Section 299.11. Laboratory certification program.

 

(1)   Definitions. As used in this section:

(a) “Accuracy" means the closeness of a measured value to its generally accepted value or its value based upon an accepted reference standard.

(b) “Certified laboratory" means a laboratory which performs tests for hire in connection with a covered program and which receives certification under sub. (7) or receives recognition as a certified laboratory under sub. (5) .

(c) “Council" means the certification standards review council created under s. 15.107 (12) .

(d) “Covered program" means test results submitted in connection with any of the following:

1. A feasibility report, plan of operation or the condition of any license issued for a solid waste facility under subch. III of ch. 289 , or hazardous waste facility under s. 291.25 (2) and (3) .

2. An application for a mining permit under s. 293.37 (2) .

3. Monitoring required by terms and conditions of a permit issued under ch. 283 .

4. The replacement of a well or provision of alternative water supplies under s. 281.75 or 281.77 .

5. Groundwater monitoring under ch. 160 .

6. The management or enforcement of the safe drinking water program under s. 280.13 (1) (b) and (d) or 281.17 (8) .

7. The terms of department contracts when specifically required in the contracts.

8. An investigation of a discharge of a hazardous substance under s. 292.11 .

9. A regulatory program specified by the department by rule if, after consultation with the council, the department finds that existing quality control programs do not provide consistent and reliable results and the best available remedy is to require that all laboratories performing the tests for that regulatory program be certified or registered.

(e) “Laboratory" means a facility which performs tests in connection with a covered program.

(f) “Precision" means the closeness of repeated measurements of the same parameter within a sample.

(g) “Registered laboratory" means a laboratory which is registered under sub. (8) or receives recognition as a registered laboratory under sub. (5) .

(h) “Results" includes measurements, determinations and information obtained or derived from tests.

(i) “Test" means any chemical, bacteriological, biological, physical, radiation or microscopic test, examination or analysis conducted by a laboratory on water, wastewater, waste material, soil or hazardous substance.

(j) “Test category" means one type of test or group of tests specified by rule under sub. (4) for similar materials or classes of materials or which utilize similar methods or related methods.

(2)   Coordination with department of agriculture, trade and consumer protection.

(a) The department shall submit to the department of agriculture, trade and consumer protection and to the state laboratory of hygiene any rules proposed under this section that affect the laboratory certification program under s. 93.12 (5) , for review and comment. These rules may not take effect unless they are approved by the department of agriculture, trade and consumer protection within 6 months after submission.

(b) The department shall enter into a memorandum of understanding with the department of agriculture, trade and consumer protection setting forth the responsibilities of each department in administering the laboratory certification programs under s. 93.12 (5) and this section. The memorandum of understanding shall include measures to be taken by each department to avoid duplication of application and compliance procedures for laboratory certification.

(3)   Certification standards review council. The council shall review the laboratory certification and registration program and shall make recommendations to the department concerning the specification of test categories, reference sample testing and standards for certification, registration, suspension and revocation and other aspects of the program.

(4)   Department may require certification or registration.

(a) Applicability. Except as provided in subs. (5) and (6) , if results from a test in a specified test category in a covered program are required to be submitted to the department, the department may require by rule that the test be conducted by a laboratory which is certified or registered to conduct tests in that specified category. The department may require that tests be conducted by a certified laboratory if the requirements for registration do not meet the requirements of an applicable federal law.

(b) Specification of test categories. After considering any recommendations by the council, the department may identify by rule specified test categories.

(c) Delayed effective date. A rule identifying specified test categories for which tests are required to be conducted by a certified or registered laboratory may not take effect until at least 120 days after publication. The department may not require a person to resubmit results of tests which were not required to be conducted by a certified or registered laboratory at the time of the original submission merely because of that fact.

(5)   Recognition of other certification or registration.

(a) Laboratories certified by the department of agriculture, trade and consumer protection. The department shall recognize the certification of a laboratory by the department of agriculture, trade and consumer protection under s. 93.12 and shall accept the results of any test conducted by a laboratory certified to conduct that category of test under that section.

(b) Reciprocity with laboratories certified or registered by other governments. The department may recognize the certification, registration, licensure or approval of a laboratory by another state or an agency of the federal government if the standards for certification, registration, licensure or approval are substantially equivalent to those established under this section. The department shall negotiate with and attempt to enter into acceptable agreements with federal agencies and agencies of other states for the purpose of reciprocal recognition of laboratory certification and registration under this section. The department may not recognize the certification, registration, licensure or approval of a laboratory by another state or an agency of the federal government unless that state or federal agency recognizes laboratories certified under this section. The department may accept the results of any tests conducted by a laboratory which it recognizes under an agreement. The department shall publish periodically a list of those agencies whose certifications, approvals or registrations it accepts. Any laboratory which is registered, certified or approved by any such agency may apply to the department to have the same recognized under this section.

(c) Private organization agreements. The department may recognize the certification, accreditation or approval of a laboratory by a private nonprofit organization if the organization's standards for certification, accreditation or approval are substantially equivalent to those established under this section. The department may negotiate with and attempt to enter into acceptable agreements with private nonprofit organizations for the purpose of recognition under this paragraph. The department shall publish periodically a list of those organizations whose certifications, accreditations or approvals it accepts. The department may accept the results of any tests conducted by a laboratory that it recognizes under an agreement. Any laboratory that is certified, accredited or approved by an organization with which the department has an agreement may apply to the department to be recognized under this paragraph.

(d) Discretionary acceptance. The department may accept the results of a test in a specified test category even though the test was not conducted by a certified or registered laboratory. The department may charge an extra fee if it is necessary to verify the results of a test submitted under this paragraph.

(6)   Not applicable to other programs. No laboratory is required to be registered or certified under this section for any purpose other than the submission of results under a covered program.

(7)   Certification procedures.

(a) Criteria. After considering recommendations by the council, the department shall promulgate by rule uniform minimum criteria, as provided in this subsection, to be used to evaluate laboratories for certification. Criteria shall be consistent with nationally recognized criteria to the maximum extent possible and shall be designed to facilitate reciprocal agreements under sub. (5) .

(b) Methodology.

1. `Accepted methodology.' The department shall prescribe by rule the accepted methodology to be followed in conducting tests in each test category. The department may prescribe by rule accepted sampling protocols and documentation procedures for a specified test category to be followed by the person collecting the samples. The department may prescribe this methodology by reference to standards established by technical societies and organizations as authorized under s. 227.21 (2) . The department shall attempt to prescribe this methodology so that it is consistent with any methodology requirements under the resource conservation and recovery act, as defined under s. 289.01 (30) , the federal water pollution control act, as amended, 33 USC 1251 to 1376 , the safe drinking water act, 42 USC 300f to 300j-10 , or the toxic substance control act, 15 USC 2601 to 2629 .

2. `Revised methodology.' The department may permit the use of a revised methodology consistent with new or revised editions or standards established by technical societies and organizations on a case-by-case basis.

3. `Alternative methodology; confidentiality.'

a. The department may permit the use of an alternative methodology on a case-by-case basis if the laboratory seeking to use that methodology submits data establishing the accuracy and precision of the alternative methodology and if the accuracy and precision obtained through the use of the alternative methodology equals or exceeds that obtained through use of the accepted methodology. The department shall establish by rule the data which is required to be submitted and the criteria for evaluating accuracy and precision of alternative methods.

b. A laboratory seeking to use an alternative methodology may request confidential treatment of any data or information submitted to the department under this paragraph. The department shall grant confidential status for any data or information relating to unique methods or processes if the disclosure of those methods or processes would tend to adversely affect the competitive position of the laboratory.

4. `Waiver of the procedure.' The department may waive any procedure prescribed in the accepted methodology on a case-by-case basis if the laboratory seeking this waiver establishes sufficient reasons for the waiver and that the waiver does not adversely affect the purpose for which the test is conducted.

(c) Reference sample testing. The department may prescribe by rule criteria for determining the accuracy of tests by certified laboratories on reference samples. The department shall provide, to the extent reasonably possible, reference samples prepared by an independent source for a representative cross section of test categories which are to be regularly and routinely performed by certified laboratories. The department may require a certified laboratory to analyze not more than 3 reference samples per year for each test category.

(d) Quality control. The department shall establish by rule minimum requirements for a quality control program which ensures that a laboratory complies with criteria for the accuracy and precision of tests in each test category and which specifies procedures to be followed if these criteria are not met. The department may accept a quality control program based upon state or federal requirements for similar test categories.

(e) Records. Where a particular time period is not otherwise specified by law, the department may prescribe by rule for each test category the length of time laboratory analysis records and quality control data specified in the laboratory's quality control program are to be retained by the laboratory.

(f) Application for certification. The department shall specify by rule the criteria and standards to be met by applicants for certification. A laboratory desiring to be certified for a specified test category shall make application on forms provided by the department.

(g) Initial certification. The department shall issue an initial certification to a laboratory for a specified test category if all of the following conditions are met:

1. `Application.' The laboratory submits an application requesting certification in a specified test category.

2. `Methodology.' The laboratory specifies a methodology prescribed or permitted under par. (b) which it intends to utilize in conducting tests in the specified test category.

3. `Accuracy.' If the department provides a reference sample, the laboratory conducts a test on the sample and obtains results which comply with the minimum criteria for accuracy for that specified test category.

4. `Quality control.' The laboratory has or agrees to implement a quality control program which meets minimum requirements under par. (d) for the specified test category and which is to commence no later than the date of certification.

(h) Certification period. Certification of laboratories shall be renewed annually. A certification is valid from the date of issuance until it expires, is revoked or suspended.

(i) Suspension and revocation. After considering recommendations from the council, the department shall establish by rule criteria and procedures for the review and evaluation of the certification of laboratories and the suspension or revocation of certifications. If, after opportunity for a contested case hearing, the department finds that a certified laboratory materially and consistently failed to comply with the criteria and procedures established by rule, it may suspend or revoke the certification of the laboratory. A person whose certification is suspended or revoked may reapply for certification upon a showing that the person meets the applicable criteria for certification and has corrected the deficiencies that led to the suspension or revocation.

(8)   Registration procedure.

(a) Criteria. Upon application, the department shall register a laboratory if the laboratory complies with the requirements of this subsection, if the laboratory does not perform tests commercially for hire and if:

1. The laboratory performs tests solely on its own behalf or on behalf of a subsidiary or other corporation under common ownership or control; or

2. The laboratory is owned or controlled by a municipality or 2 or more municipalities and performs tests solely on behalf of the municipality or municipalities.

(b) Methodology. Testing by a registered laboratory conducted in connection with a covered program shall be carried out in accordance with sub. (7) (b) .

(c) Reference sample testing. The department may require by rule reference sample tests upon application and annually thereafter. If results from these tests do not meet minimum criteria established by rule, the department may require additional reference sample testing. If the laboratory participates in a joint or split sampling program with the federal environmental protection agency, or otherwise obtains independent reference samples, the department may accept those results instead of its own reference samples.

(d) Quality control. The laboratory shall conduct self-audits and a quality control program consistent with criteria specified by rule by the department and based on methods and standards prescribed by rule and considering criteria used by the federal environmental protection agency, ASTM International, the national council on air and stream improvement, the national academy of sciences or other equivalent agency recognized by the department.

(e) Records. Where a particular time period is not otherwise specified by law, the department may prescribe by rule for each test category the length of time laboratory analysis records and quality control data specified in the laboratory's quality control program are to be retained by the laboratory.

(f) Registration. Registration of laboratories shall be renewed annually. A registration is valid from the date of issuance until it expires, is revoked or suspended.

(g) Suspension or revocation of registration. If, after opportunity for a contested case hearing, the department finds that a registered laboratory has falsified results or has materially and consistently failed to comply with the self-audit procedures and quality control programs provided in par. (d) , it may suspend or revoke the registration of the laboratory. A person whose registration is suspended or revoked may reapply for registration upon a showing that the person meets the applicable criteria for registration and has corrected the deficiencies that led to the suspension or revocation.

(h) Certification option. A laboratory which is otherwise eligible to seek registration may elect to apply for certification under sub. (7) .

(9)   Fees. The department shall promulgate by rule a graduated schedule of fees for certified and registered laboratories which are designed to recover the costs of administering this section.

1983 a. 410 ; 1985 a. 22 s. 11 ; 1985 a. 29 s. 3202 (39) ; 1985 a. 84 s. 8 ; 1985 a. 182 s. 57 ; 1989 a. 31 ; 1991 a. 32 , 39 ; 1993 a. 27 , 491 ; 1995 a. 27 ; 1995 a. 227 s. 818 ; Stats. 1995 s. 299.11; 1995 a. 417 s. 52 ; 2015 a. 186 . Cross-reference: See also chs. NR 149 and 219 , Wis. adm. code.