Hospital Fined $360,000 for Pharma Hazardous Waste Violations

For alleged improper disposal of pharmaceutical hazardous wastes over a three-year period, a teaching hospital in Wauwatosa, Wisconsin will pay $360,000. The enforcement action resulted from an anonymous tip received by EPA about the hospital’s waste disposal practices. EPA forwarded the complaint to the Wisconsin Department of Natural Resources (DNR).

Did you know? EPA has finalized new management standards for hazardous waste pharmaceuticals to streamline compliance for healthcare facilities and pharmaceutical distributors.

Find out what you need to know to apply these new requirements when Lion presents the Hazardous Waste Pharmaceuticals Rule Webinar live on February 12.

Inspection Uncovers Nine Hazardous Waste Violations 

During a hazardous waste inspection of the hospital, State regulators noted nine violations of hazardous waste regulations pertaining to management and disposal of pharmaceutical hazardous waste. The violations all stemmed from the general lack of a proper hazardous waste compliance program and included: 

• Failure to provide hazardous waste training for personnel
• Failure to properly dispose of hazardous waste
• Failure to make hazardous waste determinations
• Failure to keep records of hazardous waste determinations
• Failure to prepare hazardous waste manifests
• Failure to maintain records of hazardous waste manifests
• Failure to properly mark hazardous waste containers for transportation as required by US DOT
• Failure to report hazardous waste and waste minimization efforts on annual reports
• Failure to have a contingency plan for hazardous waste

Hospitals and healthcare facilities manage many types of hazardous substances, including, in this case, “acute” hazardous wastes like warfarin, arsenic, and nicotine, which are often present in pharmaceutical products. Under Federal and State hazardous waste regulations, wastes identified as hazardous must be stored, disposed of, and documented properly to prevent environmental contamination.

EPA's New Management Standards for HWP 

In December, US EPA finalized new management standards for hazardous waste pharmaceuticals, which allow health care facilities and distributors some flexibility under the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations. EPA has added specific requirements for hazardous waste pharmaceuticals, including:
  

• Training for certain employees who handle and accumulate these wastes
• Hazardous waste determinations
• New, unique accumulation rules and time limits
• Specific labeling requirements for certain hazardous waste pharmaceutical containers  
• Reporting, recordkeeping, and release response standards
• Land disposal restrictions (LDR) for certain hazardous waste pharmaceuticals
• Manifests for certain off-site shipments

Join Lion next month for a live Hazardous Waste Pharmaceuticals Rule Webinar to develop expertise with the new rules and keep your facility in compliance. The new requirements will impact healthcare facilities, pharmaceutical distributors/reverse distributors, and others who manage waste pharmaceuticals or contaminated empty containers.

What RCRA Training Is Required?

The hospital facing this RCRA fine is a large quantity generator of hazardous waste, or “LQG.” US EPA requires large quantity generators to provide hazardous waste training for personnel on an annual basis. Personnel with responsibilities for hazardous waste compliance must be trained within 60 days of hire or assignment. 

Questions about who needs hazardous waste training and what’s required? Our RCRA Training FAQ is packed with answers to the most common hazardous waste training questions. 

Get RCRA Trained—When You Want, Where You Want

US EPA requires hazardous waste professionals to complete annual training on the RCRA requirements. Lion makes it easy to meet your RCRA training mandate in a variety of formats—nationwide public workshops, convenient online courses, live webinars, and on-site training.

Browse RCRA training options here to find the course that fits your needs, your schedule, and your learning style.

 

Tags: fines and penalties, hazardous waste management, new rules, pharmaceuticals