(1) Manufacturers desiring to sell, advertise, or distribute an on-site sewage disposal system additive for use in Washington state must request and obtain departmental review and approval of their product(s) by submitting a complete application, including:

(a) Comprehensive, yet concise, response to the questionnaire (see subsection (3) of this section);

(b) A product sample in the labeled container intended for sale or distribution;

(2) All submitted material (written responses and other materials) must be legible, typed or printed. Hand-written responses to the application questions or hand-written notes or other submitted documentation may, at the discretion of the department, result in rejection of the application.

(3) The questionnaire for review and approval of an on-site sewage disposal system additive consists of four parts: Applicant information, product information, product literature, and certification. All applicants must provide complete written responses to the following questions:

Applicant information (AI)

(AI-1)	Applicant name, mailing address, street address, city/town, state, zip code, telephone and fax, with area code, time zone. The applicant must be vested with the authority to represent the manufacturer in this capacity.
(AI-2)	Contact individual (if different from person in Item 1) name, mailing address, street address, city/town, state, zip code, telephone and fax, with area code, time zone.
(AI-3)	Manufacturing facility location/address, mailing address, street address, city/town, state, zip code.
(AI-4)	Name of on-site sewage disposal system additive product. (One product per application. If identical formulations of product are marketed under different product names or distributor labels, list them here. If product formulations vary, submit separate applications for each product.)
(AI-5)	List of firms, companies, or persons distributing the on-site sewage disposal system additive product in Washington state. Do not list product retailers. Provide the following information for each: Contact person name, mailing address, street address, city/town, state, zip code, telephone and fax, with area code, time zone.

Product information (PI)

(PI-1)	List all physical, chemical, biological, or other agents which make up the additive and provide toxicity information for each component (provide material safety data sheet, if possible). Provide trade and scientific name and formula of chemical agents. Specify trade and scientific name(s) of bacteria and enzymes, and characterization (origin, native occurrence, pathogenicity, etc.). Report formulation in "% by weight," including inert and active ingredients, and trace amounts, if any, of prohibited ingredients (WAC 246-273-050).
(PI-2)	Describe the anticipated use of the additive in the on-site sewage system. Include in the description where and how the product is to be applied, the frequency of application, who will perform the application, and the amount and/or concentration of the product per application. For additives with chemical constituents, indicate the amount and/or concentration of each chemical constituent applied and resulting from application of the product.
(PI-3)	Describe the function of the additive within the on-site sewage disposal system and explain in detail how the additive achieves this function.
(PI-4)	List all known reactions and by-products produced by the use of the additive including:
	• The product's effect on bacteria normally found in a septic tank or aerobic treatment device and the soil surrounding a subsurface drainfield, and in the treatment media of a sand filter or sand mound system; and
	• pH range adjustment in all parts of an on-site sewage disposal system.
(PI-5)	Provide any known or projected limitation on the use of the on-site sewage disposal system additive.
(PI-6)	Provide reports of any available studies on the use of the on-site sewage disposal system additive to support the responses to questions PI-1 through PI-5 and to demonstrate the product's safety (lack of harm) to the public health, water quality, on-site sewage system components and function. Include monitoring reports and data from actual field or laboratory-based on-site sewage system studies.
(PI-7)	Attach any formal approvals or other acceptances from other jurisdictions (private sector, state, or federal) for use of the on-site sewage disposal system additive.

Product literature (PL)

(PL-1)

Attach single copies of sewage system additive product marketing, sales, distribution, advertising literature/materials intended for use in Washington state, not otherwise submitted as part of the complete application.

Certification (C)

(C-1)	The following statement must be included as part of a complete application:
	"I certify that I represent (insert manufacturing company name), that I am authorized to prepare, or direct the preparation of, this application, and that the product presented for review and approval contains no prohibited ingredients (WAC 246-273-050). I attest, under penalty of law, that this document and all attachments, to the best of my knowledge and belief, are true, accurate, and complete."
(C-2)	Lines or space must be provided for the applicant's signature, printed name of preparer (if different than the applicant), preparer's signature (if needed) and date.

PDFWAC 246-273-030

Additive review and approval application—Process and requirements.