Wisconsin Legislature: ATCP 77.23(3)(c)

(c) If an analyst is provisionally certified because of failing a proficiency evaluation under s. ATCP 77.24 and that analyst passes a proficiency evaluation under s. ATCP 77.24 on a new set of proficiency samples, the department shall restore the analyst to full certification.

(d) If an analyst is provisionally certified because they were not present to demonstrate their competence to perform the tests they are certified for during the biennial inspection of the laboratory, they shall remain in provisional certification status until they again demonstrate their competence during an inspection of the laboratory.

(e) If a provisionally certified analyst fails a proficiency evaluation on a new set of proficiency samples, or is not present to demonstrate their competence during a biennial inspection of the laboratory, the department shall summarily suspend the analyst’s certification to perform that test.

(8) Restoring certification. The department may restore the certification of any analyst whose certification is summarily suspended under sub. (5) or (7) if the analyst completes a training program approved by the department and passes a proficiency evaluation under s. ATCP 77.24 on a new set of proficiency samples. The department shall restore the analyst to full certification, even if the analyst was conditionally certified when certification was suspended.

(9) List of certified analysts. The department shall maintain, for each certified laboratory, a list of analysts currently certified to perform tests listed under s. ATCP 77.02 (1) and (2). The list shall identify the tests which each analyst is certified to perform.

(10) Notice of changes.

(a) An operator shall notify the department within 30 days after any of the following occurs:

1. An analyst certified under this section is no longer employed by the laboratory.

2. There is a change in the name of any analyst certified under this section.

(b) An operator shall notify the department of a staffing change within 7 days after that change occurs if, as a result of that change, the operator no longer meets applicable certification requirements under s. ATCP 77.08 (3).

History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; r. (2) (b) and renum. (2) (c) to be (2) (b), Register, December, 1999, No. 528, eff. 1-1-00; emerg. r. and recr. (1), eff. 11-15-01; CR 01-124: r. and recr. (1) Register December 2002 No. 564, eff. 1-1-03; CR 19-076: r. and recr. (2), am. (3) (c), r. and recr. (7) Register May 2020 No. 773, eff. 6-1-20; renum. (intro.), (a), (b) to (am), 1., 2. under s. 13.92 (4) (b) 1., Stats., Register May 2020 No. 773

ATCP 77.23 Drug residues in milk; screening tests.

(1) Laboratory approved.

(a) The department may approve a laboratory to perform a drug residue test as a screening test, even though the laboratory is not certified under s. ATCP 77.03 to perform the test as a confirmatory test. An approval expires on December 31 of each year. An approved laboratory shall comply with s. ATCP 65.76 (2) (b).

(b) The department may not approve a laboratory under par. (a) unless all of the following apply:

1. The department has approved at least one individual under sub. (2) to perform the drug residue screening test at the approved laboratory.

2. The laboratory has written agreements with one or more certified laboratories to provide the confirmatory testing required under s. ATCP 65.76 (2) (b) 3.

(c) The department shall inspect a laboratory under par. (a) before approving the laboratory to perform a visual read drug residue screening test, and before approving any individual under sub. (2) to perform a visual read drug residue screening test at that laboratory.

(2) Analysts approved.

(a) No individual may perform a drug residue screening test unless the department approves that individual to perform that test at a laboratory approved under sub. (1).

(b) Before the department approves an individual under par. (a) to perform a visual read test, the department shall perform an on-site competency evaluation under sub. (4).

(c) The department’s approval under par. (a) expires on December 31 of each year unless, by that date, the laboratory operator attests to the department that the individual has successfully completed an annual proficiency evaluation under sub. (5).

(d) The department may suspend or revoke an approval under par. (a) for cause.

(3) Approval fees. A laboratory operator shall pay the following fees to acquire and maintain a laboratory approval under sub. (1):

(a) An initial fee of $732, except as provided in par. (b) or (c).

(b) An initial fee of $180 if the laboratory tests milk for only one dairy plant operator and all the following apply:

1. The dairy plant operator receives only grade B milk.

2. The dairy plant operator receives milk from not more than 5 producers.

3. The dairy plant operator receives not more than 10,000 lbs. of raw milk per week.

(d) A fee of $36 for each individual, in excess of 3 individuals, that the department evaluates under sub. (4) at the time of the initial laboratory inspection under sub. (1) (c).

(e) An annual renewal fee of $72 for each annual renewal of the laboratory approval, except that the renewal fee is $36 if the laboratory qualifies under par. (b).

(f) A fee of $180 for each laboratory visit, other than the initial inspection under sub. (1) (c), that the department makes for the purpose of evaluating individuals under sub. (4). This single fee of $180 covers all of the individual evaluations performed during the department’s visit, regardless of the number of individuals evaluated.

(4) Competency evaluation. Before the department approves an individual to perform a visual read test, the department shall observe and evaluate that individual’s competency to perform that test. The department shall use an appropriate FDA 2400 series form to conduct the evaluation.

Note: FDA 2400 series forms are on file with the department, the secretary of state and the legislative reference bureau.

(5) Annual proficiency evaluation.

(a) An individual approved to perform a drug residue screening test shall complete an annual proficiency evaluation. An evaluator approved by the department shall administer the annual proficiency evaluation. The department may approve the laboratory operator to serve as evaluator, except that an independent evaluator shall administer annual proficiency evaluations for analysts performing visual read tests. The evaluator shall report the results of each proficiency evaluation to the department within 7 days after the evaluation is completed.

(b) In a proficiency evaluation, the evaluated individual shall examine the number of samples required under either par. (d) or (e). The evaluator may prepare the samples used in proficiency evaluations, except for samples used in a visual read proficiency test. The contents of the samples shall be known only to the evaluator, and not to the evaluated individual. The evaluator shall evaluate the individual’s proficiency by comparing the individual’s results to the known contents of the samples, and shall report those results to the department.

(c) A proficiency evaluation under par. (a) shall be conducted according to a standard evaluation procedure that the department approves in writing. A standard evaluation procedure shall comply with this subsection and shall include standards for all the following:

1. The evaluator’s preparation of proficiency evaluation samples.

2. The analyst’s examination of proficiency evaluation samples.

3. Deadlines for examining proficiency evaluation samples and reporting test results.

4. The evaluator’s review and rating of the individual’s proficiency.

(d) For a drug residue screening test other than a visual read test, a proficiency evaluation under par. (a) shall include 3 samples. To pass the proficiency evaluation, the individual shall interpret all 3 sample results correctly.

(e) For a visual read test, a proficiency evaluation under par. (a) shall include at least 6 but not more than 20 samples. To pass a proficiency evaluation involving 6 to 10 samples, an individual shall interpret no more than one sample result incorrectly. To pass a proficiency evaluation involving 11 to 20 samples, an individual shall interpret no more than 2 sample results incorrectly.

(6) Failed proficiency evaluation; loss of approval.

(a) If an individual approved to perform a drug residue screening test fails his or her first annual proficiency evaluation related to that test, the individual is no longer approved to perform that test.

(b) If an individual approved to perform a drug residue screening test passes his or her first annual proficiency evaluation related to that test, but subsequently fails 2 consecutive annual proficiency evaluations, the individual is no longer approved to perform that test.

(c) The department may restore an approval lost under par. (a) or (b) if the individual completes a training program approved by the department and passes an on-site competency evaluation under sub. (4). If the individual subsequently fails his or her first annual proficiency evaluation related to the drug residue screening test, the individual may no longer perform that test. The department may again restore the approval if the individual again meets the restoration requirements under this paragraph.

(7) List of approved analysts. The department shall maintain, for each laboratory approved under sub. (1), a list of individuals currently approved to perform drug residue screening tests at that laboratory. The list shall identify the drug residue screening tests that each individual is approved to perform.

(8) Notice of staffing changes.

(a) A laboratory operator shall notify the department within 30 days after any of the following occurs:

1. An individual approved under sub. (2) leaves employment with that laboratory.

2. There is a change in the name of any individual approved under sub. (2).

(b) A laboratory operator shall notify the department within 7 days after a staffing change if, as a result of that change, the laboratory has no individuals approved under sub. (2) to perform a drug residue screening test that the laboratory is authorized to perform.

History: Emerg. cr. eff. 11-15-01; CR 01-124: cr. Register December 2002 No. 564, eff. 1-1-03; CR 07-006: r. and recr. (1), am. (3) (d) and (f), Register January 2008 No. 625, eff. 2-1-08; CR 07-037: am. (3) (a) and (c) to (e) Register April 2008 No. 628, eff. 5-1-08; CR 14-073: am. (1) (a), (b) 2. Register August 2016 No. 728, eff. 9-1-16; CR 19-076: am. (3) (a), (b) (intro.), (c) to (f) Register May 2020 No. 773, eff. 6-1-20.

ATCP 77.24 Milk and food analysts; proficiency evaluation.

(1) Annual proficiency evaluation required. Except as provided in sub. (4), the department may not renew an analyst’s certification to perform any test listed under s. ATCP 77.02 (1) or (2) unless, within the year immediately preceding that renewal, the analyst passes a proficiency evaluation for that test. The proficiency evaluation shall comply with this section.

(2) Form of evaluation. In a proficiency evaluation under sub. (1), an analyst shall examine samples prepared by an approved evaluator under sub. (3). The contents of the samples shall be known only to the evaluator. The evaluator shall rate the analyst’s proficiency by comparing the analyst’s results to the known contents of the samples, and shall report those results and ratings to the department. The reported results and ratings are rebuttably presumed to be valid for purposes of s. ATCP 77.22 and this section.

(3) Approved evaluator. The department, or another evaluator approved by the department in writing, shall serve as a proficiency evaluator under sub. (2).

Note: The department will approve an evaluator under sub. (3) if FDA approves that evaluator for the same purpose.

(4) Evaluation procedure; general. A proficiency evaluation under sub. (1) shall be conducted according to a standard evaluation procedure which the department approves in writing. An analyst is not required to complete a proficiency evaluation for any test unless the department has approved a standard evaluation procedure for that test. A standard evaluation procedure shall comply with applicable requirements under sub. (5), and shall include standards for all of the following:

(a) The evaluator’s preparation of proficiency evaluation samples.

(b) The analyst’s examination of proficiency evaluation samples.

(d) The evaluator’s review and rating of the analyst’s proficiency.

(5) Milk tests; evaluation standards.

(a) Proficiency evaluations for the following tests under s. ATCP 77.02 (1) shall test include at least the following number of samples:

1. At least six but not more than 20 samples for standard plate count, petrifilm aerobic count, plate loop count, petrifilm rapid aerobic count, peel plate aerobic count, or phosphatase tests.

2. At least eight but not more than 20 samples for direct microscopic somatic cell counts, electronic somatic cell counts, drug residue tests, or coliform tests.

(b) To pass a proficiency evaluation under par. (a) which involves 6 to 10 samples, an analyst shall obtain no more than one unacceptable sample result. To pass a proficiency evaluation under par. (a) which involves 11 to 20 samples, an analyst shall obtain no more than 2 unacceptable sample results.

(c) In a proficiency evaluation for any of the following tests, a sample result is unacceptable if it falls outside the statistical limits established in FDA’s “Evaluation of Milk Laboratories,” 2017 edition:

1. Standard plate count.

2. Petrifilm aerobic count.

3. Plate loop count.

4m. Petrifilm Rapid Aerobic Count.

5m. Peel Plate Aerobic Count.

6. Direct microscopic somatic cell count.

7. Electronic somatic cell count.

(d) In a proficiency evaluation for a test, such as a drug residue or phosphatase test, in which sample test results are reportable as positive or negative, a sample result is unacceptable if the analyst fails to report the correct positive or negative result.

(e) In a proficiency evaluation for a coliform test, a sample result is unacceptable if the analyst fails to report the correct result.

History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 07-006: am. (2) and (5) (e), Register January 2008 No. 625, eff. 2-1-08; CR 19-076: am. (5) (a) 1., (c) (intro.), renum. (5) (c) 4., 5., to (5) (c) 6., 7., cr. (5) (c) 4m., 5m. Register May 2020 No. 773, eff. 6-1-20.

Subchapter III — Water Laboratories

ATCP 77.30 Water laboratories; procedures.

(1) Test methods. An operator who performs any test listed under s. ATCP 77.02 (3) shall perform that test according to methods specified in applicable reference materials under sub. (2), or according to methods which the department approves in writing.

(2) Reference materials. An operator who performs any test listed under s. ATCP 77.02 (3) shall keep all of the following reference materials at the certified laboratory:

(a) The manufacturer’s complete operating and maintenance instructions for equipment used to perform that test.

(b) The U.S. environmental protection agency “Manual for the Certification of Laboratories Analyzing Drinking Water,” 5th edition.

(c) “Standard Methods for the Examination of Water and Wastewater,” 18th, 19th, 20th, 21st, or 23rd edition, published by the American Public Health Association, the American Water Works Association and the Water Environment Federation.