Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations 69005 

(2) Rule 420, ‘‘Beef Feedlots,’’ adopted 

on October 10, 2006. 

* * * * * 

[FR Doc. 2010–28257 Filed 11–9–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0781; FRL–8850–3] 

Flumioxazin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flumioxazin in 

or on the commodity fish, freshwater. 

Valent U.S.A. Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 10, 2010. Objections and 

requests for hearings must be received 

on or before January 10, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0781. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn V. Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; e-mail address: 

montague.kathryn@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–2008–0781 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 January 10, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2008–0781, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of December 3, 

2008 (73 FR 73640) (FRL–8390–4), 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 8F7438) by Valent 

U.S.A. Corporation, 1600 Riviera 

Avenue, Suite 200, Walnut Creek, CA 

94596. The petition requested that 40 

CFR part 180 be amended by 

establishing tolerances for residues of 

the herbicide flumioxazin, 2-[7-fluoro3,4-dihydro-3-oxo-4-(2-propynyl)-2H1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1H-isoindole-1,3(2H)-dione and its 

metabolites APF (3-oxo-4-prop-2-ynyl-6- 

amino-7-fluoro-3,4-dihydro-1,4- 

benzoxazin) and 482–HA (N-(7-fluoro3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4- 

benzoxazin-6-yl)cyclohex-1-ene-1- 

carboxamide-2-carboxylic acid) in or on 

commodity fish, freshwater at 1.5 parts 

per million (ppm). That notice 

referenced a summary of the petition 

prepared by Valent U.S.A. Corporation, 

the registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

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 


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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 flumioxazin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with flumioxazin 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. 

Flumioxazin has mild or no acute 

toxicity when administered via the oral, 

dermal and inhalation routes of 

exposure. It has little or no toxicity with 

respect to eye or skin irritation and is 

not a dermal sensitizer. Sub-chronic and 

chronic toxicity studies demonstrated 

that the key toxic effects associated with 

flumioxazin include anemia and 

impacts on the liver and the 

cardiovascular system. Hematologic 

(hematopoietic) effects of anemia were 

noted in rats, including alterations in 

hemoglobin parameters. Increased 

absolute and relative liver weights and/ 

or increased alkaline phosphatase 

values were observed in dogs. 

There was no evidence (quantitative 

or qualitative) of susceptibility 

following in-utero oral exposure in 

rabbits. Developmental studies in the rat 

resulted in cardiovascular anomalies, 

including ventricular septal defects. In 

the 2-generation reproduction study, 

systemic effects (clinical signs and 

mortality as well as a decrease in body 

weight/gain and food consumption) 

were noted in males and females; more 

severe offspring effects (decrease in the 

number of live born and decreased pup 

body weights) were noted at lower doses 

than that which resulted in parental 

effects. 

None of the acute, sub-chronic, 

chronic, developmental or reproduction 

studies indicated an effect on the 

nervous systems. Based on the lack of 

evidence of carcinogenicity in mice and 

rats, flumioxazin is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

Flumioxazin did not induce significant 

increases in any tumor type in either 

rats or mice under the conditions of the 

studies, and it did not induce any 

mutagenic activity in the required 

battery of mutagenicity studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flumioxazin as well as 

the no observed adverse effect level 

(NOAEL) and the lowest observed 

adverse effect level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Flumioxazin. Human Health Risk 

Assessment for a Proposed Aquatic 

Use,’’ pp. 49 to 56 in docket ID number 

EPA–HQ–OPP–2008–0781. 

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 the NOAEL and LOAEL 

of concern are identified. Uncertainty/ 

safety factors (UFS) are used in 

conjunction with the POD to calculate a 

safe exposure level—generally referred 

to as a population-adjusted dose (PAD) 

or a reference dose (RfD)—and a safe 

margin of exposure (MOE). For nonthreshold 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 flumioxazin used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Flumioxazin. Human Health Risk 

Assessment for a Proposed Aquatic 

Use,’’ pp. 25 to 26 in docket ID number 

EPA–HQ–OPP–2008–0781. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flumioxazin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing flumioxazin tolerances in 40 

CFR 180.568. EPA assessed dietary 

exposures from flumioxazin 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 effect was identified 

for the general population. However, 

EPA identified potential acute effects 

(cardiovascular effects in offspring) for 

the population subgroup, females 13 to 

49 years old. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance-level 

residues, dietary exposure evaluation 

model (DEEM) default processing 

factors for all processed commodities 

(with the exception of tomato, which 

used the empirical processing factor of 

1x), and assumed 100 percent crop 

treated (PCT) for all proposed 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance-level residues, DEEM 

default processing factors for all 

processed commodities (with the 

exception of tomato, which used the 

empirical processing factor of 1x), and 

assumed 100 PCT for all proposed 

commodities. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

EPA has classified flumioxazin as ‘‘not 

likely to be carcinogenic to humans.’’ 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 


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anticipated residue and/or PCT 

information in the dietary assessment 

for flumioxazin. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The estimated drinking water 

concentrations (EDWCs) of flumioxazin, 

482–HA, APF and THPA degradates for 

acute exposures are 400 parts per billion 

(ppb) flumioxazin, at day zero and 

estimated to be 10.4 ppb, 1.6 ppb, and 

110.1 ppb for flumioxazin, 482–HA and 

APF degradates, respectively, at day 30 

for surface water. For chronic exposures 

for non-cancer assessments, the EDWCs 

of 482–HA and APF are estimated to be 

4.84 ppb and 12.85 ppb, respectively, 

for surface water. Based on the 

Screening Concentration in Ground 

Water (SCI–GROW) model, for both 

acute and chronic (non-cancer) 

exposures, the EDWCs of 482–HA and 

APF are estimated to be 45.27 ppb and 

2.66 ppb, respectively, for ground water. 

EDWCs of flumioxazin are estimated to 

be negligible in both surface and ground 

water for chronic exposures. 

The estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

peak day zero of 0.40 ppm for 

flumioxazin was used to assess the 

contribution to drinking water for the 

acute dietary risk assessment, and the 

day 30 total of 0.142 ppm for 

flumioxazin, 482–HA and APF 

degradates was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessment. 

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). 

Flumioxazin is currently registered for 

use in the following areas that could 

result in residential exposures: 

Walkways, parking lots and non-grassy 

areas around residential dwellings. EPA 

assessed residential exposure using the 

following assumptions: Short-term 

dermal and inhalation exposure to adult 

handlers resulting from the use of 

flumioxazin within residential settings. 

For the above use sites, no postapplication exposure to adults or 

children from flumioxazin is expected. 

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 flumioxazin to 

share a common mechanism of toxicity 

with any other substances, and 

flumioxazin does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that flumioxazin 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 Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for flumioxazin includes rat 

and rabbit prenatal developmental 

toxicity studies and a 2-generation 

reproduction toxicity study in rats. 

There is no evidence of increased 

susceptibility following in-utero oral 

exposure in rabbits; however, there is 

evidence of increased quantitative 

susceptibility of rat fetuses to in-utero 

exposure to flumioxazin in the oral and 

dermal developmental studies. In both 

studies, there was an increased 

incidence in fetal cardiovascular 

anomalies (including ventricular septal 

defects) in the absence of maternal 

toxicity. Additionally, quantitative 

susceptibility was observed in the 2- 

generation rat reproduction study, in 

which offspring effects (decrease in the 

number of live born and decreased pup 

body weights) were observed at lower 

doses than those which caused parental/ 

systemic toxicity (red substance in 

vagina and increased mortality in 

females as well as decreases in male and 

female body weights, body weight gains 

and food consumption). 

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 

flumioxazin is complete except for 

immunotoxicity, acute neurotoxicity, 

and sub-chronic neurotoxicity testing. 

Recent changes to 40 CFR part 158 make 

acute and sub-chronic neurotoxicity 

testing (OPPTS Test Guideline 

870.6200), and immunotoxicity testing 

(OPPTS Test Guideline 870.7800) 

required for pesticide registration; 

however, the existing data are sufficient 

for endpoint selection for exposure/risk 

assessment scenarios, and for evaluation 

of the requirements under the FQPA. 

The available data for flumioxazin do 

not show the potential for neurotoxic 

effects. In the sub-chronic and chronic 

toxicity studies, signs of anemia (a 

potential immunotoxic effect) were 

observed. In the rat, hematologic 

(hematopoietic) effects of anemia were 

noted, including alterations in 

hemoglobin parameters. Flumioxazin is 

a protoporphyrinogen oxidase (PPO) 

inhibitor, which inhibits the 

biosynthesis of chlorophyll in plants 

(giving flumioxazin its weed-control 

properties). In animals, PPO is 

responsible for one of the later steps in 

heme synthesis; therefore, the inhibition 

of PPO results in anemia. Although 

anemia can potentially be considered an 

immunotoxic effect, in this case it is 

likely the anemia is due to the inhibited 

heme formation (which can interfere 

with the porphyrin component of heme, 

a hematopoietic effect resulting in 

anemia), and the blood effects are not 

considered to be the result of potential 

immunotoxicity. Thus, EPA has 

concluded that flumioxazin does not 

directly impact the nervous system or 

directly target the immune system. The 

Agency does not believe that conducting 

a functional immunotoxicity study will 

result in a NOAEL lower than the 

regulatory dose for risk assessment; 

therefore, an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity or 

neurotoxicity. 

ii. There is no indication that 

flumioxazin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is evidence of increased 

quantitative susceptibility of the young 

following exposure to flumioxazin in 

the oral and dermal developmental 

toxicity studies in the rat and in the 2- 

generation rat reproduction study; 


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therefore, a degree of concern analysis 

was performed to determine the level of 

concern for the effects observed when 

considered in the context of all available 

toxicity data and to identify any 

residual concerns after establishing 

toxicity endpoints and traditional 

uncertainty/safety factor to be used in 

the flumioxazin risk assessment. In 

considering the overall toxicity profile 

and the endpoints and doses selected 

for the flumioxazin risk assessment, 

EPA characterized the degree of concern 

for the susceptibility observed in the rat 

developmental and 2-generation 

reproductive studies as low and 

determined that there are no residual 

uncertainties for prenatal and/or 

postnatal toxicity because: 

a. The only missing toxicity data for 

flumioxazin are the newly required 

neurotoxicity and immunotoxicity 

studies; however, no additional 

uncertainty/safety factor is needed in 

the absence of these studies because 

there is no evidence to indicate that 

flumioxazin targets the nervous system 

or the immune system. Further, EPA has 

concluded a developmental 

neurotoxicity study is not required. 

b. There are clear NOAELs and 

LOAELs for the developmental and 

offspring effects noted in the rat 

developmental toxicity and 2-generation 

reproductive toxicity studies, and the 

doses and endpoints have been selected 

from these studies for risk assessment 

for the relevant exposed populations, 

i.e., pregnant females and children (with 

the exception of the chronic dietary 

endpoint, for which a chronic study was 

chosen for endpoint selection). 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on conservative 

assumptions, including 100 PCT data 

and tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to flumioxazin 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

Post-application exposure to children is 

not expected. These assessments will 

not underestimate the exposure and 

risks posed by flumioxazin. 

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 aPAD and cPAD. For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

given the estimated aggregate exposure. 

Short-term intermediate-term, and 

chronic-term risks are evaluated by 

comparing the estimated aggregate food, 

water, and residential exposure to the 

appropriate PODs to ensure that an 

adequate MOE exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

flumioxazin will occupy 66% of the 

aPAD for females 13–49 years old, the 

population subgroup where a potential 

acute risk was identified. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to flumioxazin 

from food and water will utilize 51% of 

the cPAD for all infants less than 1 year 

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 

flumioxazin is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Flumioxazin 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 flumioxazin. 

Using the exposure assumptions 

described at http://www.regulations.gov 

in document ‘‘Flumioxazin. Human 

Health Risk Assessment for a Proposed 

Aquatic Use,’’ pp. 33 to 46 in docket ID 

number EPA–HQ–OPP–2008–0781 for 

short-term exposures from adult 

application of flumioxazin to residential 

walkways, parking lots and non-grassy 

areas and children and adults 

swimming in treated water, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

results in aggregate MOEs of 690 for 

adults and 470 for children. Because 

EPA’s level of concern for flumioxazin 

is a MOE of 100 or below, these MOEs 

are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Intermediate-term aggregate risks are 

identical to the short-term aggregate 

risks, since endpoints for short-term and 

intermediate-term risk assessments are 

the same, and since residential exposure 

durations are expected to be short-term 

in nature. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flumioxazin is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to flumioxazin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The following adequate enforcement 

methodology is available to enforce the 

tolerance expression: A gas 

chromatography/nitrogen-phosphorus 

detection (GC/NPD) method. 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 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 no Codex, Canadian or 

Mexican maximum residue limits 

(MRLs) established for residues of 

flumioxazin on commodities associated 

with this petition. 

V. Conclusion 

Therefore, tolerances are established 

for residues of herbicide flumioxazin, 2- 

[7-fluoro-3,4-dihydro-3-oxo-4-(2- 

propynyl)-2H-1,4-benzoxazin-6-yl]- 

4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)- 

dione and its metabolites APF (3-oxo-4- 

prop-2-ynyl-6-amino-7-fluoro-3,4- 

dihydro-1,4-benzoxazin) and 482-HA 


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Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Rules and Regulations 69009 

(N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2- 

ynyl-2H-1,4-benzoxazin-6-yl)cyclohex1-ene-1-carboxamide-2-carboxylic acid), 

in or on fish, freshwater at 1.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 28, 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 180.568 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (a) 

to read as follows: 

§ 180.568 Flumioxazin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Fish, freshwater .................... 1.5 

* * * * * 

* * * * * 

[FR Doc. 2010–28132 Filed 11–9–10; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF ENERGY 

48 CFR Parts 919, 922, 923, 924, 925, 

926, and 952 

RIN 1991–AB87 

Acquisition Regulation: 

Socioeconomic Programs 

AGENCY: Department of Energy. 

ACTION: Final rule. 

SUMMARY: The Department of Energy 

(DOE) is amending the Department of 

Energy Acquisition Regulation (DEAR) 

Socioeconomic Programs to make 

changes to conform to the Federal 

Acquisition Regulation (FAR), remove 

out-of-date coverage, and update 

references. Today’s rule does not alter 

substantive rights or obligations under 

current law. 

DATES: Effective Date: December 10, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Binney at (202) 287–1340 or by 

e-mail, barbara.binney@hq.doe.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Comments and Responses 

III. Procedural Requirements 

A. Review Under Executive Order 12866 

B. Review Under Executive Order 12988 

C. Review Under the Regulatory Flexibility 

Act 

D. Review Under the Paperwork Reduction 

Act 

E. Review Under the National 

Environmental Policy Act 

F. Review Under Executive Order 13132 

G. Review Under the Unfunded Mandates 

Reform Act of 1995 

H. Review Under the Treasury and General 

Government Appropriations Act, 1999 

I. Review Under Executive Order 13211 

J. Review Under the Treasury and General 

Government Appropriations Act, 2001 

K. Review Under the Small Business 

Regulatory Enforcement Fairness Act of 

1996 

L. Approval by the Office of the Secretary 

of Energy 

I. Background 

This final rule amends the existing 

Department of Energy Acquisition 

Regulation (DEAR) Subchapter D— 

Socioeconomic Programs. The purpose 

of this rule is to update DEAR 

Subchapter D—Socioeconomic 

Programs to conform it to the FAR. 

Changes are to DEAR parts 919, 922, 

923, 925, 926, and 952. A new part 924 

is added to the DEAR. There are no 

DEAR parts 920 or 921. DEAR parts 919 


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