54640 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 

Dated: September 6, 2005. 

Donald S. Welsh, 

Regional Administrator, Region III. 

■ Accordingly, the added entry for 

Delaware’s Regulation 1, Section 2, and 

revised entries for Regulation 3, 

Sections 1, 6, and 11 in 40 CFR 

52.420(c) published at 70 FR 41147 are 

withdrawn as of September 16, 2005. 

[FR Doc. 05–18565 Filed 9–15–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2003–0129; FRL–7719–9] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

fluoxastrobin, (1E)-[2-[[6-(2- 

chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its Z isomer, (1Z)-[2- 

[[6-(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on leaf petioles 

subgroup 4B; peanut; peanut, hay; 

peanut, refined oil; tomato, paste; 

vegetable, fruiting, group 8; and 

vegetable, tuberous and corm, subgroup 

1C. This regulation also establishes 

tolerances for the indirect or inadvertent 

combined residues of fluoxastrobin and 

its Z isomer, in or on alfalfa, forage; 

alfalfa, hay; cotton, gin byproducts; 

grain, cereal, forage, fodder and straw, 

group 16; grass, forage; grass, hay; and 

vegetable, foliage of legume, group 7. 

This regulation additionally establishes 

tolerances for the combined residues of 

fluoxastrobin, its Z isomer, and its 

phenoxy-hydroxypyrimidine 

metabolite, 6-(2-chlorophenoxy)-5- 

fluoro-4-pyrimidinol, expressed as 

fluoxastrobin, in or on cattle, fat; cattle, 

meat; cattle, meat byproducts; goat, fat; 

goat, meat; goat, meat byproducts; horse, 

fat; horse, meat; horse, meat byproducts; 

milk; milk, fat; sheep, fat; sheep, meat; 

and sheep, meat byproducts. Bayer 

CropScience requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). 

DATES: This regulation is effective 

September 16, 2005. Objections and 

requests for hearings must be received 

on or before November 15, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2003–

0129. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Tony Kish, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9443; e-mail address: 

kish.tony@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: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides 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 and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of April 23, 

2003 (68 FR 19991) (FRL–7303–1), 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 3F6556) by Bayer 

CropScience, 2 T.W. Alexander Drive, 

Research Triangle Park, North Carolina 

27709. The petition requests that 40 

CFR 180.609 be amended by 

establishing tolerances for the combined 

residues of the fungicide fluoxastrobin, 

(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]-oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on the raw 

agricultural commodities (RACs) alfalfa, 

forage at 0.05 parts per million (ppm); 

alfalfa, hay at 1.0 ppm; cotton, gin 

byproducts at 0.02 ppm; grain, cereal, 

forage at 0.10 ppm; grain, cereal, hay at 

0.10 ppm; grain, cereal, stover at 0.10 

ppm; grain, cereal, straw at 0.10 ppm; 

grass, forage at 0.10 ppm; grass, hay at 

0.50 ppm; legume, forage at 0.05 ppm; 

legume, hay at 0.05 ppm; legume, seed 

at 0.01 ppm; peanut at 0.01 ppm; 

peanut, hay at 20 ppm; peanut, refined 

oil at 0.10 ppm; tomato, paste at 2.0 

ppm; vegetable, foliage of legume, group 

7 at 0.05 ppm; vegetable, fruiting, group 

at 1.0 ppm; vegetable, leafy, petioles, 

except brassica, subgroup at 5.0 ppm; 

and vegetable, tuberous and corm, 

subgroup at 0.01 ppm. The petition also 

requests that 40 CFR 180.609 be 

amended by establishing tolerances for 

Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 54641 

the combined residues of fluoxastrobin, 

(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]-oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its phenoxyhydroxypyrimidine metabolite, 6-(2- 

chlorophenoxy)-5-fluoro-4-pyrimidinol, 

in or on the RACs cattle, fat at 0.10 ppm; 

cattle, meat at 0.05 ppm; cattle, meat 

byproducts at 0.20 ppm; milk at 0.01 

ppm; and milk, fat at 0.10 ppm. That 

notice included a summary of the 

petition prepared by Bayer CropScience, 

the registrant. Several comments 

concerning the notice were received. 

They are described and discussed in 

Unit V. 

Based on EPA’s review, the 

aforementioned petition was revised by 

the petitioner by adjusting some 

tolerance levels, revising the tolerance 

expression, and revising the commodity 

nomenclature to reflect the correct 

commodity definitions. The tolerance 

expression was revised to reflect the fact 

that fluoxastrobin E-isomer, and not the 

mixture of E- and Z-isomers, is the 

proposed active ingredient. The petition 

was also revised, based on extensive 

field rotational crop data, to add 

indirect tolerances for the combined 

residues of fluoxastrobin and its Zisomer in/on rotated crops. As revised, 

the petition seeks the establishment of 

tolerances for combined residues of 

fluoxastrobin, (1E)-[2-[[6-(2- 

chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its Z isomer, (1Z)-[2- 

[[6-(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on the RACs leaf 

petioles subgroup 4B at 4.0 ppm; peanut 

at 0.010 ppm; peanut, hay at 20.0 ppm; 

peanut, refined oil at 0.030 ppm; 

tomato, paste at 1.5 ppm; vegetable, 

fruiting, group 8 at 1.0 ppm; and 

vegetable, tuberous and corm, subgroup 

1C at 0.010 ppm, the establishment of 

tolerances for indirect or inadvertent 

residues for the combined residues of 

fluoxastrobin and its Z isomer, in or on 

the RACs alfalfa, forage at 0.050 ppm; 

alfalfa, hay at 0.10 ppm; cotton, gin 

byproducts at 0.020 ppm; grain, cereal, 

forage, fodder, and straw, group 16 at 

0.10 ppm; grass, forage at 0.10 ppm; 

grass, hay at 0.50 ppm; and vegetable, 

foliage of legume, group 7 at 0.050 ppm; 

and the establishment of tolerances for 

the combined residues of fluoxastrobin, 

its Z isomer, and its phenoxyhydroxypyrimidine metabolite, 6-(2- 

chlorophenoxy)-5-fluoro-4-pyrimidinol, 

expressed as fluoxastrobin, in or on the 

RACs cattle, fat at 0.10 ppm; cattle, meat 

at 0.05 ppm; cattle, meat byproducts at 

0.10 ppm; goat, fat at 0.10 ppm; goat, 

meat at 0.05 ppm; goat, meat byproducts 

at 0.10 ppm; horse, fat at 0.10 ppm; 

horse, meat at 0.05 ppm; horse, meat 

byproducts 0.10 ppm; milk at 0.02 ppm; 

milk, fat at 0.50 ppm; sheep, fat at 0.10 

ppm; sheep, meat at 0.05 ppm; and 

sheep, meat byproducts at 0.10 ppm. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal upper 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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7). 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for the fluoxastrobin tolerances 

described in Unit II. EPA’s assessment 

of exposures and risks associated with 

establishing these 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. The nature of the 

toxic effects caused by fluoxastrobin are 

discussed in Table 1. of this unit as well 

as the no observed adverse effect level 

(NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies reviewed. 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 90-Day oral toxicity-rats NOAEL was 70.4 milligrams/kilogram/day (mg/kg/day) for males; 162.9 mg/kg/day 

for females. 

LOAEL was 580.0 mg/kg/day for males based on reduced body weight gain and 

food intake, vacuolation in the zona fasciculate of the adrenal cortex, calculi in the 

urethra and kidney, and histological lesions in kidney, urinary bladder, and urethra; 1416.1 mg/kg/day for females based on increased liver weight (by 20%). 

870.3100 90-Day oral toxicity-mice Neither a NOAEL nor a LOAEL were assigned. There was a dose related increase 

in liver weight in both sexes and in kidney weight in females, in addition to other 

effects whose toxicological relevance was considered uncertain. Among these effects were increased hepatocellular hypertrophy with cytoplasmic changes in the 

high-dose males and minimal to moderate kidney tubular hypertrophy in mid- and 

high-dose females. 

54642 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued 

Guideline No. Study Type Results 

870.3150 90-Day oral toxicity-dogs NOAEL was 3.0 mg/kg/day (100 ppm) for both males and females. 

LOAEL was 24.8/24.2 mg/kg/day (800 ppm) for both males and females based on 

dose-related reductions in net body weight gain and food efficiency in addition to 

toxicity findings in the liver in both sexes (cholestasis) and in kidneys (increased 

relative weights in females and degeneration of the proximal tubular epithelium in 

males). 

870.3200 28-Day dermal toxicityrats NOAEL was 1,000 mg/kg/day (the limit dose, for both systemic and dermal effects). 

No LOAEL was identified. 

870.3700 Prenatal development-rats Maternal NOAEL was greater than or equal to 1,000 milligrams per kilogram bodyweight per day (mg/kg bw/day; limit dose). 

No maternal LOAEL was identified. 

Developmental NOAEL was greater than or equal to 1,000 mg/kg bw/day. 

No developmental LOAEL was identified. 

870.3700 Prenatal development-rabbits Maternal NOAEL was 100 mg/kg/day. 

Maternal LOAEL was 400 mg/kg/day based on cold ears, transient body weight loss, 

and decreased food consumption. 

Developmental NOAEL was greater than or equal to 400 mg/kg/day. 

No developmental LOAEL was identified. 

870.3800 Reproduction and fertility 

effects-rats 

Parental systemic NOAEL was 70.0 mg/kg/day for males and 84.7 mg/kg/day for females. 

Parental systemic LOAEL was 665.0 mg/kg/day for males and 825.4 mg/kg/day for 

females based on decreased premating body weight gain of the P-generation 

males and females and decreased premating absolute body weight of the F1

males and females. 

Reproductive NOAEL was greater than 665.0 mg/kg/day for males and greater than 

825.4 mg/kg/day for females. 

No reproductive LOAEL was identified. 

Offspring systemic NOAEL was 70.0 mg/kg/day for males and 84.7 mg/kg/day for females. 

Offspring systemic LOAEL was 665.0 mg/kg/day for males and 825.4 mg/kg/day for 

females based on decreased body weights, delayed preputial separation, and incomplete ossification in the F1 and/or F2 males and females. 

870.4100 Chronic toxicity-dogs NOAEL was 1.7 mg/kg/day for males and 1.5 mg/kg/day for females. 

LOAEL was 8.1 mg/kg/day for males and 7.7 mg/kg/day for females based on body 

weight reductions and hepatocytomegaly and cytoplasmic changes associated 

with increased serum liver alkaline phosphatase indicative of cholestasis. 

870.4200 Carcinogenicity--mice NOAEL was 775.6 mg/kg bw/day for males and 1265.1 mg/kg bw/day for females. 

No LOAEL was identified. 

There was no evidence of carcinogenicity. 

870.4300 Combined chronic toxicity/ 

carcinogenicity--rats 

NOAEL was 53.0 mg/kg/day for males and 181.3 mg/kg/day for females. 

LOAEL was 271.9 mg/kg/day for males and 1083.2 mg/kg/day for females was 

based on decreased body weight, decreased body weight gain, and decreased 

food efficiency in both sexes; decreased spleen weight in males; and microscopic 

lesions in the uterus of females. The apparent increase in tumors in the uterus 

and thyroid were addressed and resolved by an Agency committee, which concluded that no carcinogenic concern exists for fluoxastrobin. 

870.6200 Acute neurotoxicity 

screening battery--rats 

Neurotoxicity NOAEL was greater than or equal to 2,000 mg/kg (limit dose). 

No LOAEL was identified. 

870.6200 Subchronic neurotoxicity 

screening battery--rats 

Systemic NOAEL (systemic and neurotoxic) was 473.9/582.4 mg/kg/day for males 

and females, respectively. 

No LOAEL was identified. 

870.5100 Gene Mutation-in vitro 

bacterial reverse gene 

mutation 

Negative (considered non-mutagenic in Salmonella typhimurium cultures treated up 

to cytotoxic/ precipitating levels). 

870.5100 Gene Mutation--in vitro 

bacterial reverse gene 

mutation (the test substance was HEC 5725N 

(E:Z ratio of 90%:10%) 

Negative (considered non-mutagenic in this Salmonella typhimurium/microsome 

test). 

Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 54643 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued 

Guideline No. Study Type Results 

870.5100 Gene Mutation--in vitro 

bacterial reverse gene 

mutation (the test substance was HEC 5725- 

phenoxy-hydroxy-pyrimidine) 

Negative (considered non-mutagenic in this Salmonella typhimurium/mammalian activation gene mutation assay). 

870.5100 Gene Mutation--in vitro 

bacterial reverse gene 

mutation (the test substance was HEC 5725- 

dihydroxy- pyrimidine) 

Negative (considered non-mutagenic in this Salmonella typhimurium/mammalian activation gene mutation assay). 

870.5300 Gene mutation-in vitro 

mammalian forward 

gene mutation 

Negative (considered non-mutagenic in this in vitro forward mutation V79-HPRT 

test). 

870.5375 Gene Mutation--in vitro 

mammalian chromosome aberrations in 

Chinese hamster lung 

(V79) cells 

Negative (considered to be negative for clastogenicity in this in vitro mammalian cell 

test). 

870.5395 Cytogenics-in vivo mammalian cytogenetics - 

micronucleus assay 

(mouse) 

Negative (considered non-clastogenic, as indicated by no increases in micronuclei in 

bone marrow). 

870.7485 Metabolism and pharmacokinetics-rat Absorption, distribution, and metabolism were fully characterized in several rat metabolism studies using each of the three 14C-radiolabeled rings in fluoxastrobin. 

Absorption was almost complete following a single oral low dose. Peak plasma 

concentrations were attained within 0.5 to 8 hours depending on the dose and 

label position. Fecal excretion was the major route of elimination while renal excretion was a secondary route and elimination via expired air was negligible. 

Fluoxastrobin was extensively metabolized as evidenced by the extensive metabolite profiles from urine, feces, and bile and the relative absence of parent compound (except in the feces of rats given the high dose). 

870.7600 Dermal penetration--monkey Following an 8-hour dermal application in a male monkey, absorption was negligible 

(1.16% preliminary, 2.16% main). The normalized absorption value for the main 

study was 2.31%. 

870.7800 Immunotoxicity-mouse 

(subacute feeding 

study) 

No clinical signs of toxicity or mortality were found and no treatment-related effects 

were found on body weight, food intake, or B-cell activated, T-cell mediated IgM 

response to SRBC. Based on these findings, and findings in the 90-day oral rat 

study (no difference between the control and treated animals in spleen cell count, 

macrophage activities after PMA stimulation and plaque-forming cell assay after 

challenge with sheep erythrocytes), it was concluded that fluoxastrobin is not 

immunotoxic. However, the study is considered unacceptable because of uncertainty in dietary test material intake, failure to report spleen weight of each mouse 

at necropsy, and failure of the laboratory to demonstrate its capability in performing this type of assay. 

B. Toxicological Endpoints 

The highest dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences. 

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

54644 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor). 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor. 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/ 

exposures) is calculated. 

A summary of the toxicological 

endpoints for fluoxastrobin used for 

human risk assessment is shown in 

Table 2. of this unit: 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FLUOXASTROBIN FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario 

Dose Used in Risk Assessment; Interspecies, 

Intraspecies, and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary NOAEL = None Not applicable There was no indication of an adverse effect 

attributable to a single dose. An aRfD was 

not established. 

Chronic Dietary (all populations) NOAEL = 1.5 mg/kg/day 

UF = 100X 

Special FQPA SF = 1X 

cPAD = 0.015 mg/kg/day 

Chronic Toxicology-Dog 

LOAEL = 8.1 mg/kg/day for males and 7.7 

mg/kg/day for females based on body 

weight reductions, hepatocytomegaly, and 

cytoplasmic changes associated with increased serum liver alkaline phosphatase 

that is indicative of cholestasis. 

Incidental Short-Term Oral (1–

30 days) 

NOAEL = 3.0 mg/kg/day 

UF = 100X 

Residential LOC for MOE 

= 100 

90-Day Subchronic Oral Toxicology-Dog 

LOAEL = 24.8 mg/kg/day (800 ppm) for males 

and 24.2 mg/kg/day (800 ppm) for females 

based on dose-related reductions in net 

body weight gain and food efficiency; toxicity findings in the liver (cholestasis) in both 

sexes; and toxicity findings in the kidneys 

(increased relative weights in females and 

degeneration of the proximal tubular epithelium in males). 

Incidental Intermediate-Term 

Oral (1–6 months) 

NOAEL = 3.0 mg/kg/day 

UF = 100X 

Residential LOC for MOE 

= 100 

90-Day Subchronic Oral Toxicology-Dog 

LOAEL = 24.8 mg/kg/day (800 ppm) for males 

and 24.2 mg/kg/day (800 ppm) for females 

based on dose-related reductions in net 

body weight gain and food efficiency; toxicity findings in the liver (cholestasis) in both 

sexes; and toxicity findings in the kidneys 

(increased relative weights in females and 

degeneration of the proximal tubular epithelium in males). 

Short-Term Dermal (1–30 days) Not applicable None None: A 28-day dermal toxicity study in the rat 

was negative up to the limit dose and there 

are no developmental or neurotoxicity concerns. 

Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 54645 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FLUOXASTROBIN FOR USE IN HUMAN RISK

ASSESSMENT—Continued 

Exposure Scenario 

Dose Used in Risk Assessment; Interspecies, 

Intraspecies, and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Intermediate-Term Dermal (1–6 

months) 

NOAEL = 3.0 mg/kg/day 

UF = 100X 

Dermal absorption rate = 

2.3% 

Residential LOC for MOE 

= 100 

90-Day Subchronic Oral Toxicology-Dog 

LOAEL = 24.8 mg/kg/day (800 ppm) for males 

and 24.2 mg/kg/day (800 ppm) for females 

based on dose-related reductions in net 

body weight gain and food efficiency; toxicity findings in the liver (cholestasis) in both 

sexes; and toxicity findings in the kidneys 

(increased relative weights in females and 

degeneration of the proximal tubular epithelium in males). 

Long-Term Dermal (greater 

than 6 months) 

NOAEL = 1.5 mg/kg/day 

UF = 100X 

Dermal absorption rate = 

2.3% 

Residential LOC for MOE 

= 100 

Chronic Toxicology-Dog 

LOAEL = 8.1 mg/kg/day for males and 7.7 

mg/kg/day for females based on body 

weight reductions, hepatocytomegaly, and 

cytoplasmic changes associated with increased serum liver alkaline phosphatase 

that is indicative of cholestasis. 

Short-Term Inhalation (1–30 

days) 

NOAEL = 3.0 mg/kg/day 

UF = 100X 

Residential LOC for MOE 

= 100 

90-Day Subchronic Oral Toxicology-Dog 

LOAEL = 24.8 mg/kg/day (800 ppm) for males 

and 24.2 mg/kg/day (800 ppm) for females 

based on dose-related reductions in net 

body weight gain and food efficiency; toxicity findings in the liver (cholestasis) in both 

sexes; and toxicity findings in the kidneys 

(increased relative weights in females and 

degeneration of the proximal tubular epithelium in males). 

Intermediate-Term Inhalation 

(1–6 months) 

NOAEL = 3.0 mg/kg/day 

UF = 100X 

Residential LOC for MOE 

= 100 

90-Day Subchronic Oral Toxicology-Dog 

LOAEL = 24.8 mg/kg/day (800 ppm) for males 

and 24.2 mg/kg/day (800 ppm) for females 

based on dose-related reductions in net 

body weight gain and food efficiency; toxicity findings in the liver (cholestasis) in both 

sexes; and toxicity findings in the kidneys 

(increased relative weights in females and 

degeneration of the proximal tubular epithelium in males). 

Long-Term Inhalation (greater 

than 6 months) 

NOAEL = 1.5 mg/kg/day 

UF = 100X 

Residential LOC for MOE 

= 100 

Chronic Toxicology-Dog 

LOAEL = 8.1 mg/kg/day for males and 7.7 

mg/kg/day for females based on body 

weight reductions, hepatocytomegaly, and 

cytoplasmic changes associated with increased serum liver alkaline phosphatase 

that is indicative of cholestasis. 

Cancer (oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. As is described in Unit II., 

tolerances for fluoxastrobin are being 

established on a variety of raw 

agricultural commodities. Risk 

assessments were conducted by EPA to 

assess dietary exposures from 

fluoxastrobin in food as follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide, if a toxicological study 

has indicated the possibility of an effect 

of concern occurring as a result of a oneday or single exposure. The 

toxicological database for fluoxastrobin 

identified no adverse effect attributable 

to a single dose, therefore an acute 

dietary exposure assessment was not 

performed. 

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEMFCIDTM version 2.0) and the LifelineTM

model, version 2.0, both of which 

incorporate food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). The assumptions 

made for the chronic dietary exposure 

assessments were that residues, for all 

commodities, were present at 100% of 

the tolerance levels and fluoxastrobin 

was applied to 100% of each crop to 

which it may be applied. 

54646 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 

2. Dietary exposure from drinking 

water. The Agency does not have 

drinking water monitoring exposure 

data to use in a comprehensive dietary 

exposure analysis and risk assessment 

for fluoxastrobin, a new pesticidal 

chemical. Because of this the Agency 

made drinking water concentration 

estimates by use of simulation or 

modeling, which takes into account data 

on the physical and chemical 

characteristics of fluoxastrobin. 

The Agency used the Pesticide Root 

Zone Model/Exposure Analysis 

Modeling System (PRZM/EXAMS 

(PRZM version 3.12 beta and EXAMS 

version 2.98.04)), to produce estimates 

of pesticide concentrations in an index 

reservoir (the surface water 

concentration estimates). The Screening 

Concentrations in Ground Water (SCIGROW) model was used to predict 

pesticide concentrations in shallow 

ground water (the ground water 

concentration estimates). The surface 

water concentration analysis was based 

on the turf use, which has the highest 

labeled annual application rate and 

assumes the highest default value of 

87% percentage cropped area (PCA) 

land use around the index reservoir. 

The assumptions in this analysis are 

therefore also conservative. The ground 

water concentration analysis was based 

on the maximum pesticide use rate (the 

turf use again), the persistence of 

fluoxastrobin in soil, and the ability of 

fluoxastrobin to leach. 

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern. 

Estimated drinking water 

concentrations (EDWCs) derived from 

these models are used to calculate 

drinking water levels of comparison 

(DWLOCs). The DWLOCs are used as 

points of comparison against the 

EDWCs. DWLOCs are theoretical upper 

limits on the concentration of a 

pesticide that could occur in drinking 

water without exceeding the size of the 

risk cup, considering the aggregate 

exposure to that pesticide in food and 

from residential uses. Since DWLOCs 

represent maximum allowable exposure 

to fluoxastrobin in drinking water, they 

are further discussed in the aggregate 

risk sections in Unit III.E. 

Based on the PRZM/EXAMS and SCIGROW models, the EDWCs of 

fluoxastrobin for acute exposures are 28 

parts per billion (ppb) for surface water 

and less than 1 ppb for ground water. 

The EDWCs for chronic exposures are 

14 ppb for surface water and less than 

1 ppb for ground 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). 

There is potential for homeowner 

exposure to fluoxastrobin in residential 

settings by entry to turf areas where this 

fungicide has previously been applied, 

such as lawns where children might 

play or golf courses that adults might be 

active on. Therefore, risk assessments 

have been performed for residential 

postapplication scenarios. However, 

only professional pest control operators 

will be allowed to make the turf 

applications so residential handler 

exposure was not evaluated. 

Since chemical-specific data were 

unavailable, the Agency used general 

current approaches for nonoccupational assessment and believes 

that the calculated risks represent 

screening level estimates. Maximum 

application rates have been used for all 

scenarios, and the risk estimates assume 

no dissipation of residues after day zero 

and do not consider removal of residues 

as a result of periodic cutting of the 

grass. Additionally, the intermediateterm endpoint was used for dermal risk 

estimates, even though the nonoccupational exposure duration is 

believed to mostly be short-term (as a 

result of the use pattern), because no 

short-term dermal toxicity endpoint was 

identified. 

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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fluoxastrobin and any other substances 

and fluoxastrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that fluoxastrobin has 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 the policy statements 

released by EPA’s OPP concerning 

common mechanism determinations 

and procedures for cumulating effects 

from substances found to have a 

common mechanism on EPA’s web site 

at http://www.epa.gov/pesticides/ 

cumulative/. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

The toxicity database for fluoxastrobin, 

including acceptable developmental 

toxicity studies in rats and rabbits, as 

well as a two-generation reproduction 

toxicity study, provides no indication of 

prenatal and/or post-natal sensitivity. 

3. Conclusion. There is a complete 

toxicity data base for fluoxastrobin and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. The 

Agency therefore has recommended 

reducing the special FQPA SF to 1X, 

based on the following additional 

considerations. First, there are no low 

risk concerns indicated by the various 

hazard studies. The study data are of 

high quality, and there are no residual 

uncertainties with regard to the preand/or postnatal toxicity of this 

chemical. Second, the dietary food 

exposure assessment utilizes proposed 

tolerance level or higher residues and 

100% crop treated information for all 

commodities. By using these screeninglevel assessments, chronic exposures 

and risks will not be underestimated. 

Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 54647 

Third, the dietary drinking water 

assessments utilize values generated by 

models and associated modeling 

parameters which are designed to 

provide conservative, health protective, 

high-end estimates of water 

concentrations. Fourth, the residential 

exposure assessment utilizes activityspecific transfer coefficients and turf 

transferable residues (TTR), as well as 

maximum application rates for the 

postapplication scenario. The 

residential assessment is based on 

reliable data and is unlikely to 

underestimate exposure/risk. 

E. Aggregate Risks and Determination of 

Safety 

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against EDWCs. 

DWLOC values are theoretical upper 

limits on a pesticide’s concentration in 

drinking water in light of total aggregate 

exposure to a pesticide in food and 

residential uses, not regulatory 

standards for drinking water . In 

calculating a DWLOC, the Agency 

determines how much of the acceptable 

exposure (i.e., the PAD) is available for 

exposure through drinking water [e.g., 

allowable chronic water exposure (mg/ 

kg/day) = cPAD - (average food + 

residential exposure)]. This allowable 

exposure through drinking water is the 

source of the DWLOC. 

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/ 

70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer. 

When EDWCs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process. 

1. Acute risk. The toxicological 

database for fluoxastrobin identified no 

adverse effect attributable to a single 

dose, therefore fluoxastrobin is not 

expected to pose an acute dietary risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to fluoxastrobin from food 

will utilize 10% of the cPAD for the 

U.S. population, 6% of the cPAD for all 

infants less than 1 year old, and 25% of 

the cPAD for children 1 to 2 years old, 

the children subpopulation with the 

greatest exposure. Based on the use 

pattern, chronic residential exposure to 

residues of fluoxastrobin is not 

expected. However, there is the 

potential for chronic dietary exposure to 

fluoxastrobin in drinking water. After 

calculating DWLOCs and comparing 

them to the EDWCs for surface and 

ground water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in Table 3. of this 

unit: 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO FLUOXASTROBIN

Population Subgroup cPAD mg/ 

kg/day 

% cPAD 

(Food) 

Surface 

Water 

EDWC 

(ppb) 

Ground 

Water 

EDWC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.015 10 14 < 1 470 

All infants (less than 1 year old) 0.015 6.0 14 < 1 140 

Children 1 to 2 years old 0.015 25 14 < 1 110 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposures both take into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because all short- and intermediate-term 

quantitative hazard estimates (via the 

dermal and incidental oral routes) for 

fluoxastrobin are based on the same 

endpoint, a screening level, 

conservative aggregate risk assessment 

was conducted that combined the shortterm incidental oral and intermediateterm dermal exposure estimates (i.e., the 

highest exposure estimates). 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

food and residential exposures 

aggregated result in aggregate MOEs of 

1,000 for the U.S. population, 1,100 for 

females 13–49 years old, and 180 for 

children 1–2 years old. These aggregate 

MOEs do not exceed the Agency’s level 

of concern for aggregate exposure to 

food and residential uses. In addition, 

short- and intermediate-term DWLOCs 

were calculated and compared to the 

EDWCs for chronic exposure to 

fluoxastrobin in ground and surface 

water. After calculating DWLOCs and 

comparing them to the EDWCs for 

surface and ground water, EPA does not 

expect short- and intermediate-term 

aggregate exposure to exceed the 

Agency’s level of concern, as shown in 

Table 4. of this unit: 

54648 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT- AND INTERMEDIATE-TERM EXPOSURE TO FLUOXASTROBIN

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

Level of 

Concern 

(LOC) 

Surface 

Water 

EDWC 

(ppb) 

Ground 

Water 

EDWC 

(ppb) 

Short- and 

IntermediateTerm 

DWLOC 

(ppb) 

U.S. population 1,000 100 28 < 1 940 

Females 13–49 years old 1,100 100 28 < 1 820 

Children 1–2 years old 180 100 28 < 1 140 

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, and to infants and children 

from aggregate exposure to fluoxastrobin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry 

methods) is available to enforce the 

tolerance expression. The methods are 

LC/MS/MS Method No. 00604, entitled 

‘‘Analytical Determination of Residues 

of the Fungicide HEC 5725 In/On 

Cereals, Cereal Processed Products and 

Vegetables by HPLC-MS/MS [highpressure liquid chromatography--mass 

spectrometry/mass spectrometry],’’ and 

LC/MS/MS Method No. 00649, entitled 

‘‘Analytical Method 00649 for the 

Determination of Residues of HEC 5725 

In/On Matrices of Plant Origin by HPLCMS/MS.’’ The 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 currently no Mexican, 

Canadian, nor CODEX maximum 

residue limits established for 

fluoxastrobin. 

C. Conditions 

The following conditions are being 

imposed on Bayer CropScience (the 

petitioner) for the registration of 

fluoxastrobin. 

1. Submit additional information 

concerning weather conditions, 

confirmatory raw data, and soil 

characteristics data for the crop field 

trial and field rotational crop studies. 

2. Submit additional data concerning 

the chromatograms and chromatography 

in the goat metabolism study. 

3. The enforcement methods must be 

rewritten to include instructions for the 

analysis of all crops, and to specify the 

additional ions to be monitored for 

quantitation. 

4. A new peanut processing study 

must be submitted. 

5. Submit reference standard 

materials for fluoxastrobin and several 

molecules related to it, including 

isotopically labeled internal standard 

reference materials, to the EPA National 

Pesticide Standards Repository. 

6. Submit additional information 

concerning the grass forage and hay 

rotational crop field trials. 

7. Submit confirmatory data and 

additional information concerning the 

storage stability data. 

8. Submit additional information 

concerning the mouse immunotoxicity 

subacute feeding study. 

V. Comments 

In response to the notice of filing one 

communication was received from Susie 

Wilcher in the role of private citizen 

and one communication, undersigned 

by Ellen Connett, was received from the 

Fluoride Action Network (FAN). The 

communications objected to 

establishment of the proposed 

tolerances for several reasons, some of 

them specific and others involving 

generalized and unsubstantiated 

disagreement with EPA’s risk 

assessment methodologies or safety 

findings. 

Ms. Wilcher’s comments contained 

general objections to the use of 

pesticides on food and to the use of 

animal testing to determine the safety of 

pesticides. The Agency understands the 

commentor’s concerns and recognizes 

that some individuals believe that 

pesticides should be banned 

completely. However, under the existing 

legal framework provided by section 

408 of the FFDCA EPA is authorized to 

establish pesticide tolerances or 

exemptions where persons seeking such 

tolerances or exemptions have 

demonstrated that the pesticide meets 

the safety standard imposed by that 

statute. 

The Agency disagrees with the 

commenter’s objections to animal 

testing. Since humans and animals have 

complex organ systems and mechanisms 

for the distribution of chemicals in the 

body, as well as processes for 

eliminating toxic substances from their 

systems, EPA relies on laboratory 

animals such as rats and mice to mimic 

the complexity of human and higherorder animal physiological responses 

when exposed to a pesticide. EPA is 

committed, however, to reducing the 

use of animals whenever possible. EPArequired studies include animals only 

when the requirements of sound 

toxicological science make the use of an 

animal absolutely necessary. The 

Agency’s goal is to be able to predict the 

potential of pesticides to cause harmful 

effects to humans and wildlife by using 

fewer laboratory animals as models and 

have been accepting data from 

alternative (to animals) test methods for 

several years. As progress is made on 

finding or developing non-animal test 

models that reliably predict the 

potential for harm to humans or the 

environment, EPA expects that it will 

need fewer animal studies to make 

safety determinations. 

FAN submitted a number of different 

comments. First, FAN asked whether 

fluoxastrobin was already registered in 

the United States and what are the 

names of the fluoxastrobin products 

used on residential turf and golf 

courses. Fluoxastrobin is not currently 

registered but with the completion of 

this tolerance regulation that 

registration should be granted shortly. 

To the best of EPA’s knowledge, the 

product name under which 

fluoxastrobin is marketed for turf and 

golf course use is HEC 480 SC 

Fungicide. 

Second, FAN suggested that a 14- 

week feeding study using dogs showed 

an effect on the thyroid, which seems to 

conflict with the statement that 

‘‘...There is no evidence to suggest that 

fluoxastrobin has any primary 

Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 54649 

endocrine disruptive potential.’’ FAN 

stated that a ‘‘discussion or rationale’’

addressing this should have been 

provided. EPA does believe that the 

thyroid effects seen in the dog study 

indicated that fluoxastrobin is an 

endocrine disruptor. An effect on the 

thyroid gland, even though this gland is 

part of the endocrine system, does not 

necessarily mean that endocrine 

disruption has or will occur. In this 

case, the effects observed in the thyroid 

gland were induced by effects 

fluoxastrobin had on liver enzymes and 

are therefore considered secondary. 

Third, FAN claimed that a ‘‘fuller 

discussion and description of the 

metabolites of fluoxastrobin should 

have been presented.’’ The notice states: 

‘‘The residue of concern is parent 

fluoxastrobin (sum of E and Z isomers).’’

According to the Compendium of 

Pesticide Common Names, 

Fluoxastrobin ‘‘was provisionally 

approved for the (EZ)-isomer [193740–

76–0] in April 2002. The definition was 

changed to the (E)-isomer in January 

2003 at the request of the 

sponsor...Because of this change it is not 

clear from the information supplied in 

this notice what isomer/metabolite are 

of concern.’’

Fluoxastrobin is the accepted 

common name for the pesticidally 

active E-isomer of (2-[6-(2- 

chlorophenoxy)-5-fluoro-4- 

pyrimidinyl]oxy phenyl)-5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime. The Z-isomer of 

fluoxastrobin is typically present at 

much lower levels (E:Z ratio of 

approximately 90:10). Additionally, the 

Z-isomer of fluoxastrobin is considered 

to be a metabolite (photo-degradate) of 

fluoxastrobin. The CAS Number Bayer 

CropScience initially obtained for 

fluoxastrobin pertained to both isomers 

combined. After consultation with the 

Agency, the petitioner requested that 

fluoxastrobin (the pesticidally active Eisomer only) be designated as the active 

ingredient. The tolerances that are being 

established today include both 

fluoxastrobin (i.e. the E-isomer) and the 

Z-isomer and the risk assessment for 

these tolerances was based on exposures 

resulting from both isomers. 

Fourth, FAN requested that the 

Agency begin to incorporate the 

Chemical Abstract Service (CAS) 

numbers for ‘‘every chemical, and its 

metabolite(s)’’ in ‘‘all future reports, 

especially those published in the 

Federal Register.’’ EPA is evaluating the 

feasibility of such a step. EPA would 

note, however, that not every molecule 

or substance has a CAS number. Many 

metabolites do not have a CAS number, 

for example, because no application for 

a CAS number was made or is required. 

CAS is also often not willing to assign 

CAS numbers to substances it believes 

are not able to be characterized well 

enough (some petroleum distillates, for 

example). In addition, CAS numbers 

may be inappropriate in some types of 

reports. However, the CAS number 

could be a useful identifier in certain 

documents for molecules which have 

one. 

FAN also commented that the data 

references cited in the notice of filing 

were not available in the docket, and 

that without this information, it was not 

possible to comment on the findings 

presented. In response, the Agency 

transmitted to FAN the human health 

risk assessment and the toxicological 

studies used in that risk assessment. 

VI. Conclusion 

Therefore, tolerances requested for 

fluoxastrobin in the revised petition are 

established. 

VII. Objections and Hearing Requests 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2003–0129 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 

on or before November 15, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VII.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2003–0129, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of he PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

54650 Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VIII. 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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this 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). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism(64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

IX. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: September 2, 2005. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR part 180 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 180.609 is added to read as 

follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for the combined residues of 

fluoxastrobin, (1E)-[2-[[6-(2- 

chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its Z isomer, (1Z)-[2- 

[[6-(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on the following raw 

agricultural commodities: 

Commodity Parts per 

million 

Leaf petioles subgroup 4B ....... 4.0 

Peanut ...................................... 0.010 

Peanut, hay .............................. 20.0 

Peanut, refined oil .................... 0.030 

Tomato, paste ........................... 1.5 

Vegetable, fruiting, group 8 ...... 1.0 

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0.010 

(2) Tolerances are established for the 

combined residues of fluoxastrobin, 

(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, its Z isomer, (1Z)-[2-[[6- 

(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its phenoxyVerDate Aug<31>2005 15:20 Sep 15, 2005 Jkt 205001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\16SER1.SGM 16SER1
Federal Register / Vol. 70, No. 179 / Friday, September 16, 2005 / Rules and Regulations 54651 

hydroxypyrimidine metabolite, 6-(2- 

chlorophenoxy)-5-fluoro-4-pyrimidinol, 

in or on the following raw agricultural 

commodities: 

Commodity Parts per 

million 

Cattle, fat .................................. 0.10 

Cattle, meat .............................. 0.05 

Cattle, meat byproducts ........... 0.10 

Goat, fat .................................... 0.10 

Goat, meat ................................ 0.05 

Goat, meat byproducts ............. 0.10 

Horse, fat .................................. 0.10 

Horse, meat .............................. 0.05 

Horse, meat byproducts ........... 0.10 

Milk ........................................... 0.02 

Milk, fat ..................................... 0.50 

Sheep, fat ................................. 0.10 

Sheep, meat ............................. 0.05 

Sheep, meat byproducts .......... 0.10 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent combined 

residues of fluoxastrobin, (1E)-[2-[[6-(2- 

chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, and its Z isomer, (1Z)-[2- 

[[6-(2-chlorophenoxy)-5-fluoro-4- 

pyrimydinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on the following raw 

agricultural commodities when present 

therein as a result of the application of 

fluoxastrobin to the growing crops listed 

in paragraph (a)(1) of this section: 

Commodity Parts per 

million 

Alfalfa, forage ........................... 0.050 

Alfalfa, hay ................................ 0.10 

Cotton, gin byproducts ............. 0.020 

Grain, cereal, forage, fodder, 

and straw, group 16 .............. 0.10 

Grass, forage ............................ 0.10 

Grass, hay ................................ 0.50 

Vegetable, foliage of legume, 

group 7 .................................. 0.050 

[FR Doc. 05–18421 Filed 9–15–05; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF DEFENSE 

48 CFR Part 205 

[DFARS Case 2004–D025] 

Defense Federal Acquisition 

Regulation Supplement; Provision of 

Information to Cooperative Agreement 

Holders 

AGENCY: Department of Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD has adopted as final, 

without change, an interim rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement Section 816 of 

the National Defense Authorization Act 

for Fiscal Year 2005. Section 816 

increased, from $500,000 to $1,000,000, 

the threshold at which a DoD contract 

must include a requirement for the 

contractor to provide to cooperative 

agreement holders, upon their request, a 

list of the contractor’s employees who 

are responsible for entering into 

subcontracts. 

DATES: Effective September 16, 2005. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Robin Schulze, Defense Acquisition 

Regulations Council, 

OUSD(AT&L)DPAP(DAR), IMD 3C132, 

3062 Defense Pentagon, Washington, DC 

20301–3062. Telephone (703) 602–0326; 

facsimile (703) 602–0350. Please cite 

DFARS Case 2004–D025. 

SUPPLEMENTARY INFORMATION: 

A. Background 

DoD published an interim rule at 70 

FR 8536 on February 22, 2005, to 

implement Section 816 of the National 

Defense Authorization Act for Fiscal 

Year 2005 (Pub. L. 108–375). Section 

816 amended 10 U.S.C. 2416(d) to 

increase, from $500,000 to $1,000,000, 

the threshold at which a DoD contract 

must include a requirement for the 

contractor to provide to cooperative 

agreement holders, upon their request, a 

list of the contractor’s employees who 

are responsible for entering into 

subcontracts. The interim rule amended 

the prescription for use of the clause at 

DFARS 252.205–7000, Provision of 

Information to Cooperative Agreement 

Holders, to reflect the new dollar 

threshold. 

DoD received no comments on the 

interim rule. Therefore, DoD has 

adopted the interim rule as a final rule 

without change. 

This rule was not subject to Office of 

Management and Budget review under 

Executive Order 12866, dated 

September 30, 1993. 

B. Regulatory Flexibility Act 

DoD certifies that this final rule will 

not have a significant economic impact 

on a substantial number of small entities 

within the meaning of the Regulatory 

Flexibility Act, 5 U.S.C. 601, et seq. 

While the rule reduces administrative 

burdens for contractors, the economic 

impact is not expected to be substantial. 

C. Paperwork Reduction Act 

The information collection 

requirements of the clause at DFARS 

252.205–7000, Provision of Information 

to Cooperative Agreement Holders, have 

been approved by the Office of 

Management and Budget, under Control 

Number 0704–0286, for use through 

September 30, 2007. 

List of Subjects in 48 CFR Part 205 

Government procurement. 

Michele P. Peterson, 

Editor, Defense Acquisition Regulations 

System. 

Interim Rule Adopted as Final Without 

Change 

■ Accordingly, the interim rule 

amending 48 CFR Part 205, which was 

published at 70 FR 8536 on February 22, 

2005, is adopted as a final rule without 

change. 

[FR Doc. 05–18476 Filed 9–15–05; 8:45 am] 

BILLING CODE 5001–08–P 

DEPARTMENT OF DEFENSE 

48 CFR Part 217 

[DFARS Case 2004–D024] 

Defense Federal Acquisition 

Regulation Supplement; Multiyear 

Contracting 

AGENCY: Department of Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD has adopted as final, 

without change, an interim rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement Section 8008 of 

the Defense Appropriations Act for 

Fiscal Year 2005 and Section 814 of the 

National Defense Authorization Act for 

Fiscal Year 2005. Sections 8008 and 814 

contain requirements related to the 

funding of multiyear contracts. 

DATES: Effective September 16, 2005. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Robin Schulze, Defense Acquisition 

Regulations Council, 

OUSD(AT&L)DPAP(DAR), IMD 3C132, 

3062 Defense Pentagon, Washington, DC 

20301–3062. Telephone (703) 602–0326; 

facsimile (703) 602–0350. Please cite 

DFARS Case 2004–D024. 

SUPPLEMENTARY INFORMATION: 

A. Background 

DoD published an interim rule at 70 

FR 24323 on May 9, 2005, to implement 

Section 8008 of the Defense 

Appropriations Act for Fiscal Year 2005 

(Pub. L. 108–287) and Section 814 of the