Page 1 of 7 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 controlle d. 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 pharmaceutic al 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 u nderstands 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 Po sition Paper outlines a more holistic management approach that could apply to all post

- manufacturing pharmaceutical wastes, not only those regulated as a hazardous waste. 1 In developing this Paper, several articles and publications
were reviewed. A complet e 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 show n 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 pharmaceuti cal 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 t echnologies 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 w hile still handling the RCRA hazardous pharmaceutical wastes in accordance with current regulations. 444 North Capitol Street, N.W., Suite 315 Washington, D.C. 20001 Washington, DC 20001 tel: (202) 624

- 5828 fax: (202) 624

- 7875

www.astswmo.org T el: (202) 624

- 5828 Fax: (202) 624

- 7875 www.astswmo.orgPage 2 of 7

thoroughly studied, of pharmaceuticals making their way into surface or gro und 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 agencie s 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 Su btitle 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. 2 Since tha t 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 haza rdous 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 P

or U

- list of hazardous wastes, EPA must first perform an extensive evaluation of the material pursuant to 40 CFR 261.11 4 prior to initiating the rulemaking process; a costly, time

- consuming, and often unpredicta ble 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

ne w 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 Safet y 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 tho se with high alcohol content may be characteristic

. 3 Since 1996, the F DA 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.Page 3 of 7

being listed as acutely hazardous. 5 Clearly, a single manageme nt 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 und er 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 b etween 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” se ttings 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 prima ry 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 w ith 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 wi ll 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 actua lly 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 proce ss 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.Page 4 of 7

Since the most appropriate treatment technology for destroying p harmaceuticals, 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 fr om 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 pharmace utical 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 envir onment. 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 protec tive 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 temperatur e, 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 exhibi ted 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 mana gement 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, prod ucer 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
fro m being disposed in the trash or down the drain.

6 ASTSWMO recognizes that pharmac euticals 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 household

exempt pharmaceuticals specifically mentions incineration as the optimal method for disposal.Page 5 of 7

CONCLUSION

The pharmaceutical waste problem will continue to grow as the United States population ag es and new drugs are developed. ASTSWMO believes the current RCRA Subtitle C framework is ill

equipped 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 po st

manufacturing pharmaceutical wastes must be considered to help ensure adequate protection of the environment. The ASTSWMO Board of Directors recommends EPA consider the approach o utlined in this Position Paper. ASTSWMO would be happy to assist EPA with the development of regulations to implement such an approach.

A dopted by the ASTSWMO Board of Directors on April 23, 2013

, in Bi llings, MT.Page 6 of 7 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

, Scien ce 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. G ray, 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 Liqui d 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 Hazardous Drugs

, OSHA Technical Manual, Section VI: Chapter 2 , 1999 (Online at http://www.osha.gov/dts/os ta/otm/otm_vi/otm_vi_2.html).

Pait, Anthony S., Robert A. Warner, S. Ian Hartwell, Judd O. Nelson, Percy A. Pacheco, Andrew L. Mason, Human Use Pharmaceuticals in the Estuarine Environment: A Survey of the ChesapeakePage 7 of 7

Bay, Biscayne Bay and Gulf of the Fara llones

, NOAA Technical Memorandum NOS NCCOS 7

, August 2006.

Richardson, Mervin L., and Judith M. Bowron, The fate of pharmaceutical chemicals in the aquatic environment

, J. Pharm. Pharmacol. , 37:1

- 12, 1985.

Rudzinski, Suzanne, Containers that Once Held P

- listed Pharmaceuticals

, EPA Memorandum, November 4, 2011.

Rudzinski, Suzanne, Recommendations on the Disposal of Household Pharmaceuticals Collected by Take

- Back Events, Mail

- Back, and Other Collection Programs

, EPA Memorandum, September 26, 2012.

Yang, Yun

- Ya, James L. Gray, Edward T. Furlong, Jessica G. Davis, Rhiannon C. ReVello, Thomas Borch, Steroid Hormone Runoff from Agricultural Test Plots Applied with Municipal Biosolids

, Environ. Sci. Technol. , 46:2746

- 2754, 2012.