New EPA rules may change haz waste operations for healthcare facilities, labs

The Environmental Protection Agency (EPA) is currently considering rule changes governing how hazardous waste generators are classified that will have direct impact on healthcare facilities.


EPA recently closed the public comment period on an important new rule in a long-running process to update and modernize how the agency regulates hazardous waste and classifies hazardous waste generators.


In revising its hazardous waste generator regulations under the Resource Conservation and Recovery Act (RCRA), the EPA is aiming to help improve compliance from small, medium and large businesses across a range of industry sectors. A close review of the proposed changes, however, suggests that this reform effort may bring significant change to healthcare facilities.


In particular, another proposed rule revision under RCRA focuses specifically on hazardous waste pharmaceuticals, which directly impacts how hazardous waste management programs at doctor’s offices, hospitals and clinics, and other healthcare facilities must be managed.


With current laws established 30 years ago, the goal of the proposed rule changes is to address gaps, revise some components of the hazardous waste generator regulatory program, and improve generators’ understanding of the regulations. As in any regulatory rulemaking setting, the details are where potential pitfalls lie.


EPA likely to set in motion new rules in 2016


The two new proposed rules have the regulated community preparing for a fundamentally different reality when it comes to hazardous waste regulations. Whether the promised flexibility and clarity ultimately emerge, the effect on the healthcare industry is clear: a renewed focus on compliance.


According to the EPA, the rule-making process will be finalized sometime in 2016, after the agency reviews all submitted public comments. Rule changes would take effect at the federal level six months later, impacting hospitals, and more broadly, organizations that sell or dispense prescription or nonprescription pharmaceuticals. These could include retail pharmacies, doctors’ and dentists’ offices, health clinics, and long-term care facilities. The new rule also extends beyond these organizations to “reverse distributors” of pharmaceuticals, which typically receive unused or expired pharmaceuticals for manufacturer return for credit, or to be destroyed.


EPA drafted the proposed hazardous waste pharmaceuticals rule to reduce the burden on healthcare workers and pharmacists working in healthcare facilities by creating a specific set of regulations for hospitals, clinics and retail chains with pharmacies and reverse distributors that generate hazardous waste. EPA’s goal is to enhance drinking and surface water quality by preventing the flushing of hazardous waste pharmaceuticals by healthcare facilities. The effect should be to protect the environment while making disposal more streamlined for businesses.


The agency has cited three primary reasons for updating how healthcare facilities handle, categorize and dispose of pharmaceuticals as hazardous waste. According to the proposed rule:


  1. Healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the RCRA hazardous waste regulations, but are often involved in the implementation of the regulations.
  2. A healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed.
  3. Some active pharmaceutical ingredients are listed as acute hazardous wastes, which are regulated in small amounts.


While it’s not clear yet exactly what the new rules will require in terms of compliance and implementation, several outcomes seem likely. Healthcare facilities should prepare for more record-keeping requirements and—as pharmaceuticals, in particular, get properly disposed of instead of simply flushed—a higher volume of shipments. New management standards will emerge and players throughout the supply chain can expect additional data tracking and reporting requirements under the new rules.


On the generator side, existing hazardous waste regulations categorize many pharmaceutical manufacturers and their suppliers as “large quantity generators” (LQG) of hazardous waste. The proposed rule changes include a restructuring of such outdated generator regulations, a shift that can substantially impact the status of a generator.


Costs of non-compliance


Every facility also has its own complex combination of budgets, workflows, formularies and delivery systems, which can make it difficult to determine which of many waste regulations are applicable. Managing multiple waste streams and regulations can distract from patient care, while a mistake or oversight can result in serious regulatory consequences.


A healthcare facility can have a range of considerations for its hazardous waste management program, from the basic to the multi-faceted. Experts can deliver service offerings tailored to provide any healthcare facility with savings, efficiency, compliance and confidence. Among the typical management services available for healthcare hazardous waste:

  • Lab packing
  • Waste collection
  • Universal and e-waste disposal
  • Transportation services
  • Training and recordkeeping
  • Laboratory analysis
  • Emergency response
  • Neutralization tank cleaning
  • Departmental waste pick-up and centralization
  • Hazardous chemical and biologic management
  • Hazardous waste
  • Program management
  • Sustainability program


Preparing for the Proposed EPA Rule Changes


The new rules will directly impact healthcare facilities and other industry sectors, placing greater importance on data tracking and reporting, volume of waste, and new management standards under the EPA’s new rules. While the new rules should produce more clarity for the regulated industry, the task of properly managing hazardous waste introduces multiple potential pain points for facilities or businesses that don’t understand the changes or know how to plan the right way. It’s critical that hospitals, clinics, pharmacy chains and other businesses dealing with pharmaceuticals and medical waste assess the impact of the new EPA rule changes and what they mean for their generator status and their hazardous waste disposal strategy. With federal rule changes pending, now is the time for healthcare facilities to revisit their hazardous waste management practices.


Mike Rozembajgier is vice president at Stericycle Environmental Solutions, a leading provider of environmental and regulated waste management solutions. Rozembajgier is responsible for all aspects of the company’s environmental service offerings, including development of strategic business initiatives and product enhancements. Prior to joining Stericycle, Rozembajgier held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.