Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices 27723

SUMMARY: A meeting of the National

Advisory Committee for Acute Exposure

Guideline Levels for Hazardous

Substances (NAC/AEGL Committee)

will be held on June 8–10, 1998, in

Washington, DC. At this meeting, the

NAC/AEGL Committee will address the

various aspects of the acute toxicity and

the development of Acute Exposure

Guideline Levels (AEGLs) for the

following chemicals: acrolein, carbon

tetrachloride, chloroform,

crotonaldehyde, hydrogen sulfide,

nickel carbonyl, nitrogen oxides,

peracetic acid, propylene imine, and

propylene oxide.

DATES: A meeting of the NAC/AEGL

Committee will be held from 10 a.m. to

5 p.m. on Monday, June 8, 1998; from

8:30 a.m. to 5 p.m. on Tuesday, June 9,

1998; and from 8:30 a.m. to 1 p.m. on

Wednesday, June 10, 1998.

ADDRESSES: The meeting will be held at

the National Endowment for the Arts,

1100 Pennsylvania Ave., NW., Rm. M09,

Washington, DC 20506 (located in the

Old Post Office Building, across the

street from the Federal Triangle Metro

stop).

FOR FURTHER INFORMATION CONTACT: Paul

S. Tobin, Designated Federal Officer

(DFO), Office of Prevention, Pesticides,

and Toxic Substances (7406), 401 M St.,

SW., Washington, DC 20460; (202) 260–

1736; e-mail: tobin.paul@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Electronic Availability

Internet

Electronic copies of this notice and

various support documents are available

from the EPA Home Page at the Federal

Register—Environmental Documents

entry for this document under ‘‘Laws

and Regulations’’ (http://www.epa.gov/

fedrgstr/).

Fax-On-Demand

Using a faxphone call (202) 401–0527

and select item 4800 for an index of

items in this category.

II. Meeting Procedures

For further information on the

meeting, the meeting agenda, the

submission of information, or

presentation of information on

chemicals to be discussed, contact the

DFO.

The meeting of the NAC/AEGL

Committee will be open to the public.

Oral presentations or statements by

interested parties will be limited to 10

minutes. Interested parties should

contact the DFO to schedule statements

or presentations before the NAC/AEGL

Committee. Since seating for outside

observers may be limited, those wishing

to attend the meeting as observers

should also contact the DFO as soon as

possible to ensure adequate seating

arrangements. Direct all inquiries

regarding oral presentations, oral

statements, submission of written

statements, or chemical-specific

information to the DFO.

Another meeting of the NAC/AEGL

Committee is expected to be held

September 1998, but the exact date and

meeting location are not yet determined.

It is anticipated that the chemicals to be

addressed at this meeting will include,

but are not limited to, the following:

cylohexylamine, ethylene diamine,

glycol ether acetate, HFC–134a, HCFC–

141b, methyl isocyanate, piperidine

sulfur dioxide, sulfur trioxide, and

sulfuric acid. Direct inquiries regarding

the submission of data, written

statements, or chemical-specific

information on the chemicals listed for

the September 1998 meeting to the DFO

as soon as possible to allow for

consideration of this information in the

preparation of the NAC/AEGL

Committee materials.

List of Subjects

Environmental protection, Hazardous

substances, Health.

Dated: May 14, 1998.

William H. Sanders, III,

Director, Office of Pollution Prevention and

Toxics.

[FR Doc. 98–13445 Filed 5–19–98; 8:45am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–793; FRL–5773–2]

Notice of Filing of Pesticide Petition

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 the pesticide

chemical pymetrozine, in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–793, must be

received on or before June 19, 1998.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7506C), Office of Pesticides 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.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

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: The

product manager listed in the table

below:

Product Manager Office location/telephone number Address

Leonard Cole ................. Rm. 211, CM #2, 703–305–5412, e-mail:cole.leonard@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various food commodities under section

408 of the Federal Food, Drug, and

Comestic Act (FFDCA), 21 U.S.C. 346a.

EPA has determined that these petitions
27724 Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices

contain 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 supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–793]

(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 official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

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. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 file format or ASCII

file format. All comments and data in

electronic form must be identified by

the docket number (insert docket

number) and appropriate petition

number. Electronic comments on this

notice may be filed online at many

Federal Depository Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: May 6, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them 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.

Norvartis Crop Protection, Inc.

PP 8F4929

EPA has received a pesticide petition

(PP 8F4929) from Norvartis Crop

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

Greensboro, NC 27419–8300 proposing

pursuant to section 408(d) of the Federal

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

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

establishing a tolerance for residues of

Pymetrozine in or on the raw

agricultural commodity cucumbers,

fruiting vegetables, potatoes, hops at

0.02, 0.05 parts per million. 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 supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of CGA–215944 in plants is understood

for the purposes of the proposed

tolerance. Studies in rice, tomatoes,

cotton and potatoes gave similar results.

Identified metabolic pathways have

demonstrated that pymetrozine is the

residue of concern for tolerance setting

purposes.

2. Analytical method— i. Crops.

Novartis has submitted two analytical

methods for the determination of

pymetrozine and its major crop

metabolite, in crop substrates. For both

methods, the limit of detection (LOD) is

1.0 ng and the limit of quantitation

(LOQ) is 0.02 ppm. Samples are

extracted using acetonitrile: 0.05M

sodium borate and an aliquot is taken

for each method. The aliquots were

cleaned up with solid-phase and/or

liquid-liquid partitions and analyzed by

HPLC with column-switching and UV

detection. Both methods have

undergone independent laboratory

validation. The pymetrozine Analytical

Method is proposed as the tolerance

enforcement method.

ii. Livestock. Novartis has also

submitted analytical methods for the

determination of pymetrozine in eggs,

milk and poultry, dairy and goat tissues,

and for its major livestock metabolite in

dairy and goat tissues and milk. This

method also accounts for a phosphate

conjugate, which is a significant

metabolite found only in milk. The LOD

for the analytical method is 1.0 ng and

the LOQ is 0.01 ppm. Samples are

extracted using acetonitrile: Water,

cleaned up with solid-phase and liquidliquid partitions, and analyzed for

pymetrozine by HPLC with column

switching and UV detection. The LOD

for the metabolite method is 1.5 ng and

the is LOQ of 0.01 ppm. Samples are

extracted using methanol: Water. Milk

samples are heated to hydrolyze the

phosphate conjugate, and all samples

are cleaned up with solid-phase

partitions and analyzed by HPLC with

UV detection. The parent Analytical

Method has successfully undergone

independent laboratory validation.

3. Magnitude of residues—i.

Cucurbits. Twenty-two field trials were

conducted in 13 states representing

typical fruiting vegetables growing areas

in the United States, including Arizona,

California, Florida, Georgia, Indiana,

Michigan, New York, North Carolina,

Ohio, Oregon, South Carolina, and

Texas. Cantaloupes, summer squash,

and cucumbers were treated with two

post foliar applications of pymetrozine

50WG at 21 and 14 days prior to harvest

of mature fruit using a 1X rate of 80 g

a.i./A per application (160 g a.i. or 0.35

lb a.i.per a). Samples of summer squash

and cucumbers from early harvest

harvest intervals (pre-harvest interval

(PHI) < 14 days) were collected to

demonstrate decline of residues of

pymetrozine.

Residue data were generated for

pymetrozine for tolerance setting and

dietary exposure estimates. Data was

generated for a major metabolite for

dietary exposure purposes only as this

metabolite does not need to be part of

the tolerance expression. No

pymetrozine residues were found in

cantaloupes treated at the 1X rate and

harvested at the target PHI of 14 days.

Maximum GS–23199 residues of 0.02

ppm were found in only 1 of 16

cantaloupe samples. The maximum

pymetrozine residues found in summer

squash samples treated at the 1X rate

were 0.02 ppm in a sample harvested at

0–day PHI. No pymetrozine residues

were found in any 3–day, 7–day, or 14–

day sample of squash treated at the 1X

rate. No metabolite residues were found

in any summer squash sample at any

PHI. No pymetrozine or metabolite

residues were found in any sample of

cucumbers treated at the 1X rate and

harvested at 14 days PHI.

No residues of pymetrozine are

expected in cucurbits vegetables treated

at the 1X rate and harvested 14 days

after the last application.

ii. Fruiting vegetables. Seventeen field

trials were conducted in 12 states

representing typical fruiting vegetable

growing areas in the United States,

including California, Florida, Indiana,

Maryland, Michigan, New Jersey, New

Mexico, North Carolina, Ohio,

Pennsylvania, Tennessee, and Texas.

Tomatoes and peppers were treated
Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices 27725

with two post foliar applications of

pymetrozine 50 WP 21 and 14 days

prior to harvest of mature fruit using a

1X rate of 80 g active ingredient/acre

(a.i./A), a 2X rate of 160 g a.i./A, a 3X

rate of 240 g a.i./A, and a 5X rate of 400

g a.i./A per application. Samples from

early harvest intervals (pre-harvest

interval < 14 days) were collected to

demonstrate decline of residues of

pymetrozine. Mature fruit from two

tomato field trials were processed under

simulated commercial practice.

Residue data were generated for

pymetrozine for tolerance setting and

dietary exposure estimates. Data was

generated for the major metabolite for

dietary exposure purposes only as this

metabolite does not need to be part of

the tolerance expression. Pymetrozine

residues were found in 0– and 3–day

PHI samples of tomatoes treated at the

1X rate, but in none of the 7–day PHI

1X samples analyzed. No pymetrozine

residues were found in tomatoes treated

at the 1X rate and harvested at the target

PHI of 14 days. No residues of the

metabolite were found in samples

harvested with 0–, 3–, or 7–day PHI, but

metabolite residues of 0.02 ppm were

found in 1 of 22 1X tomato samples

harvested with a 14–day PHI.

All analyzed tomato samples treated

at exaggerated rates were harvested with

a 14–day PHI. No pymetrozine residues

were found in any 2X tomato sample.

The maximum pymetrozine residues

found in 3X and 5X samples were 0.04

ppm and 0.10 ppm. The maximum

residues found in 2X, 3X, and 5X

samples were 0.02 ppm, 0.08 ppm, and

0.10 ppm.

All analyzed processed tomato

fractions were from tomatoes harvested

with a 14–day PHI. No residues of

pymetrozine were found in any

processed fraction from tomatoes treated

at exaggerated rates. No 1X processed

tomato fraction samples were analyzed.

The maximum residues of metabolite

found in tomato processed fractions

were 0.4 ppm in juice from tomatoes

treated at the 5X rate.

All pepper samples analyzed were

treated at the 1X rate. Pymetrozine

residues of 0.04 ppm were found in 1 of

20 pepper samples harvested at a 14–

day PHI. Pymetrozine residues were

found in all eight 0–day PHI samples,

but in none of the four 3–day or 7–day

PHI samples analyzed. No metabolite

residues were found in any pepper

sample at any PHI.

Little or no residues of pymetrozine

are expected in fruiting vegetables

treated at the 1X rate and harvested 14

days after the last application.

Tuberous and corm vegetables.

Sixteen field trials were conducted in 13

States representing typical potato

growing areas in the United States,

including Idaho, Washington, Oregon,

California, Florida, North Dakota,

Minnesota, North Carolina, Wisconsin,

Colorado, Maine, New York, and

Michigan. Potatoes were treated with

two foliar applications of pymetrozine

50 WP made 21 and 14 days prior to

first harvest using a 1X rate of 40 g a.i./

A, a 3X rate of 120 g a.i./A, and a 5X

rate of 400 g a.i./A per application.

Samples from early harvest intervals

(PHI < 14 days) were collected to

demonstrate decline of residues of

pymetrozine.

Residue data was generated for

pymetrozine for tolerance setting and

dietary exposure estimates. Data was

generated for the major metabolite for

dietary exposure purposes only as this

metabolite does not need to be part of

the tolerance expression. No residues of

pymetrozine or GS–23199 were found in

potatoes or processed fractions for any

application rate at any PHI in this study.

iii. Tobacco. Five field trials were

conducted in five states representing

typical tobacco growing areas in the

United States, including North Carolina,

South Carolina, Tennessee, Kentucky,

and Virginia. Tobacco was treated with

two post foliar applications of

pymetrozine 50 WP 21 and 14 days

prior to harvest of mature leaves. Rates

of 20 g a.i./A and 40 g a.i./A per

application were used. Samples from

early harvest intervals (PHI < 14 days)

were collected to demonstrate decline of

residues of pymetrozine.

The maximum residues of

pymetrozine found in green leaves of

tobacco harvested at 14 days after last

application were 0.05 ppm. The

maximum residues of metabolite found

in green leaves harvested at 14 days

after last application were 0.04 ppm.

The maximum Detectable residues of

pymetrozine found in 23 of 24 samples

of cured leaves of tobacco harvessted at

14 days after last application was 0.39

ppm. The maximum residues of

metabolite found in cured leaves

harvested at 14 days after last

application were 0.20 ppm.

In decline studies, detectable residues

of pymetrozine were found to decrease

with increasing PHI in green leaves.

Maximum average metabolite GS–23199

residues were found in 3– and 7– day

samples with the lowest average

residues in 14–day samples.

iv. Hops. Data from eight field trials,

conducted in Germany, were submitted

August 6,1996. The residue data support

a tolerance of 5.0 ppm with a 14–day

PHI.

v. Livestock. A three-level dairy

feeding study was conducted using

pymetrozine as the test substance.

Holstein dairy cows were dosed daily

with pymetrozine at levels equivalent to

0 (Control), 1.0 ppm, 3.0 ppm and 10

ppm. These rates represents 8, 24 and

80 times the maximum expected

contribution to the diet. This study was

designed to provide data concerning the

level of residues of pymetrozine, as

pymetrozine and CGA–313124, in milk

and tissues which could occur as a

result of feeding crops treated with

pymetrozine to dairy cows. The results

are used to estimate the transfer of

residues from the diet to the tissues and

milk of livestock.

No detectable residues of pymetrozine

or CGA–313124 were observed in

samples of liver, kidney, perirenal fat,

omental fat, round muscle, or tenderloin

muscle from cows dosed with 10 ppm

(80X) pymetrozine. No detectable

residues of pymetrozine were observed

in samples of milk from cows dosed

with 10 ppm (80X), 3 ppm (24X), or 1

ppm (8X) pymetrozine at any sampling

interval. Detectable residues of CGA–

313124 occurred only in milk samples

from 80X dosed cows at a maximum

level of 0.05 ppm. These results indicate

that there is no need to establish a meat

and milk tolerance.

B. Toxicological Profile

1. Acute toxicity. Pymetrozine has low

acute toxicity. The oral LD50 in rats is

> 5,820 milligrams per kilogram (mg/kg)

for males and females, combined. The

rat dermal LD50 is > 2,000 mg/kg and the

rat inhalation LC50 is > 1.8 mg/L air.

Pymetrozine is not a skin sensitizer in

guinea pigs and does not produce

dermal irritation in rabbits. It produces

minimal eye irritation in rabbits. Enduse water-dispersible granule

formulations of pymetrozine have

similar low acute toxicity profiles.

2. Genotoxicty. Pymetrozine did not

induce point mutations in bacteria

(Ames assay in Salmonella

typhimurium and Escherichia coli) or in

cultured mammalian cells (Chinese

hamster V79) and was not genotoxic in

an in vitro unscheduled DNA synthesis

assay in rat hepatocytes. Chromosome

aberrations were not observed in an in

vitro test using Chinese hamster ovary

cells and there were no clastogenic or

aneugenic effects on mouse bone

marrow cells in an in vivo mouse

micronucleus test. These studies show

that pymetrozine is not genotoxic.

3. Reproductive and developmental

toxicity. In a teratology study in rats,

pymetrozine caused decreased body

weights and food consumption in

females given 100 and 300 mg/kg/day

during gestation. This maternal toxicity

was accompanied by fetal skeletal
27726 Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices

anomalies and variations consistent

with delayed ossification. The noobserved-effect level (NOEL) for

maternal and fetal effects in rats was 30

mg/kg/day. A teratology in rabbits

showed that pymetrozine caused

maternal death and reduced body

weight gain and food consumption at

125 mg/kg/day (highest dose tested).

Maternal toxicity was accompanied by

embryo- and feto-toxicity (abortion in

one female and total resorptions in two

females). Body weight and food

consumption decreases, early

resorptions and postimplantation losses

were also observed in maternal rabbits

given 75 mg/kg/day. There was an

increased incidence of fetal skeletal

anomalies and variations at these

maternally toxic doses. The NOEL for

maternal and fetal effects in rabbits was

10 mg/kg/day. Pymetrozine is not

teratogenic in rats or rabbits. In a two

generation reproduction study in rats,

parental body weights and food

consumption were decreased, liver and

spleen weights were reduced and

histopathological changes in liver,

spleen and pituitary were observed at

2,000 ppm (highest dose tested). Liver

hypertrophy was observed in parental

males at 200 ppm (approximately 10–40

mg/kg/day). Reproductive parameters

were not affected by treatment with

pymetrozine. The NOEL for

reproductive toxicity is 2,000 ppm

(approximately 110–440 mg/kg/day).

Offspring body weights were slightly

reduced at 2,000 and 200 ppm and eye

opening was slightly delayed in pups at

2,000 ppm. Effects on offspring were

secondary to parental toxicity. The

NOEL for toxicity to adults and pups is

20 ppm (approximately 1–4 mg/kg/day).

4. Subchronic toxicity. Pymetrozine

was evaluated in 13–week subchronic

toxicity studies in rats, dogs and mice.

Liver, kidneys, thymus and spleen were

identified as target organs. The NOEL

was 500 ppm (33 mg/kg/day) in rats and

100 ppm (3 mg/kg/day) in dogs. In mice,

increased liver weights and

microscopical changes in the liver were

observed at all doses tested. The NOEL

in mice was < 1,000 ppm (198 mg/kg/

day). No dermal irritation or systemic

toxicity occurred in a 28–day repeated

dose dermal toxicity study with

pymetrozine in rats given 1,000 mg/kg/

day. Minimum direct dermal absorption

(1.1%) of pymetrozine was detected in

rats over a 21 hour period of dermal

exposure. Maximum radioactivity left

on or in the skin at the application site

and considered for potential absorption

was 11.9%.

5. Chronic toxicity. Based on chronic

toxicity studies in the dog and rat, a

reference dose (RfD) of 0.0057 mg/kg/

day is proposed for pymetrozine. This

RfD is based on a NOEL of 0.57 mg/kg/

day established in the chronic dog study

and an uncertainty factor of 100 to

account for interspecies extrapolation

and interspecies variability. Minor

changes in blood chemistry parameters,

including higher plasma cholesterol and

phospholipid levels, were observed in

the dog at the lowest-observed-effect

level (LOEL) of 5.3 mg/kg/day. The

NOEL established in the rat chronic

toxicity study was 3.7 mg/kg/day, based

on reduced body weight gain and food

consumption, hematology and blood

chemistry changes, liver pathology and

biliary cysts.

6. Animal metabolism. The

metabolism of pymetrozine (CGA–

215944) in the rat is well understood.

Metabolism involves oxidation of the 5-

methylene group of the triazine ring

yielding 4,5-dihydro-5-hydroxy-6-

methyl-4-[(3-

pyridinylmethylene)amino]-1,2,4-

triazin-3(2H)-one (CGA–359009).

Oxidation of the methyl substituent of

the triazine ring led to 4,5-dihydro-6-

(hydroxymethyl)-4-[(3-

pyridinylmethylene)amino]-1,2,4-

triazin-3(2H)-one (CGA–313124) which

was further oxidized to the

corresponding carboxylic acid, 4,5-

dihydro-6-carboxy-4-[(3-

pyridinylmethylene)amino]-1,2,4-

triazin-3(2H)-one. Hydrolysis of the

enamino bridge yielded 4-amino-6-

methyl-1,2,4-triazin-3,5(2H,4H)-dione

(CGA–294849). This was further

degraded to 6-methyl-1,2,4-triazin3,5(2H,4H)-dione (METABOLITE).

Hydrolysis of the enamino bridge of

CGA–215944 produced CGA–215525

which undergoes either acylation (CGA–

259168) or deamination yielding 4,5-

dihydro-6-methyl-1,2,4-triazin-3(2H)-

one (CGA–249257). Hydrolysis of the

enamino bridge also formed 3-

pyridinecarboxaldehyde (CGA–300407),

nicotinic acid (CGA–180777),

nicotinamide (CGA–180778), 3-

pyridinemethanol (CGA–128632) and

1,6-dihydro-1-methyl-6-oxo-3-

pyridinecarboxamide. Identified

metabolic pathways in animals and

plants are similar.

7. Metabolite toxicology. The residue

of concern for tolerance setting purposes

is the parent compound. Metabolites of

pymetrozine are considered to be of

equal or lesser toxicity than the parent.

8. Endocrine disruption. Pymetrozine

does not belong to a class of chemicals

known or suspected of having adverse

effects on the endocrine system. There

is no evidence that pymetrozine has any

effect on endocrine function in

developmental and reproduction

studies. Furthermore, histological

investigation of endocrine organs in

chronic dog, rat and mouse studies did

not indicate that the endocrine system

is targeted by pymetrozine.

C. Aggregate Exposure

1. Food. For purposes of assessing the

potential dietary exposure under the

proposed tolerances, Novartis has

estimated aggregate exposure based on

exposure from residues of 0.05 ppm on

fruiting vegetables, 0.02 ppm on

cucurbits, 0.02 ppm on potatoes and 5

ppm on hops. A 100% market share was

assumed.

2. Drinking water. Another potential

source of exposure of the general

population to pymetrozine is via

residues in drinking water. Pymetrozine

is not expected to contaminate drinking

water based on its environmental

attributes and the low application rates

applied. Pymetrozine breaks down

relatively quickly in the environment by

a wide variety of mechanisms and

degradation pathways. Leaching studies

showed that pymetrozine is tightly

bound to soil and is unlikely to leach in

the field. Field dissipation studies show

little movement beyond the uppermost

soil horizon.

3. Non-dietary exposure. There are no

other uses currently registered for

pymetrozine. The proposed uses involve

application of pymetrozine to crops

grown in an agricultural environment.

There are no proposed uses which

would be expected to result in

residential exposure of pymetrozine.

Therefore, there is no potential for nonoccupational exposure to the general

population. is not expected to be

significant.

D. Cumulative Effects

The potential for cumulative effects of

pymetrozine and other substances that

have a common mechanism of toxicity

has also been considered. Pymetrozine

belongs to a new chemical class known

as pyridine azomethines. It exhibits a

unique mode of action which can be

characterized as nervous system

inhibition of feeding behavior. It does

not have a general toxic or paralyzing

effect on insects, but selectively

interferes with normal feeding activities

by affecting nervous system regulation

of fluid intake. There is no reliable

information to indicate that toxic effects

produced by pymetrozine would be

cumulative with those of any other

chemical including another pesticide.

Therefore, Novartis believes it is

appropriate to consider only the

potential risks of pymetrozine in an

aggregate risk assessment.
Federal Register / Vol. 63, No. 97 /Wednesday, May 20, 1998 / Notices 27727

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions and

the proposed RfD described above, the

aggregate exposure to pymetrozine will

utilize 3.78% 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

exposure over a lifetime will not pose

appreciable risks to human health.

Therefore, Novartis concludes that there

is a reasonable certainty that no harm

will result from aggregate exposure to

pymetrozine residues.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

pymetrozine, data from developmental

toxicity studies in the rat and rabbit and

a two-generation reproduction study in

the rat have been considered.

In a teratology study in rats,

developmental toxicity anomalies and

variations associated was observed only

at maternally toxic doses. Similarly, in

a rabbit teratology study, was observed

only at maternally toxic doses. The

NOELs in the rat and rabbit teratology

studies were 30 and 10 mg/kg/day,

respectively. In the two-generation

reproduction study, there were no

effects on reproductive parameters.

Offspring body weights were slightly

reduced and eye opening was slightly

delayed at dose levels producing

parental toxicity. The NOEL for parental

and offspring toxicity was 20 ppm

(approximately 1–4 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- and

post-natal toxicity and the completeness

of the database. Based on the current

toxicological requirements, the database

relative to pre- and post-natal effects for

children is complete. Further, for

pymetrozine, the NOEL of 0.57 from the

chronic feeding study in dogs, which

was used to calculate the RfD (0.0057

mg/kg/day), is already lower than the

developmental NOELs (30 and 10 mg/

kg/day) from the teratogenicity studies

in rats and rabbits by a factor of more

than tenfold. In the pymetrozine rat

reproduction study, the mild nature of

the effects observed (decreased body

weight) at the systemic LOEL (10–40

mg/kg/day) and the fact that the effects

were observed at a dose that is more

than 10 times greater than the NOEL in

the chronic dog study (0.57 mg/kg/day)

suggest that there is no additional

sensitivity for infants and children.

Therefore, it is concluded that an

additional uncertainty factor is not

warranted to protect the health of

infants and children and that an RfD of

0.0057 mg/kg/day based on the chronic

dog study is appropriate for assessing

aggregate risk to infants and children

from pymetrozine.

Using the exposure assumptions

described above, the percent of the RfD

that will be utilized by aggregate

exposure to residues of pymetrozine is

0.43% for nursing infants less than 1

year old, 1.49% for non-nursing infants,

3.44% for children 1–6 years old and

2.72% for children 7–12 years old.

Therefore, based on the completeness

and reliability of the toxicity database,

Novartis concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to pymetrozine

residues.

F. International Tolerances

There are no Codex maximum levels

established for residues of pymetrozine.

[FR Doc. 98–13447 Filed 5–19–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–804; FRL–5788–8]

Westvaco Corporation; Pesticide

Tolerance Petition Filing

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 the

docket control number PF–804, must be

received on or before June 19, 1998.

ADDRESSES: By mail submit written

comments to: Information and Records

Integrity Branch, Public Information and

Services Divison (7502C), Office of

Pesticides Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person bring

comments to: Rm. 119, CM #2, 1921

Jefferson Davis Highway, Arlington, VA.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

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. 119 at the address

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

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT:

Bipin C. Gandhi, Registration Support

Branch, 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. 4-W53, Crystal

Station ι1, 2800 Jefferson Davis

Highway, Arlington, VA 22202, (703)

308–8380; e-mail:

gandhi.bipin@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemical in or on

various food commodities 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 supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–804]

(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 official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

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. Comment and data will