Administrative Rule 74:04:07 | South Dakota Legislature

74:04:07:01. Definitions. Terms defined in SDCL 34A-3A-2 have the same meaning when used in this chapter. In addition, terms used in this chapter mean:

(1) "Acceptable results," the results of performance evaluation audits with one or more concentrations of a parameter within two standard deviations;

(2) "Certified laboratory," a laboratory that meets the requirements necessary to provide accurate and timely data for the analysis of drinking water samples;

(3) "Deficiency," a lack of the equipment, personnel, or quality control necessary to produce reliable chemical or microbiological data;

(4) "EPA," the United States Environmental Protection Agency;

(5) "Laboratory," a place equipped for the analysis of public water system samples;

(6) "Laboratory certification compliance officer," the certification program compliance officer appointed by the secretary of the department;

(7) "Laboratory certification officer," the certification officer appointed by the secretary of the department, with the concurrence of the director of health laboratories, to perform on-site evaluations of laboratories for the environmental disciplines involved with drinking water analyses;

(8) "On-site evaluation," an inspection of the laboratory by the laboratory certification officer for the purpose of reviewing the adequacy of equipment, supplies, personnel, methods of analysis, quality control, and laboratory data for producing accurate analyses;

(9) "Performance evaluation audit," analysis of a set of samples of known chemical or microbiological concentration supplied semiannually by EPA or the state;

(10) "Provisionally certified," a laboratory which has minor deficiencies but is able to produce reliable data;

(11) "Quality assurance plan," a written protocol established by the laboratory which contains procedures for sample handling, sample analysis, calibration of equipment, frequency of quality control requirements, data validation, reporting of data, and other requirements as specified by the secretary;

(12) "Quality control," the process of introducing duplicate samples, samples of known concentrations, and other procedures into a sample set to assure that the data produced by the laboratory is accurate;

(13) "Secretary," the secretary of the Department of Agriculture and Natural Resources or a designated agent of the secretary;

(14) "Unacceptable results," the results of performance evaluation audits with one or both concentrations of a parameter outside established control limits.

Source: 16 SDR 196, effective May 21, 1990; 21 SDR 40, effective September 6, 1994; SL 2021, ch 1, §§ 8, 19, effective April 19, 2021.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

Rule 74:04:07:02 Requirements for laboratory certification.

74:04:07:02. Requirements for laboratory certification. Laboratories desiring to conduct analytical measurements of drinking water for public water systems regulated under chapter 74:04:05, Drinking Water Standards, must meet the requirements of this chapter.

Source: 16 SDR 196, effective May 21, 1990.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

Rule 74:04:07:03 Requirements for certification.

74:04:07:03. Requirements for certification. Laboratories must meet the following criteria to achieve or maintain certification:

(1) Submit acceptable results on all parameters for which the laboratory is certified for at least one semiannual performance evaluation audit each year;

(2) Undergo an on-site evaluation at least once every three years by the state laboratory certification officer for each area of analysis. An on-site evaluation may be conducted more frequently if substantial changes are made in laboratory staff, operation, equipment, or ownership that cause the overall performance of the laboratory to be adversely affected or if unacceptable audit results are submitted by the laboratory;

(3) Produce valid data as indicated by performance evaluation samples, internal audit samples, on-site review of data validation results, and transcription procedures and calculations;

(4) Adhere to the provisions in the laboratory's written quality assurance plan;

(5) Submit additional information to the state concerning the laboratory's staff, equipment, methods, and other information as requested;

(6) To receive certification to conduct inorganic chemical analyses, the laboratory must achieve quantitative results on analyses that are within acceptance limits as specified in 47 Fed. Reg. 31,840-31,841 (July 17, 1992) except that the acceptance limits for antimony are ± 30% @ ³ 0.006 mg/L;

(7) To receive certification to conduct volatile organic chemical analyses, the laboratory must meet the requirements specified in 40 C.F.R. § 141.24(f)(20) (July 1, 1992), 40 C.F.R. § 141.40(h) (July 1, 1992), and 57 Fed. Reg. 31,841 (July 17, 1992);

(8) To receive certification to conduct synthetic organic chemical analyses, the laboratory must achieve quantitative results on analyses that are within the acceptance limits specified in 57 Fed. Reg. 31,842 (July 17, 1992); and

(9) To receive certification to conduct lead and copper analyses, the laboratory must meet the requirements specified in 40 C.F.R. § 141.89 (July 1, 1992).

Laboratories may conduct inorganic chemical and volatile organic chemical sample analyses under provisional certification until January 1, 1996.

Source: 16 SDR 196, effective May 21, 1990; 21 SDR 40, effective September 6, 1994.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

Rule 74:04:07:04 Criteria for revoking certification.

74:04:07:04. Criteria for revoking certification. Revocation of certification shall be based on one or more of the following criteria and may be for one or more analytical parameters:

(1) Production of unacceptable results for two consecutive performance evaluation audits;

(2) Failure to correct identified deviations from laboratory certification requirements specified in an on-site evaluation report;

(3) Failure to meet time requirements for reporting data;

(4) Failure to perform analyses in accordance with the following methods:

(a) Inorganic chemicals - 40 C.F.R. § 141.23 (July 1, 1992) and 57 Fed. Reg. 31,839-31,840 (July 17, 1992);

(b) Synthetic organic chemicals - 40 C.F.R. § 141.24(h)(12-13) (July 1, 1992) and 57 Fed. Reg. 31,842 and 31,846 (July 17, 1992);

(d) Radionuclides - 40 C.F.R. § 141.25 (July 1, 1992);

(e) Total coliform - 40 C.F.R. §§ 141.21(f) and 141.74(a) (July 1, 1992);

(f) Fecal coliform - 40 C.F.R. §§ 141.21(f) and 141.74(a) (July 1, 1992);

(g) Escherichia coli - 40 C.F.R. § 141.21(f) (July 1, 1992);

(h) Heterotrophic plate count - 40 C.F.R. § 141.74(a) (July 1, 1992);

(i) Turbidity - 40 C.F.R. § 141.74(a) (July 1, 1992);

(j) Volatile organic chemicals - 40 C.F.R. §§ 141.24(f)(16) and 141.40(g-h) (July 1, 1992) and 57 Fed. Reg. 31,841 and 31,845 (July 17, 1992);

(k) Residual disinfectant concentration - 40 C.F.R. §§ 141.74(a) (July 1, 1992);

(l) Temperature - 40 C.F.R. § 141.74(a) (July 1, 1992);

(m) pH - 40 C.F.R. § 141.74(a) (July 1, 1992);

(n) Lead and copper parameters as specified in §§ 74:04:05:74 to 74:04:05:99, inclusive - 40 C.F.R. § 141.89 (July 1, 1992);

(5) Failure to generate reliable data on a routine basis;

(6) Submission of a performance evaluation sample or any routine sample to another laboratory and reporting the data to be generated as its own; or

(7) Falsification of data or other deceptive practices.

Source: 16 SDR 196, effective May 21, 1990; 21 SDR 40, effective September 6, 1994.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

Rule 74:04:07:05 Certification status of new laboratories.

74:04:07:05. Certification status of new laboratories. For laboratories requesting first-time certification or certification to analyze additional or newly regulated parameters, the certificate compliance officer may administratively grant a laboratory provisional certification status, pending an on-site evaluation. Provisional certification may be granted only when the certification compliance officer has determined that the laboratory has the proper equipment and trained personnel to perform the analyses and has satisfactorily analyzed performance evaluation samples for the parameters in question.

Source: 16 SDR 196, effective May 21, 1990.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

Rule 74:04:07:06 Criteria for downgrading to provisional certification status.

74:04:07:06. Criteria for downgrading to provisional certification status. The secretary shall notify the laboratory in writing that it has been downgraded from certified to provisionally certified for a particular analytical parameter for any of the following reasons:

(1) Failure to analyze a performance evaluation sample within acceptance limits established by EPA, unless the laboratory has identified and corrected the problem within one month after being notified of the failure and the laboratory certification compliance officer is satisfied with the explanation of the failure. Acceptance limits established by EPA are determined through analysis of numerous samples submitted by laboratories nationwide. If the laboratory certification compliance officer determines that the laboratory need not be downgraded, he shall verify that the problem was corrected by having the laboratory analyze an unknown sample within one month. A follow-up on-site evaluation may also be performed to verify that the problem was corrected. If the laboratory fails to analyze the unknown sample within EPA acceptance limits, the laboratory shall be downgraded to provisionally certified; or

(2) Failure to notify the laboratory certification officer of major changes which might impair analytical capability.

The laboratory may remain provisionally certified for a period of six months before certification is revoked. An additional six months may be granted if the continued provisional status does not affect the generation of valid data. The laboratory must notify its clients of its downgraded status and supply a copy of the notice to the laboratory certification compliance officer.

Source: 16 SDR 196, effective May 21, 1990.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

Rule 74:04:07:07 Procedure for revocation and appeal of revocation.

74:04:07:07. Procedure for revocation and appeal of revocation. The procedure for revocation of certification is as follows:

(1) The secretary shall issue a letter of intent to revoke certification to the laboratory by certified mail with return receipt requested;

(2) If the laboratory wishes to challenge the revocation, it may request a hearing before the secretary. This may be done by submitting a written request within 30 days after receipt of the revocation notice. The request must contain the reasons for the challenge and must be signed by the laboratory director; and

(3) After a contested case hearing conducted pursuant to SDCL 1-26, a decision concerning the revocation shall be made by the secretary.

If certification is revoked, the laboratory may not analyze drinking water for compliance purposes until certification has been reinstated.

Source: 16 SDR 196, effective May 21, 1990.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2), 34A-3A-4(2).

Rule 74:04:07:08 Reinstatement of certification.

74:04:07:08. Reinstatement of certification. Certification may be reinstated after an on-site evaluation demonstrating that the deficiencies which caused the revocation or downgrading have been corrected and after the required parameters are successfully analyzed during the next performance evaluation audit.

Source: 16 SDR 196, effective May 21, 1990.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

Rule 74:04:07:09 Reciprocal certification.

74:04:07:09. Reciprocal certification. The secretary may issue a certificate of reciprocity and may continue reciprocal certification to out-of-state laboratories according to the following criteria:

(1) The laboratory is certified by EPA or the state in which it is located;

(2) The laboratory has successfully analyzed the last two performance evaluation audits; and

(3) The laboratory has provided a copy of its quality assurance manual to the laboratory certification compliance officer.

The reciprocally certified laboratory must send copies of its most recent performance evaluation audits and evidence of recertification by its certifying agency to the secretary within 30 days after receipt of those documents.

Reciprocal certification shall be revoked if all the criteria in this section are not met. There is no reciprocal provisional certification.

Source: 16 SDR 196, effective May 21, 1990.

General Authority: SDCL 34A-3A-3.

Law Implemented: SDCL 34A-3A-3(2).

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