Administrative Rules of the State of Montana

BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

In the matter of the amendment of ARM 37.12.301, 37.12.304, 37.12.305, 37.12.306, 37.12.310, 37.12.312, 37.12.313, 37.12.314, 37.12.315, 37.12.316, 37.12.320, 37.12.324, 37.12.325, 37.12.326, 37.12.333, 37.12.336, 37.12.337, 37.12.338, 37.12.341, 37.12.342, 37.12.345, and 37.12.346, pertaining to licensure of laboratories conducting analyses of public water supplies

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NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT

TO: All Concerned Persons

1. On July 13, 2011, at 10:00 a.m., the Department of Public Health and Human Services will hold a public hearing in the auditorium of the Department of Public Health and Human Services Building, 111 North Sanders, Helena, Montana, to consider the proposed amendment of the above-stated rules.

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on July 5, 2011, to advise us of the nature of the accommodation that you need. Please contact Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail [email protected].

3. The rules as proposed to be amended provide as follows, new matter underlined, deleted matter interlined:

37.12.301 DEFINITIONS For the purpose of this subchapter:

(1) through (5) remain the same.

(6) "Conditional licensure" refers to a laboratory applying for a license for the first time that is in compliance with most requirements for licensure but has not yet met all of the requirements of this subchapter, but whose deficiencies do not affect the capability of the laboratory to perform valid analyses.

(6) through (9) remain the same but are renumbered (7) through (10).

~~(10)~~ (11) "EPA laboratory certification manual" means the EPA publication entitled "Manual for the Certification of Laboratories Analyzing Drinking Water," ~~March, 1997, 4th edition (EPA 815-B-97-001)~~ January 2005, 5th edition (EPA 815-R-05-004).

(11) through (13) remain the same but are renumbered (12) through (14).

(15) "Interim licensure" refers to a status that may be granted by the certifying agency to a fully licensed laboratory without an on-site inspection for a particular analyte or interdependent analyte group if the certifying agency determines with appropriate documentation that the laboratory has the appropriate instrumentation, is using a previously approved method, has adequately trained personnel to perform the analyses, and has satisfactorily analyzed PT samples, if available for the analytes in question.

(14) remains the same but is renumbered (16).

~~(15)~~ (17) "Method detection limit" means the minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero as determined from analysis of a sample containing the analyte in a given matrix as described in 40 CFR Part 136, Appendix B, ~~July 1995~~ July 2003 edition.

(16) and (17) remain the same but are renumbered (18) and (19).

(20) "Proficiency testing (PT)" refers to testing an unknown sample to evaluate the ability of the laboratory to produce precise and accurate results and is used interchangeably with performance evaluation (PE).

(21) "Provisional licensure" refers to the downgraded status of a laboratory previously holding full certification due to noted deficiencies, but in the opinion of the certifying agency the laboratory can still demonstrate their ability to consistently produce valid data.

(18) through (22) remain the same but are renumbered (22) through (26).

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.304 LABORATORY LICENSURE: COVERAGE (1) A laboratory that conducts analyses of water from public water supplies must meet the licensure requirements of these rules before the analyses or reports of the analyses may be accepted by the Department of Environmental Quality (DEQ) for the purpose of meeting the requirements of Title 75, chapter 6, MCA, and rules of the ~~department of environmental quality~~ (DEQ) concerning public water supplies.

(2) A laboratory may be licensed to perform microbiology testing, ~~chemistry~~ chemical testing, or both. Microbiology testing and chemical testing are separate licensure categories. If a laboratory requests licensure for both categories, it must submit to the department a separate license application and undergo a separate inspection for each category, and it will receive a separate license for each category for which it qualifies.

(3) A license granted by the department constitutes permission to perform only those analyses of analytes and using only those methods for which the laboratory requests the licensure to cover and that the department finds the laboratory is capable of performing in accordance with the provisions of this subchapter.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.305 PROCEDURE FOR LICENSURE (1) Any laboratory not currently licensed but desiring licensure under this subchapter must:

(a) submit a completed application to the Department of Public Health and Human Services, ~~Operations and Technology Division~~ Laboratory Services Bureau, ~~Environmental Laboratory,~~ 1400 Broadway, Cogswell Building, P.O. Box ~~202951~~ 4369, Helena, MT ~~59620-2951~~ 59604-4369, on forms provided by the department. The application must include:

(i) through (8) remain the same.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.306 STANDARDS, INSPECTIONS, AND TESTS REQUIRED FOR LICENSURE (1) In order to be licensed, a laboratory must:

(a) remains the same.

(b) at least once during the three-year term of its license, pass an on-site inspection by an agent of the environmental laboratory that shows compliance with the requirements of these rules for the license category in question; ~~and~~

(c) if the laboratory performs chemical analyses, have performed analyses on at least two performance evaluation (PE) samples for each analyte or interdependent analyte group and each method each year during the term of its license~~, at least one of which indicates a successful identification of each analyte that it is approved under its license to analyze.~~ ; and

(d) if the laboratory performs microbiological analyses, have successfully performed analyses on at least two performance evaluation (PE) samples for each analyte and method each year during the term of its license.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.310 LICENSURE FEES (1) The following fees calculated on a flat fee yearly schedule, must be submitted to the department, under the circumstances noted, by laboratories conducting analyses of public water supplies:. All licensure fees are due January 1 of each calendar year. New laboratories that wish to be licensed prior to July 1 will pay full licensure fees; after July 1 of the fiscal year the licensure fees will be prorated 50%:

(a) $250 with an application for an initial microbiology, inorganic chemistry, or organic chemistry license ~~or renewal of a microbiology or chemistry license;~~. This application fee will only be charged when issuing a first-time license or issuing a new license after a license has lapsed;

(b) $550 licensure fee for an organic chemistry license for an in-state laboratory;

(d) $350 licensure fee for an inorganic chemistry license for an in-state laboratory;

(e) $600 licensure fee for an inorganic chemistry license for a laboratory licensed by reciprocity;

(f) $350 licensure fee for a microbiology license for an in-state laboratory;

(g) $600 licensure fee for a microbiology license for a laboratory licensed by reciprocity;

~~(b) $150 for an inspection to determine if the holder of a provisional license qualifies for a full license;~~

~~(c)~~ (h) ~~$250~~ $300 plus travel expenses for an inspection to determine if the holder of a conditional license qualifies for a full license or for a second inspection during the three-year term of a license that is necessary for approval of a new laboratory location; there is no charge for one inspection during the term of the license;

~~(d) $300 annually for a chemistry license;~~

~~(e) $200 annually for a microbiology license;~~

~~(f)~~ (i) $125 per day for training in the environmental laboratory;

~~(g)~~ (j) ~~$250~~ $300 per day, plus travel expenses of environmental laboratory staff, for on-site training and technical assistance outside of licensure inspections by the ~~environmental laboratory~~ Laboratory Services Bureau staff.

AUTH: 50-1-202, MCA

IMP: 50-1-202, MCA

37.12.312 ~~PROVISIONAL~~ LICENSE (1) In the case of a laboratory applying for a license for the first time, the department may grant a ~~provisional~~ conditional license to a laboratory that:

(a) and (b) remain the same.

(2) ~~Provisional~~ Conditional licensure will be granted only after an on-site inspection, and is in effect for one year or until full licensure is granted under provisions of ARM 37.12.311, whichever is earlier.

(3) In order for a laboratory applying for a chemistry license for the first time to upgrade from ~~provisional~~ conditional licensure status to fully licensed status, it must perform analyses of a minimum of two PE samples over the course of a year that indicate at least two successful analyses of each analyte or interdependent analyte group and method for which they seek licensure to analyze, and undergo a second on-site inspection that shows full compliance with licensure standards.

(4) In order for a laboratory applying for a microbiology license for the first time to upgrade from ~~provisional~~ conditional licensure status to fully licensed status, a microbiology laboratory must be in continual operation for one year, ~~accurately~~ analyze and successfully pass at least two performance evaluation (PE) sets for each analyte and method ~~any required audit samples~~, and undergo a second on-site inspection to verify that its methodologies and quality control meet the standards of this subchapter.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.313 RECIPROCITY (1) The department may issue a license to an out-of-state laboratory to perform analyses for public drinking water systems in Montana provided that the laboratory:

(a) through (d) remain the same.

(e) the laboratory performs, ~~and accurately~~ analyzes, and successfully passes PE ~~samples~~ audits for analytes from sources approved by the department. The provider of the PE samples shall report results of the analyses directly to the department; and

(f) remains the same.

(2) The department may license a laboratory that is accredited by the National Environmental Laboratory Accreditation Program (NELAP) if:

(a) it provides evidence of its accreditation and applies for licensure on that basis; ~~and~~

(b) it obtains approval from the department of the testing procedures for each analyte or interdependent analyte group and method and meets the approval requirements of this rule. ; and

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.314 RESTRICTION OF LICENSE (1) The department may downgrade a laboratory to provisional status and place conditions upon the license of a laboratory. The provisionally licensed laboratory must notify clients of its downgraded status in writing, on any applicable report. The department will notify the Department of Environmental Quality of any laboratories that have been downgraded to provisional status. Downgrading to provisional status may occur under the following circumstances:

(a) the laboratory reports results of an analysis of PE samples that are outside acceptable limits, or it fails to report results of a PE sample analysis for any analyte that the laboratory is approved to analyze. In this case:

(i) the laboratory's license is ~~conditional~~ provisional only in regard to the laboratory's approval to conduct analyses of the particular analyte or method involved;

(ii) the ~~conditional~~ provisional status remains in effect until the next available PE results are reported to the department, at which time:

(A) the conditions will be removed if acceptable PE results are reported to the department; or

(B) approval to conduct the analysis in question will be revoked if unacceptable PE results are reported to the department.

(b) the laboratory notifies the department, after the fact, of changes in personnel, equipment, or ~~procedures~~ a change in location that have a material effect on the analyses of analytes for which it is approved. In this case, ~~conditional~~ provisional approval will remain in effect until:

(i) and (ii) remain the same.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.315 REVOCATION OR DENIAL OF LICENSE (1) The department may deny or revoke a license at any time that a laboratory is not in compliance with the requirements for licensure under this subchapter, including if the laboratory:

(a) through (g) remain the same.

(h) reports data that were obtained using equipment, procedures, analysts, methods, or facilities that are not approved by the department; or

(i) fails to report to the Department of Environmental Quality within the time frames described in ARM 37.12.341 the results of any sample required under ARM Title 17, chapter 38, subchapter 2, and accepted by the laboratory for analysis, that exceeds a maximum contaminant level (MCL) or triggers additional actions; or unsatisfactory test results of samples or maximum contaminant level (MCL) violations to the department of environmental quality as required under Title 17, chapter 38, subchapter 2 of the Administrative Rules of Montana.

(j) fails to report results on forms or formats acceptable to the Department of Environmental Quality.

(2) remains the same.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.316 REISSUANCE OF LICENSE (1) through (3) remain the same.

(4) The department hereby adopts and incorporates by reference the EPA laboratory certification manual (~~EPA 815-B-97-001~~ EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water", ~~March, 1997~~ January 2005), which contains criteria, procedures, and quality assurance standards required by the Environmental Protection Agency that must be met by laboratories analyzing drinking water to determine compliance with the federal Clean Water Act and its rules. A copy of the manual may be obtained from the Department of Public Health and Human Services, ~~Operations and Technology Division, Environmental Laboratory~~ Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box ~~202951~~ 4369, Helena, MT ~~59620-2951~~ 59604-4369, telephone: 406-444-3444, or may be downloaded at the EPA web site: www.epa.gov/safewater/methods/pdfs/manual_labcertification.pdf.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.320 PROFICIENCY TESTING (1) remains the same.

(2) In order to initially obtain and to maintain approval, the laboratory must:

(a) whenever required by the EPA, enroll and participate in a proficiency testing program approved by the environmental laboratory for each analyte or interdependent analyte group, or, for each analyte or interdependent analyte group and method for which proficiency testing is not available or required, the laboratory must establish, maintain, and document the accuracy and reliability of its procedures through a quality assurance plan;

(b) successfully participate in at least two proficiency tests annually ~~to be evaluated to obtain or maintain approval to analyze an analyte or interdependent analyte group~~;

(c) prior to obtaining approval, notify the department of the authorized proficiency testing program or programs in which it has enrolled for each analyte or interdependent analyte group and method approved under its license to analyze;

(d) through (f) remain the same.

(3) In addition to the requirements of (2), in order to remain approved for testing an analyte or interdependent analyte group, a laboratory must:

(a) in each calendar year, successfully complete at least two separate proficiency testing audits for each analyte or interdependent analyte group and method;

(b) maintain a copy of all proficiency testing records, including analytical data and worksheets and a copy of the proficiency testing provider report forms authorized by the environmental laboratory and used by the laboratory to record proficiency testing results for a period of five years;

(5) Results of proficiency tests must be within the control limits established by the EPA as specified in ~~chapter IV of~~ the EPA laboratory certification manual (EPA 815-R-05-004) "Manual for the Certification of Laboratories Analyzing Drinking Water", January 2005) for each analysis for which the laboratory requests approval. ~~These limits are determined by using the known concentration of the analyte in the sample, and by the application of accepted statistical procedures.~~

(a) Specific chemistry acceptance criteria are listed in Table IV-10. "MCL and Proficiency Testing Sample Acceptance Criteria in the CFR, Primary and Secondary Drinking Water Regulations" of the EPA laboratory certification manual.

(b) Specific microbiology acceptance criteria is correctly analyzing a minimum of nine of ten samples, with no false negative result (i.e., a single false positive result would be considered acceptable).

(6) through (8) remain the same.

(9) The department adopts and incorporates by reference the acceptance limits for regulated parameters in chapter IV of the EPA laboratory certification manual (~~EPA 815-B-97-001~~ EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water", ~~March, 1997~~ January 2005), which contains the critical elements for chemistry that a laboratory must meet, including the acceptance limits required by the EPA for metals, inorganics, volatic organic compounds, and synthetic organics in drinking water samples. A copy of chapter IV may be obtained from the Department of Public Health and Human Services, ~~Operations and Technology Division, Environmental Laboratory~~ Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box ~~202951~~ 4369, Helena, MT ~~59620-2951~~ 59604-4369, telephone: 406-444-3444, or may be downloaded at the EPA web site: www.epa.gov/safewater/methods/pdfs/manual_labcertification.pdf.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.324 REQUIRED NOTIFICATION OF CHANGES (1) Whenever a laboratory makes any change in personnel, or equipment~~, or procedures~~ that has a material effect on the analysis of analytes, the laboratory must notify the department of that fact within 30 days after making the change, but prior to reporting results of tests used in regulatory compliance. A change in personnel is defined as the loss or replacement of the laboratory supervisor or a situation in which a trained and experienced analyst is no longer available to analyze a particular parameter for which licensure has been granted.

(2) After receiving the above notification, the department ~~will~~ may place conditions upon the laboratory's license pursuant to ARM 37.12.314.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.325 REQUIRED NOTIFICATION OF CHANGE IN NAME (1) A licensed laboratory that changes its name or business organizational status must report the change in writing to the department within 30 days of the change.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.326 REQUIRED NOTIFICATION OF CHANGE IN LOCATION

(1) remains the same.

(2) If, in view of the information received pursuant to (1), the department is satisfied that the laboratory can produce valid results at the new location, it shall place conditions on the laboratory license as specified in ARM ~~37.12.324~~ 37.12.314.

(3) remains the same.

(4) Within 30 days after the on-site inspection, the department shall issue a determination either that the laboratory license is:

(a) revoked;

(b) its ~~conditional~~ provisional status is retained; or

(5) and (6) remain the same.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.333 APPROVAL TO CONDUCT ANALYSES (1) and (2) remain the same.

(3) An applicant laboratory must request approval to analyze for an analyte or interdependent analyte group and the method(s) used as part of its application for licensure or renewal of a license.

(4) Approval for such analyses will be granted only after an on-site assessment. The applicant laboratory shall submit:

(a) remains the same.

(b) for chemistry analysis, documentation that the laboratory has successfully passed two proficiency testing audits for the analyte and method in question from an approved ~~in a~~ proficiency testing program;

(6) At a time other than when applying for a license renewal:,

~~(a)~~ a licensed laboratory may request approval to analyze for an additional analyte or interdependent analyte group by submitting a written request together with the documentation required in (1).

~~(b)~~ (a) If the analyte for which approval is requested is an addition to, or a group similar to, analytes that have already received approval, the ~~state environmental laboratory~~ certifying agency may grant ~~a provisional~~ interim approval for the analyte which shall remain in effect until the next review for license renewal as long as the laboratory continues to successfully complete proficiency testing on the analyte.

~~(c)~~ (b) If the analyte for which approval is requested is unrelated to previously approved analytes, or requires specialized equipment and/or personnel training, the ~~state environmental laboratory~~ certifying agency shall require a new application packet and an application fee to be submitted, as well as an update of the laboratory licensure file, and shall perform an on-site assessment prior to approval.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.336 QUALITY ASSURANCE (1) through (4) remain the same.

(5) As part of the quality assurance program, the laboratory must document and retain records for a period of five years demonstrating that it has maintained compliance with its quality assurance program. The laboratory may be requested by the department to provide quality assurance data to monitor compliance.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.337 SAFETY (1) A laboratory shall develop and maintain a safety program, including an education-based safety program, which meets the requirements of the Montana Safety Culture Act, Title 39, chapter 71, part 15, MCA, and ARM 24.30.2501~~, 24.30.2503, 24.30.2507, 24.30.2521, 24.30.2541, 24.30.2542, 24.30.2551, 24.30.2553, 24.30.2554 and~~ through 24.30.2558 implementing that act and adopted by the Department of Labor and Industry.

(a) The department adopts and incorporates by reference those portions of ARM 24.30.2501~~, 24.30.2503, 24.30.2507, 24.30.2521, 24.30.2541, 24.30.2542, 24.30.2551, 24.30.2553, 24.30.2554 and~~ through 24.30.2558, which contain requirements that employers must meet concerning the establishment of educational safety programs and safety programs for employers who employ more than five employees. A copy of those rules may be obtained from the Department of Public Health and Human Services, Office of Legal Affairs, ~~1400 Broadway~~ 111 North Sanders, ~~Cogswell~~ Sanders Building, P.O. Box ~~202951~~ 4210, Helena, MT ~~59620-2951~~ 59604-4210.

(2) and (3) remain the same.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.338 LABORATORY EQUIPMENT AND SUPPLIES (1) through (3) remain the same.

(4) The laboratory must have a source of distilled, or deionized, or reagent grade water that meets all the requirements listed in the EPA laboratory certification manual and the requirements of the analytical method being used.

(5) For chemical analyses of drinking water, the laboratory must have a source of reagent water having a specific resistance value of at least 0.5 megohms (less than 2.0 umhos/cm) at 25C. Reagent water for organic analysis must be free of interferences for the analytes being measured.

~~(6)~~ (5) The department adopts and incorporates by reference the standards contained in the EPA laboratory certification manual (~~EPA 815-B-97-001~~ EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water", ~~March, 1997~~ January 2005) for sources of distilled, or deionized water, or reagent grade water. A copy of the manual may be obtained from the Department of Public Health and Human Services, ~~Operations and Technology Division, Environmental Laboratory~~ Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box ~~202951~~ 4369, Helena, MT ~~59620-2951~~ 59604-4369, telephone: 406-444-3444, or may be downloaded at the EPA web site: www.epa.gov/safewater/methods/pdfs/manual_labcertification.pdf.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.341 REPORTING REQUIREMENTS (1) ~~Reporting requirements for laboratories performing microbiological or chemical analyses of water from public water supplies are as follows:~~

(a) All analyses of samples not meeting the requirements of Title 17, chapter 38, subchapter 2 of the Administrative Rules of Montana must be promptly, on that day or no later than noon of the next working day, reported by telephone to the department of environmental quality (phone 406-444-5313 for chemistry results and 406-444-3425 for microbiology results);

(b) When a maximum contaminant level set out in Title 17, chapter 38, subchapter 2 of the Administrative Rules of Montana is found to be exceeded in any sample, the laboratory must notify the water supplier within 24 hours after the analysis is completed and request resampling from the sampling point according to the requirements of Title 17, chapter 38, subchapter 2 of the Administrative Rules of Montana, with the exception noted in (1)(c) below;

(c) If a test shows a positive total coliform, fecal coliform, or E. coli result, a laboratory must immediately notify the supplier and within 24 hours notify the department of environmental quality (DEQ) of that fact. A total coliform-positive result is based on a confirmed phase for the multiple tube fermentation technique and presence-absence (P-A) coliform test, or verified test for membrane filter technique. No requirement exists for confirmation of positive Colilert/Colisure tests, fecal coliform tests, or E. coli tests. In those rare cases where a presumptive total coliform-positive culture does not confirm or verify as such, but is found to be fecal coliform or E. coli positive, the sample is considered total coliform-positive and fecal coliform/E.coli positive;

(~~d) Written reports of contaminated microbiological samples must be sent to the department of environmental quality (DEQ) within 48 hours after the test is completed; and~~

~~(e) Written reports of all microbiological samples other than those which are contaminated must be sent to the department of environmental quality within 5 days after the tests are completed.~~

(1) The Montana Department of Environmental Quality must be promptly notified, on that day or no later than noon the next working day, of all results from samples collected from a public water supply system and accepted by the laboratory for analysis, that exceeds a maximum contamination level (MCL) or triggers additional actions under ARM Title 17, chapter 38, subchapter 2. Notice must be reported to the Public Water Supply Section of the Montana DEQ either electronically to [email protected] or by telephone to (406) 444-1947. The actual sample result must be reported on forms and in formats approved by the DEQ within 48 hours of completion of the analysis. When a maximum contaminate level as set out in ARM Title 17, chapter 28, subchapter 2 is found to be exceeded in any sample, the reporting laboratory accepting the sample for analysis from the water supplier must notify the water supplier within 24 hours after the analysis is completed.

(2) Result of all microbiological or chemical samples accepted by the laboratory for analysis, other than those which are defined in ARM 37.12.341(1), must be reported to the Department of Environmental Quality within a week upon completion of the analysis. The results must be reported on forms and in formats approved by the DEQ.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.342 REPORTING RESULTS FROM OTHER LABORATORIES

(1) If a laboratory refers testing to another laboratory, that referral laboratory must be licensed in Montana to perform drinking water analysis for that analyte and method.

(2) A laboratory that reports analyses ~~from~~ performed by other laboratories is required to report all analyte results that are used for regulatory compliance must report all such laboratory results on the original reporting document, or a copy thereof, of the other laboratory performing the analyses and must attest that the laboratory performing the analyses is a laboratory licensed to perform drinking water analysis in Montana.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.345 CRITICAL ELEMENTS FOR CHEMISTRY LABORATORY LICENSURE (1) through (3) remain the same.

(4) The laboratory's analysts must:

(a) meet all of the qualifications and conditions set forth in chapter IV of the EPA laboratory certification manual, ~~except those noted in (5) and (6),~~ and: if responsible for the operation of analytical instrumentation, complete specialized training offered by the manufacturer or another qualified training facility approved by the department, or served a period of apprenticeship under an experienced analyst. The duration of this apprenticeship should be proportional to the sophistication of the instrument; and

(b) ~~if operating~~ provide certification and/or training and experience documentation to the department for review and approval as part of the laboratory licensure and inspection process. ~~the following, have the training noted, unless the department approves a specialized training course as a substitute:~~

(i) if using a gas chromatograph, liquid chromatograph, mass spectrometer, or an inductively coupled plasma atomic emission spectrophotometer, have satisfactorily completed a short course in their operation offered by the equipment manufacturer, a professional organization, a university, or another department-approved training facility acceptable to the department; and

(ii) if operating an atomic absorption, an ion chromatograph, a gas chromatograph, or an inductively coupled plasma atomic emission spectrophotometer, have a minimum of 6 months previous experience in their operation;

~~(iii) if operating a gas chromatograph or mass spectrometer, have a minimum of 12 months previous experience in its operation.~~

~~(5) A test for ortho-phosphate may not be filtered.~~

~~(6) The wavelength settings of variable wavelength spectrophotometers must be verified quarterly with color standards.~~

~~(7)~~ (5) The department adopts and incorporates by reference chapter IV of the EPA laboratory certification manual (~~EPA 815-B-97-001~~ EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water", ~~March, 1997~~ January 2005), which establishes qualifications for staff training and experience and conditions for approval of laboratories conducting chemical analyses of public drinking water. A copy of the above chapter IV may be obtained from the Department of Public Health and Human Services, ~~Operations and Technology Division, Environmental Laboratory~~ Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box ~~202951~~ 4369, Helena, MT ~~59620-2951~~ 59604-4369, or may be downloaded at the EPA web site: www.epa.gov/safewater/methods/pdfs/manual_labcertification.pdf.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

37.12.346 CRITICAL ELEMENTS FOR MICROBIOLOGY LABORATORY LICENSURE (1) through (4) remain the same.

(5) A laboratory must meet all of the qualifications and conditions set forth in chapter V of the EPA laboratory certification manual. ~~, except that:~~

~~(a) the first sentence of paragraph 6.4 is replaced by the following:~~

"The Total Coliform Rule (TCR), 40 CFR 141.21(f)(3), and EPA's Manual for the Certification of Laboratories Analyzing Drinking Water, Fourth Edition, March 1997, limit the time from sample collection to initiation of analysis to 30 hours. Public water systems (PWSs) must make every effort to meet the 30 hour holding time requirement. Laboratories may continue to analyze samples that are up to 48 hours old with the following two additional requirements:

~~1. Laboratories must flag samples that are greater than 30 and less than or equal to 48 hours old.~~

2. Laboratories must continue to invalidate a total coliform negative sample that shows signs of heterotrophic interference (40 CFR 141.21(c)(2)) regardless of the holding time. However, replacement samples may not exceed 30 hours; and

~~(b)~~ (a) Analysts must have a minimum of ~~four~~ two days of training at the environmental laboratory with a successful evaluation from the state training personnel~~, with the exception that up to two days training may be waived at the discretion of the microbiology certification officer based upon education and experience of the analyst~~. Documentation of independent certification or prior experience and training as approved by the department may be substituted for this training.

~~(6) Each membrane filter lot must be checked by comparing recovery of coliform organisms against membrane filters from a previously acceptable lot.~~

~~(7)~~ (6) The department adopts and incorporates by reference chapter V of the EPA laboratory certification manual (~~EPA 815-B-97-001~~ EPA 815-R-05-004, "Manual for the Certification of Laboratories Analyzing Drinking Water", ~~March, 1997~~ January 2005), which establishes qualifications for staff training and experience and conditions for approval of laboratories conducting microbiological analyses of public drinking water. A copy of chapter V may be obtained from the Department of Public Health and Human Services, ~~Operations and Technology Division, Environmental Laboratory~~ Laboratory Services Bureau, 1400 Broadway, Cogswell Building, P.O. Box ~~202951~~ 4369, Helena, MT ~~59620-2951~~ 59604-4369, or may be downloaded at the EPA web site: www.epa.gov/safewatermethods/pdfs/manual_labcertification.pdf.

AUTH: 50-1-202, MCA

IMP: 50-1-202, 75-6-106, MCA

4. STATEMENT OF REASONABLE NECESSITY:

The Department of Public Health and Human Services, Laboratory Services Bureau (the department) is proposing rule changes to ARM 37.12.301, subchapter 3, Licensure of Laboratories Conducting Analyses of Public Water Supplies. These rules govern the licensing procedures, including inspections, fees, reciprocity, proficiency testing, reporting requirements, quality assurance, and required notifications. It is necessary to amend these rules to provide clarification in the existing licensing rules, including the fee schedule, proficiency testing, and reporting requirements.

The last time these rules were revised was 2003, and there are some provisions that need to be updated. The Department of Environmental Quality, as the agency that receives reports of testing from licensed laboratories, has also been involved with these revisions.

The majority of the changes are general housekeeping, with updated citations and accesses. We have included additional definitions, clarified that proficiency testing (PT) must be successful and what constitutes a successful PT challenge, updated the fees to be commensurate with the actual cost of providing the service, revised the reporting requirements and requirements for training at the environmental laboratory, removed some detailed language and cited a published standard instead, and removed the 30-day rule exemption.

Over a period of months, staff from the Laboratory Services Bureau, including the laboratory director and two EPA-certified water certification officers, along with staff from the Department of Environmental Quality, Water Quality Section, met to review and revise these rules. After a draft was agreed upon, the proposed changes were presented to a group of certified in-state laboratory staff members. Feedback from this informal session was incorporated into the proposed rules that are being proposed.

ARM 37.12.301 – Definitions

The department is proposing to change and redefine "provisional licensure" to "conditional licensure" to be in accordance with EPA guidelines. "Interim licensure" is being added to be in accordance with EPA guidelines. "Proficiency testing" is proposed to be added since it is used interchangeably with performance evaluation throughout the rules.

ARM 37.12.306 – Standards, Inspections, and Tests Required for Licensure

The department is proposing to add language to clarify that performance evaluation samples (PE) must be "successfully" performed on at least two performance evaluation (PE) samples for each analyte and interdependent group and each method each year during the term of its license.

ARM 37.12.310 – Licensure Fees

The department is proposing to clarify the fee schedule, change fees to be commensurate with the actual cost of providing the service and put the fee schedule on a flat fee yearly basis for ease in tracking. Licenses are being proposed to be awarded on a calendar year with payment due January 1 of each year. New laboratories that wish to be licensed prior to July 1 would pay full annual license fees; after July 1 of the fiscal year, the fees will be 50% of the published annual license fee.

The department is proposing a new laboratory application fee of $250 for each certification (microbiology, organic, inorganic). This fee is proposed to be charged when issuing a first-time license or issuing a new license after a license has lapsed.

Proposed Fee Schedule

Annual License Fee Laboratories Licensed

payable yearly: In-state Laboratories by Reciprocity

Microbiology $350 $600

Chemistry (Organic) $550 $900

Chemistry (Inorganic) $350 $600

The department is proposing $300 for an inspection to determine if the holder of a conditional license qualifies for a full license or for a second inspection during the 3-year term of a license that is necessary for approval of a new laboratory location. There is no proposed charge for one inspection during the term of the 3-year license.

The department is proposing $125 per day for training in the environmental laboratory and $300 per day, plus travel expenses for laboratory staff, for on-site training and technical assistance outside of the licensure inspections by Laboratory Services Bureau staff.

ARM 37.12.312 – Conditional License

The department is proposing to replace "provisional" with "conditional" in this section to be in accordance with EPA guidelines, as "provisional" has a different definition than the conditions outlined in this section. The term "conditional" was selected to reflect the status of a laboratory that is newly licensed and needs to be operating successfully for a period of time prior to issuing a full license.

ARM 37.12.314 – Restriction of License

The department is proposing to add language that a provisionally licensed laboratory must notify clients of its downgraded status in writing, on any applicable report. The department would notify the Department of Environmental Quality (DEQ) of any laboratories that have been downgraded to provisional status. This is being proposed to ensure that DEQ and clients are informed that a license status has been downgraded.

ARM 37.12.315 – Revocation or Denial of License

The department is proposing to clarify language about what results need to be reported to DEQ and the specified time frames. Also the department is proposing to add the following language: "fails to report on forms or formats acceptable to the DEQ" so that a standardized reporting format is used.

ARM 37.12.320 – Proficiency Testing

The department is proposing to clarify proficiency testing (PT) criteria by citing the EPA laboratory certification manual and adding a provision to maintain records for a period of five years for record look-back and to monitor quality assurance.

ARM 37.12.324 – Required Notification of Changes

The department is proposing to clarify when notifications of changes must be done by adding the language "prior to reporting results of tests used in regulatory compliance".

ARM 37.12.336 – Quality Assurance

For the purposes of record look-back and quality assurance compliance, the department is proposing to add a time frame for record retention (a period of five years) and that the laboratory may be requested by the department to provide quality assurance data to monitor compliance.

ARM 37.12.338 – Laboratory Equipment and Supplies

The department is proposing to include reagent water with the distilled and deionized requirements, and remove the specific reagent water section.

ARM 37.12.341 – Reporting Requirements

The department is proposing to change the entire language in this rule, to clarify what samples must be reported within certain timeframes, how that reporting is to be done (e-mail or updated telephone number), when notification must be made to the public water supplier, and that formats must be acceptable to DEQ for standardization.

ARM 37.12.342 – Reporting Results From Other Laboratories

The department is proposing to clarify language that referral laboratories must be licensed in Montana, and the reporting of referral laboratory results.

ARM 37.12.345 – Critical Elements for Chemistry Laboratory Licensure

The department is proposing to clarify the training requirements for analysts and remove language about specific instrumentation.

ARM 37.12.346 – Critical Elements for Microbiology Laboratory Licensure

The department is proposing to remove the language that allows testing of samples that exceeded the 30-hour time limit but were received within 48 hours to bring the rules into compliance with federal standards, and clarify training requirements for analysts.

Fiscal Impact

Currently, the average yearly total fees collected for microbiology and chemistry licensure activities is $19,783.33. The new proposed fees projected average yearly total for microbiology and chemistry licensure activities is $33,550. The current number of in-state licensed laboratories is 17, and the number of laboratories licensed by reciprocity is 18.

5. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail [email protected], and must be received no later than 5:00 p.m., July 21, 2011.

6. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

7. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency. Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 5 above or may be made by completing a request form at any rules hearing held by the department.

8. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register. The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered. In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

9. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

/s/ Shannon McDonald /s/ Anna Whiting Sorrell

Rule Reviewer Anna Whiting Sorrell, Director

Public Health and Human Services

Certified to the Secretary of State June 13, 2011