PROPOSED RULES
Continuance of WSR 00-11-146.
Preproposal statement of inquiry was filed as WSR 00-08-095.
Title of Rule: Chapter 16-42 WAC, Biological products.
Purpose: The purpose of chapter 16-42 WAC is to detail rules for control of sale, distribution and use of biological products. At the first hearing held June 27, 2000, changes were requested which go beyond minor technical changes. Making these changes will bring the rules into congruence with what individuals, livestock organizations and interested parties requested.
Statutory Authority for Adoption: RCW 16.36.040.
Statute Being Implemented: RCW 16.36.010, [16.36.]020, [16.36.]040, [16.36.]050, [16.36.]060, [16.36.]090, [16.36.]096, and [16.36.]100.
Summary: Changes update the definitions, modernize the language and make technical corrections.
Reasons Supporting Proposal: Modernizes the chapter, provides updated definitions, removes unnecessary language and makes technical corrections in terminology and testing methods.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Kathleen M. Connell, DVM, 1111 Washington Street, Olympia, WA 98504, (360) 902-1835.
Name of Proponent: Washington State Department of Agriculture, WSU College of Veterinary Medicine Agricultural Animal Health Program Advisory Board, Washington Pork Producers and USDA APHIS Veterinary Services Area Office, private and governmental.
Agency Comments or Recommendations, if any, as to Statutory Language, Implementation, Enforcement, and Fiscal Matters: Generally, since language is being modernized, there is little change.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The purpose of chapter 16-42 WAC is to detail rules necessary 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.
Proposal Changes the Following Existing Rules: Changes update the definitions, modernize the language and make technical corrections in terminology and testing methods. The first hearing was held June 27, 2000. There were significant changes beyond minor technical changes. WAC 16-42-022 Biologics, should be repealed and a new section adopted, "Sale of licensed products." WAC 16-42-025 Purchasing and administering biologics limited, should be repealed and a new section adopted, "Restricted products." These changes will bring the rules into congruence with what individuals, livestock organizations, and interested parties requested.
No small business economic impact statement has been prepared under chapter 19.85 RCW. Because only language is being modernized, the overall impact of these changes is fiscally neutral. The regulatory burden on small agricultural businesses stays the same.
Section 201, chapter 403, Laws of 1995, does not apply to this rule adoption. The Washington State Department of Agriculture is not a listed agency in section 201.
Hearing Location: Conference Room 250, 2nd Floor, Natural Resources Building, 1111 Washington Street, Olympia, WA 98504-2577, on August 8, 2000, at 1:00 p.m.
Assistance for Persons with Disabilities: Contact Jodi Truett by August 7, 2000, TDD (360) 902-1996, or (360) 902-1878.
Submit Written Comments to: Kathleen M. Connell, DVM, Assistant State Veterinarian, P.O. Box 42577, Olympia, WA 98504-2577, fax (360) 902-2087, by August 8, 2000, 5:00 p.m.
Date of Intended Adoption: August 14, 2000.
June 30, 2000
Candace A. Jacobs, DVM, MPH
Assistant 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. |