Current through Register Vol. 24-21, November 1, 2024
Section 246-272A-0145 - Proprietary distribution product registration-Process and requirements(1) Manufacturers shall register their proprietary distribution products with the department by submitting a complete application for review and approval in the format provided by the department, including:(a) Manufacturer's name, mailing address, phone number, email address, and website address;(b) Contact person's name, title, mailing address, email address, and phone number. The contact person must be vested with the authority to represent 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 the use of the product;(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) Most current, dated copies of product brochures and manuals: Sales & Promotional; Design; Installation; Operation & Maintenance; and Owner 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) The fee established in WAC 246-272-2000.(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, including dated and current copies of all required manuals; and(b) If approved, place the product on the list of registered on-site treatment and 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 shall: (a) Apply for renewal of product registration using the form or in the format provided by the department;(b) Provide an attestation to the department verifying whether or not the product has changed over the previous year. If the product has changed, the attestation 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;(c) Provide a statement that all required dated manuals are current, or submit the updated and dated new manuals; and(d) Submit the fee established in WAC 246-272-2000.(6) As part of product registration renewal, the department will:(a) Request field assessment comments from local health officers before November 1st 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 TAG any field assessment information that may impact product registration renewal;(c) Notify the manufacturer of any product to be discussed with the TAG, prior to discussion with the TAG, regarding the nature of comments received;(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 TAG, concludes product registration renewal should not be given or should be delayed until the manufacturer submits information that satisfactorily answers concerns and issues; and(e) Provide a compliance plan to the manufacturer within 90 days based on departmental concerns of public health risk related to the product.(7) The department shall maintain a list of proprietary distribution 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 product information for designers, regulators, OSS owners and other interested parties posted on the manufacturer's website including the most current dated version of: (c) Installation instructions;(d) Operation and maintenance;(e) Owner instructions; and(f) How to locate a list of representatives and manufacturer certified maintenance service providers, if any.Wash. Admin. Code § 246-272A-0145
Amended by WSR 24-06-046, Filed 3/1/2024, effective 4/1/2024Statutory Authority: RCW 43.20.050. 05-15-119, § 246-272A-0145, filed 7/18/05, effective 9/15/05.