[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR160.29]



[Page 145-146]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                  Subpart B_Organization and Personnel

 

Sec. 160.29  Personnel.





    (a) Each individual engaged in the conduct of or responsible for the 

supervision of a study shall have education, training, and experience, 

or combination thereof, to enable that individual to perform the 

assigned functions.

    (b) Each testing facility shall maintain a current summary of 

training and experience and job description for each individual engaged 

in or supervising the conduct of a study.

    (c) There shall be a sufficient number of personnel for the timely 

and proper conduct of the study according to the protocol.

    (d) Personnel shall take necessary personal sanitation and health 

precautions designed to avoid contamination of test, control, and 

reference substances and test systems.

    (e) Personnel engaged in a study shall wear clothing appropriate for 

the duties they perform. Such clothing shall be changed as often as 

necessary



[[Page 146]]



to prevent microbiological, radiological, or chemical contamination of 

test systems and test, control, and reference substances.

    (f) Any individual found at any time to have an illness that may 

adversely affect the quality and integrity of the study shall be 

excluded from direct contact with test systems, and test, control, and 

reference substances, and any other operation or function that may 

adversely affect the study until the condition is corrected. All 

personnel shall be instructed to report to their immediate supervisors 

any health or medical conditions that may reasonably be considered to 

have an adverse effect on a study.