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
Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices 6529

and one of Saccharomyces cerevisiae,

with and without activation.

Additional data on calcium and

sodium propionate indicate that:

a. Calcium propionate tested in three

strains of S. typhimurium and one strain

of S. cerevisiae, with several activation

systems, gave negative results.

b. Sodium propionate showed higher

incidence of abnormalities in

developing chick embryos only at the

highest level (10 mg/egg) by air cell

administration, not in yolk treatment;

however, 5 and 10 mg/egg levels had

increased mortality.

3. Reproductive and developmental

toxicity. Based on the available data:

a. No maternal or fetal effects were

seen upon feeding calcium propionate

to pregnant animals at rates up to 300

mg/kg/day for rats and mice, or up to

400 mg/kg/day for hamsters and rabbits.

b. No teratogenicity was found in

developing chick embryos when up to

100 mg/kg calcium propionate was

injected into the yolk or air cell,

although there was increased mortality

at 5 and 10 mg/kg.

4. Subchronic toxicity. Data on

calcium and sodium propionate were

used to assess subchronic toxicity of

propionic acid. When rats were fed

calcium or sodium propionate at 1

percent of the diet (equivalent to about

750 mg/kg/day of propionic acid) for 4

weeks followed by 3 percent (equivalent

to about 1,200 mg/kg/day propionic

acid) for 3 weeks, they had no changes

in weight gain compared to controls.

Rats fed 5 percent propionic acid in the

diet (about 5,000 mg/kg body weight) for

110 days developed lesions of the

forestomach.

Propionic acid was given in the feed

to dogs at 220, 735, or 2,066 mg/kg/day

(3,000, 10,000, and 30,000 ppm) for 90

days. The high dose dogs showed

reduced food consumption, increased

incidence of epithelial hyperplasia in

the esophagus, and increased nitrite in

the urine. These effects were no longer

present in dogs held for a 6 week

recovery period. A limited study with

calcium propionate in dogs for 90 days

showed vomiting and diarrhea in

animals fed 2,523 mg/kg/day (43,500

ppm).

Addition of sodium propionate to the

diet of chicks and young rats

accentuated the growth depression seen

when their diet was deficient in vitamin

B12. Body weight gain in young lambs

was not affected by 5,600 mg/kg/day of

sodium propionate in the diet for 50

days.

When an adult male human was fed

6.0 g/day sodium propionate, the only

effect noted was slightly alkaline urine.

5. Chronic toxicity. Twenty male rats

per group were fed 0.4 or 4.0 percent

propionic acid in the diet for 2 years.

The high dose animals had hyperplasia

and hyperplastic ulcers in the

forestomach. (The rat forestomach has

no counterpart in human anatomy).

Data on calcium and sodium

propionate indicate that rats fed bread

containing sodium propionate (4,000

mg/kg/day) for a year showed no

adverse effects, nor did rats fed a similar

diet for 32 weeks, other than an initial

depression of growth.

6. Animal metabolism. Propionic acid

is rapidly absorbed from the mammalian

gastro-intestinal tract. Propionic acid is

a normal intermediary metabolite in the

body. It is utilized by most organs and

tissues, and can be metabolized to

glucose, carbohydrates, amino acids,

and lipids. It is produced in large

quantities in ruminants. In nonruminants, propionic acid is one of the

metabolic products from the breakdown

of several amino acids. Propionic acid is

formed in the oxidation of fatty acids

and from the side chain of cholesterol.

7. Metabolite toxicology. All the

metabolites of propionic acid are

naturally occurring and are utilized by

humans and animals. Nayfa believes

that the metabolite toxicity data

requirements should be waived because

these metabolites are not of

toxicological concern.

C. Aggregate Exposure

1. Dietary exposure. Since propionic

acid is utilized by most organs and

tissues, and is metabolized to glucose,

carbohydrates, amino acids and lipids

when ingested by livestock and poultry,

residues in meat, milk or poultry are

considered to be negligible. Propionic

acid or mixtures of methylene

bispropionate and oxy (bismethylene)

bispropionate are exempt from the

requirements of a tolerance when used

as a post-harvest fungicide on alfalfa,

barley grain, Bermuda grass, bluegrass,

brome grass, clover, corn grain, cowpea

hay, fescue, lespedeza, lupines, oat

grain, orchard grass, peanut hay,

peavine hay, rye grass, sorghum grain,

soybean hay, sudan grass, timothy,

vetch, and wheat grain (40 CFR

180.1023). Propionic acid is also 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). Propionic acid is

Generally Recognized As Safe (GRAS)

(21 CFR 184.1081), by FDA for use in

food.

2. Non-dietary exposure. The only

non-dietary exposure to propionic acid

is the occupational exposure. Propionic

acid end-use products are sprayed on

grain and forage at application rates

ranging from 1 - 4 gallons of 85% –

100% a.i., depending on the moisture

content of grain or forage, and type and

length of storage desired. They are also

applied to livestock and poultry

drinking water and grain storage areas.

Based on the use patterns, the potential

exposure of applicators to propionic

acid could be significant as well as to

workers in the spray area. The potential

for post-application exposure should be

minimal (assuming the area is

adequately ventilated).

Certain protective clothing is

appropriate for propionic acid users due

to eye and skin hazards. The Agency

requires applicators to wear protective

clothing if the products contain in

excess of 63% propionic acid as active

ingredient.

D. Cumulative Effects

1. Environmental fate assessment.

Under anaerobic conditions propionic

acid acts as a carbon source for various

microbes and is metabolized to acetic

acid, methane, carbon dioxide and

water. The only incident reports

concerning propionic acid were

detections in the tissue of the mussel

(Mytilus Sdulis) and in ground water as

the result of the break-down of

petroleum pollution. All environmental

fate data requirements are waived for

the currently registered uses based on

the fact that propionic acid tends to be

used as a carbon source by many

microbes and is metabolized to carbon

dioxide and water.

E. Safety Determination

1. Human health assessment.

a. U.S. population. Propionic acid is

a normal component of metabolism in

the human body and humans ordinarily

consume propionic acid as a natural

component of common foods and as an

added ingredient. It is a natural

component of butter and cheese, and

may constitute as much as 1 percent of

Swiss cheese. Dietary exposure from

pesticidal use would be very low.

b. Infants and children. As noted

above, propionic acid is produced by

human body. The humans include not

only adult population but also children

and infants who receive propionic acid

through common foods including those

that contain this ingredient as a food

additive. Additionally, children and

infants consume dairy products such as

butter and cheese which contain

propionic acid. Therefore, dietary

exposure from pesticidal use would be

very minimal.
6530 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

F. International Tolerances

There are no known international

tolerances for residues of propionic acid

in food or animal feed.

G. Tolerance Exemptions for Proposed

Uses

The petitioner proposes new uses

which include application of propionic

acid to sugar beets, potatoes and sweet

potatoes. The petitioner requests

tolerance exemption for residues of

propionic acid in or on sugar beets,

potatoes and sweet potatoes. The

petitioner also requests waivers for all

tests for determining the residues

including the analytical method.

The petitioner proposes tolerance

exemption for propionic acid for its use

on or in:

a. Sugarbeets (stored sugarbeets and

seed sugarbeets, and also dried-pulp

and dried-molasses intended for animal

feed);

b. Potatoes (stored potatoes -

marketable and frozen and stored seed

potatoes, and also stored potatoes for

animal feed); and,

c. Sweet potatoes (stored sweet potato

and stored seed sweet potatoes).

The maximum amount of propionic

acid applied to these RACs during

storage will be 6 lb/ton.

II. Administrative Matters

EPA invites interested persons to

submit comments on this notice of

filing. Comments must bear a

notification indicating the document

control number [PF–694]. 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–694] (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

‘‘ADDRESSEES’’ 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: February 3, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

[FR Doc. 97–3227 Filed 2–11–97; 8:45 am]

BILLING CODE 6560–50–F

[PF–702; FRL–5586–3]

Valent U.S.A. Corporation; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of filing.

SUMMARY: This notice announces the

filing of a pesticide petition proposing

the establishment of a regulation for

residues of the herbicide clethodim in

or on tomato, alfalfa, dry bean, and

peanut commodities. The summary of

the petition was prepared by the

petitioner, Valent U.S.A. Corporation

(Valent).

DATES: Comments, identified by the

docket control number [PF–702], must

be received on or before, March 13,

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., S.W.,

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 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 in

unit II. of 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 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Product Manager

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

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: EPA has

received pesticide petitions (PP 5F4572

and PP 5F4440) from Valent U.S.A.

Corporation, 1333 N. California Blvd.,

Walnut Creek, CA 94596 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 part

180 by establishing tolerances for

residues of the herbicide clethodim in

or on the following raw or processed

agricultural commodities: tomatoes at

1.0 part per million (ppm); tomato puree

at 2.0 ppm; tomato paste at 3.0 ppm;

alfalfa forage at 6.0 ppm; alfalfa hay at

10.0 ppm; peanut nutmeat at 3.0 ppm;

peanut hay at 3.0 ppm; peanut meal at

5.0 ppm; and dry bean seeds at 2.0 ppm.

The proposed enforcement analytical

method for these commodities is EPARM-26D-3, a high-performance liquid

chromatography (HPLC) method. 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

petitions. Additional data may be

needed before EPA rules on the

petitions.