Economic Analysis of Final Effluent Limitations Guidelines and Standards for the211 Pharmaceutical Manufacturing Industry

摘要

This economic analysis (EA) examines compliance costs and economic impacts211u001eresulting from the U.S. Environmental Protection Agency's (EPA's) Final Effluent 211u001eLimitations Guidelines and Standards for the Pharmaceutical Manufacturing 211u001eIndustry Point Source Category. It also investigates the costs and impacts 211u001eassociated with an air rule requiring Maximum Achievable Control Technology 211u001e(MACT) to control air emissions, both separately and together with the Final 211u001ePharmaceutical Industry Effluent Guidelines. The EA estimates the economic 211u001eeffects of compliance with both final rules in terms of total aggregate 211u001eannualized costs of compliance, facility closures, impacts on firms (likelihood 211u001eof bankruptcy and effects on profit margins), and impacts on new sources. The EA 211u001ealso investigates secondary impacts on employment and communities, foreign trade, 211u001especific demographic groups, and environmental justice. This report includes a 211u001eFinal Regulatory Flexibility Analysis (FRFA) detailing the impacts on small 211u001ebusinesses within the pharmaceutical industry to meet the requirements of the 211u001eRegulatory Flexibility Act (RFA), as amended by the Small Business Regulatory 211u001eEnforcement Fairness Act (SBREFA). Finally, the EA presents a cost-benefit 211u001eanalysis to meet the requirements of Executive Order 12866 and the Unfunded 211u001eMandates Reform Act.