Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Live Vaccines
meat-poultry · Animal and Plant Health Inspection Service · Rule · Published 2007-12-21 · Effective 2008-01-22 · 72 FR 72563
Document
Document number
E7-24649
Federal Register citation
72 FR 72563
CFR reference
9 CFR 113
Type
Rule
Action
Final rule.
Category
meat-poultry
Sub-agency
Animal and Plant Health Inspection Service
Publication date
2007-12-21
Effective date
2008-01-22
USDA docket
Docket No. APHIS-2006-0079
Abstract
We are amending the Virus-Serum-Toxin Act regulations for certain live bacterial and viral vaccines by removing the requirement to retest the Master Seeds for immunogenicity 3 years after the initial qualifying immunogenicity test. In addition, we are amending the requirement concerning mouse safety tests prescribed for a biological product recommended for animals other than poultry. These changes update the standard requirements by eliminating unnecessary testing of Master Seed bacteria and viruses and other forms of bulk or completed biological product.