The scope statement for this rule, SS 078-12 was approved by the Governor on October 10, 2010 and published in the Administrative Register on October 31, 2012in Register number 682, and approved by the Natural Resources Board on May 22, 2013. This rule was approved by the Governor on_______________.
ORDER OF THE STATE OF WISCONSIN NATURAL RESOURCES BOARD
REPEALING AND RECREATING RULES
The Wisconsin Natural Resources Board proposes an order to repeal and recreate NR 149 relating to laboratory accreditation and affecting small business.
Analysis Prepared by the Department of Natural Resources
1. Statute Interpreted:
2. Statutory Authority:
3. Explanation of Agency Authority:
Section 299.11 (3) Stats. authorizes the department to seek recommendations of the certification standards review council for the general administration of the laboratory certification and registration program. Section 299.11 (4), Stats. defines the applicability of the certification and registration rules to laboratories submitting data for covered programs. Section 299.11 (5) Stats. allows the department to recognize certifications from other agencies, governments, and private organizations. 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.