Section 246-272A-0120. Proprietary treatment product registration—Process and requirements.

(1) Manufacturers shall register their proprietary treatment 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 represent the manufacturer in this capacity;

(c) Name, including specific brand and model, of the proprietary treatment product;

(d) A description of the function of the proprietary treatment product along with any known limitation on the use of the product;

(e) Product description and technical information, including process flow drawings and schematics; materials and characteristics; component design specifications; design capacity, volumes and flow assumptions and calculations; components; dimensioned drawings and photos;

(f) For treatment systems in Category 2, daily capacity of the model or models in pounds per day of CBOD5;

(g) Siting and installation requirements;

(h) Detailed description, procedure and schedule of routine service and system maintenance events;

(i) Estimated operational costs for the first five years of the treatment component's life. This shall include both estimated annual electricity costs, and routine maintenance costs, including replacement of parts;

(j) Identification of information subject to protection from disclosure of trade secrets;

(k) Copies of product brochures & manuals: Sales & Promotional; Design; Installation; Operation & Maintenance; and Homeowner Instructions;

(l) The most recently available product test protocol and results report;

(m) 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 registration. I attest, under penalty of law, that this document and all attachments are true, accurate, and complete. I understand and accept that the product testing results reported with this application for registration are the parameters and values to be used for determining conformance with Treatment System Performance Testing Levels established in chapter 246-272A WAC";

(n) A signed and dated certification from the testing entity including the statement, "I certify that I represent (INSERT TESTING ENTITY NAME), that I am authorized to report the testing results for this proprietary treatment product. I attest, under penalty of law, that the report about the test protocol and results is true, accurate, and complete"; and

(o) The fee described in WAC 246-272A-990.

(2) Products within a single series or model line (sharing distinct similarities in design, materials, and capacities) may be registered under a single application, consistent with the provisions of their test protocol for the certification of other products within a product series. 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 treatment products.

(4) All registrations are valid for up to one year, expiring on December 31 of each year. Fees are not prorated.

(5) In order to renew technology registration, a manufacturer shall:

(a) Apply for renewal of product registration using the form or in the format provided by the department.

(b) Submit the results of retesting, if the product has completed retesting according to the protocol required for registration and a report from the testing entity has been issued since initial registration or previous renewal. Renewal shall be based on the most recent test results.

(c) 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 for initial registration.

(d) Submit the fee established in WAC 246-272A-990.

(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 treatment products meeting the registration requirements established in this chapter. The 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-0120, filed 7/18/05, effective 9/15/05.]

RCW 43.20.050. WSR 05-15-119, § 246-272A-0120, filed 7/18/05, effective 9/15/05.

Rules

246-272A,246-272A-990,246-272A-990,