Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 60327 

considered). Based on these 

calculations, the EPA concludes that 

hog tolerance should be lowered as 

follows: Hog, meat – 0.50 ppm; hog, fat 

– 5.0 ppm; and hog, meat byproducts – 

2.0 ppm. 

As part of the current request, the 

petitioner submitted a poultry 

magnitude of the residue study 

monitoring spinosad residues following 

both the proposed dermal application 

scenario (0.9x) and the currentlyregistered premise treatment (1x). Based 

on these data and the current poultry 

MRDB, the EPA concludes that the 

poultry meat byproducts tolerance 

should be increased to 0.20 ppm 

(tolerance for the combined residues of 

spinosyns A and D). All other poultry 

tolerances remain adequate. 

V. Conclusion 

Therefore, tolerances are established 

for residues of spinosad in or on poultry 

at 0.20 ppm poultry, meat byproducts; 

and tolerances are increased as 

indicated for the following established 

commodities: Hog, fat 5.0 ppm; hog, 

meat 0.50 ppm; hog, meat byproducts 

2.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

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: September 24, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.495 is amended by 

revising the following entries in the 

table in paragraph (a) to read as follows: 

§ 180.495 Spinosad; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

* * * * * 

Hog, fat ........................... 5.0 

Hog, meat byproducts .... 2.0 

Hog, meat ....................... 0.50 

* * * * * 

Poultry, meat byproducts 0.20 

* * * * * 

* * * * * 

[FR Doc. 2010–24573 Filed 9–29–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0677; FRL–8845–7] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluoxastrobin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Arysta LifeScience North 

America, LLC requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 30, 2010. Objections and 

requests for hearings must be received 

on or before November 29, 2010, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0677. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 


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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: John 

Bazuin, Registration Division (7504P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7381; e-mail address: 

bazuin.john@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2007–0677 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 29, 2010. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2007–0677, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerances 

In the Federal Register of October 7, 

2009 (74 FR 51597) (FRL–8792–7), 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 9F7567) by Arysta 

LifeScience North America, LLC, 15401 

Weston Parkway, Suite 150, Cary, NC 

27513. The petition requested that 40 

CFR 180.609 be amended by 

establishing tolerances for residues of 

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

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

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

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

pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime in or on aspirated grain 

fractions at 15 parts per million (ppm); 

meat byproducts (cattle, goat, horse, 

sheep) at 0.2 ppm; sweet corn, forage at 

13 ppm; sweet corn (kernels plus cob 

with husks removed) at 0.02 ppm; sweet 

corn, stover at 10 ppm; wheat, bran at 

0.2 ppm; wheat, forage at 7.0 ppm; 

wheat, grain at 0.09 ppm; wheat, hay at 

17 ppm; and wheat, straw at 11 ppm. 

The proposed tolerance in or on 

aspirated grain fractions is actually a 

decrease in the pre-existing tolerance for 

fluoxastrobin and its Z isomer in 40 CFR 

180.609 of 20 ppm. The proposed meat 

byproduct tolerances are actually 

changes in the tolerance expression 

from fluoxastrobin, its Z isomer, and its 

phenoxy-hydroxypyrimidine 

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

fluoro-4-pyrimidinol to fluoxastrobin 

and its Z isomer and an increase in the 

pre-existing tolerance levels in 40 CFR 

180.609 of 0.10 ppm for meat 

byproducts of cattle, goat, horse, and 

sheep. That notice referenced a 

summary of the petition prepared by 

Arysta LifeScience North America, LLC, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has made 

the following changes to the proposed 

fluoxastrobin tolerances. Minor changes 

have been made to several commodity 

names to conform them to the Agency’s 

Food and Feed Commodity Vocabulary. 

The tolerance expression for the meat 

byproduct commodities has been 

corrected to add the phenoxyhydroxypyrimidine metabolite. The 

proposed tolerance of 0.02 ppm in or on 

sweet corn, kernels plus cob with husks 

removed and of 0.2 ppm in or on wheat, 

bran have been reduced and the 

proposed tolerance of 15 ppm in or on 

aspirated grain fractions has been 

increased. The reasons for these changes 

are explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 


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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 fluoxastrobin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluoxastrobin 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. 

Fluoxastrobin has a low order of acute 

toxicity via the oral, dermal and 

inhalation routes of exposure. 

Fluoxastrobin is a moderate eye irritant 

but is neither a dermal irritant nor a 

skin sensitizer. 

Fluoxastrobin appears to have mild or 

low toxicity following repeated 

administration in all tested species 

other than the dog. In both the 90–day 

and 1–year oral feeding dog studies, 

there was liver toxicity in the form of 

cholestasis as evidenced by 

hepatocytomegaly and cytoplasmic 

granular changes associated with 

increased liver weight and increased 

serum liver alkaline phospatase (ALP). 

In addition, several phase I and phase 

II liver drug metabolizing enzymes were 

induced. Other toxicity in dogs 

included body weight loss or reduced 

gain, decreased food efficiency, and 

effects on kidneys including increased 

relative weight in females and 

degeneration of proximal tubular 

epithelium in males. The no observed 

adverse effect level (NOAEL) of 1.5 

milligrams/kilograms/day (mg/kg/day) 

in the 1–year dog study was used for 

setting the chronic reference dose (RfD). 

The liver appeared to be a target organ 

in other studies, as well, but the 

toxicological relevance of liver findings 

in species other than the dog is 

questionable. For example, among the 

changes noted in the treated animals 

were increased liver weight in the 

mouse and rat, and hypertrophy and 

cytoplasmic changes in the mouse, but 

there were no increases in any of the 

serum liver enzymes including ALP. 

In the 90–day oral toxicity study in 

rats, the urinary system in males was a 

target organ as evidenced by increased 

kidney weight and histopathology 

findings in kidneys, urinary bladder, 

and urethra including the presence of 

calculi in the urethra and kidneys. In 

another rat study, there were markedly 

increased urinary pHs in males in 

addition to increased urinary calcium 

excretion in the form of calcium oxalate 

crystals. Kidney changes were also seen 

in a 90–day mouse feeding study with 

increased kidney weights and tubular 

hypertrophy in females. Following 90– 

day administration in dogs, there was 

degeneration of the proximal tubular 

epithelium in males. 

The adrenal glands seem to be another 

target organ in males of the 90–day rat 

study where vacuolation was seen in the 

zona fasciculata of the adrenal cortex. In 

another 30–day rat feeding study, 

adrenal cortical cytomegaly with fine 

vacuolization was seen in all high dose 

males and the responses were 

comparable between the groups treated 

with the pure fluoxastrobin E- or 2:1 E/ 

Z-isomers. The adrenal changes are not 

likely to be endocrine related effects. 

In the rat and rabbit developmental 

toxicity studies and the 2–generation 

reproduction rat study, there was no 

increased susceptibility to prenatal or 

postnatal exposure to fluoxastrobin and 

no effects on reproduction. 

Fluoxastrobin is not acutely 

neurotoxic in rats up to a single high 

dose of 2,000 mg/kg/day or by repeated 

dietary feeding in the rat subchronic 

neurotoxicity screening study where the 

top dose was nearly half the limit dose 

of 1,000 mg/kg/day. Other studies in 

rats including the subchronic, chronic 

toxicity/carcinogenicity, 2–generation 

reproduction, and developmental 

toxicity were tested to or above the limit 

dose with no indication of clinical 

signs, histopathology or other signs of 

toxicity that could be attributed to 

neurotoxicity. Also, in both the 90–day 

and 1–year dog studies, neurologic 

examinations, including mental status/ 

behavior, gait characteristics, postural 

status and reactions, and spinal/cranial 

reflexes, were carried out and were 

found to be within normal limits. 

Fluoxastrobin is not immunotoxic 

based on repeated dosing studies in rats 

and mice. In the 90–day oral toxicity rat 

study, there was no difference between 

the control and treated animals in 

spleen cell count, macrophage activities 

after PMA stimulation and plaqueforming cell assay after challenge with 

sheep erythrocytes. Slight decreases 

were noted in IgG concentration in the 

high dose males but not females. An 

unacceptable subchronic 

immunotoxicity study in mice found no 

apparent decrease on B-cell activated, Tcell mediated IgM response to sheep red 

blood cell (SRBC) at doses as high as 

2,383 mg/kg/day. 

Fluoxastrobin and major metabolites 

were negative in a battery of 

genotoxicity tests. 

The carcinogenic potential of 

fluoxastrobin was adequately tested in 

rats and mice of both sexes. The results 

demonstrated a lack of treatment-related 

increase in tumor incidence in rats or 

mice. There was no mutagenicity 

concern and no structure activity 

relationship alert. It was concluded that 

there was no incidence of 

carcinogenicity for fluoxastrobin. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluoxastrobin as well 

as the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in the 

final rule published in the Federal 

Register of September 16, 2005 (70 FR 

54640) (FRL–7719–9). 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level – generally referred to as 

a population-adjusted dose (PAD) or a 


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reference dose (RfD) – and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for fluoxastrobin used for 

human risk assessment can be found in 

‘‘Fluoxastrobin. Human Health Risk 

Assessment for Proposed Uses on Sweet 

Corn, Field Corn/Sweet Corn Grown for 

Seed, and Wheat; Revised Tolerances on 

Peanut and Refined Peanut Oil Based on 

a Peanut Processing Study; and Label 

Revision Allowing Homeowner 

Residential Application to Turf 

Grasses,’’ p. 23 in docket ID number 

EPA–HQ–OPP–2007–0677. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluoxastrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fluoxastrobin tolerances in 40 

CFR 180.609. EPA assessed dietary 

exposures from fluoxastrobin 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. 

No such effects were identified in the 

toxicological studies for fluoxastrobin; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA performed an 

unrefined (food and drinking water) 

exposure assessment. The assumptions 

of this dietary assessment included 

tolerance level residues and 100% crop 

treated. Based on processing studies, the 

processing factors for tomato puree, 

potato chips, dry potato (granules/ 

flakes), and potato flour were reduced to 

1. Separate tolerances were set for 

peanut oil, wheat bran and tomato 

paste; therefore, the processing factors 

for these commodities were set at 1. For 

all other processed commodities, 

Dietary Exposure Evaluation Model 

version 7.81 default processing factors 

were assumed. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluoxastrobin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for floxastrobin. Tolerance level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluoxastrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluoxastrobin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models the estimated drinking 

water concentrations (EDWCs) of 

fluoxastrobin for chronic exposures for 

non-cancer assessments are estimated to 

be 33 parts per billion (ppb) for surface 

water and less than 1 ppb for ground 

water. The modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. For chronic dietary 

risk assessment, the water concentration 

of value 33 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). 

Fluoxastrobin has previously been 

registered for the following uses that 

could result in post-application 

residential exposures: Turf, including 

lawns and golf courses. However, 

applications to residential turf have 

previously been restricted to certified 

pest control operators. Under 

consideration in the current risk 

assessment is a proposed label that 

would allow homeowner residential 

application to turf, which would result 

in residential handler exposure. 

Residential handlers may be exposed 

via loading and applying granular 

fluoxastrobin for spot treatments and/or 

broadcast control of turf diseases. 

EPA assessed residential application 

exposure using the following 

assumptions: Because of the potential 

for application four times per year, 

exposure duration is expected to be 

short-term and intermediate-term. A 

short-term dermal endpoint was not 

identified so only intermediate-term 

dermal risks were assessed. Short- and 

intermediate-term inhalation risks were 

also assessed. Homeowner residential 

applicators are expected to be adults. 

There is also the potential for 

homeowners and their families (of 

varying ages) to be exposed as a result 

of entering areas that have previously 

been treated with fluoxastrobin. 

Exposure might occur on areas such as 

lawns used by children or recreational 

areas such as golf courses used by adults 

and youths. Potential routes of exposure 

include dermal (adults and children) 

and incidental oral ingestion (children). 

Since no acute hazard has been 

identified, an assessment of episodic 

granular ingestion was not conducted. 

While it is assumed that most 

residential use will result in short-term 

(1 to 30 days) postapplication 

exposures, it is believed that 

intermediate-term exposures (greater 

than 30 days up to 180 days) are also 

possible. The best data and 

methodology currently available were 

used in the fluoxastrobin residential 

assessment. Since chemical-specific 

data were not available, the Agency 

used the current approaches for 

residential assessment, many of which 

include recent upgrades to the standard 

operating procedures (SOPs). For 

example, for the hand-to-mouth 

calculations for children (three to less 

than six years old), a 5% transferability 

factor was applied to calculate residue 

levels appropriate for this exposure 

pathway. Overall, the Agency believes 

that the calculated risks represent 

screening level estimates. Estimates are 

thought to be conservative, even when 

measures of central tendency (e.g., most 

transfer coefficients) are used, because 

values that would be considered to be 

in the lower percentile aspect of any 

input parameter have not been used in 

the calculations. In addition, maximum 

application rates have been used for all 

scenarios. The risk estimates also 

assume no dissipation of residues after 

day zero and do not take into account 

the periodic growth and cutting of the 

grass. Actual residues should be 

considerably lower, which is why 

intermediate-term exposures are 

unlikely. Further, because a short-term 

dermal toxicity endpoint was not 

identified, the intermediate-term 


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Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 60331 

endpoint was used for all dermal risk 

estimates, even though the residential 

exposure duration is believed to be 

mostly short-term based on the use 

pattern. Finally, based on the Agency’s 

current practices, a quantitative postapplication inhalation exposure 

assessment was not performed at this 

time, primarily because fluoxastrobin 

has a very low vapor pressure. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

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

science/trac6a05.pdf. 

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 fluoxastrobin to 

share a common mechanism of toxicity 

with 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 

assumed that fluoxastrobin does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (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. 

The toxicity database for fluoxastrobin, 

including acceptable developmental 

toxicity studies in rats and rabbits, as 

well as a 2–generation reproductive 

toxicity study, provides no indication of 

prenatal and/or postnasal sensitivity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children is adequately 

protected if the FQPA SF is reduced to 

1X. That decision is based on the 

following findings: 

i. The toxicity database for 

fluoxastrobin is complete except for a 

functional immunotoxicity study as 

required by the recent changes to the 

pesticide data requirements. The 

Agency does have an immunotoxicity 

study for fluoxastrobin but it has 

deficiencies that make it unacceptable at 

this time. Nonetheless, the Agency does 

not believe that conducting a new 

immunotoxicity study will result in a 

lower NOAEL than the regulatory dose 

for risk assessment because available 

data showed no apparent decrease in Bcell activated, T-cell mediated 

immunoglobulin M (IgM) response to 

sheep red blood cells (SRBC) at doses as 

high as 2,383 mg/kg/day. The Agency 

therefore believes that no additional 

safety factor is needed to account for the 

lack of this study, but the registrant will 

be required to upgrade it. 

ii. There is no indication that 

fluoxastrobin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

fluoxastrobin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary food exposure 

assessments utilized tolerance-level 

residues and 100 PCT information for 

all commodities. Use of these screeninglevel assessment values helps ensure 

that chronic exposures and risks will 

not be underestimated. EPA 

additionally made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to fluoxastrobin in 

drinking water. EPA used similarly 

conservative assumptions to assess 

residential post-application exposure of 

children as well as incidental oral 

exposure of toddlers to fluoxastrobin. 

These assessments will not 

underestimate the exposure and risks 

posed by fluoxastrobin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, fluoxastrobin is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluoxastrobin 

from food and water will utilize 42% of 

the cPAD for children (1-2 years old), 

the population subgroup receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

fluoxastrobin is not expected. 

3. Short- and intermediate-term risk. 

Fluoxastrobin is currently registered for 

uses that could result in both short- and 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short- and intermediate-term residential 

exposures of adults and children to 

fluoxastrobin. Short- and intermediateterm aggregate exposure assessments 

take into account short-and 

intermediate-term residential exposure, 

respectively, plus chronic exposure to 

food and water (considered a 

background exposure level). Because all 

short- and intermediate-term 

quantitative hazard assessments (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 exposure estimates (i.e., the 

highest exposure estimates) in the risk 

assessments for adults. The Agency 

believes that most residential exposure 

will be short-term, based on the use 

pattern. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short- and intermediate-term 

food, water, and residential exposures 

result in aggregate MOEs of 470 for 

adult males; 510 for adult females (13- 


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60332 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 

49 years old); 220 for children (1-2 years 

old), short-term; and 210 for children (1- 

2 years old), intermediate-term. 

Residential exposure for adults is 

intermediate-term dermal exposure from 

application of the product plus postapplication dermal exposure plus shortand intermediate-term inhalation 

exposure from application of the 

product. Short-term residential 

exposure for children is incidental oral 

exposure. Intermediate-term residential 

exposure for children is postapplication dermal exposure and postapplication incidental oral exposure. 

Because EPA’s level of concern for 

fluoxastrobin is a MOE of 100 or below, 

these residential MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. As is explained in Unit 

III.A., the Agency has concluded that 

fluoxastrobin is not likely to be 

carcinogenic to humans. Therefore 

cancer risk is not of concern for this 

chemical. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to fluoxastrobin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/mass 

spectrometry/mass spectrometry) is 

available to enforce the tolerance 

expression. Method No. 00604 is 

available for plant commodities and 

Method No. 00691 is available for 

animal commodities. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

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

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

There are currently no Codex or 

Canadian maximum residue limits 

(MRLs) or tolerances for fluoxastrobin in 

or on sweet corn or wheat. 

C. Revisions to Petitioned-For 

Tolerances 

EPA converted ‘‘aspirated grain 

fractions’’ to ‘‘grain, aspirated grain 

fractions’’; ‘‘sweet corn (kernels plus cob 

with husks removed)’’ to ‘‘corn, sweet, 

kernel plus cob with husks removed’’; 

‘‘sweet corn, forage’’ to ‘‘corn, sweet, 

forage’’; ‘‘sweet corn, stover’’ to ‘‘corn, 

sweet, stover’’; ‘‘meat byproducts (cattle, 

goat, horse, sheep)’’ to ‘‘cattle, meat 

byproducts’’, ‘‘goat, meat byproducts’’, 

‘‘horse, meat byproducts’’, and ‘‘sheep, 

meat byproducts’’ to conform them to 

the Agency’s Food and Feed Commodity 

Vocabulary. EPA also corrected the 

tolerance expression for the meat 

byproduct commodities from 

fluoxastrobin and its Z isomer to 

fluoxastrobin, its Z isomer, and its 

phenoxy-hydroxypyrimidine 

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

fluoro-4-pyrimidinol. The proposed 

tolerance of 0.02 ppm in or on sweet 

corn, kernels plus cob with husks 

removed has been reduced to 0.01 ppm 

in or on corn, sweet, kernel plus cob 

with husks removed, based on the 

highest observed residues in the sweet 

corn crop field trials and the limit of 

quantitation of the residue method of 

0.01 ppm for combined residues of 

fluoxastrobin and its Z isomer. The 

proposed tolerance of 0.2 ppm in or on 

wheat, bran has been reduced to 0.15 

ppm and the proposed tolerance of 15 

ppm in or on aspirated grain fractions 

has been increased to 60 ppm in or on 

grain, aspirated grain fractions because 

the wheat field trials indicate that the 

highest average field trial residue of 0.11 

ppm for wheat grain is 0.11 ppm and 

the wheat processing study indicates 

that residues of fluoxastrobin may 

concentrate in wheat, bran (1.3x) and 

aspirated grain fractions (518x). This is 

also an increase in the pre-existing 

tolerance of 20 ppm for fluoxastrobin in 

or on aspirated grain fractions. 

V. Conclusion 

Therefore, tolerances are established 

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

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

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

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

pyrimidinyl]oxy]phenyl](5,6-dihydro1,4,2-dioxazin-3-yl)methanone Omethyloxime, in or on corn, sweet, 

forage at 13 ppm; corn, sweet, kernel 

plus cob with husks removed at 0.01 

ppm; corn, sweet, stover at 10 ppm; 

wheat, bran at 0.15 ppm; wheat, forage 

at 7.0 ppm; wheat, hay at 17 ppm; and 

wheat, straw at 11 ppm. A pre-existing 

tolerance for the residues of 

fluoxastrobin and its Z isomer in or on 

grain, aspirated grain fractions is 

increased from 20 ppm to 60 ppm. Preexisting tolerances are also increased for 

the residues of fluoxastrobin, its Z 

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

chlorophenoxy)-5-fluoro-4-pyrimidinol, 

in cattle, meat byproducts from 0.10 

ppm to 0.20 ppm; in goat, meat 

byproducts from 0.10 ppm to 0.20 ppm; 

in horse, meat byproducts from 0.10 

ppm to 0.20 ppm; and in sheep, meat 

byproducts from 0.10 ppm to 0.20 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 


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Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Rules and Regulations 60333 

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: September 24, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

371. 

■ 2. Section 180.609 is amended by: 

i. Removing ‘‘Aspirated grain 

fractions’’ in paragraph (a)(1) in the 

table; 

ii. Adding alphabetically the 

following commodities to the table in 

paragraph (a)(1); and 

iii. Revising the entries for Cattle, 

meat byproducts; Goat, meat 

byproducts; Horse, meat byproducts; 

and Sheep, meat byproducts in the table 

in paragraph (a)(2). 

The amendments read as follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per million 

* * * * * 

Corn, sweet, forage ........ 13 

Corn, sweet, kernel plus 

cob with husks removed ......................... 0.01 

Corn, sweet, stover ........ 10 

Grain, aspirated grain 

fractions ....................... 60 

* * * * * 

Wheat, bran .................... 0.15 

Wheat, forage ................. 7.0 

Wheat, hay ..................... 17 

Wheat, straw ................... 11 

(2) * * * 

Commodity Parts per million 

* * * * * 

Cattle, meat byproducts 0.20 

* * * * * 

Goat, meat byproducts ... 0.20 

* * * * * 

Horse, meat byproducts 0.20 

* * * * * 

Sheep, meat byproducts 0.20 

* * * * * 

[FR Doc. 2010–24575 Filed 9–29–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Parts 171, 173, and 178 

[Docket No. PHMSA–06–25736 (HM–231)] 

RIN 2137–AD89 

Hazardous Material; Miscellaneous 

Packaging Amendments 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), DOT. 

ACTION: Final rule. 

SUMMARY: On February 2, 2010, the 

Pipeline and Hazardous Materials Safety 

Administration published a final rule 

amending the Hazardous Materials 

Regulations to: Revise several packaging 

related definitions; add provisions to 

allow more flexibility when preparing 

and transmitting closure instructions, 

including conditions under which 

closure instructions may be transmitted 

electronically; add a requirement for 

shippers to retain packaging closure 

instructions; incorporate new language 

that allows for a practicable means of 

stenciling the United Nations (UN) 

symbol on packagings; and clarify a 

requirement to document the 

methodology used when determining 

whether a change in packaging 

configuration requires retesting as a new 

design or may be considered a variation 

of a previously tested design. The 

February 2 final rule also incorporated 

requirements for the construction, 

maintenance, and use of Large 

Packagings. This final rule responds to 

one petition for reconsideration and 

four appeals submitted in response to 

the February 2 final rule and also 

corrects several errors that occurred in 

that rulemaking. 

DATES: Effective Date: October 1, 2010. 

Voluntary Compliance Date: 

Compliance with the requirements 

adopted herein is authorized as of 

September 30, 2010. However, persons 

voluntarily complying with these 

regulations should be aware that 

appeals may be received and as a result 

of PHMSA’s evaluation of these appeals, 

the amendments adopted in this final 

rule correction may be revised 

accordingly. 

FOR FURTHER INFORMATION CONTACT: 

Eileen Edmonson, Office of Hazardous 

Materials Standards, (202) 366–8553, or 

Ben Moore, Office of Hazardous 

Materials Technology, (202) 366–4545; 

Pipeline and Hazardous Materials Safety 

Administration, U.S. Department of 

Transportation, 1200 New Jersey 


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