EPA Proposes Rules Governing Disposal of Certain Pharmaceuticals as “Hazardous Wastes”

Physicians, dentists and other health care providers may now add the EPA to the list of government agencies regulating their activities.  On September 25, 2015, the EPA  issued proposed rules regulating the disposal of certain drugs, pharmaceutical waste material (e.g., containers, pill bottles, IV bags, etc.) and the handling of hazardous medical waste in the healthcare sector. Interested parties have until November 24, 2015, to submit comments on these rules. The proposed rules will not take effect until after the comment period ends, but the regulated community should expect them to be effective in mid-2016.

Summarizing very briefly, the proposed rules:

• prohibit disposal of any hazardous waste pharmaceutical “down the drain.” The generator of the waste—the clinic, doctor and dental offices, patient care facility, hospital doctor’s office or other related entity—is responsible for properly disposing of the waste;
• remove an exemption from disposal regulations for many long-term care facilities (e.g., assisted living, hospices, nursing homes, skilled nursing facilities, and the assisted living and skilled nursing care portions of continuing care retirement communities), which now will potentially be regulated generators of waste rather than being entirely exempt;
• attempt to make it simpler for affected offices to return unused pharmaceutical material for credit—properly returned hazardous waste pharmaceuticals would be exempt from regulation; and
• also attempt to reduce dual (DEA and EPA) regulation of certain drugs.

The new regulations cannot and do not affect DEA reporting and handling requirements for drugs and other materials regulated by that agency. They do not affect stricter state standards for disposal of medical waste, pharmaceuticals and other medicines.

For many in this sector, realization that they must comply with EPA rules may come as a surprise. The EPA estimates that approximately 174,000 healthcare facilities will be affected if the rules go into effect in their present form. Problems are exacerbated by the EPA’s classification of hazardous wastes—some drugs and compounds are specifically categorized as hazardous wastes (e.g., compounds containing warfarin), but other products become hazardous because the are “characteristic wastes;” that is, they are hazardous because they are ignitable (e.g. rubbing alcohol), corrosive (highly acidic or basic), reactive (e.g., silver nitrate), or toxic (e.g., vaccines containing Thimerosal, metal compounds or amalgams containing certain metals).

The other surprise for potentially regulated facilities may come in the form of a notice from the EPA of alleged violations of the rules once they take effect. Historically, the EPA has followed up changes to or expansions of its rules with enforcement initiatives. Facilities should not blithely assume that these rules can be ignored. The time to start preparing is now.

Does your facility generate more than 100kg of hazardous waste or 1 kg of acute classified waste per month? If so, your facility may (if these rules go into effect) be subject to requirements as to permitting, where the waste is shipped, personnel training and limits on how much can be accumulated. It is important for potentially affected facilities to become familiar with the proposed rules now and to begin self-examination concerning potential applicability of the rules to the facility. This is an area where consulting with legal and environmental professionals familiar with EPA rules and enforcement will be the proverbial “stitch in time.”

If you have questions about the issues covered in this alert, you may contact Thomas B. Alleman (talleman@dykema.com or 214-698-7830), or your relationship attorney.