This section of the FEDERAL REGISTER

contains documents other than rules or

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Notices Federal Register

59338

Vol. 62, No. 212

Monday, November 3, 1997

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 97–071–1]

Availability of an Environmental

Assessment and Finding of No

Significant Impact for Field Testing

Salmonella Typhimurium Vaccine

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice.

SUMMARY: We are advising the public

that the Animal and Plant Health

Inspection Service has prepared an

environmental assessment and a finding

of no significant impact for the

shipment for field testing of an

unlicensed bacterial vaccine for use in

chickens. A risk analysis, which forms

the basis for the environmental

assessment, has led us to conclude that

shipment of this veterinary vaccine for

field testing will not have a significant

impact on the quality of the human

environment. Based on our finding of no

significant impact, we have determined

that an environmental impact statement

need not be prepared. With this notice,

we state our intention to authorize

shipment of this vaccine for field testing

14 days after the date of this notice,

unless new substantial issues bearing on

the effects of the action contemplated

here are brought to our attention. We

also state our intention to issue a

veterinary biological product license for

this vaccine, provided the field trial

data support the conclusions of the

environmental assessment and finding

of no significant impact and the product

meets all other requirements for

licensure.

ADDRESSES: Copies of the environmental

assessment and finding of no significant

impact may be obtained by contacting

the person listed under FOR FURTHER

INFORMATION CONTACT. Please refer to the

docket number, date, and complete title

of this notice when requesting copies.

Copies of the environmental assessment

and finding of no significant impact (as

well as the risk analysis with

confidential business information

removed) are also available for public

inspection at USDA, room 1141, South

Building, 14th Street and Independence

Avenue SW., Washington, DC, between

8 a.m. and 4:30 p.m., Monday through

Friday, except holidays. Persons

wishing to inspect those documents are

requested to call ahead on (202) 690–

2817 to facilitate entry into the reading

room.

FOR FURTHER INFORMATION CONTACT: Dr.

Jeanette Greenberg, Technical WriterEditor, Center for Veterinary Biologics,

Licensing and Policy Development, VS,

APHIS, USDA, 4700 River Road Unit

148, Riverdale, MD 20737–1231;

telephone (301) 734–5338; fax (301)

734–8910; e-mail

jgreenberg@aphis.usda.gov.

SUPPLEMENTARY INFORMATION: Under the

Virus-Serum-Toxin Act (21 U.S.C. 151

et seq.), a veterinary biological product

must be shown to be pure, safe, potent,

and efficacious before a veterinary

biological product license may be

issued. A field test is generally

necessary to satisfy prelicensing

requirements for veterinary biological

products. In order to ship an unlicensed

veterinary biological product for the

purpose of conducting a proposed field

test, a person must receive authorization

from the Animal and Plant Health

Inspection Service (APHIS).

In determining whether to authorize

shipment for field testing of the

unlicensed veterinary biological product

referenced in this notice, APHIS

conducted a risk analysis to assess the

potential effect of this product on the

safety of animals, public health, and the

environment. Based on the risk analysis,

APHIS has prepared an environmental

assessment (EA). APHIS has concluded

that shipment of the unlicensed

veterinary biological product for field

testing will not significantly affect the

quality of the human environment.

Based on this finding of no significant

impact (FONSI), we have determined

that there is no need to prepare an

environmental impact statement. An EA

and FONSI have been prepared by

APHIS for the shipment of the following

unlicensed veterinary biological product

for field testing:

Requester: Maine Biological

Laboratories, Inc.

Product: Salmonella Typhimurium

Vaccine, Avirulent Live Culture, Code

19C1.01.

Field test locations: Alabama,

Delaware, Georgia, Maryland, North

Carolina, and Virginia.

The above-mentioned product is a

gene-deleted vaccine for use as an aid in

preventing paratyphoid in young

chickens.

The EA and FONSI have been

prepared in accordance with: (1) The

National Environmental Policy Act of

1969, as amended (NEPA) (42 U.S.C.

4321 et seq.), (2) regulations of the

Council on Environmental Quality for

implementing the procedural provisions

of NEPA (40 CFR parts 1500–1508), (3)

USDA regulations implementing NEPA

(7 CFR part 1b), and (4) APHIS’ NEPA

Implementing Procedures (7 CFR part

372).

Unless substantial environmental

issues are raised in response to this

notice, APHIS intends to authorize the

shipment of the above product and the

initiation of the field tests 14 days from

the date of this notice.

Because the issues raised by

authorization of a field trial and

issuance of a license are identical,

APHIS has concluded that the EA and

FONSI that were generated for the field

trial would also be applicable to the

proposed licensing action. Furthermore,

provided that the field trial data support

the conclusions of the original EA and

FONSI, APHIS does not intend to

generate a separate EA to support the

issuance of the product license, and

would determine that an environmental

impact statement need not be prepared.

Therefore, APHIS intends to issue a

veterinary biological product license for

this vaccine following the completion of

the field trial, provided no adverse

impacts on the human environment are

identified as a result of field testing and

provided the product meets all other

requirements for licensure.

Authority: 21 U.S.C. 151–159.

Done in Washington, DC, this 28th day of

October 1997.

Terry L. Medley,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 97–29018 Filed 10–31–97; 8:45 am]

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