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).
4. The department may offer certification or registration in other analytical technologies if they are approved by EPA or approved by the department as an emerging technology.
NR 149.13(3)(b)
(b) Laboratories analyzing drinking water samples shall be certified to perform methods promulgated or approved by the EPA.
NR 149.13(3)(b)1.
1. Methods available for the certification of laboratories analyzing drinking water are contained in
ch. NR 809 and the "Manual for the Certification of Laboratories Analyzing Drinking Water", EPA815-R-05-004, fifth edition, EPA, Office of Groundwater and Drinking Water, January 2005.
NR 149.13(3)(b)2.
2. The department may certify laboratories to analyze drinking water using methods not contained in the sources cited in
subd. 1. if EPA has promulgated the methods or has granted approval for their use.
NR 149.13(4)
(4) Tier 3–analyte or analyte group. The third tier of the certification fields shall be analyte or analyte group, when the department determines that offering analyte groups improves the efficiency of administering certifications.
NR 149.13(4)(a)
(a) The analytes and analyte groups available for certification and registration are contained in appendices I and II.
NR 149.13(4)(b)
(b) The department may offer certification or registration for additional analytes or analyte groups that are not contained in appendices I and II upon request by a covered program or when EPA requires their analysis, after consultation with the certification standards review council.
NR 149.13(4)(c)
(c)
Analyte groups are organized into classes. Laboratories analyzing aqueous and solid matrices may be certified or registered for analyte groups belonging to the analytical classes contained in Table 3 of this subchapter.
Table 3
Classes of analytes groups for aqueous and solid matrices
-
See PDF for table 
NR 149.13(4)(d)
(d) 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 Table 4 of this subchapter.
NR 149.13 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08; correction to (4) (d) made under s.
13.92 (4) (b) 1., Stats.,
Register April 2008 No. 628.
NR 149.14
NR 149.14
Application for certification or registration. NR 149.14(1)(a)(a) The certification and registration process requires laboratories to:
NR 149.14(1)(a)1.
1. Submit applications for seeking, revising or transferring certifications or registrations.
NR 149.14(1)(a)2.
2. Declare the fields of certification or registration being sought, revised or transferred in corresponding applications.
NR 149.14(1)(a)3.
3. Declare the methods of analysis that will be used to analyze analyte and analyte groups in the fields of certification or registration being sought, revised or transferred.
NR 149.14(1)(a)5.
5. Submit acceptable results for proficiency testing samples when the department requires the analysis of these samples.
NR 149.14(1)(a)6.
6. Submit a statement of intent to perform analyses for regulatory samples originating in Wisconsin for laboratories that are not physically located in the state of Wisconsin. Intent to perform analyses for regulatory samples originating in Wisconsin can be manifested by:
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 for a specific field of certification or registration.
NR 149.14(1)(a)8.
8. Allow the department to perform an on-site evaluation, when the department requires it or determines that an evaluation is necessary to determine potential or actual compliance with this chapter.
NR 149.14(1)(a)10.
10. Agree to comply with this chapter by signing a statement to that purpose in an application.
NR 149.14(1)(b)
(b) Laboratories seeking, revising or transferring certifications or registrations shall declare their intent by completing forms provided by the department.
NR 149.14(1)(c)
(c) The department may not accept applications seeking, revising or transferring certifications or registrations from laboratories that:
NR 149.14(1)(c)1.
1. Have been issued a notice of violation for nonconformance with this chapter if the nonconformance has not been corrected.
NR 149.14(1)(c)2.
2. Have been issued an administrative order of suspension or revocation for a violation of this chapter when the violation has not been corrected and the suspension or revocation period specified in an order has not elapsed.
NR 149.14(1)(c)3.
3. Are not in compliance with this chapter at the time they voluntarily relinquish their certifications or registrations, the nonconformance existing prior to relinquishing their certifications or registrations has not been resolved, and at least 6 months have not elapsed since the voluntary action was undertaken.
NR 149.14(1)(d)
(d) The department shall void any application from laboratories that have not submitted all the information and materials required in an application within a year of the receipt of the application form.
NR 149.14(1)(e)
(e) The department may require on a case-by-case basis the submittal with an application of additional information necessary to determine a laboratory's actual or potential compliance with the provisions of this chapter.
NR 149.14(2)(a)(a) Laboratories seeking direct certifications or registrations by the department and that have never been certified or registered under this chapter, that have let all their certifications or registrations lapse or expire for more than a year, or that have voluntarily relinquished all their certifications or registrations shall submit initial applications to become certified or registered.
NR 149.14(2)(b)
(b) Laboratories seeking certifications or registrations for additional matrices shall submit initial applications for the desired matrices.
NR 149.14(2)(c)
(c) Laboratories seeking reinstatement of their certifications or registrations after a suspension or revocation shall submit initial applications for the desired certifications or registrations.
NR 149.14(2)(d)
(d) Laboratories seeking to change their valid registrations into certifications shall submit initial applications to effect the conversion.
NR 149.14(2)(e)
(e) Laboratories requesting that their certifications or registrations be transferred to a new owner that are ineligible for a transfer shall submit initial applications if they desire to maintain their certifications or registrations. Transfer of ownership transactions involving the purchase or lease of equipment and where less than 60% of the analytical staff are retained are ineligible for transfer of accreditations.
NR 149.14(3)(a)(a) Laboratories holding valid certifications or registrations shall submit revised applications to seek certifications or registrations in additional:
NR 149.14(3)(a)2.
2. Analytes or analyte groups within a certified or registered analytical technology.
NR 149.14(3)(b)
(b) Laboratories seeking reinstatement of their certifications or registrations within a year after failing to renew them shall submit revised applications for the desired certifications and registrations.
NR 149.14(3)(c)
(c) Laboratories seeking to convert their valid certifications into registrations shall submit revised applications to effect the conversion.
NR 149.14(4)
(4) Applications for transfer of certifications or registrations. NR 149.14(4)(a)(a) When the department determines that the valid certifications or registrations of a laboratory are eligible to be transferred to a new owner, the laboratory shall submit an application for transfer of certifications or registrations. Transfer of ownership transactions which do not involve the purchase or lease of equipment and where at least 60% of the analytical staff are retained are eligible for transfer of accreditations.
NR 149.14(4)(b)
(b) When the department determines that the valid certifications or registrations of a laboratory are not eligible to be transferred to a new owner, the laboratory shall submit an initial application to be eligible to retain its certifications or registrations.
NR 149.14(5)
(5) Applications for certifications or registrations through reciprocal agreement recognition. NR 149.14(5)(a)(a) Laboratories holding valid certifications, registrations, accreditations, licenses or approvals from government bodies or private organizations with which the department has established a reciprocal agreement may have their certifications, registrations, accreditations, licenses or approvals considered for recognition by the department by submitting reciprocity applications.
NR 149.14(5)(b)
(b) Laboratories applying for recognition by the department under an existing reciprocal agreement shall submit certificates or official documents of their certifications, registrations, accreditations, licenses or approvals with their applications.
NR 149.14(5)(c)
(c) Laboratories applying for recognition by the department under an existing reciprocal agreement shall agree to notify the department of any changes, within 30 days of their occurrence, in the laboratories' certification, registration, accreditation, licensure or approval status with the entity with which the department has the agreement.
NR 149.14(5)(d)
(d) Laboratories applying for recognition by the department under an existing reciprocal agreement shall submit a copy of the report of the last on-site evaluation performed by the entity with which the department has the agreement.
NR 149.14(6)
(6) Procedures for revising certification or registration as a result of the 2007 amendments. NR 149.14(6)(a)(a) Prior to September 1, 2008, the department shall provide and the laboratories shall complete and submit a one-time status update form to facilitate the conversion of the test categories and demonstrate that the requirements of
s. NR 149.15 (2) have been met. The department may not assess fees for the conversion to the amended program structure in
s. NR 149.13.
NR 149.14(6)(b)
(b) The purpose of the status update form is to convert current certifications or registrations under the existing program structure into equivalent certifications or registrations under the revised program structure. The status update form may not be used to add additional analytes or analyte groups to a laboratory's list of certifications or registrations. If the laboratory wishes to become certified or registered in additional test categories, the laboratory shall comply with provisions of
s. NR 149.14 (3). The laboratory may apply for the additional test categories on the status update form.
NR 149.14(7)
(7) Issuance of certifications or registrations. NR 149.14(7)(a)(a) The department shall issue certifications and registrations to laboratories through certificates that meet the criteria specified in
s. NR 149.06.
NR 149.14(7)(b)
(b) The department shall issue a certificate to a laboratory submitting an initial, revised or reciprocal application for certification or registration 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.
NR 149.14(7)(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(7)(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(7)(c)
(c) Following an on-site evaluation, the department may issue certification or registration, on a case-by-case basis, for selected fields of certification or registration under application in fields that are unaffected by any deficiencies encountered during the on-site evaluation.
NR 149.14 History
History: CR 06-005: cr.
Register April 2008 No. 628, eff. 9-1-08.
NR 149.15
NR 149.15
Period, renewal and expiration of certification or registration. NR 149.15(1)(a)(a) The certification and registration period shall commence on September 1 and end on August 31 of the following year for all laboratories certified or registered by the department.
NR 149.15(1)(b)
(b) The department shall renew the certifications or registration of laboratories that meet the requirements of this section prior to September 1 of each year.
NR 149.15(2)(a)(a) Prior to September 1 of each year, each directly certified or registered laboratory shall:
NR 149.15(2)(a)1.
1. Pay the required annual renewal fee and any assessed administrative fees.
