70902 Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 

10.20 Miscellaneous Hazardous 

Materials (Hazard Class 9) 

* * * * * 

10.20.2 Mailability 

[Revise the second sentence of 10.20.2 

as follows:] 

* * * A miscellaneous hazardous 

material that can qualify as an ORM–D 

material (until January 1, 2015) when 

intended for ground transportation, or a 

mailable air-eligible consumer 

commodity material when intended for 

air transportation, is permitted for 

domestic mail via air or surface 

transportation, subject to the applicable 

49 CFR requirements. 

10.20.3 Marking 

[Revise 10.20.3 as follows:] 

For surface transportation, the 

mailpiece must be plainly and durably 

marked on the address side with 

‘‘Surface Only’’ or ‘‘Surface Mail Only’’ 

and ‘‘ORM–D’’ immediately following 

or below the proper shipping name (or 

with a DOT square-on-point marking 

under 10.8b). For air transportation, 

packages must bear the DOT square-onpoint marking including the symbol 

‘‘Y,’’ an approved DOT Class 9 

hazardous material warning label, 

Identification Number ‘‘ID8000,’’ the 

proper shipping name ‘‘Consumer 

Commodity,’’ and a shipper’s 

declaration for dangerous goods. 

* * * * * 

We will publish an appropriate 

amendment to 39 CFR part 111 to reflect 

these changes. 

Stanley F. Mires, 

Attorney, Legal Policy and Legislative Advice. 

[FR Doc. 2012–28673 Filed 11–27–12; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0644; FRL–9366–1] 

Fenpropathrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpropathrin 

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 

November 28, 2012. Objections and 

requests for hearings must be received 

on or before January 28, 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–2009–0644, 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; email address: 

nollen.laura@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://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–2009–0644 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 28, 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– 

2009–0644, 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 October 7, 

2009 (74 FR 51597) (FRL–8792–7), EPA 

issued a notice pursuant to FFDCA 

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

announcing the filing of a pesticide 

petition (PP 9E7594) by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.466 be 

amended by establishing tolerances for 


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residues of the insecticide 

fenpropathrin, alpha-cyano-3-phenoxybenzyl 2,2,3,3- 

tetramethylcyclopropanecarboxylate, in 

or on acerola, feijoa, guava, jaboticaba, 

passionfruit, starfruit and wax jambu at 

1.5 parts per million (ppm); longan, 

lychee, pulasan, rambutan and Spanish 

lime at 3.0 ppm; atemoya, biriba, 

cherimoya, custard apple, ilama, 

soursop and sugar apple, at 1.0 ppm; 

and tea at 2.0 ppm. That notice 

referenced a summary of the petition 

prepared on behalf of IR–4 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 revised 

the proposed tolerances for several 

commodities. The Agency has also 

revised the tolerance expression for all 

established commodities to be 

consistent with current Agency policy. 

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 fenpropathrin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenpropathrin 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. 

Fenpropathrin is a member of the 

pyrethroid class of insecticides. 

Pyrethroids have historically been 

classified into two groups—Type I and 

Type II, based on chemical structure 

and toxicological effects. Type I 

pyrethroids induce in rats a syndrome 

consisting of aggressive sparring, altered 

sensitivity to external stimuli, 

hyperthermia, and fine tremors, 

progressing to whole-body tremors, and 

prostration (T-syndrome). Type II 

pyrethroids, which contain an alphacyano moiety, produce in rats a 

syndrome that includes pawing, 

burrowing, salivation, hypothermia, and 

coarse tremors leading to 

choreoathetosis (CS-syndrome). 

Fenpropathrin is a mixed type 

pyrethroid because the biochemical 

responses and resulting clinical signs of 

neurotoxicity are intermediate between 

those of Type I and Type II pyrethroids. 

The adverse outcome pathway shared 

by pyrethroids involves the ability to 

interact with voltage-gated sodium 

channels in the central and peripheral 

nervous systems, leading to changes in 

neuron firing and, ultimately, 

neurotoxicity. 

Fenpropathrin exhibits high acute 

toxicity via the oral and dermal routes, 

but low toxicity via the inhalation route 

of exposure. Fenpropathrin is a mild eye 

irritant, but does not cause dermal 

irritation or skin sensitization. 

Toxicological effects characteristic of 

Type I pyrethroids were seen in most of 

the experimental toxicology studies 

including the acute, subchronic, and 

developmental neurotoxicity studies, 

subchronic studies in the rat and dog, 

the chronic carcinogenicity study in the 

rat, the developmental studies in the rat 

and rabbit, and in the 3-generation 

reproduction study in rats. Tremors 

were the most common indication of 

neurotoxicity; however, ataxia, 

increased sensitivity (e.g., heightened 

response) to external stimuli, 

convulsions, and increased auditory 

startle response were also observed. 

In developmental toxicity studies in 

rats and rabbits, maternal toxicity 

included neurological effects such as 

ataxia, sensitivity to external stimuli, 

tremors in the rat, and flicking of 

forepaws in the rabbit. Developmental 

effects were limited to incomplete or 

asymmetrical ossification of sternebrae 

at the maternally toxic dose in the rat. 

There were no developmental effects in 

the rabbit. There were no indications of 

immunotoxicity in any of the guideline 

studies, including the immunotoxicity 

study in rats. In a 3-generation 

reproduction study in the rat, maternal 

and offspring effects were observed at 

the mid- and high-dose. At the high 

dose, maternal effects included 

increased deaths and clinical signs of 

toxicity (tremors, muscle twitches, and 

increased sensitivity) during lactation. 

Pup deaths were noted at this level. At 

the mid-dose, minimal signs of 

treatment-related effects were observed 

for both adults and pups, reducing 

concern for quantitative or qualitative 

sensitivity. 

There was no evidence of 

carcinogenicity in either the rat or 

mouse long-term dietary studies, nor 

was there any mutagenic activity in 

bacteria or cultured mammalian cells. 

Fenpropathrin 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 fenpropathrin as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document, 

‘‘Fenpropathrin. Human Health Risk 

Assessment for Section 3 Registration 

on Tropical Fruit and a Request for a 

Tolerance without U.S. Registration on 

Tea’’ at pp 40–45 in docket ID number 

EPA–HQ–OPP–2009–0644. 

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 


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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 

Fenpropathrin used for human risk 

assessment is shown in the following 

Table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FENPROPATHRIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure and 

uncertainty/safety 

factors 

RfD, PAD for risk 

assessment Study and toxicological effects 

Acute dietary (General population, including 

children ≥ 6 years old).

Wolansky BMDL1SD = 

5.0 mg/kg.

UFA = 10X 

UFH = 10X 

FQPA SF = 1X 

aRfD = 0.05 mg/kg/ 

day.

aPAD = 0.05 mg/kg/ 

day. 

Wolansky BMD1SD = 6.4 mg/kg based on decreased motor activity. 

Acute dietary (< 6 years old) ............................ Wolansky BMDL1SD = 

5.0 mg/kg.

UFA = 10X 

UFH = 10X 

FQPA SF = 3X 

aRfD = 0.05 mg/kg/ 

day.

aPAD = 0.017 mg/kg/ 

day. 

Wolansky BMD1SD = 6.4 mg/kg based on decreased motor activity. 

Chronic dietary (All populations) ...................... Because of the rapid reversibility of the most sensitive neurotoxicity endpoint used for quantifying risks, there is no increase in hazard with increasing dosing duration. Therefore, the 

acute dietary endpoint is protective of the endpoints from repeat dosing studies, including 

chronic dietary exposures. 

Cancer (Oral, dermal, inhalation) ..................... Fenpropathrin has been classified as ‘‘not likely to be carcinogenic to humans.’’ Cancer risk is 

not of concern. 

FQPA SF = Food Quality Protection Act Safety Factor. mg/kg/day = milligram/kilogram/day. PAD = population adjusted dose (a = acute, 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). BMD = Benchmark Dose Analysis. BMD1SD = dose level where effect is 1SD 

from control value. BMDL1SD = lower 95% confidence limit of the BMD value. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpropathrin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing fenpropathrin tolerances in 40 

CFR 180.466. EPA assessed dietary 

exposures from fenpropathrin 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. Such effects were identified 

for fenpropathrin. In estimating acute 

dietary exposure, EPA used food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA utilized percent crop 

treated (PCT) estimates and tolerance 

level residues, distributions of field trial 

values, and distributions of Pesticide 

Data Program (PDP) monitoring data. 

Residue distributions were used for 

the commodities that made the most 

significant contributions to the risk 

estimates. Distributions of USDA’s PDP 

monitoring data from 2007 through 2010 

were used for broccoli (translated to 

Chinese mustard cabbage and 

cauliflower), watermelon, squash, 

oranges (translated to tangerines), 

apples, apple juice, pears, blueberries 

(translated to huckleberries), grapes, 

grape juice, and strawberries. 

Distributions of field trial data were 

used for cherries, peaches, plums, 

grapefruit, raspberries, blackberries, 

apricots, cabbage, papaya, olives, 

tomatoes, cucumbers, Brussels sprouts, 

and guava. Tolerance-level residues 

were assumed for all other commodities 

having existing or proposed tolerances. 

Dietary Exposure Evaluation Model 

(DEEM) default processing factors were 

used for those commodities for which 

they were available. In some cases, 

empirical processing factors were used. 

ii. Chronic exposure. Based on the 

data summarized in Unit III.A., there is 

no bincrease in hazard from repeated 

exposures to fenpropathrin; the acute 

dietary exposure assessment is 

protective for chronic dietary exposures 

because acute exposure levels are higher 

than chronic exposure levels. 

Accordingly, a dietary exposure 

assessment for the purpose of assessing 

chronic dietary risk was not conducted. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fenpropathrin 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. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 


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• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

FFDCA section 408(b)(2)(F), EPA may 

require registrants to submit data on 

PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

Apples, 15%; apricots, 2.5%; 

blueberries, 2.5%; broccoli, 2.5%; 

Brussels sprouts, 10%; cabbage, 2.5%; 

cauliflower, 2.5%; cherries, 5%; cotton, 

2.5%; cucumbers, 2.5%; grapefruit, 

35%; grapes, 10%; nectarines, 2.5%; 

oranges, 35%; peaches, 2.5%; pears, 

10%; plums, 2.5%; prune plums, 2.5%; 

squash, 2.5%; strawberries, 50%; 

tangerines, 15%; tomatoes, 10%; and 

watermelons, 2.5%. 

In most cases, EPA uses available data 

from U.S. Department of Agriculture/ 

National Agricultural Statistics Service 

(USDA/NASS), proprietary market 

surveys, and the National Pesticide Use 

Database for the chemical/crop 

combination for the most recent 6 to 7 

years. EPA uses an average PCT for 

chronic dietary risk analysis. The 

average PCT figure for each existing use 

is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 1. 

In those cases, 1% is used as the average 

PCT and 2.5% is used as the maximum 

PCT. EPA uses a maximum PCT for 

acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which fenpropathrin may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fenpropathrin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fenpropathrin. 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 First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of 

fenpropathrin for acute exposures are 

estimated to be 10.3 parts per billion 

(ppb) for surface water and 0.005 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 10.3 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). 

Fenpropathrin is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

The Agency is required to consider 

the cumulative risks of chemicals 

sharing a common mechanism of 

toxicity. The Agency has determined 

that the pyrethroids and pyrethrins, 

including fenpropathrin, share a 

common mechanism of toxicity. The 

members of this group share the ability 

to interact with voltage-gated sodium 

channels, ultimately leading to 

neurotoxicity. The cumulative risk 

assessment for the pyrethroids/ 

pyrethrins was published in the 

November 9, 2011 issue of the Federal 

Register (76 FR 69726) (FRL 8888–9), 

and is available at http:// 

www.regulations.gov in the public 

docket, EPA–HQ–OPP–2011–0746. 

Further information about the 

determination that pyrethroids and 

pyrethrins share a common mechanism 

of toxicity may be found in document 

ID: EPA–HQ- OPP–2008–0489–0006. 

The Agency has conducted a 

quantitative analysis of the proposed 

tolerances for fenpropathrin and has 

determined that it will not contribute 

significantly or change the overall 

findings presented in the pyrethroid 

cumulative risk assessment. In the 

cumulative assessment for pyrethroids, 

residential exposures were the greatest 

contributor to the total exposure. As 

there are no residential uses for 

fenpropathrin, the proposed new uses 

will have no impact on the residential 

component of the cumulative risk 

estimates. 

Dietary exposures make a minor 

contribution to the total pyrethroid 

exposure. The dietary exposure 

assessment performed in support of the 

pyrethroid cumulative assessment was 

much more highly refined than that 

performed for the single chemical, 

fenpropathrin. In addition, for the 

fenpropathrin risk assessment, the most 

sensitive apical endpoint in the 

fenpropathrin database was selected to 

derive the POD. Additionally, the POD 

selected for fenpropathrin is specific to 

fenpropathrin, whereas the POD 

selected for the cumulative assessment 

was based on common mechanism of 

action data that are appropriate for all 

20 pyrethroids included in the 

cumulative assessment. The proposed 

food uses of fenpropathrin will not 

contribute significantly or change the 

overall findings in the pyrethroid 

cumulative risk assessment, as the 

dietary risks are a minor component of 

total pyrethroid cumulative risk. For 

information regarding EPA’s efforts to 

evaluate the risk of exposure to 

pyrethroids, refer to http:// 

www.epa.gov/oppsrrd1/reevaluation/ 

pyrethroids-pyrethrins.html. 


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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. 

The fenpropathrin toxicity database 

includes developmental toxicity studies 

in rats and rabbits and a 3-generation 

reproduction study in rats, and a 

developmental neurotoxicity (DNT) 

study in rats. There was no evidence of 

increased qualitative or quantitative 

susceptibility noted in any of these 

studies. This lack of susceptibility is 

consistent with the results of the 

guideline prenatal and postnatal testing 

for other pyrethroid pesticides. 

There are several in vitro and in vivo 

studies that indicate pharmacodynamic 

contributions to pyrethroid toxicity are 

not age-dependent. A study of the 

toxicity database for pyrethroid 

chemicals also noted no residual 

uncertainties regarding age-related 

sensitivities for the young, based on the 

absence of prenatal sensitivity observed 

in 76 guideline studies for 24 

pyrethroids and the scientific literature. 

However, high-dose studies at LD50

doses noted that younger animals were 

more susceptible to the toxicity of 

pyrethroids. These age-related 

differences in toxicity are principally 

due to age-dependent pharmacokinetics; 

the activity of enzymes associated with 

the metabolism of pyrethroids increases 

with age. Nonetheless, the typical 

environmental exposures to pyrethroids 

are not expected to overwhelm the 

clearance capacity in juveniles. In 

support, at a dose of 4.0 milligrams/ 

kilogram (mg/kg) for deltamethrin (near 

the Wolansky study LOAEL value of 3.0 

mg/kg for deltamethrin), the change in 

the acoustic startle response was similar 

between adult and young rats. 

3. Conclusion. EPA is reducing the 

FQPA SF to 3X for infants and children 

less than 6 years of age. For the general 

population, including children greater 

than 6 years of age, EPA is reducing the 

FQPA SF to 1X. The decisions regarding 

the FQPA SF being used are based on 

the following considerations: 

i. The toxicity database for 

fenpropathrin is not complete. While 

the database is considered to be 

complete with respect to the guideline 

toxicity studies for fenpropathrin, EPA 

lacks additional data to address the 

potential for juvenile sensitivity to all 

pyrethroids. In light of the literature 

studies indicating a possibility of 

increased sensitivity to fenpropathrin in 

juvenile rats at high doses, EPA has 

requested proposals for study protocols 

which could identify and quantify 

fenpropathrin’s potential juvenile 

sensitivity. The reasons discussed in 

Unit III.D.3.ii, and the uncertainty 

regarding the protectiveness of the 

intraspecies uncertainty factor raised by 

the literature studies warrant 

application of an additional 3X for risk 

assessments for infants and children 

less than 6 years of age. 

ii. There is no evidence that 

fenpropathrin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in a 3-generation rat 

reproduction study. This is consistent 

with the results of the guideline prenatal and postnatal testing for other 

pyrethroid pesticides. There are, 

however, high dose LD50 studies 

(studies assessing what dose results in 

lethality to 50 percent of the tested 

population) in the scientific literature 

indicating that pyrethroids can result in 

increased quantitative sensitivity in the 

young. Examination of pharmacokinetic 

and pharmacodynamic data indicates 

that the sensitivity observed at high 

doses is related to pyrethroid agedependent pharmacokinetics, the 

activity of enzymes associated with the 

metabolism of pyrethroids. Predictive 

pharmacokinetic models indicate that 

the differential adult-juvenile 

pharmacokinetics will result in 

otherwise equivalent administered 

doses for adults and juveniles producing 

a 3X greater dose at the target organ in 

juveniles compared to adults. 

No evidence of increased quantitative 

or qualitative susceptibility was seen in 

the pyrethroid scientific literature 

related to pharmacodynamics (the effect 

of pyrethroids at the target tissue) both 

with regard to interspecies differences 

between rats and humans and to 

differences between juveniles and 

adults. Specifically, there are in vitro 

pharmacodynamic data and in vivo data 

indicating similar responses between 

adult and juvenile rats at low doses and 

data indicating that the rat is a 

conservative model compared to the 

human based on species-specific 

pharmacodynamics of homologous 

sodium channel isoforms in rats and 

humans. 

In light of the high dose literature 

studies showing juvenile sensitivity to 

pyrethroids and the absence of the 

requested data on juvenile sensitivity to 

pyrethroids, EPA is retaining a 3X 

additional safety factor as estimated by 

pharmacokinetic modeling. For several 

reasons, EPA concludes there are 

reliable data showing that a 3X factor is 

protective of the safety of infants and 

children. First, the high doses that 

produced juvenile sensitivity in the 

literature studies are well above normal 

dietary exposure levels of pyrethroids to 

juveniles and these lower levels of 

exposure are not expected to overwhelm 

the ability to metabolize pyrethroids as 

occurred with the high doses used in 

the literature studies. This is confirmed 

by the lack of a finding of increased 

sensitivity in prenatal and postnatal 

guideline studies in any pyrethroid, 

including fenpropathrin, despite the 

relatively high doses used in those 

studies. Second, the portions of both the 

inter- and intraspecies uncertainty 

factors that account for potential 

pharmacodynamic differences 

(generally considered to be 

approximately 3X for each factor) are 

likely to overstate the risk of inter- and 

intraspecies pharmacodynamic 

differences given the data showing 

similarities in pharmacodynamics 

between juveniles and adults and 

between humans and rats. Finally, as 

indicated, pharmacokinetic modeling 

only predicts a 3X difference between 

juveniles and adults. 

iii. There are no residual uncertainties 

identified in the exposure databases. 

Although the acute dietary exposure 

estimates are refined, as described in 

Unit III.C.1.i., the exposure estimates 

will not underestimate risk for the 

established and proposed uses of 

fenpropathrin. The residue levels used 

are based on distributions of residues 

from field trial data, monitoring data 

reflecting actual residues found in the 

food supply, and tolerance-level 

residues for several commodities; the 

use of estimated PCT information; and, 

when appropriate, processing factors 

measured in processing studies or 

default high-end factors representing the 

maximum concentration of residue into 

a processed commodity. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to fenpropathrin 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by fenpropathrin. 

Further information about the 

reevaluation of the FQPA SF for 


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Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 70907 

pyrethroids may be found in document 

ID: EPA–HQ–OPP–2011–0746–0011, at 

regulations.gov. 

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. Shortterm, intermediate-term, and chronicterm 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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fenpropathrin will occupy 97% of the 

aPAD for children 3 to 5 years old, the 

population group receiving the greatest 

exposure from the dietary assessment 

for infants and children less than 6 

years old; and 27% of the aPAD for 

children 6 to 12 years old, the 

population group receiving the greatest 

exposure from the dietary assessment 

for the general population other than 

children less than 6 years old. 

2. Chronic risk. Based on the data 

summarized in Unit III.A., there is no 

increase in hazard with increasing 

dosing duration. Furthermore, chronic 

dietary exposures will be lower than 

acute exposures. Therefore, the acute 

aggregate assessment is protective of 

potential chronic aggregate exposures. 

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). A short-term adverse 

effect was identified; however, 

fenpropathrin is not registered for any 

use patterns that would result in shortterm residential exposure. Short-term 

risk is assessed based on short-term 

residential exposure plus chronic 

dietary exposure. Because there is no 

short-term residential exposure and 

acute dietary exposure has already been 

assessed under the appropriately 

protective aPAD (which is at least as 

protective as the POD used to assess 

short-term risk), no further assessment 

of short-term risk is necessary, and EPA 

relies on the acute dietary risk 

assessment for evaluating short-term 

risk for fenpropathrin. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, fenpropathrin is 

not expected to pose an intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fenpropathrin 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 

fenpropathrin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology utilizing gas 

chromatography with electron capture 

detection (GC/ECD, Residue Method 

Number RM–22–4) 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 

fenpropathrin in or on tea, green and 

black at 2.0 ppm. Using the 

Organization for Economic Cooperation 

and Development (OECD) MRL 

calculation procedures, the 

recommended U.S. tolerance for tea, 

dried would be 3.0 ppm. However, for 

the purposes of harmonization of the 

U.S. tolerance with the established 

Codex MRL, EPA is recommending the 

tolerance of 2.0 ppm for tea, dried. The 

Agency considers this tolerance level to 

be adequate because the highest field 

trial value noted for tea, dried was 1.38 

ppm. 

C. Revisions to Petitioned-for Tolerances 

Based on the data supporting the 

petitions, EPA revised the proposed 

tolerances on acerola, feijoa, guava, 

jaboticaba, passionfruit, startfruit and 

wax jambu from 1.5 ppm to 3.0 ppm; 

longan, lychee, pulasan, rambutan, and 

Spanish lime from 3.0 ppm to 7.0 ppm; 

and atemoya, birba, cherimoya, custard 

apple, ilama, soursop, and sugar apple, 

from 1.0 ppm to 1.5 ppm. The Agency 

revised these tolerance levels based on 

analysis of the residue field trial data 

using the OECD tolerance calculation 

procedures. EPA also revised the 

proposed commodity definition for tea 

to tea, dried in order to reflect the 

Agency’s commodity nomenclature. 

Finally, the Agency has revised the 

tolerance expression to clarify (1) that, 

as provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of fenpropathrin not 

specifically mentioned; and (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 fenpropathrin, alphacyano-3-phenoxy-benzyl 2,2,3,3- 

tetramethylcyclopropanecarboxylate, in 

or on acerola, feijoa, guava, jaboticaba, 

passionfruit, starfruit and wax jambu at 

3.0 ppm; longan, lychee, pulasan, 

rambutan and Spanish lime, at 7.0 ppm; 

atemoya, biriba, cherimoya, custard 

apple, ilama, soursop and sugar apple, 

at 1.5 ppm; and tea, dried at 2.0 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 


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70908 Federal Register / Vol. 77, No. 229 / Wednesday, November 28, 2012 / Rules and Regulations 

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: November 15, 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 § 180.466, paragraph (a), revise 

the introductory text, alphabetically add 

the following commodities and footnote 

1 to the table to read as follows: 

§ 180.466 Fenpropathrin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of 

fenpropathrin, including its metabolites 

and degradates, in or on the 

commodities in the following table. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only fenpropathrin (alphacyano-3-phenoxy-benzyl 2,2,3,3 

tetramethylcyclopropanecarboxylate). 

Commodity Parts per 

million 

Acerola .................................. 3.0 

* * * * * 

Atemoya ................................ 1.5 

* * * * * 

Biriba ..................................... 1.5 

* * * * * 

Cherimoya ............................ 1.5 

* * * * * 

Custard apple ....................... 1.5 

* * * * * 

Feijoa .................................... 3.0 

* * * * * 

Guava ................................... 3.0 

* * * * * 

Ilama ..................................... 1.5 

Jaboticaba ............................ 3.0 

* * * * * 

Longan .................................. 7.0 

Lychee .................................. 7.0 

Commodity Parts per 

million 

* * * * * 

Passionfruit ........................... 3.0 

* * * * * 

Pulasan ................................. 7.0 

Rambutan ............................. 7.0 

* * * * * 

Soursop ................................ 1.5 

Spanish lime ......................... 7.0 

* * * * * 

Starfruit ................................. 3.0 

* * * * * 

Sugar apple .......................... 1.5 

Tea, dried 1 ........................... 2.0 

* * * * * 

Wax jambu ............................ 3.0 

1There are no U.S. registrations as of November 28, 2012, for the use of fenpropathrin 

on tea, dried. 

* * * * * 

[FR Doc. 2012–28721 Filed 11–27–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0060; FRL–9365–1] 

Dinotefuran; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of dinotefuran in 

or on rice grain, egg, and poultry meat 

byproducts. Mitsui Chemicals Agro Inc., 

c/o Landis International, Inc., requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 28, 2012. Objections and 

requests for hearings must be received 

on or before January 28, 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–2012–0060, 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 


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