Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58493 

No Takings Implications 

The Department has analyzed the 

final rule in accordance with the 

principles and criteria in E.O. 12630 

and has determined that this final rule 

will not pose the risk of a taking of 

private property. 

Civil Justice Reform 

The Department has reviewed this 

final rule under E.O. 12988 on civil 

justice reform. After adoption of this 

final rule, (1) All State and local laws 

and regulations that conflict with this 

final rule or that impede its full 

implementation will be preempted; (2) 

no retroactive effect will be given to this 

final rule; and (3) it will not require 

administrative proceedings before 

parties may file suit in court challenging 

its provisions. 

Unfunded Mandates 

Pursuant to Title II of the Unfunded 

Mandates Reform Act of 1995 (2 U.S.C. 

1531–1538), the Department has 

assessed the effects of this final rule on 

State, local, and tribal governments and 

the private sector. This final rule will 

not compel the expenditure of $100 

million or more by any State, local, or 

tribal government or anyone in the 

private sector. Therefore, a statement 

under section 202 of the Act is not 

required. 

Energy Effects 

The Department has reviewed this 

final rule under E.O. 13211 of May 18, 

2001, Actions Concerning Regulations 

That Significantly Affect Energy Supply. 

The Department has determined that 

this final rule does not constitute a 

significant energy action as defined in 

the E.O. 

Controlling Paperwork Burdens on the 

Public 

This final rule does not contain any 

recordkeeping or reporting requirements 

or other information collection 

requirements as defined in 5 CFR part 

1320 that are not already required by 

law or not already approved for use. 

Accordingly, the review provisions of 

the Paperwork Reduction Act (44 U.S.C. 

3501 et seq.) and its implementing 

regulations at 5 CFR part 1320 do not 

apply to this final rule. 

List of Subjects in 36 CFR Part 261 

Law enforcement, National forests. 

Therefore, for the reasons set forth in 

the preamble, the Forest Service is 

amending subpart B of part 261 of Title 

36 of the Code of Federal Regulations to 

read as follows: 

PART 261—PROHIBITIONS 

Subpart B—General Prohibitions 

■ 1. The authority citation for part 261 

continues to read as follows: 

Authority: 7 U.S.C. 1011(f); 16 U.S.C. 472, 

551, 620(f), 1133(c), (d)(1), 1246(i). 

■ 2. In § 261.52, revise paragraph (j) to 

read as follows: 

* * * * * 

§ 261.52 Fire. 

* * * * * 

(j) Operating or using any internal or 

external combustion engine without a 

spark arresting device that is properly 

installed, maintained, and in effective 

working order in accordance with U.S. 

Forest Service Standard 5100–1. 

* * * * * 

Dated: September 14, 2012. 

Tim DeCoster, 

Acting Chief, Forest Service. 

[FR Doc. 2012–23319 Filed 9–20–12; 8:45 am] 

BILLING CODE 3410–11–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0593; FRL–9358–3] 

Flumioxazin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flumioxazin in 

or on multiple commodities which are 

identified and discussed later in this 

document. Valent U.S.A. Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 21, 2012. Objections and 

requests for hearings must be received 

on or before November 20, 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–2011–0593, is 

available either electronically through 

http://www.regulations.gov or in hard 

copy at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

Bethany Benbow, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8072; email address: 

benbow.bethany@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://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 


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58494 Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 

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–2011–0593 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 20, 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 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–2011–0593, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 28221T, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• 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 of August 26, 

2011, 76 FR 53374 (FRL–8884–9), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 1F7886) by Valent U.S.A. 

Corporation, 1600 Riviera Ave., Suite 

200, Walnut Creek, CA 94596. The 

petition requested that 40 CFR 180.568 

be amended by establishing tolerances 

for residues of the herbicide, 

flumioxazin, 2-[7-fluoro-3,4-dihydro-3- 

oxo-4-(2-propynyl)-2H-1,4-benzoxazin6-yl]-4,5,6,7-tetrahydro-1H-isoindole1,3(2H)-dione, in or on Pea and bean, 

dried shelled (except soybean), crop 

subgroup 6C at 0.1 parts per million 

(ppm); Rapeseed, crop subgroup 20A at 

0.35 ppm for seed, 0.04 ppm for meal, 

and 0.02 ppm for refined oil; Sunflower, 

crop subgroup 20B at 0.5 ppm for seed, 

0.03 for meal, 0.02 ppm for refined oil; 

and Wheat at 0.35 ppm for grain, 5.0 

ppm for straw, 0.02 ppm for forage, 0.02 

ppm for hay, 0.35 ppm for bran, 0.05 

ppm for flour, 0.35 ppm for germ, 0.08 

ppm for middlings, 0.11 ppm for shorts, 

110 ppm for aspirated grain fractions. In 

addition, the petition requested 

revocation of the existing tolerance for 

residues of flumioxazin in or on beans, 

dry seed, if a tolerance for Crop 

subgroup 6C (which includes this 

commodity) is set as requested. That 

notice referenced a summary of the 

petition prepared by Valent U.S.A. 

Corporation, the registrant, which is 

available in the docket, EPA–HQ–OPP– 

2011–0593 at 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 and use of the 

OECD tolerance calculation procedures, 

EPA has determined that a single 

tolerance to cover all of the 

commodities within each of the crop 

subgroups is appropriate versus 

individual tolerances for each of the 

commodities within the crop subgroups. 

In addition, EPA has determined that 

several of the proposed tolerances for 

wheat commodities, including wheat 

bran, flour, germ, middlings, and shorts, 

are not required. The reason 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 

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 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. A summary of the 

toxicological findings are as follows: 

Flumioxazin has mild or low acute 

toxicity when administered orally, 

dermally, or by inhalation. It is not an 

eye or skin irritant, or a dermal 

sensitizer. In general, the subchronic 

and chronic toxicity studies 

demonstrated that toxic effects 

associated with flumioxazin include 

anemia as well as effects on the liver 

and the cardiovascular system. 

Developmental effects were observed in 

developmental rat studies but not in 

developmental rabbit studies. 

Hematologic (hematopoietic) effects of 

anemia were noted in rats, consisting of 

alterations in hemoglobin parameters. 

Increased renal toxicity in male rats was 

also reported following chronic 

exposure. There is no evidence of 

neurotoxicity or immunotoxicity in the 

recently submitted guideline studies. 

Increased quantitative susceptibility 

was seen in the rat developmental 

toxicity studies. Fetal effects were 

observed in the absence of maternal 

toxicity. In addition, both increased 

qualitative and quantitative 

susceptibility were observed in the rat 

reproduction study. Severe fetal effects 

were observed at lower doses than 

milder parental effects. In most of the 

available mutagenicity studies, 

flumioxazin was negative for 

mutagenicity; however, aberrations were 

seen in a chromosomal aberration assay 

(CHO cells). Based on the lack of 

evidence of carcinogenicity in mice and 

rats, flumioxazin is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

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 


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

toxicity studies can be found at http:// 

www.regulations.gov in the document, 

Flumioxazin. Human Health Risk 

Assessment for the Proposed Uses on 

Wheat, Sunflower, Safflower, Flax, 

Lentils and Field Peas on page 20 in 

docket ID number EPA–HQ–OPP–2011– 

0593. 

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 (U/SF) 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 is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUMIOXAZIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

NOAEL = 3 mg/kg/ 

day UFA = 10x.

UFH = 10x. 

FQPA SF = 1x. 

Acute RfD = aPAD = 

0.03 mg/kg/day.

Oral Developmental and Supplemental Pre-natal Studies (Rat) 

LOAEL = 10 mg/kg/day, based on cardiovascular effects in 

fetuses. 

Acute dietary (General population including infants and 

children).

No appropriate toxicological effects attributable to a single exposure (dose) were observed in oral toxicity studies including maternal effects in developmental studies in rats and rabbits. Therefore, a dose and endpoint 

were not identified for this risk assessment. 

Chronic dietary (All populations) NOAEL= 2.0 mg/kg/ 

day.

UFA = 10x. 

UFH = 10x. 

FQPA SF = 1x. 

Chronic RfD= cPAD 

= 0.02 mg/kg/day.

2-Year Chronic/Carcinogenicity Study (Rat) LOAEL = 18 mg/ 

kg/day, based on increased chronic nephropathy in males 

and decreased hematological parameters in females. 

Incidental oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL= 6.3 mg/kg/ 

day.

UFA = 10x. 

UFH = 10x. 

FQPA SF = 1x. 

LOC for MOE = 100 2-Generation Reproduction Study (Rat) LOAEL = 12.7 mg/kg/ 

day, based on decreased pup body weight and testicular atrophy in F1 males. 

Dermal-Children short-term (1 

to 30 days) and intermediateterm (1 to 6 months).

NOAEL = 6.3 mg/kg/ 

day (dermal absorption factor = 

8%).

UFA = 10x. 

UFH = 10x. 

FQPA SF = 1x. 

LOC for MOE = 100 2-Generation Reproduction Study (Rat) LOAEL = 12.7 mg/kg/ 

day, based on decreased pup body weight and testicular atrophy in F1 males. 

Dermal-Adults All Durations ...... NOAEL= 30 mg/kg/ 

day.

UFA = 10x. 

UFH = 10x. 

FQPA SF = 1x. 

LOC for MOE = 100 Dermal Developmental Study (Rat) LOAEL = 100 mg/kg/day, 

based on cardiovascular effects in fetuses. 

Inhalation short-term (1 to 30 

days) and Intermediate term 

(1 to 6 months).

oral study NOAEL= 

3 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x. 

UFH = 10x. 

FQPA SF = 10x. 

UFDB.

LOC for MOE = 

1000.

Oral Developmental Study (Rat) LOAEL = 10 mg/kg/day, based 

on cardiovascular effects in fetuses. 

Inhalation Long-term (> 6 

months).

NOAEL = 2 mg/kg/ 

day (inhalation absorption rate = 

100%).

UFA = 10x. 

UFH = 10x. 

FQPA SF = 10x. 

UFDB.

LOC for MOE = 

1000.

2-Year Chronic/Carcinogenicity Study (Rat) LOAEL = 18 mg/ 

kg/day, based on increased chronic nephropathy in males 

and decreased hematological parameters in females. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLUMIOXAZIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (Oral, dermal, inhalation).‘‘Not likely to be a carcinogenic to humans,’’ based on the lack of carcinogenicity in a 2-year rat study, an 18- 

month mouse study, and a battery of mutagenic studies. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use 

of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. 

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. 

Such effects were identified for 

flumioxazin. 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 assumed residues are 

present in all commodities at the 

tolerance level and that 100% of 

commodities with tolerances are treated 

with flumioxazin. In addition, EPA used 

default concentration factors to estimate 

residues of flumioxazin in processed 

commodities. Acute dietary exposure 

was only estimated for females 13–49 

years old based on cardiovascular 

effects in fetuses observed in the oral 

developmental and supplemental prenatal rat studies. An endpoint of 

concern was not established for acute 

dietary assessment of the general 

population. 

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 

assumed residues are present in all 

commodities at the tolerance level and 

that 100% of commodities with 

tolerances are treated with flumioxazin. 

In addition, EPA used default 

concentration factors to estimate 

residues of flumioxazin in processed 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that flumioxazin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk was not 

conducted. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for flumioxazin in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of flumioxazin. 

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. 

Modeled estimates of drinking water 

concentrations, based on the estimated 

environmental concentrations (EECs) for 

flumioxazin and its major degradates 

(482–HA and APF) under the use as an 

aquatic herbicide, were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 400 parts per 

billion (ppb) was used to assess the 

contribution to drinking water. For 

chronic dietary risk assessment, the 

water concentration of value 142 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). 

Flumioxazin is currently registered for 

the following uses that could result in 

residential exposures: Aquatic areas, 

ornamental gardens, ornamental trees, 

and turf in residential lawns, athletic 

fields, parks, and golf courses. EPA 

assessed residential exposure with the 

assumption that homeowner handlers 

wear shorts, short-sleeved shirts, socks, 

and shoes, and that they complete all 

tasks associated with the use of a 

pesticide product including mixing/ 

loading, if needed, as well as the 

application. Residential handler 

exposure scenarios for both dermal and 

inhalation are considered to be shortterm only, due to the infrequent use 

patterns associated with homeowner 

products. EPA uses the term ‘‘postapplication’’ to describe exposure to 

individuals that occur as a result of 

being in an environment that has been 

previously treated with a pesticide. 

Flumioxazin can be used in many areas 

that can be frequented by the general 

population including residential areas, 

golf courses, lakes, and ponds. As a 

result, individuals can be exposed by 

entering these areas if they have been 

previously treated. Therefore, short-term 

and intermediate dermal postapplication exposures and risks were 

assessed for adults and children. In 

addition, oral post-application 

exposures and risks were assessed for 

children to be protective of possible 

hand-to-mouth, object-to-mouth, and 

soil ingestion activities that may occur 

on treated turf areas. 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 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 


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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. 

Evidence of increased susceptibility to 

fetuses was observed in the oral and 

dermal developmental rat studies [i.e. 

cardiovascular anomalies (ventricular 

septal defect)] that occurred in the 

absence of maternal toxicity. 

Additionally, the rat reproduction study 

demonstrated evidence of qualitative 

and quantitative post-natal 

susceptibility because reproductive 

effects in offspring were observed at 

doses lower than those that caused 

parental/systemic toxicity, and because 

the reproductive effects in offspring 

were considered to be more severe than 

the parental/systemic effects. 

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 for oral and dermal 

exposures, but be retained at 10X for 

inhalation exposures. That decision is 

based on the following findings: 

i. The toxicity database for 

flumioxazin is largely complete with the 

exception of an inhalation 

developmental study, which was 

recently determined necessary, in order 

to better assess route-specific inhalation 

risks. In the absence of this study, a 10x 

FQPA safety factor to account for 

database uncertainty is needed to 

protect the safety of infants and children 

to assess risks for all inhalation 

exposure scenarios. The toxicity profile 

can be characterized for all effects, 

including potential developmental and 

reproductive toxicity, immunotoxicity 

and neurotoxicity with the current 

database. 

ii. There is no indication that 

flumioxazin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although increased susceptibility 

was seen in the rat developmental and 

reproductive studies, EPA’s concern for 

these effects is low, and there are no 

residual uncertainties for pre- and/or 

postnatal toxicity because: The 

developmental toxicity NOAELs/ 

LOAELs are well characterized after oral 

and dermal exposure; the offspring 

toxicity NOAEL and LOAEL are well 

characterized in the reproduction study 

and; the Points of Departure (POD) for 

assessing risk to developing fetuses, 

infants, and children have been selected 

either from the developmental and 

reproductive toxicity studies from the 

chronic study which established a lower 

POD for chronic effects than the studies 

in pre- and postnatal animals. Thus, the 

regulatory endpoints for flumioxazin are 

protective of the increased susceptibility 

seen in the developmental and 

reproduction studies, and there are no 

residual concerns for these effects. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

Because the acute and chronic dietary 

exposure estimates were based on 

several conservative assumptions (100% 

of crops treated with residues present at 

tolerance levels, default processing 

factors and screening level drinking 

water estimates), EPA is confident that 

the dietary exposure assessments do not 

underestimate risk to the general U.S. 

population and various population 

subgroups. Similarly, EPA does not 

believe that the non-dietary residential 

exposures are underestimated because 

they are based on the conservative 

assumptions of EPA’s Draft Standard 

Operating Procedures (SOPs) for 

Residential Exposure Assessments 

(December 1997), and updates 

contained in the Science Advisory 

Council Policy 12 (February 2001) as 

well as the uses specified in the 

proposed labels. 

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-, 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. Acute aggregate risk 

takes into account exposure to residues 

in food and drinking water alone. 

Therefore, acute aggregate risk is 

equivalent to the acute dietary risk as 

discussed in Unit III.C.1.i. The acute 

dietary exposure estimate for females 

13–49 years old will utilize 68% of the 

aPAD, which is below the Agency’s LOC 

(100% of the aPAD). 

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 54% of 

the cPAD for all infants (< 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. 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. 

Different methodologies were used for 

the presentation of short-term aggregate 

risk for adults and children. An 

aggregate risk estimate (ARI) approach 

was required to estimate short-term 

adult aggregate risk because there are 

different LOCs for adult dermal and 

inhalation exposures, 100 and 1,000, 

respectively. For short-term child 

aggregate risk, the combined MOE 

approach was used because the 

endpoint of concern (decreased pup 

weight) and the LOC are the same. 

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 

ARI of 1.15 for adults and aggregate 

MOE of 150 for children. Because EPA’s 

LOC for flumioxazin is an ARI of 1 or 

below and a MOE of 100 or below, these 

aggregate risk estimates 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). 

Since the short- and intermediate-term 

toxicological endpoints for flumioxazin 

are the same for each route of exposure, 

only short-term exposures were 

assessed. 


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58498 Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 

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 

Adequate enforcement methodology 

(gas chromatography/nitrogenphosphorus detection (GC/NPD) 

method, Valent Method RM30–A–1) is 

available to enforce the tolerance 

expression. 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 no 

MRLs established by Codex, Canada, or 

Mexico for any of the proposed 

commodities in the current registration 

actions. 

C. Revisions to Petitioned-For 

Tolerances 

EPA has revised the requested 

tolerances by adjusting the tolerance 

values, substituting crop group 

tolerances for individual tolerances, and 

dropping unnecessary tolerances. The 

tolerance levels were revised based on 

analysis of the field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. EPA believes 

they differ from the petitioner’s 

proposed tolerances for dried pea, 

rapeseed subgroup 20A, and wheat 

grain and straw due to the petitioner 

having possibly used the National 

Technology Transfer and Advancement 

Act of 1995 (NAFTA) tolerance 

calculation procedures as opposed to 

the OECD procedure. In addition, EPA 

is setting single tolerances for the crop 

subgroups (6C, 20A and 20B) versus 

individual tolerances for each 

commodity within the subgroups since 

maximum residues of the commodities 

within the crop subgroups differ by less 

than 5X. The proposed tolerances for 

wheat commodities (bran, flour, germ, 

middlings, and shorts) are also not 

necessary since they are covered by the 

tolerance being set for wheat grain. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flumioxazin, 2-[7-fluoro3,4-dihydro-3-oxo-4-(2-propynyl)-2 H 

-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1 H -isoindole-1,3(2 H)-dione, including 

its metabolites and degradates, in or on 

the commodities as set forth in the 

regulatory text. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

flumioxazin. 

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) (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 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. 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 184 / Friday, September 21, 2012 / Rules and Regulations 58499 

Dated: September 10, 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. Section 180.568 is amended by: 

■ a. Alphabetically adding the following 

commodities to the table in paragraph 

(a); 

■ b. Removing the commodity, ‘‘bean, 

dry seed’’ from the table in paragraph 

(a). 

The amendments read as follows: 

§ 180.568 Flumioxazin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Grain, aspirated fractions ....... 100 

* * * * * 

Pea and bean, dried shelled, 

except soybean, subgroup 

6C ........................................ 0 .07 

* * * * * 

Rapeseed subgroup 20A ........ 0 .40 

* * * * * 

Sunflower subgroup 20B ........ 0 .50 

* * * * * 

Wheat, forage ......................... 0 .02 

Wheat, grain ........................... 0 .40 

Wheat, hay ............................. 0 .02 

Wheat, straw ........................... 6 .0 

* * * * * 

[FR Doc. 2012–23352 Filed 9–20–12; 8:45 am] 

BILLING CODE 6560–50–P 

COMMITTEE FOR PURCHASE FROM 

PEOPLE WHO ARE BLIND OR 

SEVERELY DISABLED 

41 CFR Parts 51–1 

Substitution of Term in a Definition; 

Addition and Adoption of the Use of 

Specific Interchangeable or 

Synonymous Terms 

AGENCY: Committee for Purchase From 

People Who Are Blind or Severely 

Disabled. 

ACTION: Final rule. 

SUMMARY: The Committee for Purchase 

From People Who Are Blind or Severely 

Disabled (the Committee) administers 

the AbilityOne® Program pursuant to 

the authority of the Javits-Wagner-O’Day 

(JWOD) Act. The Committee is 

substituting the term ‘‘disabled’’ for 

‘‘handicapped’’ in a term defined in its 

regulation. Additionally, the Committee 

has deliberated and unanimously voted 

to approve the use of ‘‘severely’’ 

disabled and ‘‘significantly’’ disabled as 

interchangeable or synonymous terms 

when referring to people who are 

severely disabled within the AbilityOne 

Program. The Committee’s approval to 

use ‘‘severely’’ and significantly’’ as 

interchangeable or synonymous terms 

within the AbilityOne Program 

specifically does not make any change 

to the definition of ‘‘severely disabled 

individual’’ in the JWOD Act or expand 

the population of individuals served 

within the AbilityOne Program. 

DATES: Effective Date: September 21, 

2012. 

ADDRESSES: The Committee office is 

located at 1421 Jefferson Davis 

Highway, Suite 10800, Arlington, VA 

22202–3259. 

FOR FURTHER INFORMATION CONTACT: 

Dennis Lockard, General Counsel, by 

telephone (703) 603–7740, or by 

facsimile at (703) 603–0030, or by mail 

at the Committee for Purchase From 

People Who Are Blind or Severely 

Disabled, 1421 Jefferson Davis Hwy., 

Suite 10800, Arlington, VA 22202–3259. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Committee for Purchase From 

People Who Are Blind or Severely 

Disabled (Committee) administers the 

AbilityOne® Program pursuant to the 

authority of the Javits-Wagner-O’Day 

(JWOD) Act (41 U.S.C. 8501et seq.). The 

AbilityOne Program provides 

employment opportunities for people 

who are blind or have other severe 

disabilities through the manufacture 

and delivery of products and services to 

the Federal Government. 41 U.S.C. 

8503(d) authorizes the Committee to 

make rules and regulations necessary to 

carry out the purpose of the Act and the 

Committee has done so at 41 CFR 

Chapter 51. Within the AbilityOne 

Program, the term ‘‘severely disabled’’ is 

used to describe people with severe 

disabilities who qualify to participate in 

the program; however, within the 

Committee’s regulation, the terms other 

severely handicapped and severely 

handicapped individuals are used to 

define persons with severe disabilities. 

The Committee is amending its 

regulation to correct the terminology 

and remove references to ‘‘handicap’’ or 

‘‘handicapped’’ in the list of definitions. 

Additionally, the Committee is aware 

that the term ‘‘severely disabled’’ is no 

longer the description of choice of all 

disability advocates and terms such as 

‘‘significantly disabled’’ have gained 

acceptance within the disability 

communities. The Committee is also 

cognizant that the term ‘‘individual with 

a significant disability’’ (instead of 

severe disability) was included and 

defined in the 1998 reauthorization of 

the Rehabilitation Act of 1973 and the 

term is being included in other 

congressional actions and agency 

regulations. In conjunction with the 

broader use of the terms ‘‘significant’’ 

disability and ‘‘significantly’’ disabled, 

the AbilityOne Program’s participants, 

stakeholders and supporters have 

increasingly accepted and used these 

terms within the program. 

Consequently, in order to ensure 

alignment and consistency throughout 

the AbilityOne Program, the Committee 

has voted to permit use of the terms 

‘‘significant’’ or ‘‘significantly’’ as 

interchangeable or synonymous with 

‘‘severe’’ or ‘‘severely’’ when describing 

individuals with severe disabilities who 

qualify to participate in the AbilityOne 

Program. The action by the Committee 

to use the terms interchangeably or 

synonymously does not, however, result 

in any change to the definition or 

eligibility (either expand or narrow) of 

the population served in the AbilityOne 

Program under the authority of the 

JWOD Act. In addition, this action does 

not make any change to the statutory 

name of the Committee or permit the 

use of the synonymous term when 

describing the Committee. 

The Committee has issued a final rule 

because this rule does not have a 

significant effect beyond the internal 

operating procedures of the AbilityOne 

Program and does not have a significant 

cost or administrative impact on others 

not associated with the AbilityOne 

Program. Therefore, public comment is 

not required. This interpretive rule is 

action by the Committee to ensure that 

appropriate terminology is used within 

the AbilityOne Program to describe a 

significant portion of the people who 

are served under this program. 

II. Statutory and Executive Order 

Reviews 

Executive Orders 12866 and 13563 

direct agencies to assess costs, benefits 

and burdens of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effective, distributive impacts, and 

equity). This is not a significant 


pmangrum on DSK3VPTVN1PROD with RULES