Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices 76249

samples before 1988. Of these

detections, 85% were at concentrations

0.13 μg/L or lower and the maximum

was 4.6 μg/L. The maximum

concentration reported was 4.6 μg/L.

Comparing these values to the DWLOC

shows an even greater degree of

protection for all of the population

subgroups.

HCB contamination of ground water

resources is relatively unlikely due to its

high binding potential. Based on

monitoring data and fate properties it is

unlikely that long term HCB

concentrations in surface water would

exceed 10 ppt. Therefore, exposure from

water is below EPA’s drinking water

level of concern of 34 ppt for chronic

dietary exposure to HCB for the U.S.

population.

In summary, these data on potential

water exposure indicate insignificant

additional dietary intake and risk for

picloram.

2. Non–dietary exposure. This is a

restricted use chemical that has no

residential uses at this time; therefore,

there are no human risks associated

with residential uses. Entry into a

treated area soon after the application of

picloram is expected to be rare given the

cultural practices typically associated

with the use sites (rights–of–way,

forestry, pastures, range lands, and

small grains) defined by the picloram

labels at this time. Furthermore, if entry

should occur, the potential exposures

are expected to be minimal due to the

characteristics of those use–sites.

D. Cumulative Effects

The potential for cumulative effects of

picloram and other substances that have

a common mechanism of toxicity was

considered. The mammalian toxicity of

picloram is well defined. However, the

biochemical mechanism of toxicity of

this compound is not well known. No

reliable information exists to indicate

that toxic effects produced by picloram

would be cumulative with those of any

other chemical compounds. Therefore,

consideration of a common mechanism

of toxicity with other compounds is not

appropriate. Thus, only the potential

risks of picloram are considered in the

aggregate exposure assessment.

E. Safety Determination

1. U.S. population. In the meeting of

September 30, 1993, the OPP RfD Peer

Review Committee recommended that

the RfD for this chemical be based on a

NOAEL of 20 mg/kg/day for a dose–

related increase in size and altered

tinctorial properties of centrilobular

hepatocytes in males and females at 60

and 200 mg/kg/day in a chronic toxicity

study in rats. An uncertainty factor (UF)

of 100 was used to account for the inter–

species extrapolation and intra–species

variability. On this basis, the RfD was

calculated to be 0.20 mg/kg/day. The

theoretical maximum residue

contribution (TMRC) from existing

tolerances is 0.001845 mg/kg/day.

Existing tolerances utilize < 1% of the

RfD. It should be noted that no

regulatory value has been established

for this chemical by the World Health

Organization (WHO) up to this date. The

committee classified picloram as a

‘‘Group E’’ chemical, no evidence of

carcinogenicity for humans.

Using the conservative exposure

assumptions described above and based

on the completeness and reliability of

the toxicity data, it is concluded that

aggregate exposure to picloram will

utilize approximately 1% of the RfD for

the U.S. population. Generally,

exposures below 100% of the RfD are of

no concern because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risk to

human health. Thus, there is a

reasonable certainty that no harm will

result from aggregate exposure to

picloram residues.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

picloram, data from developmental

toxicity studies in the rat and rabbit and

a 2–generation reproduction study in

the rat were considered. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism during

prenatal development resulting from

pesticide exposure to one or both

parents. Reproduction studies provide

(i) information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and (ii) data on systemic

toxicity.

Developmental toxicity was studied

using rats and rabbits. The

developmental study in rats resulted in

a developmental NOAEL of > 298 mg/

kg/day and a maternal toxicity NOAEL

of 280 mg/kg/day. A study in rabbits

resulted in a maternal NOAEL of 34 mg/

kg/day and a developmental NOAEL of

344 mg/kg/day. Based on all of the data

for picloram, there is no evidence of

developmental toxicity at dose levels

that do not result in maternal toxicity.

In a 2–generation reproduction study

in rats, the NOAEL for parental systemic

toxicity is 200 mg/kg/day. There was no

effect on reproductive parameters at

1,000 mg/kg/day, nor was there an

adverse effect on the morphology,

growth or viability of the offspring.

Thus, the reproductive NOAEL is 1,000

mg/kg/day.

FFDCA section 408 provides that EPA

may apply an additional safety factor for

infants and children in the case of

threshold effects to account for pre–

natal and post–natal toxicity and the

completeness of the data base. Based on

the current toxicological data

requirements, the data base relative to

pre–natal and post–natal effects for

children is complete. Therefore, it is

concluded that an additional UF is not

warranted and that the RfD at 0.2 mg/

kg/day is appropriate for assessing

aggregate risk to infants and children.

Using the conservative exposure

assumption previously described, it is

concluded that the percent of the RfD

that will be utilized by aggregate

exposure to residues of picloram will be

less than 4% of the RfD for all

populations and subgroups. Since this

estimate represents the ‘‘worst case’’

exposure for a given population (Non–

nursing infants, < 1 year old), exposures

will be less for all other sub–

populations, e.g., children, 1–6 years.

Therefore, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment, it

is concluded that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to picloram residues.

F. International Tolerances

There are no Codex maximum residue

levels established for residues of

picloram.

[FR Doc. 00–31057 Filed 12–5–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–984; FRL–6755–4]

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–984, must be

received on or before January 5, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

76250 Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices

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–984 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Support Branch, 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:

Categories NAICS

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–

984. 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–984 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–984. 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

Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices 76251

under section 408 of the Federal Food,

Drug, and Comestic 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 22, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petitions

The petitioner summary of the

pesticide petition is printed below as

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

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.

Interregional Research Project Number 4

9E6063 and 7E4865

EPA has received pesticide petitions

(9E6063 and 7E4865) from Interregional

Research Project Number 4, Technology

Centre of New Jersey, 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

clomazone in or on the raw agricultural

commodities (RAC) tuberous and corm

vegetable (except potato) crop subgroup

and cucurbit vegetable crop group at

0.05 parts per million (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 supports granting of the

petitions. Additional data may be

needed before EPA rules on the

petitions.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of clomazone in plants is adequately

understood.

2. Analytical method. There is a

practical analytical method for detecting

and measuring levels of clomazone in or

on tuberous and corm vegetable (except

potato) crop subgroup and cucurbit

vegetable crop group, with a limit of

detection that allows monitoring of food

for residues at or above the levels

proposed in this tolerance. Samples are

analyzed using an analytical method

consisting of an acid reflux, a C18 solid

phase extraction (SPE), a Florisil SPE

clean–up followed by gas

chromatography (GC)-mass selective

detection (MSD). The method limit of

quantitation (LOQ) is 0.05 ppm. The

method limit of detection (LOD) is 0.01

ppm.

3. Magnitude of residues. The

representative commodity for the

tuberous and corm vegetable (except

potato) subgroup, is sweet potato. IR-4

has previously submitted residue data

for clomazone use on sweet potato

(MRID # 40572701). Four field trials,

with two different applications timings

were conducted. No clomazone residues

were found above the LOQ (0.05 ppm)

in any of the treated samples. FMC

Corporation submitted additional data

for clomazone on sweet potatoes (MRID

# 44441405).

B. Toxicological Profile

1. Acute toxicity. The following

mammalian toxicity studies have been

conducted with clomazone technical

(unless noted otherwise) to support

registrations and/or tolerances of

clomazone:

i. A rat acute oral study with an lethal

dose (LD)50 of 2,077 mg/kg (male) and

1,369 mg/kg (female).

ii. A rabbit acute dermal lethal

concentration (LC)50 of > 2,000 mg/kg.

iii. A rat acute inhalation LC50 of 6.25

mg/L/4 hrs. (male), 4.23 mg/L/hrs.

(female) and 4.85 mg/L/4 hrs.

(combined sexes).

iv. A primary eye irritation study in

the rabbit which showed practically no

irritation.

v. A primary dermal irritation study

in the rabbit which showed minimal

irritation.

vi. A primary dermal sensitization

study in the guinea pig which showed

no sensitization.

vii. Acute delayed neurotoxicity –

clomazone, and its known metabolites,

are not structurally related to known

neurotoxic substances.

2. Genotoxicity. The following

genotoxicity tests were all negative:

Ames Assay; CHO/HGPRT Mutation

Assay; and Structural Chromosomal

Aberration. The Unscheduled DNA

Synthesis genotoxicity was negative

with activation; weakly positive without

activation.

3. Reproductive and developmental

toxicity. A 2–generation reproduction

study was conducted in the rat with a

parental systemic no observed adverse

effect level (NOAEL) of 1,000 ppm (50

mg/kg/day) based on decreased body

weight and food consumption at 2,000

ppm; and a progeny systemic NOAEL of

1,000 ppm (50 mg/kg/day) based on

decreased pup body weight at 2,000

ppm. The reproductive performance

NOAEL was > 4,000 ppm which was the

highest dose tested (HDT). There was an

unexplained decrease in the fertility

index during mating of the F1b

generation at 4,000 ppm which was not

observed in the F1a litter or repeated in

the F2 generation. Additionally, there

was one F2a pup at 1,000 ppm which

had non–functional hindlimbs and one

F2b pup at 4,000 ppm which had

extended hindlimbs with no flexion at

the ankle. These limb abnormalities

were not considered treatment–related

for the following reasons (i) there was

no dose response observed, (ii) the

findings were not statistically

significant, (iii) the findings were not

repeated at the 1,000 ppm dose level in

the F2b litter or found in the F1a or F1b

litters, and (iv) these findings or related

hindlimb abnormalities were not

observed in developmental studies at

gavage dose levels up to 100 mg/kg/day

in the rat or 240 mg/kg/day in the rabbit.

A developmental toxicity study in rats

given gavage doses of 100, 300 and 600

mg/kg/day and with maternal and fetal

NOAELs of 100 mg/kg/day. The

maternal NOAEL is based on decreased

locomotion, genital staining and runny

eyes and the developmental NOAEL is

based on increased incidence of delayed

ossification at 300 mg/kg/day. This

study was negative for developmental at

all doses tested.

A developmental toxicity study in

rabbits given gavage doses of 30, 240

and 700 mg/kg/day with maternal and

fetal NOAELs of 240 mg/kg/day. The

maternal NOAEL is based on a decrease

in body weight and the developmental

NOAEL is based on an increase in the

number of fetal resorptions at 700 mg/

kg/day. This study was negative for

teratogenicity at all doses tested.

In all cases, the reproductive and

developmental NOAELs were equal to

the parental NOAELs, thus indicating

that clomazone does not pose any

increased risk to infants or children.

4. Subchronic toxicity. In a 90–day

feeding subchronic study in mice the

76252 Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices

NOAEL was 20 ppm (< 2.9 mg/kg/

day)based on liver cytomegaly at 20

ppm.

5. Chronic toxicity. A 12–month

feeding study in the dog with a NOAEL

of 500 ppm (14.0 mg/kg/day for males;

14.9 mg/kg/day for females) based on

increased blood cholesterol and liver

weights at 2,500 ppm.

A 24–month chronic feeding/

carcinogenicity study in the rat with a

NOAEL of 100 ppm (4.3 mg/kg/day for

males; 5.5 mg/kg/day for females) based

on increased liver weights and

increased liver cytomegaly at 500 ppm.

There were no carcinogenic effects

observed under the conditions of the

study.

A 24–month chronic feeding/

carcinogenicity study in the mouse with

a NOAEL of 100 ppm (15 mg/kg/day)

based on an increase in the white blood

cell count. There were no carcinogenic

effects observed under the conditions of

the study.

Using the Guidelines for Carcinogen

Risk Assessment, it is proposed that

clomazone be classified as Group E for

carcinogenicity (no evidence of

carcinogenicity) based on the results of

carcinogenicity studies in rats and mice.

The reference dose (RfD) for

clomazone has been established at 0.043

mg/kg/day. The RfD for clomazone is

based on the 24–Month Feeding/

Carcinogenicity Study in the Rat with a

NOAEL of 4.3 mg/kg/day and an

uncertainty factor of 100.

6. Animal metabolism. The

metabolism of clomazone in animals is

adequately understood. Clomazone

degrades rapidly and extensively in rats,

goats and poultry to a variety of

metabolites which were readily excreted

from the body via excreta.

7. Metabolite toxicology. No

clomazone related metabolite residues

have been identified as being of

toxicological concern. The residue of

significance is parent.

8. Endocrine disruption. No specific

tests have been conducted with

clomazone to determine whether the

herbicide may have an effect in humans

that is similar to an effect produced by

a naturally occurring estrogen or other

endocrine effects. It should be noted,

however, that the chemistry of

clomazone is unrelated to that of any

compound previously identified as

having estrogen or other endocrine

effects. Additionally, a standard battery

of required studies has been completed.

These studies include an evaluation of

the potential effects on reproduction

and development, and an evaluation of

the pathology of the endocrine organs

following repeated or long-term

exposure. No endocrine effects were

noted in any of these studies with

clomazone.

C. Aggregate Exposure

1. Dietary exposure—i. Food For

purposes of assessing the potential

dietary exposure, EPA has estimated

aggregate exposure based on the

Theoretical Maximum Residue

Contribution (TMRC) from the

established tolerances for clomazone.

The TMRC is a ‘‘worst case’’ estimate of

dietary exposure since it is assumed that

100 percent of all crops for which

tolerances are established are treated

and that pesticide residues are present

at the tolerance levels. Dietary exposure

to residues of clomazone in or on food

will be limited to residues on cabbage

(0.1 ppm), cottonseed (0.05 ppm),

cucurbit vegetables (0.05 ppm),

succulent peas (0.05 ppm), peppers

(0.05 ppm), soybeans (0.05 ppm), sweet

potato (0.05 ppm), snap beans (0.05

ppm) rice (0.05 ppm), sugar (from cane)

(0.05 ppm) and residues on tuberous

and corm vegetable (except potato) (0.05

ppm each). As noted above, this

exposure assessment is based on very

conservative assumptions, i.e., 100% of

crops treated will contain clomazone

residues and those residues would be at

the level of the tolerance. It is FMC’s

opinion that these assumptions result in

an overestimate of human exposure.

ii. Drinking water. It is unlikely that

there will be exposure to residues of

clomazone through drinking water

supplies. A field mobility study was

conducted at a loamy sand location.

Clomazone was found only in the top 0-

1 ft. soil samples during the 61 day

study period. No clomazone residue

(< 0.02 ppm) was detected in the deeper

soil levels (1-2, 2-3 and 3-4 ft.).

Detectable residues of clomazone were

found only in the 0-6 horizon. Should

movement into surface water occur,

potential for clomazone residues to be

detected in drinking water supplies at

significant levels is minimal.

Accordingly, there is no reasonable

expectation that there would be an

additional incremental aggregate dietary

contribution of clomazone through

groundwater or surface water.

2. Non–dietary exposure. Clomazone

is only registered for use on food crops.

Since the proposed use on the tuberous

and corm vegetable (except potato) crop

subgoup and cucurbit vegetable crop

group is consistent with existing

registrations, there will be no non–

dietary, non–occupational exposure.

D. Cumulative Effects

Clomazone is an isoxazolidinone

herbicide. No other registered chemical

exists in this class of chemistry.

Therefore, given clomazone’s unique

chemistry low acute toxicity, the

absence of genotoxic, oncogenic,

developmental or reproductive effects,

and low exposure potential (see

Sections A and C), the expression of

cumulative human health effects with

clomazone and other natural or

synthetic pesticides is not anticipated.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above, based on the

completeness and reliability of the

toxicology data, it is concluded that

aggregate exposure due to existing

registered uses, and pending uses, of

clomazone will utilize less than 1% of

the RfD for the U.S. population.

Additionally, an analysis concluded

that aggregate exposure to clomazone

adding use on cucurbit vegetable crop

group and tuberous and corm vegetable

(except potato) crop subgroup at a 0.05

ppm will utilize a negligible (i.e.,

0.011% or less for cucurbits and 0.002%

or less for these root crops) percent of

the RfD for the U.S. population. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. It is concluded that

there is a reasonable certainty that no

harm will result from aggregate

exposure to residues of clomazone,

including all anticipated dietary

exposure.

2. Infants and children. Based on the

current toxicological data requirements,

the data base relative to prenata and

postnatal effects for children is

complete (See Section B.3). Further, for

clomazone, the NOAEL in the two year

feeding study which was used to

calculate the RfD (0.043 mg/kg/day) is

already lower than the NOAELs from

the reproductive and developmental

studies by a factor of more than 10-fold.

Therefore, it can be concluded that no

additional uncertainty factors are

warranted and that the RfD at 0.043 mg/

kg/day is appropriate for assessing

aggregate risk to infants and children as

well as adults.

Using the conservative exposure

assumptions described above, FMC has

concluded that < 1% of the RfD will be

utilized by aggregate exposure to

residues of clomazone in/on tuberous

and corm vegetable (except potato) crop

subgroup and cucurbit vegetable crop

group for non–nursing infants (< 1 year

old), the population subgroup most

sensitive.

Based on the above information, FMC

has concluded that there is a reasonable

Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices 76253

certainty that no harm will result to

infants, children or adults from dietary

food consumption exposure to

clomazone residues from tuberous and

corm vegetable (except potato) crop

subgroup and cucurbit vegetable crop

group plus all other clomazone treated

human dietary food sources.

F. International Tolerances

There are Codex residue limits for

residues of clomazone in or on oilseed

rape, potatoes, tobacco, soybeans, rice,

cottonseed, sugarcane and peas.

[FR Doc. 00–31058 Filed 12–5–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–983; FRL–6573–7]

Notice of Filing Pesticide Petitions to

Establish and to Extend Tolerances for

Certain Pesticide Chemicals 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–983, must be

received on or before January 5, 2001.

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–983 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: For

Pesticide Petition (PP 9F5079) contact:

Cynthia Giles-Parker, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington DC 20460; Telephone

number: (703) 305–7740; e-mail address:

giles-parker.cynthia@epa.gov.

For Pesticide Petitions (PP 8F3654

8F3674) contact: Mary Waller,

Registration Division (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington DC 20460;

Telephone number: (703) 308–9354; email address: waller.mary@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

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–

983. 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 (CM #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–983 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, CM#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–983. 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.