Federal Register / Vol. 66, No. 26 / Wednesday, February 7, 2001 / Notices 9319

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 OPP–30505. 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. Offer alternative ways to improve

the registration activity.

7. Make sure to submit your

comments by the deadline in this

notice.

8. 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. Registration Applications

EPA received applications as follows

to register pesticide products containing

an active ingredient not included in any

previously registered products pursuant

to the provisions of section 3(c)(4) of

FIFRA. Notice of receipt of the

application does not imply a decision

by the Agency on the applications.

Products Containing an Active

Ingredient Not Included in Any

Previously Registered Products

1. File Symbol: 34704–IEU.

Applicant: Platte Chemical Company,

419 18th St., Greeley, CO 80632–0667.

Product Name: Smolder G. Product

type: Biological herbicide. Active

ingredient: Alternaria destruens at

4.40%. Proposed classification/Use:

Control of dodder (Cuscuta spp.).

2. File Symbol: 34704–IEL. Applicant:

Platte Chemical Company. Product

Name: Smolder WP. Biological

herbicide. Active ingredient: Alternaria

destruens at 4.10%. Proposed

classification/Use: Control of dodder

(Cuscuta spp.).

List of Subjects

Environmental protection, Pesticides

and pest.

Dated: January 5, 2001.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 01–3165 Filed 2–6–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–995; FRL–6765–6]

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–995, must be

received on or before March 9, 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–995 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Jim Tompkins, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 305–5697; e-mail address:

tompkins.jim@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/.

9320 Federal Register / Vol. 66, No. 26 / Wednesday, February 7, 2001 / Notices

2. In person. The Agency has

established an official record for this

action under docket control number PF–

995. 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–995 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–995. 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: January 25, 2001.

James Jones,

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

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioner.

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.

Aventis CropScience

0F6161

EPA has received a pesticide petition

(0F6161) from Aventis CropScience

USA LP, P.O. Box 12014, 2 T.W.

Alexander Drive, Research Triangle

Park, NC 27709 proposing, pursuant to

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

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

establishing tolerances for residues of 2-

[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]

carbonyl] amino] sulfonyl]-4-

(formylamino)-N, N-dimethylbenzamide

(CAS #173159–57–4)(foramsulfuron,

company code AE F130360) in or on the

raw agricultural commodities (RAC)

corn grain at 0.02 parts per million

(ppm), and corn forage and corn stover

at 0.1 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.

Federal Register / Vol. 66, No. 26 / Wednesday, February 7, 2001 / Notices 9321

A. Residue Chemistry

1. Plant metabolism. The metabolism

of foramsulfuron in corn has been

investigated and is understood. Two

primary routes of degradation occur for

foramsulfuron. One pathway involves

the hydrolysis of the sulfonylurea

bridge, resulting in AE F153745 (4-

formylamino-N, N-dimethyl-2-

sulfamoylbenzamide) and AE F092944

(2-amino-4,6-dimethoxypyrimidine).

Foramsulfuron also hydrolyzes at the

formamide moiety on the phenyl ring to

produce AE F130619 (4-amino-2-[3-(4,6-

dimethoxypyrimidin-2-

yl)ureidosulfonyl]-N, Ndimethylbenzamide). All these

metabolites are subjected to further

degradation leading to the formation of

highly polar, water soluble components.

The two metabolites resulting from

cleavage of the sulfonylurea bridge,

namely AE F153745 and AE F092944

were found in the extractable residue of

the forage and stover. Only traces of AE

F130619 (from hydrolysis of the

formamide moiety) were found also in

the forage and stover. The major

metabolite detected in plants (AE

F153745) was also identified in the rat

and livestock metabolism studies.

2. Analytical method. Based on the

results of the metabolism studies, the

analytical targets selected were parent

compound (AE F130360) and the

metabolite AE F153745. Extractable

residues of foramsulfuron and AE

F153745 are removed from the crop

matrix by blending with aqueous

acetonitrile. After filtration, the extract

is rotary evaporated down to a reduced

volume. The aqueous/organic extract is

transferred to a separatory funnel and

washed with hexane. After the hexane

wash, the extract is cleaned up via

special column chromatography then

analyzed by high performance liquid

chromotography/mass spectrometry

(HPLC/MS).

3. Magnitude of residues. The

metabolism studies with 14C–labelled

foramsulfuron in corn using exaggerated

application rates (over 2.5–fold the

normal rate) demonstrated that in

general, low residues were detected in

the plant samples. These results have

been confirmed in a total of 29 North

American residue field trials using a

water dispersible granule (WG)

formulation containing 50% weight/

weight (w/w) foramsulfuron. The

preparation was applied in split

applications. The predominant regimen

was 30 gram/health advisories (g/ha)

followed by 60 g/ha or alternatively, 2

times 45 g/ha. Pre-harvest intervals

(PHI) were between 37 and 67 days, 60

and 121 days or 67 and 151 days

respectively for forage, grain, or stover.

Grain, stover, and forage of field corn

did not contain residues of

foramsulfuron at or above the respective

limits of quantification (LOQ) of 0.01,

0.05, and 0.05 milligram/kilogram (mg/

kg). Also no residues of the metabolite

AE F153745 were found in corn grain,

stover, or forage at harvest above the

respective LOQ of 0.02, 0.05, and 0.05

mg/kg. Residues trials included testing

the effects of adding typical non-ionic

surfactants, esterified seed oils, or crop

oil concentrates to the spray mix. In no

case were residues above the LOQ

observed. Although AE F153745 was the

major metabolite detected in the corn

metabolism study, it did not exceed

10% of the total formasulfuron-derived

residue in grain, stover, or forage at

harvest. It is proposed, therefore, that

AE F153745 is not included in the

tolerance expression as field trials

confirmed its lack of formation at levels

above the LOQ. Tolerances of

foramsulfuron are proposed at twice the

LOQ of the analytical method, namely

0.02, 0.1, and 0.1 mg/kg in grain, stover,

and forage, respectively. In a corn

processing study, no residues of AE

F130360 above 0.01 mg/kg or AE

F153745 above 0.02 mg/kg were

observed in corn grain following

treatment of the crop at the nominal rate

of 150 followed by 300 g/ha. This

exaggerated rate is approximately five

times the maximum proposed label rate.

Since no residues were observed in the

RAC, neither analysis of the processed

commodities nor tolerances are

required. Although corn grain is fed to

cattle, and poultry and cattle may be

grazed on forage, or fed stover,

tolerances in meat, milk, or eggs are not

necessary because none of these

commodities contained foramsulfuron

or its metabolite.

B. Toxicological Profile

1. Acute toxicity. Foramsulfuron has

been shown to have very low acute

toxicity to mammals irrespective of the

route of exposure. Only non-specific

clinical signs were seen after oral

administration of 5,000 mg/kg to rats

and after inhalation exposure of rats to

5.04 milligram/liter (mg/L). These signs

had completely resolved 4 days

following oral treatment and by day 1

after inhalation exposure. There was no

evidence of systemic toxicity following

acute dermal exposure to 2,000 mg/kg

foramsulfuron. It was not irritant to

rabbit skin and only mildly irritating to

rabbit eyes. Foramsulfuron did not

induce delayed contact hypersensitivity

(skin sensitization) in a Magnusson and

Kligman maximization test. Based on

these results, foramsulfuron would be

classified as EPA category III for dermal

toxicity and eye irritation, and EPA

category IV for skin irritation, oral, and

inhalation toxicity.

2. Genotoxicity. Genotoxic potential

was evaluated in a battery of tests which

examined gene mutation in bacteria and

mammalian cells, chromosome damage

in vitro and in vivo and DNA damage in

mammalian cells in vivo. The only

finding was weak evidence in vitro of

chromosome aberrations in human

lymphocytes in the absence of metabolic

activation. The increases in incidences

occurred only at the highest dose level

tested, 2,400 μg/mL, and were only just

outside the historical control range.

However, there was no evidence of

chromosome damage in vivo, no effects

in the in vivo assay for unscheduled

DNA synthesis and no oncogenic

activity or developmental toxicity.

Thus, the overall weight of evidence

indicates that foramsulfuron does not

possess significant genotoxic activity.

3. Reproductive and developmental

toxicity. A 2–generation reproduction

study in rats evaluated continuous

dietary dose levels of 0, 100, 1,225, and

15,000 ppm of technical foramsulfuron.

No treatment-related effects were

observed, including no effects on

reproductive parameters (fertility,

mating, gestation, parturition, litter size

sex ratios), parental toxicity, neonatal

toxicity, or on markers of endocrine

function (oestrous cycling,

balanopreputial separation, vaginal

opening, spermatogenetic function and

capacity). Therefore, the no observed

adverse effect level (NOAEL) was 15,000

ppm, equivalent to a mean daily intake

of 1,038 mg/kg foramsulfuron body

weight (bwt) for F0 and F1 males and

1,430 mg/kg/day for F0 and F1 females

combined (about 1,234 mg/kg/day for

the study overall).

A rat developmental toxicity

(teratogenicity) study was conducted

with dose levels of 0, 5, 71, and 1,000

mg/kg foramsulfuron bwt/day. There

was no evidence of any maternal or

embryo foetal toxicity up to and

including the 1,000 mg/kg dose level,

the international limit dose for this type

of study. Therefore the NOAEL for both

maternal and embryofetal toxicity was

1,000 mg/kg. Foramsulfuron was not

teratogenic in rats.

The rabbit developmental toxicity

(teratogenicity) study was conducted

with dose levels of 0, 5, 50, and 500 mg/

kg foramsulfuron bwt/day. Maternal

toxicity was seen at the high dose of 500

mg/kg/day, as evidenced by reduced

body weight gain and slightly decreased

food consumption during the treatment

period. There was no embryofetal

toxicity at any dose level. The NOAEL

9322 Federal Register / Vol. 66, No. 26 / Wednesday, February 7, 2001 / Notices

for maternal toxicity was 50 mg/kg and

500 mg/kg for developmental toxicity

(teratogenicity). Foramsulfuron was not

teratogenic in the rabbit.

Results of the 2–generation and the

developmental toxicity (teratogenicity)

studies, show that foramsulfuron gives

no evidence of reproductive,

embryofetal, or neonatal toxicity.

Parental (maternal) toxicity was only

seen in the rabbit at 1,000 mg/kg, the

international limit dose.

Therefore, foramsulfuron was of very

low reproductive toxicity.

4. Subchronic toxicity. In a 90–day rat

feeding study, groups of 10 male, and 10

female Sprague Dawley rats were fed

diets containing either 0, 20, 200, 500,

or 20,000 ppm of foramsulfuron. There

was no treatment-related mortalities or

effects seen at any dose level. The

NOAEL for this study was considered to

be 20,000 ppm (approximately 1,677

mg/kg/day which is in excess of the

1,000 mg/kg/day international limit

dose).

In a 90–day feeding study in mice,

foramsulfuron was administered at

dietary concentrations of 64, 3,200, and

6,400 ppm. There was no treatmentrelated deaths or effects found in mice

at any dose level. The NOAEL for this

study was 6,400 ppm (equivalent to

1,002 mg/kg/day for males and 1,178

mg/kg/day for females).

Groups of 4 males and 4 females

Beagle dogs were administered

foramsulfuron at dietary concentrations

of 0, 10, 250, and 1,000 mg/kg/ bwt/day

for 13 consecutive weeks. There were no

mortalities, and no clinical signs

directly related to treatment at any dose

level. The NOAEL for both sexes was

1,000 mg/kg/day, the international limit

dose.

5. Chronic toxicity. The oncogenic

potential of foramsulfuron was

examined in bioassays with rats and

mice with dietary exposure periods of 2

years and 18 months, respectively.

In rats, dietary administration of up to

20,000 ppm of foramsulfuron for 2

years, equivalent to achieved intakes of

849 and 1,135 mg/kg/day for males and

females, respectively, did not yield any

evidence of toxicity or oncogenicity.

The mean daily intakes over the 1–year

period were 976 and 1,305 mg/kg/day

for males and females, respectively.

Thus this dose level approximated to

the international regulatory limit dose of

1,000 mg/kg/day.

Similarly in mice, no oncogenic

activity was found after dietary

treatment with up to 8,000 ppm

(equating to 1,115 and 1,358 mg/kg/day

in males and females, respectively) for

18 months, which was slightly in excess

of the international limit dose.

Based on the achieved intakes, the rat

is the most sensitive species in these

long-term studies and the overall lowest

NOAEL was 849 mg/kg foramsulfuron

body weight/day. Given the absence of

any carcinogenicity, significant

genotoxicity, reproduction toxicity,

developmental toxicity or any other

special hazard potential, and taking into

consideration the low toxicity profile,

poor absorption and rapid excretion

(predominantly of parent compound), a

safety factor of 100 is considered

appropriate. Therefore the proposed

reference dose (RfD) is 8.5 mg/kg bwt/

day.

Aventis CropScience believes

foramsulfuron should be classified as a

‘‘not likely’’ carcinogen based on the

lack of carcinogenicity in rats and mice.

6. Animal metabolism. Following a

single oral administration of either 10 or

1,000 mg/kg to rats, 91.5% of the dose

was found in the excreta between 0 and

24 hours post-dosing. There were no

sex-specific differences in the route of

excretion, and tissue residues were

generally low. The metabolism of

foramsulfuron showed that at both dose

rates the main excretion product was

unchanged foramsulfuron, excreted

mainly in the faeces. Two metabolic

routes were identified leading to the

formation of metabolites also detected

in plants: AE F130619, an amine formed

via hydrolysis at the formamide moiety

on the phenyl and the cleavage product

AE F153745, as minor metabolites. A

number of unidentified, minor (<4%),

polar metabolites formed from both the

phenyl or pyrimidyl ring-labelled

compound were also excreted.

Six laying hens were orally dosed

with (U–14C-phenyl)-foramsulfuron for

14 consecutive days with a mean daily

dose of 1.50 mg per bird per day,

equivalent to approximately 10 ppm in

the diet. The levels of radioactive

residues in the hen tissues at necropsy

were low, with the highest

concentration being found in the liver

(0.023 μg equivalents/g). The residues in

the muscle, fat, and skin were all found

to be 0.003 μg equivalents/g or less,

which is below the concentration

requiring further analysis. The

unchanged parent compound and the

cleavage product AE F153745 were the

only metabolites identified in the edible

tissues, eggs and excreta, which are also

significant in the cow and rat.

A dairy cow was orally dosed with

(U–14C-phenyl)-foramsulfuron for 7

consecutive days with a mean daily

dose of 187.4 mg, equivalent to 16 ppm

in the diet. Radioactive residues were

detectable in all edible tissues at very

low levels between 0.004 and 0.036 μg

equivalents/g tissue at necropsy. The

major metabolites identified in all

tissues were unchanged foramsulfuron

and AE F153745. Some very minor

metabolites were also seen in the liver

and fat but were not identified. The

results show that foramsulfuron is

poorly absorbed and is excreted mainly

in the faeces. The only identifiable

metabolic product of foramsulfuron

detected in the tissues and excreta of the

dairy cow was AE F153745, which is

also the principal metabolite identified

in the hen, rat, and corn.

7. Endocrine disruption. No special

studies have been conducted to

investigate the potential of

foramsulfuron to induce estrogenic or

other endocrine effects. However, no

evidence of estrogenic or other

endocrine effects have been noted in

any of the standard toxicology studies

that have been conducted with this

product and there is no reason to

suspect that any such effects would be

likely.

C. Aggregate Exposure

1. Dietary exposure. Foramsulfuron is

proposed for use as an herbicide on

corn. No non-agricultural uses are

anticipated. The potential sources of

exposure would consist of any potential

residues in food and drinking water. As

indicated above, there are no acute

toxicity concerns and thus only chronic

exposure has been evaluated.

i. Food. Chronic dietary analysis was

conducted to estimate exposure to

potential foramsulfuron residues in/on

corn. A Tier 1 analysis was conducted

using the dietary exposure evaluation

system (DEEMtm) software and the

1994–1996 CSFII food consumption

data. It was assumed that residues were

at tolerance levels of 0.02 ppm (twice

the LOQ) in grain and that 100% of the

crop was treated. Additionally, based on

the results from appropriate studies, it

was assumed that there was no

concentration into processed

commodities and that contributions

from residues in meat, milk, or eggs are

not required. A chronic RfD of 8.5 mg/

kg/day is derived from the male rat

NOAEL of 849 mg/kg/day. Using these

inputs the chronic dietary exposure

estimate from residues of foramsulfuron

for the U.S. population was 0.000032

mg/kg/day or <0.001% of its RfD. For

the sub-population with the highest

exposure, non-nursing infants, the

chronic dietary exposure estimate from

residues of foramsulfuron was 0.000080

mg/kg/day, again <0.001% of its RfD.

These values are highly conservative,

having been based on worst case

assumptions of tolerance level residues

and 100% of the crop treated.

Federal Register / Vol. 66, No. 26 / Wednesday, February 7, 2001 / Notices 9323

ii. Drinking water. Unites States EPA’s

standard operating procedure (SOP) for

drinking water exposure and risk

assessments was used to perform the

drinking water assessment. This SOP

uses a variety of tools to conduct a

screening level drinking water

assessment. These tools include water

models such as screening concentration

ground water (SCI-GROW), generic

expected environmental concentration

(GENEEC), EPA’s pesticide root zone

model (PRZMS)/EXAMS, and

monitoring data. If monitoring data is

not available then the models are used

to predict potential residues in surface

and ground water and the highest value

is assumed to be the potential drinking

water residue. In the case of

foramsulfuron monitoring data do not

exist therefore model calculations were

used to estimate a water residue. The

calculated drinking water levels of

concern (DWLOC) for chronic exposures

for adults is 297,498 (ppb) parts per

billion (297 ppm). The chronic DWLOC

for children/toddlers is 84,999 ppb (84

ppm). The worst case chronic drinking

water estimated concentration (DWEC)

is 0.225 ppb based on a PRZM/EXAMS

simulation of runoff into surface water

in a standard EPA exposure assessment

scenario for corn (MLRA 111, Ohio).

The calculated DWLOCs for chronic

exposures for all adults and children

therefore greatly exceed the DWECs

from the models.

2. Non-dietary exposure. Exposure to

foramsulfuron for the mixer/loader/

ground boom/aerial applicator was

calculated using the pesticide handlers

exposure data base (PHED). It was

assumed that the product would be

applied to a maximum of 50 hectares

per day (125 A/day) by ground boom

applicatior and 140 hectares per day

(350 A/day) by aerial applicator at a

maximum use rate of 45 grams a.i./ha.

Normal work attire consisting of longsleeved shirt, long pants, and protective

gloves was assumed in the PHED

assessment. Margins of exposure

(MOEs) for a 70 kg operator were

calculated utilizing a dermal NOAEL of

1,000 mg/kg bwt/day from the rat

dermal toxicity study and an inhalation

NOAEL of 50 mg/kg bwt/day based on

an oral administration, developmental

toxicity study in the rabbit. There were

no signs of developmental toxicity in

the rabbit developmental toxicity study.

The combined MOE (inhalation plus

dermal) for foramsulfuron was 126,000

for a ground operator undertaking

mixing, loading, and spraying. For aerial

application where the mixer/loader was

assumed to be a different operator from

the pilot combined MOEs were 60,400

for the mixer/loader and 1,425,000 for

the pilot. The results indicate that large

margins of safety exist for the proposed

use of foramsulfuron.

The timing of foramsulfuron

application to corn is such that field

reentry shortly after spraying is atypical.

Therefore estimations of worker reentry

exposure were not considered

necessary.

D. Cumulative Effects

There is no available data at this time

to determine whether foramsulfuron has

a common mechanism of toxicity with

other substances or how to include this

pesticide in a cumulative risk

assessment. Therefore a cumulative

assessment was not done for this

chemical.

E. Safety Determination

1. U.S. population. Using the

conservative assumptions described

above, based on the completeness and

reliability of the toxicity data, it is

concluded that aggregate exposure, in

this case food only, to the proposed uses

of foramsulfuron will utilize <0.001% of

the reference dose for the U.S.

population. The actual exposure is

likely to be much less as more realistic

data and models are developed. EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risk to human

health. DWLOC based on the dietary

exposure are much greater than highly

conservative estimated levels, and

would be expected to be well below the

100% level of the RfD, if they occur at

all. Therefore, there is a reasonable

certainty that no harm will occur to the

U.S. population from aggregate exposure

(food and drinking water) to

foramsulfuron.

2. Infants and children. No evidence

of increased sensitivity to fetuses was

noted in developmental toxicity studies

in rats or rabbits. There has been no

indication of reproductive effects or

indication of increased sensitivity to the

offspring in the 2–generation rat

reproduction study. No additional safety

factor to protect infants and children is

necessary as there is no evidence of

increased sensitivity in infants and

children.

Using the conservative assumptions

described in the exposure section above,

the percent of the reference dose that

will be used for exposure to residues of

foramsulfuron in food for non-nursing

infants (the most highly exposed sub

group) is <0.001%. The children (1–6)

exposure uses are also <0.001% of the

reference dose. As in the adult situation,

DWLOC are much higher than the worst

case DWEC and are expected to use well

below 100% of the RfD, if they occur at

all. Therefore, there is a reasonable

certainty that no harm will occur to

infants and children from aggregate

exposure to residues of foramsulfuron.

F. International Tolerances

There are no Codex Alimentarius

Commission (CODEX) maximum

residue levels (MRLs) established for

residues of foramsulfuron.

[FR Doc. 01–3093 Filed 2–6–01; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–994; FRL–6764–8]

Notice of Filing 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 a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–994, must be

received on or before March 9, 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–994 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: 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.

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: