Wis. Admin. Code ch. ATCP 77 previously referred to discretionary inspections, but the fees for this type of inspection were not clearly defined. The rule now specifies that the fee for a discretionary inspection is the same as the supplemental survey fee of $180. Documentation of temperature for temperature-controlled equipment
The current rule requires all laboratories to measure and record equipment temperatures at least daily. Many laboratories are thereby required to staff Sundays and holidays in order to read and record equipment temperatures. Both the FDA and the EPA exempt laboratories from recording equipment temperatures on days when the laboratory is not normally staffed. This modification to Wis. Admin. Code ch. ATCP 77 aligns the rule with the FDA and EPA. Further, the modification will eliminate a staffing burden for laboratories and result in a cost savings to these businesses.
Inspections Every 3 years
Laboratories operating pursuant to the FDA cooperative agreement must be inspected once every two (2) years. Laboratories operating pursuant to the EPA primacy agreement must be evaluated once every three (3) years.
The Department’s revised position is that those laboratories solely performing water testing will only be required to be evaluated once every three (3) years. This revision, pertaining to the frequency of water laboratory evaluation, will also create more flexibility for the Department and laboratories in scheduling laboratory surveys.
Similar Methodology
The proposed rule includes language that enables laboratories certified for one specific test method to add or switch to an alternative test method, which uses the same or very similar test methodology, without the mandate of requiring the laboratory to undergo a lab re-inspection by the Department. This modification to the proposed rule will speed up the certification process for laboratories interested in implementing a new test procedure. This will also result in cost savings because laboratories will no longer be required to pay for an additional supplemental survey fee.
Analyst term of certification and provisional status
As currently written in Wis. Admin. Code ch. ATCP 77, analysts lose their certification if they fail to be present for their laboratory’s mandatory inspection. The language will be altered to state that an analyst faces termination of certification only if the laboratory administrator requests withdrawal of the analyst’s certification or the laboratory does not pay the analyst’s annual renewal fee. Thus, should an analyst miss the laboratory’s mandatory inspection, the analyst’s certification will be placed in provisional status, absent the laboratory administrator’s request for withdrawal of the analyst’s certification or failure to pay the analyst’s annual renewal fee. An analyst in provisional status, due to the analyst’s failure in attending the mandatory inspection, will remain in provisional status until the analyst demonstrates competence during an inspection of the laboratory. However, the analyst would lose certification in the event the analyst fails proficiency testing or fails to be present for the laboratory’s next mandatory inspection.
This change will align the rule with FDA requirements and will create less of a hardship for analysts who fail to attend an on-site evaluation due to a family emergency or illness.
Fecal coliform to E. coli
The WDNR change in water testing, which targets bacteria from fecal coliform to Escherichia coli for drinking water testing, required the Department to change the directions for preparation of the water proficiency samples to also contain the target organism of Escherichia coli.
Other Revisions
The rule contains other revisions to match updated terminology and technology, adds newly approved test procedures, and removes test procedures that are no longer approved or commercially available. Some revisions align the rule with recent changes in state and federal law. Among these revisions are the following:
The Division’s name has changed from the Division of Food Safety to the Division of Food and Recreational Safety. This change has been made throughout the document.
The rule expands the definition of milk to include the other species of animals (water buffalo and camelids) that are recognized by the FDA.
The rule aligns the list of approved test procedures with the lists of currently approved procedures from the FDA and EPA, and corrects some of the technical names.
The rule adds the requirement that the operator of a laboratory provide not just name and address, but also the e-mail address of the laboratory.
The rule indicates current revisions of reference materials.
As required, the new test procedures have been added to the proficiency evaluation standards specifying the number of samples that shall be run each year and how “acceptable” and “unacceptable” test results will be determined.The Department held three public hearings on this rule on June 25, 2019 at Moraine Park Technical College in Fond du Lac, WI; June 26, 2019 at CESA 10 - Teleconference Center in Chippewa Falls, WI; and June 27, 2019 at the Department of Agriculture, Trade and Consumer Protection - Board Room 106 in Madison, WI.
Public hearing notices were posted at the State Legislature’s Active Rules Clearinghouse website and in the Administrative Register. Notices were mailed out to all Department licensed facilities as well as affected industry groups. A total of five persons/organizations attended the hearings and/or submitted comments. Attendees included representatives from Sartori Company, Plymouth; Marshfield Utilities, and Matrix Sciences/Northland Laboratories. Comments were also received from industry groups including the Midwest Food Products Association and the Wisconsin Cheese Makers Association.
Feedback received from industry groups and organization representatives was generally in support of the proposed rule change. A commenter concurred with the Department’s change to inspection frequency, equipment temperature documentation only when the laboratory is staffed, and the change to the status of a certified analyst. Both industry groups advocated for the proposed fee increase and encouraged the Department to be more diligent in adjusting program costs to reflect the actual requirements to staff and equip the program. The Department has already begun tracking costs, as suggested. The Department also heeded suggested editorial changes to improve sentence structure and increase readability within the proposed rule.
The Department received a written proposal from a licensed laboratory concerning ATCP 77.20 (2) (c) (3) and the NCIMS program’s prohibition against the use of microwave ovens to prepare media. The Department is obligated to follow the requirement outlined within the FDA and NCIMS standard, which does not allow the use of microwave ovens. For any test type this requirement does not apply to, the laboratory is able to use microwave ovens for media preparation.
The Department also received a proposed edit to eliminate the sentence in ATCP 77.22 (7) (e)
“or is not present to demonstrate their competence during a biennial inspection of the laboratory.” This change cannot be made because the FDA requires the decertification of a provisionally certified analyst that has a “second miss” of either split samples or on-site evaluation.
Summary of, and Comparison with, Existing or Proposed Federal Statutes and Regulations
State milk and drug residue screening laboratories operate under a cooperative agreement with the FDA through the NCIMS. The laboratory certification program was established to be in accordance with the FDA program documents, as well as the grade “A” Pasteurized Milk Ordinance (PMO) and the Evaluation of Milk Laboratories (EML), which are amended biennially. The latest revisions of these documents are dated 2017. The PMO is incorporated by reference in federal specifications for the procurement of milk and milk products and is used as the model regulation for milk and milk products.
State water laboratories operate under a primacy agreement between the EPA and WDNR. The Department has a memorandum of understanding with the WDNR for the certification of these laboratories. The accreditation of water laboratories was established to be in accordance with the EPA’s manual for the certification of laboratories analyzing water and wastewater. The Safe Drinking Water Act and the Revised Total Coliform Rule give the EPA the responsibility for ensuring the safety of drinking water in this country.
Comparison with Rules in Adjacent States
Participation in the NCIMS requires a state milk regulatory program to meet the requirements laid out in the PMO and EML for approval of milk and milk products analysis laboratories. The water laboratory certification rules in Illinois are more proscriptive than Wisconsin. For example, the Illinois rule sets minimum requirements for use of specific pieces of equipment. The Wisconsin rule does not spell out this requirement, allowing greater flexibility to incorporate new technologies.
The Minnesota rule is more open in that it allows for mobile laboratories, but stricter in requiring laboratories to respond to any deficiencies found within 30 days. ATCP 77 does not prescribe a time frame, which enables each program to determine its own corrective action time frames. The Minnesota rule also requires laboratories to have a written set of standard operating procedures, whereas ATCP 77 only requires reference materials to be kept on-site.
Summary of Factual Data and Analytical Methodologies
Input and analysis were provided by Department experts. The Department reviewed and studied statutory provisions and federal regulations. Over the last several years, the Department gathered information from stakeholders. A copy of the draft of the proposed rule was presented at meetings to representatives of each type of laboratory affected by the proposed change, including: The WDNR, the Wisconsin association of local health departments and boards, and the Wisconsin laboratory association.
Analysis and Supporting Documents used to Determine Effect on Small Business
The Department consulted with representatives from each type of laboratory (large milk, small milk, drug residue, large water, and small water) as well as other interested parties such as the WDNR.
Effect on Small Business
The Department believes the changes proposed will have a minimal effect on small businesses. While fees are increasing, eliminating the need to conduct a supplemental survey if the lab switches to a similar test method, or an analyst misses a mandatory inspection, should help offset some of those costs. For a substantial program of this size, the overall cost of the fee increase over the entire program (both large and small businesses) will be approximately $35,864.
Changes from the Hearing Draft
The Department incorporated all technical corrections suggested by the Legislative Council Rules Clearinghouse. Changes based on the public hearings and comments sent to the Department are discussed above in the “Plain Language Analysis.”
Next Steps
If the Board approves this final draft rule, the Department will submit the final draft rule to the Governor for written approval. If the Governor approves the final rule, the Department will then submit the rule to the Legislature for legislative committee review. If the Legislature has no objection to the rule, the Department Secretary will sign the final rulemaking order and transmit it for publication. The rule will take effect on the first day of the month following publication.
