Concept Sciences, Inc. (CSI), a chemical manufacturer, was in the business of producing hydroxylamine, a chemical used in the pharmaceutical and semi-conductor industries as a stripping or cleaning agent. At high levels of concentration, hydroxylamine can be unstable and explosive. On February 19, 1999, CSI experienced an explosion that resulted in the death of four employees and one non-employee. D was charged with twelve counts under 29 U.S.C. § 666 (e), which imposes criminal liability on an employer who 'willfully violates' a safety regulation promulgated pursuant to the Act if the violation results in the death of an employee. D moved to dismiss the indictments. The PSM Regulation 'contains requirements for preventing or minimizing the consequences of a catastrophic release of toxic, reactive, flammable, or explosive chemicals. P contends that D failed to: (1) perform an initial process hazard analysis appropriate to the complexity of the process and failed to identify, evaluate and control the hazards involved in the process, in violation of 29 C.F.R. § 1910.119(e)(1); (2) develop and implement written operating procedures and provide clear instructions for safely conducting activities consistent with the process safety information, in violation of 29 C.F.R. § 1910.119(f)(1)(ii)(A) and (ii)(B); and (3) train each employee before becoming involved in operating a newly assigned process, train each employee in an overview of the process and in operating procedures, and provide each employee with effective information and training on the physical and health hazards of the chemicals in the work area, in violation of 29 C.F.R. §§ 1910.119(g)(1) and 1910.1200(h)(3)(ii). Hydroxylamine in a 50% aqueous solution is the highest concentration of hydroxylamine that is commercially available. During the distillation process on February 19, 1999, the solution at issue reached a concentration of 86.5% hydroxylamine.