Rules Clearinghouse No. 19-076 December 16, 2019
PROPOSED ORDER
OF THE WISCONSIN DEPARTMENT OF AGRICULTURE,
TRADE AND CONSUMER PROTECTION
ADOPTING RULES
The Wisconsin department of agriculture, trade and consumer protection hereby proposes the following rule to re-number ATCP 77.02 (3) (q), 77.24 (5) (c) 4. and 5.; to amend ATCP 77.01 (4m), (7), (11), 77.02 (1) (3), 77.04 (1) (b), and 77.04 (1) (e) 3. (Note), 77.06 (1) (a) to (d), and (2) (a) and (b), 77.08 (5), 77.10 (2) (b), 77.14 (1) (b) and (c), 77.20 (2) (c) (intro.) and 3., 77.22 (3) (c), 77.23 (3) (a), (b) (intro.), and (c) to (f), 77.24 (5) (a) (1) and 5. (c) (intro.), 77.34 (5) (a) 1. to 3. and (b); to repeal and recreate ATCP 77.22 (2) and (7); to create ATCP 77.24 (5) (c) 4m. and 5m.; relating to milk, food and water testing laboratories.
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Analysis Prepared by the Department
of Agriculture, Trade and Consumer Protection
Under Wis. Admin. Code ch. ATCP 77 (Laboratory Certification), the Wisconsin Department of Agriculture, Trade and Consumer Protection (Department) oversees the certification of 81 certified milk or food laboratories and the approval of 96 drug residue screening laboratories under a cooperative agreement with the Federal Food and Drug Administration (FDA) through direction from the National Conference on Interstate Milk Shipments (NCIMS). Also, under this rule the Department accredits 127 safe drinking water testing laboratories under a primacy agreement with the U.S. Environmental Protection Agency (EPA) through the Wisconsin Department of Natural Resources (WDNR). Statutes Interpreted
Statute Interpreted: Wis. Stat. §§ 93.07 and 93.12. Statutory Authority
Statutory Authority: Wis. Stat. §§ 93.07 (1) and 93.12 (5) and (7). Explanation of Statutory Authority
The Department has specific authority under Wis. Stat. § 93.12 (5) to make and enforce regulations to establish uniform minimum standards to be used in the evaluation and certification of laboratory examinations. The Department also has authority under Wis. Stat. § 93.12 (7) to establish a fee schedule to offset the cost of certifying the laboratories and the collection of those fees. Additionally, the Department has general authority, under Wis. Stat. § 93.07 (1), to adopt rules to implement programs under its jurisdiction. Related Statutes and Rules
Wis. Admin. Code ch. ATCP 65 (Milk and Milk Products)
Wis. Admin. Code ch. ATCP 76 (Safety, Maintenance, and Operation of Public Pools and Water Attractions)
Wis. Admin. Code ch. NR 809 (Safe Drinking Water)
Wis. Admin. Code ch. NR 812 (Well Construction and Pump Installation). Plain Language Analysis
In revising Wis. Admin. Code ch. ATCP 77 (Laboratory Certification), the Department is revising the laboratory certification fee structure, updating requirements to reflect modern laboratory practices, and providing flexibility for laboratory operations. Revised Fee Structure
The fees for laboratory certification were last updated in 2008. The proposed fee increases are 20% and consistent with changes in the consumer price index since 2008. An exception is the prorated monthly fee for the addition of a milk or water test to a laboratory’s license mid-year. Those fees were not increased properly in 2008. Monthly fees now correctly reflect 1/12th of the annual fee.
Annual fee for a laboratory, for each milk or food test the laboratory is certified for, changes from $410 to $492.
Annual fee for a certified analyst changes from $30 to $36.
Annual fee for a laboratory, for each water test the laboratory is certified for, changes from $340 to $408.
The prorated fee for the addition of a test procedure mid-year changes from $23 to $35 per month for each water test, and from $28 to $42 per month for each milk or food test.
The fee for a supplemental inspection done at a time other than the mandatory inspection changes from $150 to $180.
Initial fee for licensing of a drug residue screening laboratory changes from $610 to $732 for most facilities, and from $150 to $180 for very small facilities.
Drug residue screening laboratory annual fees change from $60 to $72 for most facilities, and from $30 to $36 for very small facilities.Discretionary Inspection fees
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
