Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 73951 

Dated: December 4, 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 § 180.566 revise paragraph (a)(1), 

and the introductory texts of paragraphs 

(a)(2), (a)(3) and (b) to read as follows: 

§ 180.566 Fenpyroximate; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide fenpyroximate, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene]amino]oxy]

methyl]benzoate and its Z-isomer, (Z)- 

1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1H-pyrazol-4-yl)methylene]

amino]oxy]methyl]benzoate, calculated 

as the stoichiometric equivalent of 

fenpyroximate. 

Commodity Parts per 

million 

Almond, hulls ............................ 3 .0 

Avocado .................................... 0 .15 

Bean, snap, succulent .............. 0 .40 

Berry, low growing, subgroup 

13–07G ................................. 1 .0 

Canistel ..................................... 0 .15 

Citrus, dried pulp ...................... 2 .5 

Citrus, oil ................................... 10 

Corn, field, forage ..................... 2 .0 

Corn, field, grain ....................... 0 .02 

Corn, field, refined oil ............... 0 .05 

Corn, field, stover ..................... 7 .0 

Corn, pop, forage ..................... 2 .0 

Corn, pop, grain ........................ 0 .02 

Corn, pop, stover ...................... 7 .0 

Cotton, gin byproducts ............. 10 

Cotton, undelinted seed ........... 0 .10 

Cucumber ................................. 0 .40 

Fruit, citrus, group 10–10 ......... 0 .50 

Fruit, pome, group 11–10 ......... 0 .30 

Grain, aspirated fractions ......... 0 .40 

Grape ........................................ 1 .0 

Hop, dried cones ...................... 10 

Mango ....................................... 0 .15 

Melon subgroup 9A .................. 0 .10 

Nut, tree, group 14 ................... 0 .10 

Papaya ...................................... 0 .15 

Peppermint, tops ...................... 7 .0 

Pistachio ................................... 0 .10 

Sapodilla ................................... 0 .15 

Sapote, black ............................ 0 .15 

Sapote, mamey ........................ 0 .15 

Spearmint, tops ........................ 7 .0 

Star, apple ................................ 0 .15 

Commodity Parts per 

million 

Tea, dried 1 ............................... 20 

Vegetable, fruiting, group 8–10 0 .20 

1There are no U.S. Registrations. 

(2) Tolerances are established for 

residues of the insecticide 

fenpyroximate, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene]amino]oxy]

methyl]benzoate and its metabolites (E)- 

4-[(1,3-dimethyl-5-phenoxypyrazol-4- 

yl)-methyleneaminooxymethyl]benzoic 

acid and (E)-1,1-dimethylethyl-2- 

hydroxyethyl 4-[[[[(1,3-dimethyl-5- 

phenoxy-1H-pyrazol-4-yl)methylene]

amino]oxy]methyl]benzoate, calculated 

as the stoichiometric equivalent of 

fenpyroximate. 

* * * * * 

(3) Tolerances are established for 

residues of the insecticide 

fenpyroximate, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl)methylene]amino]oxy]

methyl]benzoate and its metabolite (E)- 

4-[(1,3-dimethyl-5-phenoxypyrazol-4- 

yl)-methyleneaminooxymethyl]benzoic 

acid, calculated as the stoichiometric 

equivalent of fenpyroximate. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of the insecticide 

fenpyroximate, including its metabolites 

and degradates in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified in the table is to be 

determined by measuring only the sum 

of fenpyroximate, (E)-1,1-dimethylethyl 

4-[[[[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl) methylene]amino]

oxy]methyl]benzoate and its Z-isomer, 

(Z)-1,1-dimethylethyl 4-[[[[(1,3- 

dimethyl-5-phenoxy-1H-pyrazol-4-yl)

methylene]amino]oxy]methyl]benzoate, 

calculated as the stoichiometric 

equivalent of fenpyroximate. 

* * * * * 

[FR Doc. 2012–29900 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1012; FRL–9365–6] 

Pyriproxyfen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyriproxyfen 

in or on multiple commodities which 

are identified and discussed later in 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 

December 12, 2012. Objections and 

requests for hearings must be received 

on or before February 11, 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–2011–1012, 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; email address: 

ertman.andrew@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 


emcdonald on DSK67QTVN1PROD with 
73952 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

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://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2011–1012 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 February 11, 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– 

2011–1012, 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.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 March 14, 

2012 (77 FR 15012) (FRL–9335–9), 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 1E7950) by IR–4, IR–4 

Project Headquarters, 500 College Rd. 

East, Suite 201 W, Princeton, NJ 08540. 

The petition requested that 40 CFR 

180.510 be amended by establishing 

tolerances for residues of the insecticide 

pyriproxyfen, 2-[1-methyl-2-(4- 

phenoxyphenoxy)ethoxypyridine, in or 

on vegetable, bulb, group 3–07 at 0.70 

parts per million (ppm); vegetable, 

fruiting, group 8–10 at 0.20 ppm; fruit, 

citrus, group 10–10 at 0.30 ppm; fruit, 

pome, group 11–10 at 0.20 ppm; 

caneberry subgroup 13–07A at 1.0 ppm; 

bushberry subgroup 13–07B at 1.0 ppm; 

berry, low growing, except strawberry, 

subgroup 13–07H at 1.0 ppm; and herb 

subgroup 19A at 50 ppm. Also, due to 

the establishment of the tolerances for 

the new crop groups listed in this unit, 

the petition proposed the removal of the 

following commodities as unnecessary: 

Vegetable, bulb, group 3, except onion, 

bulb; onion, bulb; vegetable, fruiting, 

group 8; okra; fruit, citrus; fruit, pome; 

caneberry subgroup 13–A; bushberry 

subgroup 13–B; cranberry; loganberry; 

juneberry; lingonberry; and salal. That 

document referenced a summary of the 

petition prepared by Valent USA 

Corporation, 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 

modified the levels at which tolerances 

are being established for several 

commodities. The reason for these 

changes is 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 pyriproxyfen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyriproxyfen 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. 

Pyriproxyfen is of low acute toxicity 

by oral, dermal, inhalation, and ocular 

routes of exposure. Pyriproxyfen is not 

a skin irritant and was negative in the 

dermal sensitization study in guinea 

pigs. Based on repeated dose studies in 

mice, rats, and dogs the liver and kidney 

are the principal target organs, with 

slight anemia occurring in rodent 

species. The review of the acute and 

subchronic neurotoxicity studies 

indicates pyriproxyfen is not a 

neurotoxic chemical. There was no 

evidence of prenatal or postnatal 

sensitivity or increased susceptibility in 

developmental studies in rats and 

rabbits, and in reproduction studies in 

rats. In the 2-generation reproduction 

toxicity study, offspring toxicity 

(decreased body weight on pups during 

lactation days 14 to 21) occurred in the 

presence of decreased body weight in 

parental animals at the same dose level. 

An immunotoxicity study showed no 

adverse effects on the immune system. 

No significant systemic toxicity was 


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observed in either the 21-day dermal 

toxicity study in rats. In a 28-day 

inhalation study, the Lowest-observedadverse-effect-level (LOAEL) of 1 

milligram/Liter (mg/L) based on 

salivation in females and sporadic 

decreased body weight gains in males 

was not considered biologically 

relevant. With respect to carcinogenicity 

pyriproxyfen has been classified as a 

‘‘Group E’’ chemical—no evidence for 

carcinogenicity to humans based on the 

absence of carcinogenicity in mice and 

rats. Pyriproxyfen is negative for 

mutagenic activity in a battery of 

mutagenicity studies conducted with 

both the parent and/or metabolites. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyriproxyfen as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov on pp. 28–33 in 

the document titled ‘‘Pyriproxyfen. 

Human Health Risk Assessment for the 

Request to Add Uses on Herb Subgroup 

19A, and the Expansions of Existing 

Crop Group Uses to Numerous Crop 

Subgroups’’ in docket ID number EPA– 

HQ–OPP–2011–1012. 

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 pyriproxyfen used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRIPROXYFEN 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 (Females 13–50 

years of age and general 

population).

An appropriate endpoint attributable to a single oral dose was not available in the data base, including the developmental and reproduction toxicity studies. 

Chronic dietary (All populations) NOAEL = 35.1 mg/ 

kg/day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

Chronic RfD = 0.35 

mg/kg/day.

cPAD = 0.35 mg/kg/ 

day.

Subchronic and chronic rat (co-critical) 

LOAEL = 141.28 mg/kg/day based on decreased body weight 

and alterations in clinical pathology parameters. 

Incidental oral short-term (1 to 

30 days).

NOAEL = 100 mg/ 

kg/day.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 Rat developmental toxicity Maternal LOAEL = 300 mg/kg/day 

based on decreased body weight, body weight gain, and 

food consumption, and increased water consumption. 

Incidental oral intermediateterm (1 to 6 months).NOAEL = 35.1 mg/ 

kg/day.

UFA= 10X 

UFH= 10X 

FQPA SF = 1X 

LOC for MOE = 100 Subchronic and chronic rat (co-critical) 

LOAEL = 141.28 mg/kg/day based on decreased body weight 

and alterations in clinical pathology parameters. 

Dermal long-term (6 months— 

lifetime).

Oral study NOAEL = 

35.1 mg/kg/day 

(dermal absorption 

rate = 30%.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

LOC for MOE = 100 Subchronic and chronic rat (co-critical) 

LOAEL = 141.28 mg/kg/day based decreased body weight and 

alterations in clinical pathology parameters. 

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 (c = chronic). 

RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity 

among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyriproxyfen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyriproxyfen tolerances in 40 

CFR 180.510. EPA assessed dietary 

exposures from pyriproxyfen 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 pyriproxyfen; 


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therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of Agriculture 

(USDA) 1994–1996 and 1998 

Continuing Survey of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA assumed 100 percent crop 

treated (PCT) and tolerance level 

residues. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that pyriproxyfen 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 percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for pyriproxyfen. 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 pyriproxyfen in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyriproxyfen. 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 Tier 1 Rice Model and 

the Generic Estimated Exposure 

Concentration (GENEEC) model the 

estimated drinking water concentrations 

(EDWCs) of pyriproxyfen for chronic 

exposure assessments are estimated to 

be 2.98 parts per billion (ppb) for 

surface water and 0.006 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 2.98 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). 

Pyriproxyfen is currently registered 

for flea and tick control (home 

environment and pet treatments) as well 

as products for ant and roach control 

(indoor and outdoor applications). 

Formulations include carpet powders, 

foggers, aerosol sprays, liquids 

(shampoos, sprays, and pipettes for pet 

treatments), granules, bait (indoor and 

outdoor), and impregnated materials 

(pet collars). EPA assessed residential 

exposure using the following 

assumptions: Although there is the 

potential for short-term residential 

handler dermal and inhalation exposure 

as well as short or intermediate postapplication exposure from the registered 

uses of pyriproxyfen, there are no shortterm dermal or inhalation PODs and 

quantitative assessments were not 

conducted. 

Based on the registered use patterns, 

the following post-application scenarios 

were assessed: Short- and intermediateterm hand-to-mouth exposures for 1 to 

<2 year olds from treated carpets and 

flooring and petting treated animals 

(shampoos, sprays, spot-on treatments 

and collars); long-term hand-to-mouth 

exposures for 1 to <2 year olds from 

treated carpets and flooring and petting 

treated animals; and long-term dermal 

exposures from treated carpets, flooring, 

and pets. 

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 pyriproxyfen to 

share a common mechanism of toxicity 

with any other substances, and 

pyriproxyfen does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pyriproxyfen 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 factors (SF) when 

reliable data available to EPA support 

the choice of a different factor. 

2. Prenatal and postnatal sensitivity. 

Based on the available data, there is no 

quantitative and qualitative evidence of 

increased susceptibility observed 

following in utero pyriproxyfen 

exposure to rats and rabbits or following 

prenatal/postnatal exposure in the 2- 

generation reproduction study. 

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 

pyriproxfen is complete. 

ii. There is no indication that 

pyriproxyfen 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 

pyriproxyfen 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 assessments 

were 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 pyriproxyfen 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by pyriproxyfen. 

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 


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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, pyriproxyfen 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 pyriproxyfen 

from food and water will utilize 12% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. A long-term post-application 

residential assessment was performed 

for toddlers only since they are 

anticipated to have higher exposures 

than adults from treated home 

environments and pets due to their 

behavior patterns. The total chronic 

dietary and residential aggregate MOE is 

220 for children 1–2 years old. As this 

MOE is greater than 100, the chronic 

aggregate risk does not exceed EPA’s 

level of concern. 

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). Pyriproxyfen 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 pyriproxyfen. 

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 2,000 for children 1– 

2 years old, the population subgroup 

receiving the greatest exposure. Because 

EPA’s level of concern (LOC) for 

pyriproxyfen 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). 

Pyriproxyfen is currently registered 

for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to pyriproxyfen. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 720 for children 

1–2 years old, the population subgroup 

receiving the greatest exposure. Because 

EPA’s LOC for pyriproxyfen is a MOE of 

100 or below, this MOE is not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

pyriproxyfen 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 pyriproxyfen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography with Nitrogen 

Phosphorous Detection; GC/NPD) 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 

pyriproxyfen in or on citrus fruit at 0.50 

ppm. This MRL is the same as the 

tolerance being established for 

pyriproxyfen on the citrus group 10–10 

in the United States. There are no Codex 

MRLs for the other commodities 

addressed by this final rule. 

C. Revisions to Petitioned-for Tolerances 

Based on calculations using the 

Organization for Economic Co-operation 

and Development (OECD) MRL 

calculator, the Agency is establishing 

the tolerance for the herb subgroup 19A 

at 100 ppm instead of the proposed 

level of 50 ppm. In addition, the 

tolerance for the citrus fruit group 10– 

10 is being revised to 0.5 ppm to 

harmonize with Codex and the tolerance 

for the fruiting vegetable group 8–10 is 

being revised to 0.8 ppm to harmonize 

with the Canadian MRL for bell 

peppers. 

Lastly, EPA has revised the tolerance 

expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of 

pyriproxyfen not specifically 

mentioned. 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyriproxyfen, 2-[1- 

methyl-2-(4-phenoxyphenoxy) 

ethoxypyridine, in or on vegetable, bulb, 

group 3–07 at 0.70 ppm; vegetable, 

fruiting, group 8–10 at 0.80 ppm; fruit, 

citrus, group 10–10 at 0.50 ppm; fruit, 

pome, group 11–10 at 0.20 ppm; 

caneberry subgroup 13–07A at 1.0 ppm; 

bushberry subgroup 13–07B at 1.0 ppm; 

berry, low growing, except strawberry, 

subgroup 13–07H at 1.0 ppm; and the 

herb subgroup 19A at 100 ppm. Also, 

due to the establishment of the 

tolerances for the new crop groups 

listed in this unit, the following are 

being removed as unnecessary: 

Vegetable, bulb, group 3, except onion, 

bulb; onion, bulb; vegetable, fruiting, 

group 8; okra; fruit, citrus; fruit, pome; 

caneberry subgroup 13–A; bushberry 

subgroup 13–B; cranberry; loganberry; 

juneberry; lingonberry; salal; and citrus 

hybrids. 

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 


emcdonald on DSK67QTVN1PROD with 
73956 Federal Register / Vol. 77, No. 239 / Wednesday, December 12, 2012 / Rules and Regulations 

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: December 4, 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 § 180.510: 

■ a. Revise the introductory text of 

paragraph (a)(1). 

■ b. Remove from the table in paragraph 

(a)(1) the commodities: ‘‘Bushberry 

subgroup 13–B’’; ‘‘Caneberry subgroup 

13–A’’; ‘‘Citrus hybrids’’, ‘‘Cranberry’’; 

‘‘Fruit, citrus’’; ‘‘Fruit, pome’’; 

‘‘Juneberry’’; ‘‘Lingonberry’’; 

‘‘Loganberry’’; ‘‘Okra’’; ‘‘Onion, bulb’’; 

‘‘Salal’’; and ‘‘Vegetable, bulb, group 3, 

except onion, bulb’’; and ‘‘Vegetable, 

fruiting, group 8’’. 

■ c. Add alphabetically the following 

commodities to the table in paragraph 

(a)(1). 

The amendments read as follows: 

§ 180.510 Pyriproxyfen; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of pyriproxyfen, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified is 

determined by measuring only 

pyriproxyfen, 2-[1-methyl-2-(4- 

phenoxyphenoxy) ethoxy]pyridine, in 

or on the commodity. 

Commodity Parts per 

million 

* * * * * 

Berry, low growing, except 

strawberry, subgroup 13– 

07H ...................................... 1 .0 

Commodity Parts per 

million 

* * * * * 

Bushberry subgroup 13–07B .. 1 .0 

* * * * * 

Caneberry subgroup 13–07A 1 .0 

* * * * * 

Fruit, citrus, group 10–10 ....... 0 .50 

Fruit, pome, group 11–10 ....... 0 .20 

* * * * * 

Herb subgroup 19A ................ 100 

* * * * * 

Vegetable, bulb, group 3–07 .. 0 .70 

* * * * * 

Vegetable, fruiting, group 8– 

10 ........................................ 0 .80 

* * * * * 

* * * * * 

[FR Doc. 2012–29978 Filed 12–11–12; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 101 

[WT Docket No. 10–153; RM–11602; FCC 

12–122] 

Facilitating the Use of Microwave for 

Wireless Backhaul and Other Uses and 

Providing Additional Flexibility to 

Broadcast Auxiliary Service and 

Operational Fixed Microwave 

Licensees 

AGENCY: Federal Communications 

Commission. 

ACTION: Correcting amendments. 

SUMMARY: The Federal Communications 

Commission (FCC) published a 

document in the Federal Register of 

September 5, 2012. In this document, 

the FCC on its own motion, pursuant to 

§ 1.108 of the Commission’s rules, 

corrects the channel center frequencies 

to align the wider 60 and 80 megahertz 

channels with the existing 30 and 40 

megahertz channels in part 101 of our 

rules in the Wireless Backhaul 2nd R&O 

and issues this limited modification of 

the Wireless Backhaul 2nd R&O, in 

order to establish more efficient channel 

assignments, consistent with the 

Commission’s intent to improve 

spectrum utilization in these bands. In 

addition, the FCC corrects an entry to 

the table in § 101.115(b)(2). 

DATES: Effective December 12, 2012. 

FOR FURTHER INFORMATION CONTACT: John 

Schauble, Wireless Telecommunications 


emcdonald on DSK67QTVN1PROD with