Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 70143 

New York State regulation State effective 

date Latest EPA approval date Comments 

Redesignation of non-attainment areas to attainment areas 

(200.1(av)) does not relieve a source from compliance with 

previously applicable requirements as per letter of Nov. 13, 

1981 from H. Hovey, NYSDEC. 

Changes in definitions are acceptable to EPA unless a previously approved definition is necessary for implementation 

of an existing SIP regulation. 

EPA is including the definition of ‘‘Federally enforceable’’ with 

the understanding that (1) the definition applies to provisions of a Title V permit that are correctly identified as 

Federally enforceable, and (2) a source accepts operating 

limits and conditions to lower its potential to emit to become a minor source, not to ‘‘avoid’’ applicable requirements. 

Section 200.9, Table 1 (Part 

231 references).

3/5/09 11/17/10, [Insert FR page citation].EPA is approving reference documents that are not already 

Federally enforceable. 

Sections 200.6, 200.7 and 

200.9.

2/25/00 4/22/08, 73 FR 21548 ............ EPA is approving reference documents that are not already 

Federally enforceable. 

* * * * * * * 

Subpart 201–2.1(b)(21), Definitions.3/5/09 11/17/10, [Insert FR page citation].EPA is including the definition of ‘‘Major stationary source or 

major source or major facility’’ with the understanding that 

the definition applies only to provisions of Part 231. 

* * * * * * * 

Part 231, New Source Review 

for New and Modified Facilities.

3/5/09 11/17/10, [Insert FR page citation].Partial approval; no action taken on provisions that may require PSD permits for sources of greenhouse gas (GHG) 

emissions with emissions below the thresholds identified in 

EPA’s final PSD and Title V GHG Tailoring Rule at 75 FR 

31514, 31606 (June 3, 2010). 

* * * * * * * 

§ 52.1689 [Reserved] 

■ 4. Section 52.1689 is removed and 

reserved. 

[FR Doc. 2010–28964 Filed 11–16–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0812; FRL–8851–7] 

Acequinocyl; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of acequinocyl in 

or on bean, edible podded; hop, dried 

cones; okra and vegetable, fruiting, 

group 8. The Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 17, 2010. Objections and 

requests for hearings must be received 

on or before January 18, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0812. 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: 

Sidney Jackson, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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 


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the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0812 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 18, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0812, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

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

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-for Tolerance 

In the Federal Register of January 6, 

2010 (75 FR 868) (FRL–8801–5), 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 9E7598) by IR–4 

Project Headquarters, 500 College Road 

East, Suite 201W, Princeton, NJ 08540. 

The petition requested that 40 CFR 

180.599 be amended by establishing 

tolerances for residues of the insecticide 

acequinocyl, 2-(acetyloxy)-3-dodecyl1,4-naphthalenedione, and its 

metabolite, 2-dodecyl-3-hydroxy-1,4- 

naphthoquinone, calculated as the 

stoichiometric equivalent of 

acequinocyl and by establishing a 

tolerance for the residues of 

acequinocyl, including its metabolites 

and degradates in or on vegetable, 

fruiting, group 8 at 0.7 parts per million 

(ppm); okra at 0.7 ppm; bean, edible 

podded at 0.25 ppm and hop, dried 

cone at 3.5 ppm. That notice referenced 

a summary of the petition prepared on 

behalf of IR–4 by Arysta LifeScience 

North America LLC, the registrant, 

which is available 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 petition, EPA has revised 

the proposed tolerance for hop dried 

cones from 3.5 ppm to 4.0 ppm as 

available data submitted support the 

higher tolerance. The reason(s) for these 

changes are explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * * ’’ 

Consistent with 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 acequinocyl 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with acequinocyl follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. 

Acequinocyl exhibits low acute 

toxicity in oral, dermal and inhalation 

routes of exposure, as well as, primary 

eye and primary skin irritation studies. 

It is not a dermal sensitizer. 

In rat studies including a subchronic 

oral toxicity study, a 28-day dermal 

toxicity study, and a chronic feeding/ 

oncogenicity study, acequinocyl 

increased prothrombin and activated 

partial thromboplastin. Internal 

hemorrhages were observed in both a rat 

and rabbit developmental toxicity study, 

a mouse subchronic/chronic toxicity 

study, and in a 2-generation 

reproduction rat study. In a combined 

chronic toxicity/oncogenicity study in 

rats, enlarged eyeballs were observed. 

Hepatotoxicity in the mouse was 

evidenced by histopathology and 

increased liver enzymes. 

In both rat and rabbit developmental 

toxicity studies, acequinocyl increased 

the number of resorptions. 

Developmental effects (i.e., resorptions) 

occurred at a dose that was higher than 

or the same as the dose that caused 

maternal toxicity. In the 2-generation 

reproduction toxicity study in the rat, 

there was no evidence of reproductive 

toxicity, though there were notable toxic 

effects observed in offspring that were 

not observed in adults including 

swollen body parts, protruding eyes, 

clinical signs, delays in pupil 

development and increased mortality 

occurring mainly after weaning. 

There was no evidence of 

carcinogenic potential in either the rat 

or mouse carcinogenicity study, 

indicating that acequinocyl is ‘‘not 

likely’’ to be carcinogenic to humans. 

There was no concern for mutagenic 

activity as indicated by several 


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mutagenicity studies. Acequinocyl 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 acequinocyl as well as 

the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document, 

‘‘Acequinocyl; Human-Health Risk 

Assessment for Proposed Section 3 Uses 

on Fruiting Vegetables, Hops, Okra, and 

Edible-Podded Beans’’ dated August 26, 

2010, at pp. 32–35 in docket ID number 

EPA–HQ–OPP–2009–0812–0004. 

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 acequinocyl used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ACEQUINOCYL 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 ....................................................

(General population including infants and children).

N/A ............................. N/A ............................. An endpoint attributable to a single dose was 

not identified in the database. 

Chronic dietary .................................................

(All populations) ................................................

NOAEL = 2.7 mg/kg/ 

day.

UFA = 10x ..................

UFH = 10x ..................

FQPA SF = 1x ...........

Chronic RfD = 0.027 

mg/kg/day.

cPAD = 0.027 mg/kg/ 

day.

Carcinogenicity study in mice (18 month); 

LOAEL = 7.0 mg/kg/day based on the clinical chemistry and microscopic nonneoplastic lesions (brown pigmented cells and 

perivascular inflammatory cells in liver). 

Short-term .........................................................

(1 to 30 days) and intermediate-term (1–6 

months) dermal.

Dermal NOAEL = 200 

mg/kg/day.

LOC (occupational/ 

residential) for MOE 

= <100.

28-day dermal study in rats; 

LOAEL = 1000 mg/kg/day based on increased clotting factor times. 

Short-term (1 to 30 days) inhalation ................ Oral NOAEL = 60 mg/ 

kg/day (inhalation 

absorption rate = 

100%).

UFA = 10x ..................

UFH = 10x ..................

LOC (occupational/ 

residential) = MOE 

<100.

Developmental toxicity study in rabbits; 

Maternal LOAEL = 120 mg/kg/day based on 

clinical signs (hematuria, reduced fecal output, body weight loss, and reduced food 

consumption) and gross necropsy findings 

(pale lungs and liver, hemorrhaging uterus, 

fluid in the cecum, fur in the stomach, 

blood stained vaginal opening, bloodstained urinary bladder contents/urine). 

Cancer (oral, dermal, inhalation) ...................... Classification: ‘‘Not likely to be Carcinogenic to Humans.’’ 

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. 

MOE = margin of exposure. 

LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to acequinocyl, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing acequinocyl tolerances in 40 

CFR 180.599. EPA assessed dietary 

exposures from acequinocyl 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 acequinocyl; 

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 U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 and the 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, EPA conducted a 

chronic dietary exposure analysis of 

acequinocyl based on the assumption of 

tolerance level residues and 100 percent 

crops treated (PCT) for all existing and 

proposed uses. 


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70146 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that acequinocyl does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

acequinocyl. Tolerance level residues 

and 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 acequinocyl in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of acequinocyl. 

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 

acequinocyl for chronic exposures for 

non-cancer assessments are estimated to 

be 2.45 parts per billion (ppb) 

acequinocyl for surface water and 

0.0036 ppb (acequinocyl and its 

metabolite, acequinocyl-OH) for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 2.45 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). 

Acequinocyl is currently registered 

for the following uses that could result 

in residential exposures: Landscape 

ornamentals in residential and public 

areas for use by commercial applicators 

and homeowners. EPA assessed 

residential exposure using the following 

assumptions: In assessing residential 

exposure/risk, the homeowner handlers 

are expected to complete all tasks 

associated with the use of a pesticide 

product including mixing and loading 

(if needed), and application. No 

chemical-specific data were available 

with which to assess potential exposure 

to pesticide handlers. The estimates of 

exposure to pesticide handlers are based 

upon surrogate study data available 

from the Outdoor Residential Exposure 

Task Force (ORETF) and the Pesticide 

Handlers Exposure Data (PHED). 

Homeowner handler assessments are 

based on the assumption that 

individuals are wearing shorts, shortsleeved shirts, socks, and shoes. 

Residential handler exposure scenarios 

are considered to be short-term only, 

due to infrequent use patterns 

associated with homeowner products. 

Based upon the proposed use pattern, 

the following residential handler 

scenarios have been assessed: 

(1) Mixing/loading/applying liquids 

with low-pressure handwand (ORETFfruit trees and ornamentals). 

(2) Mixing/loading/applying liquids 

with hose-end sprayer (ORETF-fruit 

trees and ornamentals). 

No significant dermal postapplication exposure is expected from 

landscape ornamentals uses. 

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 acequinocyl to 

share a common mechanism of toxicity 

with any other substances, and 

acequinocyl does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that acequinocyl 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 website 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. 

In the rat prenatal developmental 

toxicity study, developmental toxicity 

was indicated by increased resorptions 

and fetal variations. The developmental 

toxicity study in rabbits identified an 

increased number of complete 

resorptions. In the rat two-generation 

reproductive toxicity study, both the 

maternal and reproductive toxicity 

LOAELs were not observed, however 

the LOAEL for parental males was 58.9/ 

69.2 mg/kg/day based on hemorrhagic 

effects. The offspring systemic LOAEL 

was also 58.9 mg/kg/day. Though the 

offspring LOAEL was similar to that of 

parental male’s, there were effects 

specific to the pups which in addition 

to the hemorrhagic effects noted in both 

generations, included swollen body 

parts, protruding eyes, clinical signs, 

delays in pupil development and 

increased mortality occurring mainly 

after weaning. 

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. At this time, the Agency is making 

permanent registration of these new 

uses conditional pending resolution of 

toxicological issues and has identified 

the following studies needed, including: 

(1) A 28-day inhalation study; (2) an 

immunotoxicity study; and (3) acute 

and subchronic neurotoxicity studies. 

Except for the 28-day inhalation study, 

the remaining studies are required 

under new EPA regulations. The 

toxicology database for acequinocyl 

does not show any evidence of 

treatment-related effects on the immune 

system. The overall weight of evidence 

suggests that this chemical does not 

directly target the immune system. An 

immunotoxicity study is required as a 

part of new data requirements in the 40 

CFR part 158 for conventional pesticide 

registration; however, the Agency does 

not believe that conducting a functional 

immunotoxicity study will result in a 

lower point of departure (POD) than that 

currently in use for overall risk 

assessment, and therefore, a database 

uncertainty factor (UFDB) is not needed 

to account for lack of this study. 


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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 70147 

Although a 28-day inhalation study is 

not available, EPA has determined that 

the additional FQPA SF is not needed. 

Residential inhalation risk was 

estimated by calculating exposure using 

the Agency’s Residential SOPs. For 

chemicals with low vapor pressure (7.5 

× 10¥5 mmHg or below for outdoor uses 

at 20–30 °C), these standard 

assumptions are expected to 

overestimate the exposure via the 

inhalation route. Acequinocyl is such a 

compound (1.69 × 10¥11 mmHg at 25 

°C) and exposure through the inhalation 

route is expected to be minimal. 

Therefore, the risk estimate is 

conservative and is considered 

protective and the additional FQPA SF 

is not needed. Since all calculated 

inhalation MOEs for residential 

handlers are significantly greater than 

the Agency’s LOC (MOE >100), even 

retaining the FQPA SF would not affect 

EPA’s conclusion on safety. 

There is potential evidence of 

neurotoxicity or neuropathology in the 

2-generation reproduction study as well 

as the rat subchronic oral toxicity study, 

however these toxicities are not 

considered to be primary effects since 

they occur in the presence of more 

severe systemic effects in both studies. 

Therefore, although an acute and 

subchronic neurotoxicity studies are 

now required as a part of new data 

requirements in the 40 CFR part 158 for 

conventional pesticide registration, the 

agency does not believe that conducting 

these studies will result in a lower point 

of departure (POD) than that currently 

used for overall risk assessment. 

ii. There is no evidence that 

acequinocyl results in increased 

susceptibility in in utero rat or rabbit 

fetuses in the prenatal developmental 

studies or in young rats in the 

2-generation reproduction study. In the 

2-generation rat reproduction study, 

more severe effects were observed in the 

offspring, however these effects were 

observed at the same doses as parental 

effects, and a clear NOAEL was 

established which is being used in 

endpoint selection. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground water and surface water 

modeling used to assess exposure to 

acequinocyl in drinking water. The 

residential use (ornamentals) is not 

expected to result in post-application 

exposure to infants and children. These 

assessments will not underestimate the 

exposure and risks posed by 

acequinocyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, acequinocyl 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 acequinocyl 

from food and water will utilize 45% of 

the cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. Based on the use pattern, 

chronic residential exposure to residues 

of acequinocyl is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Acequinocyl 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 acequinocyl. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, drinking 

water, and dermal and inhalation 

residential exposures result in aggregate 

MOE of 2,700 for adults 50+ years old, 

the highest exposed population. 

Because EPA’s level of concern for 

chemical name is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Acequinocyl is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Intermediate-term risk is assessed based 

on intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for acequinocyl. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity, 

acequinocyl 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 acequinocyl 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available for enforcing tolerances for 

acequinocyl residues of concern in/on 

the proposed/registered plant 

commodities. Methods include two 

high-performance liquid 

chromatography methods with tandem 

mass-spectroscopy detection (HPLC/ 

MS/MS). 

The methods 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 U.S. 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. 


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70148 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 

The Codex has not established MRLs 

for acequinocyl. 

C. Revisions to Petitioned-for Tolerances 

The Agency revised the 3.5 ppm 

proposed tolerance on hop, dried cones 

to 4.0 ppm. The Agency’s tolerance 

spreadsheet as specified by the 

Guidance for Setting Tolerances Based 

on Field Trial Data SOP (August 2009 

version) was used to determine 

appropriate tolerance levels. 

EPA has revised the tolerance 

expression for acequinocyl to clarify 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

acequinocyl not specifically mentioned; 

and 

2. That compliance with the specific 

compounds mentioned in the tolerance 

expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of acequinocyl including its 

metabolites and degradates in or on 

bean, edible podded at 0.25 ppm, hop, 

dried cones at 4.0 ppm, okra at 0.70 

ppm, and vegetable, fruiting, group 8 at 

0.70 ppm. Compliance with the 

tolerance levels specified is to be 

determined by measuring only the sum 

of acequinocyl [2-(acetyloxy)-3-dodecyl1,4-naphthalenedione] and its 

metabolite, 2-dodecyl-3-hydroxy-1,4- 

naphthoquinone, calculated as the 

stoichiometric equivalent of 

acequinocyl, in or on the commodity. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

et seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 4, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.599 is amended by 

revising paragraph (a) introductory text 

and alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.599 Acequinocyl; tolerance for 

residues. 

(a) General. Tolerances are 

established for residues of acequinocyl, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of acequinocyl [2-(acetyloxy)-3-dodecyl1,4-naphthalenedione] and its 

metabolite, 2-dodecyl-3-hydroxy-1,4- 

naphthoquinone, calculated as the 

stoichiometric equivalent of 

acequinocyl, in or on the commodity. 


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Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Rules and Regulations 70149 

Commodity Parts per million 

*****

Bean, edible podded ...... 0 .25 

*****

Hop, dried cones ............ 4 .0 

*****

Okra ................................ 0 .70 

*****

Vegetable, fruiting, group 

8 .................................. 0 .70 

* * * * * 

[FR Doc. 2010–28973 Filed 11–16–10; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 54 

Universal Service Support 

Mechanisms 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: The Federal Communications 

Commission has published a number of 

requirements related to the universal 

service support mechanisms. This 

document announces the approval of 

the Office of Management and Budget 

(OMB) for information collection 

requirements contained in the sections 

outlined in the DATES section. 

DATES: Effective November 17, 2010, the 

following regulations have been 

approved by OMB: 

54.5—71 FR 38796, July 10, 2006. 

54.409(d)—69 FR 34600, June 22, 2004. 

54.410—69 FR 34600, June 22, 2004. 

54.416—69 FR 34601, June 22, 2004. 

54.513(c)—69 FR 6191, Feb. 10, 2004. 

54.514(b)—68 FR 36942, June 20, 2003. 

54.609(d)(2)—68 FR 74502, Dec. 24, 

2003. 

54.609(e)—70 FR 6373, Feb. 7, 2005. 

54.621—68 FR 74503, Dec. 24, 2003. 

54.703(c)—63 FR 70573, Dec. 21, 1998. 

54.708—71 FR 38797, July 10, 2006. 

54.712—71 FR 38797, July 10, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Nicholas Degani, Telecommunications 

Access Policy Division, Wireline 

Competition Bureau, at (202) 418–7400. 

SUPPLEMENTARY INFORMATION: 

On April 19, 2000, OMB approved the 

information collection requirements 

contained in § 54.703(c) of title 47 of the 

United States Code as a revision to OMB 

Control Number 3060–0876. OMB had 

previously temporarily approved this 

information collection several times. 

On March 16, 2004, OMB approved 

the information collection requirements 

contained in §§ 54.609(d)(2) and 54.621 

of title 47 of the United States Code as 

a revision to OMB Control Number 

3060–0804. 

On July 13, 2004, OMB approved the 

information collection requirements 

contained in § 54.513(c) of title 47 of the 

United States Code as a part of OMB 

Control Number 3060–1062. 

On November 12, 2004, OMB 

approved the information collection 

requirements contained in § 54.514(b) of 

title 47 of the United States Code as a 

revision to OMB Control Number 3060– 

0806. 

On May 12, 2005, OMB approved the 

information collection requirements 

contained in §§ 54.409(d), 54.410, and 

54.416 of title 47 of the United States 

Code as a revision to OMB Control 

Number 3060–0819. 

On June 28, 2005, OMB approved the 

information collection requirements 

contained in §§ 54.609(e) of title 47 of 

the United States Code as a revision to 

OMB Control Number 3060–0804. 

On March 19, 2007, OMB approved 

the information collection requirements 

contained in §§ 54.5, 54.708, and 54.712 

of title 47 of the United States Code as 

a revision to OMB Control Number 

3060–0855. OMB had previously 

temporarily approved these information 

collections on October 20, 2006. 

These information collection 

requirements required OMB approval in 

order to become effective. The 

Commission publishes this document as 

an announcement of those approvals. If 

you have any comments on the burden 

estimates listed below, or how the 

Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Thomas 

Butler, Federal Communications 

Commission, Room 5–C457, 445 12th 

Street, SW., Washington, DC 20554. 

Please include the OMB Control 

Numbers, 3060–0804, 3060–0806, 3060– 

0819, 3060–0855, 3060–0876, 3060– 

1062, in your correspondence. The 

Commission will also accept your 

comments via the Internet if you send 

them to PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an e-mail to 

fcc504@fcc.gov or call the Consumer & 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval for the 

information collection requirements 

described above. The OMB Control 

Numbers are 3060–0804, 3060–0806, 

3060–0819, 3060–0855, 3060–0876, and 

3060–1062. The total annual reporting 

burden for respondents for these 

collections of information, including the 

time for gathering and maintaining the 

collection of information, has been most 

recently approved to be: 

For 3060–0804: 59,464 responses, for a 

total annual burden of 67,468 

hours, and no annual costs. 

For 3060–0806: 221,000 responses, for a 

total annual burden of 525,003 

hours, and no annual costs. 

For 3060–0819: 227,055 responses, for a 

total annual burden of 61,788 

hours, and no annual costs. 

For 3060–0855: 36,068 responses, for a 

total annual burden of 273,129 

hours, and no annual costs. 

For 3060–0876: 22 responses, for a total 

annual burden of 560 hours, and no 

annual costs. 

For 3060–1062: 100 responses, for a 

total annual burden of 100 hours, 

and no annual costs. 

An agency may not conduct or 

sponsor a collection of information 

unless it displays a current, valid OMB 

Control Number. No person shall be 

subject to any penalty for failing to 

comply with a collection of information 

subject to the Paperwork Reduction Act, 

which does not display a current, valid 

OMB Control Number. The foregoing 

notice is required by the Paperwork 

Reduction Act of 1995, Public Law 104– 

13, October 1, 1995, and 44 U.S.C. 3507. 

List of Subjects in 47 CFR Part 54 

Telecommunications, Universal 

service. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. 2010–29016 Filed 11–16–10; 8:45 am] 

BILLING CODE 6712–01–P 


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