Section 299.11 (7) Stats. authorizes the department to promulgate rules for the certification of laboratories submitting data for covered program. Section 299.11 (8) Stats. authorizes the department to promulgate rules for the registration of laboratories submitting data for covered programs. Section 299.11 (9) Stats. authorizes the department to establish a regulated schedule of fees to cover the costs of administering a laboratory certification and registration program.
4. Related Statutes or Rules:
Chs. NR 106, 110, 123, 131, 132, 140, 150, 153, 155, 157, 182, 200, 206, 210, 211, 212, 214, 216, 219,347, 507, 528, 662, 664, 665, 700, 712, 716, 738, 747, 809, 810, 811, 812 and 845.
5. Plain Language Analysis:
Chapter NR 149 sets requirements for the certification and registration of laboratories that submit data to the department for covered programs. Since the last major revision of the chapter, laboratory operations have undergone significant advances. Other state and national certification programs have promulgated and revised rules that reflect these advances. This version of ch. NR 149 incorporates many of those changes and, where appropriate, moderates them by incorporating suggestions expressed by our regulated community.
The proposed rule introduces efficiencies for administering the certification and registration program, improves the structure used for certification and registration of laboratories, identifies clear steps and procedures for the certification and registration process, establishes a more equitable fee structure, clarifies requirements for proficiency testing of laboratories, stipulates procedures for on-site evaluations of laboratories, and adds specificity and flexibility to quality systems requirements for laboratories.
6. Summary of, and Comparison with, Existing or Proposed Federal Statutes and Regulations:
The US EPA has established a program for the certification of laboratories that analyze drinking water for compliance with the safe drinking water act. The US EPA delegates the authority to certify laboratories to states that have established equivalent programs. The proposed rule incorporates the latest changes in the regulations and the manual used by EPA to certify drinking water laboratories. Thus this revision makes the Wisconsin certification and registration program current with the US EPA’s.
The US EPA sponsors a National Environmental Laboratory Accreditation Program (NELAP) for states that voluntarily seek such recognition. The procedures for accrediting laboratories under NELAP are contained in standards promulgated by the National Environmental Laboratory Accreditation Conference (NELAC). The proposed rule contains elements of the NELAC Standards recommended for incorporation by our regulated community. In most cases, the incorporated elements address standard practices commonly performed by laboratories.
7. Comparison with Similar Rules in Adjacent States:
All of the adjacent states, Minnesota, Illinois, Michigan, and Iowa, have primacy from the US EPA to certify laboratories analyzing drinking water. Their rules must mirror federal requirements to maintain the states’ authority. Our proposed revision makes the drinking water portion of our chapter current with those of the adjacent states.
Wisconsin, Minnesota, Iowa, and Illinois have similar certification, registration, or accreditation programs for laboratories analyzing wastewater, hazardous waste, and solid waste. Michigan requires certification only for those laboratories analyzing drinking water. Illinois and Minnesota are recognized NELAP accrediting authorities and its rules agree or are stricter than those the department proposes for ch. NR 149. In addition, the Minnesota Pollution Control Agency (MPCA) accredits wastewater laboratories and its rules are similar to those proposed for ch. NR 149. Iowa has a certification program that is more limited in scope than ours because the state has few laboratories providing environmental analytical services other than the University of Iowa State Hygienic Laboratory.
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
• Wisconsin Environmental Laboratories Association (WELA)
• Municipal Environmental Group (MEG)
• Wisconsin State Laboratory of Hygiene
• Laboratory Certification and Registration Program
The NR 149 RAC envisioned a code that had greater specificity without sacrificing flexibility and alternatives for compliance. Over the course of approximately 20 meetings held from January 2014 to April 2017, the NR 149 RAC offered advice and guidance on every aspect of the Certification and Registration 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 draft of the proposed chapter in March 2017. The comments received and the input received by the Certification and Registration 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:
Input from all stakeholders on all aspects of the Laboratory Certification and Registration Program.
Decision Making Rule
NR 149 RAC made decisions by reaching substantial agreement and when necessary, registering consensus.
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.
Alternatives for certification and registration structure, fee structure, applications, and quality systems.
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.
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 32% 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 $947 per laboratory per year. The rest of the commercial laboratories (68%) are projected to see a decrease in fees paid per year. On average these commercial laboratories will see an estimated $124 per laboratory per year decrease in fees. One industrial laboratory will see an annual increase of $310. The remaining 49 industrial laboratories will see an estimated $56 decrease in fees per laboratory per year.
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:
2984 Shawano Avenue
Green Bay, WI 54313
12. Place where comments are to be submitted and deadline for submission:
Written comments may be submitted at the public hearings, by regular mail, fax or email to:
Same as above
Deadline for comments: July 12, 2017
Time: 11:00 – 12:00 AM