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Notices Federal Register

36661

Vol. 65, No. 112

Friday, June 9, 2000

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

[Docket No. 00–046–1]

Availability of a Draft Environmental

Assessment for Field Testing

Rinderpest Vaccine, Vaccinia Vector

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 a draft

environmental assessment concerning

authorization to ship to Kenya for the

purpose of field testing, and then to

field test in Kenya, an unlicensed,

genetically engineered, vacciniavectored rinderpest vaccine for use in

cattle. The environmental assessment,

which is based on a risk analysis

prepared to assess the risks associated

with the field testing of this vaccine,

examines the potential effects that field

testing this veterinary vaccine could

have on the quality of the human

environment. Based on the risk analysis,

we have reached a preliminary

determination that field testing this

veterinary vaccine will not have a

significant impact on the quality of the

human environment. We intend to

authorize shipment of this vaccine for

field testing following the close of the

comment period for this notice unless

new substantial issues bearing on the

effects of this action are brought to our

attention.

DATES: We invite you to comment on

this docket. We will consider all

comments that we receive by July 10,

2000.

ADDRESSES: Please send your comments

and three copies to: Docket No. 00–046–

1, Regulatory Analysis and

Development, PPD, APHIS, Suite 3C03,

4700 River Road, Unit 118, Riverdale,

MD 20737–1238. Please state that your

comment refers to Docket No. 00–046–

1.

Copies of the draft environmental

assessment 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. A copy of the draft

environmental assessment (as well as

the risk analysis with confidential

business information removed) and any

comments that we receive on this

docket are available for public

inspection in our reading room. The

reading room is located in room 1141 of

the USDA South Building, 14th Street

and Independence Avenue SW.,

Washington, DC. Normal reading room

hours are 8 a.m. to 4:30 p.m., Monday

through Friday, except holidays. To be

sure someone is there to help you,

please call (202) 690–2817 before

coming.

APHIS documents published in the

Federal Register, and related

information, including the names of

organizations and individuals who have

commented on APHIS dockets, are

available on the Internet at http://

www.aphis.usda.gov/ppd/rad/

webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr.

Albert P. Morgan, Chief Staff Officer,

Center for Veterinary Biologics,

Licensing and Policy Development, VS,

APHIS, USDA, 4700 River Road Unit

148, Riverdale, MD 20737–1231; (301)

734–8245.

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 have a reasonable expectation of

efficacy before a field trial may be

authorized. The purpose of a field trial

is to gather additional information

concerning the safety and efficacy of a

vaccine when used under field

conditions that are similar to those in

the area(s) where the vaccine will be

distributed and used. Prior to

conducting a field test on an

experimental vaccine, 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.

To determine whether to authorize

shipment and grant approval for the

field testing of the unlicensed vaccine

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 a draft

environmental assessment (EA)

concerning the field testing of the

following unlicensed veterinary

biological product:

Requester: Dr. Tilahun Yilma,

Director, International Laboratory of

Molecular Biology for Tropical Disease

Agents, School of Veterinary Medicine,

University of California, Davis.

Product: A live, genetically

engineered, vaccinia-vectored

rinderpest vaccine.

Field test location: Kikuyu, Kenya.

The above-mentioned vaccine is for

use as an aid in the prevention of

rinderpest in cattle. The vaccine was

constructed with the Wyeth vaccine

strain of the vaccinia virus and further

attenuated by insertional inactivation of

the thymidine kinase and hemagglutinin

genes of the vaccinia virus.

The draft EA has been prepared in

accordance with: (1) The National

Environmental Policy Act of 1969

(NEPA), as amended (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 issue a final

EA and finding of no significant impact

and authorize shipment of the above

product for the initiation of field tests

following the close of the comment

period for this notice.

Authority: 21 U.S.C. 151–159.

Done in Washington, DC, this 5th day of

June 2000.

Bobby R. Acord,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 00–14615 Filed 6–8–00; 8:45 am]

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