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 AMENDMENT

 

TO:  All Concerned Persons

 

1.  On June 23, 2011, the Department of Public Health and Human Services published MAR Notice No. 37-550 pertaining to the public hearing on the proposed amendment of the above-stated rules at page 1059 of the 2011 Montana Administrative Register, Issue Number 12.

 

2.  The department has amended ARM 37.12.301, 37.12.304, 37.12.305, 37.12.306, 37.12.310, 37.12.312, 37.12.313, 37.12.315, 37.12.316, 37.12.324, 37.12.325, 37.12.326, 37.12.333, 37.12.336, 37.12.337, 37.12.338, 37.12.345, and 37.12.346 as proposed.

 

3.  The department has amended the following rules as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined.

 

            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, and does not successfully perform analysis on a second set of PE samples within 90 days of receipt of the original report, 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) through (b)(ii) remain as proposed.

 

AUTH:  50-1-202, MCA

IMP:     50-1-202, 75-6-106, MCA

 

37.12.320  PROFICIENCY TESTING  (1) and (2) remain as proposed.

            (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) remains as proposed.

            (b)  maintain a paper or electronic 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;

            (c) through (9) remain as proposed.

 

AUTH:  50-1-202, MCA

IMP:     50-1-202, 75-6-106, MCA

 

            37.12.341  REPORTING REQUIREMENTS  (1)  All results of samples collected from a public water supply system and accepted by the laboratory for analysis that exceed a maximum contaminant level (MCL) or that trigger additional actions under ARM Title 17, chapter 38, subchapter 2 must be promptly, on the day the result is determined or no later than noon the next working day, reported by the laboratory to Tthe Montana Department of Environmental Quality (MDEQ) 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 Results must be reported to the Public Water Supply Section of the Montana MDEQ either electronically to [email protected] or by telephone to (406) 444-1947.  The actual written sample result must be reported submitted to MDEQ on forms and in formats approved by the MDEQ within 48 hours of completion of the analysis.  When a maximum contaminate contaminant level as set out in ARM Title 17, chapter 28 38, 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 of that result within 24 hours after the analysis is completed.

            (2)  The analytical Rresult 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 MDEQ within a week upon after completion of the analysis.  The results must be reported submitted on forms and in formats approved by the MDEQ.

 

AUTH:  50-1-202, MCA

IMP:     50-1-202, 75-6-106, MCA

 

            37.12.342  REPORTING RESULTS FROM OTHER LABORATORIES 

            (1) remains as proposed.

            (2)  A laboratory that reports analyses performed by other laboratories is required to report all analyte results that are used for regulatory compliance, to the Montana Department of Environmental Quality.

 

AUTH:  50-1-202, MCA

IMP:     50-1-202, 75-6-106, MCA

 

            4.  The department has thoroughly considered the comments and testimony received.  A summary of the comments received and the department's responses are as follows:

 

COMMENT #1:  A commenter questioned the need for a required second inspection for newly licensed laboratories or for established laboratories changing physical location.  The commenter asserted that, since the actual building housing the lab is irrelevant, the inspection would be a waste of time and money.

 

RESPONSE #1:  The department disagrees with the premise that the facility housing a laboratory is almost irrelevant.  An adequate facility is the foundation for laboratory activities.  The Environmental Protection Agency (EPA) Manual for the Certification of Laboratories Analyzing Drinking Water devotes several paragraphs in sections IV and V to laboratory facilities.  Secondly, a change in physical location means that all equipment and instrumentation must be disassembled, transported, and reassembled in the new facility.  Depending upon the level of complexity of the equipment and instrumentation, this may require substantial validation and calibration which needs to be reviewed.

 

COMMENT #2:  A commenter asked, "Why would you have to visit a lab a second time to inspect a new facility?"  The EPA manual states the requirements needed.  The proper methodologies and quality control should be checked on the first inspection.  Inspecting the facility a second time is "silly and an even bigger waste of your time and money."

 

RESPONSE #2:  A second inspection is required of a newly established facility to ensure continued adherence to approved procedures and policies.

 

COMMENT #3:  A commenter questioned the definition of the performance evaluation (PE) audit and the requirement that PE providers be certified by the department.

 

RESPONSE #3:  PE is clearly defined in ARM 37.12.301(20).  Audit refers to the process of completing analyses and reporting of PE samples.  The department will not certify PE providers.  The requirement is for department approval, and does not specify EPA or National Environmental Laboratory Accreditation Conference (NELAC) to not be restrictive.

 

COMMENT #4:  A commenter questioned the downgrading of laboratories for failed PE audits.

 

RESPONSE #4:  The department agrees and is adding text to clarify ARM 37.12.314.

 

COMMENT #5:  A commenter questioned the advisability of the department providing copies of administrative rule and EPA Guidance to customers, and to provide web links and addresses in the rule.

 

RESPONSE #5:  The provision and interpretation of regulations is vital to the department's role as certifier of laboratories.  It is important for customers to have references and contacts.  Upon request, the department will direct customers to an electronic copy of the EPA Manual, will e-mail a copy, or will provide a printed copy if a customer is unable to retrieve the electronic copy.

 

COMMENT #6:  A commenter questioned the maintenance of proficiency testing provider report forms, since most PE providers are transitioning to electronic reporting.

 

RESPONSE #6:  The department agrees and is adding text to clarify the rule.

 

COMMENT #7:  A commenter questioned the requirement to report new equipment and new staff to the department.  The commenter also questioned the ability of the department to keep track of this information as well as information pertaining to analyst training.

 

RESPONSE #7:  The department maintains a file of analysts performing microbiology testing that includes completion of mandatory training.  Certification officers review the qualifications of all personnel during on-site audits.

 

EPA Guidance devotes Chapter IV, Section 1 and Chapter 5, Section 1 to describing personnel qualifications and requirements.  The rule specifically states that the reporting of new equipment and new staff is required if it has a material effect on the analysis of analytes.  Examples would be a new lead operator or a change in equipment that changes the testing procedures.  The department considers the maintenance of qualified personnel and the appropriateness of equipment to be of utmost importance.

 

COMMENT #8:  A commenter asked, "If I am running arsenic by graphite furnace atomic absorption (GFAA), and I want to add lead by GFAA, you have to do an on-site assessment?"

 

RESPONSE #8:  The department would not perform an on-site assessment in this case because the question involves a group of similar analytes using the same method.  The requirement for on-site assessment is limited to cases in which an analyte for which approval is required is unrelated to previously approved analytes, or requires specialized equipment and/or personnel training.

 

COMMENT #9:  A commenter said that the language in ARM 37.12.341, which describes reporting requirements timelines is too complicated.  It should be within 24 hours.  The commenter also stated that the use of the word "contaminate" should be changed to "contaminant".

 

RESPONSE #9:  The department does not agree that the reporting requirement timelines are too complicated.  The current wording takes into account weekends and holidays.  The department does agree that the use of the word "contaminate" should be changed to "contaminant" and will make that amendment.

 

COMMENT #10:  A commenter questioned the requirement that samples submitted for compliance to the Total Coliform Rule (TCR), 40 CFR 141.21(f)(3) be limited to a maximum time of 30 hours between sample collection and initiation of analysis.

 

RESPONSE #10:  EPA rule specifically requires that time from sample collection to initiation of analysis not exceed 30 hours.  While the department understands the inherent difficulties involved with compliance, the department has no authority to deviate from EPA requirements.

 

COMMENT #11:  A commenter questioned the licensure fee for out-of-state laboratories performing organic chemistry analyses.

 

RESPONSE #11:  The fee section contains an error.  The intended fee for an out-of-state chemistry license is $900.  The fee schedule was not included in this rulemaking, so cannot be amended at this time. 

 

COMMENT #12:  A commenter questioned the need and advisability of defining fees in administrative rule.

 

RESPONSE #12:  The department includes licensure fees in rule, through the rulemaking process, to ensure that the public has input into, and understands the rationale.

 

COMMENT #13:  A commenter requested that the use of the title, Montana Department of Environmental Quality, be added to ARM 37.12.342.

 

RESPONSE #13:  The department agrees and has amended ARM 37.12.342.

 

COMMENT #14:  A commenter proposed an amendment to the language in ARM 37.12.341, to clarify sample results language and reporting time.

 

RESPONSE #14:  The department agrees to the proposed language and has amended ARM 37.12.342(2) as submitted by the commenter.

 

            5.  The department intends to apply the effective date of November 1, 2011 to these amendments.

 

 

 

 

/s/ Shannon McDonald                              /s/ Mary E. Dalton acting for                      

Rule Reviewer                                             Anna Whiting Sorrell, Director

                                                                        Public Health and Human Services

 

Certified to the Secretary of State October 17, 2011