Northeast Waste Management Officials’ Association 

Terri L. Goldberg 

Executive Director 

129 Portland Street 

6th Floor 

Boston, MA 02114 

Tel 617-367-8558 

Fax 617-367-0449 

www.newmoa.org 

February 21, 2012 

Suzanne Rudzinski, Director 

Office of Resource Conservation and Recovery 

USEPA Headquarters 

Ariel Rios Building 

1200 Pennsylvania Avenue, N. W. 

Mail Code: 5301P 

Washington, DC 20460 

Dear Ms. Rudzinski: 

On July 25, 2011, the Northeast Waste Management Officials' Association (NEWMOA) 

sponsored a conference call to discuss RCRA pharmaceutical waste management. During 

that call, representatives from EPA's Office of Resource Conservation and Recovery reported 

that EPA is no longer supporting the December 2008 proposal to add pharmaceutical wastes 

currently regulated under RCRA Subtitle C to the universal waste rule (Federal Register, Vol. 

73, No. 232, Tuesday, December 2, 2008). Instead EPA is now considering several new 

options for RCRA pharmaceutical waste, including a “sector-based” approach (similar to the 

academic labs rule). EPA expressed an interest in receiving feedback on this issue. The 

Connecticut, Massachusetts, New Jersey, New York, Rhode Island, and Vermont 

environmental agencies (the participating NEWMOA members) offer the following 

comments and suggestions on this topic. The agencies from Maine and New Hampshire 

intend to comment on EPA’s regulatory proposals when they become available. 

NEWMOA commends EPA for seeking a new approach to regulation of pharmaceutical 

wastes. However, following that conference call, staff from several NEWMOA states 

expressed concern that EPA was “missing the forest for the trees” with respect to the 

regulation of pharmaceutical waste. Increasing amounts of pharmaceuticals are being 

prescribed, dispensed, or purchased over the counter, resulting in a growing amount of 

unused, expired, and /or waste pharmaceuticals requiring proper disposal. Meanwhile, in 

recent years, pharmaceutical compounds have been detected in drinking water supplies and in 

landfill leachate. The participating NEWMOA members believe that these issues cannot be 

adequately addressed through a rule that applies only to the handful of pharmaceutical wastes 

that are currently RCRA-regulated (according to a 2010 EPA presentation, existing RCRA 

regulations apply to approximately 5-10 percent of all pharmaceuticals). 

We believe that a lengthy rulemaking effort focused on regulating pharmaceutical wastes 

under RCRA Subtitle C only addresses the “tip of the iceberg” and would do little to enhance 

environmental protection. As such, EPA’s rulemaking deliberations need to take into account 

that a significant part of the pharmaceuticals in the environment problem is due to “nonRCRA” factors such as: 

• the disposal of countless non-RCRA regulated pharmaceuticals in landfills, which 

may adversely impact the environment; 

• the substantial quantity of hazardous pharmaceuticals subject to EPA’s household 
2 

hazardous waste exclusion; and 

• the vast quantity of pharmaceuticals disposed into sewer and septic systems. 

In addition, there are numerous examples of pharmaceutical products/materials that, under the 

current regulatory framework, generate extensive interpretive questions for state and federal 

officials. Waste nicotine gum, nicotine patches, and “empty” Coumadin bottles are just a few 

of the materials that are subject to regulation as acutely hazardous waste. 

Given these factors, competing federal jurisdictions (e.g., DEA and FDA), state and federal 

resource constraints, and the likelihood that the volume and complexity of the overall 

pharmaceutical waste stream will continue to increase as our population ages and new 

compounds are developed, the participating NEWMOA members believe that EPA should 

consider an entirely different and streamlined approach to managing most pharmaceutical 

wastes. We suggest that EPA look at the problem holistically, leverage the resources of all of 

the relevant federal agencies and, in concert with those agencies develop comprehensive 

pharmaceutical waste management standards that are in line with the risks associated with 

pharmaceutical wastes and take resulting costs into account. 

While the participating NEWMOA members recognize that certain pharmaceutical wastes 

should be fully regulated under RCRA Subtitle C (e.g., highly toxic pharmaceuticals, wastes 

resulting from pharmaceutical manufacturing), we urge EPA and the other relevant federal 

agencies to develop a direct and uncomplicated approach to ensuring proper management of 

the remaining pharmaceutical wastes that individually do not warrant full regulation under 

RCRA. Collectively, however, these mostly unregulated materials may have a greater 

potential for significant environmental impact than those currently regulated under RCRA. 

To this end, we strongly suggest that EPA consider managing these waste pharmaceuticals 

through some kind of extended producer responsibility (EPR) system. 

We support the DEA take back programs for residentially-generated pharmaceutical wastes 

and the use of reverse distribution facilities to collect, handle, and ultimately dispose of the 

wastes generated by pharmacies, hospitals, and other healthcare facilities. As such, we 

suggest that this existing reverse distribution system be utilized as an integral part of the 

infrastructure for implementing an EPR program. In addition, pharmaceutical waste handling 

and disposal protocols should be developed for residential care facilities, such as assisted 

living centers and nursing homes. 

In conclusion, the portion of the pharmaceutical waste stream that is currently regulated under 

RCRA Subtitle C is very small compared to the overall universe of waste pharmaceuticals. 

Given that both state and federal hazardous waste programs are facing significant resource 

constraints, we believe that we must keep state RCRA programs focused on the most critical 

hazardous waste management issues. We recommend that EPA’s approach should be to reexamine and clarify which waste pharmaceuticals should be subject to full RCRA regulation 

and then with other federal agencies develop a holistic approach to the safe management of 

the remaining majority of waste pharmaceuticals outside of the RCRA regulatory system. We 

believe that federal establishment of streamlined but concise standards for the management of 

all pharmaceutical wastes would improve environmental protection and public safety. 
We appreciate your consideration of the concerns and suggestions outlined in this letter. 

Please contact Terri Goldberg, NEWMOA at tgoldberg@newmoa.org or (617) 367-8558 

x302 to discuss the issues described above and identify some next steps. We look forward to 

working with you on this important effort. 

Sincerely, 

Peter Pettit, P.E. 

NEWMOA Vice Chair 

CC: Charlotte Mooney, EPA 

 Lisa Lauer, EPA 

 Beth Deabay, EPA Region 1 

 Andy Bellina, EPA Region 2 

 Dania Rodriguez, ASTSWMO 

 

3