Chapter ATCP 77

ATCP 77.10(3) (3) Notice of material changes. An operator shall notify the department whenever the operator remodels laboratory facilities or installs new equipment if the remodeling or installation materially affects the performance of tests under s. ATCP 77.02 which the operator is certified to perform at that laboratory.

ATCP 77.10 History History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 19-076: am. (2) (b) Register May 2020 No. 773, eff. 6-1-20.

ATCP 77.12 ATCP 77.12 Laboratory administrator. The laboratory administrator or a designated agent of the administrator shall be present at every certified laboratory during daytime business hours. The laboratory administrator shall do all of the following on behalf of the laboratory operator:

ATCP 77.12(1) (1) Supervise the laboratory and its compliance with this chapter.

ATCP 77.12(2) (2) Review and approve, for submission to the department, every certification application which the operator submits for that laboratory under s. ATCP 77.04.

ATCP 77.12(3) (3) Supervise the procurement and maintenance of laboratory facilities, equipment and supplies, and notify the department of material changes under s. ATCP 77.10 (3).

ATCP 77.12(4) (4) Facilitate department inspections of the laboratory. At the request of the department, the administrator shall grant the department access to laboratory facilities, equipment and records, and shall arrange for analysts to demonstrate their testing proficiency.

ATCP 77.12(5) (5) Notify the department of changes in laboratory analysts under s. ATCP 77.22 (10).

ATCP 77.12(6) (6) Notify all laboratory customers if the department suspends or revokes all or part of the laboratory’s certification.

ATCP 77.12(7) (7) Report test results to the appropriate regulatory agency, if required by law.

ATCP 77.12(8) (8) Supervise laboratory recordkeeping under s. ATCP 77.16.

ATCP 77.12 History History: Cr. Register, September, 1999, No. 525, eff. 10-1-99.

ATCP 77.14 ATCP 77.14 Inspecting a laboratory.

ATCP 77.14(1) (1) Mandatory inspections. The department shall inspect a laboratory at all of the following times:

ATCP 77.14(1)(a) (a) Before certifying the operator under s. ATCP 77.03, for the first time, to perform tests at that laboratory.

ATCP 77.14(1)(b) (b) At least once every 2 years after the department first certifies the operator under s. ATCP 77.03 to perform tests under s. ATCP 77.02 (1) at that laboratory and at least once every 3 years after the department first certifies the operator under s. ATCP 77.03 to perform any tests under s. ATCP 77.02 (2) or (3).

ATCP 77.14(1)(c) (c) Before the department certifies the operator to perform a test under s. ATCP 77.02 which the department has not previously certified that operator to perform at that laboratory unless the laboratory is currently certified for a test that utilizes the same or very similar methodology.

ATCP 77.14(2) (2) Discretionary inspections. The department may inspect a certified laboratory whenever any of the following occurs:

ATCP 77.14(2)(a) (a) The operator materially alters laboratory facilities or equipment.

ATCP 77.14(2)(b) (b) The operator assigns a new analyst to perform a test for which the operator is currently certified.

ATCP 77.14(2)(c) (c) The department concludes that an inspection is necessary to determine whether the operator, or the operator’s laboratory, complies with this chapter.

ATCP 77.14(3) (3) Inspection authority. The department may exercise its authority under ss. 93.08, 93.14, 93.15, 93.16 and 97.12, Stats., in support of an inspection under this chapter. The department may suspend or revoke the certification of any operator who obstructs or fails to permit an inspection under this section.

ATCP 77.14 Note Note: The department conducts its inspections during laboratory business hours. The department ordinarily pre-arranges inspection dates and times that are acceptable to laboratory operators, but is not required to do so. A person who obstructs or interferes with an inspection may also be subject to penalties under s. 93.21 (2) or (4) or s. 97.12 (4), Stats.

ATCP 77.14 History History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 19-076: am. (1) (b), (c) Register May 2020 No. 773, eff. 6-1-20.

ATCP 77.16 ATCP 77.16 Laboratory records.

ATCP 77.16(1) (1) Records required. An operator shall make complete records related to all of the following:

ATCP 77.16(1)(a) (a) The training, experience and proficiency testing of every analyst who performs tests for which the laboratory is certified.

ATCP 77.16(1)(b) (b) Laboratory evaluations required under this chapter.

ATCP 77.16(1)(c) (c) Laboratory policies and procedures.

ATCP 77.16(1)(d) (d) Laboratory facilities, equipment and supplies, including records related to procurement, calibration, testing and maintenance.

ATCP 77.16(1)(e) (e) Quality control procedures and monitoring.

ATCP 77.16(1)(f) (f) Tests performed at the laboratory, including records related to the nature of the test, the person for whom the test is performed, the assigned analysts, the test methods used, the date and time of testing, and the test results obtained.

ATCP 77.16(1)(g) (g) Test reports filed with the department and other government agencies.

ATCP 77.16 Note Note: For example, see reporting requirements under chs. ATCP 65 and 70 and chs. NR 809 and 812.

ATCP 77.16(2) (2) Record retention; availability.

ATCP 77.16(2)(a) (a) The operator of a milk or food laboratory shall retain all records under sub. (1) for at least 2 years. The operator of a water laboratory shall retain all records under sub. (1) for at least 5 years.

ATCP 77.16(2)(b) (b) An operator shall make records under sub. (1) available to the department for inspection and copying upon request.

ATCP 77.16(2)(c) (c) An operator may keep records under sub. (1) in hard copy or electronic form, or both, provided that the department can obtain ready access to the records.

ATCP 77.16(2)(d) (d) An operator shall take reasonable security measures to prevent record loss, damage or tampering.

ATCP 77.16(3) (3) Falsifying records. No operator may falsify any laboratory records.

ATCP 77.16 History History: Cr. Register, September, 1999, No. 525, eff. 10-1-99.

subch. II of ch. ATCP 77 Subchapter II — Milk and Food Laboratories

ATCP 77.20 ATCP 77.20 Milk and food laboratories; procedures.

ATCP 77.20(1) (1) Test methods. An operator who performs any test listed under s. ATCP 77.02 (1) and (2) 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.

ATCP 77.20(2) (2) Reference materials.

ATCP 77.20(2)(a) (a) General. An operator who performs any test listed under s. ATCP 77.02 (1) or (2) shall keep, at the certified laboratory, the manufacturer’s complete operating and maintenance instructions for equipment used to perform that test.

ATCP 77.20(2)(b) (b) Milk tests. An operator who performs any test listed under s. ATCP 77.02 (1) shall keep the following reference materials at the certified laboratory:

ATCP 77.20(2)(b)1. 1. The FDA 2400 series laboratory evaluation forms for that test.

ATCP 77.20(2)(b)2. 2. The “Standard Methods for the Examination of Dairy Products,” 17th edition, published by the American Public Health Association.

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.

ATCP 77.22(7)(d) (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.

ATCP 77.22(7)(e) (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.

ATCP 77.22(8) (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.

ATCP 77.22(9) (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.

ATCP 77.22(10) (10) Notice of changes.

ATCP 77.22(10)(a) (a) An operator shall notify the department within 30 days after any of the following occurs:

ATCP 77.22(10)(a)1. 1. An analyst certified under this section is no longer employed by the laboratory.

ATCP 77.22(10)(a)2. 2. There is a change in the name of any analyst certified under this section.

ATCP 77.22(10)(b) (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).

ATCP 77.22 History 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 ATCP 77.23 Drug residues in milk; screening tests.