Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices 41455

DEPARTMENT OF ENERGY

Federal Agency Regulatory

Commission

[Project No. 2035–006 Colorado]

City and County of Denver; Notice of

Availability of Final Environmental

Assessment

June 28, 2000.

In accordance with the National

Environmental Policy Act of 1969 and

the Federal Energy Regulatory

Commission’s (Commission)

regulations, 18 CFR part 380 (Order No.

486, 52 FR 47897), the Office of Energy

Projects has reviewed the application

for a new license for the Gross Reservoir

Hydroelectric Project, and has prepared

a Final Environmental Assessment

(FEA). The project is located on South

Boulder Creek, near the city of Boulder,

in Boulder County, Colorado. The

Project occupies federal lands managed

by the U.S. Forest Service, Roosevelt

National Forest, and the Bureau of Land

Management.

In the FEA, the Commission’s staff

has analyzed the existing and potential

future environmental impacts of the

project and has concluded that licensing

the project, with appropriate

environmental protective or

enhancement measures, would not

constitute a major federal action that

would significantly affect the quality of

the human environment.

Copies of the FEA are available for

review in the Public Reference Room,

Room 2A, of the Commission’s offices at

888 First Street, NE., Washington, DC

20426. The FEA may be viewed on

http://www.ferc.fed.us/online/rims.htm

(call (202) 208–2222 for assistance).

Linwood A. Watson, Jr.,

Acting Secretary.

[FR Doc. 00–16839 Filed 7–3–00; 8:45 am]

BILLING CODE 6717–01–M

ENVIRONMENTAL PROTECTION

AGENCY

[PF–948; FRL–6590–6]

Notice of Filing of Pesticide Petitions

to Establish Tolerances for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by docket

control number PF–948, must be

received on or before August 4, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–948 in the subject

line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; 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 affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production.

112 Animal production.

311 Food manufacturing.

32532 Pesticide manufacturing.

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 the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

948. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

claimed as confidential business

information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Rm. 119, Crystal Mall

#2, 1921 Jefferson Davis Highway,

Arlington, VA, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The PIRIB telephone number

is (703) 305–5805.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–948 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA. The PIRIB is open from

8:30 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

PIRIB telephone number is (703) 305–

5805.

41456 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

3. Electronically. You may submit

your comments electronically by e-mail

to: ‘‘opp-docket@epa.gov,’’ or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–948. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under ‘‘FOR FURTHER INFORMATION

CONTACT.’’

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

EPA has received pesticide petitions

as follows proposing the establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Comestic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

these petitions contain data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petitions. Additional data may be

needed before EPA rules on the

petitions.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: June 26, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

The petitioner summaries of the

pesticide petitions are printed below as

required by section 408(d)(3) of the

FFDCA. The summaries of the petitions

were prepared by the petitioner and

represents the view of the petitioner.

The petition summaries announce the

availability of a description of the

analytical methods available to EPA for

the detection and measurement of the

pesticide chemical residues or an

explanation of why no such method is

needed.

Interregional Research Project Number

4 (IR-4)

9E6041, 0E6101, 0E6102, 0E6104,

0E6106, and 0E6156

EPA has received pesticide petitions

9E6041, 0E6101, 0E6102, 0E6104,

0E6106, and 0E6156 from the

Interregional Research Project No. 4, 681

U.S. Highway #1 South, North

Brunswick, NJ 08902–3390 proposing,

pursuant to section 408(d) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(d), to amend 40 CFR part

180 by establishing tolerances for

residues of the insecticide imidacloprid,

1-(6-chloro-3-pyridinyl)methyl-N-nitro2-imidazolidinimine in or on the

following raw agricultural commodities:

1. PP 9E6041 proposes the

establishment of a tolerance for cilantro

at 3.5 parts per million (ppm).

2. PP 0E6101 proposes the

establishment of a tolerance for edible

podded bean at 1.0 ppm.

3. PP 0E6102 proposes the

establishment of a tolerance for hops at

4.0 ppm.

4. PP 0E6104 proposes the

establishment of a tolerance for

succulent shelled bean at 1.0 ppm.

5. PP 0E6106 proposes the

establishment of a tolerance for sweet

corn at 0.05 ppm, sweet corn forage at

0.1 ppm, and sweet corn stover at 0.2

ppm.

6. PP 0E6156 proposes the

establishment of a tolerance for turnip

tops (leaves) at 3.5 ppm.

EPA has determined that the petitions

contain data or information regarding

the elements set forth in section

408(d)(2) of the FFDCA; however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support granting of the

petitions. Additional data may be

needed before EPA rules on the

petitions. This notice includes a

summary of the petitions prepared by

Zeneca Ag Products, Wilmington, DE

19850–5458.

A. Residue Chemistry

1. Plant metabolism. The nature of the

imidacloprid residue in plants and

livestock is adequately understood. The

residues of concern are combined

residues of imidacloprid and it

metabolites containing the 6–

chloropyridinyl moiety, all calculated as

imidacloprid.

2. Analytical method. The analytical

method is a common moiety method for

imidacloprid and its metabolites

containing the 6–chloropyridinyl

moiety using a permanganate oxidation,

silyl derivatization, and capillary gas

chromatography mass spectrometry

(GC/MS) selective ion monitoring. This

method has successfully passed a

petition method validation in EPA labs.

There is a confirmatory method

specifically for imidacloprid and several

metabolites utilizing GC/MS and high

performance liquid chromatography

using ultra-violet detection (HPLC-UV)

which has been validated by EPA as

well. Imidacloprid and its metabolites

are stable for at least 24 months in the

commodities when frozen.

3. Magnitude of residues— i. Turnip

tops. IR–4 has received requests from

the California, Oregon, Texas,

Mississippi, Oklahoma, Florida, Ohio,

and Tennessee agricultural experiment

stations for the registration of

imidacloprid on turnip tops (leaves). No

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices 41457

data are presented in support of this

petition; rather, IR–4 requests that the

registrant’s Brassica vegetable data be

used to support this request for turnip

tops. Turnips are very closely related to

the Brassica vegetables. This request

does not include a tolerance for turnip

roots.

ii. Succulent shelled beans. Seven

field trials were conducted in order to

provide information on the magnitude

of imidacloprid residues on lima beans

following planting application plus

three foliar applications of

imidacloprid. Trials were conducted in

Maryland, South Carolina, Georgia,

Ohio, California and Washington.

Residue levels ranged from <0.05 ppm

to 0.67 ppm. A tolerance of 1.0 ppm is

being proposed by IR–4.

iii. Edible podded beans. Six field

trials were conducted in order to

provide information on the magnitude

of imidacloprid residues on snap beans

following the planting application plus

3 foliar applications of imidacloprid.

Trials were conducted in South

Carolina, Florida, Wisconsin, Ohio, New

York, and Washington. Residue levels

ranged from <0.05 ppm to 0.89 ppm. A

tolerance of 1.0 ppm is being proposed

by IR–4.

iv. Sweet corn. IR–4 received a

request from New York for registration

of imidacloprid seed treatment on sweet

corn. Imidacloprid is currently

registered for use on field corn.

Tolerances for kernel + cob with husk

removed (K + CWHR), sweet corn forage

and sweet corn stover were requested

based on field corn data and validation

of method on K + CWHR samples.

v. Cilantro. The nature of

imidacloprid residues is adequately

understood and an analytical method is

available for enforcement purposes. IR–

4 requests that EPA grant an

imidacloprid tolerance for cilantro

based on the similarity of cilantro to

other leafy non-Brassica vegetables

(especially fresh parsley) for which

imidacloprid is already registered.

Based on the available information, and

the currently registered use patterns for

leafy non-Brassica vegetables on the

Admire and Provado labels, the

establishment of a tolerance for cilantro

(fresh leaves and stems) would protect

the public health, and would not expose

man or the environment to unreasonable

adverse effects.

vi. Hops. Based on available data, the

proposed use, foliar treatment of

pirimicarb insecticide at the rate of 1 lb

(0.5 lb active) per acre up to a maximum

of 1 lb active ingredient/acre (ai/acre)

per year, minimum 7–day pre-harvest

interval, should be supported. Based on

the available information, the

establishment of the tolerance proposed

in the petition would protect the public

health, and would not expose man or

the environment to unreasonable

adverse effects, while providing growers

with a safe and effective insectide.

B. Toxicological Profile

1. Acute toxicity. The acute oral lethal

dose (LD)50 values for imidaclopridtechnical ranged from 424 milligrams/

kilograms (mg/kg) in the male rat and

>450 mg/kg in the female rat. The acute

dermal LD50 was >5,000 mg/kg in the

rat. The 4–hour rat inhalation lethal

concentration (LC)50 was >5.33

milligram/Liter (mg/L). Imidacloprid

was not irritating to rabbit skin or eyes.

Imidacloprid did not cause skin

sensitization in guinea pigs. In an acute

neurotoxicity study, the lowest observed

adverse effect level (LOAEL) = 42 mg/

kg body weight (bwt)/day.

2. Genotoxicity. Mutagenicity studies

have demonstrated that imidacloprid is

non-mutagenic both in vivo and in vitro.

3. Reproductive and developmental

toxicity. In a developmental toxicity

study with Sprague-Dawley rats, groups

of pregnant animals (25/group) received

oral administration of imidacloprid

(94.2%) at 0, 10, 30, or 100 mg/kg bwt/

day during gestation days 6 through 16.

Maternal toxicity was manifested as

decreased body weight gain at all dose

levels and reduced food consumption at

100 mg/kg bwt/day. No treatmentrelated effects were seen in any of the

reproductive parameters (i.e., Cesarean

section evaluation). At 100 mg/kg bwt/

day, developmental toxicity manifested

as wavy ribs (fetus =7/149 in treated vs.

2/158 in controls and litters, 4/25 vs. 1/

25). For maternal toxicity, the LOAEL

was 10 mg/kg bwt/day lowest dose

tested (LDT) based on decreased body

weight gain; a no observed adverse

effect level (NOAEL) was not

established. For developmental toxicity,

the NOAEL was 30 mg/kg bwt/day, and

the LOAEL was 100 mg/kg bwt/day

based on increased wavy ribs.

In a developmental toxicity study

with Chinchilla rabbits, groups of 16

pregnant does were given oral doses of

imidacloprid (94.2%) at 0, 8, 24, or 72

mg/kg bwt/day during gestation days 6

through 18. For maternal toxicity, the

NOAEL was 24 mg/kg bwt/day and the

LOAEL was 72 mg/kg bwt/day based on

mortality, decreased body weight gain,

increased resorptions, and increased

abortions. For developmental toxicity,

the NOAEL was 24 mg/kg bwt/day and

the LOAEL was 72 mg/kg bwt/day based

on decreased fetal body weight,

increased resorptions, and increased

skeletal abnormalities.

In a 2–generation reproductive

toxicity study, imidacloprid (95.3%)

was administered to Wistar/Han rats at

dietary levels of 0, 100, 250, or 700 ppm

(0, 7.3, 18.3, or 52.0 mg/kg bwt/day for

males and 0, 8.0, 20.5, or 57.4 mg/kg

bwt/day for females). For parental/

systemic/reproductive toxicity, the

NOAEL was 250 ppm (18.3 mg/kg bwt/

day) and the LOAEL was 750 ppm (52

mg/kg bwt/day), based on decreases in

body weight in both sexes in both

generations. Based on these factors, the

parental/systemic/reproductive NOAEL

and LOAEL are 250 and 700 ppm,

respectively, based upon the body

weight decrements observed in both

sexes in both generations.

4. Subchronic toxicity. In a dermal

toxicity study, groups of 5 male and 5

female New Zealand white rabbits

received repeated dermal applications

of imidacloprid (95%) at 1,000 mg/kg

bwt/day (limit dose), 6–hours/day, 5–

days/week for 3–weeks. No dermal or

systemic toxicity was seen. For systemic

and dermal toxicity, the NOAEL was

>1,000 mg/kg bwt/day; a LOAEL was

not established.

In an oral toxicity study, groups of

Fischer 344 rats (12/sex/dose) were fed

diets containing imidacloprid (98.8%) at

0, 150, 1,000, or 3,000 ppm (0, 9.3, 63.3,

or 196 mg/kg bwt/day in males and 0,

10.5, 69.3, or 213 mg/kg bwt/day in

females, respectively) for 90–days. No

treatment-related effects were seen at

150 ppm. Treatment-related effects

included decreases in body weight gain

during the first 4 weeks of the study at

1,000 ppm (22% in males and 18% in

females) and 3,000 ppm (50% in males

and 25% in females) with an associated

decrease in forelimb grip strength

especially in males. The NOAEL was

150 ppm (9.3 and 10.5 mg/kg bwt/day

in males and females, respectively) and

the LOAEL was 1,000 ppm (63.3 and

69.3 mg/kg bwt/day in males and

females, respectively).

In a rat inhalation study (28–day

study in which rats were exposed 6

hours/day, 5 days/week for 4 weeks),

the NOAEL for imidacloprid was 5.5

mg/m3.

5. Chronic toxicity. In a chronic

toxicity study, groups of Beagle dogs (4/

sex/dose) were fed diets containing

imidacloprid (94.9%) at 0, 200, or

1,250/2,500 ppm (0, 6.1, 15, or 41/72

mg/kg bwt/day, respectively) for 52

weeks. The 1,250 ppm dose was

increased to 2,500 ppm from week 17

onwards. The threshold NOAEL was

1,250 ppm (41 mg/kg bwt/day). The

LOAEL was 2,500 ppm (72 mg/kg bwt/

day) based on increased cytochrome-P–

450 levels in both sexes and was

considered to be a threshold dose. Due

41458 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

to the lack of toxicity at 1,250 ppm, a

LOAEL was not established in this

study; following the dose increase to the

2,500 ppm level, toxicity was observed,

thus making 1,250 ppm the threshold

NOAEL and 2,500 ppm the threshold

LOAEL.

6. Animal metabolism. The

metabolism of NTN 33893

(imidacloprid) in rats was reported in

seven studies. Data showed that

imidacloprid was rapidly absorbed and

eliminated in the excreta (90% of the

dose within 24 hours), demonstrating no

biologically significant differences

between sexes, dose levels, or route of

administration. Elimination was mainly

renal (70–80% of the dose) and fecal

(17–25%). The major part of the fecal

activity originated in the bile. Total

body accumulation after 48 hours

consisted of 0.5% of the radioactivity

with the liver, kidney, lung, skin and

plasma being the major sites of

accumulation. Therefore,

bioaccumulation of imidacloprid is low

in rats. Maximum plasma concentration

was reached between 1.1 and 2.5 hours.

Two major routes of biotransformation

were proposed for imidacloprid. The

first route included an oxidative

cleavage of the parent compound

rendering 6–chloronicotinic acid and its

glycine conjugate. Dechlorination of this

metabolite formed the 6–

hydroxynicotinic acid and its

mercapturic acid derivative. The second

route included the hydroxylation

followed by elimination of water of the

parent compound rendering NTN

35884. A comparison between

[methylene--14C]-imidacloprid and

[imidazolidine-4,5-14C]-imidacloprid

showed that while the rate of excretion

was similar, the renal portion was

higher with the imidazolidine-labeled

compound. In addition, accumulation in

tissues was generally higher with the

imidazolidine-labeled compound. Also,

a comparison between imidacloprid and

one of its metabolites, WAK 3839,

showed that the total elimination was

the same for both compounds. The

proposed metabolic pathways for these

two compounds were different. WAK

3839 was formed following pretreatment

(repeated dosing) of imidacloprid.

7. Endocrine disruption. The

toxicology data base for imidacloprid is

current and complete. Studies in this

data base include evaluation of the

potential effects on reproduction and

development, and an evaluation of the

pathology of the endocrine organs

following short-term or long-term

exposure. These studies revealed no

primary endocrine effects due to

imidacloprid.

C. Aggregate Exposure

1. Dietary exposure. Assessments

were conducted to evaluate potential

risks due to chronic and acute dietary

exposure of the U.S. population and

selected population subgroups to

residues of imidacloprid. These

analyses cover all registered crops

including rotational crops; uses pending

with the EPA on citrus, leafy petiole

crop group, corn, and sweet corn; active

and proposed Section 18 uses on

blueberries, cranberries, table beets,

strawberries, turnips; new proposed IR–

4 uses on succulent beans, blueberries,

turnips and cilantro; and an import

tolerance petition on bananas.

Novigen Sciences, Inc.’s dietary

exposure evaluation model (DEEMTM),

which is licensed to Bayer, was used to

estimate the chronic and acute dietary

exposure. Version 6.76 was used for the

chronic analysis and version 6.79 for the

acute analysis. This software uses the

food consumption data from the 1994–

1996 U.S. Department of Argiculture

(USDA) continuing surveys of food

intake by individuals CSFII 1994–1996.

The endpoint for acute dietary risk

assessments is based on neurotoxicity

characterized by decreases in motor or

locomotor activity in female rats at 42

mg/kg bwt/day (LOAEL) from an acute

neurotoxicity study. Based on an

uncertainty factor (UF) of 10X for

interspecies and 10X for intraspecies the

acute reference dose (RfD) = 0.42 mg/kg

bwt/day. EPA has determined that an

additional UF for FQPA (reduced to 3X)

applies to all population subgroups for

acute risk. Application of the additional

3X safety factor results in an acute

population adjusted dose (aPAD) 0.14

mg/kg bwt/day or a margin of exposure

(MOE) of 300.

For chronic dietary analyses, EPA has

established the RfD for imidacloprid at

0.057 mg/kg/day based on a NOAEL of

5.7 mg/kg bwt/day from a rat chronic

toxicity carcinogenicity study and UFs

of 10X for interspecies and 10X for

intraspecies. EPA has determined that

an UF for FQPA (reduced to 3X) applies

to all population subgroups for chronic

risk. Application of the additional 3X

safety factor results in a chronic

population adjusted dose (cPAD) of

0.019 mg/kg bwt/day.

Results from the acute and chronic

dietary exposure analyses described

below demonstrate a reasonable

certainty that no harm to the overall

U.S. population or any population

subgroup will result from the use of

imidacloprid on currently registered

and pending uses.

i. Food. Acute and chronic (tier 3) risk

assessments were made using the results

of field trials conducted at maximum

label application rates and the shortest

post harvest interval (PHI). For some of

the vegetable crops, these residue data

were collected at 1.5X or greater than

the maximum label rate of 0.5 lb ai/acre

per season. In addition, no adjustments

were made to account for dissipation of

residues during storage, transportation

from the field to the consumer, washing

or peeling. Therefore, the actual dietary

exposure will be less than that

presented here.

For the chronic analysis, mean field

trial residues were calculated. For the

acute Monte Carlo analysis, the entire

distribution of residue field trial data

was used for the ‘‘non-blended’’ and

‘‘partially-blended’’ foods as determined

by EPA. For the foods considered as

‘‘blended’’ by EPA, mean field trial

residue data were used. As allowed in

EPA’s draft guidance for submission of

probabilistic human health exposure

assessments one half limit of detection/

limit of quantitation (LOD/LOQ) values

were used for all non-detected values

(values below the sensitivity of the

method).

ii. Acute. Bayer’s acute Monte Carlo

dietary exposure assessment estimated

percent of the aPAD and corresponding

margins of exposure (MOE) for the

overall U.S. population (all seasons) and

various subpopulations. In this analysis,

the exposure for the total U.S.

population was equal to 6.82% of the

aPAD at the 99.9th percentile. The most

highly exposed population subgroup,

children (1–6 yrs), had an exposure

equal to 13.44% of the aPAD at the

99.9th percentile. Therefore, the acute

dietary exposure estimates are below

EPA’s level of concern for the overall

U.S. population as well as the various

subpopulations.

iii. Chronic. Bayer’s chronic dietary

exposure estimated the percent of the

cPAD for the overall U.S. population (all

seasons) and various subpopulations. In

this analysis, the exposure for the total

U.S. population was equal to 1.4% of

the cPAD. The most highly exposed

population subgroup, children (1–6 yrs),

had an exposure equal to 2.7% of the

cPAD. Therefore, the chronic exposure

estimates are below EPA’s level of

concern for the overall U.S. population

as well as the various subpopulations.

iv. Drinking water. EPA has

determined that imidacloprid is

persistent and could potentially leach

into ground water. However, there is no

established maximum concentration

level (MCL) or health advisory levels

established for imidacloprid in drinking

water. EPA’s ‘‘pesticides in ground

water data base’’ has no entry for

imidacloprid. In addition, Bayer is not

Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices 41459

aware of imidacloprid being detected in

any wells, ponds, lakes, streams, etc.

from its use in the U.S. In studies

conducted in 1995, imidacloprid was

not detected in 17 wells on potato farms

in Quebec, Canada. Therefore,

contributions to the dietary burden from

residues of imidacloprid in water would

be inconsequential.

2. Non-dietary exposure— i.

Residential turf. Bayer has conducted an

exposure study to address the potential

exposures of adults and children from

contact with imidacloprid treated turf.

The population considered to have the

greatest potential exposure from contact

with pesticide treated turf soon after

pesticides application are young

children. Margins of safety of 7,587 –

41,546 for 10–year-old children and

6,859 – 45,249 for 5–year-old children

were estimated by comparing dermal

exposure doses to the imidacloprid

NOAEL of 1,000 mg/kg/day established

in a 15–day dermal toxicity study in

rabbits. The estimated safe residue

levels of imidacloprid on treated turf for

10–year-old children ranged from 5.6 –

38.2 g/cm2 and for 5–year-old children

from 5.1 – 33.5 g/cm2. This compares

with the average imidacloprid

transferable residue level of 0.080 g/cm2

present immediately after the sprays

have dried. According to Bayer, these

data indicate that children can safely

contact imidacloprid-treated turf as

soon after application as the spray has

dried.

ii. Termiticide. Imidacloprid is

registered as a termiticide. Due to the

nature of the treatment for termites,

exposure would be limited to that from

inhalation and was evaluated by EPA’s

Occupational and Residential Exposure

Branch’s (OREB) and Bayer. Data

indicate that the margins of safety for

the worst case exposures for adults and

infants occupying a treated building

who are exposed continuously (24

hours/day) are 8.0 x 107 and 2.4 x 108,

respectively. According to Bayer,

exposure can be considered negligible.

iii. Tobacco smoke. Studies have been

conducted to determine residues in

tobacco and the resulting smoke

following treatment. Residues of

imidacloprid in cured tobacco following

treatment were a maximum of 31 ppm

(7 ppm in fresh leaves). When this

tobacco was burned in a pyrolysis

study, only 2% of the initial residue was

recovered in the resulting smoke (main

stream plus side stream). This would

result in an inhalation exposure to

imidacloprid from smoking of

approximately 0.0005 mg per cigarette.

Using the measured subacute rat

inhalation NOAEL of 5.5 mg/m3, it is

apparent that exposure to imidacloprid

from smoking (direct and/or indirect

exposure) would not be significant.

iv. Pet treatment. Human exposure

from the use of imidacloprid to treat

dogs and cats for fleas has been

addressed by EPA’s OREB who have

concluded that due to the fact that

imidacloprid is not an inhalation or

dermal toxicant and that while dermal

absorption data are not available,

imidacloprid is not considered to

present a hazard via the dermal route.

D. Cumulative Effects

No other chemicals having the same

mechanism of toxicity are currently

registered, therefore, there is no risk

from cumulative effects from other

substances with a common mechanism

of toxicity.

E. Safety Determination

1. U.S. population. Based on the

exposure assessments described above

and on the completeness and reliability

of the toxicity data, it can be concluded

that the exposure estimates from all

label and pending uses of imidacloprid

are 6.82% of the aPAD and 1.4% of the

cPAD for dietary exposures. EPA

generally has no concerns for exposures

below 100% of the PAD. Thus, Bayers

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to imidacloprid

residues.

2. Infants and children. In the Federal

Register (63 FR 49837, September 18,

1998) (FRL–6027–1). EPA has assessed

the potential for additional sensitivity of

infants and children to residues of

imidacloprid. EPA has considered data

from developmental toxicity studies in

the rat and rabbit and a 2–generation

reproduction study in the rat. These

studies are discussed under section A

(toxicology profile) above. The

developmental toxicity data

demonstrated no increased sensitivity of

rats or rabbits to in utero exposure to

imidacloprid. In addition, the multigeneration reproductive toxicity study

did not identify any increased

sensitivity of rats to in utero or postnatal

exposure. Parental NOAELs were lower

or equivalent to developmental or

offspring NOAELs. The developmental

toxicity studies are designed to evaluate

adverse effects on the developing

organism resulting from maternal

pesticide exposure during gestation.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 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 unless,

EPA determines 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

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard uncertainty

factor (usually 100 for combined

interspecies and intraspecies variability)

and not the additional tenfold MOE/

uncertainty factor when EPA has a

complete data base under existing

guidelines and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the standard

MOE/safety factor.

Although developmental toxicity

studies showed no increased sensitivity

in fetuses as compared to maternal

animals following in utero exposures in

rats and rabbits, no increased sensitivity

in pups as compared to adults was seen

in the 2–generation reproduction

toxicity study in rats, and the toxicology

data base is complete as to core

requirements, the EPA has determined

that the additional safety factor for the

protection of infants and children will

be retained but reduced to 3X based on

the following weight-of-the-evidence

considerations relating to potential

sensitivity and completeness of the data:

i. There is concern for structure

activity relationship. Imidacloprid, a

chloronicotinyl compound, is an analog

to nicotine and studies in the published

literature suggests that nicotine, when

administered causes developmental

toxicity, including functional deficits, in

animals and/or humans that are exposed

in utero.

ii. There is evidence that imidacloprid

administration causes neurotoxicity

following a single oral dose in the acute

study and alterations in brain weight in

rats in the 2–year carcinogenicity study.

iii. The concern for structure activity

relationship along with the evidence of

neurotoxicity dictates the need of a

developmental neurotoxicity study for

assessment of potential alterations on

functional development.

Because a developmental

neurotoxicity study potentially relates

to both acute and chronic effects in both

the mother and the fetus, EPA has

applied the additional UF for FQPA for

all population subgroups, and in both

acute and chronic risk assessments.

Based on the exposure assessments

described above and on the

41460 Federal Register / Vol. 65, No. 129 / Wednesday, July 5, 2000 / Notices

completeness and reliability of the

toxicity data, it can be concluded that

the dietary exposure estimates from all

label and pending uses of imidacloprid

are 13.44% of the aPAD at the 99.9th

percentile and 2.7% of the cPAD for the

most highly exposed population

subgroup, children (1–6 yrs). Thus,

Bayer concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

imidacloprid residues.

F. International Tolerances

No CODEX maximum residue levels

have been established for residues of

imidacloprid on any crops at this time.

[FR Doc. 00–16765 Filed 7–3–00; 8:45 am]

BILLING CODE 6560–50–F

FARM CREDIT ADMINISTRATION

Privacy Act System Notices

AGENCY: Farm Credit Administration.

ACTION: Notice of amendment of a

system of records maintained on

individuals; request for comments.

SUMMARY: Under the Privacy Act of

1974, as amended (5 U.S.C. 552a), the

Farm Credit Administration (FCA) is

amending Privacy Act systems of

records FCA–5, Assignments and

Correspondence Tracking System and

renaming it FCA–5, Assignments and

Communication Tracking System. The

amended system of records will help us

collect, maintain, use, and disclose

information about individuals.

We filed an Altered Systems Report

with Congress and the Office of

Management and Budget (OMB) on June

29, 2000.

DATES: You should forward written

comments by August 4, 2000. We will

adopt this notice without further

publication on August 28, 2000, unless

we change it to incorporate public

comments and publish another notice.

ADDRESSES: You may mail written

comments (in triplicate) to Debra

Buccolo, Privacy Act Officer, Farm

Credit Administration, 1501 Farm

Credit Drive, McLean, Virginia 22102–

5090. You may send comments by Email to BuccoloD@fca.gov. Copies of all

comments we receive will be available

for review by interested parties at FCA

headquarters.

FOR FURTHER INFORMATION CONTACT:

Debra Buccolo, Privacy Act Officer,

Farm Credit Administration, 1501

Farm Credit Drive, McLean, Virginia

22102–5090, (703) 883–4022, TDD

(703) 883–4444

or

Jane M. Virga, Senior Attorney, Office of

General Counsel, Farm Credit

Administration, 1501 Farm Credit

Drive, McLean, Virginia, 22102–5090,

(703) 883–4071, TDD (703) 883–4444.

SUPPLEMENTARY INFORMATION: We are

amending FCA–5, Assignments and

Correspondence Tracking System and

renaming it FCA–5, Assignments and

Communication Tracking System. The

amendments will allow FCA to track

written and oral communications

between FCA staff and external parties.

As required by 5 U.S.C. 552a(r) of the

Privacy Act, we have notified OMB, the

Committee on Government Reform of

the House of Representatives, and the

Committee on Governmental Affairs of

the Senate of the amended system of

records. The notice is published in its

entirety below.

FCA–5

SYSTEM NAME:

Assignments and Communication

Tracking System—FCA.

SYSTEM CLASSIFICATION:

None.

SYSTEM LOCATION:

Farm Credit Administration, 1501

Farm Credit Drive, McLean, VA 22102–

5090.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Current or former FCA employees,

and external parties.

CATEGORIES OF RECORDS IN THE SYSTEM:

This system contains incoming letters,

outgoing correspondence, memoranda,

documents pertaining to FCA’s

operations, and communication logs.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

12 U.S.C. 2243, 2252.

PURPOSE(S):

We use information in this system of

records for reference, to track employee

assignments, and to track oral and

written communications between FCA

staff and external parties. This

information aids Agency management in

its deliberations.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

See the ‘‘General Statement of Routine

Uses.’’

DISCLOSURE TO CONSUMER REPORTING

AGENCIES:

None.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

Storage:

We maintain incoming letters or

inquiries and their responses in file

folders, on computer disks, and on

computers. We store communication

logs on a computer.

RETRIEVABILITY:

We file incoming letters or inquiries

and their responses by Farm Credit

District or alphabetically by requester’s

name. The automated communication

log can sort and retrieve entries by Farm

Credit District, subject, and name of

FCA staff and external party.

SAFEGUARDS:

We maintain file folders in a cabinet

in an area that is secured after business

hours. Only authorized personnel have

access to the computers, computer

disks, and the automated

communication log.

RETENTION AND DISPOSAL:

We destroy data in the automated

system as well as the file folders after 6

years.

SYSTEM MANAGER(S) AND ADDRESS:

Chief Information Officer, Farm Credit

Administration, 1501 Farm Credit Drive,

McLean, VA 22102–5090.

NOTIFICATION PROCEDURE:

Direct all inquiries about this system

of records to: Privacy Act Officer, Farm

Credit Administration, 1501 Farm

Credit Drive, McLean, VA 22102–5090.

RECORD ACCESS PROCEDURES:

To obtain a record, contact: Privacy

Act Officer, Farm Credit

Administration, 1501 Farm Credit Drive,

McLean, VA 22102–5090, as provided

in 12 CFR Part 603.

CONTESTING RECORD PROCEDURES:

Direct requests for amendments of a

record to: Privacy Act Officer, Farm

Credit Administration, 1501 Farm

Credit Drive, McLean, VA 22102–5090,

as provided in 12 CFR Part 603.

RECORD SOURCE CATEGORIES:

Persons making general inquiries or

requests for information, persons

communicating with the Agency, FCA

staff, Farm Credit System institutions,

and other external parties.

EXEMPTIONS CLAIMED FOR THE SYSTEM:

None.

Dated: June 29, 2000.

Jeanette Brinkley,

Acting Secretary, Farm Credit Administration

Board.

[FR Doc. 00–16908 Filed 7–3–00; 8:45 am]

BILLING CODE 6705–01–P