WHAT IS THE POINT OF THE EM PROGRAM? In trying to determine the appropriate parameters of a complex program such as environmental moni- toring, we first have to agree upon the scope and purpose of the program. The purpose of the EM program is to document the state of control of the faCility, not to determine the quality ofthe finished product. The US Food and Drug Administration gUidance document (2) is very clear on this point in section X.A.I and states: