Act No. 229
Public Acts of 2004
Approved by the Governor
July 21, 2004
Filed with the Secretary of State
July 21, 2004
EFFECTIVE DATE: July 21, 2004
STATE OF MICHIGAN
92ND LEGISLATURE
REGULAR SESSION OF 2004
Introduced by Rep. Caul
ENROLLED HOUSE BILL No. 5742
AN ACT to amend 1994 PA 451, entitled "An act to protect the environment and natural resources of the state; to codify, revise, consolidate, and classify laws relating to the environment and natural resources of the state; to regulate the discharge of certain substances into the environment; to regulate the use of certain lands, waters, and other natural resources of the state; to prescribe the powers and duties of certain state and local agencies and officials; to provide for certain charges, fees, and assessments; to provide certain appropriations; to prescribe penalties and provide remedies; to repeal certain parts of this act on a specific date; and to repeal certain acts and parts of acts," (MCL 324.101 to 324.90106) by adding part 205.
The People of the State of Michigan enact:
PART 205 LABORATORY DATA QUALITY ASSURANCE
Sec. 20501. This part may be cited as the "V. Harry Adrounie laboratory data quality assurance act".
Sec. 20503. As used in this part:
(a) "Analytical data" means the qualitative or quantitative measurements generated by chemical, physical, biological, microbiological, radiological, or other scientific determination.
(b) "Calibration" means a set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards established as follows:
(i) In calibration of support equipment, through the use of reference standards that are traceable to the international system of units.
(ii) In calibration according to analytical methods, typically through the use of reference materials that are either purchased by the laboratory with a certificate of analysis or purity, or prepared by the laboratory using support equipment that has been calibrated or verified to meet specifications.
(c) "Commercial laboratory" means a privately owned laboratory that generates analytical data required under this act pertaining to the operations of a third person regulated under this act.
(d) "Council" means the laboratory data quality assurance advisory council created in section 20517.
(e) "Department" means the department of environmental quality.
(f) "Director" means the director of the department.
(g) "Fund" means the laboratory data quality recognition program fund created in section 20509.
(h) "In-house laboratory" means a privately owned laboratory that generates analytical data required under this act pertaining to the operations of the owner of that laboratory or an affiliate of the owner.
(i) "Laboratory" means a body that engages in calibration or testing, or both, at a specified location.
(j) "Proficiency testing" means a method of evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.
(k) "Public laboratory" means a municipal or other publicly owned laboratory that generates analytical data for submission to the department under this act.
(l) "Quality recognition program" means the laboratory data quality recognition program provided for in section 20505.
Sec. 20505. (1) The department shall implement a laboratory data quality recognition program to identify commercial laboratories that the department considers to be qualified to generate analytical data for submission to the department for compliance purposes under this act.
(2) Participation in the quality recognition program by a commercial laboratory is voluntary. A commercial laboratory shall not be restricted or prohibited from generating analytical data for submission to the department for compliance purposes under this act based on nonparticipation or unsuccessful participation in the quality recognition program.
(3) Each time the department lets a contract or contracts for state-funded laboratory work authorized under this act, the department shall use only those commercial laboratories that are successful participants in the quality recognition program. Exceptions may be made if desired analytical support services are not available from a commercial laboratory that is a successful participant in the quality recognition program.
(4) The quality recognition program shall determine whether the quality of analytical data is maintained through quality systems in which staff responsibilities and operational procedures are defined, documented, and subjected to an internal assessment by the commercial laboratory itself on a regular basis, with timely corrective action taken by the commercial laboratory as needed. The quality systems shall include quality assurance policies and quality control procedures and shall be documented in a written plan.
Sec. 20507. To participate in the quality recognition program, a commercial laboratory shall do all of the following:
(a) Submit an application to the department.
(b) Pay the department a fee based on the department's actual costs of administering the quality recognition program but not exceeding $750.00 for an initial application or $500.00 for a renewal application.
(c) Grant the department access to the laboratory and laboratory records for inspections during normal business hours without prior notice.
(d) If required by the department, participate in proficiency testing conducted by the department, the United States environmental protection agency, or any other nationally recognized proficiency testing program.
Sec. 20509. (1) The laboratory data quality recognition program fund is created within the state treasury.
(2) Fees collected under section 20507 shall be deposited in the fund. The state treasurer may also receive money or other assets from any other source for deposit into the fund. The state treasurer shall direct the investment of the fund. The state treasurer shall credit to the fund interest and earnings from fund investments.
(3) Money in the fund at the close of the fiscal year shall remain in the fund and shall not lapse to the general fund.
(4) The department shall expend money from the fund, upon appropriation, only to administer the quality recognition program.
Sec. 20511. (1) Subject to subsection (3), the department shall maintain and post on its website all of the following information:
(a) A list of laboratories that have successfully participated in the quality recognition program together with a statement that substantially sets forth the provisions of section 20505(2) and (3).
(b) The types of analytical data with respect to which a laboratory successfully participated in the quality recognition program, if the laboratory successfully participated only with respect to certain types of analytical data.
(2) Subject to subsection (3), the successful participation of a commercial laboratory in the quality recognition program shall be recognized by the department as provided in subsection (1) and section 20505(3) for a 2-year period. A laboratory may apply under section 20507 to renew its participation in the quality recognition program.
(3) The department may terminate recognition of a commercial laboratory as a successful participant in the quality recognition program upon determining that the commercial laboratory no longer meets the standards for successful participation in the quality recognition program.
Sec. 20515. The department shall enforce this part and, pursuant to the administrative procedures act of 1969, 1969 PA 306, MCL 24.201 to 24.328, may promulgate rules as it considers necessary to carry out its duties under this part. However, the department shall not promulgate any additional rules under this part after December 31, 2006.
Enacting section 1. This amendatory act does not take effect unless all of the following bills of the 92nd Legislature are enacted into law:
(a) Senate Bill No. 1135.
(b) House Bill No. 5743.
This act is ordered to take immediate effect.
Clerk of the House of Representatives
Secretary of the Senate
Approved
Governor