Section 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 $610, except as provided in par. (b) or (c) .

(b) An initial fee of $150 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.

(c) An initial fee of $60 if the laboratory does not apply for approval to perform any visual read test.

(d) A fee of $30 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 $60 for each annual renewal of the laboratory approval, except that the renewal fee is $30 if the laboratory qualifies under par. (b) .

(f) A fee of $150 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 $150 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.

(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.

Note

FDA 2400 series forms are on file with the department, the secretary of state and the legislative reference bureau. Microsoft Windows NT 6.1.7601 Service Pack 1