NR 149.08(4)(a)(a) The department may negotiate with and attempt to enter into agreements with private not for profit organizations to recognize laboratories under this chapter.
NR 149.08(4)(b)
(b) The department may recognize the certification, registration, 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 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.09
NR 149.09
Certification standards review council. NR 149.09(1)(1) The certification standards review council shall advise the department on the standards used to certify, register, suspend and revoke laboratories.
NR 149.09(2)
(2) The certification standards review council shall advise the department on training and outreach activities the department may offer or sponsor to facilitate compliance of laboratories with this chapter.
NR 149.09(3)
(3) The department shall prepare annually for review by the certification standards review council:
NR 149.09(3)(a)
(a) A summary of laboratory evaluations performed. The certification standards review council shall advise the department on the frequency and scope of evaluations necessary to determine compliance of laboratories with this chapter.
NR 149.09(3)(b)
(b) A list of required proficiency testing samples and available sample providers. The department shall seek the advice of the certification standards review council before requiring the analysis of additional proficiency testing samples and approving sample providers.
NR 149.09(3)(c)
(c) A summary of fees scheduled to be assessed to laboratories. The department shall seek the advice of the certification standards review council before implementing changes in the fees assessed to laboratories.
NR 149.09(3)(d)
(d) A summary of variances issued. The department shall seek the advice of the certification standards review council in granting variances.
NR 149.09 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.10(1)(1)
Administrative procedures. A laboratory's certification is valid until it expires, is suspended, or revoked. A laboratory's registration is valid until it expires or is revoked. If, after opportunity for a contested case hearing, the department finds that a certified or registered laboratory materially and consistently failed to comply with the provisions of this chapter, the department may suspend or revoke a laboratory's certification or revoke a laboratory's registration by whole or in part by matrix, analytical technology, or analyte or analyte group. Contested case hearings for out-of-state laboratories regulated by 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 quality program requirements as specified in subch.
VII.
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, or 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 quality program requirements as specified in subch.
VII.
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 approved 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 2 consecutive proficiency testing 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. Demonstrated incompetence manifested by the chronic inability to meet the requirements of this chapter.
NR 149.10(2)(b)9.
9. 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) 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(3)(b)
(b) Material and consistent failure to maintain records as required in this chapter.
NR 149.10(3)(c)
(c) Material and consistent failure to comply with the quality program requirements as specified in subch.
VII.
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) Demonstrated incompetence manifested by the chronic inability to meet the requirements of this chapter.
NR 149.10(4)
(4) Procedure for suspension or revocation of certification or revocation of registration. NR 149.10(4)(a)(a) An order suspending or revoking certification or revoking registration 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 certification, the order may include a timetable for correcting the deficiencies that led to the suspension. For orders revoking certification or registration, the department may set a time period for the revocation.
NR 149.10(4)(b)
(b) An order suspending or revoking a certification or revoking a registration shall take effect on the thirtieth day after the order is mailed, unless the owner of a certified or registered 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, which 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 10 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 revocation. NR 149.10(5)(a)(a) A laboratory which has had its certification suspended may reapply for certification or registration if all of 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 which has had its certification or registration revoked may reapply for certification or registration 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)(b)3.
3. The time period for which the revocation is in effect has expired.
NR 149.10(5)(c)
(c) Laboratories reapplying for certification or registration 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 certification or registration for which analysis results are submitted to the department for compliance monitoring or for analyses which require certification or registration under
ch. NR 662,
664 or
665, may be referred by the department to the attorney general's office for enforcement.
NR 149.10 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.11
NR 149.11
Discretionary acceptance. NR 149.11(1)
(1) The department may accept, on a case-by-case basis, the results of tests originating in a laboratory not certified or registered for fields of certification or registration required by a covered program, if the results meet all other requirements of this chapter.
NR 149.11(2)
(2) The department may not accept the results of tests originating in a laboratory not certified or registered for the corresponding fields of certification or registration if the results do not meet all other requirements of this chapter.
NR 149.11(3)
(3) The department may not accept the results of tests originating in a laboratory not certified for the corresponding fields of certification for any tests associated with monitoring required under
ch. NR 809.
NR 149.11(4)
(4) 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 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
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 are essential to or have no effect on the department's objectives. Before granting variances, the department shall take into account 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's director of the bureau of integrated science services as far in advance as feasible. Each variance request shall contain:
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 determination of justification.
NR 149.12(2)(d)
(d) A statement as to whether the same or a similar variance has been requested previously, and if so, the circumstances of the previous request.
NR 149.12 Note
Note: Requests for variance should be addressed to:
NR 149.12 Note
Bureau Director, Science Services
NR 149.12 Note
Wisconsin Department of Natural Resources
NR 149.12 Note
101 So. Webster Street
NR 149.12 Note
PO Box 7921
NR 149.12 Note
Madison, WI 53707-7921.
NR 149.12(3)
(3) Approval of variance. The department shall send a letter approving or denying the requested variance to the applicant within 60 days of receiving all the information referenced in
sub. (2). If the request is denied, the letter shall state the reasons for the denial. A copy of all letters approving or denying variances shall be retained in the department's files.
NR 149.12 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
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 is offered as either certification or registration. Fields of certification and registration consist of 3 tiers describing the analytical capability of laboratories. Specific fields of certification and registration shall be structured as in Table 1 of this subchapter.
NR 149.13(2)
(2) Tier 1–matrix. The first tier of certification or registration designates the matrices a laboratory may analyze and shall consist of aqueous, solids, and drinking water matrices.
NR 149.13(3)
(3) Tier 2–technology or method. The second tier of certification or registration shall be analytical technology for aqueous and solid matrices or method for drinking water matrix.
NR 149.13(3)(a)
(a) Laboratories analyzing aqueous and solid samples may be certified or registered for the analytical technologies contained in table 2 of this subchapter.
NR 149.13(3)(a)1.
1. The department shall include any associated sample preparation techniques, such as digestions, distillations, extractions, cleanups, concentration, and dilution as part of the certification or registration for a given field of accreditation.
NR 149.13(3)(a)2.
2. Laboratories may employ multiple approved methods of analysis for a given analytical technology under the same field of accreditation.
1. Waste characterization extractions offered for solid matrices (Tier 1) only and include extraction procedure toxicity, synthetic precipitation leaching procedure, toxicity characteristic leaching procedure and shake extraction of solid waste with water. Laboratories shall also maintain certification or registration for any analyte to be determined in the resulting extract from any waste characteristic extraction.
2. Waste characterization assays are offered for solid matrices (Tier 1) only and shall include tests required to determine if a material meets the hazardous definition in
s. NR 661.03 and those used to fulfill the requirements of waste analysis plans under
ch. NR 664 or
665.
3. Certification or registration for this technology is only available for aqueous matrices (Tier 1).
