NR 149.06 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21; renum. (2) (intro.), (a) to (2) (ag), (ar) under s. 13.92 (4) (b) 1., Stats., Register February 2021 No. 782. NR 149.08
NR 149.08 Acceptance of other accreditations, licenses, or approvals. NR 149.08(1)(1)
Agriculture, trade, and consumer protection agreement. The department shall accept the accreditation, licensure, or approval by the department of agriculture, trade, and consumer protection for microbiological testing performed by a laboratory submitting or generating data for a covered program.
NR 149.08(2)
(2)
Laboratories accredited, licensed, or approved by other governments. NR 149.08(2)(a)
(a) The department may negotiate with and attempt to enter into agreements with federal agencies and agencies of other states to reciprocally accept accreditations of laboratories under this chapter.
NR 149.08(2)(b)
(b) The department may accept the accreditation, licensure, or approval of a laboratory by another state or an agency of the federal government if the standards used for the qualification of a laboratory are substantially equivalent to those established in this chapter.
NR 149.08(2)(c)
(c) The department may not accept the accreditation, licensure, or approval of a laboratory by another state or an agency of the federal government, unless that state or federal agency accepts laboratories accredited under this chapter.
NR 149.08(3)(a)
(a) The department may enter into agreements with private not-for-profit organizations to accept accreditation of laboratories under this chapter.
NR 149.08(3)(b)
(b) The department may accept the accreditation, licensure, or approval of a laboratory by a private not-for-profit organization if the organization's standards used for the qualification of a laboratory are substantially equivalent to those established in this chapter.
NR 149.08 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.09
NR 149.09 Certification standards review council. NR 149.09(1)(1)
The council shall advise the department on the standards used to certify, register, suspend, and revoke laboratories.
NR 149.09(2)
(2) The council shall advise the department on training and outreach activities that the department may offer or sponsor to facilitate compliance of laboratories with this chapter.
NR 149.09(3)
(3) The council shall advise the department on the frequency and scope of evaluations necessary to determine compliance of laboratories with this chapter.
NR 149.09(4)
(4) The department shall seek the advice of the council before requiring the analysis of additional PT samples and approving PT sample providers.
NR 149.09(5)
(5) The department shall seek the advice of the council before implementing changes in the fees assessed to laboratories.
NR 149.09(6)
(6) The department shall seek the advice of the council in granting variances.
NR 149.09(7)
(7) The department shall prepare annually the following for review by the council:
NR 149.09(7)(b)
(b) A list of required PT samples and available PT sample providers.
NR 149.09(7)(c)
(c) A summary of fees scheduled to be assessed to laboratories.
NR 149.09 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.10(1)(1)
Administrative procedures. A laboratory's accreditation is valid until it expires, is suspended, or is revoked. If, after opportunity for a contested case hearing, the department finds that an accredited laboratory materially and consistently failed to comply with the provisions of this chapter, the department may suspend or revoke a laboratory's accreditation in whole or in part by matrix, analytical technology, method, analyte, or analyte group. Contested case hearings for out-of-state laboratories regulated under this chapter shall be held in Madison, Wisconsin.
NR 149.10(2)
(2)
Suspension or revocation of certified laboratories. NR 149.10(2)(a)(a) Causes for suspension of certification include any of the following:
NR 149.10(2)(a)1.
1. Material and consistent failure to comply with the requirements of this chapter.
NR 149.10(2)(a)2.
2. Reporting data to the department after a laboratory is deemed temporarily incapable of performing analysis in any matrix, analytical technology, method, analyte, or analyte group.
NR 149.10(2)(a)3.
3. Suspension of certification, accreditation, license, or approval by another state or agency of the federal government for which the laboratory holds certification if the grounds for suspension are substantially equivalent to any of those listed in this paragraph.
NR 149.10(2)(b)
(b) Causes for revocation of certification include any of the following:
NR 149.10(2)(b)1.
1. Material and consistent failure to maintain records as required in this chapter.
NR 149.10(2)(b)2.
2. Failure to allow the department to perform on-site evaluations as specified in subch.
VI.
NR 149.10(2)(b)3.
3. Material and consistent failure to comply with the requirements of this chapter.
NR 149.10(2)(b)4.
4. Material and consistent failure to submit requested records to the department.
NR 149.10(2)(b)5.
5. Material and consistent failure to follow specified procedural or quality control requirements prescribed in methods.
NR 149.10(2)(b)6.
6. 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.
NR 149.10(2)(b)7.
7. Failure of two consecutive PT samples for any method and analyte or analyte group combination for laboratories holding certification in the drinking water matrix.
NR 149.10(2)(b)8.
8. Revocation of certification, registration, accreditation, license, or approval by another state or agency of the federal government for which the laboratory holds certification if the grounds for revocation are substantially equivalent to any of those listed in this paragraph.
NR 149.10(3)
(3)
Revocation of registered laboratories. Causes for revocation of registration include any of the following:
NR 149.10(3)(a)
(a) Material and consistent failure to maintain records as required in this chapter.
NR 149.10(3)(b)
(b) Failure to allow the department to perform on-site evaluations as specified in subch.
VI.
NR 149.10(3)(c)
(c) Material and consistent failure to comply with the requirements of this chapter.
NR 149.10(3)(d)
(d) Material and consistent failure to submit requested records to the department.
NR 149.10(3)(e)
(e) Material and consistent failure to follow specified procedural or quality control requirements prescribed in approved methods.
NR 149.10(3)(f)
(f) 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.
NR 149.10(4)
(4)
Procedure for suspension or revocation of accreditation. NR 149.10(4)(a)
(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.
NR 149.10(4)(b)
(b) 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).
NR 149.10(4)(c)
(c) 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
Note:
Refer to ch.
NR 2 for additional information on the contested hearing process.
NR 149.10(4)(d)
(d) The final determination of the department is subject to review under ch.
227, Stats.
NR 149.10(5)
(5)
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:
NR 149.10(5)(a)1.
1. The deficiencies that led to the suspension have been corrected in accordance with the timetable contained in the order.
NR 149.10(5)(a)2.
2. Any conditions for reapplication specified in the order have been met.
NR 149.10(5)(b)
(b) A laboratory that has had its accreditation revoked may reapply for accreditation if all of the following have been met:
NR 149.10(5)(b)1.
1. The deficiencies that led to the revocation have been corrected.
NR 149.10(5)(c)
(c) Laboratories reapplying for accreditation following suspension or revocation shall submit an initial application as identified in s.
NR 149.14 (1) and
(2).
NR 149.10(6)(a)(a) Any violation of this chapter may be referred to the attorney general's office for enforcement under ss.
299.95 and
299.97, Stats.
NR 149.10(6)(b)
(b) 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
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.
NR 149.11(2)
(2)
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.
NR 149.11(3)
(3)
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.
NR 149.11(4)
(4) 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
Note:
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 History
History: 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 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.13
NR 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 Note
Note:
Biosolids and sludges are a non-aqueous matrix for accreditation purposes.
