Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 60709 

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) (2 U.S.C. 1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 26, 2013. 

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 § 180.364, remove the entry for 

‘‘Canola, seed’’ from the table in 

paragraph (a)(1) and add alphabetically 

‘‘Canola, seed’’ to the table in paragraph 

(a)(2) to read as follows: 

§ 180.364 Glyphosate; tolerances for 

residues. 

(a) * * * 

(2) * * * 

Commodity Parts per 

million 

Canola, seed ........................ 20 

* * * * * 

* * * * * 

[FR Doc. 2013–24128 Filed 10–1–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0912; FRL–9399–6] 

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 in this document. 

Additionally, this regulation removes 

several established time-limited and 

permanent tolerances, as they will be 

superseded by tolerances established by 

this document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 2, 2013. Objections and 

requests for hearings must be received 

on or before December 2, 2013, 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–2012–0912, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., 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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 


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60710 Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2012–0912 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 December 2, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0912, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (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.html. 

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 January 16, 

2013 (78 FR 3377) (FRL–9375–4), EPA 

issued a document pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 2E8118) 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 (3-methoxy-2- 

methylbenzoic acid 2-(3,5- 

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

hydrazide) in or on atemoya at 0.6 parts 

per million (ppm); berry, low growing, 

except cranberry, subgroup 13–07G at 

1.5 ppm; biriba at 0.6 ppm; caneberry 

subgroup 13–07A at 6 ppm; cherimoya 

at 0.6 ppm; custard apple at 0.6 ppm; 

date at 7 ppm; fruit, pome, group 11–10 

at 1.5 ppm; fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

at 1 ppm; grain, aspirated grain fractions 

at 80 ppm; herb subgroup 19A, except 

chive at 400 ppm; ilama at 0.6 ppm; pea 

and bean, dried shelled, except soybean, 

subgroup 6C, except pea, blackeyed, 

seed and pea, southern, seed at 0.5 ppm; 

sorghum, grain, forage at 9 ppm; 

sorghum, grain, grain at 4 ppm; 

sorghum, grain, stover at 15 ppm; 

sorghum, sweet, forage at 9 ppm; 

sorghum, sweet, grain at 4 ppm; 

sorghum, sweet, stalk at 9 ppm; 

sorghum, sweet, stover at 15 ppm; 

soursop at 0.6 ppm; sugar apple at 0.6 

ppm; and vegetable, fruiting, group 8–10 

at 2 ppm. 

Additionally, the petition requested 

that EPA establish tolerances under 

paragraph (d)(2) for indirect or 

inadvertent residues of 

methoxyfenozide in or on rapeseed 

subgroup 20A at 1.0 ppm and sunflower 

subgroup 20B at 1.0 ppm, and to amend 

the tolerance for herb and spice, group 

19, except coriander, leaves at 4.5 ppm 

to spice subgroup 19B at 4.5 ppm. Upon 

approval of the proposed tolerances 

listed under ‘‘New Tolerances,’’ the 

petition finally requested that EPA 

remove the following commodities from 

paragraph (a)(1): Bean, dry seed at 0.24 

ppm; coriander, leaves at 30 ppm; grape 

at 1.0 ppm; fruit, pome, group 11 at 1.5 

ppm; okra at 2.0 ppm; pea, dry seed at 

2.5 ppm; strawberry at 1.5 ppm; and 

vegetable, fruiting, group 8 at 2.0 ppm. 

That document referenced a summary of 

the petition prepared on behalf of IR–4 

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 petition, EPA has revised 

the proposed tolerance levels for several 

commodities. The Agency has also 

removed the time-limited tolerances for 

several commodities and the established 

tolerance in or on grain, aspirated grain 

fractions. 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. 

The main target organs identified 

from the toxicity studies on 

methoxyfenozide were the liver, 

thyroid, and red blood cells, though 

many of the available short-term or 

subchronic toxicity studies showed 


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little or no toxicity. Effects of 

methoxyfenozide on the blood in 

mammals (methemoglobinemia, 

decreased red blood cell parameters, 

Heinz body formation) are consistent 

with those of other hydrazine 

compounds. Hematologic parameters in 

the rat and dog were affected by 

exposure to methoxyfenozide. Mild 

anemia (decreases in red blood cell 

count, hematocrit and hemoglobin) was 

observed in both species following 

chronic dietary exposure, along with 

methemoglobinemia and red blood cell 

structural abnormalities. Increased 

platelets were also observed. An 

increase in the cellularity of rib and 

sternum bone marrow, along with 

macrophage pigmentation in the liver 

and spleen, were reported in the dog. 

No significant hematological changes 

were seen in the dog or rat subchronic 

studies, or the rat 2 week range-finding 

studies; however, hematological effects 

were observed in the dog 2 week rangefinding study, along with increased 

spleen weight. No hematological effects 

were reported in the mouse. 

Increased liver weight and periportal 

hypertrophy were observed in the rat 

and dog. These findings were observed 

in the rat following 2-week, subchronic 

or chronic dietary exposure and in the 

dietary reproductive toxicity study, and 

in the dog following chronic exposure. 

In the rat 2-week toxicity study, 

increased adrenal gland weight and 

minimal hypertrophy of the zone 

fasciculata, and increased thyroid 

follicular cell hypertrophy/hyperplasia 

were also observed. Thyroid 

hypertrophy and altered colloid and 

increased adrenal weights were 

observed in the rat chronic oral study, 

and the incidence and severity of 

chronic progressive 

glomerulonephropathy was increased. 

Thyroid weights were increased in the 

dog following chronic exposure. 

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 

developmental toxicity studies. In the 

rat 2-generation reproductive toxicity 

study, no offspring or reproductive 

toxicity was observed, and parental 

effects were limited to increased liver 

weight and microscopic periportal 

hypertrophy. In an immunotoxicity 

study in the rat, no immunotoxicity was 

observed. 

There was no evidence of 

carcinogenicity in the rat combined 

chronic toxicity and carcinogenicity 

study or the mouse carcinogenicity 

study. No mutagenic or clastogenic 

potential was observed in the battery of 

genotoxicity studies on 

methoxyfenozide. Based on these 

findings, methoxyfenozide has been 

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: 

‘‘Methoxyfenozide. Human Health Risk 

Assessment to Support Proposed New 

Uses on Herbs, Caneberries, Dates and 

Sorghum; to Establish Rotational Crop 

Tolerances in the Rapeseed and 

Sunflower Oilseed Subgroups; as well 

as to Extend and Update Crop Group 

Tolerances on Multiple Commodities’’ 

at pp. 35–41 in docket ID number EPA– 

HQ–OPP–2012–0192. 

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 discussed in 

Unit III.B. of the final rule published in 

the Federal Register of July 11, 2012 (77 

FR 40806) (FRL–9354–1). 

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 Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID) Version 3.16, which uses food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, ‘‘What We Eat in 

America’’ (NHANES/WWEIA) from 

2003 through 2008. As to residue levels 

in food, EPA utilized tolerance-level 

residues, DEEM (Version 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/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for methoxyfenozide in drinking water. 

These simulation models take into 

account data on the physical, chemical, 


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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 Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of 

methoxyfenozide for chronic exposures 

for non-cancer assessments are 

estimated to be 51.6 parts per billion 

(ppb) for surface water and 251 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 251 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: Ornamental 

uses, including on residential property. 

EPA assessed residential exposure using 

the following assumptions: Adult 

handlers were assessed for short-term 

inhalation exposures from mixing, 

loading, and applying methoxyfenozide 

using a manually pressurized hand 

wand, backpack sprayer, or hose-end 

sprayer. Since the short- and 

intermediate-term toxicological 

endpoints are the same, only short-term 

exposures have been assessed and are 

assumed to be protective of 

intermediate-term exposures. A 

postapplication exposure assessment 

was not conducted for adults because 

the handler assessment is expected to be 

protective of postapplication exposure 

via the inhalation route. Although there 

is also potential for dermal exposure, 

there is no expectation of dermal risk to 

any population, including infants and 

children, based on the lack of dermal 

toxicity for methoxyfenozide. 

Furthermore, the potential for 

postapplication oral exposures to 

children is not expected since the extent 

to which young children engage in 

activities associated with areas where 

residential ornamentals are grown or 

use these areas for prolonged periods of 

play is low. 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 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 Safety 

Factor (FQPA 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 

pre- or 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. 

ii. There is no indication that 

methoxyfenozide is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (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 chronic dietary food exposure 

assessment was performed based on 100 

PCT and tolerance-level residues. EPA 

made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to methoxyfenozide in drinking water. 

Based on the discussion in Unit III.C.3., 

residential exposures to children or 

toddlers are not expected. 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 84% 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. 


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Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 60713 

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, 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 an 

aggregate MOE of 530 for adult 

handlers. Because EPA’s level of 

concern for methoxyfenozide is a MOE 

of 100 or below, this MOE is 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). 

Methoxyfenozide is currently registered 

for uses that could result in 

intermediate-term residential exposure. 

However, based on the information in 

Unit III.C.3., an intermediate-term 

aggregate exposure assessment was not 

performed and is not necessary. 

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, 

using high performance liquid 

chromatography (HPLC), with either 

mass spectrometric detection (LC/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. 

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 commodities 

associated with this action. Codex has 

established MRLs in or on grapes at 1 

milligram/kilogram (mg/kg); pepper and 

tomato at 2 mg/kg; pome fruits at 2 mg/ 

kg; and strawberries at 2 mg/kg. The 

U.S. tolerances for small vine climbing 

fruit, except fuzzy kiwifruit subgroup 

13–07F at 1.0 ppm (represented by 

grape); and vegetable, fruiting, group 8– 

10 (represented by commodities 

including pepper and tomato) at 2.0 

ppm are harmonized with the Codex 

MRLs for grape and for pepper and 

tomato, respectively. 

Additionally, the EPA is establishing 

a tolerance in or on fruit, pome, group 

11–10 at 2.0 ppm, which is increased 

from the current tolerance of 1.5 ppm 

for fruit, pome, group 11, in order to 

harmonize with the Codex MRL in or on 

fruit, pome at 2 mg/kg. The Agency is 

also establishing a tolerance in or on 

berry, low growing, subgroup 13–07G, 

except cranberry (represented by 

strawberry) at 2.0 ppm, in order to 

harmonize with the Codex MRL in or on 

strawberry at 2 mg/kg. The 13–07G 

tolerance is being increased from the 

current tolerance of 1.5 ppm in or on 

strawberry. 

The recommended tolerance of 0.50 

ppm in or on pea and bean, dried 

shelled, except soybeans subgroup 6C, 

was proposed at the Agency’s request to 

better harmonize with the existing 

Codex MRL of 0.5 mg/kg in or on dried 

beans. This tolerance will supersede the 

current tolerances in or on dried beans 

at 0.24 ppm, and in or on dried peas at 

2.5 ppm. The Codex has not established 

MRLs for other commodities associated 

with this action. 

C. Revisions to Petitioned-For 

Tolerances 

Based on the data supporting the 

petition, EPA has revised the proposed 

tolerances for several commodities, as 

follows: Date from 7.0 ppm to 8.0 ppm; 

grain, aspirated grain fractions from 80 

ppm to 120 ppm; sorghum, grain, forage 

from 9.0 ppm to 15 ppm; sorghum, 

grain, grain from 4.0 ppm to 6.0 ppm; 

sorghum, grain, stover from 15 ppm to 

20 ppm; sorghum, sweet, forage from 9.0 

ppm to 15 ppm; sorghum, sweet, grain 

from 4.0 ppm to 6.0 ppm; sorghum 

sweet, stalk from 9.0 ppm to 15 ppm; 

and sorghum, sweet, stover from 15 

ppm to 20 ppm. The Agency revised 

these tolerance levels based on analysis 

of the residue field trial data using the 

Organization for Economic Cooperation 

and Development (OECD) tolerance 

calculation procedures. As previously 

discussed, EPA has also revised the 

following proposed tolerances in order 

to harmonize with established Codex 

MRLs: Berry, low growing, subgroup 

13–07G, except cranberry from 1.5 ppm 

to 2.0 ppm, and fruit, pome, group 11– 

10 from 1.5 ppm to 2.0 ppm. 

EPA is establishing a tolerance in or 

on herb subgroup 19A, except chive at 

400 ppm. The petition to the Agency 

requested concurrently to amend the 

established tolerance for indirect or 

inadvertent residues in or on herb and 

spice, group 19, except coriander, leaves 

at 4.5 ppm to spice subgroup 19B at 4.5 

ppm, because a permanent tolerance in 

or on subgroup 19A was proposed to be 

established and an inadvertent tolerance 

is no longer needed when a commodity 

has a tolerance allowing for direct 

treatment. However, because the 

permanent tolerance being established 

in or on herb subgroup 19A does not 

include a tolerance for chive and chive 

is not included in subgroup 19B, the 

Agency determined that it is also 

necessary to maintain a tolerance for the 

indirect or inadvertent residues of 

methoxyfenozide in or on chive, as the 

commodity was previously covered by 

the group 19 indirect or inadvertent 

residue tolerance. Therefore, EPA is also 

establishing an individual tolerance for 

the indirect or inadvertent residues of 

methoxyfenozide in or on chive at 4.5 

ppm. 

Additionally, EPA determined that 

the time-limited tolerances in or on 

sorghum, forage at 30.0 ppm; sorghum, 

grain at 0.05 ppm; and sorghum, stover 

at 60.0 ppm should be removed because 

the tolerances expired on December 31, 

2012, and because they will be 

superseded by permanent tolerances for 

these commodities. Finally, the Agency 

has determined that the established 


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60714 Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 

tolerance in or on grain, aspirated 

fractions at 2.0 ppm should be removed, 

as it will be superseded by the grain, 

aspirated grain fractions tolerance at 120 

ppm. 

V. Conclusion 

Therefore, tolerances are established 

for residues of methoxyfenozide (3- 

methoxy-2-methylbenzoic acid 2-(3,5- 

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

hydrazide) in or on atemoya at 0.60 

ppm; berry, low growing, subgroup 13– 

07G, except cranberry at 2.0 ppm; biriba 

at 0.60 ppm; caneberry subgroup 13– 

07A at 6.0 ppm; cherimoya at 0.60 ppm; 

custard apple at 0.60 ppm; date at 8.0 

ppm; fruit, pome, group 11–10 at 2.0 

ppm; fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13–07F at 1.0 

ppm; grain, aspirated grain fractions at 

120 ppm; herb subgroup 19A, except 

chive at 400 ppm; ilama at 0.60 ppm; 

pea and bean, dried shelled, except 

soybean, subgroup 6C, except pea, 

blackeyed, seed and pea, southern, seed 

at 0.50 ppm; sorghum, grain, forage at 

15 ppm; sorghum, grain, grain at 6.0 

ppm; sorghum, grain, stover at 20 ppm; 

sorghum, sweet, forage at 15 ppm; 

sorghum, sweet, grain at 6.0 ppm; 

sorghum, sweet, stalk at 15 ppm; 

sorghum, sweet, stover at 20 ppm; 

soursop at 0.60 ppm; sugar apple at 0.60 

ppm; and vegetable, fruiting, group 8–10 

at 2.0 ppm. This regulation additionally 

establishes tolerances for indirect or 

inadvertent residues in or on rapeseed 

subgroup 20A at 1.0 ppm and sunflower 

subgroup 20B at 1.0 ppm. The 

regulation also amends the tolerance for 

indirect or inadvertent residues in or on 

herb and spice, group 19, except 

coriander, leaves at 4.5 ppm to spice 

subgroup 19B at 4.5 ppm and chive at 

4.5 ppm. 

This regulation additionally removes 

the established tolerances in or on bean, 

dry, seed at 0.24 ppm; coriander, leaves 

at 30 ppm; fruit, pome, group 11 at 1.5 

ppm; grain, aspirated fractions at 2.0 

ppm; grape at 1.0 ppm; okra at 2.0 ppm; 

pea, dry, seed at 2.5 ppm; strawberry at 

1.5 ppm; and vegetable, fruiting, group 

8 at 2.0 ppm. Finally, this regulation 

removes the time-limited tolerances in 

or on sorghum, forage at 30.0 ppm; 

sorghum, grain at 0.05 ppm; and 

sorghum, stover at 60.0 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) (2 U.S.C. 

1501 et seq.). 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 26, 2013. 

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: 

■ a. Remove bean, dry, seed; coriander, 

leaves; fruit, pome, group 11; grain, 

aspirated fractions; grape; okra; pea, dry 

seed; strawberry; and vegetable, fruiting, 

group 8 from the table in paragraph 

(a)(1). 

■ b. Remove and reserve paragraph (b). 

■ c. Remove herb and spice, group 19, 

except coriander, leaves from the table 

in paragraph (d)(2). 

■ d. Add the following commodities in 

alphabetical order to the tables in 

paragraphs (a)(1) and (d)(2) as shown. 

§ 180.544 Methoxyfenozide; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Atemoya ........................................ 0 .60 

* * * * * 

Berry, low growing, subgroup 13– 

07G, except cranberry .............. 2 .0 

Biriba ............................................. 0 .60 

* * * * * 

Caneberry subgroup 13–07A ....... 6 .0 

* * * * * 

Cherimoya .................................... 0 .60 


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Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Rules and Regulations 60715 

Commodity Parts per 

million 

* * * * * 

Custard apple ............................... 0 .60 

Date .............................................. 8 .0 

* * * * * 

Fruit, pome, group 11–10 ............. 2 .0 

Fruit, small, vine climbing, except 

fuzzy kiwifruit, subgroup 13– 

07F ............................................ 1 .0 

* * * * * 

Grain, aspirated grain fractions .... 120 

* * * * * 

Herb subgroup 19A, except chive 400 

* * * * * 

Ilama ............................................. 0 .60 

* * * * * 

Pea and bean, dried shelled, except soybean, subgroup 6C, except pea, blackeyed, seed and 

pea, southern, seed .................. 0 .50 

* * * * * 

Sorghum, grain, forage ................. 15 

Sorghum, grain, grain ................... 6 .0 

Sorghum, grain, stover ................. 20 

Sorghum, sweet, forage ............... 15 

Sorghum, sweet, grain ................. 6 .0 

Sorghum, sweet, stalk .................. 15 

Sorghum, sweet, stover ................ 20 

Soursop ........................................ 0 .60 

* * * * * 

Sugar apple .................................. 0 .60 

* * * * * 

Vegetable, fruiting, group 8–10 .... 2 .0 

* * * * * 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

(d) * * * 

(2) * * * 

Commodity Parts per 

million 

* * * * * 

Chive ............................................. 4 .5 

* * * * * 

Rapeseed subgroup 20A .............. 1 .0 

Spice subgroup 19B ..................... 4 .5 

Sunflower subgroup 20B .............. 1 .0 

[FR Doc. 2013–24127 Filed 10–1–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0885; FRL–9397–8] 

Sedaxane; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of sedaxane in or 

on potato and potato, wet peel. 

Syngenta Crop Protection, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 2, 2013. Objections and 

requests for hearings must be received 

on or before December 2, 2013, 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–2012–0885, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., 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: Lois 

Rossi, Registration Division, Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–7090; 

email address: RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

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–2012–0885 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 December 2, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0885, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, EPA/DC, 

(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://


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