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

Public Response and 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

rulemaking, 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 rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping.

Dated: March 18, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–7494 Filed 3–25–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–722; FRL–5592–8]

DowElanco; Pesticide Tolerance

Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of Filing.

SUMMARY: This notice is a summary

announces the filing of a pesticide

petition proposing the establishment of

a regulation for residues of cloransulammethyl in or on soybeans. This notice

contains a summary was prepared by

the petitioner, DowElanco.

DATES: Comments, identified by the

docket number [PF–722], 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 be 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 in ASCII file format. All

comments and data in electronic form

must be identified by docket control

number [PF–722]. Electronic comments

on this notice may be filed online at

many Federal Depository Libraries.

Additional information on electronic

submissions can be found below this

document.

Information submitted as a comments

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:

Philip Errico, Product Manager (PM) 25,

Registration Division, (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M. St., SW.,

Washington, D.C. Office location,

telephone number and e-mail address:

Rm. 237, CM#2, 1921 Jefferson Davis

Highway, Arlington, VA 703–305–6027.

e-mail: errico.phillip@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP 5F4560

from DowElanco, 9330 Zionsville Road,

Indianapolis, IN 46268-1054 proposing

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act, 21 U.S.C.

section 346a(d), to amend 40 CFR part

180 by establishing a tolerance for

residues of the herbicide N-(2-

carboxymethyl-6-chlorophenyl)-5-

ethoxy-7-fluoro[1,2,4]

triazolo[1,5c]pyrimidine-2-sulfonamide,

(cloransulam-methyl) in or on the raw

agricultural commodity soybeans at 0.02

ppm, soybean forage at 0.1 part per

million (ppm) and soybean hay at 0.2

ppm. The proposed analytical method is

gas chromatography coupled with a

mass selective detector (GC-MSD).

EPA has determined that the petition

contains data or information regarding

the elements set forth in section

408(d)(2); however, EPA has not fully

evaluated the sufficieny of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

Availability of the analytical method:

The proposal analytical method of

enforcement which measures residues

of cloransulam-methyl in soybeans, and

soybean forage and hay discussed below

has not been validated by the Agency.

Public versions of the analytical method

can be obtained from the Pesticide

Docket, U.S. Environmental Protection

Agency, Office of Pesticide Programs,

401 M. St., SW., Washington, D.C.

20460, (703) 305–5805.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act,

DowElanco included in the petition a

summary of the petition and

authorization for the summary to be

published in the Federal Register in a

notice of receipt of the petition. The

summary represents the views of

DowElanco; EPA, as mentioned above,

is in the process of evaluating the

petition. As required by section

408(d)(3) EPA is including the summary

as a part of this notice of filing. EPA

may have made minor edits to the

summary for the purpose of clarity.

I. Petition Summary

A. Residue Chemistry

1. Plant metabolism. Nature of residue

studies demonstrated that residues of

cloransulam-methyl and its metabolites

would not be expected to accumulate to

significant levels in soybeans treated

either pre-plant or post-emergence, and

that it was appropriate to base the

magnitude of total terminal residues and

proposed tolerances only on residues of

the parent compound, cloransulammethyl. A rotational crop study showed

no significant level of cloransulammethyl or any structurally-related

metabolite in any crop, or crop

fractions, grown in rotation 120 days

after soil treatment.

2. Analytical method. Residue

analytical methods were validated based

upon gas chromatography coupled with

a mass selective detector (GC- MSD).

The limit of detection of the methods is

0.005 ppm and a level of quantitation is

0.01 ppm.

3. Magnitude of residues. No

detectable residues of cloransulammethyl resulted in soybeans from either

preplant incorporated or post emergence

applications, in soybean forage or hay
Federal Register / Vol. 62, No. 58 / Wednesday, March 26, 1997 / Notices 33

following preplant applications, and in

the majority of cases, in soybean forage

or hay following postemergence

applications. No residues of

cloransulam-methyl were detected in

the soybeans or processed fractions

above the analytical method limit of

detection of 0.005 ppm following 5× the

proposed maximum postemergence

application rate.

B. Toxicological Profile

1. Acute toxicity. Cloransulam-methyl

acute toxicity is low. Acute oral LD50 in

the rat is >5,000 mg/kg in both males

and females and the acute dermal LD50

in the rabbit is >2,000 mg/kg. The

inhalation LC50 in the rat is >3.77 mg/

l of air, which is the highest obtainable

respirable aerosol concentration.

Cloransulam-methyl produced no

indications of dermal irritation in

rabbits or sensitization in the guinea

pig, and only slight transient eye

irritation in the rabbit following acute

exposure.

2. Genotoxicity. In a battery of shortterm genotoxicity tests, cloransulammethyl showed no evidence of a

mutagenic potential. These tests

included a bacterial reverse mutation

assay (Ames test), an in vitro cytogenic

assay in Chinese hamster ovary cells

(CHO/HGPRT assay), an in vitro

chromosomal aberration assay in rat

lymphocytes, and an in vivo cytogenetic

assay in mouse bone marrow cells.

3. Reproductive and developmental

toxicity. Cloransulam-methyl exhibited

no effects on reproduction or fetal

development. In a multigeneration

reproduction study in rats, no effects on

reproductive performance or neonatal

survival were seen at the highest dose

tested.

In a developmental toxicity study in

rats, no maternal or developmental

toxicity was seen at the highest dose

tested (limit test at 1,000 mg/kg).

In a developmental toxicity study in

rabbits, the maternal NOEL was 100 mg/

kg/day and the developmental NOEL

was at least 300 mg/kg/day.

4. Subchronic toxicity. In a 21-day

repeated dermal application study in

rabbits, cloransulam-methyl when given

at a dose of 1,000 mg/kg/day produced

only slight anemia in female rabbits

while male rabbits were unaffected at

the highest dose tested. The NOEL was

500 mg/kg/day for females and 1,000

mg/kg/day in males. Cloransulammethyl was evaluated in 13-week

dietary studies in rats, mice and dogs.

The primary target organs identified in

these studies were the kidneys (rat), the

liver (mouse and dog), and thyroid (rat).

An NOEL was not determined in the rat

base upon minor histopathological

changes in the kidney (males) and the

liver (females). In the mouse, the NOEL

was 50 mg/kg/day in male mice and 100

mg/kg/day in female mice based upon

hepatocellular hypertrophy. An NOEL

was not established in the dog based

upon slightly lower body weights at the

lowest dose tested, 40 mg/kg/day.

5. Chronic toxicity. In a 2-year

combined chronic toxicity/oncogenicity

study in the rat, the NOEL for chronic

toxicity was 10 mg/kg/day based upon

kidney and thyroid effects: hypertrophy

of collecting duct epithelial cells and

vacuolation consistent with fatty change

in the proximal tubules of males and

females, and an increase in the

incidence of mineralization of the renal

pelvis in males. Thyroid changes were

confined to the high dose males and

consisted of hyperplasia and

hypertrophy of follicular epithelium. In

a 2- year dietary feeding study in

B6C3F1 mice, the NOEL for chronic

toxicity was also 10 mg/kg/day base

upon the liver as he primary target

organ. There were increased liver

weights and histologic changes

consisting of centrilobular hypertrophy

in males. Kidney weights were

decreased in males and females, and

depletion of the normal ctyoplasmic

vacuoles and decreases in the incidence

of renal mineralization and renal

tubular degeneration were noted in

males. All of these histologic changes

were interpreted to be non-adverse.

There was no evidence of an oncogenic

response in either male or female mice

or rats. In a 1-year chronic toxicity study

in dogs, the NOEL was 5 mg/kg/day

based upon an increase in accumulation

of pigment in Kuppfer cells and

hepatocytes with changes in hepaticrelated serum chemistry parameters.

6. Animal metabolism. Metabolism

studies conducted on cloransulammethyl indicated over 90 percent of a

single or repeated dose was absorbed at

5 mg/kg and at 1,000 mg/kg/day, there

was incomplete absorption of

cloransulam-methyl, with only 28-30

percent of the dose absorbed. Urinary

elimination was rapid with half-lives of

approximately 6-9 hours. Sex dependent

differences in disposition of the 5 mg/

kg dose were traced to more efficient

elimination of unchanged cloransulammethyl in the female versus male kidney

but are of no known toxicologic

significance. Due to its rapid

elimination, cloransulam-methyl has

little potential to accumulate upon

repeated administration.

7. Metabolite toxicology. The residue

of concern for tolerance setting purposes

is the parent material (cloransulammethyl). Thus there is no need to

address metabolite toxicity.

C. Aggregate Exposure

1. Dietary Exposure

a. Food. For Purpose of assessing the

potential dietary exposure from use of

cloransulam-methyl on soybeans, a

conservative estimate of aggregate

exposure is determined by TMRC

assuming that 100 percent of the

soybean crop has a residue of

cloransulam-methyl at the tolerance

level of 0.02 ppm. This results in an

extremely conservative estimate of

exposure for cloransulam-methyl,

because no residues were detected in

soybeans at a level 4× lower than the

proposed tolerance level based upon

applications made either at the

proposed maximum label rate, or at a

rate 5× higher than the proposed

maximum application rate in an

exaggerated rate residue study. The

potential dietary exposure is obtained

by multiplying the tolerance residue

level on soybeans (0.02 ppm) by the

consumption data which estimates the

amount of soybean products consumed

by various population subgroups. The

maximum potential average daily dose

(ADD) of cloransulam-methyl values

determined for various populations are

clearly significant overestimates

compared with actual exposure. When

ADDs are compared to the Reference

Dose (RfD), which used the lowest

NOEL of 5 mg/kgBW/day from the 1-

year dog chronic toxicity study and an

uncertainty factor of 100, the ADD for

the average U.S. consumer utilizes only

about 0.01 percent of the RfD, and even

the highest risk group, non-nursing

infants, would theoretically be exposed

to less than 0.07 percent of the RfD. If

the margin of safety (MOS) or safety

factor approach is used, the calculated

MOSs are 7,600 for the average U.S.

population and 1,500 for non-nursing

infants. DowElanco believes it is evident

from these very conservative estimates

that cloransulam-methyl poses no

significant dietary risk to any human

population.

b. Drinking water. Another potential

source of dietary exposure are residues

in drinking water. Base upon the

available environmental studies

conducted with cloransulam-methyl

wherein it’s properties show little

potential for mobility in soil and

extremely rapid photolysis in water,

DowElanco concludes, there is no

anticipated exposure to residues of

cloransulam-methyl in drinking water.

2. Non-dietary exposure. There are no

other uses currently registered for

cloransulam-methyl. The proposed use

in on soybeans involves application of

cloransulam-methyl to crop grown in an

agricultural environment. Thus, the
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