34 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Notices

potential for non-occupational, nondietary exposure to the general

population is not expected to be

significant.

D. Cumulative Effects

There is no reliable information to

indicate that cloransulam-methyl has a

common mechanism of toxicity with

any other chemical compound or that

potential toxic effects of cloransulammethyl would be cumulative with those

of any other pesticide chemical. Thus

DowElanco believes it is appropriate to

consider only the potential risks of

cloransulam-methyl in its exposure

assessment.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above, and based on the

completeness and reliability of the

toxicity data, DowElanco has concluded

that aggregate exposure to cloransulammethyl will utilize only about 0.01

percent of the RfD for the U.S.

population. EPA generally has no

concern for exposures below 100

percent 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. Therefore, DowElanco

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to cloransulammethyl residues (<0.02 ppm) on

soybeans. The complete toxicology

profile for cloransulam-methyl shows

no evidence of physiological effects

characteristic of the disruption of the

hormone estrogen. Based upon this

observation, cloransulam-methyl does

not meet the criteria for an estrogenic

compound.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

cloransulam-methyl, data from

developmental toxicity studies in rats

and rabbits and a multigeneration

reproduction study in the rat are

considered. The developmental toxicity

studies are designed to evaluate adverse

effects on the developing organism

resulting from pesticide exposure

during prenatal development to one or

both parents. Reproduction studies

provide information relating to effects

from exposure to the pesticide on the

reproductive capability and potential

systemic toxicity of mating animals and

on various parameters associated with

the well-being of offspring.

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- and

post-natal toxicity and the completeness

of the data base. Base on the current

toxicological data requirements, the data

base for cloransulam-methyl relative to

pre- and post-natal effects for children

is complete. Further, for cloransulammethyl, the NOEL in the chronic feeding

study which was used to calculate the

RfD (0.05 mg/kg/day) is already lower

than the NOELs from the developmental

studies in rats and rabbits by a factor of

more than 60 to 200–fold.

Concerning the reproduction study in

rats, there were no effects on

reproduction or fetal development, even

at a dose 100× the NOEL used to

establish the RfD. Therefore, DowElanco

concludes that an additional uncertainty

factor is not needed and that the RfD at

0.05 mg/kg/day is appropriate for

assessing risk to infants and children.

Using the conservative exposure

assumptions previously described, the

percent RfD utilized by the aggregate

exposure to residues of cloransulammethyl on soybeans is 0.07 percent for

non-nursing infant, the most sensitive

population subgroup. Thus, based on

the completeness and reliability of the

toxicity data and the conservative

exposure assessment, DowElanco

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to cloransulam-methyl on

soybeans.

F. International Tolerances

There are no Codex maximum residue

levels established for residues of

cloransulam-methyl on soybeans or any

other food or feed crop.

II. Public Record

Interested persons are invited to

submit comments on this notice of

filing. Comments must bear a notation

indicating the docket control number,

[PF–722]. All written comments filed in

response to this petition will be

available in the Public Response and

Program Resources Branch, at the

address given above from 8:30 a.m. to 4

p.m., Monday through Friday, except

legal holidays.

A record has been established for this

notice under docket control number

[PF–722] including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Rm. 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as ASCII file avoiding the use

of special characters and any form of

encryption.

The official record for this notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Authority: 21 U.S.C. 346a.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping.

Dated: March 13, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–7496 Filed 3–25–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–718; FRL–5590–3]

Novartis; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice is a summary of

a pesticide petition (PP) 6F4621

proposing the establishment of a

regulation for residues of the herbicide

norflurazon and its desmethyl

metabolite in or on bermudagrass forage

and bermudagrass hay. This summary

was prepared by the petitioner,

Novartis. The original petitioner,

Sandoz Agro, Inc., merged with CibaGeigy Corp., to form a new corporation,

Novartis Crop Protection, Inc., on

January 1, 1997, thus the name of the

Petitioner has been changed.

DATES: Comments, identified by the

docket control number [PF–718], must

be received on or before, April 25, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and
Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Notices 35

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Rm. 1132, CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202. Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne Miller, Product Manager

(PM) 23, Registration Division (7505C),

Office of Pesticide Programs.

Environment Protection Agency, 401 M

St. SW., Washington, DC 20460. Office

location and telephone number: Rm.

237, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA 22202. (703)

305–6224, e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP)

6F4621 from Novartis Crop Protection,

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

27419, proposing to amend 40 CFR part

180, pursuant to section 408(d) of the

Federal Food, Drug and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(d), by

establishing tolerances for combined

residues of the herbicide norflurazon,

(4-chloro-5-(methylamino)-2-(alpha,

alpha, alpha-trifluoro-m-tolyl)-3-(2H)-

pyridazinone) and its desmethyl

metabolite (4-chloro-5-(amino)-2-alpha,

alpha alpha-trifluoro-m-tolyl)-3(2H)-

pyridazinone) in or on bermudagrass

forage at 3.0 ppm and bermudagrass hay

at 2.0 ppm. The proposed analytical

method of determining residues was gas

chromatography. The initial notice of

filing was published previously in the

Federal Register of February 1, 1995 (61

FR 3698)(FRL–4994–3). The current

notice of filing is required by EPA to

fulfill FQPA requirements. Tolerances

requested are the same as those

proposed in the initial filing.

Pursuant to the section 408(d)(2)(A)(i)

of the FFDCA, as amended, Novartis

Crop Protection Inc., has submitted the

following summary information, data

and arguments in support of their

pesticide petition. This summary was

prepared by Novartis and EPA has not

fully evaluated the merits of the

petition. EPA edited the summary to

clarify the summary and to remove

certain extraneous material and that the

conclusions and arguments are the

petitioners and not necessarily the

EPA’s.

I. Petition Summary

A. Chemical Uses

Norflurazon, (4-chloro-5-

(methylamino)-2-(alpha, alpha, alphatrifluoro-m-tolyl)-3-(2H)-pyridazinone),

is a selective, pre-emergent herbicide

used to control germinating annual

grasses and broadleaf weeds.

Norflurazon is noncorrosive and is

stable under alkaline and acid

conditions, but is sensitive to light.

Norflurazon is only slightly soluble in

water (<40 parts per million (ppm)).

B. Norflurazon Safety

Novartis has submitted over 70

separate toxicology studies in support of

tolerances for Norflurazon. EPA has

classified norflurazon as a nonquantifiable Group C, possible human

carcinogen. According to Novartis,

norflurazon is not a mutagen and has

low oral and dermal toxicity to

mammals. (Updated studies have

recently been submitted to the EPA.)

Risk assessment calculations indicate

margins of safety for agricultural

workers and the population in general

far exceed the EPA required level of

100.

The following mammalian toxicity

studies have been conducted to support

the tolerances of Norflurazon:

Acute Oral, Rat (Male) LD50: 9.3 g/kg

(Tox Category IV)

Acute Dermal, Rabbit: LC50 ≥20,000

mg/kg (Tox Category IV)

Acute Inhalation, Rat: LC50 > 2.4 mg/

l (Tox Category III)

Primary Eye Irritation, Rabbit: nonirritating (Tox Category IV)

Primary Dermal Irritation, Rabbit: no

irritation (Tox Category IV)

Dermal Sensitization, in male Guinea

Pig: technical norflurazon at 0.1 percent

did not cause sensitization (Tox

Category IV)

90–day rat feeding study: The

systemic no-observable-effect-level

(NOEL) was considered to be 12.50 mg/

kg/day in male rats, and 25.0 mg/kg/day

in female rats.

A 6–month dog feeding study: The

systemic NOEL was determined to be

1.53 mg/kg/day for males, and 1.58 mg/

kg/day for females. The systemic LEL

was determined to be 5.02 mg/kg/day

for males, and 4.77 mg/kg/day for

females.

A 3–week rabbit dermal study: The

systemic NOEL was 375 mg/kg/day for

males and females. The dermal NOEL

was also 375 mg/kg/day for both sexes.

A 28–day rat feeding study: NOEL of

50.0 mg/kg/day.

A 28–day mouse feeding study: NOEL

of 63.0 mg/kg/day.

A rat dermal absorption study: No

more than 0.1 percent of applied dose

was absorbed at doses up to 10 mg/rat.

Gene mutation assays: Negative.

There was no evidence of cytotoxicity in

any of the strains at any of the dose

concentrations used. In an in vitro

unscheduled DNA synthesis assay,

norflurazon failed to induce

unscheduled DNA synthesis in primary

rat hepatocytes. In an in vitro

chromosomal aberration assay,

norflurazon did not cause a clastogenic

response in the presence of liver S–9 or

in the absence of S–9.

A developmental study in rats: No

maternal or developmental effects at 400

mg/kg/day. Maternal NOEL was <100

mg/kg/day; maternal LEL was 100 mg/

kg/day, based on reductions in body

weight for the period of dosing and for

the dosing plus post-dosing period.

A developmental study in rabbits: The

NOEL for maternal toxicity was 30 mg/

kg/day based on maternal body weight

decreases at 60 mg/kg/day. The NOEL

for developmental toxicity was 30 mg/

kg/day. Developmental effects seen at 60

mg/kg/day were decreased fetal weight

and incomplete ossification of the skull,

fore and hind limb middle phalanx,

metacarpal, and proximal epiphysis of

the tibia.

A three generation reproduction study

in rats showed no apparent effects on

reproductive performance at any dose

level tested.

A chronic toxicity and carcinogenicity

study in Sprague-Dawley rats: No

significant effects of technical

norflurazon were evident for survival,

body weight, body weight gain, or food

consumption in male or female rats at

any dose level tested. The systemic

NOEL was determined to be 18.75 mg/

kg/day for both sexes.

A carcinogenicity study in mice: No

significant effects were observed on

body weight, body weight gain, and
36 Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Notices

food consumption at any dose. The

systemic NOEL was determined to be

12.8 mg/kg/day for male mice, and 58.7

mg/kg/day for female mice.

A rat metabolism study: A rat

metabolism study at single oral doses of

2 or 110 mg/kg, a single i.v. dose of 2.0

mg/kg, or a single oral dose at 2 mg/kg

after animals had ingested 0.1 mg/kg for

14 days showed that less than 1.0

percent of the administrated dose

remained 96 hours after dosing.

Thirteen metabolites were isolated.

Norflurazon appears to be metabolized

by N-demethylation, displacement of

the chlorine atom by glutathione,

glutatione attack on the aromatic ring,

and replacement of the chlorine atom

with hydrogen. Norflurazon appears to

be rapidly absorbed from the

gastrointestinal tract and extensively

metabolized.

C. Threshold Effects

Chronic effects: Based on the

available chronic toxicity data, EPA has

set the Reference Dose (RfD) for

norflurazon at 0.02 mg/kg/bwt/day. The

RfD for norflurazon is based on the 6-

month dog feeding study with a

threshold NOEL of 1.53 mg/kg/day and

an uncertainty factor of 100.

Acute toxicity: Because

developmental effects were seen in the

rabbit developmental study, the Agency

assessed acute dietary risk from

developmental effects for the subgroup

females (13+ years) the only appropriate

group of acute dietary concern. The

Margin of Exposure (MOE), a measure of

how closely the high-end exposure

comes to the NOEL, was calculated as

the ratio of the NOEL to the exposure

and determined to be 3,000. The Agency

is not generally concerned unless the

MOE is below 100 when based upon

data generated in animal studies.

D. Non-threshold Effects

Carcinogenicity: The EPA’s Health

Effects Division Peer Review Committee

classified norflurazon as a Group C,

possible human carcinogen, based on

the criteria in the Agency’s Guideline

for the Classification of Carcinogens

published in the Federal Register of

September 24, 1986, (51 FR 33992–

34003), and the statistically significant

increase in comparison to controls in

hepatocellular adenomas and combined

hepatocellular adenomas and

carcinomas in male CD–1 mice as well

as the statistically significant positive

trend for hepatocellular adenomas and

combined adenomas and carcinomas.

That committee also recommended

that for the purposes of risk

characterization the RfD approach

should be used for the quantification of

human risk. This recommendation was

supported by the presence of only

benign tumors in only one sex of one

species at one dose level, and adequate

but negative mutagenicity data and no

positive analogues. EPA believes

norflurazon poses a negligible cancer

risk to humans.

E. Aggregate Exposure:

For the purposes of assessing the

potential dietary exposure, Novartis has

estimated the aggregate exposure based

on the Theoretical Maximum Residue

Contribution (TMRC) from the

tolerances for all crops on which

norflurazon-based products are labeled.

The TMRC from the established and the

proposed tolerances is 0.002041 and

utilizes 10.2 percent of the RfD for the

overall U.S population. The exposure of

the most highly exposed subgroup in

the population, non-nursing infants, is

0.009356 mg/kg/bwt/day and utilizes

46.8 percent of the RfD.

No norflurazon-based products are

labeled for residential use. Nonoccupational exposure for norflurazon

has not been estimated since the current

registrations for norflurazon-based

products are limited to commercial crop

production. The potential for nonoccupational exposure to the general

population is, therefore, insignificant.

EPA consideration of a common

mechanism of toxicity is not appropriate

at this time because Sandoz and EPA do

not have information to indicate that

toxic effects produced by norflurazon

would be cumulative with those of any

other chemical compounds.

F. Determination of Safety for US

population

Reference Dose (RfD): Using a 100-

fold safety factor and the NOEL of 1.53

mg/kg/day determined by the most

sensitive species (the 6-month dog

feeding study), the RfD is 0.02 mg/kg/

bwt/day. The TMRC from the

established and the proposed tolerances

is 0.002041 and utilizes 10.2 percent of

the RfD for the overall U.S population.

Based on the completeness and

reliability of the toxicity data and the

conservative exposure assessment,

Sandoz concludes that there is a

reasonable certainty that no harm will

result from the aggregate exposure of

residues of norflurazon including all

anticipated dietary exposure.

G. Determination of Safety for Infants

and Children

The exposure of the most highly

exposed subgroup in the population,

non-nursing infants, is 0.009356 mg/kg/

bwt/day and utilizes 46.8 percent of the

RfD. Based on the completeness and

reliability of the toxicity data and the

conservative exposure assessment,

Sandoz concludes that there is a

reasonable certainty that no harm will

result to infants and children from the

aggregate exposure of residues of

norflurazon including all anticipated

dietary exposure.

H. Estrogenic Effects

No specific tests have been conducted

with norflurazon to determine whether

the pesticide may have an effect in

humans that is similar or an effect

produced by a naturally occurring

estrogen or other endocrine effects.

I. Chemical Residue

The nature of the residue is

adequately understood, and an adequate

analytical method, gas chromatography

using electron capture detection, is

available for enforcement purposes.

Tolerances have been established for

norflurazon in almonds, hulls and

nutmeat; apples; apricots; asparagus;

avocados; blackberries; blueberries;

cattle, fat, meat, and meat-by-products

(mbyp); cherries; citrus fruit;

cottonseed; cranberries; filberts; goats,

fat, meat and mbp; grapes; hogs, fat,

meat, and mbp; hops, green; horses, fat,

meat, and mbp; milk; nectarines;

peaches; peanuts; peanut hay, hulls and

vines; pecans; pears; plums (fresh

prunes); poultry, fat, meat and mbp;

raspberries; sheep, fat, meat and mbp;

soybeans, forage and hay; and walnuts.

The metabolism of norflurazon in plants

is adequately understood. Metabolism of

norflurazon in livestock has been

studied and tolerances for livestock

commodities have been established. A

ruminant study adequately identified

the metabolites in milk, liver and

kidney. Norflurazon was not detected in

ruminant milk or tissue, and total

radioactive residues in fat and muscle

were <0.01 ppm.

J. Environmental Fate

The environmental fate of norflurazon

is adequately understood. Norflurazon

is persistent and may be mobile.

Norflurazons primary route of

dissipation appears to be

photodegradation in water and on soil

to desmethyl norflurazon with a half-life

of 2–3 days and 12–15 days

respectively. Norflurazon is stable to

hydrolysis and degrades slowly under

aerobic soil conditions with a half-life of

130 days. In an anaerobic aquatic study,

norflurazon degrades to desmethyl

norflurazon with a half-life of about 8

months.

Fish accumulation data show that

norflurazon has low potential to

bioaccumulate in bluegill sunfish.
Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Notices 37

Norflurazon is not currently regulated

under the Safe Drinking Water Act

(SWDA). Therefore, no MCL has been

established and water systems are not

required to sample and analyze for it.

Novartis is currently performing

groundwater monitoring studies to

better evaluate the leaching potential of

norflurazon.

Norflurazon is practically non-toxic to

avian species on an acute oral and

subacute dietary basis. Norflurazon is

also practically nontoxic to mammals

and insects (honeybees).

K. International Tolerances

No international tolerances have been

established under CODEX. Therefore,

there is no need to ensure consistency.

II. Public Record

A record has been established for this

notice under docket control number

[PF–718] (including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The public

record is located in Rm 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Authority: 21 U.S.C. 346a.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: March 11, 1997.

Stephen L. Johnson,

Director, Registration Division Office of

Pesticide Programs.

[FR Doc. 97–7065 Filed 3–25–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–727; FRL–5595–6]

Novartis Crop Protection, Inc.;

Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice is a summary of

a pesticide petition proposing the

establishment of a regulation for the

residues of CGA–248757, acetic acid [[2-

chloro-4-fluoro-5-[(tetrahydro-3-oxo1H,3H-[1,3,4]thiadiazolo[3,4-

α]pyridazin-1-ylidene)

amino]phenyl]thio]-methyl ester in or

on soybeans. This summary was

prepared by the petitioner.

DATES: Comments, identified by the

docket control number [PF-727], must

be received on or before April 25, 1997.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

comments to: Rm. 1132 CM #2, 1921

Jefferson Davis Highway, Arlington, VA

22202.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[PF–727]. Electronic comments on this

notice may be filed online at many

Federal Depository Libraries. Additional

information on electronic submissions

can be found in Unit II. of this

document.

Information submitted as comments

concerning this notice may be claimed

confidential by marking any part or all

of that information as ‘‘Confidential

Business Information’’ (CBI). No CBI

should not be submitted through e-mail.

Information marked as CBI will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne Miller, Product Manager

(PM) 23, Registration Division (7505W),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: Rm. 237, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

(703) 305–6224, e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: A notice

of filing of pesticide petition 6F4614

was published in the Federal Register of

June 12, l996 (61 FR 29752) (FRL–5354–

7). The Notice stated that Ciba Crop

Protection, Ciba-Geigy Corporation had

proposed to amend 40 CFR part 180 by

establishing a tolerance for residues of

the herbicide, acetic acid [[2-chloro-4-

fluoro-5-[(tetrahydro-3-oxo-1H,3H-

[1,3,4]thiadiazolo[3,4-α]pyridazin-1-

ylidene) amino]phenyl]thio]-methyl

ester in or on the raw agricultural

commodity soybeans at 0.02 part per

million (ppm). The proposed analytic

method for determining residues was

gas chromatographic. On January 1,

l997, Ciba Crop Protection merged with

Sandoz, Inc. to form a new corporation,

Novartis Crop Protection, Inc.

EPA has received a second notice of

filing of (PP) 6F4614, from Novartis

Crop Protection, Inc., P.O. Box 18300,

Greensboro, NC 27419, proposing

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

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

CFR part 180 by establishing a tolerance

for residues of the herbicide CGA–

248757, acetic acid [[2-chloro-4-fluoro5-[(tetrahydro-3-oxo-1H,3H-

[1,3,4]thiadiazolo[3,4-α]pyridazin-1-

ylidene) amino]phenyl]thio]-methyl

ester in or on the raw agricultural

commodity soybeans at 0.01 ppm. The

proposed analytical method is gas

chromatography using a nitrogen

phosphorus detector and a large-bore

fused silica column.

Pursuant to section 408(d)(2)(A)(i) of

the FFDCA, as amended, Novartis Crop

Protection, Inc. has submitted the

following summary of information, data

and arguments in support of their

pesticide petition. This summary was

prepared by Novartis and EPA has not

fully evaluated the merits of the