Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55733 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

V. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and 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 the rule in 

the Federal Register. This 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: September 19, 2005. 

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. 

§ 180.910 [Amended] 

■ 2. Section 180.910 is amended by 

removing, in the table, the following 

entries: Casein; fish meal; soy protein, 

isolated; and wheat, including flour, 

bran, and starch. 

§ 180.920 [Amended] 

■ 3. Section 180.920 is amended by 

removing, in the table, the following 

entry: Sodium caseinate. 

§ 180.930 [Amended] 

■ 4. Section 180.930 is amended by 

removing, in the table, the following 

entries: Rhodamine B; soy protein, 

isolated; and wheat shorts. 

[FR Doc. 05–19056 Filed 9–22–05; 8:45 am] 

BILLING 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0246; FRL–7737–8] 

Pyriproxyfen; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyriproxyfen 

in or on grass, forage, fodder, and hay, 

group 17, forage; grass, forage, fodder, 

and hay, group 17, hay; vegetable, 

legume, group 6; onion, dry bulb; grape; 

strawberry; sapote, white; and citrus 

hybrids. Interregional Research Project 

Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 23, 2005. Objections and 

requests for hearings must be received 

on or before November 22, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0246. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

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

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Shaja R. Brothers, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703–308–3194; e-mail address: 

brothers.shaja@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: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

55734 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides 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 and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines athttp://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of August 17, 

2005 (70 FR 48413) (FRL–7732–1, EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions (PP 3E6596, 3E6750, 

4E6866, 4E6865, and 3E6582) by IR-4, 

681 US Highway #1 South, North 

Brunswick, NJ 08902–3390. The 

petitions requested that 40 CFR 180.510 

be amended by establishing tolerances 

for residues of the insecticide 

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

phenoxyphenoxy)ethoxy]pyridine, in or 

on legume vegetables, crop subgroups 

6a, 6b, and 6c at 0.2 part per million 

(ppm) (PP 3E6596); onion, dry bulb at 

0.05 ppm (PP 3E6750); grape at 2.5 ppm, 

and raisin at 4.0 ppm (PP 4E6866); 

strawberry at 0.3 ppm (PP 4E6865); 

white sapote, and ugli fruit at 0.3 ppm 

(PP 3E6582). The petition for onion, dry 

bulb (PP 3E6750) was subsequently 

amended from 0.05 ppm to 0.15 ppm. 

The Agency has also determined a 

separate tolerance for raisin is not 

necessary. In addition, ugli fruit has 

been translated to citrus hybrids. No 

comments were recived on the notice of 

filing. 

Additionally, in the Federal Register 

of December 22, 2004 (69 FR 76724) 

(FRL–7689–6), 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 4F6847) 

by Valent USA Corporation, 1600 

Riviera Ave., Suite 200, Walnut Creek, 

California 94596–8025. The petition 

requested that 40 CFR 180.510 be 

amended by establishing tolerances for 

residues of the insecticide pyriproxyfen, 

[2-[1-methyl-2-(4- 

phenoxyphenoxy)ethoxy]pyridine], in 

or on grass forage and hay (crop group 

17). The Agency has subsequently 

amended the petition to establish 

tolerances for grass, forage, fodder, and 

hay, group 17, forage at 0.70 ppm 

(previously requested at 0.5 ppm), and 

grass, forage, fodder, and hay, group 17, 

hay at 1.1 ppm (previously requested at 

1.0 ppm). That notice included a 

summary of the petitions prepared by 

Valent USA Corporation], the registrant. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

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. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/health/ 

human.htm 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of these 

actions. EPA has sufficient data to 

assess the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for tolerances for residues of 

pyriproxyfen on vegetable, legume, 

group 6 at 0.20 ppm; onion, dry bulb at 

0.15 ppm; grape at 2.5 ppm; strawberry 

at 0.30 ppm; white sapote at 0.30 ppm; 

citrus hybrids at 0.30 ppm; grass, forage, 

fodder, and hay, group 17, forage at 0.70 

ppm; and grass, forage, fodder, and hay, 

group 17, hay at 1.1 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing these 

tolerances follow. 

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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

pyriproxyfen as well as the no observed 

adverse effect level (NOAEL) and the 

lowest observed adverse effect level 

(LOAEL) from the toxicity studies can 

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

fedrgstr/EPA-PEST/2003/May/Day-14/ 

p12022.htm. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which NOAEL from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the LOAEL 

of concern identified is sometimes used 

for risk assessment if no NOAEL was 

achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect 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. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55735 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. 

A summary of the toxicological 

endpoints for pyriproxyfen used for 

human risk assessment is shown in the 

following Table 1: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PYRIPROXYFEN FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/Scenario 

Dose Used in Risk Assessment, 

Interspecies and Intraspecies 

and any Traditional UF 

Special FQPA SF and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute dietary (females 13–

50 years of age) and 

general population 

None None An appropriate endpoint attributable to a 

single oral dose was not available in the 

data base, including maternal toxicity in 

the developmental toxicity studies 

Chronic dietary (all populations) NOAEL = 35.1 mg/kg/day 

UF = 100 

Chronic Reference Dose (cRfD) 

= 0.35 mg/kg/day 

Special FQPA SF = 1X 

Chronic Population Adjusted 

Dose (cPAD) = cRfD 

Special FQPA SF = 0.35 mg/ 

kg/day 

Subchronic toxicity and chronic toxicity 

(feeding) - rat 

LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results 

Short-term incidental, oral 

(1 to 30 days) (Residential) 

Oral Maternal 

NOAEL = 100 mg/kg/day 

LOC for Margin of Exposure 

(MOE) = 100 (Residential) 

Rat developmental toxicity study 

LOAEL = 300 mg/kg/day based on decreased body weight, body weight gain, 

and food consumption, and increased 

water consumption 

Intermediate-term incidental, oral (1–6 

months) (Residential) 

Oral NOAEL = 35.1 mg/kg/day LOC for MOE = 100 (Residential) Subchronic toxicity and chronic toxicity 

(feeding) - rat (co-critical) 

LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results 

Short-term, and intermediate-term dermal (1–

30 days and 1–6 

months) (Occupational/ 

Residential) 

None None Based on the systemic toxicity NOAEL of 

1,000 mg/kg/day (limit dose) in the 21-day 

dermal toxicity study in rats, quantification 

of dermal risks is not required. In addition, 

no developmental concern (toxicity) were 

seen in either rats or rabbits 

Long-term dermal (6 

months to lifetime) (Occupational/Residential) 

Dermal (or oral) study NOAEL = 

35.1 mg/kg/day 

LOC for MOE = 100 (Residential) Subchronic toxicity and chronic toxicity 

(feeding) - rat(co-critical) 

LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results 

Short-term, and intermediate-term dermal (1 

to 30 days and 1–6 

months)(Residential) 

None None 28-day inhalation toxicity - rats. Based on 

the absence of significant toxicity at the 

LOAEL of 1.0 mg/L (limit dose), the quantification of inhalation risks is not required. 

In addition, no developmental concern 

(toxicity) were seen in either rats or rabbits 

Long-term dermal (6 

months to lifetime) (Occupational/Residential) 

Dermal oral study NOAEL = 35.1 

mg/kg/day (inhalation absorption rate = 100%) 

LOC for MOE = 100 (Residential) Subchronic and chronic toxicity (feeding) - 

rat (co-critial) 

LOAEL = 141.28 mg/kg/day based on decreased body weight and clinical pathology results 

Cancer (oral, dermal, inhalation) Cancer classification (‘‘Group E’’) None No evidence of carcinogenicity 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.510) for the 

residues of pyriproxyfen, in or on the 

following raw agricultural commodities: 

Acerola at 0.10 part per million (ppm); 

almond, hulls at 2.0 ppm; apple, wet 

pomace at 0.8 ppm; atemoya at 0.20 

ppm; avocado at 1.0 ppm; biriba at 0.20 

ppm; black sapote at 1.0 ppm; brassica, 

head and stem, subgroup at 5A at 0.70 

ppm; brassica, leafy greens, subgroup 5B 

at 2.0 ppm; bushberry subgroup 13B at 

1.0 ppm; canistel at 1.0 ppm; cherimoya 

at 0.20 ppm; citrus, oil at 20 ppm; 

citrus, dried pulp at 2.0 ppm; cotton, gin 

byproducts at 2.0 ppm; cotton, 

undelinted seed at 0.05 ppm; custard 

apple at 0.20 ppm; feijoa at 0.10 ppm; 

fig at 0.30 ppm; fig, dried at 1.0 ppm; 

fruit, citrus at 0.3 ppm; fruit, pome at 

0.2 ppm; fruit, stone, group 12 at 1.0 

ppm; guava at 0.10 ppm; ilama at 0.20 

ppm; jaboticaba at 0.10 ppm; juneberry 

at 1.0 ppm; lingonberry at 1.0 ppm; 

logan at 0.30 ppm; lychee at 0.30 ppm; 

55736 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

mamey sapote at 1.0 ppm; mango at 1.0 

ppm; okra at 0.02 ppm; olive at 1.0 ppm; 

olive, oil at 2.0 ppm; papaya at 1.0 ppm; 

passionfruit at 0.10 ppm; pistachio at 

0.02 ppm; pulasan at 0.30 ppm; 

rambutan at 0.30 ppm; salal at 1.0 ppm; 

sapodilla at 1.0 ppm; soursop at 0.20 

ppm; spanish lime at 0.30 ppm; star 

apple at 1.0 ppm; starfruit at 0.10 ppm; 

sugar apple at 0.20 ppm; tree nut at 0.02 

ppm; vegetable, cucurbit, group 9 at 

0.10 ppm; vegetable, fruiting, group 8 at 

0.2 ppm; walnut at 0.02 ppm; and wax 

jambu at 0.10 ppm. Risk assessments 

were conducted by EPA to assess 

dietary exposures from pyriproxyfen in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1 day or single 

exposure. No such effects were 

identified in the toxicological studies 

for pyriproxyfen, therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the Dietary 

Exposure Evaluation Model software 

with the Food Commodity Intake 

Database (DEEMTM/FCID), which 

incorporates food consumption data as 

reported by respondents in the U.S. 

Department of Agriculture (USDA) 

1994–1996, and 1998 nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the chronic exposure 

assessments: The Tier 1 chronic analysis 

assumed 100% crop treated, DEEMTM

7.81 default processing factors and 

tolerance-level residues for all 

commodities. Percent crop treatedand/ 

or anticipated residues were not used. 

iii. Cancer. The Agency classified 

pyriproxyfen as a ‘‘Group E’’ chemical, 

no evidence for carcinogenicity to 

humans, based on the absence of 

evidence of carcinogenicity in male and 

female rats as well as in male and 

female mice. Therefore, a cancer risk 

assessment was not performed. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

pyriproxyfen in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

pyriproxyfen. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on EPA’s Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and, Screening 

Concentration in Ground Water (SCIGROW) models, the Estimated 

Environmental Concentrations (EECs) of 

pyriproxyfen for ground water 

exposures are estimated to be 0.006 

parts per billion (ppb) (acute and 

chronic). Surface water exposures are 

estimated to be 2.15 ppb (peak 

concentration), and 0.40 ppb (long term 

average). 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model 

DEEMTM/FCID using long-term average 

concentrations for surface water (0.40 

ppb) to access the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Pyriproxyfen is currently registered 

for use on the following residential nondietary sites: Residential products for 

flea and tick control (home environment 

and pet treatments), and ant and roach 

control (indoor and outdoor 

applications). Formulations include 

carpet powders, foggers, aerosol sprays, 

liquids (shampoos, sprays and pipettes 

for pet treatments), granules, bait 

(indoor and outdoor), and impregnated 

materials (pet collars). Adults and 

toddlers could potentially be exposed to 

pyriproxyfen residues on treated 

carpets, floors, upholstery, and pets; 

however, since the Agency did not 

select any short-term dermal or 

inhalation endpoints, only a postapplication residential assessment was 

conducted. Toddlers are anticipated to 

have higher exposures than adults from 

treated home environments and pets 

due to their behavior patterns. The risk 

assessment was conducted using the 

following residential exposure 

assumptions: 

i. Hand-to-mouth: Short-term, 

intermediate term, and long-term handto-mouth exposures to toddlers from 

treated carpets, flooring (note the 

efficacy of carpet powders is 

approximately 365 days). 

ii. Hand-to-mouth: Short-term and 

intermediate-term hand-to-mouth 

exposures to toddlers from petting 

treated animals (shampoos, sprays, spoton treatments and collars). Long-term 

hand-to-mouth exposures to toddlers 

from petting treated animals (pet collars; 

note efficacy of pet collars up to 365 

days). 

iii. Dermal: Long-term dermal 

exposures from treated carpets, flooring, 

and pets (note that treated furniture is 

included in the carpet/flooring 

assessment). 

iv. Ingestion of granules or bait by 

toddlers (acute, episodic event). 

v. Combined short-term and 

intermediate-term hand-to-mouth 

exposures (toddlers): 

• Treated carpet (powder application) 

and treated pet (collar/pet shampoo/pet 

spray). 

• Treated carpet (spray application) 

and treated pet (collar/pet shampoo/pet 

spray). 

• Treated home environment (fogger 

application) and treated pet (collar/pet 

shampoo/pet spray). 

vi. Combined long-term hand-tomouth and dermal exposures (toddlers): 

• Dermal exposure from pet hugging. 

• Dermal contact with treated carpet. 

• Hand-to-mouth exposures from 

treated carpets. 

• Hand-to-mouth exposures from 

treated pets. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the Federal 

Food, Drug, and Cosmetic Act (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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

pyriproxyfen and any other substances 

and pyriproxyfen does not appear to 

produce a toxic metabolite produced by 

other substances. EPA has also 

evaluated comments submitted that 

suggested there might be a common 

mechanism among pyriproxyfen and 

other named pesticides that cause brain 

effects. EPA concluded that the 

evidence did not support a finding of 

common mechanism for pyriproxyfen 

and the named pesticides. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

pyriproxyfen has a common mechanism 

of toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see the policy statements 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55737 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty factors (UFs) (safety) in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional UFs and/or special FQPA 

safety factors, as appropriate. 

2. Prenatal and postnatal sensitivity. 

Based on the available data, there is no 

quantitative and qualitative evidence of 

increased susceptibility observed 

following in utero pyriproxyfen 

exposure to rats and rabbits or following 

prenatal/postnatal exposure in the 2- 

generation reproduction study. 

3. Conclusion. There is a complete 

toxicity data base for pyriproxyfen and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. EPA 

determined the 10X safety factor for 

infants and children should be reduced 

to 1X. The FQPA safety factor was 

reduced: 

i. Due to the lack of evidence of 

prenatal or postnatal extra sensitivity, or 

increased susceptibility in 

developmental studies (rats and rabbits), 

and reproduction studies (rats). 

ii. The lack of quantitative or 

qualitative evidence of increased 

susceptibility for rats and rabbits 

identified in the guideline prenatal 

developmental toxicity studies. 

iii. The lack of evidence of 

quantitative or qualitative increased 

susceptibility in the two non-guideline 

studies that evaluated perinatal and 

prenatal development. 

iv. Offspring toxicity (decreased body 

weight on pups during lactation days 14 

to 21) in the reproduction toxicity study 

occurred only in the presence of 

decreases in body weight in parental 

animals at the same dose level (i.e., 

comparable toxicity in adults and 

offspring). 

E. Aggregate Risks and Determination of 

Safety 

The Agency currently has two ways to 

estimate total aggregate exposure to a 

pesticide from food, drinking water, and 

residential uses. First, a screening 

assessment can be used, in which the 

Agency calculates drinking water levels 

of comparison (DWLOCs) which are 

used as a point of comparison against 

estimated environmental concentrations 

(EECs). The DWLOC values are not 

regulatory standards for drinking water, 

but are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + residential exposure). This 

allowable exposure through drinking 

water is used to calculate a DWLOC. 

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter L/70 

kg (adult male), 2L/60 kg (adult female), 

and 1L/10 kg (child). Different 

populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer. 

When EECs for surface water and 

ground water are less than the 

calculated DWOCs, EPA concluded with 

reasonable certainty that exposures to 

the pesticide in drinking water (when 

considered along with other sources of 

exposures for which EPA has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because EPA considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

changes. When new uses are added EPA 

reassesses the potential impacts of 

residues of the pesticide in drinking 

water as a part of the aggregate 

assessment process. 

More recently the Agency has used 

another approach to estimate aggregate 

exposure through food, residential and 

drinking water pathways. In this 

approach, modeled surface water and 

ground water EECs are directly 

incorporated into the dietary exposure 

analysis, along with food. This provides 

a more realistic estimate of exposure 

because actual body weights and water 

consumption from the CSFII are used. 

The combined food and water exposures 

are then added to estimated exposure 

from residential sources to calculate 

aggregate risks. The resulting exposure 

and risk estimates are still considered to 

be high end, due to the assumptions 

used in developing drinking water 

modeling inputs. 

1. Acute risk. An acute aggregate 

exposure analysis was not conducted 

since no acute doses or endpoints were 

selected for the general U.S. population 

(including infants and children) or the 

females 13–50 years old population 

subgroup. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to pyriproxyfen from food 

and water will utilize 3.2% of the cPAD 

for the U.S. population, 4.4% of the 

cPAD for all infants <1 year old, 9.9% 

of the cPAD for children 1–2 years old, 

and 2.4% of the cPAD for females 13–

49 years old. 

Chronic aggregate exposure takes into 

account chronic residential exposure 

plus chronic exposure to food and 

water. Pyriproxyfen is currently 

registered for use that could result in 

chronic residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic food, 

water, and residential exposures for 

pyriproxyfen. 

Using the exposure assumptions 

described in this unit for chronic 

exposures, EPA has concluded that 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

3,200 for the U.S. population; 820 for all 

infants <1 year old; 560 for children 1–

2 years old; and 4,700 for females 13–

49 years old. These aggregate MOEs do 

not exceed the Agency’s level of 

concern for aggregate exposure to food 

and residential uses, as shown in the 

following Table 2: 

55738 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO PYRIPROXYFEN

Population/Subgroup cPAD/mg/ 

kg/day 

%cPAD/ 

(Food) Target MOE 

Aggregate 

MOE (food 

+ water + 

residential) 

U.S. population 0.35 3.2 100 3200 

All infants (<1 year old) 0.35 4.4 100 820 

Children (1–2 years old) 0.35 9.9 100 560 

Females (13–49 years old) 0.35 2.4 100 4700 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Pyriproxyfen is currently registered 

for use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term exposures for pyriproxyfen. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

9,000 for the U.S. population; 1,600 for 

all infants <1 year old; 1,200 for 

children 1–2 years old; and 1,3000 for 

females 13–49 years old. These 

aggregate MOEs do not exceed the 

Agency’s level of concern for aggregate 

exposure to food and residential uses. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Pyriproxyfen is currently registered 

for use(s) that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic food 

and water and intermediate-term 

exposures for pyriproxyfen. 

Using the exposure assumptions 

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

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

3,200 for the U.S. population; 560 for all 

infants <1 year old, 430 for children 1–

2 years old, and 4,700 for females 13–

49 years old. These aggregate MOEs do 

not exceed the Agency’s level of 

concern for aggregate exposure to food 

and residential uses. 

5. Aggregate cancer risk for U.S. 

population. A cancer aggregate risk 

assessment was not performed since 

pyriproxyfen has not been classified as 

a potential carcinogen. 

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, and to infants and children 

from aggregate exposure to pyriproxyfen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

In conjunction with the crop field 

trial studies, the petitioner submitted 

adequate concurrent recovery data for a 

gas chromatography/nitrogenphosphorus detector (GC/NPD) method 

(RM-33P-1-3a or 9.66 V 1) used to 

determine residues of pyriproxyfen in/ 

on the subject crops. The method has 

undergone an adequate radiovalidation, 

independent laboratory validation (ILV) 

trial, petition method validation (PMV) 

trial, and has been forwarded to the 

Food and Drug Administration (FDA) 

for inclusion in PAM Vol. II. The GC/ 

NPD method RM-33P-1-3a is adequate 

for enforcement of the recommended 

tolerance levels for residues of 

pyriproxyfen per se in/on the subject 

crops. 

B. International Residue Limits 

There are currently no established 

Codex, Canadian, or Mexican maximum 

residue limits (MRLs) for pyriproxyfen. 

C. Response to Comments 

Several comments were received from 

a private citizen on objecting to 

pesticide body load, IR-4 profiteering, 

animal testing, establishing tolerances, 

pesticide residues, and pesticide 

exemptions. 

The Agency has received these same 

comments from this commenter of 

numerous previous occasions. Refer to 

the Federal Register of June 30, 2005 

(70 FR 37686) (FRL–7718–3), January 7, 

2005 (70 FR 1349) (FRL–7691–4), and 

October 29, 2004 (69 FR 63083) (FRL–

7681–9) for the Agency’s response to 

these objections. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyriproxyfen, [2-[1- 

methyl-2-(4- 

phenoxyphenoxy)ethoxy]pyridine], in 

or on vegetable, legume, group 6 at 0.20 

ppm; onion, dry bulb at 0.15 ppm; grape 

at 2.5 ppm; strawberry at 0.30 ppm; 

white sapote at 0.30 ppm; citrus hybrids 

at 0.30 ppm; grass, forage,fodder, and 

hay, group 17, forage at 0.70 ppm; and 

grass, forage, fodder, and hay, group 17, 

hay at 1.1 ppm. 

VI. Objections and Hearing Requests 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2005–0246 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 

on or before November 22, 2005. 

Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55739 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2005–0246, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerances 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

55740 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: September 19, 2005 

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. Section 180.510 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.510 Pyriproxyfen; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

*****

Citrus hybrids ................................................................................................................................................... 0.30 

*****

Grape ............................................................................................................................................................... 2.5 

Grass, forage, fodder, and hay, group 17, forage .......................................................................................... 0.70 

Grass, forage, fodder, and hay, group 17, hay ............................................................................................... 1.1 

*****

Onion, dry bulb ................................................................................................................................................ 0.15 

*****

Strawberry ........................................................................................................................................................ 0.30 

*****

Vegetable, legume, group 6 ............................................................................................................................ 0.20 

*****

White sapote .................................................................................................................................................... 0.30 

*****

* * * * * 

[FR Doc. 05–19059 Filed 9–22–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0133; FRL–7738–7] 

Fenpropathrin; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpropathrin 

in or on bushberry subgroup 13B; 

lingonberry; juneberry; salal; pea, 

succulent; and vegetable, fruiting, group 

8. Interregional Research Project 

Number 4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 23, 2005. Objections and 

requests for hearings must be received 

on or before November 22, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0133. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

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

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Shaja R. Brothers, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–3194; e-mail address: 

brothers.shaja@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: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also