WSR 18-09-048 PERMANENT RULES STATE BOARD OF HEALTH [Filed April 13, 2018, 9:39 a.m., effective May 14, 2018] Effective Date of Rule: Thirty-one days after filing. Purpose: Chapter 246-390 WAC, Drinking water laboratory certification and data reporting, duplicative certification requirements have been repealed in this chapter which are now covered in the department of ecology's (ecology) Accreditation of environmental laboratories, chapter 173-50 WAC. The rule adopts reporting requirements for labs to send analytical data results to public water systems and the department of health, and adopts laboratory guidance and test panel templates for submitting written and electronic analytical data results by reference. Citation of Rules Affected by this Order: New WAC 246-390-055, 246-390-065, 246-390-075, 246-390-085 and 246-390-095; repealing WAC 246-390-020, 246-390-040, 246-390-050, 246-390-060, 246-390-070 and 246-390-990; and amending WAC 246-290-001, 246-390-010, 246-390-030, and 246-390-100. Adopted under notice filed as WSR 18-03-175 on January 24, 2018. Changes Other than Editing from Proposed to Adopted Version: WAC 246-390-055(2), the amendment clarifies that confirmation must be within fourteen calendar days except for samples that have a shorter holding time.
WAC 246-390-075(5), the amendment changes the reporting time frame from seven business days to ten business days to align with chapter 246-290 WAC reporting requirements.
WAC 246-390-100(2), the amendment clarifies that an appeal must be within twenty-eight days of receipt, not service.
A final cost-benefit analysis is available by contacting Theresa Phillips, Department of Health, P.O. Box 47820, Olympia, WA 98504-7820, phone 360-236-3147, TTY 360-833-6388 or 711, email theresa.phillips@doh.wa.gov. Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0. Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0. Number of Sections Adopted on the Agency's own Initiative: New 5, Amended 4, Repealed 6. Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0. Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 5, Amended 4, Repealed 6. Date Adopted: April 10, 2018. Michelle A. Davis Executive Director
Chapter 246-390 WAC
DRINKING WATER LABORATORY CERTIFICATION ((RULES)) AND DATA REPORTING AMENDATORY SECTION (Amending WSR 92-15-152, filed 7/22/92, effective 8/22/92)
WAC 246-390-001 Purpose((—Objectives)).
(1) The purpose of this chapter is to ((establish a state drinking water program for certification of laboratories analyzing public drinking water under RCW 43.20.050. The certification program is designed to satisfy the intent of the primacy agreement with United States Environmental Protection Agency and the state, in compliance with 40 C.F.R. 142.10, 7/1/90.
(2) The department certification program:
(a) Requires laboratories to demonstrate capability to accurately analyze drinking water samples;
(b) Aids laboratories in improving quality assurance;
(c) Offers technical assistance in all drinking water analyses; and
(d) Fosters cooperation between the state department of health, local health agencies, and operators of laboratories)) set minimum certification and data reporting requirements for environmental laboratories that analyze drinking water samples.
(2) This chapter conforms to EPA primary enforcement responsibility requirements of 40 Code of Federal Regulations (C.F.R.) 142.10 for the certification of laboratories.
(3) Certified laboratories must comply with the requirements of this chapter, chapter 173-50 WAC, and applicable state and federal drinking water laws and regulations.
AMENDATORY SECTION (Amending WSR 92-15-152, filed 7/22/92, effective 8/22/92)
WAC 246-390-010 Definitions, abbreviations, and acronyms.
The definitions, abbreviations, and acronyms in this section ((shall)) apply throughout this chapter, unless the context clearly ((indicated)) indicates otherwise.
(1) (("Administrative Procedure Act" means the adjudicative proceedings governed by chapter 34.05 RCW and chapter 246-08 WAC.
(2) "Analytical data" means the recorded qualitative and/or quantitative results of a chemical, physical, biological, microbiological, or radiological determination.
(3) "Certification" means the formal contractual agreement between the department and the certified laboratory indicating a laboratory is capable of producing accurate analytical data and is authorized to test drinking water compliance samples. The department will issue a certificate to the laboratory indicating the contaminants the laboratory is authorized to analyze. Certification does not guarantee validity of analytical data submitted by a certified laboratory.
(4) "Certification authority" means the designated official or a representative of the official authorized by the department as the head of the certification program.
(5) "Certification manual" means the most recent revision of the procedural and technical criteria of the drinking water certification rules. This document, entitled "Certification Manual for Laboratories Analyzing Washington State Drinking Water," is available from the Department of Health, Public Health Laboratory, Drinking Water Certification Program, 1610 NE 150th St., Seattle, Washington 98155-7224.
(6) "Certification official (CO)" means the designated official authorized by the department to certify drinking water laboratories.
(7) "Compliance sample" means a drinking water sample collected in accordance with WAC 246-290-300 and/or 246-290-320 and submitted to a state certified laboratory for analysis.
(8))) "Acute" means posing an immediate risk to human health.
(2) "Analyte" means the constituent or property of a sample measured using an analytical method for compliance purposes under chapters 246-290 and 246-291 WAC.
(3) "C.F.R." means the Code of Federal Regulations.
(4) "Chronic" means human exposure over many years to a contaminant at levels above the MCL.
(5) "Close of business" means the latest time during a business day when a lab is no longer in routine operation for accepting or performing drinking water sample analysis.
(6) "Confirmation" means an additional sample is analyzed from the same location where a detection has occurred to confirm the detection. The original sample and the confirmation sample are collected and analyzed within a reasonable period of time, generally not to exceed two weeks. Confirmation occurs when the confirmation sample analysis result falls within plus or minus thirty percent of the original sample result. This confirmation analysis is in addition to any analytical method confirmation requirements.
(7) "Contracted lab" means a certified lab that receives a drinking water sample from another certified lab for analysis.
(8) "Contracting lab" means a certified lab that sends a drinking water sample to another certified lab to be analyzed.
(9) "Department" means the Washington state department of health.
(((9) "EMSL-CI" means the EPA Environmental Monitoring and Support Laboratory, Cincinnati, Ohio.
(10) "EMSL-LV" means the EPA Environmental Monitoring System Laboratory, Las Vegas, Nevada.)) (10) "Ecology" means the Washington state department of ecology.
(11) "EPA" means the United States Environmental Protection Agency.
(12) (("Intercomparison studies" means a series of cross check samples sent to radiochemistry laboratories by EPA to compare the results between participating laboratories.
(13) "Laboratory" means any facility under the ownership and technical management of a single entity in a single geographical locale. A laboratory is where scientific examinations are performed on drinking water samples.
(14) "Maximum contaminant level (MCL)")) "Estimated concentration" means the level of the analyte reported to the department is above a lab's MDL, but below the lab's MRL.
(13) "GWR" means groundwater rule.
(14) "Lab" or "certified lab" means an environmental lab accredited under chapter 173-50 WAC for one or more drinking water analytes and meets the requirements of this chapter.
(15) "Maximum contaminant level (MCL)" means the maximum permissible level of a contaminant in water ((the purveyor)) that a public water system delivers to ((any public water system user, measured at the location identified under WAC 246-290-300, Table 4.
(15) "Official methods" means methodologies specified by EPA drinking water regulations under 40 C.F.R. 141.21 - 141.30, 141.41 - 141.42, 7/1/90 and approved by the department.
(16) "Parameter" means a single determination or group of related determinations using a specific written official method.
(17) "Performance evaluation (PE)" means an evaluation of the results of analysis of samples from an external testing source whose true values are unknown to the laboratory conducting the analysis. The external testing service must be approved by the department and/or CO if other than EPA sources are used.
(18) "On-site audit" means an on-site inspection performed by the department to determine a laboratory's capabilities and facilities.
(19) "Quality assurance (QA)" means all those planned and systematic actions necessary to provide confidence that an analysis, measurement, or surveillance program produces data of known and defensible quality.
(20) "Quality controls (QC)" means internal written procedures and routine analyses of laboratory reference materials, samples, and blanks to insure precision and accuracy of methodology, equipment and results.
(21) "State advisory level (SAL)" means a department-established value for a chemical without an existing MCL. The SAL represents a level which when exceeded, indicates the need for further assessment to determine if the chemical is an actual or potential threat to human health)) consumers. MCLs are established in chapters 246-290 and 246-291 WAC.
(16) "Minimum detectable activity (MDA)" means the smallest activity or concentration of radioactive material in a sample that will yield a net count (above sample background) that can be detected with ninety-five percent probability.
(17) "Minimum detection level (MDL)" means the minimum measured concentration of a substance that can be reported with ninety-nine percent confidence that the measured concentration is distinguishable from the method blank results.
(18) "Method reporting limit (MRL)" means the lowest concentration of a standard used for calibration.
(19) "Proficiency testing (PT)" means the evaluation of sample analysis results, the true values of which are known to the supplier of the samples, but unknown to the lab conducting the analysis. PT samples are provided by a source external to the certified lab.
(20) "Public water system" is defined and referenced under WAC 246-290-020 and 246-291-010.
(21) "Quality control (QC)" means a set of measures used during an analytical method to ensure that the process is within specified control parameters.
(22) "State detection reporting limit (SDRL)" means the minimum reportable detection of an analyte as established in Tables 1 through 4 of this chapter.
AMENDATORY SECTION (Amending WSR 92-15-152, filed 7/22/92, effective 8/22/92)
WAC 246-390-030 Certification.
(((1) The department may grant certification to a laboratory after conducting a complete assessment of the laboratory's capabilities, including:
(a) Submission of a completed application;
(b) Submission of the proper fees;
(c) Satisfactory performance on PE studies, and intercomparison samples where necessary;
(d) Submission of an updated QA plan; and
(e) Successful completion of an on-site inspection.
(2) The department may grant less than full certification based on terms and conditions incorporated in the contractual agreement between the laboratory and the department.)) To be certified to analyze drinking water samples, a lab shall:
(1) Be accredited under chapter 173-50 WAC; and
(2) Comply with data reporting requirements under this chapter.
NEW SECTION
WAC 246-390-055 Reporting contracted analytical results.
A contracting lab that contracts with another lab shall:
(1) Verify that the contracted lab is a certified lab;
(2) Confirm that the contracted lab receives the sample within fourteen calendar days of the contracting lab receiving the sample, but not to exceed an analyte holding time if the holding time is less than fourteen calendar days;
(3) Provide the following information to the contracted lab:
(a) The public water system's department assigned water system identification number;
(b) The name of the public water system;
(c) The date the sample was collected;
(d) The location where the sample was collected;
(e) The public water system's department assigned source identification number;
(f) The purpose for the sample;
(g) The sample composition; and
(h) The sample type.
(4) The contracted lab shall submit to the department a copy of the analytical results following the requirements under WAC 246-390-065 and 246-390-075;
(5) The contracted lab shall submit a copy of the analytical results to the contracting lab in the format and time frame per the contract terms.
NEW SECTION
WAC 246-390-065 Notification requirements.
(1) In addition to the data reporting requirements under WAC 246-390-075, a lab shall notify the department and the public water system for:
(a)(i) Routine, repeat, GWR, triggered source water monitoring, and assessment source water monitoring results, as required under chapter 246-290 WAC, that are E. coli bacteria present.
(ii) Notification occurs with no less than three attempts to contact the department and the public water system by telephone, facsimile, or email as soon as possible after sample results have been determined, but no later than the close of business.
(b)(i) Routine, repeat, GWR, triggered source water monitoring, and assessment source water monitoring results that are total coliform bacteria present.
(ii) Notification occurs with one attempt to contact the department and the public water system by telephone (voice mail is acceptable), facsimile, or email as soon as possible after sample results have been determined, but no later than the close of business on the next business day. For labs that operate seven days per week or observe regular holidays; weekends and holidays are not considered "business days" for the purposes of this subsection.
(c) Routine or confirmation sample results for nitrate or nitrite that exceed the MCL under chapters 246-290 and 246-291 WAC; or
(d)(i) Routine or confirmation sample results for inorganic, organic, or radiological contaminants that exceed four times the contaminant's primary MCL under chapters 246-290 and 246-291 WAC.
(ii) For (c) and (d) of this subsection, notification occurs with one attempt to contact the department and public water system by telephone, facsimile, or email as soon as possible after sample results have been verified by quality control staff, but no later than the close of business.
(2) A lab shall:
(a) Document all notification attempts required under subsection (1) of this section by recording the following information in a paper or electronic logbook:
(i) Date;
(ii) Time;
(iii) Sample number;
(iv) Public water system name and department-assigned identification number;
(v) The contact person and telephone number, facsimile number, or email address for the public water system;
(vi) The contact person and telephone number, facsimile number, or email address of the department; and
(vii) The initials of the lab person that made the attempt.
(b) Make the logbook available to the department upon request; and
(c) Retain the logbook for a minimum of two years after the last entry date.
NEW SECTION
WAC 246-390-075 Reporting.
(1) A lab shall report analytical results to the department and the public water system.
(2) Effective December 1, 2018, a lab submitting paper reports shall complete and submit to the department data reports following the procedures and templates in the department's Laboratory Reporting Guidance, Publication DOH 331-530, March 2018.
(3) A lab submitting electronic reports shall complete and submit to the department data reports following the procedures in the department's Electronic Reporting Guidance, Publication 331-289, March 2018.
(4) Labs shall submit reports to the public water system in the format and time frame that was agreed upon when executing the service agreement between the laboratory and the public water system.
(5) Labs shall submit reports of acute contaminant results within ten business days after receiving the sample.
(6) Labs shall submit reports of chronic contaminants within forty-five business days after receiving the sample.
(7) Analytical results must be complete, legible, and accurate.
(8) A lab shall report numerical results consistent with the accuracy of the EPA-approved methods and any associated lab instruments, glassware, or tools.
(9) A lab shall report numerical results out to, but not exceed, one decimal place past the SDRL in cases where the last definitely known digit exceeds one decimal place past the SDRL as follows:
(a) If the SDRL is 1.1 and the result, out to the last definitely known digit is 1.132, then the value reported to the department is 1.13;
(b) If the digit 6, 7, 8, or 9 is dropped, increase the preceding digit by one unit;
(c) If the digit 0, 1, 2, 3, or 4 is dropped, do not alter the preceding digit; or
(d) If the digit 5 is dropped, round off the preceding digit to the nearest even number. For example, 2.25 becomes 2.2, and 2.35 becomes 2.4.
(10) A lab shall include the following data qualifiers adjacent to the results that are affected:
(a) "B" - This data qualifier is used when the target analyte is detected in the method blank above the lab's established MRL or SDRL, whichever is lower;
(b) "J" - This data qualifier is used when the result is an estimated concentration per subsections (13) and (14) of this section;
(c) "NDDS" - This data qualifier is used when the analyte is not detected in duplicate sample; or
(d) "U" - This data qualifier is used when the radiochemistry analyte is not detected at or above the lab's established MDA.
(11) A lab shall notate on the report to the public water system and the department when any analysis is completed using a provisional accreditation.
(12) At the department's request, a lab shall submit the following information:
(a) The method specific QC for any given analytical report.
(b) The most recent MDL procedures performed for any given analyte.
(c) The most recent PT study performed for any given analyte.
(13) The SDRLs for organic chemical analytes are established in Table 1 of this section.
(a) Labs shall attach to the lab report a copy of the method specific QC results for any organic chemical detection that is reported to the department which is at or above the SDRLs listed in Table 1 of this section except for:
(i) Chloroform (0027);
(ii) Bromodichloromethane (0028);
(iii) Dibromochloromethane (0029);
(iv) Bromoform (0030);
(v) Monochloroacetic Acid (0411);
(vi) Dichloroacetic Acid (0412);
(vii) Trichloroacetic Acid (0413);
(viii) Monobromoacetic Acid (0414);
(ix) Monobromoacetic Acid (0415); and
(x) Total Organic Carbon (0421).
(b) A lab shall report organic chemical analyte results when the lab's established MRL is greater than the SDRL as:
(i) "Nondetect" or "ND" when a lab's result is less than the SDRL and MRL;
(ii) An estimated concentration, notated with a "J" data qualifier when a result is equal to or greater than the SDRL, but less than the lab's established MRL;
(iii) A number when a result is equal to or greater than the lab's established MRL.
(c) A lab shall report organic chemical analyte results when the lab's established MRL is less than the SDRL as:
(i) "Nondetect" or "ND" when a lab's result is less than the lab's established MRL;
(ii) "Nondetect" or "ND" when a lab's result is less than the lab's established SDRL; or
(iii) A number when a result is equal to or greater than the SDRL.
(d) A lab shall report organic chemical analyte results when their established MRL is equal to the SDRL as:
(i) "Nondetect" or "ND" when a lab's result is less than the SDRL and MRL; or
(ii) A number when a result is equal to or greater than the SDRL and the lab's established MRL.
Table 1 - Organic Chemicals
(14) The SDRLs for inorganic chemical analytes are established in Table 2 of this section.
(a) A lab shall report inorganic chemical analyte results when the lab's established MRL is greater than the SDRL as:
(i) "Nondetect" or "ND" when a lab's result is less than the SDRL and MRL;
(ii) An estimated concentration, notated with a "J" data qualifier, when a result is equal to or greater than the SDRL, but less than the lab's established MRL; or
(iii) A number when a result is equal to or greater than the lab's established MRL.
(b) A lab shall report inorganic chemical analyte results when the lab's established MRL is less than the SDRL as:
(i) "Nondetect" or "ND" when a lab's result is less than the lab's established MRL;
(ii) "Nondetect" or "ND" when a lab's result is less than the lab's established SDRL; or
(iii) A number when a result is equal to or greater than the SDRL.
(c) A lab shall report inorganic chemical analyte results when the lab's established MRL is equal to the SDRL as:
(i) "Nondetect" or "ND" when a lab's result is less than the SDRL and MRL; or
(ii) A number when a result is equal to or greater than the SDRL and the lab's established MRL.
Table 2 - Inorganic Chemicals
(15) The SDRLs for radiochemistry analytes are established in Table 3 of this section.
(a) A lab's MDA must meet the established SDRL levels for the analysis to be considered for compliance purposes.
(b) A lab shall report radiochemistry analyte results as:
(i) A number and a "U" qualifier if the analyte was analyzed for, but not detected at or above the lab's established MDA; or
(ii) A number when a result is equal to or greater than the MDA.
Table 3 - Radiochemistry
(16) The units for microbiology analytes are established in Table 4 of this section.
(a) Total coliform and E. coli results for routine and repeat samples in accordance with 40 C.F.R. 141 Subpart Y - Revised Total Coliform Rule, GWR triggered, and GWR assessment source sample results that are absent or present as follows:
(i) "Satisfactory" if no total coliforms are detected.
(ii) "Unsatisfactory" if:
(A) Total coliforms are detected; and
(B) E. coli absent if E. coli is not detected; or
(C) E. coli present if E. coli is detected.
(b) A lab shall report routine filtered and unfiltered surface water microbiology analyte results as a number.
(c) A lab shall report routine heterotrophic plate count results as a number.
(d) A lab shall report results of investigative samples or samples collected for information only to the public water system for total coliforms, fecal coliforms, and E. coli as a number or, as absent or present. Investigative samples or samples collected for information only are not required to be reported to the department.
Table 4 - Microbiology
NEW SECTION
WAC 246-390-085 Enforcement.
(1) When a lab fails to comply with the requirements of this chapter, the department may initiate one or more of the following enforcement actions:
(a) An informal letter directing appropriate corrective measures;
(b) A notice of violation requiring appropriate corrective measures;
(c) A compliance schedule of specific actions needed to achieve compliance;
(d) A notice of correction with specific actions needed within a designated time period to achieve compliance.
(2) If a lab fails to comply with a notice of correction as specified in subsection (1)(d) of this section, the department may revoke or suspend a lab's drinking water certification in accordance with WAC 246-390-095.
NEW SECTION
WAC 246-390-095 Revocation and suspension.
(1) The department may suspend a lab's certification for up to one year or revoke a lab's certification for up to five years if a lab fails to comply with a notice of correction as specified in WAC 246-390-085.
(2) A lab whose certification is suspended or revoked may, after the period of suspension or revocation has ended, apply for certification in conformance with the requirements at the time of application.
(3) If ecology suspends or revokes a lab's accreditation for drinking water analytes as authorized under chapter 173-50 WAC, the department shall immediately suspend or revoke a lab's certification to analyze drinking water samples. The lab must immediately notify the department and public water systems of any samples that are invalidated as a result of the revocation or suspension.
AMENDATORY SECTION (Amending WSR 92-15-152, filed 7/22/92, effective 8/22/92)
WAC 246-390-100 Appeals.
((A laboratory manager may appeal any certification action such as denial and revocation in writing to the CO. If the question is not satisfactorily resolved, the laboratory manager may appeal in writing by certified mail to the certification authority within thirty days of the decision of the CO. Decisions of the certification authority may be appealed to the secretary of the department within thirty days of notification of final action. The adjudication procedure is governed by the Administrative Procedure Act, this chapter, and chapter 246-08 WAC. Laboratories may be allowed to maintain certification during the appeal process.)) (1) A certified lab may appeal a revocation or suspension action taken by the department in accordance with chapters 246-10 WAC, 34.05 RCW, and RCW 43.70.115.
(2) To appeal a notice of revocation or suspension action, the certified lab must file a written appeal with the department within twenty-eight days of receipt of the initiating documents. The written appeal must contain the specific grounds for an appeal.
(3) A certified lab that requests a hearing may continue to operate until the department issues a final order unless the department takes a summary action due to a high public health risk.
REPEALER
The following sections of the Washington Administrative Code are repealed:
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