EPA’s September 25, 2015, proposal covering hazardous waste pharmaceuticals applies to the management of those materials at heathcare facilities and reverse distributors; the proposal does not cover hazardous waste pharmaceuticals from households.  As it does with other types of hazardous waste, the EPA exempts pharmaceutical hazardous waste in private residences from the federal Resource Conservation and Recovery Act (RCRA) regulations.  (Those exemptions may not apply in individual states, which are entitled to issue and enforce hazardous waste regulations that are more stringent than the federal baseline rules.)  In a memo issued just after the proposal was published, EPA’s Office of Solid Waste and Emergency Response (OSWER) discussed the relationship between the RCRA exemption for household pharmaceutical hazardous waste and the pharmaceutical take-back program implemented by the U.S. Drug Enforcement Administration (DEA).

New collection points

In September 2014, the DEA issued regulations to implement the Secure and Responsible Drug Disposal Act of 2010.  The regulations significantly expanded the options available to collect pharmaceutical controlled substances for the purposes of safe disposal.  Before this DEA regulation, members of the public could not deliver their controlled substances to any person for the purpose of disposal other than “by surrender to law enforcement” (e.g., a collection program run by state, local, or tribal law enforcement or the DEA).

This restrictive approach to disposal limited the availability and effectiveness of collection programs, noted OSWER, and at the same time, it was discovered that the abuse of household pharmaceuticals though diversion was increasing.  Under the new regulation, a DEA-authorized collector can conduct programs to collect old, expired, or unwanted pharmaceutical controlled substances from households.  For example, a local retail pharmacy may install a collection receptacle on its premises for household pharmaceutical wastes if it becomes a DEA-authorized collector.

Exemption applies

In the memo, OSWER clarifies that the RCRA exemption applies to DEA-authorized collection facilities.

OSWER states: “In light of the new DEA rule, the EPA would like to reiterate that pharmaceuticals from a home, to the extent they would otherwise be hazardous wastes, are excluded from RCRA hazardous waste regulation as household waste (§ 261.4(b )( l )). This exclusion applies even when household hazardous wastes are collected outside the home such as the current pharmaceuticals collected at DEA authorized collection receptacles. Non-household pharmaceutical hazardous waste continues to be regulated.”

Incineration recommended

Furthermore, OSWER memo draws attention to its 2012 recommendation that collected household waste pharmaceuticals be incinerated, preferably at a permitted hazardous waste incinerator, but when that is not feasible, at a municipal waste combustor. 

“The Agency believes that this practice is already common among collection programs since one goal of many collection programs is to divert household pharmaceuticals from municipal landfills,” says OSWER.

OSWER’s October 2, 2015, memo on DEA-authorized collectors is here.