NR 149.11 NoteNote: Refer to s. NR 149.42 for additional information on the use of alternative methods. NR 149.11(5)(5) The department may charge a fee under s. 299.11 (5) (d), Stats., if it is necessary to verify the results of tests for which a laboratory requests discretionary acceptance. NR 149.11 HistoryHistory: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.12(1)(1) General. The department may approve variances from non-statutory requirements of this chapter when the department determines that the variances have no effect on the department’s objectives. Before granting variances, the department shall consider factors such as good cause, circumstances beyond the control of the laboratory, and financial hardship. NR 149.12(2)(2) Request for variance. Requests for variances shall be submitted to the department. Each variance request shall contain all the following: NR 149.12(2)(b)(b) The section of this chapter from which a variance is sought. NR 149.12(2)(c)(c) A description of the circumstances under which the variance will be exercised, including any pertinent background information relevant to making a justification. NR 149.12(3)(3) Approval of variance. The department shall approve or deny the requested variance to the applicant within 60 days of receiving all the information referenced in sub. (2). If the request is denied, the department shall state the reasons for the denial. NR 149.12(4)(4) Repeal of variances. The department will annually review approved variances and may repeal those where the initial justification for the variance no longer applies. Once the department notifies the laboratory of the repeal, the laboratory will have six months before the repeal is effective. NR 149.12 HistoryHistory: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.13NR 149.13 Fields of accreditation: certification and registration. NR 149.13(1)(1) General. The department shall certify and register laboratories by specific fields of accreditation. Accreditation shall be by certification under s. 299.11 (7), Stats., or registration under s. 299.11 (8), Stats. Fields of accreditation consist of 3 tiers describing the analytical capability of laboratories. NR 149.13(2)(2) Tier 1 – matrix. The first tier of accreditation is comprised of aqueous, non-aqueous, and drinking water matrices. NR 149.13 NoteNote: Biosolids and sludges are a non-aqueous matrix for accreditation purposes.
NR 149.13(3)(ag)(ag) The second tier of accreditation is comprised of analytical technologies for the aqueous and non-aqueous matrices or methods for the drinking water matrix. NR 149.13(3)(ar)(ar) The department may certify or register laboratories that analyze aqueous and non-aqueous matrices for the analytical technologies contained in this section, Table 1. NR 149.13(3)(b)(b) The department shall include any associated sample preparation techniques, such as digestions, distillations, extractions, cleanups, concentrations, and dilutions as part of the certification or registration for a given field of accreditation. NR 149.13(3)(c)(c) Laboratories may employ multiple methods of analysis for a given analytical technology under the same field of accreditation. Table 1 - Analytical Technologies for Aqueous and Non-Aqueous Matrices
1. Accreditation for this technology is only available for the aqueous matrix – Tier 1.
2. Accreditation for this technology is only available for the non-aqueous matrix – Tier 1.
3. The department may offer accreditation in other analytical technologies if the technology is approved by the EPA or is approved by the department as an emerging technology.
NR 149.13(3)(d)(d) The department may certify laboratories analyzing drinking water samples using methods promulgated or approved by the EPA under 40 CFR Part 141. NR 149.13 NoteNote: Links to 40 CFR Part 141 can be found on the Wisconsin department of natural resources laboratory accreditation program website. NR 149.13(4)(ag)(ag) The third tier of the accreditation is comprised of analytes or analyte groups. The department may certify or register laboratories by analyte groups if it improves the efficiency of administering accreditations. NR 149.13(4)(ar)(ar) The analytes and analyte groups available for accreditation under this subsection are contained in Appendix I. NR 149.13(4)(b)(b) The department, upon consultation with the council, may offer accreditation for additional analytes or analyte groups that are not contained in Appendix I upon request by the manager of a covered program or when the EPA requires the additional analytes or analyte group analysis. NR 149.13(4)(c)(c) For aqueous and non-aqueous matrices, the analytes and analyte groups are organized into classes. Laboratories analyzing aqueous and non-aqueous matrices may be accredited for analytes and analyte groups belonging to the analytical classes contained in this section, Table 2. Table 2 - Analytical Classes for Aqueous and Non-Aqueous Matrices
1. Hazardous Waste Characteristics and Leaching Procedures are only offered for non-aqueous matrices – Tier 1.
2. Leaching Procedures require that laboratories also maintain accreditation for any analyte to be determined in the resulting leachate in the non-aqueous matrix.
NR 149.13(4)(d)(d) For the drinking water matrix, the analytes and analyte groups are organized into classes. Laboratories analyzing drinking water may be certified for analytes or analyte groups belonging to the analytical classes contained in this section, Table 3. Table 3 - Analytical Classes for the Drinking Water Matrix
NR 149.13 HistoryHistory: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21; renum. (3) (intro.), (a), (4) (intro.), (a) to (3) (ag), (ar), (4) (ag), (ar) under s. 13.92 (4) (b) 1., Stats., and correction in (3) (d) made under s. 35.17, Stats., Register February 2021 No. 782. NR 149.14NR 149.14 Application for accreditation. NR 149.14(1)(a)2.2. Declare the fields of accreditation being sought, revised, or transferred in corresponding applications. NR 149.14(1)(a)3.3. For drinking water, declare the methods of analysis for analytes and analyte groups in the fields of accreditation being sought, revised, or transferred. NR 149.14(1)(a)5.5. Submit acceptable results for PT samples when the department requires the PT sample analysis. NR 149.14(1)(a)6.6. For laboratories that are not physically located in Wisconsin, submit a statement of intent to perform analyses for regulatory samples originating in Wisconsin. Intent to perform analyses for regulatory samples originating in Wisconsin can be manifested by any of the following: NR 149.14(1)(a)6.a.a. Referencing the affiliation of the applicant laboratory with a plant, office, laboratory, or engineering firm physically located in the state of Wisconsin. NR 149.14(1)(a)6.b.b. Submitting a letter from a potential client requesting the applicant to perform analyses to determine compliance with a covered program. NR 149.14(1)(a)7.7. Submit any information identified in an application or upon request of the department such as standard operating procedures or analytical data. NR 149.14(1)(a)8.8. When the department determines that an evaluation is necessary to determine potential or actual compliance with this chapter, allow the department to perform an on-site evaluation. NR 149.14 NoteNote: Fee information is contained in s. NR 149.21 Tables 1, 2, and 3. NR 149.14(1)(b)(b) The department may not accept applications from a laboratory to which any of the following apply: NR 149.14(1)(b)1.1. The laboratory has been issued a notice of violation for nonconformance with this chapter if the nonconformance has not been corrected and the notice of violation has not been closed. NR 149.14(1)(b)2.2. The laboratory has been issued an administrative order of suspension or revocation for a violation of this chapter when the violation has not been closed and the suspension or revocation period specified in an order has not expired. NR 149.14(1)(b)3.3. The laboratory was not in compliance with this chapter at the time the laboratory voluntarily relinquished its accreditations, nonconformances existing prior to relinquishing the accreditations have not been corrected, and at least 6 months have not elapsed since the voluntary action was undertaken. NR 149.14(1)(c)(c) The department shall expire any application from a laboratory that has not submitted all the information and materials required as part of the application, or subsequent audit process, within a year of the receipt of the application form. NR 149.14(1)(d)(d) The department may require the submittal of additional information necessary, such as standard operating procedures or analytical data, to determine a laboratory’s actual or potential compliance with the provisions of this chapter. NR 149.14(2)(a)(a) A laboratory seeking direct accreditation by the department that has never been accredited under this chapter, that has let its entire accreditation lapse for more than one year, or that has voluntarily relinquished all its accreditations shall submit an initial application to become accredited. NR 149.14(2)(b)(b) A laboratory seeking reinstatement of its accreditations, following a suspension or revocation, shall submit an initial application for the desired accreditations. NR 149.14(3)(a)(a) A laboratory holding valid accreditations shall submit a revised application to seek additional accreditations in any of the following: NR 149.14(3)(a)3.3. Analytes or analyte groups within an accredited analytical technology. NR 149.14(3)(a)4.4. Analyte-method or analyte group-method combinations for the drinking water matrix. NR 149.14(3)(b)(b) A laboratory seeking reinstatement of accreditations within a year after failing to renew those accreditations shall submit a revised application for the desired accreditations. NR 149.14(3)(c)(c) A laboratory seeking to convert a valid certification into a registration or a registration into a certification shall submit a revised application. NR 149.14(4)(4) Applications for accreditations through reciprocal agreement acceptance. NR 149.14(4)(a)(a) A laboratory holding valid accreditations, licenses, or approvals from government bodies or private organizations, with which the department has established a reciprocal agreement, may have its accreditations, licenses, or approvals considered for acceptance by the department by submitting a reciprocity application. NR 149.14(4)(b)(b) A laboratory applying for acceptance under an existing reciprocal agreement shall do all the following: NR 149.14(4)(b)1.1. Submit certificates or official documents of the laboratory’s accreditations, licenses, or approvals with its application. NR 149.14(4)(b)2.2. Agree to notify the department of any changes, within 30 days of a change in its accreditation, licensure, or approval status with the entity with which the department has the agreement. NR 149.14(4)(b)3.3. Submit a copy of the report of the most recent on-site evaluation performed by the entity with which the department has the agreement. NR 149.14(5)(a)(a) The department shall issue accreditations to laboratories through certificates that meet the criteria specified in s. NR 149.06. NR 149.14(5)(b)(b) The department shall issue a certificate to a laboratory submitting an initial, revised, or reciprocity application for accreditation within 30 days of the date by which the laboratory successfully completes an on-site evaluation or the date by which the department waives an on-site evaluation, subject to all the following: NR 149.14(5)(b)1.1. The department may not schedule or waive an on-site evaluation of an applicant laboratory until all the requirements of sub. (1) have been completed. NR 149.14(5)(b)2.2. A laboratory completes an on-site evaluation successfully when it addresses, to the department’s satisfaction, any deficiencies encountered during the on-site evaluation. NR 149.14(5)(c)(c) Following an on-site evaluation, the department may issue accreditations, on a case-by-case basis, that are unaffected by any deficiencies encountered during the on-site evaluation. NR 149.14(5)(d)(d) The department shall issue a revised certificate of accreditation to an accredited laboratory within 30 days of the occurrence of any of the following: NR 149.14(5)(d)1.1. Receiving notification from that laboratory that it is changing its name without changing ownership. NR 149.14(5)(d)2.2. Approval of relocation to a new facility that does not compromise the laboratory’s ability to meet the requirements of this chapter. NR 149.14 HistoryHistory: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21; correction in (2) (a) made under s. 35.17, Stats., Register February 2021 No. 782.
