The Basis and Purpose Document provides background information on, and the rationale for, decisions made by the U. S. Environmental Protection Agency (EPA) related to the proposed standards for the reduction of hazardous air pollutants (HAP) emitted through the manufacture of pharmaceutical products covered by the source category. The source category includes processes used in chemical synthesis, formulation, fermentation, and extraction manufacturing operations. This document is intended to supplement the preamble for the proposed standards.

• Basis and Purpose Document for the proposed NESHAP for Pharmaceuticals Production (PDF)(110 pp, 221 K, January 1997)