6526 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

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

notice.

List of Subjects

Environmental protection,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 30, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

[FR Doc. 97–3224 Filed 2–11–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–704; FRL–5586–5]

Entek; Pesticide Tolerance Petition

Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

tolerances for residues of carbon

disulfide in or on almond nutmeats,

almond hulls, peaches and plums (fresh

prunes). This notice includes a

summary of the petition that was

prepared by the petitioner, Entek

Corporation.

DATES: Comments, identified by the

docket number [PF-704], must be

received on or before, March 14, 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.

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 in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by docket number

[PF-704]. 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 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:

Cynthia Giles-Parker, Product Manager

(22), Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location, telephone number, and

e-mail address: Rm. 229, CM #2, 1921

Jefferson Davis Highway, Arlington, VA,

703–305–5540, e-mail: gilesparker.cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP

5F4482) from Entek Corporation, P.O.

Box 458, Brea, CA 92822, proposing

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

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

180.467 by establishing a tolerance, at

0.1 part per million (ppm), for residues

of the fumigant carbon disulfide

resulting from the soil application of

sodium tetrathiocarbonate in or on the

raw agricultural commodities almond

nutmeats, almond hulls, peaches and

plumes (fresh prunes). The proposed

analytical method is gas

chromatography using a sulfur specific

detector. 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 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.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act (Pub. L.

104-170), Entek Corporation 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 Entek

Corporation. EPA 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 has made minor edits to the

summary for the purpose of clarity.

I. Entek’s Petition Summary

A. Residue Chemistry

1. Plant metabolism. Radiolabel

metabolism studies, using 14C labeled

sodium tetrathiocarbonate, were

conducted with potatoes and tomatoes.

The studies established that sodium

tetrathiocarbonate rapidly degrades in

soil and plants and the resulting

residues are carbon disulfide (CS2), free

and bound. No other residues of

concern were identified in the

radiolabel or other residue chemistry

studies submitted by the petitioner.

2. Analytical method. An adequate

analytical method for detecting free and

bound CS2 residues in plants is

available. The method has been

validated by EPA. In brief, plant

material is blended with water in a

sealed container. Aliquots of the gas and

liquid phases are removed and the free

CS2 content is determined by purge-andtrap gas chromatography using a sulfurspecific detector. A sample of the liquid

phase, purged for free CS2, is subjected

to hot acid hydrolysis followed by

purge-and-trap gas chromatography in

order to measure the bound CS2 content.

In general, the limit of detection for the

analytical method is 0.5 ppb and the

limit of quantitation is 1.7 parts per

billion (ppb).

3. Magnitude of residues. Two field

trials were conducted for each crop

(peaches, plums and almonds). Trials

were all conducted in California since it

is the predominant growing area for

each of the requested raw agricultural

commodities (RACs) and the petitioner

has proposed to limit use of Enzone

(the product containing sodium

tetrathiocarbonate) to Arizona,

California, Oregon, and Washington. In

each trial, sodium tetrathiocarbonate

was applied in amounts equal to or

greater than the maximum label rate and

pretreatment, control and treatment

samples were analyzed for free and

bound CS2.

In the plum and peach trials, very low

levels (<20 ppb) of free and bound CS2

were observed in pretreated, control and

treatment samples. In both almond

trials, very low levels of free or bound

CS2 (< 10 ppb) were observed in almond

nutmeats. In one of the almond trials,

unusually high levels of bound CS2

(from 567–6,761 ppb) were observed in

control and treated almond hull
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices 6527

samples. The petitioner believes that

these atypical levels were most likely

due to high natural occurrence or drift

of an ethylene bisdithiocarbamate

(EBDC) pesticide from a nearby source.

Rigorous statistical analysis of the

sample data clearly showed that there is

no increase in CS2 (free or bound) above

background levels for treated almond,

pear or plum trees when compared to

untreated or control trees.

B. Toxicological Profile

1. Acute toxicity. Technical sodium

tetrathiocarbonate (32% active

ingredient) is moderately toxic by the

oral route, with a combined acute oral

LD50 of 631 milligrams/kilograms (mg/

kg) in the rat. Technical sodium

tetrathiocarbonate is practically

nontoxic by dermal application (acute

dermal LD50 > 2,000 mg/kg) and slightly

toxic after a 4-hour inhalation exposure

(acute LC50 is 4.73 mg/L (males) and

3.17 mg/L (females). Technical sodium

tetrathiocarbonate is corrosive to skin

and eyes but is not a dermal sensitizer.

2. Genotoxicity. In the bacterial gene

mutation test (Ames) technical sodium

tetrathiocarbonate was negative, with or

without metabolic activation. Technical

sodium tetrathiocarbonate was also

negative in a mammalian gene mutation

assay (CHO/HGPRT), with or without

metabolic activation. In the

chromosome aberration assay, technical

sodium tetrathiocarbonate gave a

weakly positive result under activation

conditions. Technical sodium

tetrathiocarbonate was negative in the

unscheduled DNA Synthesis assay. On

the basis of the mutagenicity battery,

Entek concludes that sodium

tetrathiocarbonate is not mutagenic or

genotoxic.

3. Developmental toxicity.

Developmental toxicity studies with

sodium tetrathiocarbonate were

performed in the rat and rabbit. In the

rat study, pregnant rats were

administered sodium tetrathiocarbonate

at doses of 0, 150, 400, 450 and 500 mg/

kg/day on gestation days 6 through 15.

Necropsy examinations of the animals

that died and animals that survived to

final sacrifice did not reveal any lesions

which could be attributed to sodium

tetrathiocarbonate. Treatment with 150,

400 or 450 mg/kg/day of sodium

tetrathiocarbonate did not alter fetal,

skeletal or visceral development. The

developmental toxicity no observed

effect level (NOEL) for this study is 450

mg/kg/day. In the rabbit study, pregnant

rabbits were administered sodium

tetrathiocarbonate at doses of 0, 75, 150

and 185 mg/kg/day on days 7-19 of

gestation. Developmental effects

(elevated resorptions and increased

post-implantation loss) were observed at

185 mg/kg/day; developmental effects

were not observed at the lower dose

levels. The developmental toxicity no

observed effect level (NOEL) for this

study is 150 mg/kg/day.

Entek has requested waivers for

several of the toxicology studies that are

normally required for crop tolerances.

These include: 90–day oral toxicity

study (rat and dog); 2-generation

reproduction (rat); chronic toxicity

study (rat and dog); oncogenicity (rat

and mouse) and general metabolism.

The basis for the waiver request is that

the natural or background levels of CS2,

either free or bound, are not increased

from the application of sodium

tetrathiocarbonate to almonds, peaches

or plums.

In 1987, an oral reference dose (RfD)

of 0.1 mg/kg/day for CS2 was

established by EPA’s Integrated Risk

Information System (IRIS).

C. Aggregate Exposure

1. Dietary exposure— i. Food.

Extensive residue data compiled by the

petitioner and information in the public

literature has shown a natural occurring

dietary CS2 level (bound and free) of

approximately 10-20 ppb. Assuming a

dietary intake of 3,000 g/day, the daily

intake of CS2 is approximately 0.06 mg/

day. The use of sodium

tetrathiocarbonate on almonds, peaches

or plums is not anticipated to add to the

daily intake of CS2 since, as noted

above, no increases in CS2 residues

above background levels were observed

in the residue trials. It should also be

noted that there was no increase above

background CS2 levels for the crops

(grapes and citrus) currently covered by

a tolerance.

ii. Drinking water. Two state-of-art

prospective ground water monitoring

studies were conducted for sodium

tetrathiocarbonate. In both studies,

sodium tetrathiocarbonate was applied

above very shallow aquifers (3-7 ft.

below the surface) and the ground water

was analyzed for CS2. The studies

demonstrated that CS2, from sodium

tetrathiocarbonate application, is not a

residual ground water contaminant.

2. Non-dietary exposure. Carbon

disulfide is an industrial chemical used

in the manufacture of rayon fibers; in

the production of cellulose and rubber

chemicals; as a solvent for cleaning and

extraction; as an extractant for olive oil

and in the production of adhesives.

Accordingly, workers in these industries

may be exposed to low levels of CS2 in

the air. The daily exposure limit is 20

ppm (8-hr time weight average).

D. Cumulative Effects

There is no reliable information to

indicate that carbon disulfide has a

common mechanism of toxicity with

any other chemical compound.

E. Safety Determination

1. U.S. population. Since the use of

sodium tetrathiocarbonate on almonds,

peaches and plums is not anticipated to

contribute to CS2 exposures, Entek

concludes that there is a reasonable

certainty that no harm will result from

sodium tetrathiocarbonate application

to these RACs.

2. Infants and children. Entek also

concludes that there is a reasonable

certainty that no harm will result to

infants and children since no increase

in infant or child exposure to CS2 will

result from the application of sodium

tetrathiocarbonate on almonds, peaches

and plums.

F. International Tolerances

There are no Codex maximum residue

levels [MRLs] established for residues of

carbon disulfide resulting from the

application of sodium

tetrathiocarbonate.

II. Public Record

A record has been established for this

notice under docket number [PF-704]

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

Room 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

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
6528 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

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

requirements.

Dated: February 7, 1997.

Donald R. Stubbs,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–3645 Filed 2–11–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–694; FRL–5583–9]

Nayfa Industries Inc.; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA)

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

an exemption from the requirement of a

tolerance for residues of propionic acid

in or on sugarbeet, potatoes and sweet

potatoes. This notice includes a

summary of the petition prepared by the

petitioner Nayfa Industries Inc.

DATES: Comments, identified by the

docket control number [PF–694], must

be received on or before, March 14,

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 Street, 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 this document.

Information submitted as 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 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT:

Cynthia Giles-Parker, Product Manager

(PM) 22, Registration Division, (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M. St., SW., Washington, DC. Office

location, telephone number and e-mail

address: Rm. 229, CM#2, 1921 Jefferson

Davis Highway, Arlington, VA 703–

305–7740. e-mail: gilesparker.cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition (PP)

6F4770 from Nayfa Industries, Inc., c/o

1625 K St., NW., Suite 501, Washington,

DC 20006, proposing pursuant to

section 408(d) of the Federal Food, Drug

and Cosmetic Act, 21 U.S.C. section

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

exemption from the requirement of a

tolerance for residues of the herbicide

propionic acid in or on the raw

agricultural commodities sugarbeets,

potatoes and sweet potatoes. 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 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.

As required by section 408(d) of the

FFDCA, as recently amended by the

Food Quality Protection Act, Nayfa

Industries, Inc. 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 Nayfa

Industries, Inc. EPA 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 has made minor edits to the

summary for the purpose of clarity.

I. Petition Summary

A. Residue Chemistry

Propionic acid is currently exempt

from the requirement of a tolerance (40

CFR 180.1023), when used as a

fungicide for postharvest application to

prevent fungal growth. The raw

agricultural commodities include oat,

corn, barley, wheat, rice and sorghum

grains, hay, alfalfa, clover, cottonseed,

timothy, vetch, sudan grass, rye grass,

peanuts, orchard grass, lespedeza,

fescue, brome grass, lupines, soybeans,

Bermuda grass and bluegrass, cowpea,

peanut, peavine and soybean hays,

livestock and poultry drinking water,

storage areas for silage and grain, and

poultry litter.

The formula statements dated January

4, 1991 are acceptable and have been

included in this file. It is understood

that the use of methylene chloride in

this formulation is no longer consistent

with the terms of its registration.

Propionic acid naturally occurs in

animals and in dairy products in small

amounts. It is Generally Recognized As

Safe (GRAS) [21 CFR 184.1081], by FDA

for use in food. Propionic Acid is

exempt from the requirement of a

tolerance when applied (as an inert

ingredient) to growing crops or to raw

agricultural commodities after harvest

as described in 40 CFR 180.1001(c).

Nayfa Industries, Inc. requested

Residue Chemistry Data Waivers: All

the residue chemistry data requirements

covered under 40 CFR part 158

(Guideline Series 171) which covers

nature of residues in plants and

animals; residue analytical methods for

plants and animals; storage stability;

magnitude of residues in sugarbeets,

potatoes, and sweet potatoes and their

processed products, meat, milk, poultry

and eggs. The bases for waivers are prior

clearances for propionic acid by EPA

and FDA. The Agency has determined

that propionic acid as an active

ingredient in registered products may be

used for both human food and animal

feed.

B. Toxicological Profile

1. Acute toxicity. Acute oral: > 2 g/kg

(Category III); acute dermal: > 2 g/kg

(Category III); acute inhalation: > 0.5

through 5 mg/L (Category III); eye

irritation: corrosive (Category I); dermal

irritation: corrosive (Category I); skin

sensitization: not available and Nayfa

believes this data requirement should be

waived.

Contact with concentrated solutions

of propionic acid may cause local

damage to skin, eye, or mucosa. Tissue

necrosis was caused by 10 mg/24 hr

with propionic acid in a rabbit skin

irritation test, but the same quantity of

propionic acid as a 10 percent solution

in acetone had little effect. The acid has

been called moderately toxic for rabbits

but corrosive for guinea pigs in skin

irritation tests. Rats survived an eight

hour exposure to concentrated vapor of

propionic acid.

2. Genotoxicity. Propionic acid gave

negative results in mutagenicity assays

in 5 strains of Salmonella typhimurium