3745-89-10 Interim authorization for new contaminants and new methods.

The director may grant interim authorization, as defined in rule 3745-89-01 of the Administrative Code, for certified laboratories to perform drinking water analyses by using new methods, or for new contaminants, or both during a transition period necessary for implementation of new or amended regulations. Such authorization shall follow the following procedures:

(A) The director shall notify certified laboratories of the availability of interim authorization and the drinking water analyses to be included.

(B) Interim authorization shall only be available to laboratories which currently have valid certification under this chapter for the same type of drinking water analysis (microbiological contaminants, inorganic, trace metals, etc.) as the drinking water analyses to be included in the interim authorization.

(C) In order to be considered for interim authorization, the laboratory shall submit to the director an application for interim authorization, on a form provided by the director. The application shall include the following information:

(1) The name, address, and telephone number of the laboratory and of the individual(s) responsible for the laboratory;

(2) Statement of the drinking water analyses and methods for which interim authorization is sought and the analysts to be included in the interim authorization to perform the analyses. The analysts shall be individuals already identified on a valid certificate of approval for the laboratory for performing similar analyses or for analyzing the same type of contaminant;

(3) Documentation that the laboratory obtained acceptable results within the past twelve months for at least one proficiency test provided by a proficiency test provider for each drinking water analysis to be included in the interim authorization;

(4) Documentation that method detection limit (MDL) studies have been completed by the laboratory for each drinking water chemistry analysis to be included in the interim authorization; with the MDL studies indicating that the laboratory is capable of meeting any specified analytical reporting requirements; and

(5) Documentation that the director has approved parallel testing between the microbiological methods not approved by the Ohio environmental protection agency and an equivalent microbiological method that is approved by the Ohio environmental protection agency. Parallel testing shall include the following:

(a) The microbiological method not approved by the Ohio environmental protection agency for which interim authorization is being sought shall have been published in the Federal Register as having United States environmental protection agency approval for compliance testing of drinking water;

(b) Three sets of duplicate samples testing during at least one month a quarter for three consecutive quarters. Each set shall consist of twenty-five finished drinking water samples as potential 'negative' samples and ten raw, surface, or non-potable water samples (or dilutions of such) as potential 'positive' samples. Each parallel set shall include the required positive and negative controls. This environmental sample base will simulate what could be encountered when actually testing drinking water in Ohio, including seasonal variations in organisms;

(c) Any method specific quality control procedures required by the laboratory certification office; and

(d) Additionally, one microbiological proficiency test set shall be analyzed from a NIST approved proficiency test supplier with the method not approved by the Ohio environmental protection agency. The test data shall be sent directly to the state proficiency test coordinator from the proficiency test provider. The laboratory shall pass the proficiency test study with the method for which interim authorization is being sought.

(D) When granted, interim authorization shall state the individual(s) and drinking water analyses included in the interim authorization and the length of time that the interim authorization will remain in effect.

(E) An on-site survey shall be scheduled to verify acceptable performance by the laboratory granted interim authorization. Interim authorization shall remain in effect for the length of time specified by the director or until the on-site survey is completed and certification is granted under rule 3745-89-06 of the Administrative Code, whichever occurs first.

Replaces: Former 3745-89-10

R.C. 119.032 review dates: 08/28/2013 and 08/28/2018
Promulgated Under: 119.03
Statutory Authority: 6109.03 , 6109.04
Rule Amplifies: 6109.03 , 6109.04
Prior Effective Dates: 04/01/99