HB-5742, As Passed House, June 16, 2004                                     

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                              SUBSTITUTE FOR                                    

                                                                                

                           HOUSE BILL NO. 5742                                  

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                

                                                                                 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                


                                                                                

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                        

                                                                                

23  recognition program is mandatory for a commercial laboratory that           

                                                                                

24  seeks to perform testing associated with a state-funded project             

                                                                                

25  or program authorized under this act.  When the department lets             

                                                                                

26  contracts for state-funded laboratory work authorized under this            

                                                                                

27  act, the department shall use only those commercial laboratories            


                                                                                

1   that are successful participants in the quality recognition                 

                                                                                

2   program.  Exceptions may be made if desired analytical support              

                                                                                

3   services are not available from a commercial laboratory that is a           

                                                                                

4   successful participant in the quality recognition program.                  

                                                                                

5       (4) The quality recognition program shall determine whether                 

                                                                                

6   the quality of analytical data is maintained through quality                

                                                                                

7   systems in which staff responsibilities and operational                     

                                                                                

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

                                                                                

9   assessment by the commercial laboratory itself on a regular                 

                                                                                

10  basis, with timely corrective action taken by the commercial                

                                                                                

11  laboratory as needed.  The quality systems shall include quality            

                                                                                

12  assurance policies and quality control procedures and shall be              

                                                                                

13  documented in a written plan.                                               

                                                                                

14      Sec. 20507.  To participate in the quality recognition                      

                                                                                

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

                                                                                

16      (a) Submit an application to the department.                                

                                                                                

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

                                                                                

18  actual costs of administering the quality recognition program but           

                                                                                

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

                                                                                

20  renewal application.                                                        

                                                                                

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

                                                                                

22  laboratory records for inspections during normal business hours             

                                                                                

23  without prior notice.                                                       

                                                                                

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

                                                                                

25  proficiency testing conducted by the department, the United                 

                                                                                

26  States environmental protection agency, or any other nationally             

                                                                                

27  recognized proficiency testing program.                                     


                                                                                

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

                                                                                

2   program fund is created within the state treasury.                          

                                                                                

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

                                                                                

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

                                                                                

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

                                                                                

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

                                                                                

7   state treasurer shall credit to the fund interest and earnings              

                                                                                

8   from fund investments.                                                      

                                                                                

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

                                                                                

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

                                                                                

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

                                                                                

12  appropriation, only to administer the quality recognition                   

                                                                                

13  program.                                                                    

                                                                                

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

                                                                                

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

                                                                                

16  information:                                                                

                                                                                

17      (a) A list of laboratories that have successfully                           

                                                                                

18  participated in the quality recognition program together with a             

                                                                                

19  statement that substantially sets forth the provisions of section           

                                                                                

20  20505(2) and (3).                                                           

                                                                                

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

                                                                                

22  laboratory successfully participated in the quality recognition             

                                                                                

23  program, if the laboratory successfully participated only with              

                                                                                

24  respect to certain types of analytical data.                                

                                                                                

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

                                                                                

26  of a commercial laboratory in the quality recognition program               

                                                                                

27  shall be recognized by the department as provided in subsection             


                                                                                

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

                                                                                

2   apply under section 20507 to renew its participation in the                 

                                                                                

3   quality recognition program.                                                

                                                                                

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

                                                                                

5   laboratory as a successful participant in the quality recognition           

                                                                                

6   program upon determining that the commercial laboratory no longer           

                                                                                

7   meets the standards for successful participation in the quality             

                                                                                

8   recognition program.                                                        

                                                                                

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

                                                                                

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

                                                                                

11  306, MCL 24.201 to 24.328, may promulgate rules as it considers             

                                                                                

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

                                                                                

13  department shall not promulgate any additional rules under this             

                                                                                

14  part after December 31, 2006.                                               

                                                                                

15      Enacting section 1.  This amendatory act does not take                      

                                                                                

16  effect unless all of the following bills of the 92nd Legislature            

                                                                                

17  are enacted into law:                                                       

                                                                                

18      (a) Senate Bill No. 1135.                                                   

                                                                                

19      (b) House Bill No. 5743.