ATCP 77.04(1)(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:
ATCP 77.04(1)(a)
(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.
ATCP 77.04(1)(b)
(b) The name, address, telephone number, and e-mail address of the laboratory.
ATCP 77.04(1)(e)
(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:
ATCP 77.04(1)(e)1.
1. Proof that the laboratory has all of the equipment needed to perform each test.
ATCP 77.04(1)(e)2.
2. Written test procedures used for each test, or an identification of the standard test methods used for each test.
ATCP 77.04(1)(e)3.
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.
ATCP 77.04 Note
Note: An operator may obtain application forms and submit applications to the department at the following address:
ATCP 77.04 Note
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
ATCP 77.04(2)
(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:
ATCP 77.04(2)(a)
(a) The information required under sub.
(1) (a) to
(d). The application shall identify any changes since the last annual renewal.
ATCP 77.04(2)(b)
(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.
ATCP 77.04 Note
Note: The department will send renewal application forms to certified laboratories approximately 6 weeks before their current annual certifications expire.
ATCP 77.04(3)
(3) False information. No person may misrepresent or falsify any information contained in a certification application under this section.
ATCP 77.04 History
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 77.06(1)(1)
Fee amounts. Except as provided under sub.
(2) or
(3), an operator shall pay the following certification fees:
ATCP 77.06(1)(a)
(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.
ATCP 77.06(1)(b)
(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.
ATCP 77.06(1)(c)
(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.
ATCP 77.06(1)(e)
(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.
ATCP 77.06(2)
(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).
ATCP 77.06(2)(a)
(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.
ATCP 77.06(2)(b)
(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.
ATCP 77.06(3)
(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.
ATCP 77.06(4)(a)
(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.
ATCP 77.06(4)(b)
(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.
ATCP 77.06(5)
(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:
ATCP 77.06(5)(a)
(a) The additional tests for which the operator seeks certification.
ATCP 77.06 Note
Note: An operator may apply under sub. (5) at any time during a license year, and need not wait until the annual license renewal.
ATCP 77.06 History
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 77.08
ATCP 77.08
Granting and withdrawing certification. ATCP 77.08(1)(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.
ATCP 77.08(2)
(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:
ATCP 77.08(2)(b)
(b) Grant the application, grant the application subject to conditions, or deny the application.
ATCP 77.08(3)
(3) Milk and food laboratories; certified analysts. ATCP 77.08(3)(a)(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.
ATCP 77.08(4)
(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.
ATCP 77.08(5)
(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).
ATCP 77.08 History
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 77.10(1)(1)
Adequate facilities. A certified laboratory shall have all of the following:
ATCP 77.10(1)(a)
(a) Adequate facilities, equipment and supplies to perform the tests which the operator is certified to perform at that laboratory.
ATCP 77.10(1)(b)
(b) At least 5 linear feet of level bench top working space per analyst.
ATCP 77.10(1)(d)
(d) Effective climate controls to maintain proper temperature and humidity for testing.
ATCP 77.10(2)
(2) Quality control and maintenance. The operator of a certified laboratory shall do all of the following:
ATCP 77.10(2)(a)
(a) Maintain laboratory facilities, equipment and supplies in proper working condition.
ATCP 77.10(2)(b)
(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.
ATCP 77.10(2)(c)
(c) Maintain autoclaves to ensure proper temperature and pressure throughout the entire sterilization cycle, and keep a record of autoclave maintenance.
ATCP 77.10(2)(d)
(d) Calibrate each electronic test instrument as recommended by the instrument manufacturer, and record the results.
ATCP 77.10(2)(e)
(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.
ATCP 77.10(2)(f)
(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.
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(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 History
History: Cr.
Register, September, 1999, No. 525, eff. 10-1-99.
ATCP 77.14(1)(1)
Mandatory inspections. The department shall inspect a laboratory at all of the following times:
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(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.
