Monday, April 15, 2013
Amidst continued Congressional and U.S. Environmental Protection Agency (USEPA) deliberation on how to address the persistence of pharmaceuticals in the environment, Michigan has made some headway not seen in other states. In 2012, the Michigan Department of Environmental Quality (MDEQ) produced a 22 minute Pharmaceutical Waste Tutorial to educate Michigan health care providers. The tutorial provides a quick, simple approach to managing pharmaceuticals in a health care setting to assist in meeting the many complex regulations that apply to pharmaceuticals.
The federal Resource Conservation and Recovery Act (RCRA) describes how all businesses with hazardous waste (i.e., waste that is toxic, corrosive, ignitable and/or reactive as defined under the federal RCRA) must be managed and disposed. As a general matter, anywhere between 5 and 15 percent of a pharmacy's inventory is expected to meet the definition of hazardous waste.
Unlike most states, Michigan's hazardous waste regulations are found under the state's Natural Resource and Environmental Protection Act, Part 111, of Act 451, and the Part 111 rules promulgated thereunder (the state hazardous waste regulations). In Michigan, the state hazardous waste regulations are implemented instead of the federal hazardous waste regulations as detailed in the federal regulations (see 40 CFR Part 272, Subpart X). Since Michigan's hazardous waste program is implemented under state regulations, Michigan was able to promulgate rules and independently establish pharmaceuticals as Universal Waste.
As of December 16, 2004, businesses in Michigan have been able to manage their pharmaceutical waste in accordance with the universal waste rules for pharmaceuticals. These rules ease the regulatory burden, provide for safe collection and transportation, and prescribe for disposal at a hazardous waste disposal facility authorized to handle pharmaceuticals. At the federal level, only batteries, pesticides, mercury-containing equipment, and electric bulbs (lamps) are acknowledged as universal waste types that can be managed under the streamlined universal waste standards.
Since 2009, due to growing public and health care interest, Michigan has worked to clarify the regulations that apply to health care and help residents understand how to safely store and dispose of unused medications to prevent their release to its water resources. Amidst significant scientific uncertainty regarding the human health effects associated with long-term exposure to the low levels of pharmaceuticals and the current data suggesting problematic environmental consequences, Michigan embarked on a collaborative campaign focused on education and better managing what it presently can control–its inventory of waste medications. The campaign advocates that all National Institute for Occupational Safety and Health (NIOSH) hazardous drugs, regardless of origin – household or business, and all business pharmaceuticals be incinerated at authorized hazardous waste incinerators. At minimum, the campaign advocates all residential pharmaceuticals, with the exception of NOISH hazardous drugs, be incinerated at solid waste incinerators authorized to destroy pharmaceuticals.
While pharmaceuticals were first detected in our environment in the 1970's, it wasn't until 1998, that concern about their persistence emerged, following the detection of heart medication in the North Sea when sampling for pesticides. This detection triggered a U.S. investigation into the type and level of pharmaceuticals present in our environment. By 2002, the U.S. Geological Survey (USGS) had confirmed the presence of pharmaceuticals in the environment across much of the U.S. at very low levels. Since then, Congress has advocated further research and collaboration across the many agencies who govern the review, use, handling, and disposal of pharmaceuticals.
This research led to the August 2008 Managing Pharmaceutical Waste: A 10-Step Blueprint for Health care Facilities in the United States, the August 2010 Draft USEPA Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities, the 2011 U.S. Government Accountability Office Report Action Needed to Sustain Agencies' Collaboration on Pharmaceuticals in Drinking Water, the May 2012 Inspector General Report USEPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal, and the September 2012 USEPA letter Recommendation on the Disposal of Household Pharmaceuticals Collected by Take-Back Events, Mail-Back, and Other Collection Programs. Finally, in November 2012, the USEPA, USGS, U.S. Department of Agriculture, and U.S. Food & Drug Administration issued a Memorandum of Understanding for improving and sustaining coordination and collaboration on issues related to pharmaceuticals in drinking water across the U.S.
As the USEPA and other agencies continue to review pharmaceuticals as an emerging contaminant of concern to determine a grander course of action, the MDEQ has taken more immediate action to better control and manage its inventory of waste medications. While the USEPA better qualifies the impact of pharmaceuticals in the environment and how to remove excreted pharmaceuticals from our wastewater, the MDEQ has taken action, collaborating with stakeholders on a threefold approach focused on:
- increasing awareness of this issue,
- identifying ways to better manage our inventory of waste pharmaceuticals, and
- instituting measures to minimize the amount of unused pharmaceuticals generated.