16296 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 

* * * * * 

[FR Doc. 2015–06847 Filed 3–26–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0209; FRL–9924–60] 

Deltamethrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

deltamethrin in or on all food and feed 

commodities from use of deltamethrin 

as a wide-area mosquito adulticide. 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 27, 2015. Objections and requests 

for hearings must be received on or 

before May 26, 2015, 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–2014–0209, 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), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2014–0209 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 May 26, 2015. 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– 

2014–0209, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of January 28, 

2015 (80 FR 4527) (FRL–9921–60), 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 [3F8210]) by Bayer 

CropScience, 2 T.W. Alexander Dr., 

Research Triangle Park, NC 27709. The 

petition requested that 40 CFR 180.435 

be amended by establishing a tolerance 

for residues of the insecticide 

deltamethrin, (1R,3R)-R-cyano(3- 

phenoxyphenyl)methyl 3-(2,2- 

dibromoethenyl)-2,2- 

dimethylcyclopropanecarboxylate, in or 

on food and feed commodities at 0.05 

parts per million (ppm) from use as a 

wide-area mosquito adulticide. That 

document referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

docket, http://www.regulations.gov. One 

comment was received on the notice of 

filing. EPA’s response to the comment is 

discussed 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 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 16297 

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 deltamethrin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with deltamethrin 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. Deltamethrin, a 

Type II pyrethroid, targets the nervous 

system by disrupting the voltage-gated 

sodium channels, resulting in 

neurotoxicity. Neurotoxicity was 

observed throughout the toxicity 

database, and effects were seen across 

species, sexes, exposure duration, and 

routes of administration. Clinical signs 

characteristic of Type II pyrethroids, 

such as increased salivation, altered 

mobility/gait, and tremors were the 

most common effects observed. 

Increased sensitivity to external stimuli, 

abnormal vocalization, and decreased 

fore- and hind-limb grip strength were 

also commonly observed in the 

database. 

Deltamethrin is rapidly absorbed 

following an oral dose, and effects are 

typically observed within two to five 

hours after dosing. For pyrethroids, as a 

class, the combination of rapid 

absorption, metabolism, and elimination 

precludes accumulation and increased 

potency following repeated dosing. This 

is also true of deltamethrin. No observed 

adverse effect levels (NOAELs) for the 

acute and chronic studies are similar, 

and the acute endpoint is protective of 

the endpoints from repeat dosing 

studies. 

A dermal risk assessment was not 

conducted based on the lack of effects 

in a 21-day dermal study and low 

potential for dermal absorption for 

deltamethrin. These findings are 

consistent with the toxicology profile of 

many pyrethroids. 

Deltamethrin did not have any 

adverse effects on fetuses or offspring in 

the prenatal developmental studies in 

rats and rabbits. However, potential 

qualitative susceptibility was observed 

at high doses in the developmental 

neurotoxicity study (DNT) and the 

2-generation reproduction study. 

Symptoms included vocalization, 

decreased pre- and post-weaning body 

weight in pups of both sexes, decreased 

body weight and body weight gain in 

maternal animals, hyperactivity, and 

excessive salivation. The increased 

qualitative susceptibility in the DNT 

and 2-generation reproduction study 

was observed at doses 10- to 20-fold 

higher (near lethal doses) than the 

current points of departure (PODs) 

selected for risk assessment. At doses 

near the POD, no effects on parental 

animals or offspring were observed in 

either the DNT or 2-generation 

reproductive studies. Therefore, the 

current PODs are protective of the 

observed sensitivity. 

There was no evidence of 

immunotoxicity after deltamethrin 

exposure in the toxicology database or 

in an immunotoxicity study in rats. 

Deltamethrin is classified as ‘‘not likely 

to be carcinogenic to humans.’’ There 

was no evidence of carcinogenicity in 

the combined chronic/carcinogenicity 

study in rats or the carcinogenicity 

study in mice. In a battery of 

mutagenicity studies there was no 

evidence of a mutagenic effect. 

The database shows that deltamethrin 

has moderate to minimal acute toxicity 

via the oral route, moderate acute 

toxicity via the inhalation route, and 

minimal acute toxicity via the dermal 

route of exposure. Deltamethrin is 

minimally irritating to the eyes, nonirritating to the skin, and is not a skin 

sensitizer. 

The Agency is making best use of the 

extensive scientific knowledge about the 

mode of action/adverse outcome 

pathway (MOA/AOP) on pyrethroids in 

the risk assessments for this class of 

pesticides. A significant portion of the 

scientific literature on pyrethroids 

utilizes deltamethrin as the test 

chemical. In the on-going work by the 

Council for the Advancement of 

Pyrethroid Human Risk Assessment 

(CAPHRA), deltamethrin is one of two 

sentinel pyrethroids being used to 

develop the initial, extensive database 

of in vitro and in vivo toxicology studies 

and highly refined physiologicallybased pharmacokinetic (PBPK) models. 

Pharmacokinetics (PK) can be defined as 

what the body does to the chemical. The 

underlying PK of pyrethroids is an 

important determination of their 

toxicity because the concentration of 

pyrethroid at the sodium channel relates 

to the extent of toxicity; greater 

pyrethroid concentration translates as 

increased neurotoxicity. Age-dependent 

PK differences have been identified for 

several pyrethroids (i.e., there are 

differences in the ability of adults and 

juveniles to metabolize pyrethroids). 

The enzymes that metabolize and 

detoxify pyrethroids are present in rats 

and humans at birth, and as a result, 

both juveniles and adults are able to 

tolerate low doses of pyrethroids when 

the internal dose, or the amount of 

pyrethroid at the sodium channel, is 

low. However, the activity of these 

enzymes increases with age, conveying 

in adults a greater capacity to detoxify 

pyrethroids compared to juveniles and 

the PK contribution to the FQPA Safety 

Factor will be 1X for adults and 

children >6 years old, and 3X for 

children <6 years old. 

Pharmacodynamics (PD) can be 

defined as the changes that chemicals 

cause to the body, in this case, how 

pyrethroids interact with the sodium 

channels. In contrast to the age-related 

PK differences identified for 

pyrethroids, pharmacodynamic 

contributions to pyrethroid toxicity are 

not age-dependent. The occurrence and 

ontogeny of voltage-gated sodium 

channels in humans are not well 

characterized compared to those in the 

rat. The available data indicate that the 

rat is a highly-sensitive model and 

extrapolations from the rat would be 

protective of human health. Based on 

the comparable function and 

distribution of sodium channels 

between the species, the rat is an 

appropriate surrogate for the evaluation 

of human PD. Based on the body of data, 

the Agency concludes that juvenile rats 

are not more sensitive than adults with 

respect to pyrethroid PD, and the PD 

contribution to the FQPA SF will be 1X. 

The Wolansky et al. acute oral study 

(2006), in which decreased motor 

activity was observed, provides the most 

robust data set for extrapolating risk 

from exposure to deltamethrin. The 

dose used for risk assessment was 

determined using a benchmark dose 

(BMD) analysis using one standard 

deviation from the control group as the 

benchmark response (BMR) as suggested 

for continuous endpoints in the 

Agency’s BMD guidance (USEPA 2012). 

The Wolansky acute study, endpoint, 

and dose were used for all dietary 

(acute), non-occupational (incidental 

oral and inhalation), and occupational 

exposure (inhalation) scenarios because 

it was the most robust data set for 

extrapolating risk from deltamethrin, 

and there is a lack of increased hazard 

from repeated/chronic exposure to 

deltamethrin. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by deltamethrin as well 


asabaliauskas on DSK5VPTVN1PROD with RULES
16298 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 

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 document 

Deltamethrin. Human Health Risk 

Assessment for the Proposed Use of 

Deltamethrin as a Mosquito Adulticide 

over Agricultural Crops at [page 55] in 

docket ID number EPA–HQ–OPP– 

20[14]–[0209]. 

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 deltamethrin used for 

human risk assessment is discussed in 

Unit III.B of the final rule published in 

the Federal Register of [November 7, 

2014] ([79] FR [66294]) (FRL–9918–24). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to deltamethrin, EPA 

considered exposure under the 

petitioned-for tolerance as well as all 

existing deltamethrin tolerances in 40 

CFR 180.435. Acute and chronic dietary 

(food and drinking water) exposure 

assessments were conducted using the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM–FCID) Version 

3.16. This software uses 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). Specific 

information on the dietary exposure 

assessment can be found at http://

www.regulations.gov in document 

Deltamethrin. Acute and Chronic 

Dietary (Food and Drinking Water) 

Exposure and Risk Assessment for the 

Proposed Use of Deltamethrin as a Wide 

Area Mosquito Adulticide over 

Agricultural Crops in docket ID number 

EPA–HQ–OPP–20[14]–[0209]. 

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 deltamethrin. As to residue levels in 

food, EPA used tolerance-level residues 

for most commodities and Pesticide 

Data Program (PDP) monitoring data for 

a number of commodities. Maximum 

percent crop treated (%CT) estimates 

were used for some commodities. To 

account for the mosquito adulticide use, 

the maximum residue value from the 

mosquito adulticide trials was 

multiplied by the %CT estimate for the 

adulticide use (1%) for those 

commodities that would only have a 

residue as a result of the mosquito 

adulticide use. However, if the 

commodity could have residues from 

both the agricultural and mosquitocide 

uses, residue values from the adulticide 

trials were included in a distribution 

considering the 1% CT estimate 

(depending on whether the commodities 

were blended, nonblended, or partially 

blended). Default processing factors 

were used for some processed 

commodities and empirical factors were 

used for others. 

ii. Chronic exposure. As to residue 

levels in food, EPA [used tolerance-level 

residues for most commodities. The 

average PDP value was used for cereal 

grains and milk. The average mosquito 

adulticide residue value multiplied by 

the 1% CT estimate was used to account 

for the mosquito adulticide uses. Since 

deltamethrin is registered for use in 

food handling establishments (FHEs), 

one-half the FHE tolerance was used to 

account for the FHE uses. The FHE 

tolerance is based on the LOQ, and onehalf the tolerance was used as a 

refinement in the dietary assessment. 

For the commodities for which one-half 

the FHE tolerance was used, the 

assumption was made that there was a 

4.65% chance that a food item 

consumed by a person contained 

deltamethrin residues as a result of 

treatment at some point in an FHE. 

Default processing factors were used for 

some processed commodities and 

empirical factors were used for others. 

The chronic assessment was 

conducted solely for the purpose of 

obtaining estimates of background levels 

of dietary exposure for estimating 

aggregate risk. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that deltamethrin 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. 

• 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: For acute 

dietary: 2.5% for apples, cantaloupes, 

carrots, soybeans, tomatoes, and 

watermelons; and 5% for cucumbers 

and pears. For chronic dietary: 1% for 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 16299 

apples, cantaloupes, carrots, cotton, 

potatoes (some food forms), pumpkins, 

radishes, squash, tomatoes, turnips, and 

watermelon; 2.5% for cucumbers, leeks, 

onions, pears, and sunflowers; 4.65% 

(commodities with residues resulting 

only from the FHE use) for: Almonds, 

pistachios, potatoes (some food forms), 

soybeans, sweet corn, and walnuts; 5% 

for canola and peppers; and 40% for 

globe artichokes. 

In the acute and chronic assessments, 

the mosquito adulticide %CT estimate 

of 1% was used to modify the mosquito 

adulticide use residue value. Residues 

from the mosquito adulticide use were 

included for all commodities with the 

exception of livestock commodities 

because the livestock commodities 

tolerances are very conservative, and 

any residues in livestock feed items 

resulting from the mosquito adulticide 

use will not increase the established 

tolerance levels. 

In most cases, EPA uses available data 

from United States 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 6–7 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 

one. 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 deltamethrin 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 deltamethrin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

deltamethrin. 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. 

The estimated drinking water 

concentration (EDWC) of deltamethrin 

for acute and chronic exposures is 

estimated to be 0.200 parts per billion 

(ppb) for both surface water and ground 

water. The FIRST Model was used to 

determine the surface water 

concentration, and the SCI–GROW 

Model was used to determine the 

groundwater concentration. The acute 

surface water EDWC and the 

groundwater EDWC were equivalent 

because, in both cases, the value was 

limited by the solubility of 

deltamethrin. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

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). 

Deltamethrin is currently registered 

for the following uses that could result 

in residential exposures: Residential 

outdoor and indoor sites, turf, paint 

additives, and pet products. 

There are no residential handler 

exposure scenarios associated with the 

proposed mosquito control use as 

applications are to be made by Federal, 

State, Tribal or local Government 

Officials or the U.S. Military. However, 

there is potential for residential postapplication exposure resulting from 

mosquito control use. Post-application 

inhalation exposures and incidental oral 

(hand-to-mouth) contact with residues 

deposited on lawn/turf from ULV truck 

fogger applications were included in the 

quantitative risk assessment. To 

calculate post-application exposure 

from ULV truck fogger applications, 

EPA used the 2012 Residential SOPs for 

Outdoor Fogging/Misting Systems, with 

minimal modification to the well-mixed 

box (WMB) model. The WMB model 

allows for the estimation of inhalation 

exposure in the breathing zones of 

adults and children residing in areas 

being treated by ground application of 

deltamethrin. 

EPA also assessed handler and postapplication exposures for existing 

residential uses of deltamethrin (i.e., 

indoor, outdoor, pet, and paint 

additive). A quantitative dermal 

assessment for residential handlers was 

not conducted since no systemic 

toxicity associated with dermal 

exposure to deltamethrin was observed. 

MOEs were calculated for the inhalation 

route of exposure only. Adult postapplication exposures from the existing 

uses were not quantitatively assessed 

since inhalation exposures are typically 

negligible in outdoor settings. Postapplication inhalation exposure for 

adults and children is anticipated to be 

negligible for representative residential 

registered uses; therefore, a quantitative 

post-application inhalation exposure 

assessment was not performed. EPA 

assessed post-application incidental oral 

exposures to children for representative 

indoor/outdoor and pet incidental oral 

scenarios including hand-to-mouth, 

object-to-mouth, soil ingestion, and 

episodic granule ingestion scenarios. 

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.’’ 

The Agency has determined that the 

pyrethroids and pyrethrins share a 

common mechanism of toxicity: the 

ability to interact with voltage-gated 

sodium channels ultimately leading to 

neurotoxicity. The cumulative risk 

assessment (CRA) for the pyrethroids/

pyrethrins (published on 11/9/2011 and 

available at http://www.regulations.gov; 

EPA–HQ–OPP–2011–0746) did not 

identify cumulative risks of concern, 

allowing the Agency to consider new 

uses for pyrethroids. Deltamethrin was 


asabaliauskas on DSK5VPTVN1PROD with RULES
16300 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 

included in the pyrethroid/pyrethrin 

CRA. 

Dietary exposures make a minor 

contribution to the total pyrethroid 

exposure. The dietary exposure 

assessment performed in support of the 

pyrethroid CRA was much more highly 

refined than that performed for 

deltamethrin alone. Additionally, the 

PODs selected for deltamethrin are 

specific to deltamethrin, whereas the 

PODs selected for the cumulative 

assessment were based on common 

mechanism of action data that are 

appropriate for all 20 pyrethroids 

included in the CRA. Dietary exposure 

to deltamethrin residues resulting from 

the proposed wide-area mosquito 

adulticide use will contribute very little 

to the dietary exposure to deltamethrin 

alone and will have an insignificant 

impact on the cumulative risk 

assessment. No dietary, residential, or 

aggregate risk estimates of concern have 

been identified in the single chemical 

assessment. 

In the cumulative assessment, 

residential exposure was the greatest 

contributor to the total exposure. In 

order to determine if the registered 

deltamethrin indoor and turf uses will 

significantly contribute to, or change the 

overall findings in the pyrethroid CRA, 

the Agency performed a quantitative 

exposure and risk assessment. This 

assessment used the deltamethrin 

relative potency factor (RPF) as well as 

the same exposure algorithms and 

inputs that were used in the 2011 

pyrethroid CRA. In all cases, the 

estimated deltamethrin MOEs using the 

RPF method were higher (i.e., less of a 

risk concern) than those used in the 

2011 pyrethroid CRA. Thus, the Agency 

continues to support the previous 

assessment, and concludes that the 

registered deltamethrin uses will not 

significantly contribute to the overall 

findings in the 2011 pyrethroid CRA, 

and the registered deltamethrin indoor 

and turf uses will have no impact on the 

residential component of the cumulative 

risk estimates. 

For information regarding EPA’s 

efforts to evaluate the risk of exposure 

to this class of chemicals, refer to: ¥ 

http://www.epa.gov/oppsrrd1/

reevaluation/pyrethroidspyrethrins.html. 

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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There were no indications of fetal 

toxicity in any of the guideline studies. 

Evidence of increased juvenile 

qualitative sensitivity was observed in 

the DNT and 2-generation reproduction 

studies at doses that were considered to 

be relatively high (i.e., near lethal 

doses). However, at doses near the point 

of departure, no effects on parental 

animals or offspring were observed in 

either the DNT or 2-generation 

reproduction study and, therefore, there 

is no susceptibility at these doses. 

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 3X for infants and 

children <6 years old; and to 1X for 

children >6 years old, women of child 

bearing age and all adult populations. 

That decision is based on the following 

findings: 

i. The database of experimental 

toxicology studies available for 

deltamethrin is largely complete 

including developmental toxicity 

studies in rats and rabbits, a 

reproduction study in rats, and acute 

neurotoxicity (ACN), subchronic 

neurotoxicity (SCN), and developmental 

neurotoxicity (DNT) studies. The 

database provides a robust 

characterization profile for children 6 

years old and older, as well as for 

adults. In addition to the standard 

guideline studies, numerous studies 

from the scientific literature that 

describe the pharmacodynamic and 

pharmacokinetic profile of the 

pyrethroids in general have been 

considered in this assessment. Many of 

these studies were conducted with 

deltamethrin. A 28- or 90-day inhalation 

study is not available, but the Agency 

determined the study is not required for 

deltamethrin. 

ii. As with other pyrethroids, 

deltamethrin causes neurotoxicity from 

interaction with sodium channels 

leading to clinical signs of 

neurotoxicity. These effects are well 

characterized and adequately assessed 

by the body of data available to the 

Agency. 

iii. There were no indications of fetal 

toxicity in any of the guideline studies 

in the database, including 

developmental studies in the rat and 

rabbit, a developmental neurotoxicity 

study in rats, and a 2-generation 

reproduction study in rats. There was 

evidence of increased juvenile 

qualitative susceptibility at high doses 

observed in both the DNT and 2- 

generation reproduction studies. These 

observations are consistent with the 

findings of juvenile sensitivity in the 

literature for deltamethrin. However, the 

observations of increased sensitivity 

were at doses that were considered to be 

relatively high (i.e., near lethal doses), 

whereas at doses near the point of 

departure, no effects on parental 

animals or offspring were observed in 

either the developmental neurotoxicity 

(DNT) or 2-generation reproduction 

study and, therefore, there is no 

susceptibility at these doses. The 

Agency has retained a 3X uncertainty 

factor to protect for exposures of 

children <6 years of age based on 

increased quantitative susceptibility 

seen in studies on pyrethroid 

pharmacokinetics (primarily conducted 

with deltamethrin) and the increased 

quantitative juvenile susceptibility 

observed in high dose guideline and 

literature studies with deltamethrin and 

other pyrethroids. The Agency has no 

residual uncertainties regarding agerelated sensitivity for women of child 

bearing age as well as for all adult 

populations and children ≥6 years of 

age, based on the absence of pre-natal 

sensitivity observed in 76 guideline 

studies for 24 pyrethroids and the 

scientific literature. Additionally, no 

evidence of increased quantitative or 

qualitative susceptibility was seen in 

the pyrethroid scientific literature 

related to pharmacodynamics. 

iv. There are no residual uncertainties 

with regard to dietary exposure. The 

dietary exposure assessments are based 

on high-end residue levels for most 

commodities, and that account for 

parent and metabolites of concern, 

processing factors, and percent crop 

treated assumptions. Furthermore, 

conservative, upper-bound assumptions 

were used to determine exposure 

through drinking water and residential 

sources, such that these exposures have 

not been underestimated. 

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-, 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 16301 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

deltamethrin will occupy 81% of the 

aPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. A chronic dietary risk 

assessment was not conducted because 

there is no apparent increase in hazard 

from repeated/chronic exposures to 

deltamethrin. Therefore, the acute 

endpoint is protective of the endpoints 

from repeat dosing studies. A chronic 

dietary exposure assessment was 

performed in order to generate 

background exposure estimates to 

aggregate with residential exposure 

estimates for the short-term aggregate 

risk assessment. 

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). Deltamethrin 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 deltamethrin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 2,500 for the general U.S. 

population and of 520 for children 1–2 

years old, the population group 

receiving the greatest exposure. Because 

EPA’s level of concern for deltamethrin 

is an MOE of 300 or below, these MOEs 

are not of concern. 

4. Intermediate-term risk. Because no 

intermediate-term adverse effect was 

identified, deltamethrin is not expected 

to pose an intermediate-term risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

deltamethrin 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 deltamethrin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

utilizing gas chromatography with 

electron capture detection (GC/ECD), is 

available for enforcing tolerances for 

residues of deltamethrin in plant 

commodities, as described in Pesticide 

Analytical Manual (PAM) Volume II, 

Section 180.422. Another GC/ECD 

method (Method HRAV–22) is available 

for enforcing tolerances in livestock 

commodities. Adequate confirmatory 

method validation data have been 

submitted for these methods, along with 

adequate independent laboratory 

validation (ILV) trials. 

Multiresidue methods data for cisdeltamethrin and trans-deltamethrin 

were previously sent to FDA. Cisdeltamethrin is completely recovered 

through Methods 302 and 303, and 

partially recovered through Method 304. 

Trans-Deltamethrin is partially 

recovered through Method 303, but not 

recovered through Method 304. 

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. 

Harmonization of MRLs is not an 

issue for the proposed use of 

deltamethrin as a wide area 

mosquitocide since established 

tolerance levels are not changing. 

C. Response to Comments 

An anonymous citizen objected to the 

approval of the requested tolerance for 

deltamethrin. The commenter expressed 

concerns about the neurotoxicity of the 

chemical and made unsubstantiated 

claims that together with all other 

approved toxic chemicals, use of 

deltamethrin could lead to many deaths 

and injuries and that the Agency is 

harming the American people. Under 

section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA) EPA is 

authorized to establish pesticide 

tolerances where the safety standard 

imposed by that statute is met. When 

new or amended tolerances for residues 

of a pesticide in food or feed are 

requested, the Agency evaluates 

whether there is a reasonable certainty 

of no harm from aggregate exposure to 

the pesticide chemical residue. The risk 

assessment conducted by the Agency 

considers the potential risks from 

dietary exposure and other nonoccupational exposures. The Agency 

also considers the available information 

regarding cumulative toxicological 

effects of the pesticide residues and 

other substances that share a common 

mechanism of toxicity with the subject 

pesticide. Such an assessment has been 

conducted for deltamethrin. 

Deltamethrin is a Type II pyrethroid, 

and as with other pyrethroids, 

deltamethrin causes neurotoxicity. 

These effects are well characterized and 

adequately assessed by the body of data 

available to the Agency. The Agency is 

confident that it has chosen endpoints, 

points of departure, and uncertainty 

factors, that have a strong scientific 

foundation and that are protective for all 

human populations. As a result, EPA 

concludes that the tolerances for 

deltamethrin are safe. 

V. Conclusion 

Therefore, tolerances are established 

for residues of deltamethrin, (1R,3R)-3- 

(2,2-dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylic acid 

(S)-alpha-cyano-3-phenoxybenzyl ester 

and its major metabolites, transdeltamethrin (S)-alpha-cyano-mphenoxybenzyl-(1R,3R)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylate and 

alpha-R-deltamethrin[(R)-alpha-cyanom-phenoxybenzyl-(1R,3R)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylate in or 

on all food/feed items (other than those 

covered by a higher tolerance as a result 

of use on growing crops) from use as a 

wide-area mosquito adulticide at 0.05 

ppm. 

Currently, a tolerance of 0.05 ppm is 

established for residues of deltamethrin 

in or on all food/feed items (other than 

those covered by a higher tolerance as 

a result of use on growing crops) in 

food/feed handling establishments. The 

tolerance level does not need to be 

increased for the proposed use as a 

mosquito adulticide; however, EPA is 

revising 40 CFR 180.435 to clarify the 

tolerance. In addition, EPA is removing 

subparagraphs (a)(2)(i), (ii), (A) and (B) 

as they contain language that is more 


asabaliauskas on DSK5VPTVN1PROD with RULES
16302 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 

appropriately enforced under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) as use 

directions on the label. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: March 18, 2015. 

Susan Lewis, 

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 § 180.435, paragraph (a)(2) is 

revised to read as: 

§ 180.435 Deltamethrin; tolerances for 

residues. 

(a) General. * * * 

* * * * * 

(2) A tolerance of 0.05 ppm is 

established for residues of the 

insecticide deltamethrin, including its 

metabolites and degradates, in or on all 

food/feed items (other than those 

covered by a higher tolerance as a result 

of use on growing crops) when 

deltamethrin is used in food/feed 

handling establishments or as a widearea mosquito adulticide. Compliance 

with the tolerance levels specified is to 

be determined by measuring only 

deltamethrin, (1R,3R)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylic acid 

(S)-alpha-cyano-3-phenoxybenzyl ester, 

and its major metabolites, transdeltamethrin, (S)-alpha-cyano-mphenoxybenzyl(1R,3S)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylate, and 

alpha-R-deltamethrin, (R)-alpha-cyanom-phenoxybenzyl-(1R,3R)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylate, in or 

on the commodity. 

* * * * * 

[FR Doc. 2015–06861 Filed 3–26–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0632; FRL–9924–86] 

Thiram; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of thiram in or on 

banana. Taminco US, Inc. requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 27, 2015. Objections and requests 

for hearings must be received on or 

before May 26, 2015, 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–2014–0632, 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), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 


asabaliauskas on DSK5VPTVN1PROD with RULES