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
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.]
[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.]
(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
other)) prelicensed veterinary biologics into (( the))
[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.]
[Statutory Authority: RCW 16.36.040. 00-17-072, § 16-42-023, filed 8/14/00, effective 9/14/00.]
Anaplasmosis)) Avian influenza.
(e) Equine infectious anemia.
(f) Equine viral arteritis.
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
(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.]
[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.]