Request By:
Tom S. Maddox, D.V.M.
State Veterinarian
Division of Livestock Sanitation
Department of Agriculture
635 Commanche Trail
Frankfort, Kentucky 40601
Opinion
Opinion By: Steven L. Beshear, Attorney General; By: Thomas R. Emerson, Assistant Attorney General
This is in reply to your letter seeking an opinion concerning the sale of veterinary biologics in Kentucky. You have been approached by a manufacturer in the state about production in the future of a live vaccine and you raise three questions relative to 302 KAR 20:090 which provides in its entirety as follows:
"No corporation, company, partnership, organization or individual shall ship, transport or cause to be imported into the Commonwealth of Kentucky any live pathogenetic bacteria, virus or disease producing agents of animal origin unless a permit is secured in advance from the department and/or Animal and Plant Health Inspection Service, Veterinary Services, United States Department of Agriculture. All biologics for immunization or treatment shall be approved by the director of Animal and Plant Health Inspection Service, Veterinary Services, United States Department of Agriculture. No live or modified live viruses, vaccines, antigens or disease producing organisms shall be sold to any person, firm or corporation in the Commonwealth of Kentucky unless such person, firm or corporation shall be a licensed veterinarian, druggist, firm or corporation authorized under Kentucky Revised Statutes to receive, hold and sell biologics. In no event shall any live viruses, modified viruses, vaccines, antigens or any other disease producing organism be administered to any livestock except by a licensed veterinarian. "
In attempting to answer your questions involving the interpretation of 302 KAR 20:090, we have considered the definitions of selected words mentioned in the regulation and your letter. The definitions were obtained from the Attorneys' Dictionary of Medicine and Word Finder by J. E. Schmidt, M.D.
Antigen - A substance which upon introduction into the blood stream or body tissues stimulates the formation of antibodies, a defensive material which is capable of destroying the very substance which brought about its formation.
Biologic - Same as biological.
Biological - Complex medicinal preparations, derived from living organisms, as bacteria, animals and human beings, used to create immunity, to overcome infection, to replace lost body fluids, etc. Vaccines, serums, antitoxins, blood plasma, etc. are examples of biologicals.
Pathogenetic - Same as pathogenic.
Pathogenic - Causing, or capable of causing, disease; as pathogenic bacteria.
Vaccine - A medicinal material which, when introduced properly into the body, is capable of causing the body to produce certain substances (antibodies) that overcome invading viruses, bacteria or other poisons. A vaccine builds up immunity. Vaccines are composed of killed bacteria or viruses and the immunity they produce is usually effective only against the bacteria or viruses from which they are prepared.
Virus - A class of small infecting agents which may cause many diseases.
Your first question is as follows:
"The regulation (302 KAR 20:090) states that no live pathogens can be imported into Kentucky without permit, but does this exclude the manufacture of such a product within the borders of Kentucky?"
The requirement under the regulation that a permit be secured in advance from the Department of Agriculture and/or the Animal and Plant Health Inspection Service, Veterinary Services, United States Department of Agriculture, involves only those situations where any live pathogenetic bacteria, virus or disease producing agents of animal origin are shipped, transported or imported into this state. If the material in question is not being brought into this state from outside sources the permit requirement is not applicable. Furthermore, the permit can be obtained from the state Department of Agriculture or from the appropriate division of the United States Department of Agriculture or from both the state and federal departments.
While the permit requirement only applies to those named materials brought into this state, the regulation does provide that all biologics for immunization or treatment shall be approved by the director of Animal and Plant Health Inspection Services, Veterinary Services, United States Department of Agriculture. This provision would apply regardless of whether the material was produced or manufactured in this state or outside of this state and would to some extent provide for quality control in the manufacture and production of biologics.
Your second question asks:
"Can I deny this person permission to manufacture or should the Commissioner and State Board of Agriculture be involved?"
We assume you are referring to the requirement that a permit must be obtained in advance from the state Department of Agriculture and/or the Animal and Plant Health Inspection Service, Veterinary Services, United States Department of Agriculture, where any live pathogenetic bacteria, virus or disease producing agents of animal origin are brought into this state. In connection with the state's role in this matter 302 KAR 20:090 merely refers to the "department." 302 KAR 20:010(2) defines "department" as the Department of Agriculture.
The regulation, in connection with the permit requirement, merely refers to the Department of Agriculture rather than the Commissioner, the State Board of Agriculture, the State Veterinarian or any other specific person or division of the Department. The regulation was enacted pursuant to KRS Chapter 257 dealing with livestock, livestock protection and sanitation and the State Veterinarian.
In our opinion, where that part of the regulation dealing with a permit from the Department of Agriculture is applicable, the State Veterinarian, a state officer appointed by the State Board of Agriculture of the Department of Agriculture, may be the representative of the Department of Agriculture who issues or denies the permit in question. In view of the intent and purpose of the regulation with respect to livestock and the protection of livestock, and in an attempt to establish clear and concise procedures and areas of responsibilities, consideration should be given to changing the regulation to specifically provide that the State Veterinarian has the authority to issue or deny the permit as far as the state Department of Agriculture is concerned.
Your third question is as follows:
"In the next to the last sentence of the regulation, what does the term "firm or corporation authorized under Kentucky Revised Statutes to receive, hold or sell biologics' refer to?"
The sentence in question in its entirety provides:
"No live or modified live viruses, vaccines, antigens or disease producing organisms shall be sold to any person, firm or corporation in the Commonwealth of Kentucky, unless such person, firm or corporation shall be a licensed veterinarian, druggist, firm or corporation authorized under Kentucky Revised Statutes to receive, hold and sell biologics. "
That part of the sentence with which you are concerned, providing that no live or modified live viruses, vaccines, antigens or disease producing organisms shall be sold to any firm or corporation in this state unless the firm or corporation is authorized under the Kentucky Revised Statutes to receive, hold and sell biologics, in reality has no effect. There are no state statutes authorizing or regulating the receiving, holding and selling of biologics by firms or corporations in this state. Any firm or corporation could set itself up as a wholesaler of such items and purchase them. The receiving, holding and selling of biologics is a matter that should be addressed to the Kentucky General Assembly if regulation in this area is considered advisable.