Retailers: Navigating New EPA Hazardous Waste Pharmaceuticals Rule

The U.S. Environmental Protection Agency (EPA) recently published its highly anticipated final rule on the Management Standards for Hazardous Waste Pharmaceuticals.

These new regulations require retailers with pharmacies to examine – and likely restructure – their hazardous waste management practices. Additionally, the rule also has implications for retailers without pharmaceuticals, as it addresses the reverse logistics of all retail products. Failure to comply with any part of the standards can result in costly fines and brand damage.

While the new legislation was detailed in hundreds of pages, here is a summary, along with highlights on what retailers need to know to stay compliant. Click here to view the full presentation.

Key Provisions

• Eliminates “sewering” of hazardous waste pharmaceuticals.Effective immediately, this ban prohibits health care facilities from sewering any hazardous waste pharmaceuticals.
• Provides regulatory clarity on how pharmaceuticals must be managed. These new regulations eliminate the dual regulation of RCRA hazardous waste pharmaceuticals that are also DEA controlled substances.
• Offers regulatory relief to health care facilities for management of hazardous waste pharmaceuticals. The rule outlines that hazardous waste pharmaceuticals do not count toward generator status, eases labeling and manifesting and clarifies what wastes should be shipped to reverse distributors.
• Amends the listing of nicotine patches, gums and lozenges.These items no longer have to be managed as hazardous waste. However, e-cigarettes and similar products are still considered hazardous but do not count towards generator status.
• Adoption will vary. Authorized states have until July 1, 2021 to adopt the rule, while states that require statutory amendment have until July 1, 2022.

Beyond Pharmaceuticals

The new rule also has relevance to retailers without pharmaceuticals. The EPA reaffirmed that unsold retail products managed through reverse logistics centers are not solid hazardous waste if managed through reverse logistics and have a reasonable expectation of being used, reused or reclaimed.

The agency allows some flexibility related to “reasonable expectation” but points to six key considerations:

1. “Reasonable expectation:” Ultimate disposition of the item could be made at the manufacturer, distributor or reverse logistics location.
2. Expiration date: Expired items are not automatically a waste.
3. Direction to destroy: Do business rules allow for redistribution, donation or reuse?
4. Decision to discard: Is there a manufacturer’s credit?
5. Recall exemption: Items involved in approved recalls are exempt.
6. Damaged retail items: What is damaged? Leaking, broken or damaged items not allowed to be sent to reverse logistics.

Next Steps

Though these are final regulations, the current rules remain in effect until the effective date in the federal register and states adopt them. It is recommended that retailers review the regulations and begin planning for the changes to take effect.

For more information, please click here to view the full presentation. For questions, submit a request here.