New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products Guidance for Industry.

摘要

The purpose of this guidance document is to assist facilities in SIC code 5169 (chemical and allied products wholesale) to comply with the reporting requirements of Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and of Section 6607 of the Pollution Prevention Act of 1990 (PPA), commonly referred to as the Toxic Release Inventory (TRI). On May 1, 1997, EPA promulgated a rule (62 FR 23834) to require chemical distribution facilities, along with other industry groups, to be included on the list of facilities subject to the EPCRA Section 313 reporting requirements. The new facilities are subject to annual reporting requirements beginning with activities occurring in the 1998 calendar year, with the first reports due by July 1, 1999. This document explains the EPCRA Section 313 and PPA Section 6607 reporting requirements (collectively referred as the EPCRA Section 313 reporting requirements) and discusses specific release and other waste management activities encountered at many facilities in these industries. Because each facility is unique, the recommendations presented may have to be adjusted to the specific nature of operations at your facility.