{"abstract":"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.","action":"Final rule.","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1998/09/21/98-21027.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"136","title":40},{"chapter":null,"citation_url":null,"part":"439","title":40}],"citation":"63 FR 50388","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"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.","disposition_notes":null,"docket_ids":["FRL-6135-7"],"dockets":[],"document_number":"98-21027","effective_on":"1998-11-20","end_page":50437,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1998/09/21/98-21027/pharmaceutical-manufacturing-category-effluent-limitations-guidelines-pretreatment-standards-and-new","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/98-21027?publication_date=1998-09-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1998-09-21/98-21027/mods.xml","not_received_for_publication":null,"page_length":50,"page_views":{"count":989,"last_updated":"2026-07-26 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1998-09-21/pdf/98-21027.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1998-09-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1998/09/21/98-21027.txt","regulation_id_number_info":{"2040-AA13":{"issue":"199804","html_url":"https://www.federalregister.gov/regulations/2040-AA13/effluent-guidelines-and-standards-for-the-pharmaceutical-manufacturing-category","title":"Effluent Guidelines and Standards for the Pharmaceutical Manufacturing Category","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=199804&RIN=2040-AA13&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["2040-AA13"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T10:14:05Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":50388,"subtype":null,"title":"Pharmaceutical Manufacturing Category Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards; Final Rule","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":63}