WSR 00-11-146

PROPOSED RULES

DEPARTMENT OF AGRICULTURE


[ Filed May 24, 2000, 8:00 a.m. ]

Original Notice.

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.

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 Agriculture Animal Health Program Advisory Board, Washington State Veterinary Medical Association, WSU Avian Health Lab, USDA APHIS Veterinary Services Area Office and various industry groups and associations for horses, cattle, swine, poultry and sheep, 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.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Generally, 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. Washington State Department of Agriculture is not a listed agency in section 201.

Hearing Location: Cafeteria Conference Room, 1st Floor, Natural Resources Building, 1111 Washington Street, Olympia, WA 98504-2577, on June 27, 2000, at 1:00 p.m.

Assistance for Persons with Disabilities: Contact Jodi Truett by June 26, 2000, 5:00 p.m., 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 June 27, 2000.

Date of Intended Adoption: July 3, 2000.

May 23, 2000

Candace A. Jacobs, DVM, MPH

Assistant Director

OTS-4099.1


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.]


AMENDATORY SECTION(Amending Order 1866, filed 7/10/85)

WAC 16-42-017
Permits required.

(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.]


AMENDATORY SECTION(Amending Order 1866, filed 7/10/85)

WAC 16-42-022
Biologics.

Biologics produced under a regular license issued by the United States Department of Agriculture, or produced under a permit issued by the director may only be sold by persons or firms properly licensed under chapter 18.64 RCW or any veterinarian licensed pursuant to chapter 18.92 RCW.      ((Persons other than licensed veterinarians or state or federal veterinarians may administer biologics other than those listed under WAC 16-42-025 to their own domestic animals.))

[Statutory Authority: Chapter 16.36 RCW.      85-15-024 (Order 1866), § 16-42-022, filed 7/10/85.]


AMENDATORY SECTION(Amending Order 1866, filed 7/10/85)

WAC 16-42-025
Purchasing and administering biologics limited.

(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 ((of Washington)) 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

(2) All biologics used to control or diagnose any of the diseases listed in subsection (1) of this section are hereby 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. Persons other than licensed veterinarians or state or federal veterinarians may administer biologics to their own domestic animals.      The director may authorize((,)) others by written permit((, others)) to purchase ((such)) biologics listed in subsection (1) of this section for research agencies or laboratories authorized by the ((state)) department ((of agriculture)), 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((, in establishing this permit shall)) 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.

[Statutory Authority: Chapter 16.36 RCW.      85-15-024 (Order 1866), § 16-42-025, filed 7/10/85; Order 896, Regulation 4, effective 11/24/62.]


AMENDATORY SECTION(Amending Order 1866, filed 7/10/85)

WAC 16-42-035
Reports.

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.]


REPEALER

     The following section of the Washington Administrative Code is repealed:
WAC 16-42-060 Penalty.

© Washington State Code Reviser's Office