ࡱ> KMJ_ %bjbj Lbb"y  xxxxx$P<(d($V!$R)x)xx>Rxxep2,v}T0Z$W6Z$Z$xP))Z$ >: 01-001 DEPARTMENT OF AGRICULTURE, CONSERVATION AND FORESTRY DIVISION OF VETERINARY SERVICES Chapter 212: RULES GOVERNING PROCUREMENT, STORAGE, DISTRIBUTION AND USE OF BRUCELLOSIS VACCINE Table of Contents I. Introduction 1 A. Authorization 1 B. Background 1 C. Purpose of Chapter 1 II. Definitions 1 A. Accredited Veterinarian 1 B. Approved Source 1 C. Brucella Abortus Vaccine 1 D. Calfhood Vaccination Certificate for Brucellosis 2 E. Department 2 F. Grade Calves 2 G. Official Brucellosis Tattoo Mark 2 H. Official Ear Tag 2 I. Purebred Calves 2 III. Source and Distribution of Vaccine 2 IV. Storage of Vaccine 3 V. Handling and Administration of Vaccine 3 VI. Record Keeping 3 VII. Fees 3 I. INTRODUCTION A. Authorization The 112th legislature authorized the Department to procure, store and distribute brucellosis vaccine to accredited veterinarians, to establish fees to cover the associated costs and co regulate the use of the vaccine. (7 MRSA 1812). B. Background 1. As of October 1, 1986 the United States Department of Agriculture ceased providing Strain 19, Brucella abortus vaccine to the Department free of charge for distribution to licensed accredited veterinarians. 2. Legislation (7 MRSA 1812) authorized the Department to establish fees to cover the cost of obtaining, storing and distributing Brucellosis vaccine to accredited veterinarians if the Federal government stopped supplying the vaccine. C. Purpose of Chapter This chapter establishes the rules governing the procurement, storage, distribution and use of Brucellosis vaccine and establishes fees to cover the costs of the program. II. DEFINITIONS A. Accredited Veterinarians An accredited veterinarian means a licensed veterinarian who has been accredited by the United States Department of Agriculture, Animal Plant Health Inspection Service - Veterinary Services to represent the state and federal government in assuming responsibilities for disease and parasite eradication as defined by the Code of Federal Regulations, 9, Chapter 1 (1-1-86 Edition), Part 161. B. Approved Source An approved source means an establishment which holds an unexpired and unrevoked U.S. Veterinary Biologic Establishment License issued by the Deputy Administrator United States Department of Agriculture, Animals Plant Health Inspection Health Inspection Service Veterinary Services to produce Brucella abortus vaccine and which meets the requirements listed in the Code of Federal Regulations, 9, Chapter 1 (1-1-86 Edition), Part 102. C. Brucella Abortus Vaccine Brucella Abortus Vaccine means a vaccine prepared by an approved source and meeting the standards established in the Code of Federal Regulations, 9, Chapter 1 (1-1-86 Edition), Part 113.65 as a desiccated live culture bacterial vaccine from smooth colonial forms of the Brucella Abortus organism identified as Strain 19. Bacterial count requirements of the vaccine shall be for reduced dose vaccine; that is each dose of rehydrated vaccine must contain at least 3.0 billion and not more than 10.0 billion organisms per dose within the expiration period. D. Calfhood Vaccination Certificate for Brucellosis Calfhood vaccination certificate for Brucellosis means a certificate issued by the Department and designated as the Report of Calfhood Vaccination for Bang's Disease. E. Department Department means the Department of Agriculture, Conservation and Forestry. F. Grade Calves Grade calves means a domestic animal produced by cross breeding one of purebred stock with one of ordinary stock or ordinary stock with ordinary stock. G. Official Brucellosis Tattoo Mark Official Brucellosis tattoo mark means a tattoo mark applied to the right ear and including the U.S. Registered Shield and "V" which will be preceded by a number indicating the quarter of the year and followed by a number corresponding to the last digit of the year the vaccination was done. H. Official Eartag Official eartag means the special orange-colored eartag series used to identify calfhood brucellosis vaccinates and purebred registration eartags. These eartags are Veterinary Services approved and conform to the nine character alpha-numeric National Uniform Eartagging System defined in the Code of Federal Regulations, 9, Chapter 1 (1-1-86 Edition) part 78.1 I. Purebred Calves Purebred calves means a strain established through breeding many generations of unmixed stock. Purebred calves must be identified and registered by a purebred association. III. SOURCE AND DISTRIBUTION OF VACCINE A. The Department shall obtain Brucella Abortus Vaccine from an approved source. B. Brucella Abortus Vaccine shall be distributed by the Department only to accredited veterinarians. IV. STORAGE OF VACCINE A. Brucella Abortus Vaccine shall be stored in a refrigerator at a temperature of not less than 35 and not more than 45( F (2(-7(C). B. Brucella Abortus Vaccine remaining in storage after the expiration date marked on the container shall be either burned or pasteurized within two weeks of the expiration date. C. Expired Brucella Abortus Vaccine may not be returned to the Department for credit. V. HANDLING AND ADMINISTRATION OF VACCINE ACCREDITED VETERINARIANS A. Brucella Abortus Vaccine shall be administered by accredited veterinarians only. B. Brucella Abortus Vaccine shall be administered only to female cattle between the ages of 120 and 240 days. C. Brucella Abortus Vaccine shall not be administered to female cattle within 21 days of slaughter. D. Brucella Abortus Vaccine must be administered immediately after rehydration. E. The Brucella Abortus Vaccine container and all unused contents shall be burned or pasteurized. VI. RECORD KEEPING A. Officially Brucellosis vaccinated purebred calve shall be properly identified by official eartag, registration papers or registration tattoo number. B. Officially Brucellosis vaccinated grade calves shall be tagged with an official eartag. C. All officially Brucellosis vaccinated calves must be tattooed with the official Brucellosis tattoo mark. The right ear of the calf is to be used for all identification. D. The Calfhood Vaccination Certificate for Brucellosis shall be made out in triplicate by an accredited veterinarian. One copy should be left with the owner, one retained by the accredited veterinarian and the original mailed immediately to the Division of Veterinary Services. VII. FEES A. The fee for providing Brucella Abortus Vaccine to an accredited veterinarian shall equal the cost of the Brucella Abortus Vaccine to the Department plus a 25% surcharge to cover the cost for storage and handling plus any related shipping costs. B. The fee for providing vaccination supplies including but not limited to vaccination ear tags, tag pliers, tattoo pliers, dies and tattoo ink to an accredited veterinarian shall equal the cost of these vaccination supplies plus a 25% surcharge to cover the costs for storage and handling plus any related shipping costs. C. Monies received from the provision and distribution of Brucella Abortus Vaccine and vaccination supplies shall be deposited in a non lapsing dedicated account to be used to purchase vaccine and supplies and to cover the costs for storage and handling and shipping. 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