WSR 08-09-050

PROPOSED RULES

DEPARTMENT OF AGRICULTURE


[ Filed April 14, 2008, 9:00 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 08-18-041.

Title of Rule and Other Identifying Information: Chapter 16-42 WAC, Biological products.

Hearing Location(s): Natural Resources Building, 1111 Washington Street S.E., Second Floor Conference Room #259, Olympia, WA 98504, on June 4, 2008, at 9:00 a.m.

Date of Intended Adoption: June 18, 2008.

Submit Written Comments to: Dannie McQueen, Washington State Department of Agriculture, P.O. Box 42560, Olympia, WA 98504-2560, e-mail WSDARulesComments@agr.wa.gov, fax (360) 902-2092, by 5:00 p.m., June 5, 2008.

Assistance for Persons with Disabilities: Contact WSDA receptionist by May 28, 2008, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: As part of WSDA's ongoing rules review and regulatory improvement process, the department is proposing to amend chapter 16-42 WAC for readability and clarity. Changes between the proposed and existing rules includes the removal of anaplasmosis and swine erysipelas from, and the addition of avian influenza and foot and mouth disease to, the list of diseases for which veterinary biologics are restricted.

Reasons Supporting Proposal: Proposed changes to chapter 16-42 WAC will allow the director to restrict certain veterinary biologics developed to combat diseases, such as foot and mouth disease and avian influenza. In order to protect animal health, these rules require that certain veterinary biologics are purchased, administered, or otherwise used under the direct supervision of licensed accredited veterinarians.

Statutory Authority for Adoption: RCW 16.36.040 and chapter 34.05 RCW.

Statute Being Implemented: RCW 16.36.040.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Department of agriculture, governmental.

Name of Agency Personnel Responsible for Drafting: Paul Kohrs, DVM, Olympia, (360) 902-1835; Implementation and Enforcement: Leonard Eldridge, DVM, Olympia, (360) 902-1881.

No small business economic impact statement has been prepared under chapter 19.85 RCW. RCW 19.85.030 (1)(a) requires that an agency must prepare a small business economic impact statement (SBEIS) for proposed rules that impose a more than minor cost on business in an industry. The department has analyzed the economic effects of the proposed revisions and has concluded that they do not impose more than minor costs on small businesses in the regulated industry and, therefore, a formal SBEIS is not required.

A cost-benefit analysis is not required under RCW 34.05.328. The Washington state department of agriculture is not a listed agency under RCW 34.05.328 (5)(a)(i).

April 14, 2008

Leonard E. Eldridge, DVM

State Veterinarian

OTS-1062.1


AMENDATORY SECTION(Amending WSR 00-17-072, filed 8/14/00, effective 9/14/00)

WAC 16-42-005   Definitions.   (((1))) "Department" means the Washington state department of agriculture ((of the state of Washington)) (WSDA).

(((2))) "Director" means the director of ((the department of agriculture of the state of Washington or his/her)) WSDA or the director's 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.)) "Veterinary biologic" means any virus, serum, toxin, and analogous product of natural or synthetic origin, or product prepared from any type of genetic engineering, such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the antigenic or immunizing components intended for use in the diagnosis, treatment, or prevention of diseases in animals.

[Statutory Authority: RCW 16.36.040. 00-17-072, 16-42-005, filed 8/14/00, effective 9/14/00. 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 16-42-015   License.   Only veterinary biologics ((which)) that have been produced under a ((regular)) U.S. Veterinary Biological Product License ((issued by the United States Department of Agriculture)) may be imported into the state of Washington. The director may allow the importation of unlicensed veterinary biologics ((when the director determines it necessary for the protection of humans or domestic animals)) under special use permits.

[Statutory Authority: Chapter 16.36 RCW. 85-15-024 (Order 1866), 16-42-015, filed 7/10/85; Order 896, Regulation 2, effective 11/24/62.]


AMENDATORY SECTION(Amending WSR 00-17-072, filed 8/14/00, effective 9/14/00)

WAC 16-42-017   Permits required.   (1) Any person manufacturing veterinary biologics within the state for distribution within the state must first obtain a permit from the director. This permit may be revoked or suspended under chapter 34.05 RCW for any violation of this chapter.

(2) Written approval of the director is required before any newly licensed veterinary biologic is imported into the state for sale, use or distribution. The director may also require a special permit for the importation or distribution of ((other)) prelicensed veterinary biologics into ((the)) Washington state.

[Statutory Authority: RCW 16.36.040. 00-17-072, 16-42-017, filed 8/14/00, effective 9/14/00. Statutory Authority: Chapter 16.36 RCW. 85-15-024 (Order 1866), 16-42-017, filed 7/10/85.]


AMENDATORY SECTION(Amending WSR 00-17-072, filed 8/14/00, effective 9/14/00)

WAC 16-42-023   Sale of licensed products.   Veterinary 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)) under chapter 18.92 RCW. Persons other than licensed veterinarians or state or federal veterinarians may purchase and administer veterinary biologics to their own animals, except for those veterinary biologics restricted in WAC 16-42-026.

[Statutory Authority: RCW 16.36.040. 00-17-072, 16-42-023, filed 8/14/00, effective 9/14/00.]


AMENDATORY SECTION(Amending WSR 00-17-072, filed 8/14/00, effective 9/14/00)

WAC 16-42-026   Restricted products.   (1) All veterinary 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)) Avian influenza.

(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))) Foot and mouth.

(l) Vesicular stomatitis.

(m) All conditionally approved vaccines.

(2) All veterinary 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)) under chapter 18.92 RCW, or by state or federal veterinarians. The director may authorize others by written permit to purchase the veterinary 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)).

[Statutory Authority: RCW 16.36.040. 00-17-072, 16-42-026, filed 8/14/00, effective 9/14/00.]


AMENDATORY SECTION(Amending WSR 00-17-072, filed 8/14/00, effective 9/14/00)

WAC 16-42-035   Reports.   In the interest of public health and good cooperative disease control it is recommended that any person using any veterinary biologics immediately report to the department any suspected or actual disease outbreak that occurs in connection with use of the veterinary biologic.

[Statutory Authority: RCW 16.36.040. 00-17-072, 16-42-035, filed 8/14/00, effective 9/14/00. 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.]

Washington State Code Reviser's Office