Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices 19587

Existing stocks are those stocks of

registered pesticide products which are

currently in the United States and

which have been packaged, labeled, and

released for shipment prior to the

effective date of the cancellation action.

Unless the provisions of an earlier order

apply, existing stocks already in the

hands of dealers or users can be

distributed, sold or used legally until

they are exhausted, provided that such

further sale and use comply with the

EPA-approved label and labeling of the

affected product(s). Exceptions to these

general rules will be made in specific

cases when more stringent restrictions

on sale, distribution, or use of the

products or their ingredients have

already been imposed, as in Special

Review actions, or where the Agency

has identified significant potential risk

concerns associated with a particular

chemical.

List of Subjects

Environmental protection, Pesticides

and pests, Product registrations.

Dated: March 28, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

[FR Doc. 95–9663 Filed 4–18–95; 8:45 am]

BILLING CODE 6560–50–F

[OPP–300381; FRL–4944–1]

Propargite; Request for Comment on

Petition to Revoke Certain Feed

Additive Regulations

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice; receipt and availability

of petition.

SUMMARY: This document announces the

receipt of and solicits comments on a

petition proposing the revocation of the

section 409 feed additive regulation

established under the Federal Food,

Drug and Cosmetic Act (FFDCA, 21

U.S.C. 348a), for propargite on dried

apple pomace. This notice sets forth the

basis for the petitioner’s proposal and

provides opportunity for comment by

the public.

DATES: Written comments, identified by

the document control number [OPP300381], must be received on or before

May 19, 1995.

ADDRESSES: By mail, requests for copies

of the petition and comments should be

forwarded to Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, 401 M St., SW.,

Washington, DC 20460. Copies of the

petition will be available for public

inspection from 8 a.m. to 4 p.m.,

Monday through Friday, except legal

holidays in: Information Services

Branch, Program Management and

Support Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Rm. 1132, Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, 703-305-5805.

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). Information so marked 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 at the address and hours

given above.

FOR FURTHER INFORMATION CONTACT: By

mail: Niloufar Nazmi, Special Review

and Reregistration Division (7508W),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. WF32C5, Crystal Station #1, 2800

Crystal Drive, Arlington, VA,

Telephone: 703-308-8028; e-mail:

Nazmi.Niloufar@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

Introduction

A. Statutory Framework

The Federal Food, Drug and Cosmetic

Act (FFDCA) (21 U.S.C. 136 et seq.)

authorizes the establishment of

tolerances and exemptions from

tolerances for the residues of pesticides

in or on raw agricultural commodities

(RAC’s), and section 409 of the act

authorizes promulgation of food

additive regulations for pesticide

residues in processed foods.

Under section 408, EPA establishes

tolerances, or exemptions from

tolerances when appropriate, for

pesticide residues in raw agricultural

commodities. Food additive regulations

setting maximum permissible levels of

pesticide residues in processed foods

are established under section 409.

Section 409 food additive regulations

are required, however, only for certain

pesticide residues in processed food.

Under section 402(a)(2) of the FFDCA,

no section 409 food additive regulation

is required if any pesticide residue in a

processed food resulting from use on a

RAC has been removed to the extent

possible by good manufacturing

practices and is below the tolerance for

that pesticide in or on that RAC. This

exemption in section 402(a)(2) is

commonly referred to as the ‘‘flowthrough’’ provision because it allows the

section 408 raw food tolerance to flow

through to processed food. Thus, a

section 409 food additive regulation is

only necessary to prevent foods from

being deemed adulterated when despite

the use of good manufacturing practices

the concentration of the pesticide

residue in a processed food is greater

than the tolerance prescribed for the raw

agricultural commodity, or if the

processed food itself is treated or comes

in contact with a pesticide. Monitoring

and enforcement are carried out by the

Food and Drug Administration (FDA)

and the U.S. Department of Agriculture

(USDA).

The establishment of a food additive

regulation under section 409 requires a

finding that use of the pesticide will be

‘‘safe’’ (21 U.S.C. 348(C)(3)). Section 409

also contains the Delaney clause, which

specifically provides that, with limited

exceptions, no additive may be

approved if it has been found to induce

cancer in man or animals (21 U.S.C.

348(C)(5)).

In setting both section 408 tolerances

and section 409 food additive

regulations, EPA reviews residue

chemistry and toxicology data. To be

acceptable, tolerances must be both high

enough to cover residues likely to be left

when the pesticide is used in

accordance with its labeling and low

enough to protect the public health.

With respect to section 408 tolerances,

EPA determines the highest levels of

residues that might be present in a raw

agricultural commodity based on

controlled field trials conducted under

the conditions allowed by the product’s

labeling that are expected to yield

maximum residues. Generally, EPA’s

policy concerning whether a section 409

food additive regulation is needed

depends on whether there is a

possibility that the processing of a raw

agricultural commodity containing

pesticide residues would result in

residues in the processed food at a level

greater than the raw food tolerance.

II. Petitions

Uniroyal Chemical Co. has submitted

a petition requesting the revocation of

the feed additive regulation (FAR)

established under section 409 of the

FFDCA for propargite on dried apple

pomace. This regulation is codified in

40 CFR 186.5000 and is established at

80 parts per million (ppm).
19588 Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Notices

In June 1994, EPA updated Table II of

the Pesticide Assessment Guidelines,

Subdivision O, Residue Chemistry.

Table II provides a listing of all

significant food and feed commodities,

both raw and processed, for which

residue data are collected and tolerances

or FARs are established. The Agency

requires data for only those feed items

considered to be ‘‘significant.’’ Feed

items are considered to be ‘‘significant’’

if (1) the U.S. annual production of the

crop is greater than 500 million pounds

and the maximum amount in the

livestock diet is greater than 10 percent;

or (2) the commodity is grown mainly

as a livestock feed. Based on the above

criteria, the Agency has determined that

dried apple pomace is not a significant

feed item and has removed it from Table

II.

The Petitioner requests that the

Agency revoke the section 409 FAR for

this feed item because it is no longer

necessary.

It should be noted that in the Federal

Register of July 1, 1994 (59 FR 33941),

EPA issued a proposed rule to revoke

the section 409 food additive

regulations for propargite because the

Agency has determined that propargite

induces cancer in animals. Thus, the

regulation violates the Delaney clause in

section 409 of the FFDCA. The Agency

has not yet proposed similar action for

the feed additive regulation for

propargite on dried apple pomace. If

this petition is granted, dried apple

pomace will be removed from the list of

pesticides that violate the Delaney

clause and no further action will be

required under section 408 of the

FFDCA for the raw agricultural

commodity apples.

Pursuant to 40 CFR 177.125 and

177.30, EPA may issue an order ruling

on the petition or may issue a proposal

in response to the petition and seek

further comment. If EPA issues an order

in response to the petition, any person

adversely affected by the order may file

written objections and a request for a

hearing on those objections with EPA on

or before the 30th day after date of the

publication of the order (40 CFR

178.20).

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping.

Dated: April 3, 1995.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

[FR Doc. 95–9061 Filed 4–18–95; 8:45 am]

BILLING CODE 6560–50–F

[OPP–180968; FRL 4946–6]

Propazine; Receipt of Application for

Emergency Exemption, Solicitation of

Public Comment

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has received a specific

exemption request from the Colorado

Department of Agriculture (hereafter

referred to as the ‘‘Applicant’’) to use

the pesticide propazine (CAS 139–40–2)

to treat up to 272,000 acres of sorghum

to control various weeds. The Applicant

proposes the use of a new (unregistered)

chemical; therefore, in accordance with

40 CFR 166.24, EPA is soliciting public

comment before making the decision

whether or not to grant the exemption.

DATES: Comments must be received on

or before May 4, 1995.

ADDRESSES: Three copies of written

comments, bearing the identification

notation ‘‘OPP–180968,’’ should be

submitted by mail to: Public Response

and Program Resource 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, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Information submitted in any

comment concerning this notice may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information.’’

Information so marked 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 Confidential Business

Information must be provided by the

submitter for inclusion in the public

record. Information not marked

confidential may be disclosed publicly

by EPA without prior notice. All written

comments filed pursuant to this notice

will be available for public inspection in

Rm. 1132, Crystal Mall No. 2, 1921

Jefferson Davis Highway, Arlington, VA,

from 8 a.m. to 4 p.m., Monday through

Friday, except legal holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Floor 6, Crystal Station #1,

2800 Jefferson Davis Highway,

Arlington, VA, (703) 308–8417; e-mail:

beard.andrea@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Pursuant

to section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

(7 U.S.C. 136p), the Administrator may,

at her discretion, exempt a state agency

from any registration provision of

FIFRA if she determines that emergency

conditions exist which require such

exemption. The Applicant has requested

the Administrator to issue a specific

exemption for the use of propazine on

sorghum to control pigweed.

Information in accordance with 40 CFR

part 166 was submitted as part of this

request.

Sorghum is grown as a rotational crop

with cotton and wheat, in order to

comply with the soil conservation

requirements. Propazine, which was

formerly registered for use on sorghum,

was voluntarily canceled by the former

Registrant, who did not wish to support

its re-registration. The Applicant claims

that this has left many sorghum growers

with no pre-emergent herbicides that

will adequately control certain broadleaf

weeds, especially pigweed. The

Applicant states that other available

herbicides have serious limitations on

their use, making them unsuitable for

control of pigweed in sorghum. The

Applicant claims that significant

economic losses will occur without the

availability of propazine.

Although the original Registrant of

propazine has decided not to support

this chemical through re-registration,

another company has committed to

support the data requirements for this

use. Propazine was once registered for

this use, but has now been voluntarily

canceled and is therefore considered to

be a new chemical.

The Applicant proposes to apply

propazine at a maximum rate of 2.3 lbs.

active ingredient (4.6 pt. of product) per

acre, by ground or air, to a maximum of

272,000 acres of sorghum, with one

application allowed per crop growing

season. Therefore, use under this

exemption could potentially amount to

a maximum total of 625,600 lbs. of

active ingredient (156,400 gal. of

product). This notice does not constitute

a decision by EPA on the application

itself. The regulations governing section

18 require publication of a notice of

receipt of an application for a specific

exemption proposing use of a new

chemical (i.e., an active ingredient not

contained in any currently registered

pesticide). Such notice provides for