45330 Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Rules and Regulations 

Inbound International Expedited Services 2 

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Priority Mail 

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Royal Mail Group Inbound Air Parcel Post 

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Priority Mail 

[Reserved for Product Description] 

Outbound Priority Mail International 

[Reserved for Product Description] 

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[Reserved for Product Description] 

Parcel Select 

[Reserved for Group Description] 

Parcel Return Service 

[Reserved for Group Description] 

International 

[Reserved for Group Description] 

International Priority Airlift (IPA) 

[Reserved for Product Description] 

International Surface Airlift (ISAL) 

[Reserved for Product Description] 

International Direct Sacks—M–Bags 

[Reserved for Product Description] 

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Part C—Glossary of Terms and Conditions 

[Reserved] 

Part D—Country Price Lists for International 

Mail [Reserved] 

[FR Doc. E9–21208 Filed 9–1–09; 8:45 am] 

BILLING CODE 7710–FW–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0012; FRL–8433–8] 

Methoxyfenozide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

methoxyfenozide in or on citrus oil and 

fruit, citrus, group 10 with regional 

registrations; and corn, pop, grain; corn, 

pop, stover; pea, dry seed; and 

pomegranate. The Interregional 

Research Project No. 4 (IR–4) requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 2, 2009. Objections and 

requests for hearings must be received 

on or before November 2, 2009, 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–2009–0012. 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.), 


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Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Rules and Regulations 45331 

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, 

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 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2009–0012 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 

as required by 40 CFR part 178 on or 

before November 2, 2009. 

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 this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0012, 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. Petition for Tolerance 

In the Federal Register of April 8, 

2009 (74 FR 15971) (FRL–8407–4), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 8E7447) by IR-4, 

IR-4 Project Headquarters, 500 College 

Rd. East, Suite 201 W, Princeton, NJ 

08540. The petition requested that 40 

CFR 180.544 be amended by 

establishing tolerances for residues of 

the insecticide methoxyfenozide; 3,5- 

dimethylbenzoic acid N-tert-butyl-N’-(3- 

hydroxy-2-methylbenzoyl) hydrazide, 

RH-151,055 glucose conjugate of RH117,236; 3,5-dimethylbenzoic acid Ntert-butyl-N-[3(b-D-glucopyranosyloxy)- 

2-methylbenzoyl]-hydrazide and RH152,072 the malonylglycosyl conjugate 

of RH-117,236 in or on fruit, citrus, 

group 10 at 2.0 parts per million (ppm), 

and citrus oil at 70 ppm for tolerances 

with regional registrations; and pea and 

bean, dried shelled, except soybean, 

subgroup 6C at 0.35 ppm; pomegranate 

at 0.6 ppm; corn, pop, grain at 0.05 

ppm; corn, pop, stover at 125 ppm; and 

corn, pop, forage at 30 ppm. That notice 

referenced a summary of the petition 

prepared by Dow AgroSciences, LLC, 

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 petition, EPA has revised 

certain petitioned-for tolerances for 

methoxyfenozide residues as follows: 

Increase the tolerance for fruit, citrus, 

group 10 from 2.0 to 10 ppm, and the 

tolerance for citrus oil from 70 to 100 

ppm. 

Delete proposed tolerance for the 

commodity pea and bean, dried shelled, 

except soybean, subgroup 6C at 0.35 

ppm, and replace with the commodity 

pea, dry seed with a tolerance at 2.5 

ppm. 

Delete proposed tolerance for 

commodity corn, pop, forage at 30 ppm. 

The reasons for these changes are 

explained in Unit IV.C.4. 

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 


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45332 Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Rules and Regulations 

aggregate exposure for the petitioned-for 

tolerances for residues of the insecticide 

methoxyfenozide per se; benzoic acid, 

3-methoxy-2-methyl-, 2-(3,5- 

dimethylbenzoyl)-2-(1,1-dimethylethyl) 

hydrazide in or on fruit, citrus, group 10 

at 10 ppm and citrus oil at 100 ppm, 

with regional registrations; and pea, dry 

seed at 2.5 ppm; pomegranate at 0.6 

ppm; corn, pop, grain at 0.05 ppm; and 

corn, pop, stover at 125 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

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. 

Methoxyfenozide is not acutely toxic 

and not a dermal sensitizer. Minimal or 

no toxic effects were observed in studies 

in which methoxyfenozide was 

administered by the dermal or 

inhalation routes of exposure. 

Toxicology studies conducted with 

methoxyfenozide demonstrate that it 

has few or no biologically significant 

toxic effects at relatively low-dose levels 

in many animal studies and only mild 

or no toxic effects at relatively high-dose 

levels. 

In subchronic and chronic oral 

studies in rats, the most toxicologically 

significant effects were mild anemia and 

mild effects on the liver, thyroid gland, 

and adrenal gland. In subchronic and 

chronic oral studies in dogs, the 

predominant toxic effect was anemia, 

which was often accompanied by signs 

of a compensatory response. 

The database indicates that only the 

dietary route of exposure is of concern, 

and only for chronic durations. The 

chronic population adjusted dose 

(cPAD) is 0.1 milligrams/kilograms/day 

(mg/kg/day) based on changes in blood 

counts, liver toxicity, histopathological 

changes in thyroid, and possible adrenal 

toxicity observed at the lowestobserved-adverse-effect-level (LOAEL) 

of 411 mg/kg/day in a chronic toxicity 

study in rats. 

Methoxyfenozide is not neurotoxic 

and is not a developmental or 

reproductive toxicant. There was no 

evidence for increased susceptibility of 

rat or rabbit fetuses to in utero exposure 

or rat pups to postnatal exposure. 

There is no evidence of carcinogenic 

potential in rats and mice studies, and 

no genotoxicity effects in an acceptable 

battery of mutagenicity studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by methoxyfenozide as 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

Methoxyfenozide. Human Health Risk 

Assessment for Proposed Section 3 Uses 

on Dried Pea and Bean Subgroup 6C 

(Except Soybean), Pomegranate, 

Popcorn, and Citrus Crop Group 10 

(Regional Use), and Conditional 

Registrations for Uses and/or Tolerances 

on Leaf Vegetables, Rotational Crops, 

Stone Fruits, and Poultry Commodities, 

dated July 22, 2009, page 24 in docket 

ID number EPA–HQ–OPP–2009–0012. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

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. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and cPAD. The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

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 greater than that 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 methoxyfenozide used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Methoxyfenozide. Human Health Risk 

Assessment for Proposed Section 3 Uses 

on Dried Pea and Bean Subgroup 6C 

(Except Soybean), Pomegranate, 

Popcorn, and Citrus Crop Group 10 

(Regional Use), and Conditional 

Registrations for Uses and/or Tolerances 

on Leaf Vegetables, Rotational Crops, 

Stone Fruits, and Poultry Commodities, 

dated July 22, 2009, page 28 in docket 

ID number EPA–HQ–OPP–2009–0012. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to methoxyfenozide, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing methoxyfenozide tolerances in 

(40 CFR 180.544). EPA assessed dietary 

exposures from methoxyfenozide 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 

methoxyfenozide; 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 United States Department of 

Agriculture 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, chronic dietary 

exposure analysis for methoxyfenozide 

was conducted using tolerance level 

residues, and 100 percent crop treated 

(PCT) for all existing and proposed uses. 

Dietary Exposure Evaluation Model 

(Version 7.81) default processing factors 

were used for most processed 

commodities that do not have 

individual tolerances; the only 

exception was an EPA determined 

processing factor for orange juice. 

iii. Cancer. Methoxyfenozide is 

classified as ‘‘not likely to be a human 

carcinogen.’’ There was no evidence of 

carcinogenicity in the combined 

chronic/carcinogenicity studies in the 

rat and no genotoxicity shown in 

mutagenicity studies. Therefore, a 

cancer dietary exposure assessment was 

not performed. 


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iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for methoxyfenozide. The Agency 

assumed 100 PCT and tolerance-level 

residues for all existing and proposed 

uses. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for methoxyfenozide in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

methoxyfenozide. 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 (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

methoxyfenozide for chronic exposures 

for non-cancer assessments are 

estimated to be 33.1 parts per billion 

(ppb) for surface water and 7.43 ppb 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 33.1 

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). 

Methoxyfenozide 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 methoxyfenozide 

to share a common mechanism of 

toxicity with any other substances, and 

methoxyfenozide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that methoxyfenozide 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 

Food Quality Protection Act (FQPA) 

safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

There is not a concern for prenatal and/ 

or postnatal toxicity resulting from 

exposure to methoxyfenozide. Based on 

the results in the developmental toxicity 

studies in rats and rabbits and in the 2– 

generation reproduction study in rats, 

no increased sensitivity of fetuses or 

pups (as compared to adults) was 

demonstrated for methoxyfenozide. 

There are no concerns or residual 

uncertainties for prenatal/postnatal 

toxicity following exposure to 

methoxyfenozide. 

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 

methoxyfenozide is complete, with the 

exception of the required 

immunotoxicity study. The toxicology 

database for methoxyfenozide 

demonstrates that the most 

toxicologically significant effects were 

mild anemia and mild effects on the 

liver, thyroid gland, and adrenal gland; 

the immune system is not a primary 

target organ. Increased spleen weights 

and hyperplasia in bone morrow of rib 

and sternum were observed in 

subchronic and chronic oral studies in 

dogs; however, these effects were 

considered a compensatory response of 

anemia. The overall weight of evidence 

suggests that methoxyfenozide does not 

directly target the immune system, and 

observed effects were related to the 

anemic response to the exposure. 

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 POD than currently used for 

overall risk assessment; therefore, a 

database uncertainty factor (UFDB) is 

not needed to account for the lack of the 

study. 

ii. Based on weight-of-the-evidence 

considerations as follows, a 

developmental neurotoxicity (DNT) 

study in rats is not required to support 

the registration of methoxyfenozide: 

Other than the decreased hindlimb 

grip strength observed at 3 hours in 

male rats following a single oral dose of 

methoxyfenozide, no signs of 

neurotoxicity were observed in this 

study or in any other study on 

methoxyfenozide. 

The developmental toxicity studies in 

rats and rabbits and the 2–generation 

reproduction study in rats indicated no 

need for a developmental neurotoxicity 

study to resolve any concerns arising in 

these studies. 

No other observations in any of the 

toxicology studies on methoxyfenozide 

suggested the need for a developmental 

neurotoxicity study. 

iii. In developmental toxicity studies 

in rats and rabbits, no increased 

susceptibility in fetuses as compared to 

maternal animals was observed 

following in utero exposures. 

iv. In a 2–generation reproduction 

study in rats, no increased susceptibility 

in pups as compared to adults was 

observed following in utero and 

postnatal exposures. 

v. 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 for all existing 

and proposed uses. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

methoxyfenozide in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by methoxyfenozide. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 


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45334 Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Rules and Regulations 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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. Methoxyfenozide is not 

expected to pose an acute risk to any 

population subgroup. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

methoxyfenozide from food and water 

will utilize 69% of the cPAD for 

children 1–2 years old the population 

group receiving the greatest exposure. 

There are no registered residential uses 

for methoxyfenozide. 

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). 

Methoxyfenozide is not registered for 

any use patterns that would result in 

residential exposure. Therefore, the 

short-term aggregate risk is the sum of 

the risk from exposure to 

methoxyfenozide through food and 

water and will not be greater than the 

chronic aggregate risk. 

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). 

Methoxyfenozide is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to methoxyfenozide through 

food and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Methoxyfenozide is 

classified as ‘‘not likely to be 

carcinogenic to humans’’ based on the 

lack of evidence of carcinogenicity in 

rats and mice, and lack of genotoxicity 

in an acceptable battery of mutagenicity 

studies. Methoxyfenozide 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 

methoxyfenozide residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate analytical methodologies 

are available, e.g., high performance 

liquid chromatography with ultraviolet 

or mass spectrometry detection (HPLC/ 

UV or MS), for enforcing 

methoxyfenozide tolerances. Depending 

on the plant commodity, the limit of 

quantitation (LOQ) for methoxyfenozide 

in primary crop commodities is 0.01– 

0.05 ppm. 

Adequate enforcement methodology 

(HPLC/UV or MS)) is available to 

enforce the tolerance expression. The 

method may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no Codex 

maximum residue limits established for 

methoxyfenozide on commodities 

involved in this action. 

C. Revisions to Petitioned-For 

Tolerances 

EPA made certain revisions to the 

tolerance levels, added or deleted 

tolerances, or otherwise modified the 

petition as proposed in the notice of 

filing for the following reasons: 

1. EPA increased the proposed 

tolerance for fruit, citrus, group 10 from 

2.0 to 10 ppm. For citrus fruits, the 

residue values from individual of citrus 

fruits were used to calculate the 

Maximum Residue Level (MRL) for 

methoxyfenozide tolerances. The 

highest recommended MRL from the 

orange data is 10 ppm and, therefore, 

the Agency’s recommended tolerance 

for citrus, fruits, crop group 10 is 10 

ppm. 

2. The Agency increased the proposed 

tolerance for citrus oil from 70 to 100 

ppm. Based on the 56X processing 

factor for oil and the highest average 

field trial (HAFT) residues of 1.67 ppm 

for citrus fruits, the maximum expected 

residues in oil would be 93.5 ppm. 

Therefore, EPA concluded that a 

tolerance of 100 ppm is appropriate for 

citrus oil. 

3. EPA revised the proposed tolerance 

for the commodity pea and bean, dried 

shelled, except soybean, subgroup 6C at 

0.35 ppm, to a tolerance at 2.5 ppm for 

the commodity pea, dry seed. For pea, 

dry seed a separate tolerance was 

calculated using the data from the new 

trials, adjusting the residues from two 

trials (0.5X) to the 1X rate using 

proportionality (0.30 ppm), using only 

the residue data from the four field trials 

conducted at 1X (0.35 ppm), and using 

the previously reviewed data for the 

back-eyed and southern pea trials (2.5 

ppm). The highest tolerance 

recommendation of 2.5 ppm was chosen 

for the tolerance for pea, dry seed. Due 

to the >10X difference between the pea 

and bean tolerances, a pea and bean, 

dried shelled, except soybean (subgroup 

6C) tolerance is not established for 

subgroup 6C as it is inappropriate. 

Therefore, EPA concluded that the 

current bean, dry seed tolerance at 0.24 

ppm should be retained and a tolerance 

be established at 2.5 ppm for pea, dry 

seed. 

4. EPA is not establishing the 

proposed tolerance for the commodity 

corn, pop, forage at 30 ppm. Available 

residue data for field corn support the 

proposed tolerances of 0.05 and 125 

ppm in/on popcorn grain and stover, 

respectively. No tolerance is required 

for popcorn forage as it is not a 

regulated livestock feedstuff. 

5. In establishing the new tolerances 

with regional registration for citrus in 

paragraph (c) of 40 CFR 180.544, EPA 

has used its preferred method of setting 

forth the tolerance expression which 

involves separate sentences addressing: 

i. The coverage of the tolerance. 

ii. The specific residues to be 

measured in determining compliance 

with the tolerance levels. 

EPA considers this new approach to 

writing tolerance expressions to be both 

consistent with the statute and a 

clarification of what EPA intended in its 

prior tolerance expression format. 

Accordingly, in most instances where 

EPA amends an existing tolerance 

regulation to add additional 

commodities, EPA believes there is good 

cause to change to the overall tolerance 

expression for all commodities without 

prior notice. The existing tolerance 

expression for methoxyfenozide, 

however, is somewhat unusual in its 

reference to ‘‘methoxyfenozide per se.’’ 

Thus, even though EPA does not believe 

that the existing tolerance expression 

was intended to be interpreted in a 

manner different from the new clarified 

approach, EPA will not modify the 

existing tolerance expression in 

paragraph (a)(1) of 40 CFR 180.544 

without prior notice. 


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Federal Register / Vol. 74, No. 169 / Wednesday, September 2, 2009 / Rules and Regulations 45335 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide 

methoxyfenozide per se; benzoic acid, 

3-methoxy-2-methyl-, 2-(3,5- 

dimethylbenzoyl)-2-(1,1-dimethylethyl) 

hydrazide in or on fruit, citrus, group 10 

at 10 ppm and citrus oil at 100 ppm 

with regional registrations; and pea, dry 

seed at 2.5 ppm; pomegranate at 0.6 

ppm; corn, pop, grain at 0.05 ppm; and 

corn, pop, stover at 125 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 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: August 25, 2009. 

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 180.544 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a)(1) and by revising paragraph (c) to 

read as follows: 

§ 180.544 Methoxyfenozide; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per million 

*****

Corn, pop, grain .............. 0.05 

Corn, pop, stover ............ 125 

*****

Pea, dry seed ................. 2.5 

*****

Pomegranate .................. 0.6 

*****

* * * * * 

(c) Tolerances with regional 

registrations. Tolerances are established 

for residues of the insecticide 

methoxyfenozide, including its 

metabolites and degradates. Compliance 

with the tolerance levels specified in 

this paragraph is to be determined by 

measuring only methoxyfenozide, 

benzoic acid, 3-methoxy-2-methyl-, 2- 

(3,5-dimethylbenzoyl)-2-(1,1- 

dimethylethyl) hydrazide. 

Commodity Parts per million 

Citrus, Oil .............. 100 

Fruit, citrus, group 

10 ...................... 10 

* * * * * 

[FR Doc. E9–21190 Filed 9–1–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2009–0175; FRL–8951–5] 

National Oil and Hazardous Substance 

Pollution Contingency Plan National 

Priorities List 

AGENCY: Environmental Protection 

Agency. 

ACTION: Notice of Deletion of the 

Montclair/West Orange and Glen Ridge 

Radium Superfund Sites from the 

National Priorities List. 

SUMMARY: The Environmental Protection 

Agency (EPA)—Region 2 announces the 

deletion of the Montclair/West Orange 

and Glen Ridge Radium Superfund Sites 

located in Montclair, West Orange, Glen 

Ridge, Bloomfield and East Orange, New 

Jersey from the National Priorities List 

(NPL). The NPL, promulgated pursuant 

to Section 105 of the Comprehensive 

Environmental Response, Compensation 

and Liability Act (CERCLA) of 1980, as 

amended, is an appendix of the National 

Oil and Hazardous Substances Pollution 


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