64828 Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices

aggregate exposure is not expected to

exceed 100% of the RfD.

For PCA, Uniroyal has also

determined that the total possible nonoccupational aggregate exposure would

occur from the dietary route. Dietary

exposure to the U.S. population (total)

from PCA was estimated as less than

0.000001 mg/kg/day. The risk from

diflubenzuron-derived PCA can be

estimated using a linear extrapolation of

the dose-response from the rat chronic

study conducted by the National

Toxicology Program in which rats were

dosed via gavage with p-chloroaniline

(hydrochloride) for 24 months. EPA has

determined the q1* as 0.0638 based on

the combined sarcoma incidence in the

spleen of male rats.

In view of the results of recent CPU

rat mechanistic and metabolism studies,

and the DFB rat metabolism study, the

dietary risk assessment included here

considers only actual residues of PCA

found in food and animal by-products.

This is consistent with a parent

compound, such as diflubenzuron,

which is negative (category E) for

carcinogenicity.

Using the q1* of 0.0638, the risk to the

U.S. population (total) from dietary

exposure to diflubenzuron-derived PCA

is 3.09 x 10-8.

2. Infants and children. The same

assumptions as for the U.S. population

were used for the dietary exposure risk

determination in infants and children.

The dietary exposure of diflubenzuron

was calculated as 0.000110 and

0.000304 mg/kg/day, respectively for

nursing and non-nursing infants. These

values are 0.6% and 1.5%, respectively

of the RfD for diflubenzuron. The

dietary exposure from diflubenzuron in

children 1 to 6 years and 7 to 12 years

old was determined as 0.000046 mg/kg/

day and 0.000033 mg/kg/day,

respectively. These values are 0.2% of

the RfD.

As previously discussed, the NOAELs

for maternal and developmental toxicity

in rats and rabbits were greater than

1,000 mg/kg/day, and the NOAEL for

reproductive toxicity was greater than

5,000 mg/kg/day. Therefore, based on

the completeness and reliability of the

toxicity data and the conservative

exposure assessment, Uniroyal

concludes that there is reasonable

certainty that no harm will result in

infants and children from aggregate

exposure to residues of diflubenzuron

and its conversion products containing

the p-chloroaniline moiety.

F. International Tolerances

There is a Codex maximum residue

limit (MRL) for pears at 1.0 mg/kg, a

Mexican MRL at 1.0 mg/kg, and no

limits set for Canada for pears. A Codex

MRL has also been established for

plums (including prunes) at 1.0 mg/kg.

There are no Codex maximum residue

limits established for other stonefruit,

tree nuts or peppers.

[FR Doc. 01–30914 Filed 12–13–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–1057; FRL–6812–4]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical in or on Food

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–1057, must be

received on or before January 14, 2002.

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–1057 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Dani Daniel, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–5409; e-mail address:

daniel.dani@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:

Categories NAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

Categories NAICS

codes

Examples of potentially affected entities

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–

1057. 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.

Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices 64829

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–1057 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.

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–1057. 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 a pesticide petition

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 Cosmetic Act (FFDCA), 21

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

this petition contains 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

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 29, 2001.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

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

Federal Food, Drug, and Cosmetic Act

(FFDCA). The summary of the petition

was prepared by the petitioner and

represents the view of the petitioners.

EPA is publishing the petition summary

verbatim without editing it in any way.

The petition summary announces 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.

Sygenta Crop Protection Inc.

PP 1E6349

EPA has received a pesticide petition

(1E6349) from Sygenta Crop Protection

Inc., P.O. Box 18300, Greensboro, NC

27419–8300 proposing, pursuant to

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

346a(d), to amend 40 CFR part 180 by

establishing a tolerance for residues of

thiamethoxam and its metabolite, (N-(2-

chloro-thiazol-5-ylmethyl)-N’methyl-Nnitro-guanidine, in or on the raw

agricultural commodity imported green

and roasted coffee beans and instant

coffee at 0.05 parts per million (ppm).

EPA has determined that the petition

contains 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

petition. Additional data may be needed

before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The primary

metabolic pathways of thiamethoxam in

plants (corn, rice, pears, and cucumbers)

were similar to those described for

animals, with certain extensions of the

pathway in plants. Parent compound,

thiamethoxam, and its metabolite, (N-(2-

chloro-thiazol-5-ylmethyl)-N’methyl-Nnitro-guanidine, were the major residues

in all crops. The metabolism of

thiamethoxam in plants and animals is

understood for the purposes of the

proposed tolerances. Parent

thiamethoxam and the metabolite, are

the residues of concern for tolerance

setting purposes.

2. Analytical method. Syngenta Crop

Protection Inc. has submitted practical

analytical methodology for detecting

and measuring levels of thiamethoxam

in or on raw agricultural commodities.

The method is based on crop specific

cleanup procedures and determination

by liquid chromatography with either

ultraviolet (UV) or mass spectrometry

(MS) detection. The limit of detection

(LOD) for each analyte of this method is

1.25 nanogram (ng) injected for samples

analyzed by UV and 0.25 ng injected for

samples analyzed by MS, and the limit

of quantitation (LOQ) is 0.005 ppm for

64830 Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices

milk and juices and 0.01 ppm for all

other substrates.

3. Magnitude of residues. A residue

program was performed for

thiamethoxam on coffee as prescribed in

draft EPA Guidance on Import

Tolerances. A total of nine trials were

conducted in the major coffee producing

countries of Brazil (four), Columbia

(three) and Mexico (two). The

applications in these trials consisted of

soil applications (trench, furrow or

broadcast) at the proposed maximum

rate of 300 grams active ingredient per

hectare. The first applications were

made just after petal fall and a second

application at the beginning of fruit

development. There were no detectable

residues <0.02 ppm of thiamethoxam or

the metabolite CGA–322701 in coffee

berries or dried green coffee beans.

In addition, there was a single 5X

exaggerated rate processing trial

conducted. There were detectable

residues of thiamethoxam and its

metabolite (<0.022 ppm and 0.012 ppm,

respectively) in the dry beans for

processing. There were no detectable

residues (<0.005 ppm) of thiamethoxam

or it metabolite, in roasted beans,

ground roasted beans, brewed extracts,

spent grounds or instant coffee.

B. Toxicological Profile

1. Acute toxicity. The acute oral LD50

for thiamethoxam in the rat is 1,563 mg/

kg body weight. The acute dermal LD50

of thiamethoxam is >2,000 milligrams/

kilogram (mg/kg) body weight.

Thiamethoxam is non-toxic at

atmospheric concentrations of 3.72 mg/

L. Thiamethoxam is minimally irritating

to the eye, non-irritating to skin, and is

not a dermal sensitizer.

In an acute neurotoxicity screening

study in rats (OPPTS 870.6200a), the no

observed adverse effect level (NOAEL)

was 100 mg/kg/day with a NOAEL of

500 mg/kg/day based on drooped

palpebral closure, decrease in rectal

temperature and locomotor activity and

increase in forelimb grip strength (males

only). At higher dose levels, mortality,

abnormal body tone, ptosis, impaired

respiration, tremors, longer latency to

first step in the open field, crouched

over posture, gait impairment, hypoarousal, decreased number of rears,

uncoordinated landing during the

righting reflex test, slight lacrimation

(females only), and higher mean average

input stimulus value in the auditory

startle response test (males only).

2. Genotoxicity. In gene mutation

studies with S. typhimurium and E. coli

(OPPTS 870.5100 and 870.5265), there

was no evidence of gene mutation when

tested up to 5,000 μg/plate and there

was no evidence of cytotoxicity. In a

gene mutation study with chinese

hamster V79 cells at HGPRT focus

(OPPTS 870.5300) there was no

evidence of gene mutation when tested

up to the solubility limit.

In a CHO cell cytogenetics study

(OPPTS 870.5375) there was no

evidence of chromosomal aberrations

when tested up to cytotoxic or solubility

limit concentrations.

An in vivo mouse bone marrow

micronucleus study (OPPTS 870.5395)

was negative when tested up to levels of

toxicity in whole animals; however,

there was no evidence of target cell

cytotoxicity.

An UDS assay (OPPTS 870.5550) was

negative when tested up to precipitating

concentrations.

3. Reproductive and developmental

toxicity. A prenatal developmental

study in the rat (OPPTS 870.3700)

resulted in maternal and developmental

NOAELs of 30 mg/kg/day and 200 mg/

kg/day, respectively. The maternal

lowest observed adverse effect level

(LOAEL) is 200 mg/kg/day based on

decreased body weight, body weight

gain and food consumption. The

developmental LOAEL was 750 mg/kg/

day based on decreased fetal body

weight and an increased incidence of

skeletal anomalies.

A prenatal developmental study in

the rabbit (OPPTS 870.3700) resulted in

maternal and developmental NOAELs of

50 mg/kg/day. The maternal and

developmental LOAEL is 150 mg/kg/

day. The maternal LOAEL is based on

maternal deaths, hemorrhagic discharge,

decreased body weight, and food intake

during the dosing period. The

developmental LOAEL is based on

decreased fetal body weights, increased

incidence of post-implantation loss and

a slight increase in the incidence of a

few skeletal anomolies/variations.

In a reproduction and fertility effects

study in rats (OPPTS 870.3800) the

parental/systemic NOAEL is 1.84

(males), 202.06 (females) mg/kg/day; the

reproductive NOAEL is 0.61 (males),

202.06 (females) mg/kg/day, and the

offspring NOAEL is 61.25 (males), 79.20

(females) mg/kg/day. The parental/

systemic LOAEL is 61.25 (males), not

determined (females) mg/kg/day based

on increased incidence of hyaline

change in renal tubules in F0 and F1

males. The reproductive LOAEL is 1.84

(males), not determined females mg/kg/

day based on increased incidence and

severity of tubular atrophy observed in

testes of the F1 generation males. The

offspring LOAEL is 158.32 (males),

202.06 (females) mg/kg/day based on

reduced body weight gain during the

lactation period in all litters.

4. Subchronic toxicity. A 90–day oral

toxicity study in rats (OPPTS 870.3100)

resulted in a NOAEL of 1.74 (males) and

92.5 (females) mg/kg/day. The LOAEL is

17.64 (male), 182.1 (female) mg/kg/day

based on increased incidence of hyaline

change of renal tubules epithelium

(males), fatty change in adrenal gland of

females, liver changes in females, all at

the LOAEL.

A 90–day oral toxicity study in mice

(OPPTS 870.3100) resulted in an

NOAEL of 1.41 (males) and 19.2

(females) mg/kg/day. The LOAEL was

14.3 (male) and 231 (female) mg/kg/day

based on an increased incidence of

hepatocellular hypertrophy. At higher

dose levels: decrease in body weight

and body weight gain, necrosis of

individual hepatocytes, pigmentation of

Kupffer cells, and a lymphocytic

infiltration of the liver in both sexes;

slight hematologic effects and decreased

absolute and relative kidney weights in

males; and ovarian atrophy, decreased

ovary and spleen weights and increased

liver weights in females.

In a 90–day oral toxicity study in dogs

(OPPTS 870.3150), the NOAEL is 8.23

(males) and 9.27 (females) mg/kg/day.

The LOAEL is 32.0 (male), 33.9 (female)

mg/kg/day based on slightly prolonged

prothrombin times and decreased

plasma albumin and A/G ration (both

sexes); decreased calcium levels and

ovary weights and delayed maturation

in the ovaries (female); decreased

cholesterol and phospholipid levels,

testes weights, spermatogenesis, and

spermatic giant cells in testes (male).

In a 28–day dermal study in rats

(OPPTS 870.3200) the NOAEL was 250

(male) and 60 (female) mg/kg/day. The

LOAEL was 1,000 (male),and 250

(female) mg/kg/day based on an

increased plasma glucose, triglyceride

levels, and alkaline phosphatase activity

and an inflammatory cell infiltration in

the liver and necrosis if single

hepatocytes in females and a hyaline

change in renal tubules and a very slight

reduction in body weight in males. At

higher dose levels in females, chronic

tubular lesions in the kidneys and an

inflammatory cell infiltration in the

adrenal cortex were observed.

In a subchronic neurotoxicity

screening study in rats (OPPTS

870.6200) the NOAEL was 95.4 (male)

and 216.4 (female) mg/kg/day, both at

the highest dose tested. The LOAEL was

not determined. No treatment-related

observations at any dose level. LOAEL

was not achieved. May not have been

tested at sufficiently high dose levels;

however, a new study is not required

because the weight of the evidence from

other toxicity studies indicates no

evidence of concern.

Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices 64831

5. Chronic toxicity. In a chronic

toxicity study in dogs (OPPTS 870.4100)

the NOAEL was 4.05 (male), and 4.49

(female) mg/kg/day. The LOAEL was

21.0 (male) and 24.6 (female) mg/kg/day

based on an increase of creatinine in

both sexes, transient decrease in food

consumption in females, and an

occasional increase in urea levels,

decrease in ALT, and atrophy of

seminiferous tubules in males.

In a mouse carcinogenicity study

(OPPTS 870.4200) the NOAEL was 2.63

(male) and 3.68 (female) mg/kg/day. The

LOAEL was 63.8 (male) and 87.6

(female) mg/kg/day based on hepatocyte

hypertrophy, single cell necrosis,

inflammatory cell infiltration, pigment

deposition, foci of cellular alteration,

hyperplasia of Kupffer cells and

increased mitotic activity, also an

increase in the incidence of

hepatocellular adenoma (both sexes). At

higher doses, there was an increase in

the incidence of hepatocelluar

adenocarcinoma (both sexes) and the

number of animals with multiple

tumors, evidence of carcinogenicity. In

a combined chronic caricinogenicity

study in rats (OPPTS 870.4300), the

NOAEL was 21.0 (male) and 50.3

(female) mg/kg/day. The LOAEL was

63.0 (male) and 255 (female) mg/kg/day

based on an increased incidence of

lymphocytic infiltration of the renal

pelvis and chronic nephropathy in

males and decreased body weight gain,

slight increase in the severity of

hemosiderosis of the spleen, foci of

cellular alteration in liver and chronic

tubular lesions in kidney in females. No

evidence of carcinogenicity.

In a hepatic cell proliferation study in

mice, the NOAEL was 16 (male) and 20

(female) mg/kg/day. The LOAEL was 72

(male) and 87 (female) mg/kg/day based

on proliferative activity of hepatocytes.

At higher dose levels, increases in

absolute and relative liver weights,

speckled liver, heptocellular

glycogenesis/fatty change, heptocellular

necrosis, apoptosis and pigmentation

were observed.

In a 28–day feeding study to assess

replicative DNA syntehsis in the male

rat, the NOAEL was 711 mg/kg/day. The

LOAEL was not established.

Immunohistochemical staining of liver

sections from control, and high dose

animals for proliferating cell nuclear

antigen gave no indication for a

treatment-related increase in the

fraction of DNA syntesizing hepatocytes

in S-phase. Thiamethoxam did not

stimulate hepatocyte cell proliferation

in male rats.

In a special study to assess liver

biochemistry in the mouse, the NOAEL

was 17 (male) and 92 (female) mg/kg/

day. The LOAEL was 74 (male) and 92

(female) mg/kg/day based on marginal

to slight increases in absolute and

relative liver weights, a slight increase

in the microsomal protein content of the

livers, moderate increases in the

cytochrome P450 content, slight to

moderate increases in the activity of

several microsomal enzymes, slight to

moderate induction of cytosolic

glutathionw S-transfersase activity.

Treatment did not affect peroxisomal

fatty acid B-oxidation.

6. Animal metabolism. The

metabolism of thiamethoxam in rats and

livestock animals is adequately

understood. The residues of concern

have been determined to be parent

thiamethoxam and its metabolite (N-(2-

chloro-thiazol-5-ylmethyl)-N’methyl-Nnitro-guanidine).

7. Metabolite toxicology. For risk

assessment purposes, residues of the

metabolite corrected for molecular

weight are considered to be

toxicologically equivalent to parent

thiamethoxam.

C. Aggregate Exposure

1. Dietary exposure. Permanent

tolerances have been established (40

CFR 180.565) for the combined residues

of the insecticide thiamethoxam, 3-[(2-

chloro-5-thiazolyl)methyl]tetrahydro-5-

methyl-N-nitro-4H-1,3,5-oxadiazin-4-

imine and it metabolite (N-(2-chlorothiazol-5-ylmethyl)-N’-methyl-N-nitroguanidine), in or on a variety of raw

agricultutal commodities at levels

ranging from 0.02 ppm to 1.5 ppm

including barley, canola, cotton,

sorghum, wheat, cucurbit vegetables,

fruiting vegetables, pome fruits and

livestock commodities. Pending

tolerances include coffee, grapes,

raisins, grape juice, pecans, peanut

nutmeats, peanut hay, corn grain, sweet

corn (kernal with husk removed), pop

corn, corn forage and stover, head and

stem brassica, leafy brassica greens and

leafy vegetables.

i. Food—a. Acute risk. The acute

dietary risk from food use tolerances

previously set as published in the

Federal Register of December 21, 2000

(65 FR 80343) (FRL–6758–1) and May

23, 2001 (66 FR 28386) (FRL–6784–7)

indicate that acute dietary exposure

from food will occupy 3% of the acute

population adjusted dose (aPAD) for the

U.S. population, 2% of the aPAD for

females 13–50 years old, 8% of the

aPAD for infants less than 1 year old

and 7% of the aPAD for children 6–11

years old. Therefore, it is expected that

the proposed tolerances for coffee will

have minimal impact on acute dietary

risk, and that the aggregate exposure

will not exceed 100% of the aPAD.

b. Chronic risk. The chronic dietary

risk from food use tolerances previously

set as published in the Federal Register

of December 21, 2000 (65 FR 80343),

and May 23, 2001 (66 FR 28386)

indicate that chronic dietary exposure

from food will utilize 5% of the chronic

population adjusted dose (cPAD) for the

U.S. population, 13% of the cPAD for

children 1–6 years old. Therefore, it is

expected that the proposed tolerances

for coffee will have minimal impact on

chronic dietary risk and the aggregate

exposure will not exceed 100% of the

cPAD.

c. Cancer risk. Since there were no

detectable residues of thiamethoxam or

its metabolite in samples from the

residue trials conducted in Brazil,

Columbia and Mexico, it can be

concluded that there is no increased

cancer risk from the proposed use on

imported coffee. Syngenta DEEM

analysis indicates that the proposed

tolerance on coffee contributes only 3.00

x 10E–9 lifetime dietary cancer risk.

ii. Drinking water. Since the proposed

tolerance is for imported coffee, there is

no potential exposure from drinking

water.

2. Non-dietary exposure.

Thiamethoxam is not currently

registered for use on any sites that

would result in residential exposure.

D. Cumulative Effects

The potential for cumulative effects of

thiamethoxam, and other substances

that have a common mechanism of

toxicity has also been considered.

Thiamethoxam belongs to a new

pesticide chemical class known as the

neonicotinoids. There is no reliable

information to indicate that toxic effects

produced by thiamethoxam would be

cumulative with those of any other

chemical including another pesticide.

Therefore, Syngenta believes it is

appropriate to consider only the

potential risks of thiamethoxam in an

aggregate risk assessment.

E. Safety Determination

1. U.S. population. Syngenta

concludes, as described above, that

there is reasonable certainty that no

harm to the U.S. population will result

from aggregate acute or chronic dietary

exposure to thiamethoxam residues

including the proposed tolerances for

imported coffee.

2. Infants and children. Syngenta

concludes, as described above, that

there is reasonable certainty that no

harm to infants and children will result

from aggregate acute or chronic

exposure to thiamethoxam residues,

including the proposed tolerances for

imported coffee.

64832 Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices

F. International Tolerances

There are no Codex maximum residue

levels established for residues of

thiamethoxam on coffee.

[FR Doc. 01–30915 Filed 12–13–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–7118–5]

Proposed Agreement and Covenant

Not To Sue Pursuant to the

Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980, as Amended by the

Superfund Amendments and

Reauthorization Act of 1986; In Re:

Western Sand and Gravel Superfund

Site, Located on the Boundary of

Burrillville and North Smithfield, RI

AGENCY: Environmental Protection

Agency.

ACTION: Notice of proposed agreement;

request for public comment.

SUMMARY: In accordance with the

Comprehensive Environmental

Response Compensation, and Liability

Act, as amended (‘‘CERCLA’’), 42 U.S.C.

9601, et. seq., notice is hereby given of

a proposed Agreement and Covenant

Not to Sue between the United States,

on behalf of the U.S. Environmental

Protection Agency (‘‘EPA’’) and

Supreme Mid-Atlantic Corporation, Inc.

(‘‘Purchaser’’). The Purchaser plans to

acquire approximately 25 acres of

property that is currently owned by

Western Sand and Gravel, Inc., a portion

of which was used for the disposal of

liquid wastes, including hazardous

substances. The Purchaser intends to

use the property for the purpose of

constructing and operating a truck body

manufacturing plant. Under the

Proposed Agreement, the United States

grants a Covenant Not to Sue to the

Purchaser with respect to existing

contamination at the Site in exchange

for the Purchaser’s agreement to pay

EPA $25,000. In addition, the Purchaser

agrees to provide an irrevocable right of

access to representatives of EPA and to

comply with Institutional Controls.

For thirty (30) days following the date

of publication of this notice, the Agency

will receive written comments relating

to the settlement. The Agency will

consider all comments received and

may modify or withdraw its consent to

the settlement if comments received

disclose facts or considerations which

indicate that the settlement is

inappropriate, improper, or inadequate.

The Agency’s response to any comments

received will be available for public

inspection at One Congress Street,

Boston, MA 02214.

DATES: Comments must be submitted on

or before January 14, 2002.

ADDRESSES: Comments should be

addressed to the Regional Hearing Clerk,

U.S. Environmental Protection Agency,

Region I, One Congress Street, Suite

1100, Mailcode RAA, Boston,

Massachusetts 02203, and should refer

to: In re: Western Sand and Gravel

Superfund Site, U.S. EPA Docket No.

CERCLA–01–2001–0067.

FOR FURTHER INFORMATION CONTACT: A

copy of the proposed Agreement and

Covenant Not to Sue can be obtained

from Ann Gardner, Paralegal, U.S.

Environmental Protection Agency,

Region I, One Congress Street, Mailcode

SES, Boston, Massachusetts 02214, (617)

918–1895.

Dated: October 17, 2001.

Robert V. Varney,

Regional Administrator, Region I.

[FR Doc. 01–30912 Filed 12–13–01; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission

for Extension Under Delegated

Authority, Comments Requested

December 5, 2001.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection(s), as

required by 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. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

Whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before February 12,

2002. If you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Les

Smith, Federal Communications

Commissions, Room 1 A–804, 445

Twelfth Street, SW., Washington, DC

20554 or via the Internet to

lesmith@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collections contact Les

Smith at (202) 418–0217 or via the

Internet at lesmith@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control Number: 3060–0567.

Title: Section 76.962 Implementation

and certification of compliance.

Form Number: N/A.

Type of Review: Delegated.

Respondents: Business or other forprofit entities, State, local or Tribal

Government.

Number of Respondents: 500.

Estimated Time Per Response: .5

hours (30 minutes).

Total Annual Burden to Respondents:

250.

Total Annual Costs: $0.00.

Needs and Uses: Section 76.962

requires any cable operator that has

been deemed subject to remedial

requirements to certify to the

Commission its compliance with the

Commission order requiring prospective

rate reductions, refunds or other relief to

subscribers. The certification must be

filed with the Commission within 90

days from the date the Commission

released the order mandating a remedy.

These certifications are used by the

Commission to monitor a cable

operator’s compliance with Commission

rate orders.

OMB Control Number: 3060–0668.

Title: Section 76.936 Written

Decisions.

Form Number: N/A.

Type of Review: Delegated.

Respondents: State or Local, or Tribal

government.

Number of Respondents: 1,200.

Estimated Time Per Response: 1 hour.

Total Annual Burden to Respondents:

1,200 hours.

Total Annual Costs: $0.

Needs and Uses: Section 76.936 states

that a franchising authority must issue

a written decision in a rate-making

proceeding whenever it disapproves an