59268 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 

Manager, Seattle ACO, to make those 

findings. For a repair method to be approved, 

the approval must meet the certification basis 

of the airplane, and the approval must 

specifically reference this AD. 

Certain Actions Constitute Compliance With 

AD 98–11–03 R1 

(e) Accomplishment of the inspections 

specified in paragraph (c) of this AD is 

terminating action for the inspections 

required by AD 98–11–03 R1 that pertain to 

SSI F–11B of Boeing Document D6–48040–1, 

Boeing 727 SSID, Revision H, dated June 

1994, for the areas specified in paragraph (c) 

of this AD only. Accomplishment of the 

actions required by paragraph (c) of this AD 

does not terminate the inspections required 

by AD 98–11–03 R1 for the remaining areas 

of SSI F–11B and does not terminate the 

remaining requirements of AD 98–11–03 R1. 

No Reporting Required 

(f) Although the service bulletin referenced 

in this AD specifies to provide certain 

information to the manufacturer, this AD 

does not include that requirement. 

Alternative Methods of Compliance 

(g)(1) In accordance with 14 CFR 39.19, the 

Manager, Seattle ACO, is authorized to 

approve alternative methods of compliance 

(AMOCs) for this AD. 

(2) Before using any AMOC approved in 

accordance with § 39.19 on any airplane to 

which the AMOC applies, notify the 

appropriate principal inspector in the FAA 

Flight Standards Certificate Holding District 

Office. 

Incorporation by Reference 

(h) Unless otherwise specified in this AD, 

the actions must be done in accordance with 

Boeing Alert Service Bulletin 727–53A0229, 

dated March 24, 2005. This incorporation by 

reference was approved by the Director of the 

Federal Register in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. To get copies of 

this service information, contact Boeing 

Commercial Airplanes, P.O. Box 3707, 

Seattle, Washington 98124–2207. To inspect 

copies of this service information, go to the 

FAA, Transport Airplane Directorate, 1601 

Lind Avenue, SW., Renton, Washington; or to 

the National Archives and Records 

Administration (NARA). For information on 

the availability of this material at the NARA, 

call (202) 741–6030, or go to http:// 

www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Effective Date 

(i) This amendment becomes effective on 

November 16, 2005. 

Issued in Renton, Washington, on 

September 29, 2005. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 05–20075 Filed 10–11–05; 8:45 am] 

BILLING CODE 4910–13–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0260; FRL–7738–8] 

Imidacloprid; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for the combined 

residues of imidacloprid, (1-[6-chloro-3- 

pyridinyl) methyl]-N-nitro-2- 

imidazolidinimine) and its metabolites 

containing the 6-chloropyridinyl 

moiety, all expressed as parent in or on 

pomegranates. This action is in response 

to EPA’s granting of an emergency 

exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on pomegranates. 

This regulation establishes a maximum 

permissible level for residues of 

imidacloprid in this food commodity. 

The tolerance will expire and is revoked 

on December 31, 2008. 

DATES: This regulation is effective 

October 12, 2005. Objections and 

requests for hearings must be received 

on or before December 12, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0260. 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: 

Andrew Ertman, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone 

number:(703) 308–9367; e-mail address: 

Sec-18-Mailbox@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) 

• 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 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 on E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 408 

(l)(6) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a, 

is establishing a tolerance for the 

combined residues of imidacloprid, (1- 

[6-chloro-3-pyridinyl) methyl]-N-nitro2-imidazolidinimine) and its 

metabolites containing the 6- 

chloropyridinyl moiety, all expressed as 

parent in or on pomegranates at 0.20 

parts per million (ppm). This tolerance 

will expire and is revoked on December 

31, 2008. EPA will publish a document 

in the Federal Register to remove the 

revoked tolerance from the Code of 

Federal Regulations. 

Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 59269 

Section 408(l)(6) of the FFDCA 

requires EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related tolerances 

to set binding precedents for the 

application of section 408 of the FFDCA 

and the new safety standard to other 

tolerances and exemptions. Section 

408(e) of the FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . .’’

Section 18 of the FIFRA authorizes 

EPA to exempt any Federal or State 

agency from any provision of FIFRA, if 

EPA determines that ‘‘emergency 

conditions exist which require such 

exemption.’’ This provision was not 

amended by the Food Quality Protection 

Act of 1996 (FQPA). EPA has 

established regulations governing such 

emergency exemptions in 40 CFR part 

166. 

III. Emergency Exemption for 

Imidacloprid on Pomegranates and 

FFDCA Tolerances 

The State of California requested the 

use of imidacloprid on pomegranates to 

control whiteflies. The applicant stated 

that uncontrolled whitefly populations 

cause significant problems for 

producers. Immature life stages exude 

honeydew on the trees and developing 

fruit, which contribute to the 

development of molds (which mar the 

surface of the pomegranates) and also 

contribute to the sunburning of the fruit. 

Since the introduction of the pest on 

pomegranates, cull rates went from 15–

30% to 40–50%. This increase in cull 

rates is forcing growers and shippers to 

move fruit from the fresh market to the 

juice market, which in turn is causing 

significant economic damage. EPA has 

authorized under FIFRA section 18 the 

use of imidacloprid on pomegranates for 

control of whiteflies in California. After 

having reviewed the submission, EPA 

concurs that emergency conditions exist 

for this State. 

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

imidacloprid in or on pomegranates. In 

doing so, EPA considered the safety 

standard in section 408(b)(2) of the 

FFDCA, and EPA decided that the 

necessary tolerance under section 

408(l)(6) of the FFDCA would be 

consistent with the safety standard and 

with FIFRA section 18. Consistent with 

the need to move quickly on the 

emergency exemption in order to 

address an urgent non-routine situation 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing this 

tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of the 

FFDCA. Although this tolerance will 

expire and is revoked on December 31, 

2008, under section 408(l)(5) of the 

FFDCA, residues of the pesticide not in 

excess of the amounts specified in the 

tolerance remaining in or on 

pomegranates after that date will not be 

unlawful, provided the pesticide is 

applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

this tolerance at the time of that 

application. EPA will take action to 

revoke this tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this tolerance is being 

approved under emergency conditions, 

EPA has not made any decisions about 

whether imidacloprid meets EPA’s 

registration requirements for use on 

pomegranates or whether a permanent 

tolerance for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this tolerance 

serves as a basis for registration of 

imidacloprid by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance serve as the basis for 

any State other than California to use 

this pesticide on this crop under section 

18 of FIFRA without following all 

provisions of EPA’s regulations 

implementing FIFRA section 18 as 

identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for imidacloprid, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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 the 

FFDCA and a complete description of 

the risk assessment process, see the final 

rule on Bifenthrin Pesticide Tolerances 

in the Federal Register of November 26, 

1997 (62 FR 62961) FRL–5754–7). 

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

of the 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 imidacloprid and to make 

a determination on aggregate exposure, 

consistent with section 408(b)(2) of the 

FFDCA, for a time-limited tolerance for 

the combined residues of imidacloprid, 

(1-[6-chloro-3-pyridinyl) methyl]-Nnitro-2-imidazolidinimine) and its 

metabolites containing the 6- 

chloropyridinyl moiety, all expressed as 

parent in or on pomegranates at 0.20 

ppm. EPA’s assessment of the dietary 

exposures and risks associated with 

establishing the tolerance follows. 

A. Toxicological Endpoints 

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological 

endpoint. However, the lowest dose at 

which adverse effects of concern are 

identified (the LOAEL) is sometimes 

used for risk assessment if 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. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences. 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (aRfD or cRfD) where the RfD is 

equal to the NOAEL divided by the 

appropriate UF (RfD = NOAEL/UF). 

Where an additional safety factor is 

59270 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 

retained due to concerns unique to the 

FQPA, this additional factor is applied 

to the RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of FQPA safty 

factor (SF). 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the level of concern (LOC). 

For example, when 100 is the 

appropriate UF (10X to account for 

interspecies differences and 10X for 

intraspecies differences) the LOC is 100. 

To estimate risk, a ratio of the NOAEL 

to exposures (margin of exposure (MOE) 

= NOAEL/exposure) is calculated and 

compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk is expressed as 1 x106 or one 

in a million). Under certain specific 

circumstances, MOE calculations will 

be used for the carcinogenic risk 

assessment. In this non-linear approach, 

a ‘‘point of departure’’ is identified 

below which carcinogenic effects are 

not expected. The point of departure is 

typically a NOAEL based on an 

endpoint related to cancer effects 

though it may be a different value 

derived from the dose response curve. 

To estimate risk, a ratio of the point of 

departure to exposure (MOEcancer = point 

of departure/exposures) is calculated. A 

summary of the toxicological endpoints 

for imidacloprid used for human risk 

assessment is shown in the following 

Table 1: 

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

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF 

*Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute dietary all populations LOAEL = 42 mg/kg/day 

UF = 300 

ARfD = 0.14 mg/kg 

FQPA SF = 1X 

aPAD = acute RfD 

FQPA SF = 0.14 mg/kg 

Acute neurotoxicity - rat 

LOAEL = 42 mg/kg, based upon the decrease in 

motor and locomotor activities observed in females 

Chronic dietary all populations NOAEL= 5.7 mg/kg/day 

UF = 100 

Chronic RfD = 0.057 mg/ 

kg/day 

FQPA SF = 1X 

cPAD = chr RfD 

FQPA SF = 0.057 mg/kg/ 

day 

Combined chronic tox/carcinogenicity - rat 

LOAEL = 16.9 mg/kg/day, based upon increased incidence of mineralized particles in thyroid colloid in 

males 

Short-term oral (1–30 

days) 

Oral study NOAEL= 10 

mg/kg/day 

LOC for MOE = 100 Developmental toxicity - rat 

Maternal LOAEL = 30 mg/kg/day, based upon decreased body weight gain and corrected body 

weight gain 

Short-term dermal (1–30 

days) 

Oral study NOAEL= 10 

mg/kg/day (dermal absorption rate = 7.2%) 

LOC for MOE = 100 Developmental toxicity - rat 

Maternal LOAEL = 30 mg/kg/day, based upon decreased body weight gain and corrected body 

weight gain 

Short-term inhalation (1–

30 days) 

Oral study NOAEL = 10 

mg/kg/day (inhalation 

absorption rate = 100%) 

LOC for MOE = 100 Developmental toxicity - rat 

Maternal LOAEL = 30 mg/kg/day, based upon decreased body weight gain and corrected body 

weight gain 

Cancer (oral, dermal, inhalation) Group E Not applicable No evidence of carcinogenicity in rats and mice 

1 UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of 

concern 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.472) for the 

combined residues of imidacloprid, in 

or on a variety of raw agricultural 

commodities. Meat, milk, poultry and 

egg tolerances have also been 

established for the combined residues of 

imidacloprid. Risk assessments were 

conducted by EPA to assess dietary 

exposures from imidacloprid in food as 

follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse 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. The Dietary 

Exposure Evaluation Model (DEEMTM) 

analysis evaluated the individual food 

consumption 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 acute 

exposure assessments: A Tier 1, 

deterministic acute dietary exposure 

assessment was conducted using 

tolerance-level residues, 100% percent 

crop treated (PCT) information for 

registered and proposed commodities; 

and modified DEEMTM (version 2.0) 

processing factors for some commodities 

based on guideline processing studies. 

EPA estimated exposure based on the 

95th percentile value from this 

deterministic exposure assessment. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

DEEMTM analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994–1996 and 1998 nationwide CSFII 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: A 

Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 59271 

Tier 2 partially refined, deterministic 

assessment using tolerance-level residue 

and average weighted PCT information 

and modified DEEMTM (version 2.0) 

processing factors for some commodities 

based on guideline processing studies. 

iii. Cancer. A quantitative cancer 

aggregate risk assessment was not 

performed because imidacloprid is not 

carcinogenic. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(F) of the 

FFDCA states that the Agency may use 

data on the actual percent of food 

treated for assessing chronic dietary risk 

only if the Agency can make the 

following findings: Condition 1, that the 

data used are reliable and provide a 

valid basis to show what percentage of 

the food derived from such crop is 

likely to contain such pesticide residue; 

Condition 2, that the exposure estimate 

does not underestimate exposure for any 

significant subpopulation group; and 

Condition 3, if data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

section 408(b)(2)(F) of the FFDCA, EPA 

may require registrants to submit data 

on PCT. 

The Agency used PCT information as 

follows: For the chronic assessment, 

average weighted PCT information was 

used for the following commodities: 

Apple 34%; brussels sprouts 56%; 

broccoli 35%; cabbage 14%; cantaloupe 

31%; cauliflower 52%; collards 10%; 

corn, field 1%; cotton 3%; cucumber 

2%; eggplant 36%; grapefruit 3%; grape 

32%; mustard greens16%; honeydew 

26%; kale 30%; lemon 1%; lettuce, head 

49%; lime 5%; orange 1%; pear 16%; 

pepper 62%; pumpkin 7%; spinach 

15%; squash 7%; sugarbeet 1%; 

tangerine 9%; tomato 9%; watermelon 

6%; wheat 1%. A default value of 1% 

was used for all commodities which 

were-reported as having <1 CT. 

The Agency believes that the three 

conditions listed above have been met. 

With respect to Condition 1, PCT 

estimates are derived from Federal and 

private market survey data, which are 

reliable and have a valid basis. EPA uses 

a weighted average PCT for chronic 

dietary exposure estimates. This 

weighted average PCT figure is derived 

by averaging State-level data for a 

period of up to 10–years, and weighting 

for the more robust and recent data. A 

weighted average of the PCT reasonably 

represents a person’s dietary exposure 

over a lifetime, and is unlikely to 

underestimate exposure to an individual 

because of the fact that pesticide use 

patterns (both regionally and nationally) 

tend to change continuously over time, 

such that an individual is unlikely to be 

exposed to more than the average PCT 

over a lifetime. For acute dietary 

exposure estimates, EPA uses an 

estimated maximum PCT. The exposure 

estimates resulting from this approach 

reasonably represent the highest levels 

to which an individual could be 

exposed, and are unlikely to 

underestimate an individual’s acute 

dietary exposure. The Agency is 

reasonably certain that the percentage of 

the food treated is not likely to be an 

underestimation. As to Conditions 2 and 

3, regional consumption information 

and consumption information for 

significant subpopulations is taken into 

account through EPA’s computer-based 

model for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available information on the 

regional consumption of food to which 

imidacloprid may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

imidacloprid 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 

imidacloprid. 

The Agency uses the First Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone/Exposure Analysis 

Modeling System (PRZM/EXAMS) to 

produce estimates of pesticide 

concentrations in an index reservoir. 

The Screening Concentration in Ground 

Water (SCI-GROW) model is used to 

predict pesticide concentrations in 

shallow ground water. For a screeninglevel assessment for surface water EPA 

will generally use FIRST (a Tier 1 

model) before using PRZM/EXAMS (a 

Tier 2 model). The FIRST model is a 

subset of the PRZM/EXAMS model that 

uses a specific high-end runoff scenario 

for pesticides. While both FIRST and 

PRZM/EXAMS incorporate an index 

reservoir environment, the PRZM/ 

EXAMS model includes a PC area factor 

as an adjustment to account for the 

maximum percent crop coverage within 

a watershed or drainage basin. 

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

coarse screen for sorting out pesticides 

for which it is highly unlikely that 

drinking water concentrations would 

ever exceed human health levels of 

concern. 

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs) from these 

models to quantify drinking water 

exposure and risk as a %RfD or %PAD. 

Instead drinking water levels of 

comparison (DWLOCs) are calculated 

and used as a point of comparison 

against the model estimates of a 

pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to imidacloprid 

they are further discussed in the 

aggregate risk sections below. 

Based on the FIRST and SCI-GROW 

models the EECs of imidacloprid for 

acute exposures are estimated to be 

36.04 parts per billion (ppb) for surface 

water and 2.09 ppb for ground water. 

The EECs for chronic exposures are 

estimated to be 17.24 ppb for surface 

water and 2.09 ppb for ground 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). 

Imidacloprid is currently registered 

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

application to lawns and ornamental 

plants; ready-to-use spray for 

application to flowers, shrubs and house 

plants; plant spikes for application to 

indoor and outdoor residential potted 

plants; ready-to-use potting medium for 

indoor and outdoor plant containers; 

liquid concentrate for application to 

lawns, trees, shrubs and flowers; readyto-use liquid for directed spot 

application to cats and dogs. In 

59272 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 

addition, there are numerous registered 

products intended for use by 

commercial applicators to residential 

sites. These include gel baits for 

cockroach control; products intended 

for commercial ornamental, lawn and 

turf pest control; products for ant 

control; and products used as 

preservatives for wood products, 

building materials, textiles and plastics. 

As these products are intended for use 

by commercial applicators only, they 

are not be addressed in terms of 

residential pesticide handler. The risk 

assessment was conducted using the 

following residential exposure 

assumptions: EPA has determined that 

residential handlers are likely to be 

exposed to imidacloprid residues via 

dermal and inhalation routes during 

handling, mixing, loading, and applying 

activities. Based on the current use 

patterns, EPA expects duration of 

exposure to be short-term (1–30 days). 

EPA does not expect imidacloprid to 

result in residential exposure durations 

that would result in intermediate-term 

or long-term exposure. 

The scenarios likely to result in adult 

dermal and/or inhalation residential 

handler exposures are as follows: 

-Dermal and inhalation exposure from 

using a granular push-type spreader. 

-Dermal exposure from using potted 

plant spikes. 

-Dermal exposure from using a plant 

potting medium. 

-Dermal and inhalation exposure from 

using a garden hose-end sprayer (dermal 

and inhalation exposure from using a 

RTU trigger pump spray is expected to 

be negligible). 

-Dermal and inhalation exposure from 

using a water can/bucket for soil drench 

applications. 

-Dermal exposure from using pet spoton. 

EPA has also determined that there is 

potential for short-term (1 to 30 days), 

post-application exposure to adults and 

children/toddlers from the many 

residential uses of imidacloprid. Due to 

residential application practices and the 

half-lives observed in the turf 

transferable residue study, intermediateterm and long-term post-application 

exposures are not expected. The 

scenarios likely to result in dermal 

(adult and child/toddler), and incidental 

non-dietary (child/toddler) short-term 

post-application exposures are as 

follows: 

-Toddler oral hand-to-mouth exposure 

from contacting treated turf. 

-Toddler incidental oral ingestion of 

granules. 

-Toddler incidental oral ingestion of 

pesticide-treated soil. 

-Toddler incidental oral exposure 

from contacting treated pet. 

-Toddler dermal exposure from 

contacting treated turf. 

-Toddler dermal exposure from 

hugging treated pet/contacting treated 

pet. 

-Adult dermal exposure from 

contacting treated turf. 

-Adult golfer dermal exposure from 

contacting treated turf. 

-Adolescent golfer dermal exposure 

from contacting treated turf. 

-Adult dermal exposure from 

contacting treated pet 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

imidacloprid and any other substances 

and imidacloprid does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that imidacloprid 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 

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/. 

C. Safety Factor for Infants and Children 

1. In general. Section 408 of the 

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 that a different margin of 

safety (MOS) will be safe for infants and 

children. MOSs are incorporated into 

EPA risk assessments either directly 

through use of a MOE analysis or 

through using UF (safety) in calculating 

a dose level that poses no appreciable 

risk to humans. 

2. Prenatal and postnatal sensitivity. 

There is no quantitative or qualitative 

evidence of increased susceptibility of 

rat and rabbit fetuses to in utero 

exposure in developmental studies. 

There is no quantitative or qualitative 

evidence of increased susceptibility of 

rat offspring in the multi-generation 

reproduction study. There is evidence of 

increased qualitative susceptibility in 

the rat developmental neurotoxicity 

study, but the concern is low since: 

i. The effects in pups are wellcharacterized with a clear NOAEL. 

ii. The pup effects occur in the 

presence of maternal toxicity with the 

same NOAEL for effects in pups and 

dams, and 

iii. The doses and endpoints selected 

for regulatory purposes are protective of 

the pup effects noted at higher doses in 

the developmental neurotoxicity study. 

Therefore, there are no residual 

uncertainties for prenatal/postnatal 

toxicity in this study. 

3. Conclusion. There is a complete 

toxicity data base for imidacloprid and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. EPA 

determined that the 10X SF to protect 

infants and children should be reduced 

to 1X for the following reasons: 

-The toxicological database is 

complete for FQPA assessment. 

-The acute dietary food exposure 

assessment utilizes existing and 

proposed tolerance level residues and 

100% CT information for all 

commodities. By using these screeninglevel assessments, actual exposures/ 

risks will not be underestimated. 

-The chronic dietary food exposure 

assessment utilizes existing and 

proposed tolerance level residues and 

PCT data verified by the Agency for 

several existing uses. For all proposed 

uses, 100% CT is assumed. The chronic 

assessment is somewhat refined and 

based on reliable data and will not 

underestimate exposure/risk. 

-The dietary drinking water 

assessment utilizes water concentration 

values generated by model and 

associated modeling parameters which 

are designed to provide conservative, 

health protective, high-end estimates of 

water concentrations which will not 

likely be exceeded. 

-The residential handler assessment is 

based upon the residential standard 

operating procedures (SOPs) in 

conjunction with chemical-specific 

study data in some cases and the 

Pesticide Handlers Exposure Database 

(PHED) unit exposures in other cases. 

The majority of the residential postapplication assessment is based upon 

chemical-specific turf transferrable 

Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 59273 

residue data or other chemical-specific 

post-application exposure study data. 

The chemical-specific study data as well 

as the surrogate study data used are 

reliable and also are not expected to 

underestimate risk to adults as well as 

to children. In a few cases where 

chemical-specific data were not 

available, the SOPs were used alone. 

The residential SOPs are based upon 

reasonable worst-case assumptions and 

are not expected to underestimate risk. 

These assessments of exposure are not 

likely to underestimate the resulting 

estimates of risk from exposure to 

imidacloprid. 

D. Aggregate Risks and Determination of 

Safety 

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against the model 

estimates of a pesticide’s concentration 

in water (EECs). DWLOC values are not 

regulatory standards for drinking water. 

DWLOCs 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 milligrams/kilogram/ day (mg/ 

kg/day) = cPAD - (average food + 

chronic non-dietary, non-occupational 

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 the U.S. EPA 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). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

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 DWLOCs, EPA concludes 

with reasonable certainty that exposures 

to imidacloprid in drinking water (when 

considered along with other sources of 

exposure 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 

change. If new uses are added in the 

future, EPA will reassess the potential 

impacts of imidacloprid on drinking 

water as a part of the aggregate risk 

assessment process. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food to imidacloprid will 

occupy 26% of the aPAD for the U.S. 

population, 17% of the aPAD for 

females 13 to 49 years, 57% of the aPAD 

for infants <1 year old and 66% of the 

aPAD for children 1–2 years. In 

addition, despite the potential for acute 

dietary exposure to imidacloprid in 

drinking water, after calculating 

DWLOCs and comparing them to 

conservative model estimated 

environmental concentrations of 

imidacloprid in surface water and 

ground water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the aPAD, as shown in the following 

Table 2: 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO IMIDACLOPRID

Population Subgroup aPAD (mg/ 

kg) 

%aPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Acute 

DWLOC 

(ppb) 

U.S. population 0.14 26 36.04 2.09 3600 

Females (13–49 years) 0.14 17 36.04 2.09 3500 

Infants (1 year) 0.14 57 36.04 2.09 600 

Children (1–2 years) 0.14 66 36.04 2.09 470 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to imidacloprid from food 

will utilize 12% of the cPAD for the 

U.S. population, 29% of the cPAD for 

infants <1 year and 38% of the cPAD for 

children 1–2 years. Based the use 

pattern, chronic residential exposure to 

residues of imidacloprid is not 

expected. In addition, there is potential 

for chronic dietary exposure to 

imidacloprid in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface water and 

ground water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in the following 

Table 3: 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO IMIDACLOPRID

Population Subgroup cPAD mg/ 

kg/day 

%cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.057 12 17.24 2.09 1800 

Infants (1 year) 0.057 29 17.24 2.09 400 

Children (1–2 years) 0.057 38 17.24 2.09 350 

Females (13–49 years) 0.057 10 17.24 2.09 1600 

59274 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 

3. Short-term risk. The short-term 

aggregate risk assessment estimates risks 

likely to result from 1 to 30 day 

exposure to imidacloprid residues from 

food, drinking water, and residential 

pesticide uses. High-end estimates of 

the residential exposure are used in the 

short-term assessment, and average 

values are used for food and drinking 

water exposures. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that food 

and residential exposures aggregated 

result in aggregate MOEs of 310 for the 

U.S. population, and 170 for children 1–

2 years. These aggregate MOEs do not 

exceed the Agency’s level of concern for 

aggregate exposure to food and 

residential uses. In addition, short-term 

DWLOCs were calculated and compared 

to the EECs for chronic exposure of 

imidacloprid in ground water and 

surface water. After calculating 

DWLOCs and comparing them to the 

EECs for surface water and ground 

water, EPA does not expect short-term 

aggregate exposure to exceed the 

Agency’s level of concern, as shown in 

the following Table 4: 

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO IMIDACLOPRID

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

LOC 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Short-Term 

DWLOC 

(ppb) 

U.S. population 310 100 17.24 2.09 2400 

Children (1–2 years old) 170 100 17.24 2.09 400 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account non-dietary, nonoccupational exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term aggregate risk 

assessment was not performed because, 

based on the current use patterns, the 

Agency does not expect residential 

exposure durations that would result in 

intermediate-term exposures. 

5. Aggregate cancer risk for U.S. 

population. There is no evidence of 

carcinogenicity to humans based on 

carcinogenicity studies in male and 

female rats and mice. The Agency 

concludes that pesticidal uses of 

imidacloprid are not likely to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to imidacloprid 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(example—gas chromatography) is 

available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no CODEX, Canadian, or 

Mexican Maximum Residue Limits for 

imidacloprid on pomegranates. 

VI. Conclusion 

Therefore, the tolerance is established 

for the combined residues of 

imidacloprid, (1-[6-chloro-3-pyridinyl) 

methyl]-N-nitro-2-imidazolidinimine) 

and its metabolites containing the 6- 

chloropyridinyl moiety, all expressed as 

parent, in or on pomegrantes at 0.20 

ppm. 

VII. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. EPA’s 

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 the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the 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 the FFDCA, as was 

provided in the old sections 408 and 

409 of the 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–2005–0260 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 December 12, 2005. 

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 VII.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 

Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 59275 

copies, identified by the docket ID 

number OPP–2005–0260, 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 e-mail 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). 

VIII. Statutory and Executive Order 

Reviews 

This final rule establishes a timelimited [tolerance] under section 408 of 

the FFDCA. 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 FIFRA 

section 18 exemption under section 408 

of the 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. 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 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. 

IX. 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 record keeping 

requirements. 

Dated: September 27, 2005. 

Donald R. Stubbs, 

Acting 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 180.472 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (b) 

to read as follows: 

§ 180.472 Imidacloprid; tolerances for 

residues. 

* * * * * 

(b) * * * 

59276 Federal Register / Vol. 70, No. 196 / Wednesday, October 12, 2005 / Rules and Regulations 

Commodity Parts per million Expiration/revocation date 

*****

Pomegranate ............................................................................................................................................... 0.20 12/31/08 

* * * * * 

[FR Doc. 05–20209 Filed 10–11–05; 8:45 am] 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 5, 25, and 97 

[IB Docket No. 02–54; FCC 04–130] 

Mitigation of Orbital Debris 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: Pursuant to the Paperwork 

Reduction Act of 1995, Public Law 104–

13, the Federal Communications 

Commission received Office of 

Management and Budget (OMB) 

approval for the collection of orbital 

debris mitigation plans under 47 CFR 

5.63(e), 25.114(d)(14), and 97.207(g) of 

the Commission’s rules. Mitigation of 

Orbital Debris, IB Docket No. 02–54, 

OMB Control Number 3060–1013. An 

agency may not conduct or sponsor and 

a person is not required to respond to 

a collection of information unless it 

displays a currently valid control 

number. 

DATES: Effective October 19, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Duall, Attorney Advisor, 

Satellite Division, International Bureau, 

at (202) 418–1103, or via the Internet at 

Stephen.Duall@fcc.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Communications Commission 

has received OMB approval for the 

disclosures of orbital debris mitigation 

plans under 47 CFR 5.63(e), 

25.114(d)(14), and 97.207(g) of the 

Commission’s rules that were adopted 

in Mitigation of Orbital Debris, IB 

Docket No. 02–54, 69 FR 54581 

(September 9, 2004). These rules require 

a satellite system operator requesting 

FCC space station authorization, or an 

entity requesting a Commission ruling 

for access to a non-U.S.-licensed space 

station under the Commission’s satellite 

market access procedures, to submit an 

orbital debris mitigation plan to the 

Commission regarding spacecraft design 

and operation in connection with its 

request under parts 5, 25, and 97 of the 

Commission’s rules. Through this 

document, the Commission confirms 

that it received OMB approval on April 

13, 2005, OMB Control No. 3060–1013, 

and announces that the effective date of 

47 CFR 5.63(e), 25.114(d)(14), and 

97.207(g) is October 19, 2005. 

Pursuant to the Paperwork Reduction 

Act of 1995, Public Law 104–13, an 

agency may not conduct or sponsor a 

collection of information unless it 

displays a currently valid control 

number. Notwithstanding any other 

provisions of law, no person shall be 

subject to any penalty for failing to 

comply with a collection of information 

subject to the Paperwork Reduction Act 

that does not display a valid control 

number. Questions concerning the OMB 

control number and expiration dates 

should be directed to Judith B. Herman 

at 202–418–0214, 445 12th Street, SW., 

Washington, DC 20554, or via the 

Internet at Judith-B.Herman@fcc.gov. 

OMB Control No.: 3060–1013. 

OMB Approval Date: 4/13/2005. 

Expiration Date: 4/30/2008. 

Title: Mitigation of Orbital Debris. 

Form No.: N/A. 

Estimated Annual Burden: 53 

responses; 159 annual burden hours. 

Needs and Uses: The Commission is 

revising this information collection to 

reflect the new and/or modified 

information collection requirements that 

resulted from the Second Report and 

Order, ‘‘In the Matter of Mitigation of 

Orbital Debris.’’ This Second Report and 

Order was released by the Commission 

on June 21, 2004. The Commission 

amended parts 5, 25, and 97 of the 

Commission’s rules by adopting new 

rules concerning mitigation of orbital 

debris. Orbital debris consists of 

artificial objects orbiting the earth that 

are not functional spacecraft. Adoption 

of these rules will help preserve the 

United States’ continued affordable 

access to space, the continued provision 

of reliable U.S. space-based services—

including communications and remote 

sensing satellite services for U.S. 

commercial, government, and homeland 

security purposes—as well as the 

continued safety of persons and 

property in space and on the surface of 

the earth. Under the rules as amended 

today, a satellite system operator 

requesting FCC space station 

authorization, or an entity requesting a 

Commission ruling for access to a nonU.S.-licensed space station under the 

FCC’s satellite market access 

procedures, must submit an orbital 

debris mitigation plan to the 

Commission regarding spacecraft design 

and operation in connection with its 

request. This Second Report and Order 

provides guidance for the preparation of 

such plans. Adoption of these rules will 

further the domestic policy objective of 

the United States to minimize the 

creation of orbital debris and is 

consistent with international policies 

and initiatives to achieve this goal. The 

information collection requirements 

accounted for in this collection are 

necessary to mitigate the potential 

harmful effects of orbital debris 

accumulation. Without such 

information collection requirements, the 

growth in the orbital debris may limit 

the usefulness of space for 

communications and other uses in the 

future by raising the costs and lowering 

the reliability of space-based systems. 

Federal Communications Commission. 

Marlene H. Dortch, 

Secretary. 

[FR Doc. 05–20446 Filed 10–11–05; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 25 

[IB Docket 02–54; FCC 04–130] 

Mitigation of Orbital Debris 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: Pursuant to the Paperwork 

Reduction Act of 1995, Public Law 104–

13, the Federal Communications 

Commission received Office of 

Management and Budget (OMB) 

approval for the collection of orbital 

debris mitigation plans under 47 CFR 

25.114(d)(14) of the Commission’s rules. 

Mitigation of Orbital Debris, IB Docket 

No. 02–54, OMB Control Number 3060–

1013. By this document, we announce 

the revision or removal of redundant 

existing rules requiring the submission 

of orbital debris plans on a servicespecific basis that are contained in 47 

CFR 25.143(b)(1), 25.145(c)(3), 

25.146(i)(4), and 25.217(d). 

DATES: Effective October 19, 2005.