United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1998_register executive 2010-09-24 article Part III Rules and Regulations D09002ee1bdff0838 D09002ee1bdff08f7 United States Environmental Protection Agency originator org United States Government Agency or Subagency This final regulation limits the discharge of pollutants into navigable waters of the United States and into publicly owned treatment works (POTWs) by existing and new pharmaceutical manufacturing facilities. This regulation revises limitations and standards for four subcategories of the pharmaceutical manufacturing Point Source Category: Subcategory A (Fermentation), Subcategory B (Extraction), Subcategory C (Chemical Synthesis): and Subcategory D (Mixing, Compounding, and Formulating); and reformats and clarifies language without revision to certain specified provisions of these four subcategories and a fifth subcategory: Subcategory E (Research). This regulation establishes effluent limitations guidelines and standards under the Clean Water Act including ``best conventional pollutant control technology (BCT) and ``best available technology economically achievable (BAT)'' for existing direct dischargers, ``new source performance standards (NSPS)'' for new direct dischargers and pretreatment standards for existing and new indirect dischargers (PSES and PSNS). This regulation also amends and clarifies some of the limitations based on ``best practicable control technology (BPT)'' for pharmaceutical manufacturing facilities and establishes analytical methods for certain organic pollutants contained in this regulation. EPA is today also publishing final Maximum Available Control Technology (MACT) standards under the Clean Air Act (CAA) for the pharmaceutical manufacturing industry elsewhere in today's Federal Register. The MACT standards final rule will control emissions of hazardous air pollutants (HAPs) from pharmaceutical manufacturing emission sources including wastewater collection and treatment systems. The Offices of Water and Air and Radiation have coordinated the development of these regulations and have used a common technology basis in developing limitations and standards for the volatile organic compounds (VOCs). The final MACT standards and effluent limitations guidelines and standards rules will benefit the environment by removing a total of 85.4 million pounds per year of conventional, nonconventional and toxic (priority) pollutants from water discharges. The effluent limitations guidelines and standards portion of those removals is 13.9 million pounds per year of nonconventional and 16.0 million pounds per year of organic pollutants including VOCs. 63 FR 50388 https://www.govinfo.gov/app/details/FR-1998-09-21/98-21027 98-21027 fr21se98-23 RIN 2040-AA13 6560-50-P FRL-6135-7 https://www.govinfo.gov/app/details/FR-1998-09-21/98-21027 https://www.govinfo.gov/content/pkg/FR-1998-09-21/html/98-21027.htm https://www.govinfo.gov/content/pkg/FR-1998-09-21/pdf/98-21027.pdf 50 p. 50388 50437 63 FR 50388 Title 40 Part 136 40 CFR Part 136 Title 40 Part 439 40 CFR Part 439 RIN 2040-AA13 Pharmaceutical Manufacturing Category Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards; Final Rule; Federal Register Vol. 63, Issue RULE 98-21027 III ENVIRONMENTAL PROTECTION AGENCY 1998-11-20 FRL-6135-7 6560-50-P 98-21027 Final rule.

This final regulation limits the discharge of pollutants into navigable waters of the United States and into publicly owned treatment works (POTWs) by existing and new pharmaceutical manufacturing facilities. This regulation revises limitations and standards for four subcategories of the pharmaceutical manufacturing Point Source Category: Subcategory A (Fermentation), Subcategory B (Extraction), Subcategory C (Chemical Synthesis): and Subcategory D (Mixing, Compounding, and Formulating); and reformats and clarifies language without revision to certain specified provisions of these four subcategories and a fifth subcategory: Subcategory E (Research). This regulation establishes effluent limitations guidelines and standards under the Clean Water Act including ``best conventional pollutant control technology (BCT) and ``best available technology economically achievable (BAT)'' for existing direct dischargers, ``new source performance standards (NSPS)'' for new direct dischargers and pretreatment standards for existing and new indirect dischargers (PSES and PSNS). This regulation also amends and clarifies some of the limitations based on ``best practicable control technology (BPT)'' for pharmaceutical manufacturing facilities and establishes analytical methods for certain organic pollutants contained in this regulation. EPA is today also publishing final Maximum Available Control Technology (MACT) standards under the Clean Air Act (CAA) for the pharmaceutical manufacturing industry elsewhere in today's Federal Register. The MACT standards final rule will control emissions of hazardous air pollutants (HAPs) from pharmaceutical manufacturing emission sources including wastewater collection and treatment systems. The Offices of Water and Air and Radiation have coordinated the development of these regulations and have used a common technology basis in developing limitations and standards for the volatile organic compounds (VOCs). The final MACT standards and effluent limitations guidelines and standards rules will benefit the environment by removing a total of 85.4 million pounds per year of conventional, nonconventional and toxic (priority) pollutants from water discharges. The effluent limitations guidelines and standards portion of those removals is 13.9 million pounds per year of nonconventional and 16.0 million pounds per year of organic pollutants including VOCs.

This regulation shall become effective November 20, 1998. The incorportion by reference of certain publications listed in Part 136 is approved by the Director of the Federal Register as of November 20, 1998. For additional technical information call Dr. Frank H. Hund at (202) 260-7182. For additional information on the economic impact analyses contact Mr. William Anderson at (202) 260- 5131. SUPPLEMENTARY INFORMATION: Vol. 63, no. 182 Office of the Federal Register, National Archives and Records Administration 1998-09-21 continuing daily deposited born digital 346 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1998-09-21 P0b002ee180a6965a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21se98 https://www.govinfo.gov/app/details/FR-1998-09-21 https://www.govinfo.gov/content/pkg/FR-1998-09-21/pdf/FR-1998-09-21.pdf fdlp 50127 50460 DGPO 2010-09-24 2023-05-06 FR-1998-09-21 machine generated eng FR FR-1998-09-21 63 182