Many brands have implemented hazardous waste management programs in select states and regions. The proposed regulatory changes reflect increased awareness of the impact of pharmaceutical waste on public safety and the environment.
Mike Rozembajgier
Two new rules under the Resource Conservation and Recovery Act (RCRA) proposed September 25 by the Environmental Protection Agency鈥攄esigned to provide greater flexibility and streamline requirements鈥攈ave 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 pharmaceutical and retail pharmacy industries is certainly clear: a renewed focus on compliance.
One rule aims to modify the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals, while the other proposes a much-needed update to the hazardous waste generator regulations. While these new regulations, taken together, do represent an attempt to streamline the overall enforcement approach, hazardous waste compliance remains a highly complex undertaking that companies should prioritize to ensure they don鈥檛 incur costly expenses.
While we don鈥檛 yet know exactly what the new rules will require in terms of compliance and implementation, several outcomes seem likely. Waste haulers should prepare for more record-keeping requirements and 鈥� 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.
Management Standards for Hazardous Waste Pharmaceuticals
The is intended 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 stores with pharmacies and reverse distributors that generate hazardous waste. EPA鈥檚 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.
Hazardous Waste Generator Improvements
The proposes a much-needed update to the hazardous waste generator regulations to make the rules easier to understand, facilitate better compliance, provide greater flexibility in how hazardous waste is managed and close important gaps in the regulations. Two key provisions:
- Allowing a hazardous waste generator to avoid increased burden of a higher generator status when generating episodic waste, provided the episodic waste is properly managed; and
- Allowing a conditionally exempt small quantity generator (CESQG) to send its hazardous waste to a large quantity generator under control of听the same person.
Why Now for New Hazardous Waste Rules?
In short, simplification is long overdue. As healthcare facilities, retail pharmacies, and the pharmaceutical and retail industries can attest, RCRA rules governing hazardous waste disposal have always been complex and difficult to understand.
The rules date back 35 years, and were originally designed to govern hazardous waste disposal in manufacturing. Decades later, applying this governance to retail, pharmaceutical and healthcare industries can be problematic. In that time, medicine, technology and businesses processes have modernized and advanced, and the EPA is introducing the changes to reflect the modern era after working with state agencies and private sector on recommended best practices.
The agency is proposing more than 60 changes within both rules to improve the effectiveness of and compliance with the hazardous waste generator program. Among the items that may be considered pharmaceutical hazardous waste is expired prescription drugs, waste materials containing excess product and any unused drugs (including OTC) intended for discard.
On the generator side, existing hazardous waste regulations categorize many pharmaceutical manufacturers and their suppliers as 鈥渓arge quantity generators鈥� (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.
The proposed generator rule changes include replacing the phrase “conditionally exempt small quantity generator” (CESQG) with “very small quantity generator” (VSQG). This update will ensure consistency with the other two generator categories: large quantity generators (LQGs) and small quantity generators (SQG). The EPA is also proposing to allow CESQGs to send hazardous waste to an LQG that is under the control of the same person.
The pharmaceutical industry has long wrestled with the issue of generator status and the state-by-state vagaries of hazardous waste regulation and enforcement activity. Pharmaceutical manufacturers and retail pharmacy chains have traditionally focused compliance efforts on states with rigorous enforcement programs and resources. With federal rule changes pending, now is the time for these industry enterprises to adopt a nationwide hazardous waste management perspective.
Calculating the Cost of Non-Compliance
Major retail brands and household pharmaceutical names understand the myriad of business and environmental issues鈥攊ncluding fines鈥攔elating to improper disposal of hazardous waste by generators. Indeed, civil fines for RCRA hazardous waste violations can range anywhere from $37,500 per day to amounts in the seven figures.
When considered along with potential for state-issued fines, pharmaceutical companies, retail pharmacies and retailers risk even greater penalties for routine violations such as mislabeled, misidentified or improperly stored hazardous waste. The financial and legal implications of non-compliance are significant, but negative publicity attached to federal or state violations against a brand or drug maker can be disabling.
Navigating the Proposed EPA Rules
The new rules will directly impact haulers, facilities and others throughout the hazardous waste industry. More data tracking and reporting, more volume, and new management standards are all likely results of these the EPA鈥檚 new rules. And while there should be more clarity for the regulated industry, the task of properly managing presents multiple potential pain points for companies that don鈥檛 understand the changes and plan the right way. It鈥檚 critical that drug manufacturers, healthcare facilities, pharmacy chains and retailers selling pharmaceuticals assess the impact of the new EPA rule changes and what they mean for their generator status and their hazardous waste disposal strategy.
Even with the changes, the complexities of hazardous waste compliance will remain. Although many brands have implemented hazardous waste management programs in select states and regions, these proposed regulatory changes reflect increased awareness of the impact of pharmaceutical waste on public safety and the environment.听 Most of these businesses are viewing compliance as both a fundamental and nationwide issue, and are engaging with industry experts in hazardous waste disposal to create comprehensive, customized management solutions that address the changing landscape.
Mike Rozembajgier is vice president at Stericycle Environmental Solutions, a leading provider of environmental and regulated waste management solutions.听Rozembajgier is responsible for strategic business initiatives and product enhancements within all aspects of the company鈥檚 environmental service offerings. Prior to joining Stericycle, Rozembajgier held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in their Strategic Consulting practice. Mike can be reached via e-mail at [email protected].
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