Section 246-272A-0145. Proprietary distribution product registration—Process and requirements.  


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  • (1) Manufacturers shall register their proprietary distribution product(s) with the department by submitting a complete application in the format provided by the department, including:
    (a) Manufacturer's name, mailing address, street address, and phone number;
    (b) Contact individual's name, mailing address, street address, and phone number. The contact individual must be vested with the authority to act as the agent of the manufacturer in this capacity;
    (c) Name, including specific brand and model, of the proprietary distribution product;
    (d) A description of the function of the proprietary distribution product along with any known limitations on its use;
    (e) Product description and technical information, including schematics; materials and characteristics; component design specifications; design capacity, volumes and flow assumptions and calculations; components; dimensioned drawings and photos;
    (f) Siting and installation requirements;
    (g) Detailed description, procedure and schedule of routine service and system maintenance events;
    (h) Identification of information subject to protection from disclosure of trade secrets;
    (i) Copies of product brochures and manuals: Sales & Promotional; Design; Installation; Operation & Maintenance; and Homeowner Instructions;
    (j) For gravelless chamber systems a quantitative description of the actual exposed trench-bottom infiltrative surface area for each model seeking registration;
    (k) A statement from a professional engineer that certifies the technology meets the standards established in WAC 246-272A-0140;
    (l) A signed and dated certification by the manufacturer's agent specifically including the following statement, "I certify that I represent (INSERT MANUFACTURING COMPANY NAME) and I am authorized to prepare or direct the preparation of this application for product registration. I attest, under penalty of law, that this document and all attachments, are true, accurate, and complete."
    (m) A signed and dated certification from the licensed professional engineer including the statement, "I certify that I represent (INSERT PROFESSIONAL ENGINEERING FIRM NAME), that I am authorized to certify the performance characteristics for the proprietary distribution product presented in this application. I attest, under penalty of law, that the technology report is true, accurate, and complete."
    (n) The fee established in WAC 246-272A-0990.
    (2) Products within a single series or model line (sharing distinct similarities in design, materials, and capacities) may be registered under a single application. Products outside of the series or model line must be registered under separate applications.
    (3) Upon receipt of an application the department shall:
    (a) Verify that the application is complete;
    (b) If complete, place the product on the list of proprietary distribution products.
    (4) All registrations are valid for up to one year, expiring on December 31st of each year. Required fees are not prorated.
    (5) In order to renew a proprietary distribution product registration, a manufacturer must:
    (a) Apply for renewal of product registration using the form or in the format provided by the department;
    (b) Provide an affidavit to the department verifying whether or not the product has changed over the previous year. If the product has changed, the affidavit must also include a full description of the changes. If the product has changed in a way that affects performance, the product may not be renewed and shall meet the requirements of initial registration; and
    (c) Submit the fee established in WAC 246-272A-0990.
    (6) As part of product registration renewal, the department shall:
    (a) Request field assessment comments from local health officers no later than October 31st of each year. These comments may include concerns about a variety of field assessment issues, including product function, product reliability, and problems arising with operation and maintenance;
    (b) Discuss with the TAC any field assessment information that may impact product registration renewal;
    (c) Notify the manufacturer of any product to be discussed with the TAC, prior to discussion with the TAC, regarding the nature of comments received; and
    (d) Renew the product registration unless:
    (i) The manufacturer of a product does not apply for renewal; or
    (ii) The department, after deliberation with the TAC, concludes product registration renewal should not be given or should be delayed until the manufacturer submits information that satisfactorily answers concerns and issues.
    (7) The department shall maintain a list of proprietary distribution products meeting the registration requirements established in this chapter. Product registration is a condition of approval for use.
    (8) Manufacturers shall have readily accessible information for designers, homeowners, regulators, system owners and other interested parties about their product including:
    (a) Product manuals;
    (b) Design instructions;
    (c) Installation instructions;
    (d) Operation and maintenance;
    (e) Homeowner instructions; and
    (f) A list of representatives and manufacturer certified service providers, if any.
    [Statutory Authority: RCW 43.20.050. WSR 05-15-119, § 246-272A-0145, filed 7/18/05, effective 9/15/05.]
RCW 43.20.050. WSR 05-15-119, § 246-272A-0145, filed 7/18/05, effective 9/15/05.

Rules

246-272A-0140,246-272A-0990,246-272A-0990,