Skip to Content

Proposed Rule

Viruses, Serums, Toxins, and Analogous Products; Standard Requirement for Escherichia Coli Bacterins

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Animal and Plant Health Inspection Service, USDA.


Proposed rule; withdrawal.


We are withdrawing a proposed rule to amend the Virus-Serum-Toxin Act regulations by adding a Standard Requirement for Escherichia coli bacterins. The proposed rule would have provided uniform test methods, procedures, and criteria to be used by manufacturers of E. coli bacterins to ensure that such bacterins were immunogenic and potent. We are withdrawing the proposed rule after considering the comments we received following its publication.

Start Further Info


Dr. Albert P. Morgan, Section Leader, Operational Support Section, Center for Start Printed Page 12814Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737-1231; (301) 734-8245.

End Further Info End Preamble Start Supplemental Information


On October 11, 1994, we published in the Federal Register (59 FR 51390-51392, Docket No. 93-039-1) a proposed rule to amend the regulations in 9 CFR part 113 to include a Standard Requirement for Escherichia coli bacterins. We solicited comments on the proposed rule for 60 days ending on December 12, 1994. We subsequently reopened the comment period, then extended the comment period again: The first notice, published in the Federal Register on May 17, 1995 (60 FR 26384, Docket No. 93-039-2), reopened the comment period until August 15, 1995, and the second notice, published in the Federal Register on August 22, 1995 (60 FR 43573-43574, Docket No. 93-039-3), extended the comment period until September 14, 1995.

We received a total of nine comments by the close of the extended comment period. The comments were from veterinary biologics manufacturers and a trade association representing veterinary biologics manufacturers. One commenter supported the concept of a standard test procedure for E. coli bacterin, but remarked that the proposed standard lacked sufficient detail concerning the test method. Another commenter identified provisions in the proposed rule that he believed conflicted with the provisions in an interrelated proposed rule concerning in vitro testing, and requested an indefinite extension of the comment period pending resolution of the conflicting provisions. The remaining commenters requested clarification of the various technical provisions of the rule and suggested alternative wording for our consideration.

After considering all of the comments that we received, we have concluded that we will withdraw the proposed rule. Therefore, we are withdrawing the October 11, 1994, proposed rule referenced above. The concerns and recommendations of all of the commenters will be considered if any new proposed regulations concerning a Standard Requirement for E. coli bacterins are developed.

Start Authority

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

End Authority Start Signature

Done in Washington, DC, this 10th day of March 2005.

Elizabeth E. Gaston,

Acting Administrator, Animal and Plant Health Inspection Service.

End Signature End Supplemental Information

[FR Doc. 05-5155 Filed 3-15-05; 8:45 am]