Minnesota Administrative Rules

7083.4040 PROPRIETARY TREATMENT PRODUCTS REGISTRATION; PROCESS AND REQUIREMENTS.

A.

Manufacturers shall register their proprietary treatment products with the commissioner by submitting a complete application in the format prescribed by the commissioner, including:

(1)

the manufacturer's name, mailing address, street address, and telephone number;

(2)

the contact individual's name, title, mailing address, street address, and telephone number. The contact individual must be a company official with the authority to represent the manufacturer in this capacity;

(3)

the name, including specific brand and model, of the proprietary treatment product;

(4)

a description of the function of the proprietary treatment product along with any known limitation of the use of the product;

(5)

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;

(6)

for treatment systems in Category B, daily capacity of the model or models provided in pounds per day of CBOD₅;

(7)

siting and installation requirements;

(8)

a detailed description, procedure, and schedule of routine service and system maintenance events;

(9)

estimated operational costs for the first five years of the treatment component's life including estimated annual electricity usage and routine maintenance costs, including replacement of parts;

(10)

identification of information requested to be protected from disclosure of trade secrets or confidential business information;

(11)

copies of product brochures and manuals, such as sales, promotional, design, installation, operation, and maintenance materials and homeowner instructions;

(12)

the most recently available product test protocol and results report;

(13)

all available product testing results, including a listing of state approvals and denials;

(14)

a signed and dated certification by the manufacturer's authorized senior executive or authorized agent specifically including the following statement: "I certify that I represent (INSERT MANUFACTURING COMPANY HERE) 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 in this application for registration are the parameters and values to be used for determining conformance with treatment system performance testing levels established in Minnesota Rules, part 7083.4030.";

(15)

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

(16)

a technology review fee if allowed by law.

B.

Manufacturers shall submit each proprietary product for registration to the commissioner. Products within a single series or model line, sharing distinct similarities in design, materials, and capabilities, are allowed to be registered under a single application, consistent with their test protocols for the certification of other products within a product series. Products outside of the series or model line must be registered under separate applications.

C.

Upon receipt of the application, the commissioner shall, within 60 days:

(1)

review the application and verify the application for compliance with item A;

(2)

if the application is not in compliance with item A, return the application for resubmittal with the requested information for full compliance with item A; and

(3)

if the application is complete and the commissioner determines that the product meets or exceeds all applicable protocols, the commissioner shall place the product on the list of registered treatment devices. The list of registered treatment devices shall be maintained on the agency website.

D.

Registrations are valid for up to three years, expiring on December 31 of the third year of registration, unless the product is recalled for any reason, found to be defective, or no longer available.

E.

To renew technology registration, a manufacturer shall:

(1)

submit a request for renewal of product registration at least 30 days before the current registration expires, using the form or in the format prescribed by the commissioner;

(2)

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 must be based on the most recent test results; and

(3)

provide an affidavit to the commissioner certifying whether the product has changed over the previous three years. If the product has changed, the affidavit must include a full description of the changes and how the changed product fulfills the requirements for initial registration.

F.

As part of the product registration renewal, the commissioner shall:

(1)

request field assessment comments from local units of government no later than October 31 for product renewal;

(2)

discuss with the Technical Advisory Panel of the advisory committee established under part 7083.6000 any field assessment information that impacts product registration renewal;

(3)

notify the manufacturer of any product to be discussed with the Technical Advisory Panel, prior to discussion with the Technical Advisory Panel, regarding the nature of comments received; and

(4)

renew, modify, or deny the product registration, based on information received during the renewal process.

G.

The commissioner shall maintain a readily available list of proprietary treatment products meeting the registration requirements established in this chapter. The product registration is a condition of approval for use.

H.

A manufacturer shall have readily accessible information, specific to a product's registered use in Minnesota, for designers, regulators, system owners, and other interested parties about the product, including but not limited to:

(1)

a product manual;

(2)

design instructions;

(3)

installation instructions;

(4)

information regarding operation and maintenance;

(5)

homeowner instructions; and

(6)

a list of representatives and manufacturer-certified service providers, if any.

Statutory Authority:

MS s 115.03; 115.55

History:

32 SR 1420

Published Electronically:

September 10, 2018