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(n) HPC or R2A.
(o) SimPlate.
(p) m-TEC (fecal coliform).
(q) Pseudalert.
(r) Enterolert.
(s) Cryptosporidium and Giardia.
(t) Other tests under ch. NR 809 or 812 to detect microbiological contamination in drinking water.
History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 07-006: am. (intro.), r. and recr. (1) and (3), Register January 2008, No. 625, eff. 2-1-08; renumbering of (1) (aa) to (dd) to be (1) (za) to (zd) made under s. 13.92 (4) (b) 1., Stats., Register January 2008 No. 625; CR 14-073: am. (1) (zd) Register August 2016 No. 728, eff. 9-1-16; CR 19-076: am. (1) (e) to (zd), cr. (1) (ze), (zf), (zq), am. (3) (e), (g), (n), (q), renum. (3) (q) to (3) (t) and am., cr. (3) (q) to (s) Register May 2020 No. 773, eff. 6-1-20.
ATCP 77.03Laboratory certification; general.
(1)Annual certification required.
(a) Except as provided in par. (b), no person may perform any laboratory test listed under s. ATCP 77.02 to determine whether milk, food or water complies with public health standards required under federal or state law unless the department annually certifies the laboratory operator to perform that test at the laboratory where the test is performed. An annual certificate expires on December 31 of each year.
Note: A laboratory operator certified under sub. (1) (a) to perform a specified drug residue test may perform both the confirmatory drug residue test for which that operator is certified, as well as the corresponding drug residue screening test.
(b) An operator may perform a drug residue test as a screening test under s. ATCP 77.23 at the operator’s laboratory, even though the operator is not certified under par. (a) to perform that drug residue test as a confirmatory test, if the department annually approves the operator to perform that drug residue screening test at that laboratory. An annual certificate of approval expires on December 31 of each year.
(2)Scope of certification.
(a) A person who operates 2 or more laboratories shall obtain a separate certification under sub. (1) for each laboratory. A certification may not be transferred between operators or laboratories.
(b) The department shall identify, in each certification under sub. (1), the tests which the operator is certified to perform at that laboratory.
(c) An operator approved under sub. (1) (b) to perform a drug residue test as a screening test may not perform that test as a confirmatory test unless the operator is certified to do so under sub. (1) (a).
Note: The department may approve a laboratory operator, under s. ATCP 77.23, to perform a drug residue screening test on milk even though the department has not certified that laboratory operator under this section to perform that test as a confirmatory test. See also s. ATCP65.76.
(3)Certificate displayed. An operator shall display, at a prominent location in each certified laboratory, the current certification issued for that laboratory under sub. (1).
(4)Exemptions. Subsection (1) does not apply to any of the following:
(a) The United States government.
(b) Milk testing by the department.
(c) An educational institution that operates a laboratory solely for teaching or academic research purposes, and does not test milk, water or food for human consumption.
(d) A person who operates a laboratory solely to conduct quality control tests on food or water sold by that person, provided that the tests are not required by statute, rule or ordinance.
History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; emerg. renum. (2) (c) to be (2) (b), cr. (2) (c), eff. 11-15-01; CR 01-124: renum. (2) (c) to be (2) (b), cr. (2) (c) Register December 2002 No. 564, eff. 1-1-03; CR 07-003: r. and recr. (1) and (2) (c), Register January 2008 No. 625, eff. 2-1-08.
ATCP 77.04Applying for certification.
(1)Initial application. An operator shall apply for initial certification under s. ATCP 77.03 on a form provided by the department. The operator shall submit a separate application for each laboratory. An application shall include all of the following:
(a) The operator’s correct legal name and address, and any trade names used by the operator. The application shall indicate whether the operator is an individual, corporation, partnership, cooperative association, limited liability company, trust, or other organization or entity.
(b) The name, address, telephone number, and e-mail address of the laboratory.
(c) The name of the laboratory administrator under s. ATCP 77.12.
(d) The tests under s. ATCP 77.02 for which the operator seeks certification.
(e) Documentation that the laboratory is qualified to perform each test which the operator identifies under par. (d). Documentation shall include all of the following:
1. Proof that the laboratory has all of the equipment needed to perform each test.
2. Written test procedures used for each test, or an identification of the standard test methods used for each test.
3. Proof of analytical proficiency in each test. Proof may consist of quality assurance test results from comparison studies, split samples or proficiency tests which meet the proficiency evaluation requirements under s. ATCP 77.24 or 77.34. The operator of a water laboratory shall also provide documentation required under s. ATCP 77.32.
Note: An operator may obtain application forms and submit applications to the department at the following address:
Wisconsin department of agriculture, trade and consumer protection
Division of food and recreational safety, bureau of food and recreational businesses
Laboratory Certification Program
P.O. Box 8911
Madison, WI 53708-8911
(608) 224-4712
(2)Annual renewal. To renew an annual certification, the operator of a certified laboratory shall file a renewal application with the department by December 31 of each year. The operator shall file the renewal application on a form provided by the department. The renewal application shall include all of the following:
(a) The information required under sub. (1) (a) to (d). The application shall identify any changes since the last annual renewal.
(b) The information required under sub. (1) (e) if the operator requests certification to perform a test which the department has not yet certified the operator to perform.
(c) The certification fees required under s. ATCP 77.06.
Note: The department will send renewal application forms to certified laboratories approximately 6 weeks before their current annual certifications expire.
(3)False information. No person may misrepresent or falsify any information contained in a certification application under this section.
History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 19-076: am. (1) (b) Register May 2020 No. 773, eff. 6-1-20.
ATCP 77.06Certification fees.
(1)Fee amounts. Except as provided under sub. (2) or (3), an operator shall pay the following certification fees:
(a) Milk or food tests. An annual certification fee of $492 for each test under s. ATCP 77.02 (1) or (2) at each laboratory for which the operator is certified. This fee does not apply to a laboratory that is approved under s. ATCP 77.23 only to conduct drug residue screening tests on milk samples.
(b) Certified analysts; milk or food tests. An annual certification fee of $36 for each analyst who performs one or more tests under s. ATCP 77.02 (1) or (2). This fee does not apply to an individual approved under s. ATCP 77.23 only to conduct drug residue screening tests on milk samples.
(c) Discretionary inspection or additional analyst certification; milk or food tests. A supplemental fee of $180 for each discretionary inspection or requested certification of one or more analysts to conduct any test under s. ATCP 77.02 (1) or (2), if the certification occurs at any time other than during a mandatory inspection under s. ATCP 77.14 (1). This fee does not apply to an individual approved under s. ATCP 77.23 only to conduct drug residue screening tests on milk samples.
(d) Water tests. An annual certification fee of $408 for each test under s. ATCP 77.02 (3) for which the operator is certified.
(e) Drug residues in milk; screening tests. The fees provided in s. ATCP 77.23 (3) if the laboratory performs drug residue screening tests on milk samples.
(2)Partial fees. An operator of a milk or food laboratory shall pay the fee as provided in par. (a) and the operator of a water laboratory shall pay the fee as provided in par. (b).
(a) If the department certifies an operator of a milk or food laboratory to perform a test for less than a full calendar year, the operator shall pay a fee of $42 for each full month of certification for that test. This fee does not apply to a laboratory that is authorized under s. ATCP 77.23 only to conduct drug residue screening tests on milk samples.
(b) If the department certifies an operator of a water laboratory to perform a test for less than a full calendar year, the operator shall pay a fee of $35 for each full month of certification for that test.
(3)Fee exemptions. A county or municipality that contracts with the department to license and inspect retail food establishments as the department’s agent under s. 97.41, Stats., is not required to pay any certification fee.
(4)Paying certification fees.
(a) If the department has not previously certified an operator to perform any of the tests listed under s. ATCP 77.02 at the laboratory for which the operator is seeking certification, the department shall bill the operator under this section after the department inspects the laboratory under s. ATCP 77.14 (1) (a). The department may not certify the operator to perform any test until the operator pays the required certification fee for that test.
(b) If the operator of a certified laboratory applies for certification to perform additional tests under sub. (5), or files a renewal application under s. ATCP 77.04 (2), the operator shall include with that application the fees required under this section.
(5)Additional tests. The operator of a certified laboratory may, at any time, apply for certification to perform additional tests which the department has not yet certified the operator to perform at that laboratory. The operator shall apply on a form provided by the department. The application shall include all of the following:
(a) The additional tests for which the operator seeks certification.
(b) Documentation, under s. ATCP 77.04 (1) (e), that the operator is qualified to perform each additional test under par. (a).
(c) The fees required under this section.
Note: An operator may apply under sub. (5) at any time during a license year, and need not wait until the annual license renewal.
History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; am. (1) and (2) and cr. (1) (a) to (d), Register, December, 1999, No. 528, eff. 1-1-00; emerg. am. (1) (a) to (c), cr. (1) (e), r. and recr. (2), eff. 11-15-01; CR 01-124: am. (1) (a) to (c), cr. (1) (e), r. and recr. (2) Register December 2002 No. 564, eff. 1-1-03; CR 05-044: cr. (2) (intro.), am. (4) and (5) (c) Register December 2005 No. 600, eff. 1-1-06; CR 07-037: am. (1) (a), (b) and (d) Register April 2008 No. 628, eff. 5-1-08; CR 19-076: am. (1) (a) to (d), (2) (a), (b) Register May 2020 No. 773, eff. 6-1-20.
ATCP 77.08Granting and withdrawing certification.
(1)Granting certification. The department shall certify an operator under s. ATCP 77.03 if the operator and laboratory comply with this chapter. The department may conditionally certify an operator pending action by the operator to correct deficiencies which the department has identified. The department may summarily suspend a conditional certification, without prior hearing, if the operator fails to correct the deficiencies within the time specified by the department.
(2)Deadline for action on certification request. Within 40 calendar days after the department receives a complete application under s. ATCP 77.04, the department shall do all the following:
(a) Inspect the laboratory if an inspection is required under s. ATCP 77.14 (1).
(b) Grant the application, grant the application subject to conditions, or deny the application.
(3)Milk and food laboratories; certified analysts.
(a) The department may not certify an operator to perform any test under s. ATCP 77.02 (1) or (2) unless the department has certified all of the analysts who perform that test at that laboratory.
(4)Suspending or revoking certification. The department may suspend or revoke an operator’s certification for cause, including a violation of this chapter or failure to file required laboratory reports with other government agencies. The department shall comply with applicable requirements under ch. 227, Stats., and ch. ATCP 1.
Note: See ss. 93.06 (7) and 93.12, Stats.
(5)Summary suspension. The food and recreational safety administrator may issue a written notice, summarily suspending all or part of an operator’s certification, if the food and recreational safety administrator finds in the suspension notice that the operator has not complied with this chapter, that the noncompliance poses an imminent threat to the health or safety of the public or laboratory workers, and that the noncompliance is likely to continue unless the food and recreational safety administrator summarily suspends the operator’s certification. The operator may contest the summary suspension according to s. ATCP 1.03 (3).
History: Cr. Register, September, 1999, No. 525, eff. 10-1-99; CR 19-076: am. (5) Register May 2020 No. 773, eff. 6-1-20.
ATCP 77.10Laboratory facilities.
(1)Adequate facilities. A certified laboratory shall have all of the following:
(a) Adequate facilities, equipment and supplies to perform the tests which the operator is certified to perform at that laboratory.
(b) At least 5 linear feet of level bench top working space per analyst.
(c) At least 50 foot candles of light on each bench top.
(d) Effective climate controls to maintain proper temperature and humidity for testing.
(2)Quality control and maintenance. The operator of a certified laboratory shall do all of the following:
(a) Maintain laboratory facilities, equipment and supplies in proper working condition.
(b) Maintain temperature-controlled equipment, including incubators, water baths, refrigerators and freezers, so that the equipment functions effectively. The operator shall measure and record equipment temperatures at least daily when the equipment is in use and the laboratory is staffed with trained personnel.
(c) Maintain autoclaves to ensure proper temperature and pressure throughout the entire sterilization cycle, and keep a record of autoclave maintenance.
(d) Calibrate each electronic test instrument as recommended by the instrument manufacturer, and record the results.
(e) Ensure that each reagent and solution is clearly labeled to show its identity, its titer or concentration, its expiration or preparation date, instructions for proper storage, and other pertinent information. An operator shall store reagents and solutions according to the manufacturer’s specifications.
(f) Ensure that glassware is free of chips, excessive scratches or cloudiness. Glassware used for measurement, including pipettes, graduated cylinders and volumetric flasks, shall have clear graduations.
(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.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.