18 AAC 80.225 - Application to demonstrate an innovative technology or device

Current through April 6, 2022

(a) The department will approve an application to demonstrate an innovative technology or device at a public water system if the
(1) purpose of a demonstration is to
(A) assure that the innovative technology or device meets the necessary safety and performance standards of this chapter; and
(B) allow the innovative technology or device to be field-tested in this state without plan review under 18 AAC 80.200 - 18 AAC 80.210 during the demonstration period;
(2) department determines that the requirements of (e) and (f) of this section are met; and
(3) department finds that the public health and the public water system is adequately protected.
(b) The owner of a public water system who proposes the use or application of an innovative technology or device in the public water system's infrastructure shall submit an application for department approval under this section.
(c) An application under this section must be accompanied by the fee required by 18 AAC 80.1910(a) (10) and must describe the innovative technology or device, its proposed use, and its performance. The application must include
(1) the name of the innovative technology or device;
(2) a list of the construction materials;
(3) the proposed configuration;
(4) performance claims made by the manufacturer;
(5) information regarding approvals in other states or countries, if any, including if known, the name, address, and telephone number of the reviewing officer in each state or country;
(6) quality assurance information, including
(A) the name of the person responsible for overseeing the demonstration project;
(B) a plan for monitoring raw water quality, pretreatment effluent water quality, and finished water quality to verify and ensure that assumptions for the design of the treatment equipment are met;
(C) the innovative technology or device's controls for eliminating or reducing operator error; and
(D) the operational requirements for the innovative technology or device and it's ease of use;
(7) information about reliability features including unit alarms, automatic shutdown, and the system's capability for effective and safe manual operation if an automated system failure occurs;
(8) information on how the public water system's customers will be notified of the proposed and ongoing project;
(9) a description of the basic operation and maintenance needs, including
(A) chemicals, spare parts, labor, instrumentation, energy requirements, and ongoing monitoring;
(B) a replacement and maintenance schedule;
(C) the availability and cost of parts, servicing equipment, and controls;
(D) a description of periodic cleaning requirements, including the expected resulting down time;
(E) the response time of the equipment supplier to service calls;
(F) provisions for storage, auxiliary treatment, or bypassing if equipment problems occur;
(G) required backwashing frequency, the filter-to-waste capability, and any disposal and storage requirements related to backwashing;
(H) auxiliary needs, including media regeneration;
(10) pretreatment requirements;
(11) chemical feed requirements;
(12) finished water storage;
(13) operator expertise required to operate the innovative technology or device;
(14) manuals and training to be provided to the operator;
(15) the capability of the treatment process to produce finished water of a consistent quality, on a 24-hour per day, 8-hour per day, intermittent, and seasonal basis;
(16) environmental impacts, including waste disposal needs;
(17) the life cycle costs of the innovative technology or device, including the costs of
(A) the facilities;
(B) the appurtenances;
(C) the expected power consumption; and
(D) parts that must routinely be replaced such as membranes, filters, and cartridges;
(18) objective and verifiable data to support performance claims, including third-party certifications, data from independent third parties, study data, the manufacturer's test data, and approvals from other states, countries, or federal agencies; the information submitted under this paragraph must be sufficient for the department to determine, as applicable,
(A) the pathogen removal credits for the Giardia lambliavirus and other viruses as appropriate;
(B) compliance with MCLs of concern;
(C) appropriate performance standards;
(D) monitoring frequency required for the innovative technology or device; information on monitoring frequency must be obtained from product and process technical information, including shop drawings, process schematics and descriptions, power requirements, capacity and dimensional data, required auxiliary equipment, information on conditions for and limitations on process applicability, and quality control processes;
(E) the effectiveness of the innovative technology or device under site-specific conditions with respect to
(i) source water quality, considering seasonal variations;
(ii) finished water quality requirements;
(iii) finished water quality produced, including consistency;
(iv) design flow rates;
(v) the useful life of the device;
(vi) external environmental issues;
(vii) storage requirements, space requirements, and accessibility;
(viii) other treatment needs, such as pre-treatment water or post-treatment water;
(ix) the range of field extremes;
(x) the worst case and best case adaptability of the technology or device to various raw water qualities;
(xi) differential pressure conditions;
(xii) the reliability of treatment facilities, including redundancy of equipment; and
(xiii) operational conditions, including stopping and starting;
(F) the availability of technical support, including water treatment system manufacturer or supplier support;
(G) the qualifications of the water treatment system supplier;
(H) how operators will be trained;
(I) the laboratory services to be used; and
(J) the names of independent engineering consultants, if any, to be used in the project;
(19) a list of nationally recognized codes and standards that were followed in developing and planning the installation of the device;
(20) materials safety verification that includes supporting documentation concerning safety and use, the applicant may include as verification
(A) a listing within ANSI, NSF, UL, or MIL standard or an equivalent; and
(B) documentation of compliance with appropriate regulations of the United States Food and Drug Administration for food additives, found in 21 C.F.R. 170 - 190;
(21) material safety data sheets; and
(22) an operations manual for using the innovative technology or device in the proposed configuration.
(d) If the information submitted under (c) of this section is not sufficient for an approval under this section, the department will authorize a pilot test as a method of evaluating onsite performance and to prove that the technology or device is appropriate for use in this state. The department will authorize a pilot test only if the test serves the interests of public health, and only with an approved plan of action from the applicant. The plan of action must include necessary monitoring, quality control, data recording and reporting, evaluations, and a project summary. The department will provide written guidelines describing the criteria to be evaluated in the demonstration. A demonstration is not subject to the plan review requirements of 18 AAC 80.200 - 18 AAC 80.225 if the duration of the project does not exceed one year from the date of installation to the date that the demonstration ends. All other requirements of this chapter that apply to the public water system remain in effect during the demonstration. If the department allows a pilot test of the proposed technology or device, in addition to the requirements of (d) of this section, the applicant shall
(1) describe each known risk associated with the demonstration project;
(2) describe how drinking water contamination will be prevented during the demonstration project; means of preventing contamination include
(A) use of the innovative technology or device in conjunction with existing approved devices; and
(B) discharging the treated water;
(3) provide an example of the records and data to be collected during the demonstration project;
(4) provide the qualifications of each person who will record data;
(5) estimate the duration of the demonstration;
(6) provide plan drawings of the proposed installation;
(7) provide the names and telephone numbers of contact persons;
(8) identify the proposed installation site;
(9) submit a letter from the owner of the public water system, agreeing to participation.
(e) The department will evaluate an application submitted under (a) of this section to assess compliance with this chapter and the suitability of the innovative technology or device for use in the public water system. The department will base its denial or approval upon an evaluation of
(1) the potential risk of contamination entering the public water system during normal operation, abnormal operation, or catastrophic failure;
(2) the methods used to determine the potential risk of contamination entering the public water system during normal operation, abnormal operation, or catastrophic failure;
(3) factors relating to the ease of use, including the operator skills required to operate the innovative technology or device safely and effectively, the necessity for spare parts or special chemicals, and the ease of obtaining products for maintenance and repair;
(4) whether the device met performance claims and regulatory requirements during the field test;
(5) conditions particular to this state and known or suspected to limit the effectiveness of technology; those conditions include, permafrost and freezing;
(6) the history of the device in other water systems in this state, other states, or other countries.
(f) Based on a review of the innovative technology's performance, its suitability for use in this state, and the results of any pilot test or field demonstration performed under this section, the department will approve or deny the application for use of an innovative technology or device. Approval constitutes
(1) approval of a generic technology, not an endorsement or approval of a specific commercial product;
(2) site-specific approval of the innovative technology or device for initial use or for a pilot test; and
(3) approval for the proposed project only.
(g) Permanent installation of approved innovative technology is subject to 18 AAC 80.200 - 18 AAC 80.225. Engineering plans submitted under 18 AAC 80.200 must include a plan for converting from a temporary to a permanent installation.
(h) The applicant may resubmit an application that has been denied under this section after correcting each deficiency identified by the department in its denial of the initial application.
(i) The department will maintain a list of each innovative technology or device approved under this section.


18 AAC 80.225
Eff. 10/1/99, Register 151; am 4/24/2009, Register 190; am 7/25/2010, Register 195

Authority:AS 46.03.020

AS 46.03.050

AS 46.03.710

AS 46.03.720

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