56374 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 19, 2006. 

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 180.361 is amended by 

adding entries to the table in paragraph 

(a) to read as follows: 

§ 180.361 Pendimethalin, Tolerances for 

Residues. 

(a) * * * 

Commodity 

Parts 

per 

million 

Alfalfa, Forage ..................................... 3.0 

Alfalfa, Hay .......................................... 4.0 

Alfalfa, Seed ........................................ 0.10 

Apple, wet pomace .............................. 0.20 

* * * * * 

Fruit, pome, group 11 .......................... 0.10 

Fruit, stone, group 12 .......................... 0.10 

* * * * * 

Juneberry ............................................. 0.10 

Leek ..................................................... 0.20 

* * * * * 

Onion, green ........................................ 0.20 

Onion, welsh ........................................ 0.20 

* * * * * 

Pomegranate ....................................... 0.10 

* * * * * 

Shallot .................................................. 0.2 

* * * * * 

Strawberry ........................................... 0.10 

* * * * * 

Vegetable, fruiting, group 8 ................. 0.10 

Wheat, grain ........................................ 0.10 

Wheat, forage ...................................... 3.0 

Wheat, hay .......................................... 0.60 

Wheat, straw ....................................... 0.30 

[FR Doc. 06–8254 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0204; FRL–8094–5] 

Quizalofop ethyl; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for combined residues of 

quizalofop ethyl in or on the raw 

agricultural commodities barley, grain; 

barley, hay; barley, straw; flax, seed; 

milk, fat; sunflower, seed; wheat, forage; 

wheat, grain; wheat, hay; and wheat, 

straw. Nissan Chemical Industries, Ltd 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006, 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–2006–0204. All documents in the 

docket are listed in the index for the 

docket. 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 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

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

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

James A. Tompkins, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: 703–305–5697; e-mail address: 

Tompkins.jim@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 


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Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 56375 

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–2006–0204 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 27, 2006. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0204, 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 Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’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 telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of August 2, 

2006 (71 FR 43762) (FRL–8057–2), 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 0F6076) by Nissan 

Chemical Industries, Ltd (Nissan), 7-1,3- 

Chome, Kanda-Nishiki-Cho Chiyoda-Ku, 

Tokyo, 101–0054, Japan. The petition 

requested that 40 CFR 180. 441 be 

amended by establishing a tolerance for 

residues of the herbicide quizalofop-pethyl on barley, flax (seed) and wheat at 

0.05 part per million (ppm) and 

sunflower (seed) at 2.0 part per million. 

That notice included a summary of the 

petition prepared by Nissan Chemical 

Industries, Ltd, the registrant. There 

were no comments received in response 

to the notice of filing. 

During the course of the review, the 

Agency determined that based on the 

calculated maximum dietary burdens 

(MTDBs) for quizalofop-p ethyl the 

current tolerance for milk, fat should be 

increased. Therefore, the petition was 

subsequently amended to propose that 

40 CFR 180.441(a)(2) be amended by 

proposing a tolerance be established for 

the combined residues of the herbicide 

quizalofop, (2-[4-(6-chloroquinoxalin-2- 

yloxy)phenoxy]propanoic acid), 

quizalop-ethyl (ethyl-2-[4-(6- 

chloroquinoxalin-2- 

yloxy)phenoxy]propanoate), and 

quizalofop-methyl (methyl 2-[4-(6- 

chloroquinoxalin-2- 

yloxy)phenoxy]propanoate), all 

expressed as quizalofop ethyl on milk, 

fat at 0.25 ppm. This tolerance will 

replace the current milk, fat tolerance 

listing of 0.05 ppm. During the course 

of the review the Agency also 

determined that the available data 

supported a reduction in the proposed 

tolerance for sunflower, seed and that 

the commodities for barley and wheat 

needed to be defined based on current 

terminology. The petition was also 

amended propose that 40 CFR 

180.441(a)(3) be amended by proposing 

that tolerances be established for the 

combined residues of the herbicide 

quizalofop-p ethyl ester (ethyl (R)-2-(4- 

((6-chloroquinoxalin-2- 

yl)oxy)phenoxy)propanonate) and its 

acid metabolite quizalofop-p [R-(2-(4- 

((6-quinoxalin-2-yl)phenoxy)propanoic 

acid] and the S enantiomers of both the 

ester and the acid, all expressed as 

quizalofop-p-ethyl ester, in or on the 

raw agricultural commodities barley, 

grain at 0.05 ppm; barley, hay at 0.05 

ppm; barley, straw at 0.05 ppm; flax, 

seed at 0.05 ppm; sunflower, seed at 1.9 

ppm; wheat, forage at 0.05 ppm; wheat, 

grain at 0.05 ppm; wheat, hay at 0.05 

ppm; and wheat, straw at 0.05 ppm. 

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for combined 

residues of quizalofop, quizalofop-ethyl, 

and quizalofop-methyl, all expressed as 

quizalofop ethyl on milk, fat at 0.25 

ppm, and for the combined residues of 

quizalofop-p ethyl ester, quizalop-p, and 

the S-enantiomers of both the ester and 

the acid , all expressed as quizalofop 

ethyl in or barley, grain at 0.05 ppm; 

barley, hay at 0.05 ppm; barley, straw at 

0.05 ppm; flax, seed at 0.05 ppm; 

sunflower, seed at 1.9 ppm; wheat, 

forage at 0.05 ppm; wheat, grain at 0.05 

ppm; wheat, hay at 0.05 ppm; and 

wheat, straw at 0.05 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the 

tolerance 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

quizalofop ethyl as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found in the Federal Register of 

June 16, 1998 http://www.epa.gov/ 

fedrgstr/EPA-PEST/1998/June/Day-16/ 

p15746.htm. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 


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appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern(LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

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

pesticides/health/human/htm. 

A summary of the toxicological 

endpoints for quizalofop ethyl used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of June 16, 1998 

http://www.epa.gov/fedrgstr/EPA-PEST/ 

1998/June/Day-16/p15746.htm. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.441) for the 

combined residues of quizalofop, 

quizalofop-p ethyl and associated 

metabolites, all expressed as quizalofop 

ethyl , in or on a variety of raw 

agricultural commodities. Tolerances 

have been established under 40 CFR 

180.441(a)(2) for quizalofop, quizalofopethyl, and quizalofop-methyl, all 

expressed as quizalofop ethyl in meat, 

fat, and meat byproducts of cattle, goat, 

hog, horse poultry, and sheep; milk and 

milk, fat and egg. Risk assessments were 

conducted by EPA to assess dietary 

exposures from quizalofop ethyl 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 one-day or 

single exposure. 

No such effects were identified in the 

toxicological studies for quizalofop 

ethyl; therefore, a quantitative acute 

dietary exposure assessment is 

unnecessary 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM-FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII), and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

tolerance level residues for all 

commodities and 100 percent crop 

treated. The assessment included 

existing food uses as well as the newly 

proposed tolerances for uses on barley, 

wheat, sunflower, and flax. PCT and/or 

anticipated residues were not used. 

iii. Cancer. EPA concluded that 

quizalofop ethyl should be classified as 

a Category D carcinogen (not classifiable 

as to human carcinogenicity), based on 

results of rat and mouse cancer studies 

along with other relevant short-term 

toxicity, mutagenicity studies, and 

structure-activity relationships. The 

Group D classification is based on an 

approximate doubling in the incidence 

of mice liver tumors between controls 

and the high-dose. This finding was not 

considered strong enough to warrant the 

classification of a Category C (possible 

human carcinogen); the increase was of 

marginal statistical significance, 

occurred at high dose which exceeded 

the MTD, and occurred in a study in 

which the concurrent control for liver 

tumors was somewhat low as compared 

to the historical controls, while the 

high-dose control group was at the 

upper end of the previous historical 

control groups. Based on the results of 

the above adequate studies, the Agency 

believes that quizalofop-p ethyl does not 

pose a significant cancer risk to humans 

and a quantitative cancer exposure 

assessment is unnecessary. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

quizalofop ethyl in drinking water. 

Because the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

quizalofop ethyl. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed/models/water/index.htm. 

Based on the PRZM/EXAMS and SCIGROW models, the estimated 

environmental concentrations (EECs) of 

quizalofop ethyl for chronic exposures 

are 1.99 parts per billion (ppb) for 

surface water and 0.15 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model (DEEMFCID). For chronic dietary risk 

assessment, the annual average 

concentration in surface water of 1.99 

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). 

Quizalofop ethyl is not registered for 

use on any sites that would result in 

residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

quizlalofop ethyl and any other 

substances and quizalofop ethyl does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

quizalofop ethyl has a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 


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different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There are no concerns and no residual 

uncertainties for increased qualitative or 

quantitative susceptibility following in 

utero or prenatal/postnatal exposure or 

for prenatal and postnatal toxicity. See 

the Federal Register of June 16, 1998 

http://www.epa.gov/fedrgstr/EPA-PEST/ 

1998/June/Day-16/p15746.htm. 

A developmental neurotoxicity study 

is not required for quizalofop ethyl 

based on the following: 

i. Quizalofop ethyl does not appear to 

be a neurotoxic chemical. 

ii. No-treatment -related effects on 

brain weight or histopathology of the 

nervous system were observed in 

studies that measured these endpoints. 

iii. No evidence of developmental 

anamalies of the fetal nervous system 

were observed in either rats or rabbits, 

at maternally toxic doses up to 300 and 

600 mg/kg/day, respectively. 

iv. No evidence of an effect on 

functional development was observed in 

a postnatal segment of the 

developmental toxicity study in rats. 

3. Conclusion. There is a complete 

toxicity data base for quizalofop ethyl 

and exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. EPA 

determined that the 10X SF to protect 

infants and children should be removed. 

The FQPA factor is removed because the 

toxicology data base is complete; a 

developmental neurotoxicity study is 

not required; developmental toxicity 

studies showed no increased sensitivity 

in fetuses as compared to maternal 

animals following in utero exposures in 

rats and rabbits; a 2-generatioin 

reproduction study showed no 

increased sensitivity in pups as 

compared to adults; and exposure data 

are complete or are estimated based on 

data that reasonably accounts for 

potential exposures. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. Quizalofop-ethyl is not 

expected to pose an acute risk because 

no toxicological endpoints attributable 

to a single exposure (dose) were 

identified in the toxicology data base. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to quizalofop-ethyl from 

food will utilize 11% of the cPAD for 

the U.S. population, 27% of the cPAD 

for infants <1 year old, and 29% of the 

cPAD for children 1 to 2 years old.. 

There are no current or requested 

residential uses for quizalofop-ethyl that 

result in chronic residential exposure to 

quizalofop-ethyl. Therefore, EPA does 

not expect the aggregate exposures, 

which are equivalent to chronic dietary 

exposures, to exceed 100% of the cPAD. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Quizalofop ethyl is not registered for 

use on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Quizalofop ethyl is not registered for 

use on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. For the reasons stated in 

this unit, quizalofop ethyl is not 

expected to pose a greater than 

negligible cancer risk. 

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 and to infants and children 

from aggregate exposure to quizalofop 

ethyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(High Performance Liquid 

Chromatography (HPLC) Methods, 

SARS–98–06 (for flax and sunflower) 

and Morse Method Meth-147 (for wheat 

and barley)) are 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There is a Canadian maximum 

residue limit (MRL) in/on flax at 0.05 

mg/kg, which is in agreement with the 

proposed tolerance on flax, seed. There 

are no Mexican or Codex MRLs 

established for quizalofop ethyl, 

therefore compatibility is not a problem 

at this time. 

V. Conclusion 

Therefore, the tolerance is established 

under 40 CFR 180.441(a)(2) for the 

combined residues of the herbicide 

quizalofop (2-[4-(6-chloroquinoxalin-2- 

yloxy)phenoxy]propanoic acid), 

quizalop-ethyl (ethyl-2-[4-(6- 

chloroquinoxalin-2- 

yloxy)phenoxy]propanoate), and 

quizalofop-methyl (methyl 2-[4-(6- 

chloroquinoxalin-2- 

yloxy)phenoxy]propanoate), all 

expressed as quizalofop ethyl in or on 

milk, fat at 0.25 ppm. This tolerance 

will replace the current milk, fat 

tolerance listing of 0.05 ppm. 

Tolerances are also established under 40 

CFR 180.441(a)(3) for the combined 

residues of the herbicide quizalofop-p 

ethyl ester (ethyl (R)-2-(4-((6- 

chloroquinoxalin-2- 

yl)oxy)phenoxypropanonate] and its 

acid metabolite quizalofop-p [R-(2-(4- 

((6-quinoxalin-2-yl)phenoxy)propanoic 

acid] and the S enantiomers of both the 

ester and the acid, all expressed as 

quizalofop-p-ethyl ester, in or on the 

raw agricultural commodities barley, 

grain at 0.05 ppm; barley, hay at 0.05 

ppm; barley, straw at 0.05 ppm; flax, 

seed at 0.05 ppm; sunflower, seed at 1.9 

ppm; wheat, forage at 0.05 ppm; wheat, 

grain at 0.05 ppm; wheat, hay at 0.05 

ppm; and wheat, straw at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 


sroberts on PROD1PC70 with RULES
56378 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 19, 2006. 

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 180.441 is amended by 

revising the listing for milk, fat in the 

table to paragraph (a)(2) and by 

amending the table in paragraph (a)(3) 

by alphabetically adding commodities 

to read as follows: 

§ 180.441 Quizalofop ethyl; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per million 

* * * * * 

Milk, fat ........................... 0.25 

* * * * * 

(3) * * * 

Commodity Parts per million 

Barley, grain ................... 0.05 

Barley, hay ...................... 0.05 

Barley, straw ................... 0.05 

* * * * * 

Flax, seed ....................... 0.05 

Sunflower, seed .............. 1.9 

* * * * * 

Wheat, forage ................. 0.05 

Wheat, grain ................... 0.05 

Wheat, hay ..................... 0.05 

Wheat, straw ................... 0.05 

* * * * * 

[FR Doc. 06–8253 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0056; FRL–8093–5] 

Bentazon, Carboxin, Dipropyl 

Isocinchomeronate, Oil of Lemongrass 

(Oil of Lemon) and Oil of Orange; 

Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking certain 

tolerances for the fungicide carboxin, 

the insecticide dipropyl 

isocinchomeronate, and the fungicide/ 

animal repellent oil of lemon (oil of 

lemongrass) and oil of orange. Also, 

EPA is modifying certain tolerances for 

the herbicide bentazon and the 

fungicide carboxin. In addition, EPA is 

establishing new tolerances for the 

herbicide bentazon. 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006, and 

must be filed in accordance with the 


sroberts on PROD1PC70 with RULES