SB-1133, As Passed Senate, June 9, 2004                                     

SUBSTITUTE FOR

SENATE BILL NO. 1133

                                                                             A bill to amend 1994 PA 451, entitled                                             

"Natural resources and environmental protection act,"                       

(MCL 324.101 to 324.90106) by adding part 205.                              

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

1   PART 205 LABORATORY DATA QUALITY ASSURANCE

2   Sec. 20501.  This part may be cited as the "V. Harry                        

3   Adrounie laboratory data quality assurance act".

4   Sec. 20503.  As used in this part:                                          

5       (a) "Analytical data" means the qualitative or quantitative                 

6   measurements generated by chemical, physical, biological,                   

7   microbiological, radiological, or other scientific                          

8   determination.                                                              

9   (b) "Calibration" means a set of operations that establish,                 

10  under specified conditions, the relationship between values of              

11  quantities indicated by a measuring instrument or measuring                 

1   system, or values represented by a material measure or a                    

2   reference material, and the corresponding values realized by                

3   standards established as follows:                                           

4                                                                                (i) In calibration of support equipment, through the use of                         

5   reference standards that are traceable to the international                 

6   system of units.                                                            

7       (ii) In calibration according to analytical methods,                         

8   typically through the use of reference materials that are either            

9   purchased by the laboratory with a certificate of analysis or               

10  purity, or prepared by the laboratory using support equipment               

11  that has been calibrated or verified to meet specifications.                

12      (c) "Commercial laboratory" means a privately owned                         

13  laboratory that generates analytical data required under this act           

14  pertaining to the operations of a third person regulated under              

15  this act.                                                                   

16      (d) "Council" means the laboratory data quality assurance                   

17  advisory council created in section 20517.                                  

18      (e) "Department" means the department of environmental                      

19  quality.                                                                    

20      (f) "Director" means the director of the department.                        

21      (g) "Fund" means the laboratory data quality recognition                    

22  program fund created in section 20509.                                      

23      (h) "In-house laboratory" means a privately owned laboratory                

24  that generates analytical data required under this act pertaining           

25  to the operations of the owner of that laboratory or an affiliate           

26  of the owner.                                                               

27  (i) "Laboratory" means a body that engages in calibration or                

Senate Bill No. 1133 as amended June 9, 2004                                

1   testing, or both, at a specified location.                                  

2       (j) "Proficiency testing" means a method of evaluating a                    

3   laboratory's performance under controlled conditions relative to            

4   a given set of criteria through analysis of unknown samples                 

5   provided by an external source.                                             

6       (k) "Public laboratory" means a municipal or other publicly                 

7   owned laboratory that generates analytical data for submission to           

8   the department under this act.                                              

9                                                                                (l) "Quality recognition program" means the laboratory data                         

10  quality recognition program provided for in section 20505.

11  Sec. 20505.  (1) The department shall implement a laboratory                

12  data quality recognition program to identify commercial                     

13  laboratories that the department considers to be qualified to               

14  generate analytical data for submission to the department for               

15  compliance purposes under this act.                                         

16      (2) Participation in the quality recognition program by a                   

17  commercial laboratory is voluntary.  A commercial laboratory                

18  shall not be restricted or prohibited from generating analytical            

19  data for submission to the department for compliance purposes               

20  under this act based on nonparticipation or unsuccessful                    

21  participation in the quality recognition program.  <<        

22      (3) However, successful participation in the quality recognition

23  program is mandatory for a commercial laboratory that seeks to perform

24  testing associated with a state-funded project or program authorized

25  under this act. When the department lets contracts for state-funded

26  laboratory work authorized under this act, the department shall use only

27   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.>>

Senate Bill No. 1133 as amended June 9, 2004                                

1       <<(4)>> The quality recognition program shall determine whether             

2   the quality of analytical data is maintained through quality                

3   systems in which staff responsibilities and operational                     

4   procedures are defined, documented, and subjected to an internal            

5   assessment by the commercial laboratory itself on a regular                 

6   basis, with timely corrective action taken by the commercial                

7   laboratory as needed.  The quality systems shall include quality            

8   assurance policies and quality control procedures and shall be              

9   documented in a written plan.

10  Sec. 20507.  To participate in the quality recognition                      

11  program, a commercial laboratory shall do all of the following:             

12      (a) Submit an application to the department.                                

13      (b) Pay the department a fee based on the department's                      

14  actual costs of administering the quality recognition program but           

15  not exceeding $750.00 for an initial application or $500.00 for a           

16  renewal application.                                                        

17      (c) Grant the department access to the laboratory and                       

18  laboratory records for inspections during normal business hours             

19  without prior notice.                                                       

20      (d) If required by the department, participate in                           

21  proficiency testing conducted by the department, the United                 

22  States environmental protection agency, or any other nationally             

23  recognized proficiency testing program.

24  Sec. 20509.  (1) The laboratory data quality recognition                    

25  program fund is created within the state treasury.                          

26      (2) Fees collected under section 20507 shall be deposited in                

27  the fund.  The state treasurer may also receive money or other              

Senate Bill No. 1133 as amended June 9, 2004

1   assets from any other source for deposit into the fund.  The                

2   state treasurer shall direct the investment of the fund.  The               

3   state treasurer shall credit to the fund interest and earnings              

4   from fund investments.                                                      

5       (3) Money in the fund at the close of the fiscal year shall                 

6   remain in the fund and shall not lapse to the general fund.                 

7       (4) The department shall expend money from the fund, upon                   

8   appropriation, only to administer the quality recognition                   

9   program.

10  Sec. 20511.  (1) Subject to subsection (3), the department                  

11  shall maintain and post on its website all of the following                 

12  information:                                                                

13      (a) A list of laboratories that have successfully                           

14  participated in the quality recognition program together with a             

15  statement that substantially sets forth the provisions of section           

16  20505(2) <<and (3)>>.                                                       

17      (b) The types of analytical data with respect to which a                    

18  laboratory successfully participated in the quality recognition             

19  program, if the laboratory successfully participated only with              

20  respect to certain types of analytical data.                                

21      (2) Subject to subsection (3), the successful participation                 

22  of a commercial laboratory in the quality recognition program               

23  shall be recognized by the department as provided in subsection             

24  (1) and section <<20505(3)>> for a 2-year period.  A laboratory may         

25  apply under section 20507 to renew its participation in the                 

26  quality recognition program.                                                

27      (3) The department may terminate recognition of a commercial                

Senate Bill No. 1133 as amended June 9, 2004

1   laboratory as a successful participant in the quality recognition           

2   program upon determining that the commercial laboratory no longer           

3   meets the standards for successful participation in the quality             

4   recognition program.

5   Sec.  20513.  (1) The auditor general shall conduct                         

6   performance post audits covering all of the following:                      

7       (a) The quality of the analytical data generated by the                     

8   department's environmental laboratory.                                      

9       (b) The costs of operating the department's environmental                   

10  laboratory relative to the costs of operating comparable private            

11  laboratories <<that meet the requirements for successful participation in

12  the quality recognition program, to the extent sufficient data is available.>>

13      (c) The adequacy of the fees provided for in section 20507.                 

14      (2) The auditor general shall conduct and submit to the                     

15  legislature a report on a performance post audit described in               

16  subsection (1) within 1 year after the effective date of this               

17  section and every 2 years thereafter.

18  Sec. 20515.  The department shall enforce this part and,                    

19  pursuant to the administrative procedures act of 1969, 1969 PA              

20  306, MCL 24.201 to 24.328, may promulgate rules as it considers             

21  necessary to carry out its duties under this part.  However, the            

22  department shall not promulgate any additional rules under this             

23  part after December 31, 2006.

24      Enacting section 1.  This amendatory act does not take                      

25  effect unless Senate Bill No. 1135 of the 92nd Legislature is               

26  enacted into law.