Federal Register / Vol. 77, No. 206 / Wednesday, October 24, 2012 / Rules and Regulations 64911 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

This extension of a temporary stay is 

not subject to Executive Order 12898. 

Executive Order 12898 (59 FR 7629, 

February 16, 1994), establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this action 

will not have disproportionately high 

and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not change the substance of 40 CFR 

52.1628. 

K. Congressional Review Act 

This action is not subject to the 

Congressional Review Act (‘‘CRA’’). The 

CRA, 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. The Section 804 (3) of the 

CRA defines ‘‘rule’’ as having the same 

meaning given to such term in section 

551 of the APA. See 5 U.S.C. 551(4). 

Since this action is not designed to 

implement, interpret, or prescribe law 

or policy, within the meaning of APA, 

this action is exempted from the 

reporting requirements of the CRA. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur dioxide, Visibility, 

Interstate transport of pollution, 

Regional haze, Best available control 

technology. 

Dated: October 12, 2012. 

Lisa P. Jackson, 

Administrator. 

[FR Doc. 2012–26089 Filed 10–23–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0677; FRL–9365–7] 

Fluoxastrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

fluoxastrobin and its Z-isomer in or on 

poultry, liver; hog, fat; hog, meat 

byproducts; and rice, grain. Arysta 

LifeScience, North America, LLC, 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 24, 2012. Objections and 

requests for hearings must be received 

on or before December 24, 2012, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0677, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Heather Garvie, Registration Division 

(7504P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0034; email address: 

garvie.heather@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0677 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 December 24, 2012. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2009–0677, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 


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• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http://

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register issue of 

October 5, 2011 (76 FR 61647) (FRL– 

8890–5), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a pesticide petition (PP 1F7897) by 

Arysta LifeScience, North America, 

LLC, 15401 Weston Pkwy., Suite 150, 

Cary, NC 27513. The petition requested 

that 40 CFR 180.609 be amended by 

establishing tolerances for 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, 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 rice, grain at 6.0 

parts per million (ppm). That document 

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. A comment was 

received on the notice of filing. EPA’s 

response to this comment is discussed 

in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance on rice, grain to 

4.0 ppm and established additional 

tolerances for hog, fat; hog, meat 

byproducts; and poultry, liver. The 

reason for these changes are explained 

in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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. 

The most recent human health risk 

assessment for fluoxastrobin was 

conducted for use on the squash/ 

cucumber crop subgroup 9B. Since that 

time, an adequate functional 

immunotoxicity study has been 

submitted and reviewed. In accordance 

with 40 CFR part 158—Data 

Requirements for Pesticides, a 

subchronic inhalation study is also 

required for fluoxastrobin. However, the 

Agency has waived the inhalation 

toxicity study data requirement at this 

time. The hazard characterization and 

toxicity endpoints for risk assessment 

remain unchanged. 

Fluoxastrobin and its major 

metabolites were evaluated in a battery 

of genotoxicity tests and results were 

negative. 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 no-observed-adverse-effect-level 

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

toxicity studies are discussed in the 

final rule that established a tolerance for 

residues of fluoxastrobin in or on 

squash/cucumber subgroup 9B. That 

rule was published in the Federal 

Register issue of August 17, 2011 (76 FR 

50893) (FRL–8884–4). 

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 

factors (UFs)/safety factors (SFs) are 

used in conjunction with the POD to 

calculate a safe exposure level— 

generally referred to as a populationadjusted dose (PAD) or a reference dose 

(RfD)—and a safe margin of exposure 

(MOE). For non-threshold risks, the 

Agency assumes that any amount of 

exposure will lead to some degree of 

risk. Thus, the Agency estimates risk in 

terms of the probability of an occurrence 

of the adverse effect expected in a 

lifetime. For more information on the 

general principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for fluoxastrobin used for 

human risk assessment is shown in 

Table 1 of the final rule published in the 

Federal Register issue of August 17, 

2011, p. 50895. 

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 


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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 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA 

conducted a conservative dietary 

exposure assessment for fluoxastrobin. 

The assumptions of this dietary 

assessment included tolerance level 

residues and 100 percent crop treated 

(PCT). The Dietary Exposure Evaluation 

Model (DEEM) software version 7.81 

default processing factors were assumed 

except for where tolerances were 

established for processed commodities 

or when processing studies showed no 

concentration. Based on processing 

studies, the processing factors for dried 

potato (granules/flakes), potato chips, 

potato flour, and tomato puree were 

reduced to 1. Separate tolerances were 

set for peanut oil, tomato paste, and 

wheat bran; therefore, the processing 

factors for these commodities were set at 

1. 

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 fluoxastrobin. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. Based on laboratory studies, 

fluoxastrobin persists in soils for several 

months to several years and is slightly 

to moderately mobile in soil. 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 Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of fluoxastrobin for chronic 

exposures for non-cancer assessments 

are estimated to be 93 parts per billion 

(ppb) for surface water and 0.038 ppb 

for ground water. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. For chronic dietary 

risk assessment, the water concentration 

value of 93 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 is currently registered 

for the following uses that could result 

in residential exposures: Spot treatment 

and/or broadcast control of diseases on 

turf, including lawns and golf courses. 

EPA assessed residential exposure using 

the following assumptions: Residential 

handler exposure for adults is expected 

to be short-term only. Intermediate-term 

and chronic exposures are not likely 

because of the intermittent nature of 

applications by homeowners. Since 

there are no toxicity findings for the 

short-term dermal route of exposure up 

to the limit dose, the residential handler 

assessment only includes the inhalation 

route of exposure. 

There is also 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. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

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

pesticides/science/residential-exposuresop.html. 

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 Web site at 

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

cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA (Food Quality Protection Act) 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 available studies used to evaluate 

pre- and postnatal exposure 

susceptibility do not indicate increased 

susceptibility of rats or rabbits to 

fluoxastrobin. These studies include the 

following: 

i. Developmental toxicity studies in 

rats. 

ii. Developmental toxicity studies in 

rabbits. 

iii. A 2-generation reproduction study 

in rats. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

fluoxastrobin is complete. 

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. The exposure databases are 

estimated based on data that reasonably 

account for potential exposures. The 


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chronic dietary food exposure 

assessment was conservatively based on 

100 PCT assumptions, tolerance-level 

residues, and conservative ground and 

surface drinking water modeling 

estimates. New 2012 Residential 

Standard Operating Procedures (SOPs) 

were used to assess post-application 

exposure to children including 

incidental oral exposure. The residential 

post-application assessment assumes 

maximum application rates and 

conservative day zero hand-to-mouth 

activities. All of the exposure estimates 

for fluoxastrobin are based on 

conservative high-end assumptions and 

are not likely to result in 

underestimated risk. 

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 36% of 

the cPAD for the general population, 

and 75% of the cPAD for children 1–2 

years old, the population group 

receiving the greatest exposure. Based 

on the explanation in Unit III.C.3., 

regarding residential use patterns, 

chronic residential exposure to residues 

of fluoxastrobin is not expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Fluoxastrobin is currently registered 

for uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to fluoxastrobin. 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. 

There is potential short- and 

intermediate-term exposure to 

fluoxastrobin via the dietary (which is 

considered background exposure) and 

residential (which is considered 

primary) pathways. For adults, these 

pathways lead to exposure via the oral 

(background), and dermal and 

inhalation (primary) routes. For 

children, these pathways lead to 

exposure via the oral (background), and 

incidental oral and dermal (primary) 

routes. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 920 for adults and 220 for 

children (1–2 years old). Because EPA’s 

level of concern for fluoxastrobin is a 

MOE of 100 or below, these MOEs are 

not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluoxastrobin is not expected to pose a 

cancer risk to humans. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to 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; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations 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 established Mexican, 

Canadian, or Codex MRLs or tolerances 

for fluoxastrobin. 

C. Response to Comment 

One comment was received to the 

docket from the City of Sacramento, CA. 

The comment was a request that the 

EPA thoroughly review the request to 

register fluoxastrobin for use on rice 

with regard to its potential to affect 

drinking water quality. The Agency has 

determined that dietary risks for 

fluoxastrobin are below the Agency’s 

concern for dietary exposure and risk. 

D. Revisions to Petitioned-For 

Tolerances 

The petitioner requested a tolerance 

level of 6.0 ppm for rice, grain in the 

notice of filing. The Agency has revised 

the tolerance level from 6.0 ppm to 4.0 

ppm for rice, grain based on the data 

used to support the risk assessment. The 

petitioner has subsequently submitted a 

revised notice of filing to the Agency 

requesting a tolerance level of 4.0 ppm 

for rice, grain. 

The use of fluoxastrobin on rice, grain 

will result in a slight increase in the 

dietary burden to ruminants; however 

secondary residues in rumiant 

commodities are not expected to exceed 

the established tolerances for milk and 

ruminant tissues. The increased dietary 

burden to swine and poultry results in 

the need for tolerances for hog, fat at 

0.03 ppm; hog meat, byproducts at 0.06 

ppm; and poultry, liver at 0.06 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of fluoxastrobin 

and its Z-isomer, in or on rice, grain at 

4.0 ppm; hog, fat at 0.03 ppm; hog, meat 


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byproducts at 0.06 ppm; and poultry, 

liver at 0.06 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: October 15, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.609: 

■ i. Add alphabetically the commodity 

‘‘Rice, grain’’ to the table in paragraph 

(a)(1). 

■ ii. Add alphabetically the following 

commodities to the table in paragraph 

(a)(2). The additions read as follows: 

§ 180.609 Fluoxastrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Rice, grain ................................ 4.0 

* * * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Hog, fat ..................................... 0.03 

Hog, meat byproducts .............. 0.06 

* * * * * 

Poultry, liver .............................. 0.06 

* * * * * 

* * * * * 

[FR Doc. 2012–26086 Filed 10–23–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 120330235–2014–01] 

RIN 0648–BC04 

Fisheries of the Northeastern United 

States; Atlantic Sea Scallop Fishery; 

Emergency Rule Extension, Closure of 

the Delmarva Access Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary final rule; 

emergency action extension. 

SUMMARY: NMFS extends the emergency 

closure of the Delmarva Access Area 

(DMV) published on May 14, 2012, 

which is scheduled to expire on 

November 10, 2012. Specifically, this 

temporary rule extends the 180-day 

closure of the DMV in fishing year (FY) 

2012 for an additional 186 days, through 

May 13, 2013. 

DATES: This rule is effective from 

November 10, 2012, through May 14, 

2013. The expiration date of the 

temporary rule published May 14, 2012 

(77 FR 28311), is extended to May 14, 

2013, unless superseded by another 

action which will publish in the Federal 

Register. 

ADDRESSES: The Environmental 

Assessment (EA) is available by request 

from: John K. Bullard, Regional 

Administrator, National Marine 

Fisheries Service, Northeast Region, 55 

Great Republic Drive, Gloucester, MA 

01930–2276, or via the Internet at http://

www.nero.noaa.gov. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Biegel, Fishery 

Management Specialist, 978–281–9112; 

fax 978–281–9135. 

SUPPLEMENTARY INFORMATION: 


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