Chapter NR 149

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NR 149.13 History History: 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.

subch. IV of ch. NR 149 Subchapter IV — Accreditation Process

NR 149.14 NR 149.14 Application for accreditation.

NR 149.14(1) (1) General requirements.

NR 149.14(1)(a) (a) Laboratories are required to do all the following:

NR 149.14(1)(a)1. 1. Submit applications to seek, revise, or transfer accreditations.

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)4. 4. Submit a current analytical instrument list.

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(1)(a)9. 9. Remit any necessary fees required under this chapter.

NR 149.14 Note Note: Fee information is contained in s. NR 149.21 Tables 1, 2, and 3.

NR 149.14(1)(a)10. 10. Agree to comply with this chapter by signing the application.

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) (2) Initial applications.

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) (3) Revised applications.

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)1. 1. Matrices.

NR 149.14(3)(a)2. 2. Technologies for an accredited matrix.

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) (5) Issuance of accreditations.

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 History History: 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.

NR 149.15 NR 149.15 Period, renewal, and expiration of accreditation.

NR 149.15(1) (1) Accreditation period.

NR 149.15(1)(a) (a) The accreditation period shall commence on September 1 and end on August 31 of the following year for all laboratories accredited by the department.

NR 149.15(1)(b) (b) The department shall renew the accreditations of laboratories that meet the requirements of this section prior to September 1 of each year.

NR 149.15(2) (2) Renewal process. Annually, each laboratory holding valid accreditations under this chapter and wishing to renew its accreditations shall do all the following:

NR 149.15(2)(a) (a) Pay the required annual renewal fee and any assessed administrative fees prior to July 1. After July 1, a late renewal fee may be assessed to laboratories that have not paid all requisite fees. A laboratory is not eligible for renewal of accreditation if full payment is not received prior to September 1.

NR 149.15(2)(b) (b) Submit acceptable PT sample results as required in subch. V, no later than August 31.

NR 149.15(2)(c) (c) If accredited via reciprocal agreement, submit documentation of accreditations and a copy of the most recent on-site evaluation report from the entity with which the department has the agreement.

NR 149.15(3) (3) Expiration of accreditations. On September 1 of each year, the department shall expire the affected accreditations of laboratories failing to provide the information and fees specified in sub. (2).

NR 149.15(4) (4) Voluntary withdrawal of accreditations. Laboratories may voluntarily withdraw accreditations at any time by notifying the department in writing.

NR 149.15 Note Note: Conditions associated with applying for analytes for which accreditation was voluntarily withdrawn are provided in s. NR 149.14 (1) (b) 3.

NR 149.15 History History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21.

NR 149.155 NR 149.155 Required notifications.

NR 149.155(1) (1) Laboratory name change. A laboratory that changes its name without changing ownership shall notify the department, in writing, within 30 days of the effective date of the name change. The department may not charge a fee for any processing resulting solely from a name change.

NR 149.155(2) (2) Laboratory ownership change. A laboratory that changes its ownership shall notify the department, in writing, within 30 days of the effective date of the ownership change. Notification shall be in the form of a completed application for transfer of ownership.

NR 149.155(3) (3) Laboratory relocation. A laboratory relocating shall notify the department, in writing, at least 30 days prior to the relocation. Notification shall include the new address and any changes in contact information.

NR 149.155(4) (4) Key personnel changes. A laboratory making changes to key personnel, including lab director, lab manager, quality assurance manager, or whole effluent toxicity technical expert, shall notify the department within 30 days of these changes.

NR 149.155 History History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21.

NR 149.18 NR 149.18 Subcontracting.

NR 149.18(1) (1) Subcontracting samples shall be to a laboratory that holds valid certifications corresponding to the matrix, technology or method, and analyte requested.

NR 149.18(2) (2) A laboratory accepting samples under a subcontract from another laboratory shall maintain any analytical records needed to determine compliance with this chapter. The records shall be made available to the laboratory providing the samples.

NR 149.18 History History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21.

NR 149.19 NR 149.19 Requirements for certification in the drinking water matrix.

NR 149.19(1) (1) Applicability. This section contains additional requirements that apply to laboratories analyzing drinking water for compliance under ch. NR 809.

NR 149.19(2) (2) General requirements.

NR 149.19(2)(a) (a) The minimum criteria and procedures for certification in the drinking water matrix are specified in the following documents:

NR 149.19(2)(a)1. 1. As updated, the “Manual for the Certification of Laboratories Analyzing Drinking Water,” EPA 815-R-05-004, fifth edition, EPA, Office of Ground Water and Drinking Water, January 2005.

NR 149.19(2)(a)2. 2. As updated, the “Supplement 1 to the Fifth Edition of the Manual for the Certification of Laboratories Analyzing Drinking Water,” EPA 815-F-08-006 EPA, Office of Ground Water and Drinking Water, June 2008.

NR 149.19 Note Note: The documents above can be found on the Wisconsin department of natural resources laboratory accreditation program website and are available for inspection at the offices of the department and the legislative reference bureau.

NR 149.19(2)(b) (b) The department may not grant either interim or provisional certifications.

NR 149.19(2)(c) (c) A laboratory shall follow any additional criteria and procedures identified in this chapter applying to drinking water analyses.

NR 149.19(3) (3) Requirements for inorganic contaminants.

NR 149.19(3)(a) (a) To receive and maintain certification to conduct analyses of inorganic contaminants, the laboratory shall achieve MDLs no greater than the MDLs specified in 40 CFR 141.23 (a) (4) (i) and 40 CFR 141.89 (a) (1) (iii) for each accredited method.

NR 149.19 Note Note: Links to 40 CFR Part 141 can be found on the Wisconsin department of natural resources laboratory accreditation program website.

NR 149.19(3)(b) (b) Each laboratory shall successfully analyze at least one PT sample annually according to criteria specified in 40 CFR 141.23 (k) (3) (ii) or 40 CFR 141.89 (a) (1) (ii) (A) and (B) for each accredited method.

NR 149.19 Note Note: Links to 40 CFR Part 141 can be found on the Wisconsin department of natural resources laboratory accreditation program website and are available for inspection at the offices of the department and the legislative reference bureau.

NR 149.19(4) (4) Requirements for vinyl chloride.