Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11447

D. Cumulative Effects

Azoxystrobin is a new class of

chemistry for pesticides, a betamethoxyacrylate fungicide.

Azoxystrobin has the same biochemical

mode of action as the naturally

occurring strobilurins, inhibition of

electron transport. Since there are no

other registered pesticides in this

chemical class or with this mode of

action or mechanism of action,

cumulative exposure assessment is not

appropriate at this time.

No evidence or information exists to

suggest that toxic effects produced by

azoxystrobin would be cumulative with

those of any other chemical compounds.

E. Safety Determination

1. U.S. population in general. Using

the conservative assumptions described

above, based on the completeness and

reliability of the toxicity data, Zeneca

estimates that the aggregate exposure to

azoxystrobin will utilize 0.5 percent of

the RfD for the U.S. population. This

chronic dietary exposure analysis is

based on food consumption for the

combined years 1989–1992 in the

USDA’s Nationwide Food Consumption

Survey and analysis using Technical

Assessment Systems, Inc.’s ‘‘EXPOSURE

1’’ analysis software. Generally there are

no concerns for exposures below 100

percent of the RfD. The EPA defines the

RfD to represent the level at or below

which daily aggregate dietary exposure

over a lifetime will not pose appreciable

risk to human health.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

azoxystrobin Zeneca has considered the

2–generation reproduction study in the

rat and the developmental toxicity

studies in the rat and rabbit.

Azoxystrobin showed no evidence of

reproductive toxicity. Azoxystrobin

caused no developmental toxicity in the

rat or rabbit up to and including dose

levels shown to be maternally toxic.

There were no adverse effects, in the rat

or rabbit, on the number, survival and

growth of the fetuses in utero.

Based on the current toxicological

data requirements, the database relative

to pre- and post- natal effects for

children is complete. Further,

azoxystrobin shows no evidence of

reproductive or developmental toxicity,

therefore we suggest that use of an

additional uncertainty factor is not

warranted and that the RfD of 0.18 mg/

kg/day is appropriate for assessing

aggregate risk to infants and children.

Using the conservative exposure

assumption described above, Zeneca

concludes that the percent of the RfD

that will be utilized by aggregate

exposure to residues of azoxystrobin

ranges from 0.8 percent for the

population subgroups Nursing infants

and children 7–12 years old up to 1.6

percent for the population subgroup

Children 1–6 years old. Zeneca

concludes that there is reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to azoxystrobin residues.

F. International Tolerances

There are no Codex Maximum

Residue Levels established for

azoxystrobin.

II. Public Record

Interested persons are invited to

submit comments on this notice of

filing. Comments must bear a notation

indicating the docket control number,

[PF–715]. 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–715] (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 files avoiding the

use of special characters and any form

of encryption.

The official record for this notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Authority: 21 U.S.C. 346a.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 24, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–5683 Filed 3–11–97; 8:45 am]

BILLING CODE 6560–50–F

[OPP–181035; FRL 5591–3]

Mancozeb; 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 Wisconsin

Department of Agriculture, Trade, and

Consumer Protection (hereafter referred

to as the ‘‘Applicant’’) to use the

pesticide, mancozeb (CAS 8018–01–7),

formulated as Dithane DF, to treat up to

5,000 acres of ginseng to control stem

and leaf blight. Since this request

proposes a use which has been

requested or granted in any 3 previous

years, and a complete application for

registration and petition for tolerance

has not yet been submitted to the

Agency; and since mancozeb has also

been the subject of a Special Review,

EPA is soliciting public comment before

making the decision whether or not to

grant the exemption, in accordance with

40 CFR 166.24(a)(5) and (6).

DATES: Comments must be received on

or before March 27, 1997.

ADDRESSES: Three copies of written

comments, bearing the identification

notation ‘‘OPP–181035,’’ 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.

Comments and data may also be

submitted electronically by 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
11448 Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

[OPP–181035]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

Information submitted in any

comment concerning this notice may be

claimed confidential by marking any

part or all of that information as 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 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 8:30 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) 308–8791; 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 mancozeb on

ginseng to control stem and leaf blight.

Information in accordance with 40 CFR

part 166 was submitted as part of this

request.

According to the Applicant,

Alternaria blight rarely kills the ginseng

root, which is the marketed portion;

however, loss of the foliage results in

significant root yield loss in a harvested

crop, and retards root growth and

overwintering ability in younger crops.

Infestations of Alternaria blight in one

season greatly increase the potential for

epidemics in subsequent seasons, since

the fungus remains in the infected plant

debris. Rovral 50W, the only fungicide

carrying a section 3 label for use against

Alternaria blight on ginseng, is no

longer effective since Alternaria panax

has developed a resistance to it. If not

controlled, Alternaria blight can be

expected to infest all of Wisconsin’s

5,000 acres of ginseng and growers will

suffer significant economic loss.

Under the proposed exemption, 2.0

lbs of product (1.5 lbs of a.i.) per acre

may be used on up to 5,000 acres. A

maximum of 12 applications at a

minimum of 7–day intervals may be

made by ground equipment. Therefore,

use under this exemption could

potentially result in application of up to

120,000 lbs. product (90,000 lbs. a.i.)

total.

This notice does not constitute a

decision by EPA on the application

itself. The regulations governing section

18 require that the Agency publish

notice of receipt in the Federal Register

and solicit public comment on an

application for a specific exemption if

the requested chemical has been subject

to a Special Review, and is intended for

a use that could pose a risk similar to

the risk posed by any use of the

pesticide which is or has been subject

of the Special Review. [40 CFR 166.24

(a)(5)].

The Agency initiated a Special

Review of the ethylene

bisdithiocarbamate (EBDC) fungicides

on July 17, 1987, which includes

mancozeb. A notice of final

determination was issued March 2,

1992. The Agency took this action based

on an assessment of the risks from

exposure to ethylenethiourea (ETU)

present in, or formed as a result of

metabolic conversion from pesticide

products containing the active

ingredient mancozeb. ETU, a potential

human carcinogen, teratogen, and

thyroid toxicant, is present as a

contaminant, degradation product, and

metabolite of all the EBDC pesticides.

The Agency concluded that the

estimated cumulative risk of 10-5 from

all current 55 food uses was

unacceptable and, therefore, canceled

the following 11 food uses: apricots,

carrots, celery, collards mustard greens,

nectarines, peaches, rhubarb, spinach

succulent beans and turnips. These

cancellations reduce estimated lifetime

dietary risk to 1.6 x 10-6 which the

Agency has determined does not

outweigh the benefits of the 44 retained

uses.

The regulations also require the

Agency to publish a notice of receipt in

the Federal Register and solicit public

comment on an application for a

specific exemption if an emergency

exemption has been requested or

granted for that use in any 3 previous

years, and a complete application for

registration of that use has not been

submitted to the Agency [40 CFR

166.24(a)(6)]. Exemptions for the use of

mancozeb on ginseng have been

requested for the past ten years (1987 –

1996). The registrant, Rohm and Haas,

has indicated that they intend to pursue

a registration in cooperation with IR-4

this year, and it is expected that an

application for registration will be

submitted to the Agency before the end

of 1997.

A record has been established for this

notice under docket number [OPP–

181035] (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 Resource

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 notice, as

well as the public version, as described

above will be kept in paper form.

Accordingly, EPA will transfer all

comments received electronically into

printed, paper form as they are received

and will place the paper copies in the

official record which will also include

all comments submitted directly in

writing. The official record is the paper

record maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document. Accordingly, interested

persons may submit written views on

this subject to the Field Operations

Division at the address above.

The Agency, accordingly, will review

and consider all comments received

during the comment period in

determining whether to issue the

emergency exemption requested by the

Wisconsin Department of Agriculture,

Trade, and Consumer Protection.

List of Subjects

Environmental protection, Pesticides

and pests, Emergency exemptions.
Federal Register / Vol. 62, No. 48 / Wednesday, March 12, 1997 / Notices 11449

Dated: February 28, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

[FR Doc. 97–6014 Filed 3–11–97 8:45 am]

BILLING CODE 6560–50–F

[OPP–181036; FRL 5593–6]

Propamocarb Hydrochloride; Receipt

of Applications for Emergency

Exemptions, Solicitation of Public

Comment

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: EPA has received specific

exemption requests from the

Pennsylvania Department of Agriculture

and the California Department of

Pesticide Regulation (hereafter referred

to as the ‘‘Applicants’’) to use the

pesticide propamocarb hydrochloride

(CAS 25606–41–1) to treat potentially

up to 5,500 acres in Pennsylvania and

190,000 acres in California of tomatoes

to control immigrant strains of late

blight which are resistant to historically

used control materials. The Applicants

propose the first food use of an active

ingredient therefore, in accordance with

40 CFR 166.24, EPA is soliciting public

comment before making the decision

whether or not to grant the exemptions.

DATES: Comments must be received on

or before March 27, 1997.

ADDRESSES: Three copies of written

comments, bearing the identification

notation ‘‘OPP–181036,’’ 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.

Comments and data may also be

submitted electronically by 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 the docket number

[OPP–181036]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

comments on this proposed rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

Information submitted in any

comment concerning this notice may be

claimed confidential by marking any

part or all of that information as 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 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 8:30 a.m. to 4 p.m., Monday

through Friday, except legal holidays.

FOR FURTHER INFORMATION CONTACT By

mail: Libby Pemberton, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number and e-mail: Floor 6, Crystal

Station #1, 2800 Jefferson Davis

Highway, Arlington, VA, (703) 308–

8326; e-mail:

pemberton.libby@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 Applicants have

requested the Administrator to issue

specific exemptions for the use of

propamocarb hydrochloride on

tomatoes to control late blight.

Information in accordance with 40 CFR

part 166 was submitted as part of this

request.

Recent failures to control late blight in

tomatoes as well as potatoes with the

registered fungicides, have been caused

almost exclusively by immigrant strains

of late blight Phytophthora infestans,

which are resistant to the control of

choice, metalaxyl. Before the immigrant

strains of late blight arrived, all of the

strains in the U.S. were previously

controlled by treatment with metalaxyl.

The Applicants state that presently,

there are no fungicides registered in the

U.S. that will provide adequate control

of the immigrant strains of late blight.

The Applicants state that the requested

chemical has been shown to be effective

against these strains of late blight. The

active ingredient holds current

registrations throughout many European

countries for control of this disease. The

Applicants indicate that at least a 50

percent yield reduction is expected

based on the current infestation. Net

revenues are expected to be reduced by

over $500 million for the affected

acreage without the use of the requested

chemical.

The Applicants propose to apply

propamocarb hydrochloride,

manufactured by AgrEvo USA

Company, as Tattoo C, at a maximum

rate of 0.9 lbs. a.i. (2.3 pt of product) per

acre by chemigation, ground or air, with

a maximum of 5 applications per

season. A 7–day Preharvest Interval

(PHI) will be observed. Use under these

exemptions could potentially amount to

a maximum 175,950 lbs. of

propamocarb hydrochloride.

This notice does not constitute a

decision by EPA on the applications.

The regulations governing section 18

require publication of a notice of receipt

of an application for a specific

exemption proposing the first food use

of an active ingredient. Such notice

provides for opportunity for public

comment on the applications.

Accordingly, interested persons may

submit written views on this subject to

the Field Operations Division at the

address above.

A record has been established for this

rulemaking under docket number [OPP–

181036] (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.