ATCP 77.23(6)(c)(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. ATCP 77.23(7)(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. ATCP 77.23(8)(a)(a) A laboratory operator shall notify the department within 30 days after any of the following occurs: ATCP 77.23(8)(b)(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. ATCP 77.23 HistoryHistory: 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 77.24ATCP 77.24 Milk and food analysts; proficiency evaluation. ATCP 77.24(1)(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. ATCP 77.24(2)(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. ATCP 77.24(3)(3) Approved evaluator. The department, or another evaluator approved by the department in writing, shall serve as a proficiency evaluator under sub. (2). ATCP 77.24 NoteNote: The department will approve an evaluator under sub. (3) if FDA approves that evaluator for the same purpose.
ATCP 77.24(4)(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: ATCP 77.24(4)(a)(a) The evaluator’s preparation of proficiency evaluation samples. ATCP 77.24(4)(b)(b) The analyst’s examination of proficiency evaluation samples. ATCP 77.24(4)(c)(c) Deadlines for examining proficiency evaluation samples and reporting test results. ATCP 77.24(4)(d)(d) The evaluator’s review and rating of the analyst’s proficiency. ATCP 77.24(5)(a)(a) Proficiency evaluations for the following tests under s. ATCP 77.02 (1) shall test include at least the following number of samples: ATCP 77.24(5)(a)1.1. 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. ATCP 77.24(5)(a)2.2. 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. ATCP 77.24(5)(b)(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. ATCP 77.24(5)(c)(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: