Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32437 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 25, 2009. 

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 § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

***** * *

Sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006–15– 

3).

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

Sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127– 

39–9).

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

Sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922–80– 

5).

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

* * * * * 

[FR Doc. E9–16086 Filed 7–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0140; FRL–8417–4] 

d-Phenothrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

d-phenothrin [(3- 

phenoxyphenyl)methyl] 2,2-Dimethyl-3- 

(2-methyl-1- 

propenyl)cyclopropanecarboxylate in or 

on all food/feed crops at 0.01 parts per 

million (ppm) following wide-area 

mosquito adulticide applications. 

McLaughlin Gormley King Company 

requested these tolerances under the 

Federal Food, Drug and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

8, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0140. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Room S– 

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Dr., 

Arlington, VA 22202–4501. The Docket 

Facility is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Carmen Rodia, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001; telephone 

number: (703) 306–0327; fax number: 

(703) 308–0029; e-mail address: 

rodia.carmen@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to, those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 


sroberts on DSKD5P82C1PROD with RULES
32438 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2008–0140 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before September 8, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0140, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Room S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Dr., Arlington, VA 22202–4501. 

Deliveries are only accepted during the 

Docket Facility’s normal hours of 

operation (8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays). Special arrangements should 

be made for deliveries of boxed 

information. The Docket Facility 

telephone number is (703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of September 

28, 2007 (72 FR 55204) (FRL–8147–1) 

(EPA–HQ–OPP–2007–0880), EPA issued 

a notice pursuant to section 408(d)(3) of 

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

announcing the filing of a pesticide 

petition (PP 7F7251) by McLaughlin 

Gormley King Company, 8810 Tenth 

Avenue, North, Minneapolis, MN 

55427–4319. 

The petition requested that 40 CFR 

part 180 be amended by establishing 

permanent tolerances for residues of the 

insecticide d-phenothrin, [(3- 

phenoxyphenyl)methyl] 2,2-Dimethyl-3- 

(2-methyl-1- 

propenyl)cyclopropanecarboxylate), in 

or on all food/feed crops at 0.01 ppm 

following wide-area mosquito adulticide 

applications. That notice referenced a 

summary of the petition prepared by 

McLaughlin Gormley King Company, 

the registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 

tolerances for residues of the insecticide 

d-phenothrin in or on all food/feed 

crops at 0.01 ppm following wide-area 

mosquito adulticide treatments. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

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. 

d-Phenothrin has low acute toxicity 

via the oral, dermal and inhalation 

routes of exposure, is only a mild eye 

irritant, is non-irritating to the dermis 

and tests negative for skin sensitization. 

The effects on the liver are the most 

systemically sensitive endpoint 

following repeated oral exposure based 

on acceptable subchronic and chronic 

toxicity studies in rodents and dogs, 

specifically, increased liver weight, 

hepatocellular vacuolization and 

hypertrophy and, at higher doses, 

increased liver serum enzymes. Based 

on a 90–day inhalation study in rats, the 

most sensitive effects from repeated 

inhalation exposure are portal of entry 

effects (histopathological changes in the 

nasal turbinates in both sexes). This 

inhalation study also indicated 

histological effects on the liver, thyroid 

and adrenal which are of borderline 

toxicological significance alone, but 

which are supported in part by the 

increased organ weights and histological 

findings of similar occurrence in some 

oral studies. d-Phenothrin was not 

associated with any systemic toxicity up 

to the limit dose of 1,000 mg/kg/day in 

a 3–week dermal toxicity study in rats. 

Currently, d-phenothrin is lacking 

acceptable neurotoxicity studies and 

these studies are considered data gaps. 

The only available, but unacceptable/ 

non-guideline, neurotoxicity study in 


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Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32439 

rats indicated piloerection in animals 

administered at 5,000 mg/kg for 5 

consecutive days; however, the rabbit 

developmental study provides evidence 

of neurotoxicity. Indications of 

neurotoxicity from the rabbit 

developmental study include presence 

of spina bifida at the mid-dose of 100 

mg/kg/day, microphthalmia at 300 mg/ 

kg/day and hydrocephaly at the highdose of 500 mg/kg/day. While these 

neurodevelopmental effects were seen 

in only a single fetus each, the 

observations of spina bifida and 

microphthalmia can be considered 

significant because they are uncommon 

in untreated rabbits, yet they occurred 

together in the d-phenothrin rabbit 

development study. 

As noted, developmental effects were 

observed in the rabbit developmental 

study. Minimal adverse effects were 

observed at the highest dose treated in 

the rat developmental study. In two 

acceptable rat reproduction studies, 

both systemic and reproductive/ 

offspring toxicity occurred at the same 

doses with similar effects for offspring 

and dams in each study (organ weight 

changes in the 1986 study and 

decreased body weight gain in the 1995 

study). 

Endocrine-related effects were 

observed in tests which indicated 

potential estrogen, androgen and/or 

thyroid-mediated toxicity. d-Phenothrin 

produced adrenal cortex vacuolation in 

the 1–year dog feeding study and 90– 

day inhalation toxicity study in rats. In 

addition, the 90–day inhalation toxicity 

study also resulted in follicular thyroid 

cell enlargement. Hepatocellular 

enlargement was produced in the 26– 

week dog feeding study, the 1–year dog 

feeding study and the 90–day inhalation 

study, but was not always associated 

with thyroid toxicity in these studies at 

the doses tested. The endpoints selected 

for chronic dietary, incidental oral and 

inhalation exposure are protective of 

endocrine-related effects. 

d-Phenothrin has been classified as 

‘‘Not Likely to be Carcinogenic to 

Humans.’’ Rat liver tumors, namely 

hepatocellular carcinomas, occurred 

only at excessively toxic doses (limit 

dose) and were; therefore, discounted 

and mouse liver hepatocellular 

adenomas, which are common, did not 

achieve statistical significance (p <0.01). 

In addition, an acceptable battery of 

mutagenicity studies was negative for 

mutagenic potential. 

More detailed information on the 

studies received and the nature of the 

adverse effects caused by d-phenothrin 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

in the document entitled, ‘‘d-Phenothrin 

(Sumithrin®) Risk Assessment for 

Reregistration Eligibility Decision (RED) 

and Associated Section 3 Registration 

Action,’’ dated July 2, 2008, by going to 

http://www.regulations.gov. The 

referenced document is available in the 

docket established by this action, which 

is described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2008– 

0140–0024 in that docket. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2008–0140. 

Double-click on the document to view 

the referenced information on pages 50– 

54 of 66. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the NOAEL in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, the LOAEL or a 

Benchmark Dose (BMD) approach is 

sometimes used for risk assessment. 

Uncertainty/safety factors (UFs) are 

used in conjunction with the POD to 

take into account uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. Safety is assessed for 

acute and chronic dietary risks by 

comparing aggregate food and water 

exposure to the pesticide to the acute 

population adjusted dose (aPAD) and 

chronic population adjusted dose 

(cPAD). The aPAD and cPAD are 

calculated by dividing the POD by all 

applicable UFs. Aggregate short-term, 

intermediate-term and chronic-term 

risks are evaluated by comparing food, 

water and residential exposure to the 

POD to ensure that the margin of 

exposure (MOE) called for by the 

product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 d-phenothrin used for 

human risk assessment can be found in 

the document entitled, ‘‘d-Phenothrin 

(Sumithrin®) Risk Assessment for 

Reregistration Eligibility Decision (RED) 

and Associated Section 3 Registration 

Action,’’ dated July 2, 2008, by going to 

http://www.regulations.gov. The 

referenced document is available in the 

docket established by this action, which 

is described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2008– 

0140–0024 in that docket. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2008–0140. 

Double-click on the document to view 

the referenced information on pages 23– 

24 of 66. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to d-phenothrin, EPA 

considered exposure under the 

petitioned-for tolerances and assessed 

dietary exposures from d-phenothrin 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. In estimating acute dietary 

exposure, EPA conducted a screening 

level acute dietary and drinking water 

exposure assessment for the proposed 

new food use of d-phenothrin for all 

commodities and incorporated the 

Agency’s estimated surface water peak 

concentration of 1 part per billion (ppb). 

An acute dietary exposure analysis was 

performed for the population subgroup 

females 13–49 years old only as no 

acute endpoint was identified for the 

remaining population subgroups. The 

acute dietary assessment assumed 

tolerance-level residues in plant and 

livestock commodities and 100 pecent 

crop treated (PCT). 

ii. Chronic exposure. In estimating 

chronic dietary exposure, EPA 

conducted a screening level chronic 

dietary and drinking water exposure 

assessment for the proposed new food 

use of d-phenothrin and incorporated 

the Agency’s chronic or estimated 

surface water concentration of 0.0407 

ppb. The assessment assumed tolerancelevel residues in plant and livestock 

commodities and 100 PCT. 

iii. Cancer. As explained in Unit 

III.A., d-phenothrin is considered to be 

‘‘Not Likely to be Carcinogenic to 

Humans.’’ As a result, an exposure 

assessment to evaluate cancer risk is not 

needed for d-phenothrin. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue information in the 


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dietary exposure assessment for dphenothrin. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for d-phenothrin in drinking water. 

These simulation models take into 

account data on the physical, chemical 

and fate/transport characteristics of dphenothrin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of dphenothrin for acute exposures are 

estimated to be 0.1002 ppb for surface 

water and 0.00600 ppb for ground 

water. Chronic exposures for non-cancer 

assessments are estimated to be 0.0407 

ppb for surface water and 0.00600 ppb 

for ground water. Chronic exposures for 

cancer assessments are estimated to be 

0.0369 ppb for surface water and 

0.00600 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the 

estimated surface water peak 

concentration value of 1 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the chronic or estimated 

surface water concentration value of 

0.0407 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). Based on 

a review of active labels and proposed 

new uses, 12 residential exposure 

scenarios have been assessed for dphenothrin. Inhalation and incidental 

ingestion exposure assessments have 

been conducted for the residential 

scenarios. Short-term and intermediateterm exposures are expected and 

assessed for residential handler and 

post-application exposure scenarios 

based on use and expected exposure 

patterns. 

Risk assessments were conducted for 

residential exposure pathways based on 

registered uses. Residential postapplication exposure and risk to dphenothrin was assessed using both 

deterministic and probabilistic 

modeling approaches. 

The residential exposure assessment 

includes 2 handler and 10 postapplication residential exposure 

scenarios. The term ‘‘handler’’ applies 

to individuals who mix, load and apply 

the pesticide product. The term ‘‘postapplication’’ describes individuals who 

are exposed to pesticides after entering 

areas previously treated with pesticides. 

d-Phenothrin products for outdoor 

residential use are almost exclusively 

available as aerosol sprays. There are a 

small number of outdoor fogger 

products containing d-phenothrin (at 

least one); however, due to the absence 

of scenario-specific exposure data for 

outdoor foggers, the fact that there are 

very few fogger products for residential 

outdoor use and the fact that assessment 

of aerosol sprays and mosquito ultra low 

volume (ULV) applications are likely to 

address risks from foggers, residential 

use of outdoor foggers was not assessed 

separately for this analysis. 

EPA assessed residential exposure 

using the following assumptions: 

Primary assumptions for assessing postapplication exposure to use of foggers 

and aerosols in indoor residential 

settings were based on data provided by 

the Non-Dietary Exposure Task Force 

(NDETF). The NDETF was formed in 

1996 by members of the Pyrethrin Joint 

Venture and Piperonyl Butoxide Task 

Force II to respond to reregistration 

needs and to produce scientifically 

sound data on non-dietary exposures to 

pyrethrins, the pyrethroids, piperonyl 

butoxide and MGK® 264 insecticide 

synergist. 

EPA used the AGricultural DISPersal 

model (AGDISP), version 8.15.0.4, to 

calculate airborne concentrations of dphenothrin from aerial ULV mosquito 

abatement spray applications. ULV 

sprayers disperse very fine aerosol 

droplets that stay aloft and kill flying 

mosquitoes on contact. ULV 

applications involve small quantities of 

the insecticide formulation in relation to 

the size of the area treated, typically less 

than 3 ounces per acre. AGDISP 

provides estimates of the 1–hour 

average concentration and the 

downwind deposition of spray material 

released from the aircraft equipment 

and predicts the motion of spray 

material released, including the mean 

position of the material and the position 

variance about the mean as a result of 

turbulent fluctuations, providing a 

prediction of spray drift. 

For the AGDISP modeling for dphenothrin, label recommendations 

were followed, but conservative 

assumptions were made. The resultant 

data were used to assess inhalation 

exposure resulting from aerial 

application of d-phenothrin as a 

mosquito adulticide. Deposition data 

from the AGDISP model were not used 

to assess post-application incidental 

oral exposure to d-phenothrin because 

residential application of d-phenothrin 

products outdoors to patios and lawn 

areas results in higher deposition. 

Therefore, post-application incidental 

oral exposures were assessed using 

estimated deposition from homeowner 

application of outdoor house and garden 

spray products. 

Air concentrations from truckmounted ULV spray applications are 

estimated based on the SOP for 

residential exposure assessment for 

inhalation exposure from use of an 

outdoor space spray for pest control. 

The approach was modified to assume 

that 1% of the highest application rate 

for a truck-mounted ULV sprayer is 

available in the breathing zone of the 

resident. It is assumed that the full 

application rates for a truck-mounted 

ULV sprayer (with a 1% dilution factor) 

is available in the breathing zone of the 

residential bystander, i.e., an 

application rate expressed as lbs. a.i./ft2

is converted into a concentration 

expressed in a per cubic foot (ft3) basis. 

Scenario-specific data on pyrethrins 

and/or permethrin from the NDETF 

studies were used to determine 

deposition of d-phenothrin on vinyl and 

carpet flooring following use of a total 

release indoor fogger. Given the close 

structural similarity of pyrethrins, 

permethrin and d-phenothrin and the 

similarity of use patterns for these 

chemicals, EPA believes that the NDETF 

pyrethrins and/or permethrin data 

provide appropriate surrogate data for dphenothrin. Permethrin data were used 

preferentially for this assessment, if 

available, since permethrin and dphenothrin are both synthetic 

pyrethroids. 

Inhalation following application of an 

indoor total release fogger was not 

modeled separately because the aerosol 

spray application scenario is likely to 

provide a more conservative exposure 

estimate and; therefore, be protective of 

exposures following use of a total 

release fogger. While application rates 

for total release foggers and aerosol 

sprays are comparable, labels for use of 

total release foggers require that the 

room be closed and vacated during 

release of the fogger and that the room 

be opened and thoroughly ventilated for 

a period of time (e.g. 30 minutes, 1 

hour) prior to re-entry. 

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 


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‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

d-Phenothrin is a member of the 

pyrethroid class of pesticides. Although 

all pyrethroids alter nerve function by 

modifying the normal biochemistry and 

physiology of nerve membrane sodium 

channels, EPA is not currently following 

a cumulative risk approach based on a 

common mechanism of toxicity for the 

pyrethroids. Although all pyrethroids 

interact with sodium channels, there are 

multiple types of sodium channels and 

it is currently unknown whether the 

pyrethroids have similar effects on all 

channels and there is also no clear 

understanding of effects on key 

downstream neuronal function e.g., 

nerve excitability, and how these key 

events interact to produce their 

compound-specific patterns of 

neurotoxicity. There is ongoing research 

by the Agency’s Office of Research and 

Development and pyrethroid registrants 

to evaluate the differential biochemical 

and physiological actions of pyrethroids 

in mammals. When available, EPA will 

consider this research and make a 

determination of common mechanism 

as a basis for assessing cumulative risk. 

For information regarding EPA’s efforts 

to determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10x) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

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. 

d-Phenothrin demonstrated qualitative 

and quantitative susceptibility in an 

acceptable rabbit developmental study. 

Specifically, developmental toxicity 

(spina bifida) occurred at a lower 

LOAEL (100 mg/kg/day) than the 

maternal LOAEL (300 mg/kg/day) for 

decreased body weight gain and food 

consumption. In rats, d-phenothrin was 

developmentally toxic only at a dose of 

3,000 mg/kg/day. The NOAELs and 

LOAELs for maternal animals and 

fetuses were the same in this study. In 

the 1986 and 1995 rat reproduction 

studies, the NOAELs/LOAELs for both 

maternal and offspring/reproductive 

findings occurred at the same dose 

levels (both studies) and the types of 

offspring effects (organ weight changes 

(1986) and decreased mean pup weights 

(1995)) were also present in the 

respective maternal animals from the 

two studies. 

3. Conclusion. The risk assessment 

and FFDCA safety finding for dphenothrin are based on a well 

characterized but incomplete toxicity 

database. With the retention of the full 

FQPA SF of 10x, the toxicity database 

is considered adequate to evaluate the 

risks to infants and children based on 

the following findings: 

i. The toxicity database for dphenothrin is incomplete for a full 

hazard assessment. The toxicity 

database for d-phenothrin lacks 

acceptable acute, subchronic and 

developmental neurotoxicity studies 

and an immunotoxicity study. There are 

no indications in the available studies 

that organs associated with immune 

function, such as the thymus and 

spleen, are affected by d-phenothrin. An 

immunotoxicity study is required, as a 

new data requirement under the 40 CFR 

part 158 data requirements for 

registration of a pesticide (food and nonfood uses). 

ii. The only available neurotoxicity 

study in rats is an unacceptable/nonguideline study which demonstrated 

clinical signs of piloerection but no 

axonal damage. The rabbit 

developmental study provides evidence 

of neurotoxicity. Spina bifida at the 

mid-dose and treatment-related 

presence of hydrocephaly, another 

serious neurodevelopmental effect, was 

seen at the highest dose tested in the 

rabbit developmental study. Generally, 

other specific neurotoxic clinical signs 

were absent in other acute, subchronic 

and chronic d-phenothrin studies in rats 

and dogs; however, d-phenothrin does 

not display the full spectrum of Type 1 

clinical signs in rats and dogs up to the 

limit dose. 

iii. There is qualitative and 

quantitative evidence of increased 

susceptibility for d-phenothrin in the 

rabbit developmental study in the form 

of spina bifida at doses lower than those 

causing maternal toxicity. There was no 

evidence of increased susceptibility in 

the 2–generation reproduction study in 

rats. There is low concern for 

quantitative and qualitative 

susceptibility observed in the rabbit 

developmental study because the 

NOAELs/LOAELs in this study are well 

characterized and are used to establish 

the acute Reference Dose (aRfD). The 

NOAEL (7.1 mg/kg/day) selected for the 

chronic Reference Dose (cRfD) is lower 

(14x) than the dose at which 

developmental effects were observed. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessment 

utilizes proposed tolerance-level or 

higher residues and assumes 100 PCT 

for all commodities. Use of screening 

level dietary assessments ensures that 

acute and chronic dietary risks will not 

be underestimated. The Tier 1 drinking 

water assessment uses model 

parameters designed to provide 

conservative, health protective estimates 

of water concentrations. Postapplication exposure to children was 

assessed using maximum application 

rates and established exposure 

assumptions. Based on standard 

assumptions, most residential scenarios 

were not of concern (MOEs > 1,000). For 

those assessments with MOEs < 1,000, 

a refined probabilistic analysis was 

carried out and all scenarios passed (all 

MOEs > 1,000) at the 99th percentile 

level. 

The FQPA 10x SF is to be retained 

primarily due to the absence of needed 

acute, subchronic and developmental 

neurotoxicity studies in conjunction 

with a finding of increased sensitivity 

for a neurological effect in the rabbit 

developmental study. EPA finds that an 

additional 10x SF will protect the safety 

of infants and children because the 

neurotoxic effects were generally not 

seen in the d-phenothrin toxicity 

database and when those effects were 

seen it was at comparatively high doses. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 


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32442 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 

The aggregate risk assessment 

integrates the assessments conducted for 

dietary/drinking water and residential 

exposure. Since there is potential for 

concurrent exposure via the food, water 

and residential pathways, all routes of 

d-phenothrin exposure have been 

considered. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Acute dietary exposure analysis 

was performed for the population 

subgroup females 13–49 years old only. 

No adverse effect resulting from a 

single-oral exposure was identified and 

no acute dietary endpoint was selected 

for the general population or other 

population subgroups. Using the 

exposure assumptions discussed in this 

unit for acute exposure, the acute 

dietary exposure from food and water to 

d-phenothrin will occupy 1.3% of the 

aPAD for females 13–49 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to d-phenothrin 

from food and water will utilize 13% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of d-phenothrin is not 

expected. 

3. Short-term risk. The short- and 

itermediate-term aggregate risk is the 

estimated risk associated with combined 

risks from average food exposures, 

average drinking water exposures, 

incidental oral exposures and inhalation 

exposures. Exposure from oral and 

inhalation exposure pathways is not 

aggregated for d-phenothrin because the 

toxicity endpoints for these exposure 

routes are not based on common 

specific target organ toxicity effects. 

Aggregate risk from exposure to dphenothrin residues from food, drinking 

water and incidental oral exposures do 

not present risks of concern. 

4. 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 d-phenothrin 

residues. 

For more detailed information on 

non-dietary (residential) exposure, 

including the use of the AGDISP and 

CARES models and the NDETF data as 

part of assessing residential exposure to 

d-phenothrin, please refer to the 

document entitled, ‘‘d-Phenothrin 

(Sumithrin®) Risk Assessment for 

Reregistration Eligibility Decision (RED) 

and Associated Section 3 Registration 

Action,’’ dated July 2, 2008, by going to 

http://www.regulations.gov. The 

referenced document is available in the 

docket established by this action, which 

is described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2008– 

0140–0024 in that docket. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2008–0140. 

Double-click on the document to view 

the referenced information on pages 31– 

42 of 66. 

In addition, for more detailed 

information on the refinements 

incorporated as part of the probabilistic 

assessment of d-phenothrin, please refer 

to the document entitled, ‘‘d-Phenothrin 

(Sumithrin®): Addendum to Residential 

Exposure Assessment,’’ dated August 

19, 2008, by going to http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES, and is 

identified as EPA–HQ–OPP–2008– 

0140–0029 in that docket. Locate and 

click on the hyperlink for docket ID 

number EPA–HQ–OPP–2008–0140. 

Double-click on the document to view 

the referenced information. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

No multiresidue monitoring protocol 

data were submitted by the registrant for 

d-phenothrin. No analytical method was 

recommended by the registrant for 

enforcement. However, the United 

States Food and Drug Administration 

(FDA) has tested d-phenothrin through 

their multiresidue protocols. dPhenothrin is completely recovered 

through protocol 302, but only 60% 

remains after florisil cleanup, which is 

rarely used any more. No additional 

data are needed from the registrant. 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. FDA’s Pacific Regional 

Laboratory Northwest has developed a 

gas chromatography/mass spectrometry 

detection (GC/MSD) method that 

recovers d-phenothrin. 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no established 

CODEX, Canadian or Mexican 

maximum residue limits (MRLs) for 

residues of the insecticide d-phenothrin 

in or on all food/feed crops following 

wide-area mosquito adulticide 

applications. 

V. Conclusion 

Therefore, tolerances are established 

for residues of the insecticide dphenothrin ([(3-phenoxyphenyl)methyl] 

2,2-Dimethyl-3-(2-methyl-1- 

propenyl)cyclopropanecarboxylate). 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 


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Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations 32443 

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) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 19, 2009. 

Steven Bradbury, 

Acting Director, 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. Section 180.647 is added to read as 

follows: 

§ 180.647 d-Phenothrin; tolerances for 

residues. 

(a) General. A tolerance of 0.01 parts 

per million is established for residues of 

the insecticide d-phenothrin in or on all 

food/feed crops following wide-area 

mosquito adulticide applications. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. E9–15937 Filed 7–7–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0478; FRL–8423–6] 

Pyrimethanil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation replaces 

existing tolerances for residues of 

pyrimethanil on fruit, citrus, group 10 

postharvest; and fruit, stone, group 12, 

except cherry with tolerances for 

residues of pyrimethanil in or on fruit, 

citrus, group 10, except lemon, 

postharvest; fruit, stone, group 12; and 

lemon, preharvest and postharvest. 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

8, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 2009, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0478. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http://

www.epa.gpo/opptsfrs/home/

guidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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 


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