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ASTSWMO POSITION PAPER

A NEW REGULATORY APPROACH TO

PHARMACEUTICAL WASTE MANAGEMENT

INTRODUCTION

Many studies have demonstrated that pharmaceutical compounds are making their way into 

the environment. Although little can be done to prevent some pharmaceuticals from reaching 

environmental receptors, the destiny of waste pharmaceuticals can be controlled. The 

Association of State and Territorial Solid Waste Management Officials (ASTSWMO) understands 

that the U.S. Environmental Protection Agency (EPA) Office of Resource Conservation and 

Recovery is developing new regulations for management of pharmaceutical wastes to replace 

the December 2008 proposal that would have allowed those pharmaceutical wastes already 

regulated as hazardous waste under Subtitle C of the Resource Conservation and Recovery Act 

(RCRA) to be managed as universal wastes. ASTSWMO also understands that while EPA’s 

forthcoming proposal will be designed to offer flexibility to health care facilities that manage 

pharmaceutical wastes; it too will only apply to those pharmaceuticals currently regulated as a 

hazardous waste under RCRA. This Position Paper outlines a more holistic management 

approach that could apply to all post-manufacturing pharmaceutical wastes, not only those 

regulated as a hazardous waste.1In developing this Paper, several articles and publications 

were reviewed. A complete bibliography of those reviewed is included.

BACKGROUND

Significantly, concerns about the detrimental effects of pharmaceuticals in the environment 

were identified at least as far back as the late 1970s—nearly 35 years ago. Many recent studies 

have shown that a wide variety of pharmaceuticals are reaching environmental receptors (e.g. 

ground water, surface water, and tissues of aquatic life) through pathways such as discharges 

from wastewater treatment plants, which are not designed to remove pharmaceutical 

compounds during the treatment process, or discharges from animal feeding operations. Other 

studies have shown that pharmaceuticals are present in significant concentrations in landfill 

leachate, which is frequently treated using wastewater treatment technologies that do not 

remove pharmaceutical compounds. Finally, there is some evidence, though apparently not as 

 

1 ASTSWMO recognizes that the approach outlined in this Paper may not be feasible for all generators of 

pharmaceutical wastes, and it may be more cost-effective for them to dispose of non-hazardous pharmaceuticals 

through another EPA/State-approved method while still handling the RCRA hazardous pharmaceutical wastes in 

accordance with current regulations.

 444 North Capitol Street, N.W., Suite 315 

Washington, DC 20001

tel: (202) 624-5828 fax: (202) 624-7875

 www.astswmo.org 

 
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thoroughly studied, of pharmaceuticals making their way into surface or ground waters from 

septic systems. It seems clear to ASTSWMO that the current RCRA regulatory framework for 

managing pharmaceutical wastes, as well as EPA’s planned approach, is inadequate to meet 

RCRA’s stated goal of protection of human health and the environment. We believe this is, in 

large part, due to three reasons:

 identification of new hazardous waste pharmaceuticals under RCRA Subtitle C is 

cumbersome;

 waste management requirements under RCRA Subtitle C were not designed for the 

scenarios in which pharmaceutical wastes are most often generated; and

 multiple agencies have regulatory control over various pharmaceutical wastes. 

ASTSWMO believes a new approach to pharmaceutical waste management addressing each of 

these issued is needed. 

Identification of New Hazardous Waste Pharmaceuticals is Cumbersome

When RCRA Subtitle C regulations first became effective in 1980, EPA identified approximately 

31 pharmaceutical compounds in its P- and U-lists of hazardous wastes, while others became 

subject to regulation because they exhibited a hazardous characteristic.2Since that time, many 

new pharmaceuticals have been approved by the Food and Drug Administration (FDA)3 while 

use of those that were originally listed has decreased. By EPA estimates, only 5-10% of the 

pharmaceuticals currently being dispensed are regulated as hazardous waste. This means, 90-

95% of the pharmaceuticals in use today are not regulated for the purpose of environmental 

protection, and ASTSWMO believes this will remain unchanged in EPA’s newest proposal. 

Under current RCRA Subtitle C regulations, to add a new pharmaceutical waste to either the Por U-list of hazardous wastes, EPA must first perform an extensive evaluation of the material 

pursuant to 40 CFR 261.114prior to initiating the rulemaking process; a costly, time-consuming, 

and often unpredictable process. ASTSWMO believes this compound-by-compound approach 

will never allow EPA to catch up and keep up with the vast number of pharmaceuticals in use 

today and will be developed in the future. This may be part of the reason EPA has not listed any 

new pharmaceuticals since 1980. While EPA has not amended its lists of hazardous wastes to 

include new pharmaceuticals, other federal agencies (namely, the Occupational Safety and 

Health Administration [OSHA] and the National Institute for Occupational Safety and Health 

[NIOSH]) have identified many pharmaceuticals they consider “hazardous” and have made 

subject to special handling requirements. Some of these even meet the current EPA criteria for 

 

2 For example, warfarin, arsenic trioxide, cyclophosphamide, hexachlorophene and many others are listed while

those using m-cresol as a preservative or those with high alcohol content may be characteristic.

3 Since 1996, the FDA has approved an average of 30 new drugs per year. This equates to over 500 new drugs 

since 1996 and, assuming this average was approximately the same since 1980, 900 new drugs since RCRA was 

implemented.

4 This includes determining whether or not the material exhibits a hazardous characteristic or is toxic, 

carcinogenic, mutagenic, or teratogenic.
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being listed as acutely hazardous.5Clearly, a single management standard applicable to all 

post-manufacturing pharmaceutical wastes would alleviate this issue.

RCRA Subtitle C is not Designed for Pharmaceutical Waste Scenarios

ASTSWMO believes the RCRA Subtitle C regulations are a poor fit for the circumstances under 

which pharmaceutical wastes are often generated. The hazardous waste regulations were 

primarily designed for managing relatively large volumes of wastes generated in industrial 

settings and accumulated in tanks or 55-gallon drums. Pharmaceutical wastes are typically 

generated in relatively small volumes at multiple locations in one facility. Moreover, 

pharmaceutical wastes are often handled by personnel, such as nursing staff, who do not have 

the experience or training necessary to easily differentiate between the small number of 

pharmaceuticals that must be managed as hazardous waste under RCRA and the much greater 

number that do not. To further complicate matters, EPA has written a myriad of 

pharmaceutical waste policy documents that must be considered. A simplified regulatory 

approach could ensure pharmaceutical wastes are properly managed in both “low volume” 

settings such as physician offices that deal with a few dozen pharmaceuticals (e.g. injection vials 

or expired drug samples) and “high volume” settings such as hospitals, retail pharmacies, and 

prisons that must manage hundreds of different pharmaceuticals. 

Cross-Agency Jurisdictional Issues

In addition to the EPA, management standards for pharmaceuticals have also been established 

by the FDA, the Drug Enforcement Agency (DEA) and, as mentioned previously, OSHA and 

NIOSH—standards that don’t necessarily have environmental protection as a primary goal. For 

example, DEA regulations for disposal of controlled substances are mainly designed to prevent 

diversion for unauthorized uses rather than environmental protection. ASTSWMO believes any 

new regulatory approach must be developed in partnership with these other agencies to 

ensure standards do not conflict and meet the goals of each agency. 

POSITION

Today, pharmaceuticals are ubiquitous throughout society and, as the population continues to 

age, the quantity of pharmaceuticals being dispensed will likely increase. Since EPA has not 

added any pharmaceutical compounds to its P- or U-lists of hazardous waste since 1980, it 

seems apparent the slow, methodical process EPA must use to evaluate individual 

pharmaceuticals for new hazardous waste listings cannot stay abreast of this quickly-evolving 

waste stream and may actually be a detriment to doing so. Furthermore, we believe EPA’s 

planned approach to develop flexible, sector-specific regulations to be used in conjunction with 

the current listing process will not provide adequate environmental protection. To alleviate 

each of the issues identified, ASTSWMO believes post-manufacturing pharmaceutical waste 

should be regulated as a category.

 

5 For example, carmustine, dactinomycin, and oxytocin.
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Since the most appropriate treatment technology for destroying pharmaceuticals, high 

temperature combustion, already exists in many States, ASTSWMO believes this category of 

waste is extremely well-suited for an alternative (and optional) regulatory approach that would 

conditionally exclude all pharmaceutical wastes from hazardous waste determinations provided 

the following criteria are met:

1. accumulation occurs in a manner that is protective of human health and the 

environment;

2. appropriate security and tracking measures are in place to ensure accumulated 

pharmaceutical wastes are ultimately destroyed at an authorized disposal site and not 

diverted to illicit uses; and

3. destruction is accomplished via high-temperature combustion in incinerators equipped 

with appropriate controls to prevent releases into the environment.6

By conditionally excluding post-manufacturing pharmaceutical wastes from hazardous waste 

determinations, generators who may not otherwise be subject to complex RCRA standards 

could manage all pharmaceutical wastes under one streamlined and protective system instead 

of managing a few according to stringent RCRA standards while possibly discarding the 

remainder in the trash. High-temperature combustion in a RCRA or municipal solid waste 

incinerator, or other incinerators meeting specified temperature, BTU, and residence time 

requirements, will assure complete destruction and achieve the current treatment standard 

applicable to nearly all RCRA-regulated pharmaceutical wastes.7 Combustion ash would 

continue to be subject to RCRA regulation if it exhibited a hazardous characteristic. Nothing in 

this Paper precludes States from regulating the ash as a solid waste. Generators would have 

the option to either comply with the streamlined standards for all their pharmaceutical wastes 

or segregate them for management as both RCRA and non-RCRA wastes, as applicable. 

Finally, ASTSWMO believes that in addition to addressing the shortfalls of RCRA regulation for 

pharmaceuticals described above, a carefully-crafted regulatory framework that includes 

education, producer responsibility, and organized collection events may provide incentives for 

neighborhood pharmacies, law enforcement agencies and household hazardous waste 

collection facilities to accept pharmaceutical wastes from households, thus preventing these 

from being disposed in the trash or down the drain.

 

6 ASTSWMO recognizes that pharmaceuticals may frequently be mixed with infectious (i.e. red bag) wastes at 

many facilities. Provided the red bag waste is combusted according to this standard to destroy both the 

pharmaceutical and the infectious wastes, such comingling would be acceptable under this concept. 

Pharmaceutical wastes mixed with red bag wastes and sent for autoclaving would not be excluded. Pharmaceutical 

wastes or residues still in packaging could also be managed under this standard. 

7 The treatment standard for most of the listed pharmaceuticals is high-temperature combustion, so our proposal 

is consistent with current EPA requirements. EPA’s September 26, 2012 memorandum regarding householdexempt pharmaceuticals specifically mentions incineration as the optimal method for disposal. 
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CONCLUSION

The pharmaceutical waste problem will continue to grow as the United States population ages 

and new drugs are developed. ASTSWMO believes the current RCRA Subtitle C framework is illequipped to address the environmental threat posed by pharmaceutical wastes. While some 

pharmaceutical wastes, such as off-specification manufacturing wastes, should remain fully 

regulated under RCRA Subtitle C, a simplified regulatory approach that applies to all postmanufacturing pharmaceutical wastes must be considered to help ensure adequate protection 

of the environment. The ASTSWMO Board of Directors recommends EPA consider the 

approach outlined in this Position Paper. ASTSWMO would be happy to assist EPA with the 

development of regulations to implement such an approach.

Adopted by the ASTSWMO Board of Directors on April 23, 2013, in Billings, MT.
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BIBLIOGRAPHY

Andrews, William J., Jason R. Masoner, Isabelle M. Cozzarelli, Emerging Contaminants at a 

Closed and an Operating Landfill in Oklahoma, Ground Water Monitoring & Remediation, 

32:120-130, 2012.

Barnes, Kimberlee K., Dana W. Kolpin, Edward T. Furlong, Steven K Zaugg, Michael T. Meyer, 

Larry B. Barber, A national reconnaissance of pharmaceuticals and other organic wastewater 

contaminants in the United States—I) Groundwater, Science of the Total Environment, 402:192-

200, 2008.

Dougherty, Jennifer A., Peter W. Swarzenski, Richard S. Dinicola, Martin Reinhard, Occurrence 

of Herbicides and Pharmaceutical and Personal Care Products in Surface Water and 

Groundwater around Liberty Bay, Puget Sound, Washington, J. Environ. Qual., 39:1173-1180, 

2010.

EPA Office of Inspector General, EPA Inaction in Identifying Hazardous Waste Pharmaceuticals 

May Result in Unsafe Disposal, Report No. 12-P-0508, May 25, 2012.

Furlong, Edward T., James L. Gray, David M. Quanrud, Sondra S. Teske, Stephen L. Werner, 

Kathleen Esposito, Jeremy Marine, Wendell P. Ela, Steven D. Zaugg, Patrick J. Phillips, Beverley 

Stinson, Pharmaceuticals, Hormones, Anthropogenic Waste Indicators, and Total Estrogenicity 

in Liquid and Solid Samples from Municipal Sludge Stabilization and Dewatering, U.S. Geological 

Survey Open-File Report 2011-1132, 2012.

Johnson, Art, Barbara Carey, Steve Golding, Results of a Screening Analysis for Pharmaceuticals 

in Wastewater Treatment Plant Effluents, Wells, and Creeks in the Sequim-Dungeness Area, 

Washington Department of Ecology Publication No. 04-03-051, 2004.

Lauer, Lisa, EPA Office of Resource Conservation and Recovery, RCRA and Pharmaceutical 

Waste Management: A Brief Federal Overview, Online at 

http://www.epa.gov/aging/resources/presentations/2010_0112_rcra_psi_call.pdf, 2010.

National Institute for Occupational Safety and Health (NIOSH), NIOSH List of Antineoplastic and 

Other Hazardous Drugs in Healthcare Settings 2012, Department of Health and Human Services 

Publication No. 2012-150, 2012.

Occupational Safety and Health Administration (OSHA), Controlling Occupational Exposure to 

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Pait, Anthony S., Robert A. Warner, S. Ian Hartwell, Judd O. Nelson, Percy A. Pacheco, Andrew L. 

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