This section of the FEDERAL REGISTER

contains documents other than rules or

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Notices Federal Register

27916

Vol. 63, No. 98

Thursday, May 21, 1998

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 98–050–1]

Availability of an Environmental

Assessment and Finding of No

Significant Impact for Field Testing

Edwardsiella Ictaluri 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 finding

of no significant impact concerning

authorization to ship for the purpose of

field testing and the field testing of an

unlicensed live bacterial vaccine for use

in catfish. A risk analysis, which forms

the basis for the environmental

assessment, has led us to conclude that

field testing this veterinary vaccine 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 test 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 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)

734–4314; 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. Prior to conducting a field test

on an unlicensed product, an applicant

must obtain approval from the Animal

and Plant Health Inspection Service

(APHIS), as well as obtain APHIS’

authorization to ship the product for

field testing.

In determining whether to authorize

shipment and grant approval for the

field testing of the unlicensed product

referenced in this notice, APHIS

conducted a risk analysis to assess the

potential effects 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 field testing the unlicensed

veterinary biological product 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 concerning the field

testing of the following unlicensed

veterinary biological product:

Requester: Alpharma NW Inc.

Product: Edwardsiella Ictaluri

Vaccine, Avirulent Live Culture, Code

1531.R0.

Field test locations: Arkansas,

Louisiana, and Mississippi.

The above-mentioned product is an

aroA gene-deleted bacterial vaccine for

use as an aid in preventing enteric

septicemia in channel catfish.

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

shipment of the above product for the

initiation of field tests 14 days from the

date of this notice.

Because the issues raised by field

testing and by issuance of a license are

identical, APHIS has concluded that the

EA and FONSI that were generated for

field testing would also be applicable to

the proposed licensing action. Provided

that the field test data support the

conclusions of the original EA and

FONSI, APHIS does not intend to issue

a separate EA to support the issuance of

the product license, and would

determine that an environmental impact

statement need not be prepared. APHIS

intends to issue a veterinary biological

product license for this vaccine

following completion of the field test

provided no adverse impacts on the

human environment are identified and

provided the product meets all other

requirements for licensure.

Authority: 21 U.S.C. 151–159.

Done in Washington, DC, this 15th day of

May 1998.

Charles P. Schwalbe,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 98–13571 Filed 5–20–98; 8:45 am]

BILLING CODE 3410–34–P