Statement of Scope
Department of Agriculture, Trade and Consumer Protection (DATCP)
Rule No.: | Ch. ATCP 77, Wis. Adm. Code (Existing) |
Relating to: | Laboratory Certification (Permanent) |
1. Description of the objective of the rule:
Chapter ATCP 77 outlines standards and procedures for certification of Wisconsin’s milk, water, and food laboratories. The Department of Agriculture, Trade and Consumer Protection (“Department”) plans to comprehensively review ch. ATCP 77 and revise it as necessary to modernize Wisconsin’s laboratory certification standards. The last comprehensive review of ATCP 77 was in 1998. Specifically, this rule revision will update, to the extent needed, the following: 1) references, standards and test procedures for ensuring the reliability of certified laboratory testing, 2) certification fees to adequately cover costs, as required under s. 93.12 (7), Stats., 3) the structure for prorating partial-year certification fees in accordance with s. 93.12 (4), Stats., and 4) the frequency of on-site certified wastewater-testing laboratory reviews that optimizes efficiency without jeopardizing public safety, as required pursuant to s. 93.12(5), Stats. The Department may make other revisions, as needed, to update the rule and ensure the program continues to effectively and efficiently ensure the quality of Wisconsin’s laboratories responsible for examining milk, water, and food products. 2. Description of existing policies relevant to the rule and of new policies proposed to be included in the rule and an analysis of policy alternatives; the history, background and justification for the proposed rule:
Background
Section 93.12, Stats., requires the Department to certify any laboratory that performs examinations of milk, water, and food products and to designate which laboratory examinations it deems necessary for the protection of the health of the public. The laboratory certification program was transferred from the Department of Health Services to the Department in 1997. Wisconsin has 196 laboratories that are currently certified by the Department, with approximately another 100 labs that are approved by the Department only to do screening tests for the presence of drug residues in milk. The following are among the requirements of ch. ATCP 77: • Certification requirements, fees, and standards, including a requirement that a certified laboratory be evaluated by the Department before initial certification and at least once every two years afterward. The Department may also evaluate a laboratory whenever the lab alters its facilities or equipment, assigns a new laboratory analyst to perform a test, or whenever it concludes an evaluation is necessary.
• A requirement that the laboratory has a designated administrator who personally supervises the operations of a laboratory
• Requirements that laboratories perform designated tests according to recognized methods. Chapter ATCP 77 identifies the laboratory tests needed to protect public health and standards and incorporates, by reference, laboratory manuals that define the methods to be used. • Requirements that laboratories have adequate facilities, equipment, and supplies to perform the tests and have established quality control procedures that comply with current standards.
• A requirement that the Department certifies individual analysts in milk or food laboratories to perform tests after passing an annual proficiency examination. The Department does not certify individual water analysts. However, a water lab operator must annually document to the Department that analysts are trained and competent.
References and Standards
One goal of the rule revision will be to review and revise, to the extent necessary, laboratory examination references and standards to ensure they are current. Section ATCP 77.02 identifies a list of milk, food, water, wastewater, and recreational water laboratory tests the Department has declared as necessary to protect public health. The rule also incorporates certain standards by reference that identify appropriate methods for performing the identified tests. Pro-rated Fees for Partial-Year Certifications
Another goal of the rule revision will be to align the partial-year fee policy, found in ATCP 77.06 (2), with statutory requirements for prorating fees. Sections 93.12 (4) and (7), Stats., require the Department to establish fees to cover the cost of certifying laboratories, requires the certifications to be issued on a calendar-year basis, and requires the Department to issue an interim certificate for initial certification of a laboratory. The interim certificate is to be valid for the remainder of the year for which it is issued. The Department is required under s. 93.12 (4), Stats., to prorate fees at one-twelfth of the annual fee for each month remaining in the calendar year remaining for initially certified laboratories or for laboratories that apply to expand an existing certification during the calendar year. The Department may also examine the current fee structure to determine whether fees cover the cost of certifying laboratories, as required under s. 93.12 (7), Stats. Frequency of Wastewater Laboratory Certification: Coordination with the DNR Lab Certification Program
Section 93.12 (5), Stats., requires the Department to coordinate laboratory certification requirements with the Department of Natural Resources (DNR), who also operates a laboratory certification program under s. 299.11, Stats. The Department is required to consult with the DNR in administering their laboratory certification programs, to avoid duplication. The Department is also required to recognize the certification or registration of a laboratory certified by the DNR under s. 299.11, Stats., and to accept the results of any test conducted by a laboratory certified or registered under that section. The DNR is currently in the process of revising ch. NR 219; its rule related to analytical test methods and procedures. Chapter NR 219 establishes methods, sample-preservation procedures, requirements for laboratories and procedures applicable to enforcing effluent limitations for discharges from point sources as authorized under ss. 299.11 and 283.55 (1), Stats. As part of the Department’s review of ch. ATCP 77, the Department will evaluate any proposed changes to ch. NR 219 and revise ch. ATCP 77, if necessary, to maintain consistency. The Department will also examine provisions related to the frequency of on-site reviews of laboratories that analyze wastewater, to identify possible efficiencies that may be achieved by reducing the frequency of these on-site reviews. The Department is required to submit any rules establishing standards for the evaluation and certification of laboratories that affect the DNR’s laboratory certification program to the DNR and the State Laboratory of Hygiene for review and comment. The rule may not take effect unless it is approved by the DNR within 6 months after submission
Other General Rule Revisions
The Department may make other revisions, as needed, to modernize standards for certified laboratories, ensure a fair fee schedule to meet the requirements of s. 93.12 (7), Stats., and improve the efficiency and effectiveness of Wisconsin’s laboratory certification program. This rule revision will be a comprehensive review of the requirements in ch. ATCP 77 done to modernize standards for laboratories. 3. Statutory authority for the rule (including the statutory citation and language):
93.07 Department duties. It shall be the duty of the department:
Regulations. To make and enforce such regulations, not inconsistent with law, as it may deem necessary for the exercise and discharge of all the powers and duties of the department, and to adopt such measures and make such regulations as are necessary and proper for the enforcement by the state of chs. 93 to 100, which regulations shall have the force of law. 93.12 Laboratories, approval of.
(5) The department shall establish uniform minimum standards to be used in the evaluation and certification of laboratory examinations. The department shall submit any rules proposed under this subsection which affect the laboratory certification program under s. 299.11 to the department of natural resources and to the state laboratory of hygiene for review and comment. These rules may not take effect unless they are approved by the department of natural resources within 6 months after submission.
