40806 Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Rules and Regulations 

under the Congressional Review Act. 

Through this document, we correct this 

omission. We do not change any other 

aspect of the interim final rule, and its 

regulatory text remains unchanged. 

DATES: Effective July 11, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Jacquelyn Butler, U.S. Department of 

Education, 1990 K Street NW., Room 

8053, Washington, DC 20006–8542. 

Telephone: (202) 502–7890 or by email: 

jacquelyn.butler@ed.gov. 

If you use a telecommunications 

device for the deaf (TDD) or a text 

telephone (TTY), call the Federal Relay 

Service (FRS), toll free, at 1–800–877– 

8339. 

SUPPLEMENTARY INFORMATION: We make 

the following correction to the Federal 

Pell Grant Program interim final rule: 

On page 25898, in the first column, 

replace the last paragraph under the 

heading Waiver of Rulemaking and 

Delayed Effective Date with the 

following two paragraphs: 

The Administrative Procedure Act 

(APA) generally requires that 

regulations be published at least 30 days 

before their effective date, unless the 

agency has good cause to implement its 

regulations sooner (5 U.S.C. 553(d)(3)). 

In addition, this interim final rule has 

been determined to be a major rule for 

purposes of the Congressional Review 

Act (CRA) (5 U.S.C. 801, et seq.). 

Generally, under the CRA, a major rule 

takes effect 60 days after the date on 

which the rule is published in the 

Federal Register. Section 808(2) of the 

CRA, however, provides that any rule 

which an agency for good cause finds 

(and incorporates the finding and a brief 

statement of reasons therefore in the 

rule issued) that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to the public 

interest, shall take effect at such time as 

the Federal agency promulgating the 

rule determines. 

As previously stated, because this 

interim final rule merely reflects 

statutory changes and removes obsolete 

regulatory provisions and, in the case of 

new § 690.64, protects students from 

receiving reduced amounts of Pell Grant 

funds, there is good cause to waive the 

delayed effective dates in the APA and 

the CRA and make this interim final 

rule effective on the day it is published. 

Accessible Format: Individuals with 

disabilities can obtain this document in 

an accessible format (e.g., braille, large 

print, audiotape, or compact disc) on 

request to the program contact person 

listed under FOR FURTHER INFORMATION

CONTACT. 

Electronic Access to This Document: 

The official version of this document is 

the document published in the Federal 

Register. Free Internet access to the 

official edition of the Federal Register 

and the Code of Federal Regulations is 

available via the Federal Digital System 

at: www.gpo.gov/fdsys. At this site you 

can view this document, as well as all 

other documents of this Department 

published in the Federal Register, in 

text or Adobe Portable Document 

Format (PDF). To use PDF, you must 

have Adobe Acrobat Reader, which is 

available free at the site. 

You may also access documents of the 

Department published in the Federal 

Register by using the article search 

feature at: www.federalregister.gov. 

Specifically, through the advanced 

search feature at this site, you can limit 

your search to documents published by 

the Department. 

Dated: July 6, 2012. 

David A. Bergeron, 

Acting Assistant Secretary for Postsecondary 

Education. 

[FR Doc. 2012–16929 Filed 7–10–12; 8:45 am] 

BILLING CODE 4000–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0343; FRL–9354–1] 

Methoxyfenozide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

methoxyfenozide in or on multiple 

commodities which are identified and 

discussed later and for indirect or 

inadvertent combined residues of the 

methoxyfenozide on various other 

commodities. In addition, this 

regulation removes established 

tolerances for certain commodities/ 

groups superseded by this action and 

revises the tolerance expression. The 

Interregional Research Project #4 (IR–4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

11, 2012. Objections and requests for 

hearings must be received on or before 

September 10, 2012, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0343, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Debra Rate, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0309; email address: 

rate.debra@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. 


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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–2011–0343 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 September 10, 2012. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0343, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on line 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 28221T, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 20, 

2011 (76 FR 43231) (FRL–8880–1), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 1E7842) by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.544 be 

amended by establishing tolerances for 

residues of the insecticide 

methoxyfenozide (benzoic acid, 3- 

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

dimethylbenzoyl)-2-(1,1-dimethylethyl 

hydrazide), in or on the raw agricultural 

commodities fruit, citrus, group 10–10 

at 1.9 parts per million (ppm); lemon, 

oil at 45 ppm; citrus, oil (except lemon) 

at 100 ppm; vegetable, root, except sugar 

beet, subgroup 1B at 0.8 ppm; and beet, 

sugar at 0.5 ppm. In addition, the 

petition proposed that 40 CFR 180.544 

be amended by removing the tolerance 

for vegetable, root, subgroup 1A from 

paragraph (a) and the tolerances for 

fruit, citrus and citrus, oil from 

paragraph (c). Lastly, the petition 

proposed to revise the tolerance 

expressions in 40 CFR 180.544. That 

notice referenced a summary of the 

petition prepared by Dow AgroSciences 

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. 

In the Federal Register of October 27, 

2010 (75 FR 66092) (FRL–8848–3), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 0F7776) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petition proposed to reestablish 

tolerances which were inadvertently 

allowed to expire in 2010. The proposed 

tolerances in 40 CFR 180.544 are for 

indirect or inadvertent combined 

residues of the insecticide 

methoxyfenozide, (benzoic acid, 3- 

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

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

hydrazide) and its metabolites RH– 

117,236 free phenol of 

methoxyfenozide; 3,5-dimethylbenzoic 

acid N-tert-butyl-N′-(3-hydroxy-2- 

methylbenzoyl) hydrazide, RH–151,055 

glucose conjugate of RH–117,236; 3,5- 

dimethylbenzoic acid N-tert-butyl-N-[3 

(b-D-glucopyranosyloxy)-2- 

methylbenzoyl]-hydrazide) and RH– 

152,072 the malonylglycosyl conjugate 

of RH–117,236, in or on the raw 

agricultural commodities: Vegetable, 

root and tuber, group 1 at 0.1 ppm; 

vegetable, leaves of root and tuber, 

group 2 at 0.2 ppm; vegetable, bulb, 

group 3 at 0.2 ppm; vegetable, legume, 

group 6 at 0.1 ppm; vegetable, foliage of 

legume, group 7 at 10 ppm; grain, 

cereal, forage, fodder, and straw, group 

16 at 10 ppm; grass, forage, fodder and 

hay, group 17 at 10 ppm; animal feed, 

non-grass, group 18 at 10 ppm; and herb 

and spice, group 19 at 10 ppm. That 

notice referenced a summary of the 

petition prepared by Dow AgroSciences 

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 petitions, EPA has 

modified the levels at which tolerances 

are being established for some of the 

commodities. 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for methoxyfenozide 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with methoxyfenozide 

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. 

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. 


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40808 Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Rules and Regulations 

The main target organs in the rat and 

dog were the liver, thyroid and red 

blood cells (RBC). The most consistent 

findings across species and studies were 

decreased red blood cell parameters and 

increased liver, thyroid, adrenal and 

spleen weights. In the rat metabolism 

study, liver contained 2–9% of the 

administered radioactivity at maximum 

concentration (Cmax), but levels 

decreased and bioaccumulation was not 

observed. Levels in the blood were 

negligible. The effects of 

methoxyfenozide on the blood 

(methemoglobinemia, decreased red 

blood cell parameters, Heinz body 

formation) are consistent with those of 

other hydrazine compounds. 

Acute and subchronic oral 

neurotoxicity studies in the rat did not 

show evidence of potential 

neurotoxicity. In the acute study, 

decreased hindlimb grip strength on 

Day 0 was reported in males. This 

finding was only observed at the limit 

dose in males and was not observed in 

the subchronic neurotoxicity study and 

was therefore not considered evidence 

of neurotoxicity. No clinical signs of 

toxicity or neurohistopathology were 

observed in other guideline studies. 

No maternal or developmental effects 

were observed in either the rat or rabbit 

oral developmental toxicity studies. In 

the rat 2-generation reproductive 

toxicity study, parental effects were 

limited to increased liver weight and 

microscopic periportal hypertrophy. No 

offspring or reproductive toxicity was 

observed. In a 28-day dietary 

immunotoxicity study in the rat, no 

immunotoxicity was observed. The only 

observed effect was increased liver 

weight. 

Dermal effects were not observed in 

the rat following a 28-day exposure 

period (5 exposure days per week for a 

total of 20 exposures). This finding is 

consistent with the relatively low 

dermal absorption of 2% of the applied 

dose, observed in an in vivo dermal 

absorption study in rats treated with an 

80% wettable powder (WP) formulation 

product. 

There was no evidence of 

carcinogenicity in the rat dietary 24- 

month chronic toxicity/carcinogenicity 

study or the mouse dietary 18-month 

carcinogenicity study. No mutagenic or 

clastogenic potential was observed in 

the battery of genotoxicity studies on 

methoxyfenozide. Based on these 

findings, methoxyfenozide 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 methoxyfenozide as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document titled 

‘‘Methoxyfenozide Human Health Risk 

Assessment’’ starting at page 14 in 

docket ID number EPA–HQ–OPP–2011– 

0343. 

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 methoxyfenozide used for 

human risk assessment is shown in the 

Table of this unit. 


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Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Rules and Regulations 40809 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR METHOXYFENOZIDE 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 

and Females 13–49 

years of age).

No hazard was identified for a single oral exposure. 

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

(All populations) 

NOAEL = 10.2 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.10 

mg/kg/day.

cPAD = 0.10 mg/kg/ 

day 

Co-critical studies: Combined oral chronic toxicity/carcinogenicity-rat 

LOAEL = 411/491 mg/kg/day M/F based on hematological 

changes (decreased RBC parameters), periportal liver hypertrophy, thyroid hypertrophy and altered colloid; possibly increased 

adrenal weight. 

Chronic oral toxicity-dog NOAEL = 9.8/12.6 mg/kg/day M/F LOAEL 

= 106.1/110.6 mg/kg/day based on hematological changes (decreased RBC parameters, slight methemoglobinemia) and increased serum bilirubin. 

Inhalation Short-Term 

(1–30 days) and Intermediate-Term (1– 

6 months).

NOAEL = 16.8 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ... Two-week oral range finding study-dog LOAEL = 90.8 mg/kg/day 

based on hematological changes (decreased RBC parameters, increased Heinz body count, reticulocyte counts, erythrocyte morphology and methemoglobinemia) and increased spleen weights. 

Cancer (Oral, dermal, 

inhalation).

Classification: Not likely to be carcinogenic to humans. 

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

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

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). 

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 USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance level residues, Dietary 

Exposure Evaluation Model (DEEM) 

(Ver. 7.81) default processing factors (as 

necessary), an empirical processing 

factor for orange juice, and 100 percent 

crop treated (PCT) for all commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that methoxyfenozide 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 and/or PCT 

information in the dietary assessment 

for methoxyfenozide. 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 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 (SCI– 

GROW) models the estimated drinking 

water concentrations (EDWCs) of 

methoxyfenozide for chronic exposures 

for non-cancer assessments are 

estimated to be 43.4 parts per billion 

(ppb) for surface water and 4.13 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 43.4 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 currently 

registered for the following uses that 

could result in residential exposures: 

Ornamentals. EPA assessed residential 

exposure using the following 

assumptions: Adults may be exposed to 

methoxyfenozide from its currently 

registered use on ornamentals. 

Residential pesticide handlers may be 

exposed for short-term durations of 

exposure (1–30 days) only. The 

inhalation (short-term) residential 

exposure was assessed for a 

‘‘homeowner’’ mixer/loader/applicator 

using a manually pressurized 

handwand, backpack sprayer, or hoseend sprayer. 

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. 


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40810 Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Rules and Regulations 

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 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 

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 safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

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. Although 

a 28-day inhalation toxicity study has 

not been submitted, EPA has 

determined that this study is not needed 

based on a weight of evidence approach 

that considered all of the available 

hazard and exposure information, 

including the use of a conservative oral 

POD that results in MOEs ranging from 

28,000 to 4,100,000 for risk via the 

inhalation route due to residential and 

occupational exposures. Therefore, 

there is no need for additional UFs to 

account for missing studies. 

ii. There is no indication that 

methoxyfenozide is a neurotoxic 

chemical and there is no need for 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

methoxyfenozide 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. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment 

utilized 100 PCT and tolerance-level 

residues (established or recommended). 

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 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, methoxyfenozide 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 

methoxyfenozide from food and water 

will utilize 58% of the cPAD for 

children 1–2 years old the population 

group receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of methoxyfenozide 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). Methoxyfenozide is 

currently registered for uses that could 

result in short-term residential exposure 

for adults, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to methoxyfenozide. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 670. Because EPA’s level of 

concern for methoxyfenozide 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). 

Because no intermediate-term adverse 

effect was identified, methoxyfenozide 

is not expected to pose an intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity 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 enforcement methodology 

(high performance liquid 

chromatography (HPLC), with either 

tandem mass spectrometric detection 

(LC/MS/MS) or ultraviolet detection 

(HPLC/UV)) 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. 


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Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Rules and Regulations 40811 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has established MRLs for 

methoxyfenozide in or on citrus fruits at 

0.7 ppm, carrots at 0.5 ppm, and 

radishes at 0.4 ppm. These MRLs are 

different than the tolerances established 

for methoxyfenozide in the United 

States. Harmonization of tolerances in 

the currently requested commodities is 

not possible, as the U.S. and Codex use 

patterns differ potentially resulting in 

residues in citrus and vegetable, root, 

except sugar beet, subgroup 1B, which 

includes carrots and radishes, under 

U.S. use patterns that are greater than 

the corresponding Codex MRLs. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is establishing a slightly higher 

tolerance of 0.90 ppm for vegetable, 

root, except sugar beet, subgroup 1B, 

than was proposed. The 0.90 ppm 

tolerance was calculated using the 

Organization for Economic Co-operation 

and Development (OECD) tolerance 

calculation procedure. Similarly, EPA is 

establishing tolerances for citrus 

commodities that are higher than that 

proposed by IR–4. IR–4 proposed 

separate tolerances for residues in 

lemon oil and residues in all other 

citrus oils. However, because residues 

from the citrus field trials are similar 

enough to warrant a crop group 

tolerance, and a single processing factor 

was used to derive the oil tolerance, 

EPA is establishing a conservative 

tolerance in citrus oil at 100 ppm, and 

no separate tolerance for residues in 

lemon oil will be established. 

Tolerances proposed for inadvertent 

residues will not be established for 

vegetable, root and tuber group 1 at 1 

ppm since a tolerances exist in 

§ 180.544(a) for subgroups 1A and 1D. 

Therefore, only a tolerance for potato 

will be established at the Agency 

determined level of 0.02 ppm. 

Tolerances will not be established for 

vegetable, bulb, group 3 at 0.20 ppm 

since a tolerance exists in § 180.544(a) 

for subgroup 3–07B. Only a tolerance for 

onion, bulb, subgroup 3–07A will be 

established at the Agency determined 

level of 0.10 ppm. Tolerances also are 

not needed for vegetable, legume group 

6, grass forage, fodder, and hay group 

17, since tolerances for these groups 

exist under § 180.544(a). Also, since a 

tolerance exists in § 180.544(a) for 

coriander, leaves, a tolerance for Herb 

and spice, group 19, except coriander, 

leaves will be established at a lower, 

Agency determined level of 4.5 ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of methoxyfenozide 

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

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

dimethylethyl hydrazide), in or on fruit, 

citrus, group 10–10 at 3.0 ppm; citrus, 

oil at 100 ppm; vegetable, root, except 

sugar beet, subgroup 1B at 0.90 ppm; 

and beet, sugar 0.50 ppm. Also, due to 

the tolerances established above by this 

document, the following existing 

tolerance is removed as unnecessary; 

vegetable, root, subgroup 1A. All of the 

commodities covered by this crop 

subgroup are covered by the tolerances 

for vegetable, root, except sugar beet, 

subgroup 1B, and beet, sugar. In 

addition, concurrent with the 

establishment of tolerances for fruit, 

citrus, group 10–10 at 3.0 ppm and 

citrus, oil at 100 ppm in § 180.544(a), 

the tolerances for fruit, citrus, group 10 

(10 ppm) and citrus oil (100 ppm) will 

be removed from § 180.544(c). 

Tolerances will be established under 

§ 180.544(d)(1) for onion, bulb subgroup 

3–07A at 0.10 ppm and for potato at 

0.02 ppm. Tolerances will be 

established under § 180.544(d)(2) for 

grain, cereal, forage, fodder and straw, 

group 16 except corn at 6.0 ppm; animal 

feed, nongrass, group 18, straw at 8.0 

ppm; and herb and spice, group 19, 

except coriander, leaves at 4.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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


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40812 Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Rules and Regulations 

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: June 29, 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. In § 180.544: 

■ i. Revise the introductory text in 

paragraph (a)(1); 

■ ii. Remove the entry for ‘‘Vegetable, 

root, subgroup 1A’’ from the table in 

paragraph (a)(1), and add alphabetically 

the following commodities to the table; 

■ iii. Revise introductory text in 

paragraph (a)(2); and 

■ iv. Revise paragraphs (b), (c) and (d). 

The amendments read as follows: 

§ 180.544 Methoxyfenozide; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide methoxyfenozide, including 

its metabolites and degradates, in or on 

the commodities listed in the following 

table. Compliance with the tolerance 

levels specified in the following table is 

to be determined by measuring only 

methoxyfenozide (3-methoxy-2- 

methylbenzoic acid 2-(3,5- 

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

hydrazide) in or on the commodity. 

Commodity Parts per 

million 

* * * * * 

Beet, sugar, roots ............... 0 .50 

Commodity Parts per 

million 

* * * * * 

Citrus, oil ............................. 100 

* * * * * 

Fruit, citrus, group 10–10 ... 3 .0 

* * * * * 

Vegetable, root, except 

sugar beet, Subgroup 1B 0 .90 

* * * * * 

(2) Tolerances are established for 

residues of the insecticide 

methoxyfenozide, 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 the sum 

of methoxyfenozide [3-methoxy-2- 

methylbenzoic acid 2-(3,5- 

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

hydrazide] and its glucuronide 

metabolite (b-D-Glucopyranuronic acid, 

3-[[2-(1,1-dimethylethyl)-2-(3,5- 

dimethylbenzoyl)-hydrazino]carbonyl]- 

2-methylphenyl-), calculated as the 

stoichiometric equivalent of 

methoxyfenozide. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the insecticide 

methoxyfenozide, including its 

metabolites and degradates, in or on the 

specified agricultural commodities, 

resulting from use of the pesticide 

pursuant to FFIFRA section 18 

emergency exemptions. Compliance 

with the tolerance levels specified in the 

following table is to be determined by 

measuring only methoxyfenozide 

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

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

dimethylethyl)hydrazide]. The expired 

tolerances will be revoked on the date 

specified in the table. 

* * * * * 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent tolerances. 

(1) Tolerances are established for the 

indirect or inadvertent residues of the 

insecticide methoxyfenozide, including 

its metabolites and degradates, in or on 

the raw agricultural commodities in the 

following table, when present therein as 

a result of the application of 

methoxyfenozide to growing crops as 

listed in paragraph (a) of this section. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only 

methoxyfenozide [3-methoxy-2- 

methylbenzoic acid 2-(3,5- 

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

hydrazide]. 

Commodity Parts per 

million 

Onion, bulb, subgroup 3–07A 0.10 

Potato ................................... 0.02 

(2) Tolerances are established for the 

indirect or inadvertent residues of the 

insecticide methoxyfenozide, including 

its metabolites and degradates, in or on 

the raw agricultural commodities in the 

following table, when present therein as 

a result of the application of 

methoxyfenozide to growing crops as 

listed in paragraph (a) of this section. 

Compliance with the tolerance levels 

specified in the following table is to be 

determined by measuring only the sum 

of methoxyfenozide [3-methoxy-2- 

methylbenzoic acid, 2-(3,5- 

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

hydrazide] and the following 

metabolites (all calculated as the 

stoichiometric equivalent of 

methoxyfenozide): free phenol of 

methoxyfenozide [3,5-dimethylbenzoic 

acid N-tert-butyl-N′-(3-hydroxy-2- 

methylbenzoyl) hydrazide], the glucose 

conjugate of the phenol [3,5-dimethyl 

benzoic acid N-tert-butyl-N′-[3 (b-Dglucopyranosyloxy)-2-methylbenzoyl]- 

hydrazide] and the malonylglycosyl 

conjugate of the phenol [3,5-dimethyl 

benzoic acid N-tert-butyl-N′-[3 (b-D-6- 

malonyl-glucopyranosyl-1-oxy)-2- 

methylbenzoyl]-hydrazide]. 

Commodity Parts per 

million 

Animal feed, nongrass, 

group 18, straw ................. 8.0 

Grain, cereal, forage, fodder 

and straw group 16, except corn ........................... 6.0 

Herb and spice, group 19, 

except coriander, leaves ... 4.5 

[FR Doc. 2012–16824 Filed 7–10–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0507; FRL–9353–7] 

RIN 2070–ZA16 

Dicloran and Formetanate; Tolerance 

Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


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