Table Of Content

Historic, Archive Document Do not assume content reflects current scientific knowledge, policies, or practices. aSF918 -B5G39 1994 USDA, National Agricultural Library NAL Bidg 10301 Baltimore Bivd Belisvitte, MD 20705-2351 United States Department of Agriculture A National Agricultural Library re United States Animal and Biotechnology, 1 Department of Plant Health Biologics, and Agriculture Inspection Environmental Service Protection VETERINARY BIOLOGICS NOTICE Subject: Risk Analysis for Veterinary Biologics Lo; Biologics Licensees and Permittees Director, National Veterinary Services Laboratories Directors, VS Regions Deputy Director, Veterinary Biologics Field Operations, BBEP Area Veterinarians in Charge, VS The enclosed document outlines the process used by APHIS to ensure the safety of new experimental veterinary biologics. This document is provided for your information. Sincerely, ellb ap John H. Payne, Ph.D. Acting Director Enclosure py} 1. ff j } / | f Reap ~~ |[ ee J APHIS - Protecting American Agriculture « Porte wiom of Dre eager 7 anergPyre wenrs net sent A rw? oa ay . ; Mavicye rary Lerery aa. uc , hall > | j MLP OU TOR 255) shIYOu BDIDOIORS YHAMISATaV arisolul® yvranizege¥ x07 tay tend: wih seortiiuzed bie eueemeots picc t“ 8 velingarndaes scuotvrs2 Ss detiliadts ateet to. 3099 “iE Aii ae lige ae : a 7 ea. a PT Ce oe ala s an’ 7 X*4* a4? 56 : aiit~ &« ekie ’ aad woSwe DP cS w i A! ie — o = twoy tot oe is 2) Jnems sna 357 6) n as $ pay a * = - Risk Analysis for Veterinary Biologics Cyril G. Gay Chief Staff Veterinarian Biotechnology Section Veterinary biologics Biotechnology, Biologics, and Environmental Protection Richard L. Orr Senior Entomologist Planning and Risk Analysis Systems Policy and Program Development Animal and Plant Health Inspection Service (APHIS) The United States Department of Agriculture (USDA) February 4, 1994 tok Jon8 eos ametaya eleyisd& geile baa4 ’ Jasagoloved gsipos?d bee ve 4 ; 7a venir ’ S365 7 (CINTA) soivied oitoaqent ita igatl inal'l — (AG2U) swilusiigA to Inontreged 2oiaité& a PRUE:b eis TABLE OF CONTENTS Acknowledgement Glee Acronyms di I. Introduction st A. Veterinary Biologics Risk Analysis Process i B. Objective Hh Gc Applicable Regulations 1 1: The Virus-Serum-Toxin Act 1 OMS The National Environmental Policy Act 4 ie The Freedom of Information Act 4 II. Characterization of the Vaccine Microorganism 5 A. Safety Studies 5 B. Target Objectives 5 Cc; Summary Information Formats 6 ule Summary Information Format for Veterinary Biologics 6 ae Summary Information Format for Category I Veterinary Biologics 6 3. Summary Information Format for Category II Veterinary Biologics 6 4. Summary Information Format for Category III Veterinary Biologics 6 III. Risk Assessment 8 A. Hazard Identification 8 B. Release Assessment 8 is Summary Information Format for Contained Studies 9 2 Summary Information Format for Environmental Releases 9 Cc. Risk Characterization 9 a Likelihood Rating 9 2. Consequence Rating 9 3. Degree of Certainty Rating 10 4. Calculating the Expected Risk 10 Be Risk Ratings AN) Iv. Risk Management 14 14 A. Contained Studies B. Environmental Releases 16 Vv. Risk Communication ey A. Standard Review 17 B. Special Review 19 Cc. Public Access to Federal Decision-Making Information 20 VI. Summary 745% VII. References ae VIII.Appendices 23 Appendix Summary Information Format for Veterinary Biologics 24 A. Appendix Summary Information Format for Category I B. Veterinary Biologics Zo Appendix Summary Information Format for Category II Veterinary Biologics a Appendix Summary Information Format for Category III Veterinary Biologics 29 Appendix Hazard Identification for Veterinary Biologics 31 Appendix Summary Information Format for Contained Studies 32 Appendix Summary Information Format for Environmental Releases 33 Appendix Authorized User Certificate for Handling Confidential Business Information 35 Appendix Examples of Risk Analyses Conducted for Veterinary Biologics 36 ua