In terms of cost of certification, only 25 of commercial laboratories are expected to see a fee increase. The average fee increase for the commercial laboratories that are projected to see a fee increase, is estimated to be $919 per laboratory per year. Two laboratories which certify for the maximum analytical methods will see their annual fees increase by $1,222. The Department estimates that approximately 316 laboratories will see a decrease in fees by an average of $72.
10. Effect on Small Business (initial regulatory flexibility analysis):
Small business laboratories are not likely to change their scope of certification under the proposed certification structure, as long as the costs for maintaining those certifications do not increase dramatically. In general, the proposed rule maintains these costs as in check.
When given options for quality control analyses that could reduce operation costs, laboratories are selective and respond that cost is not the sole determinant in selecting an option. Some small businesses are likely to continue to choose existing, more costly practices and may need to be educated in selecting valid and more economical alternatives.
Most operating costs in laboratories are associated with maintaining staff to perform analyses. The proposed rule does not require increases in staff to ensure compliance with it.
The Department concludes that the proposed rule provides flexibility in meeting many of its requirements. Small businesses may be able to realize some savings in implementing the proposed rule by judiciously selecting among the options contained in it. The specificity and flexibility contained in the proposed rule bring equity and uniformity to all laboratory operations and are likely to increase the competitiveness of small laboratories providing analytical services in and out of state.
11. Agency Contact Person:
Tom Trainor
Certification Services/EAS
920-412-5970
WDNR
2984 Shawano Avenue
Green Bay, WI 54313
The consent of the Attorney General was requested on February 13, 2018 for the incorporation by reference of the following standards:
Standards
1.
40 CFR, Part, 136, Appendix B.3.
EPA publication “Manual for the Certification of Laboratories Analyzing Drinking Water,” EPA815-R-05-004, fifth edition, EPA, Office of Ground Water and Drinking Water, January 2005.4.
EPA publication “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 2008.6.
The State of Wisconsin Aquatic Life Toxicity Testing Methods Manual (Methods Manual).Consent was received on May 9, 2018. Consent to Incorporation is attached.
Section 1 NR 106.145 (10) (a) is amended to read
In this subsection, “method blank", “matrix spike" and “limit of detection" have the meanings specified in s. NR 149.03. Note: “Matrix spike” has the meaning specified in EPA Method 1631, Revision E: Mercury in Water by Oxidation, Purge and Trap, and Cold Vapor Atomic Fluorescence Spectrometry, August 2002, Office of Water, EPA-821-R-02-019
Note: “Method blank” is not defined as a subset of the definition of “Blank” in s. NR 149.03 (15). Section 2. NR 106.145 (10) (d) is amended to read
The laboratory performing the analyses shall be certified for mercury under the cold vapor atomic fluorescence spectrophotometry technology of ch. NR 149 s. NR 149.42 for low-level mercury analyses. Until low-level mercury certification is available, the lab shall be certified under ch. NR 149 for mercury and recognized by the department as having demonstrated its low-level mercury capabilities under the emerging technology provision contained in s. NR 149.42. Note: With the changes to ch. NR 149, effective 9-1-08, certification for low level mercury is now available. Certification for low level mercury under the emerging technology provision is no longer necessary or available. Section 3. NR 106.145 (11) is amended to read
Data rejection. The department may reject any sample results if data quality requirements specified in subs. (9) and (10) are not met or if results are produced by a laboratory that is not in compliance with certification requirements specified in ch. NR 149. Section 4. NR 140.05 (13) Note is amended to read
Note: The limit of quantitation is 10/3 or 3.333 times the limit of detection established as defined under s NR 149.48 (3).
Section 5. NR 140.16 (1) (d) Note is amended to read
Note: Refer to s. NR 149.46 149.442 for sample preservation procedures and holding times. Section 6. Chapter NR 149 is repealed and recreated to read:
LABORATORY ACCREDITATION
TABLE OF CONTENTS. Chapter NR 149 is repealed and recreated to read:
Subchapter I — General Provisions
NR 149.01 Purpose.
NR 149.02 Applicability.
NR 149.03 Definitions.
Subchapter II — Program Administration
NR 149.05 Required accreditation.
NR 149.06 Certificates.
NR 149.08 Acceptance of other accreditations, licenses, or approvals.
NR 149.09 Certification standards review council.
NR 149.10 Enforcement.
NR 149.11 Discretionary acceptance.
NR 149.12 Variances.
Subchapter III — Program Structure
NR 149.13 Fields of accreditation: certification and registration.
Subchapter IV — Accreditation Process
NR 149.14 Application for accreditation.
NR 149.15 Period, renewal, and expiration of accreditation.
NR 149.155 Required notifications.
NR 149.18 Subcontracting.
NR 149.19 Requirements for certification in the drinking water matrix.
NR 149.20 Requirements for whole effluent toxicity testing.
NR 149.21 Fees.
Subchapter V — Proficiency Testing
NR 149.22 Required proficiency testing samples and frequency of analysis.
NR 149.23 Approval of proficiency testing sample providers.
NR 149.24 Proficiency testing samples for applications and accreditation renewal.
NR 149.25 Treatment of proficiency testing samples.
NR 149.26 Reporting proficiency testing sample results.
NR 149.27 Proficiency testing sample acceptance limits and grading.
NR 149.28 Procedure for correcting unacceptable proficiency testing sample results.
