PERMANENT RULES
Date of Adoption: August 14, 2000.
Purpose: Chapter 16-42 WAC, Biological products protests animal and public health by establishing rules for control of sale, distribution and use of biological products. Certain biologics are restricted to protect animal or human health, ensure accurate diagnosis of disease, prevent spread of diseases and ensure quality state-federal animal disease control and eradication programs.
Citation of Existing Rules Affected by this Order: Chapter 16-42 WAC, Biological products; repealing WAC 16-42-022, 16-42-025 and 16-42-060; and amending WAC 16-42-005, 16-42-017, and 16-42-035.
Statutory Authority for Adoption: RCW 16.36.040.
Adopted under notice filed as WSR 00-14-076 on July 5, 2000.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 2, Amended 3, Repealed 3.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0. Effective Date of Rule: Thirty-one days after filing.
August 9, 2000
Jim Jesernig
Director
OTS-4099.3
AMENDATORY SECTION(Amending Order 1866, filed 7/10/85)
WAC 16-42-005
Definitions.
(1) "Department" means the department of agriculture of the state of Washington.
(2) "Director" means the director of the department of agriculture of the state of Washington or his/her authorized representative.
(3) "Biologics," sometimes referred to as biologicals or biological products, means all bacteria, viruses, serums, toxins, and analogous products of natural or synthetic origin, or products prepared from any type of genetic engineering, such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms and the antigenic or immunizing components of microorganisms intended for use in the diagnosis, treatment, or prevention of diseases in animals.
[Statutory Authority: Chapter 16.36 RCW. 85-15-024 (Order 1866), § 16-42-005, filed 7/10/85.]
(1) Any person
manufacturing biologics within the state for distribution within
the state ((shall)) must first obtain a permit from the director.
((Such)) This permit may be revoked or suspended ((in the manner
provided for)) under chapter ((34.04)) 34.05 RCW for any
violation of this chapter.
(2) ((Prior to importation of)) Written approval of the
director is required before any newly licensed biologic is
imported into the state for sale, use or distribution ((within
the state, the written approval of the director shall be
required. When deemed necessary,)). The director may also
require a special permit for the importation or distribution of
other biologics into the state.
[Statutory Authority: Chapter 16.36 RCW. 85-15-024 (Order 1866), § 16-42-017, filed 7/10/85.]
Biologics produced in accordance with WAC 16-42-015 or 16-42-017 may be sold over the counter as well as by persons or firms properly licensed under chapter 18.64 RCW and by any veterinarian licensed pursuant to chapter 18.92 RCW. Persons other than licensed veterinarians or state or federal veterinarians may purchase and administer biologics to their own animals, except for those biologics restricted in WAC 16-42-026.
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(1) All biologics now in existence or newly developed to diagnose, prevent, or combat the following diseases are declared by the director to be of such a nature that their control is necessary to protect animal or human health and welfare, to ensure accurate diagnosis, to prevent the spread of infectious, contagious, communicable, and dangerous diseases affecting domestic animals within the state and/or to effectuate state-federal animal disease control and eradication programs:
(a) Anaplasmosis.
(b) Anthrax.
(c) Bluetongue.
(d) Brucellosis.
(e) Equine infectious anemia.
(f) Equine viral arteritis.
(g) Paratuberculosis.
(h) Pseudorabies.
(i) Rabies.
(j) Tuberculosis.
(k) Swine erysipelas (Avirulent vaccine exempted).
(l) Vesicular stomatitis.
(m) All conditionally approved vaccines.
(2) All biologics used to control or diagnose any of the diseases listed in subsection (1) of this section are restricted, and may only be purchased, administered, or otherwise used by or under the direct supervision of veterinarians licensed pursuant to chapter 18.92 RCW, or by state or federal veterinarians. The director may authorize others by written permit to purchase biologics listed in subsection (1) of this section for research agencies or laboratories authorized by the department, for emergency disease control programs, or for other limited and controlled purposes which are not likely to create a hazard to the public health or to the health of domestic animals. In issuing this permit, the director will consider:
(a) The known effectiveness of the biologic;
(b) Whether or not the disease for which the biologic is used or intended to be used is present in this state and to what extent it is present;
(c) Degree of isolation of the animals and area, and availability of veterinary service; and
(d) Any other factor which, having due regard for the properties of the biologic, may constitute a hazard to animal or public health in this state.
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In the interest of public health
and good cooperative disease control it is recommended that any
person using any biologics((, as defined in WAC 16-42-005,))
immediately report to the department any suspected or actual
disease outbreak that occurs in connection with use of the
biologic.
[Statutory Authority: Chapter 16.36 RCW. 85-15-024 (Order 1866), § 16-42-035, filed 7/10/85; Order 896, Regulation 6, effective 11/24/62.]
The following sections of the Washington Administrative Code are repealed:
| WAC 16-42-022 | Biologics. |
| WAC 16-42-025 | Purchasing and administering biologics limited. |
| WAC 16-42-060 | Penalty. |