Federal Register / Vol. 77, No. 77 / Friday, April 20, 2012 / Rules and Regulations 23625 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: February 29, 2012. 

Susan Hedman, 

Regional Administrator, Region 5. 

40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart O—Illinois 

■ 2. Section 52.720 is amended by 

adding paragraph (c)(190) to read as 

follows: 

§ 52.720 Identification of plan. 

* * * * * 

(c) * * * 

(190) On June 10, 2011, the Illinois 

Environmental Protection Agency 

submitted a revision to its state 

implementation plan. The revision to 

the SIP allows an adjusted standard to 

the general rule, Use of Organic Material 

Rule, known as the eight pound per 

hour (8 lb/hr) rule, for volatile 

organic matter, for Leisure Properties 

LLC/D/B/A Crownline Boats 

manufacturing facility located in West 

Frankfort, Illinois. The adjusted 

standard is that the facility takes an 

alternative standard of the emission 

limit requirements set forth in the 

MACT under 40 CFR part 63 subpart 

VVVV as published in 40 CFR Part 63 

(§ 63.1200 to end) revised as of July 1, 

2002. 

(i) Incorporation by reference. 

(A) July 22, 2004, Opinion and Order 

of the Illinois Pollution Control Board, 

AS–04–01, (identified in error as July 

22, 2002 in the document heading), 

effective July 22, 2004. 

(ii) Additional material. 

(A) Letter from Laurel L. Kroack, 

Illinois Environmental Protection 

Agency, to Cheryl Newton, EPA, dated 

September 2, 2011, identifying that due 

to an ownership change to Crownline 

Boats, the Board transferred the 

adjusted standard to Leisure Properties 

LLC D/B/A Crownline Boats, which is 

the successor to Crownline Boats, by 

Board order AS04–l, effective October 7, 

2010. 

[FR Doc. 2012–9440 Filed 4–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–1018; FRL–9340–5] 

Quizalofop Ethyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of quizalofop 

ethyl in or on multiple commodities 

which are identified and discussed later 

in this document. This regulation 

additionally removes established 

tolerances on canola seed and canola 

meal, as they will be superseded by new 

tolerances. Finally, this regulation 

removes several time-limited tolerances, 

as they have expired. Interregional 

Research Project Number 4 (IR–4) 

requested these tolerances, under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

20, 2012. Objections and requests for 

hearings must be received on or before 

June 19, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–1018. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@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. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp and 

select ‘‘Test Methods and Guidelines,’’ 

which is listed under ‘‘Documents 

related to our mission.’’ 

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–2010–1018 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 


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received by the Hearing Clerk on or 

before June 19, 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–2010–1018, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerances 

In the Federal Register of February 

25, 2011 (76 FR 10584) (FRL–8863–3), 

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 0E7802, by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.441 be 

amended by establishing tolerances for 

residues of the herbicide quizalofop 

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

yl oxy)phenoxy]propanoate, including 

its metabolites and degradates, in or on 

rapeseed subgroup 20A, except flax, 

seed at 1.0 parts per million (ppm); gold 

of pleasure, meal at 1.5 ppm; crambe, 

meal at 1.5 ppm; sorghum, grain at 0.2 

ppm; sorghum, forage at 0.2 ppm; 

sorghum, stover at 0.35 ppm; and 

sorghum, aspirated grain at 1.0 ppm. 

The petition additionally requested that 

EPA amend tolerances in 40 CFR 

180.441 by removing the established 

tolerance for canola, seed at 1.0 ppm 

from the table in paragraph (a)(3), as the 

individual tolerance will be superseded 

by inclusion in rapeseed subgroup 20A, 

except flax, seed. The petition also 

proposed to remove the tolerances in 

§ 180.441(a)(4), as these tolerances 

expired on June 14, 1999. 

The petition, PP 0E7802, also 

proposed to amend 40 CFR 180.441 by 

combining the tables for sections (a)(1) 

and (a)(3) into one table under section 

(a)(1), and by removing section (a)(3). It 

further proposed to revise the tolerance 

expression under section (a)(1). The 

petition, PP 0E7802, additionally 

proposed to revise the tolerance 

expression under section (a)(2). 

Finally, PP 0E7802 proposed to revise 

the tolerance expression under section 

(c). That notice referenced a summary of 

the petition prepared on behalf of IR–4 

by E.I. du Pont de Nemours and 

Company, the registrant, which is 

available to the public in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petitions, EPA has 

revised the proposed tolerance level 

and/or commodity definition for several 

commodities. The Agency has also 

removed the established tolerance on 

canola, meal, as the data were used to 

establish a tolerance on rapeseed meal, 

the preferred commodity terminology. 

The reasons for these changes are 

explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue * * *.’’ 

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

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for quizalofop ethyl 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with quizalofop ethyl 

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. 

Quizalofop ethyl has low acute 

toxicity via the oral, dermal, and 

inhalation routes of exposure. It is not 

an eye or dermal irritant nor a skin 

sensitizer. The liver has been identified 

as the target organ, as evidenced by 

increased liver weights and 

histopathological changes in the liver. 

There were no effects observed in the 

oral toxicity studies that could be 

attributable to a single-dose exposure 

and no observed toxicity in a 

subchronic dermal toxicity study in 

rabbits. Following subchronic oral 

exposures, decreased body weight gains, 

increased liver weight and centrilobular 

liver cell enlargement were noted in 

rats, and an increased incidence of 

testicular atrophy was noted in dogs. A 

combined chronic toxicity/ 

carcinogenicity study in rats noted an 

increased incidence of centrilobular 

enlargement of the liver in both sexes 

and mild anemia in males. No 

treatment-related effects on brain weight 

or histopathology of the nervous system 

were observed in studies that measured 

those endpoints. 

In developmental toxicity studies in 

rats and rabbits, maternal effects, 

including decreased body weight gains 

and food consumption, were noted at a 

level that did not result in 

developmental effects. In the 2- 

generation reproduction study in rats, 

maternal effects including decreased 

body weight and body weight gains 

were noted at the same dose level that 

resulted in prenatal and postnatal 

effects (decreased percentage of pups 

born alive and decreased pup weights). 

Carcinogenicity studies in rats and 

mice disclosed no more than very 

limited data suggestive of a potential for 

carcinogenic risk. No evidence of 

carcinogenicity was seen in female mice 

and in male or female rats. Liver tumors 

were found in male mice. However, 


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these tumors were seen only at an 

excessive dose, occurred at low 

incidence, showed marginal statistical 

significance at the high dose (no dose 

response), and were not accompanied 

with corroborative pre-neoplastic 

lesions. Further, liver tumors are 

common and occur with a high degree 

of variability in male mice. In addition, 

mutagenicity studies conducted on 

quizalofop ethyl did not demonstrate 

evidence of mutagenic potential. 

Consequently, there is no concern for 

the carcinogenicity following exposure 

to quizalofop ethyl. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by quizalofop ethyl as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observed

-adverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document: 

‘‘Quizalofop-P-ethyl: Human Health 

Risk Assessment for New Uses on 

Sorghum, Rapeseed Crop Group 20 A, 

and Field Corn,’’ at pp. 33–34 in docket 

ID number EPA–HQ–OPP–2010–1018. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for quizalofop ethyl used for 

human risk assessment is shown in the 

Table of this unit. 

TABLE —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR QUIZALOFOP ETHYL 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 (All populations).No appropriate endpoint was identified. There were no effects observed in oral toxicity studies that could be attributed to a single-dose exposure. 

Chronic dietary (All populations).NOAEL = 0.9 mg/kg/day ...

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.009 mg/ 

kg/day.

cPAD = 0.009 mg/kg/day. 

Chronic toxicity/Carcinogenicity study in rats. LOAEL = 

3.7 mg/kg/day based on increased incidence of 

centrilobular enlargement of the liver in both sexes 

and mild anemia in males. 

Cancer (Oral, dermal, inhalation).No concern as to human carcinogenicity. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. Mg/kg/day= milligrams/kilograms/day. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to quizalofop ethyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing quizalofop ethyl tolerances in 

40 CFR 180.441. EPA assessed 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 1-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 food consumption data 

from the USDA 1994–1996 and 1998 

Continuing Surveys of Food Intakes by 

Individuals (CSFII). As to residue levels 

in food, EPA incorporated tolerancelevel residues and 100 percent crop 

treated (PCT) for all commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that there is no concern with 

regard to carcinogenicity. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is not 

needed. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for quizalofop ethyl. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for quizalofop ethyl in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

quizalofop ethyl. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

quizalofop ethyl for chronic exposures 

for non-cancer assessments are 

estimated to be 2 parts per billion (ppb) 

for surface water and 1.29 ppb for 

ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 


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water concentration of value 2 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 

any specific use patterns that would 

result in residential exposure. 

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 quizalofop ethyl to 

share a common mechanism of toxicity 

with 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 

assumed that quizalofop ethyl 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 quizalofop ethyl toxicity database is 

adequate to evaluate potential increased 

susceptibility of infants and children, 

and includes developmental toxicity 

studies in rats and rabbits and a 2- 

generation reproduction study in rats. In 

developmental toxicity studies in rats 

and rabbits, maternal effects, including 

decreased body weight gains and food 

consumption, were noted (100 mg/kg/ 

day for rats and 60 mg/kg/day for 

rabbits) in the absence of developmental 

effects. In the 2-generation reproduction 

study in rats, maternal effects 

(decreased body weight and body 

weight gains) were noted at 20 mg/kg/ 

day, the same dose level that resulted in 

prenatal and postnatal effects (decreased 

percentage of pups born alive and 

decreased pup weights). 

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 quizalofop 

ethyl is complete except for acute and 

subchronic neurotoxicity testing. Recent 

changes to 40 CFR part 158 imposed 

new data requirements for acute and 

subchronic neurotoxicity testing 

(OPPTS Guideline 870.6200) for 

pesticide registration. HED has 

determined from available studies in the 

quizalofop ethyl toxicity database that 

quizalofop does not have specific 

neurotoxicity. More specifically, there 

were no treatment-related effects on 

brain weight or histopathology of the 

nervous system seen in studies that 

measured these endpoints. There was 

no evidence of effects on functional 

development observed in a postnatal 

segment of the reproduction study in 

rats. In addition, quizalofop ethyl does 

not belong to a chemical class that is 

considered neurotoxic. Although 

clinical signs possibly indicative of 

neurotoxicity were seen, they were only 

observed at high doses and, even then, 

were rare. The requested acute and 

subchronic neurotoxicity studies are 

expected to confirm that there are no 

indications of neurotoxicity. Therefore, 

EPA does not believe that conducting 

acute and subchronic neurotoxicity 

studies will result in a NOAEL less than 

the chronic NOAEL of 0.9 mg/kg/day 

already set for quizalofop ethyl. Based 

on the information in this unit, EPA has 

also determined that there is no need for 

a developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

ii. There is no evidence that 

quizalofop ethyl results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The chronic dietary exposure 

assessments were performed based on 

100 PCT and tolerance-level residues, 

and EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to quizalofop ethyl in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by quizalofop ethyl. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, quizalofop ethyl is 

not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to quizalofop 

ethyl from food and water will utilize 

29% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for quizalofop ethyl. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short- or 

intermediate-term adverse effect was 

identified, quizalofop ethyl is not 

expected to pose a short- or 

intermediate-term risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the information 

described in Unit III.A., there is no 

concern for human carcinogenicity. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to quizalofop 

ethyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Morse Method Meth-147, a high 


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Federal Register / Vol. 77, No. 77 / Friday, April 20, 2012 / Rules and Regulations 23629 

performance liquid chromatography 

method) is available to enforce the 

tolerance expression for plant 

commodities. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 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. The 

Codex has not established a MRL for 

quizalofop ethyl. 

C. Revisions to Petitioned-For 

Tolerances 

Based on analysis of the residue field 

trial data supporting the petitions, EPA 

revised the proposed tolerances on 

rapeseed subgroup 20A, except flax, 

seed from 1.0 ppm to 1.5 ppm; sorghum, 

grain, stover from 0.35 ppm to 0.30 

ppm; crambe, meal from 1.5 ppm to 2.0 

ppm; and gold of pleasure, meal from 

1.5 ppm to 2.0 ppm. The Agency revised 

these tolerance levels based on analysis 

of the residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. 

Based on available canola processing 

data, a tolerance for canola, meal was 

previously established at 1.5 ppm. 

Using the available canola processing 

data, EPA has recommended a tolerance 

for gold of pleasure, meal; and crambe, 

meal at 2.0 ppm, by adjusting for the 

proposed application rate. As such, the 

previously established tolerance on 

canola, meal at 1.5 ppm was also 

revised to 2.0 ppm, and EPA is revising 

the commodity definition for canola, 

meal to rapeseed, meal in order to 

reflect the correct commodity 

terminology. Therefore, EPA determined 

that a tolerance should be established 

on rapeseed, meal at 2.0 ppm, and the 

established tolerance on canola, meal at 

1.5 ppm should be removed. 

The Agency also revised several other 

proposed and established commodity 

definitions to reflect the correct 

terminology, as follows: Bean, dry to 

bean, dry seed; sorghum, grain to 

sorghum, grain, grain; sorghum, forage 

to sorghum, grain, forage; sorghum, 

stover to sorghum, grain, stover; 

sorghum, aspirated grain to sorghum, 

grain, aspirated grain fractions; and 

soybean to soybean, seed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of quizalofop ethyl, ethyl-2- 

[4-(6-chloroquinoxalin-2-yl 

oxy)phenoxy]propanoate, in or on 

crambe, meal at 2.0 ppm; gold of 

pleasure, meal at 2.0 ppm; rapeseed, 

meal at 2.0 ppm; rapeseed, subgroup 

20A, except flax, seed at 1.5 ppm; 

sorghum, grain, grain at 0.20 ppm; 

sorghum, grain, forage at 0.20 ppm; 

sorghum, grain, stover at 0.30 ppm; and 

sorghum, grain, aspirated grain fractions 

at 1.0 ppm. This final rule additionally 

removes the established tolerances for 

canola, seed at 1.0 ppm; and canola, 

meal at 1.5 ppm. This regulation also 

deletes time-limited tolerances for 

quizalofop ethyl on beet, sugar, 

molasses at 0.2 ppm; beet, sugar, roots 

at 0.1 ppm; beet, sugar, tops at 0.5 ppm; 

vegetable, foliage of legume, except 

soybean, subgroup 7A at 3.0 ppm; and 

vegetable, legume, group 6 at 0.25 ppm, 

as the tolerances expired on June 14, 

1999. Finally, this final rule revises the 

tolerance expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

quizalofop ethyl not specifically 

mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

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 


tkelley on DSK3SPTVN1PROD with RULES
23630 Federal Register / Vol. 77, No. 77 / Friday, April 20, 2012 / Rules and Regulations 

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: April 11, 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 180.441 is amended as 

follows: 

■ i. Revise paragraph (a)(1); 

■ ii. Revise paragraph (a)(2) 

introductory text; 

■ iii. Remove paragraphs (a)(3) and 

(a)(4); and 

■ iv. Revise paragraph (c) introductory 

text. 

The revisions read as follows: 

§ 180.441 Quizalofop ethyl; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the herbicide 

quizalofop ethyl, including its 

metabolites and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only those 

quizalofop ethyl residues convertible to 

2-methoxy-6-chloroquinoxaline, 

expressed as the stoichiometric 

equivalent of quizalofop ethyl, in or on 

the commodity. 

Commodity Parts per 

million 

Barley, grain ....................... 0 .05 

Barley, hay .......................... 0 .05 

Barley, straw ....................... 0 .05 

Bean, dry, seed .................. 0 .4 

Bean, succulent .................. 0 .25 

Beet, sugar, molasses ........ 0 .2 

Beet, sugar, roots ............... 0 .1 

Beet, sugar, tops ................ 0 .5 

Cotton, undelinted seed ..... 0 .1 

Commodity Parts per 

million 

Cowpea, forage .................. 3 .0 

Cowpea, hay ....................... 3 .0 

Crambe, meal ..................... 2 .0 

Flax, seed ........................... 0 .05 

Gold of pleasure, meal ....... 2 .0 

Lentil, seed ......................... 0 .05 

Pea, dry .............................. 0 .25 

Pea, field, hay ..................... 3 .0 

Pea, field, vines .................. 3 .0 

Pea, succulent .................... 0 .3 

Peppermint, tops ................ 2 .0 

Rapeseed, meal ................. 2 .0 

Rapeseed subgroup 20A, 

except flax, seed ............. 1 .5 

Sorghum, grain, aspirated 

grain fractions ................. 1 .0 

Sorghum, grain, forage ....... 0 .20 

Sorghum, grain, grain ......... 0 .20 

Sorghum, grain, stover ....... 0 .30 

Soybean, flour .................... 0 .5 

Soybean, hulls .................... 0 .02 

Soybean, meal .................... 0 .5 

Soybean, seed .................... 0 .05 

Soybean, soapstock ........... 1 .0 

Spearmint, tops .................. 2 .0 

Sunflower, seed .................. 1 .9 

Wheat, forage ..................... 0 .05 

Wheat, grain ....................... 0 .05 

Wheat, hay ......................... 0 .05 

Wheat, straw ....................... 0 .05 

(2) Tolerances are established for 

residues of the herbicide quizalofop 

ethyl, including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only those quizalofop ethyl 

residues convertible to quizalofop (2-[4- 

(6-chloroquinoxalin-2-yloxy)phenoxy]propanoic acid), expressed 

as quizalofop, in or on the commodity. 

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances with regional 

registration are established for residues 

of the herbicide quizalofop ethyl, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only those quizalofop ethyl 

residues convertible to 2-methoxy-6- 

chloroquinoxaline, expressed as the 

stoichiometric equivalent of quizalofop 

ethyl, in or on the commodity. 

* * * * * 

[FR Doc. 2012–9447 Filed 4–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 0, 1, and 54 

[WC Docket Nos. 11–42, 03–109, 12–23 and 

CC Docket No. 96–45; Report No. 2948] 

Lifeline and Link Up Reform and 

Modernization; Advancing Broadband 

Availability Through Digital Literacy 

Training, et al. 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; petition for 

reconsideration. 

SUMMARY: In this document, Petitions 

for Reconsideration (Petitions) have 

been filed in the Commission’s 

Rulemaking proceeding concerning 

rules that comprehensively reform and 

modernize the Lifeline program to 

strengthen protections against waste, 

fraud and abuse; improve program 

administration and accountability; 

improve enrollment and consumer 

disclosures; initiate modernization of 

the program for broadband; and 

constrain the growth of the program. 

DATES: Oppositions to the Petitions 

must be filed by May 7, 2012. Replies 

to an opposition must be filed May 15, 

2012. 

ADDRESSES: Federal Communications 

Commission, 445 12th Street SW., 

Washington, DC 20554. 

FOR FURTHER INFORMATION CONTACT: Kim 

Scardino or Garnet Hanly, Wireline 

Competition Bureau, (202) 418–1500 or 

TTY: (202) 418–0484. 

SUPPLEMENTARY INFORMATION: This is a 

summary of Commission’s document, 

Report No. 2948, released April 5, 2012. 

The full text of this document is 

available for viewing and copying in 

Room CY–B402, 445 12th Street SW., 

Washington, DC or may be purchased 

from the Commission’s copy contractor, 

Best Copy and Printing, Inc. (BCPI) (1– 

800–378–3160). The Commission will 

not send a copy of this Notice pursuant 

to the Congressional Review Act, 5 

U.S.C. 801(a)(1)(A), because this Notice 

does not have an impact on any rules of 

particular applicability. 

Subject: Lifeline and Link Up Reform 

and Modernization; Advancing 

Broadband Availability through Digital 

Literacy Training, et al., published at 77 

FR 12952, March 2, 2012 in WC Docket 

Nos. 11–42, 03–109, 12–23 and CC 

Docket No. 96–45, and published 

pursuant to 47 CFR 1.429(e). See 

1.4(b)(1) of the Commission’s rules (47 

CFR 1.4(b)(1)). 

Number of Petitions Filed: 8. 


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