| #Q001 | administrative | unknown | mandatory | Permit Incorporation for Dischargers | wastewater | The Effluent Guidelines and Standards are incorporated into NPDES permits for direct dischargersdirect dischargersA point source that discharges pollutants to waters of the United States, such as streams, lakes, or oceans., and permits or other control mechanisms for indirect dischargersindirect dischargersA facility that discharges pollutants to a publicly owned treatment works (municipal sewage treatment plant). | Applies to direct and indirect dischargers regulated under the Pesticides Chemicals Category. | low |
| #Q002 | administrative | reporting | mandatory | NPDES Permit Incorporation | wastewater | The Effluent Guidelines are incorporated into NPDES permits for direct dischargers and permits or other control mechanisms for indirect dischargers. | Applicable to direct and indirect pharmaceutical manufacturing dischargers. | high |
| #Q003 | operational | operational | mandatory | Facility Subcategory Classification | wastewater | The regulation applies to facilities organized into the following five subcategories: Fermentation Products (Subpart A), Extraction Products (Subpart B), Chemical Synthesis Products (Subpart C), Mixing/Compounding and Formulation (Subpart D), Research (Subpart E). | | high |
| #Q004 | monitoring | unknown | mandatory | Use of Approved Analytical Methods for Pharmaceuticals | wastewater | Approved Analytical Methods for Pharmaceutical Pollutants | Applicable for compliance monitoring of pharmaceutical industry specific pollutants. | high |
| #Q005 | administrative | unknown | guidance | NPDES Permit Development Guidance | wastewater | Assists permit writers and pretreatment coordinators in developing appropriate NPDES permits and pretreatment requirements for pharmaceutical facilities | Guidance document (2006) for use by regulatory authorities. | high |
| #Q006 | administrative | reporting | mandatory | Permit Incorporation for Pharmaceutical Dischargers | wastewater | The Effluent Guidelines are incorporated into NPDES permits for direct dischargers and permits or other control mechanisms for indirect dischargers. | Applies to direct and indirect dischargers regulated under the Pharmaceutical Manufacturing Category (40 CFR Part 439). | high |
| #Q007 | operational | health | mandatory | Lead Pipe Identification and Replacement | drinking water | drinking water systems across the country to identify and replace lead pipes within 10 years | Completion required within 10 years | high |
| #Q008 | monitoring | health | mandatory | Rigorous Drinking Water Testing | drinking water | The Lead and Copper Rule Improvements (LCRI) also require more rigorous testing of drinking water | | high |
| #Q009 | corrective_action | health | mandatory | Lead Exposure Action Threshold | drinking water | a lower threshold requiring communities to take action to protect people from lead exposure in water | Applicable when lead exposure threshold is met | high |
| #Q010 | administrative | reporting | mandatory | NPDES Permit Reapplication Requirement | wastewater | The authority issues the permit to the facility for a specific time period (not to exceed five years) with a requirement that the facility reapply prior to the expiration date. | Applies to facilities holding an individual NPDES permit; reapplication must occur prior to the permit's expiration date. | high |
| #Q011 | administrative | reporting | mandatory | Individual Permit Application Submission | wastewater | Once a facility submits the appropriate application(s), the permitting authority develops a permit for that particular facility based on the information contained in the permit application (e.g., type of activity, nature of discharge, receiving water quality). | Required for the development and issuance of an individual NPDES permit. | high |
| #Q012 | administrative | reporting | mandatory | Individual Permit Reapplication | wastewater | The authority issues the permit to the facility for a specific time period (not to exceed five years) with a requirement that the facility reapply prior to the expiration date. | Applicable to all facilities holding individual NPDES permits. | high |
| #Q013 | monitoring | treatment | mandatory | CWA Analytical Methods Compliance | wastewater | laboratory analytical methods and test procedures that are used to analyze the chemical, physical, and biological components of wastewater and other environmental samples that are required by the Clean Water Act (CWA). | Required for environmental samples and wastewater analysis under the Clean Water Act. | high |