Material and consistent failure to follow specified procedural or quality control requirements prescribed in approved methods.
Falsification of analytical results, testing dates, or any other information submitted to the department by the laboratory. Falsification includes alteration or modification of a certificate.
Procedure for suspension or revocation of accreditation. NR 149.10(4)(a)
An order suspending or revoking accreditation shall be mailed to the laboratory and shall state the reasons for suspension or revocation. The order shall include the conditions under which reapplication will be accepted. For orders suspending accreditation, the order may include a timetable for correcting the deficiencies that led to the suspension. For orders revoking accreditation, the department may set a time for the revocation.
An order suspending or revoking an accreditation shall take effect on the 30th day after the order is mailed unless the owner of an accredited laboratory submits a petition for a hearing. Petitions for a hearing shall be submitted to the department within 30 days of receiving the order. The petition for hearing shall specify the findings or conclusions, or both, that the laboratory disputes and conform to the requirements of s. NR 2.05 (5)
If a request for a hearing is submitted and meets the requirements of s. 227.42
, Stats., the suspension or revocation shall be stayed, and the department shall conduct a contested case hearing on the matter. At least ten days prior to the date of the hearing, the department shall send a written notice to the laboratory indicating the date, time, and location of the hearing. The final determination of the department, including the basis for the decision, shall be provided by written order to the laboratory after the hearing.
NR 149.10 Note
Refer to ch. NR 2
for additional information on the contested hearing process.
The final determination of the department is subject to review under ch. 227
Reapplication following suspension or revocation. NR 149.10(5)(a)(a)
A laboratory that has had its accreditation suspended may reapply for accreditation if all the following are met:
The deficiencies that led to the suspension have been corrected in accordance with the timetable contained in the order.
Any conditions for reapplication specified in the order have been met.
A laboratory that has had its accreditation revoked may reapply for accreditation if all of the following have been met:
The deficiencies that led to the revocation have been corrected.
Laboratories reapplying for accreditation following suspension or revocation shall submit an initial application as identified in s. NR 149.14 (1)
Any violation of this chapter may be referred to the attorney general's office for enforcement under ss. 299.95
Any laboratory operating without proper accreditation for which analysis results are submitted to the department for compliance monitoring or for analyses that require certification or registration under any covered program may be referred by the department to the attorney general's office for enforcement.
NR 149.10 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.11
Discretionary acceptance. NR 149.11(1)(1)
Except for results of tests required under ch. NR 809
the department may accept, on a case-by-case basis, the results of tests originating in a laboratory not accredited as required by a covered program if the results meet all other requirements of this chapter.
The requirements of this chapter may be waived by the department when there is a multi-agency response to a hazardous substance discharged in boundary areas of the state.
The requirements of this chapter may be waived by the department when the environmental protection agency national enforcement investigations center laboratory is utilized for EPA or department led enforcement cases.
The department may not accept the results of tests originating in a laboratory not accredited, unless the results are generated in accordance with requirements substantially equivalent to those outlined in this chapter.
NR 149.11 Note
Refer to s. NR 149.42
for additional information on the use of alternative methods.
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 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.12(1)(1)
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.
Request for variance.
Requests for variances shall be submitted to the department. Each variance request shall contain all the following:
The section of this chapter from which a variance is sought.
A description of the circumstances under which the variance will be exercised, including any pertinent background information relevant to making a justification.
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.
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 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.13
Fields of accreditation: certification and registration. NR 149.13(1)(1)
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.
Tier 1 – matrix.
The first tier of accreditation is comprised of aqueous, non-aqueous, and drinking water matrices.
NR 149.13 Note
Biosolids and sludges are a non-aqueous matrix for accreditation purposes.
The second tier of accreditation is comprised of analytical technologies for the aqueous and non-aqueous matrices or methods for the drinking water matrix.
The department may certify or register laboratories that analyze aqueous and non-aqueous matrices for the analytical technologies
contained in this section, Table 1.
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.
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
- See PDF for table
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.
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 Note
Links to 40 CFR Part 141
can be found on the Wisconsin department of natural resources laboratory accreditation program website.
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.
The analytes and analyte groups available for accreditation under this subsection are contained in Appendix I.
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.
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
- See PDF for table
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.
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.
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. NR 149.14
Application for accreditation. NR 149.14(1)(a)1.
Submit applications to seek, revise, or transfer accreditations.
Declare the fields of accreditation being sought, revised, or transferred in corresponding applications.
For drinking water, declare the methods of analysis for analytes and analyte groups in the fields of accreditation being sought, revised, or transferred.
Submit acceptable results for PT samples when the department requires the PT sample analysis.
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:
Referencing the affiliation of the applicant laboratory with a plant, office, laboratory, or engineering firm physically located in the state of Wisconsin.
Submitting a letter from a potential client requesting the applicant to perform analyses to determine compliance with a covered program.
Submit any information identified in an application or upon request of the department such as standard operating procedures or analytical data.
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 Note
Fee information is contained in s. NR 149.21
Tables 1, 2, and 3.
The department may not accept applications from a laboratory to which any of the following apply:
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.
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.
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.
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.
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.