition to EPA under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

requesting an amendment of the existing 

exemption from the requirement of a 

tolerance to cover use in or on all 

agricultural commodities and remove 

the regulatory text specifying ‘‘when 

applied as a seed treatment.’’ This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Bacillus subtilis GB03 in 

or on all raw agricultural commodities. 

DATES: This regulation is effective 

August 27, 2008. Objections and 

requests for hearings must be received 

on or before October 27, 2008, 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–2007–1020. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket identification (ID) number 

where indicated and select the 

‘‘Submit’’ button. Follow the 

instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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. 


sroberts on PROD1PC70 with RULES