To compare fees between the states, we used an average annual proposed fee for the 30 largest commercial laboratories as one category, and used a wastewater laboratory certified for BOD, TSS, Ammonia, and Phosphorous as an indicator of the typical wastewater laboratory fee. Using these two categories, Wisconsin proposed fees are $5,311/$1,114 for commercial/wastewater laboratories. Illinois assesses $8,400/$3,400 annually for these same types of laboratories. Minnesota's fees are $10,900/$1,800. Iowa's fees are lower than WI's for wastewater laboratories, but higher for commercial laboratories ($10,800/$800). Michigan charges $6,729 for certification of drinking water laboratories; no certification for wastewater laboratories is required.
8. Summary of Factual Data and Analytical Methodologies Used and How Any Related Findings Support the Regulatory Approach Chosen:
To create this proposed rule, the Department engaged in a structured process to seek input from all stakeholders. The core of this effort consisted in convening a rule revision advisory committee (RAC) composed of all the members of the Certification Standards Review Council, a body authorized by s. 15.107 (1), Stats. The following constituencies were represented in the NR 149 RAC: • Small and Large Municipal Wastewater Treatment Plants
• Commercial Laboratories
• Industrial Laboratories
• Municipal Environmental Group (MEG)
• Wisconsin State Laboratory of Hygiene
• Laboratory Accreditation Program
The NR 149 RAC envisioned a code that had greater specificity without sacrificing flexibility and alternatives for compliance. Over the course of approximately 30 meetings held from January 2014 to December 2017, the NR 149 RAC offered advice and guidance on every aspect of the Laboratory Accreditation Program. Meetings were facilitated by program staff. The agreements reached were captured in standardized documents reviewed and endorsed by the NR 149 RAC. These documents were used in drafting specific language included in the proposed rule.
The NR 149 RAC reviewed a complete final draft of the proposed chapter in February 2018. The comments received and the input received by the Laboratory Accreditation Program and other Department programs are reflected in this proposed rule.
The following table illustrates the methodologies and data considered in producing this proposed rule:
Methodology | Data Considered |
Advisory Committee | Input from all stakeholders on all aspects of the Laboratory Accreditation Program. |
Decision Making Rule | NR 149 RAC made decisions by reaching substantial agreement and when necessary, registering consensus. |
Topic Prompters | Captured decisions made by NR 149 RAC on program administration, program structure, certification and registration process, proficiency testing, on-site laboratory evaluations and quality control. |
Model Documents | Alternatives for certification and registration structure, fee structure, applications, and quality systems. |
Comparative Analysis | Scope of certification and registration of current laboratories in the program to arrive at equitable fee structure. Analytical technologies were assessed and assigned a fee based on relative workload to evaluate them. Fee structure and assessments of certification programs in other states. |
Feasibility | Certification and covered program staff reviewed changes endorsed by RAC to determine feasibility of implementation. |
9. Analysis and Supporting Documents Used to Determine the Effect on Small Business or in Preparation of an Economic Impact Report:
In order to be equitable and efficient to all laboratories, the new fee schedule attempts to match the time spent by WDNR staff during laboratory inspections to fees paid (RVU’s) by removing the restrictive cap on the fees that larger laboratories are required to pay.
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
