Room 472
Eau Claire
State of Wisconsin
State Office Building
718 Clairemont Avenue
Eau Claire, Wisconsin
Room 139
Green Bay
State of Wisconsin
State Office Building
200 North Jefferson
Green Bay, Wisconsin
Room 618
Milwaukee
State of Wisconsin
State Office Building
819 North 6th Street
Milwaukee, Wisconsin
Room 542
Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
Statutory authority: ss. 93.07(1) and 93.12(3), (5) and (7)
Statutes interpreted: ss. 93.06(7) and (8), 93.08, 93.12, 93.14, 93.15, 93.16 and 97.12, Stats.
The 1995-97 biennial budget act, 1995 Wis. Act 27, transferred much of the administration of Wisconsin's laboratory certification program from the Department of Health and Family Services (“DHFS") to the Department of Agriculture, Trade and Consumer Protection (“DATCP").
Under this program, DATCP is now responsible for certifying laboratories that test milk, food and drinking water for compliance with public health standards. (DHFS retains jurisdiction over certain public health laboratories, such as medical laboratories.) Laboratory certification helps ensure that public health lab tests are accurate and reliable.
This rule is the foundation for the lab certification program now located in DATCP. This rule does not make major changes in the current lab certification program. However, this rule streamlines and clarifies current rules so they will be easier to read and understand. This rule repeals former DHFS lab certification rules under ch. HFS 165, Wis. Adm. Code. It also repeals and recreates DATCP's interim lab certification rules under ch. ATCP 77, Wis. Adm. Code.
Coverage
Under s. 93.12, Stats., and this rule, DATCP must certify laboratories that perform certain tests on milk, water or food, to determine compliance with federal, state or local public health standards. This rule specifies the tests for which a laboratory must be certified. Both private and public laboratories must be certified under this rule. However, certification is not required for any of the following:
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The United States government.
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Water testing by the state of Wisconsin laboratory of hygiene.
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Milk testing by DATCP.
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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 .
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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.
Scope of Certification
DATCP must certify a laboratory on an annual basis. An annual certification expires on December 31 of each year. A person who operates 2 or more laboratories must obtain a separate certification for each lab. DATCP must specify, in its certification, the tests which the laboratory is certified to perform.
Applying for Certification
A laboratory must apply to DATCP for certification, and must pay an annual certification fee of $216 per test. If DATCP certifies a lab to perform a test for less than a full year, the lab must pay a certification fee of $18 for each full month of certification.
DATCP must act on a certification application within 40 calendar days after it receives a complete application. A laboratory may apply, at any time, for certification to perform additional tests. A certified laboratory must file an annual renewal application by December 31 of each year.
Granting and Withdrawing Certification
DATCP may certify a laboratory that complies with this rule. DATCP may conditionally certify a laboratory pending action to correct deficiencies which DATCP has identified. DATCP may summarily suspend a conditional certification if the laboratory fails to correct the deficiencies within the time specified by DATCP.
Laboratory Facilities
A laboratory must have adequate facilities, equipment and supplies to perform the tests for which DATCP certifies that laboratory. A laboratory must also maintain the facilities, equipment and supplies in proper working condition. This rule establishes some specific facility and maintenance requirements. Under this rule, a laboratory must notify DATCP whenever the it remodels lab facilities or installs new equipment that materially affects the performance of certified tests.
Laboratory Procedures
A certified laboratory must perform tests according to recognized methods. This rule incorporates, by reference, authoritative lab manuals which spell out those recognized methods. As required under s. 227.21, Stats., DATCP has requested permission from the attorney general and the revisor of statutes to incorporate these manuals by reference in this rule.
Laboratory Administrator
A certified laboratory must designate an administrator who personally supervises the operations of the laboratory. The administrator or a designated agent of the administrator must be present at the laboratory during daytime business hours, and must do all of the following on behalf of the lab operator:
Supervise the lab and its compliance with this rule.
Review and approve the lab's certification applications to DATCP.
Supervise the procurement and maintenance of lab facilities, equipment and supplies.
Facilitate DATCP inspections of the lab.
Notify DATCP of changes in lab facilities or personnel that affect the lab's certification.
Notify lab customers if DATCP suspends or revokes the lab's certification.
Report lab test results to the appropriate regulatory agency, if required by law.
Supervise lab recordkeeping.
Laboratory Analysts
Analysts who perform tests at a certified laboratory must be proficient in performing those tests. Whenever DATCP first certifies a laboratory, or performs its biennial inspection of a certified laboratory, DATCP must evaluate the proficiency of all the analysts who are then performing tests for which the lab is certified. DATCP evaluates the analysts by watching them perform the tests.
DATCP may not certify a laboratory to test milk or water unless DATCP specifically certifies the proficiency of at least one analyst to perform each test for which the lab is certified. (This is different from DATCP's general evaluation lab analysts, described above.) DATCP must follow specific federal procedures when certifying individual milk or water analysts, and must maintain a list of certified analysts. An analyst's certification remains in effect until the analyst leaves the lab, or until DATCP suspends or revokes the analyst's certification.
A laboratory must notify DATCP if the lab no longer has certified analysts on staff to perform milk or water tests. A laboratory must also notify DATCP whenever the lab assigns a new analyst to perform any test for which the lab is certified.
Inspecting a Laboratory
DATCP must inspect a laboratory at all of the following times:
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Before certifying the laboratory for the first time.
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At least once every 2 years after it certifies the laboratory.
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Before certifying the laboratory to perform a test for which it was not previously certified.
DATCP may inspect a laboratory whenever any of the following occurs:
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The laboratory materially alters its facilities, equipment or procedures.
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The laboratory assigns a new analyst to perform a test for which the lab is currently certified.
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DATCP concludes that an inspection is necessary to determine whether the lab complies with this rule.
Milk and Water Laboratories; Proficiency Evaluation
A laboratory certified to test milk or water must undergo an annual lab proficiency evaluation. In an annual lab proficiency evaluation, the laboratory must examine samples prepared by an approved evaluator. The contents of the samples are known to the evaluator, but not to the laboratory. The evaluator must rate the laboratory's proficiency (not the proficiency of individual analysts) by comparing the laboratory's results to the known contents of the samples, and must report those results and ratings to DATCP.
DATCP, or another evaluator approved by DATCP, must evaluate a lab's proficiency in performing milk or food tests. The Wisconsin state lab of hygiene, or another evaluator approved by DATCP, must evaluate a lab's proficiency in performing water tests.
DATCP must approve lab evaluation procedures. A laboratory is not required to undergo an annual proficiency evaluation for any test unless DATCP has approved an evaluation procedure for that test. An evaluation procedure must include standards for all of the following:
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The evaluator's preparation of test samples.
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The lab's examination of test samples.
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Deadlines for examining test samples and reporting test results.
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The evaluator's review and rating of operator proficiency.
This rule specifies evaluation procedures for milk and water tests. To pass an annual milk test evaluation, a laboratory must accurately test at least 80 percent of the samples provided by the evaluator. To pass an annual water test evaluation, a laboratory must accurately test at least 90 percent of the samples provided by the evaluator.
Laboratory Records
A laboratory must keep complete records related to all of the following:
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The training, experience and proficiency testing of analysts.
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Laboratory evaluations.
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Laboratory policies and procedures.
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Laboratory facilities, equipment and supplies, including records related to procurement, calibration, testing and maintenance.
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Quality control procedures and monitoring.
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Tests performed at the laboratory, including 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.
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Test reports filed with the department and other government agencies.
A laboratory must keep these records for at least 5 years, and must make them available for inspection and copying by DATCP upon request. A laboratory may not falsify any records.
