National Emission Standards for Pharmaceuticals Production

The EPA is taking direct final action to amend the national emission standards for hazardous air pollutants (NESHAP) for pharmaceuticals production. This direct final rule provides additional compliance options for process vent and storage tank emissions, specifies additional methods that may be used to analyze wastewater, shifts one compound from the list of partially soluble hazardous air pollutants (HAP) to the list of soluble HAP, eliminates an unintended restriction on the use of enhanced biological treatment, allows a sewer line between drains and the first downstream junction box to be vented, clarifies how to assign storage tanks that are shared among pharmaceutical manufacturing process units and other types of process units, clarifies the monitoring frequency requirements for connectors, clarifies and simplifies recordkeeping and reporting requirements, eliminates inconsistencies, and corrects several referencing and typesetting errors. We view these revisions to be minor and noncontroversial, and we anticipate no adverse comment. In compliance with the Paperwork Reduction Act (PRA), this action also amends the table that lists the Office of Management and Budget (OMB) control numbers issued under the PRA for the pharmaceuticals production rule.