03-3838. Availability of an Environmental Assessment for Licensing of Brucella Abortus Vaccine, Strain RB-51, Live Culture

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

We are advising the public that an environmental assessment has been prepared by the Animal and Plant Health Inspection Service relative to the licensing of Brucella Abortus Vaccine, Strain RB-51, Live Culture. The environmental assessment, which is based on a risk analysis prepared to assess the risks associated with the licensing of this vaccine, examines the potential effects that the licensing of this veterinary vaccine could have on the quality of the human environment. Based on the environmental assessment, we have reached a preliminary determination that the licensing of this veterinary vaccine will not have a significant impact on the quality of the human environment, and that an environmental impact statement need not be prepared. We intend to issue a U.S. Veterinary Biological Product license for this vaccine for use in cattle after 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 will consider all comments that we receive on or before March 20, 2003.

ADDRESSES:

You may submit comments by postal mail/commercial delivery or by e-mail. If you use postal mail/commercial delivery, please send four copies of your comment (an original and three copies) to: Docket No. 03-020-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 03-020-1. If you use e-mail, address your comment to [e-mail]. Your comment must be contained in the body of your message; do not send attached files. Please include your name and address in your message and “Docket No. 03-020-1” on the subject line.

You may request a copy of the environmental assessment (as well as the risk analysis with confidential business information removed) by writing to Dr. Connie S. Smellich-Sandage, USDA, APHIS, VS, CVB-LPD, 510 South 17th Street, Suite 104, Ames, IA 50010, or by calling [phone]. Please refer to the docket number, date and complete title of this notice when requesting copies.

A copy of the 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 [phone] 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, Operational Support Section, Center for Veterinary Biologics, Licensing and Policy Development, VS, APHIS, USDA, 4700 River Road, Unit 148, Riverdale, MD 20737-1231; phone [phone]; fax [phone]. For information regarding the environmental assessment or the risk analysis, contact Dr. Connie S. Smellich-Sandage, USDA, APHIS, VS, CVB-LPD, 510 South 17th Street, Suite 104, Ames, IA 50010; [phone].

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. In determining whether to issue a veterinary biological product license for the vaccine 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) concerning the licensing of the following product:

Requester: Colorado Serum Company.

Product: Brucella Abortus Vaccine, Strain RB-51, Live Culture, Code 1261.00.

Action: Issuance of product license.

The above-mentioned vaccine is for use in cattle as an aid in the prevention of clinical signs due to Brucella abortus. The vaccine is prepared from a naturally occuring, rifampicin resistant mutant strain of the organism.

The 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).

We have reached a preliminary determination that the licensing of this veterinary vaccine will not have a significant impact on the quality of the human environment, and that an environmental impact statement need not be prepared. Unless substantial issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a finding of no significant impact based on the EA and issue a veterinary biological product license for this vaccine following the close of the comment period for this notice.

Authority: 21 U.S.C. 151-159.

Done in Washington, DC, this 11th day of February, 2003.

Peter Fernandez,

Acting Administrator, Animal and Plant Health Inspection Service.