ATCP 77.20(2)(c) (c) Food tests. An operator who performs any test listed under s. ATCP 77.02 (2) shall keep or have online access to all of the following reference materials at the certified laboratory:

ATCP 77.20(2)(c)1. 1. The authoritative reference manual, if any, that applies to each type of food testing for which the laboratory is certified.

ATCP 77.20(2)(c)2. 2. The “Compendium of Methods for the Microbiological Examination of Foods,” 4th edition, published by the American Public Health Association.

ATCP 77.20(2)(c)3. 3. The FDA “Bacteriological Analytical Manual,” current on-line edition, if the operator performs a microbiological test on food.

ATCP 77.20 Note Note: Copies of “Standard Methods for the Examination of Dairy Products” and “Compendium of Methods for the Microbiological Examination of Foods” are on file with the department and the legislative reference bureau and may be obtained from the “APHA Bookstore” at http://secure.apha.org/iMIS/APHA/Store .

ATCP 77.20 Note Copies of the “Bacteriological Analytical Manual” are on file with the department and the legislative reference bureau and may be viewed online at http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006949.htm.

ATCP 77.20(3) (3) Culture media. Culture media used for any test listed under s. ATCP 77.02 (1) or (2) shall be effectively sterilized before they are used. Culture media shall be autoclaved for the total cycle time and sterilization time specified by the media manufacturer or by the applicable test method under this section.

ATCP 77.20 History History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 07-006: am. (2) (b) 2. and (c) 2. and 3., Register January 2008 No. 625, eff. 2-1-08; CR 19-076: am. (2) (c) (intro.), (3) Register May 2020 No. 773, eff. 6-1-20.

ATCP 77.22 ATCP 77.22 Milk and food laboratories; certified analysts.

ATCP 77.22(1) (1) Certification required.

ATCP 77.22(1)(a) (a) Except as provided in par. (b), no analyst may perform a test listed under s. ATCP 77.02 (1) or (2) unless the department certifies that analyst under this section to perform that test.

ATCP 77.22(1)(b) (b) Paragraph (a) does not apply to an individual who is solely engaged in performing a drug residue screening test, provided that the department has approved that individual under s. ATCP 77.23 (2) to perform that test.

ATCP 77.22(1)(c) (c) The department shall certify the analysts employed at a laboratory when it conducts a mandatory inspection of that laboratory under s. ATCP 77.14 (1). The department may certify new analysts, or certify analysts to perform other tests, at other times.

ATCP 77.22(2) (2) Term of certification. An analyst’s certification to perform a test remains in effect until one of the following occurs:

ATCP 77.22(2)(a) (a) The laboratory administrator or designated agent requests the analyst’s certification to be withdrawn.

ATCP 77.22(2)(b) (b) The certified laboratory does not pay the annual license fee for the analyst.

ATCP 77.22(2)(c) (c) The department suspends or revokes the analyst’s certification.

ATCP 77.22(3) (3) Competency evaluation.

ATCP 77.22(3)(a) (a) Before the department certifies an analyst to perform any test listed under s. ATCP 77.02 (1) or (2), the department shall observe and evaluate that analyst’s competency to perform that test.

ATCP 77.22(3)(b) (b) Whenever the department performs a mandatory inspection of a laboratory under s. ATCP 77.14 (1), the department shall perform a competency evaluation under par. (a) of every analyst who performs a test listed under s. ATCP 77.02 (1) or (2).

ATCP 77.22(3)(c) (c) The department shall use an appropriate FDA 2400 series form or if no FDA 2400 series form applies, another standard form to evaluate an analyst’s competency under par. (a). If an analyst performs plate loop counts, electronic bacteria counts, or electronic somatic cell counts, the department shall check the analyst’s accuracy based on any statistical comparisons required by those tests.

ATCP 77.22(4) (4) Annual proficiency evaluation. An analyst who performs a test listed under s. ATCP 77.02 (1) or (2) shall complete an annual proficiency evaluation for that test if an annual proficiency evaluation is required under s. ATCP 77.24.

ATCP 77.22(5) (5) Conditional certification. If the department determines under sub. (3) that an analyst is competent to perform a test, but the analyst has not yet completed a proficiency evaluation under s. ATCP 77.24 for that test, the department shall conditionally certify the analyst. If a conditionally certified analyst fails a proficiency evaluation under s. ATCP 77.24, the department shall summarily suspend the analyst’s certification to perform that test.

ATCP 77.22(6) (6) Full certification. If the department determines under sub. (3) that an analyst is competent to perform a test, and the analyst also passes a proficiency evaluation under s. ATCP 77.24 for that test, the department shall fully certify that analyst to perform that test.

ATCP 77.22(7) (7) Provisional certification and restoration of full certification.

ATCP 77.22(7)(am) (am) An analyst shall be placed in provisional certification if one of the following occurs:

ATCP 77.22(7)(am)1. 1. If a fully certified analyst fails a proficiency evaluation under s. ATCP 77.24 for any test, the department shall issue a notice stating that the analyst is provisionally certified to perform that test.

ATCP 77.22(7)(am)2. 2. If the department conducts a biennial inspection of a laboratory under s. ATCP 77.14 (1) and a fully certified analyst is not present to demonstrate competence to perform the test(s) they are certified for, the department shall issue a laboratory report stating that the analyst is provisionally certified to perform that test.

ATCP 77.22(7)(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.