In January 2010, New York Attorney General (AG) Andrew Cuomo announced settlements with two critical-access hospitals and three nursing homes, as part of an ongoing investigation of health care facilities that dump unused pharmaceuticals down their drains.1 The agreements call for the facilities to pay civil penalties for past violations, reimburse the state for the investigation, and implement pharmaceutical “take-back” programs for area households.
The agreements, which the AG’s office described as the “first-ever settlements requiring sources of pharmaceutical releases to end this risky disposal practice,”2 allege violations of New York laws and regulations implementing the federal Resource Conservation and Recovery Act (RCRA) and Clean Water Act.3 The enforcement actions are all the more remarkable for the AG’s statements in court filings that “no showing of adverse health impacts to consumers of New York City water or other drinking water sources has been made at this point in time at current concentration levels” and, similarly, “[r]esearch concerning potential adverse effects of pharmaceutical wastes on the environment is also at an early stage.”4 Based not on demonstrated harm or a showing that the facilities in question discharged specific hazardous wastes, the prosecutions instead rely on the general statement that some pharmaceutical wastes are classified as hazardous under RCRA, such as certain flu vaccines and insulin, which contain hazardous preservatives, and the blood thinning drug warfarin.5 Beyond this, the settlement agreement cites recommendations from the U.S. Environmental Protection Agency (EPA) and New York’s Department of Environmental Conservation that precautionary measures should be taken to minimize the release of pharmaceuticals into federal and state waters by stopping the flushing of unused drugs down toilets and sinks.6
New York’s aggressive enforcement action comes at a time when EPA is still struggling for solutions. EPA classifies pharmaceuticals and personal care products as contaminants of emerging concern and expects to finalize best practices guidance by the end of 2010, under the umbrella of its sewage pretreatment program.7 EPA intends this guidance for not only hospitals and nursing homes, but any similar facility that may use significant quantities of pharmaceuticals, including medical and dental offices and even veterinary clinics. EPA’s review extends even to common products such as cosmetics, fragrances, and sunscreens.
Disposal of unwanted pharmaceuticals and personal care products is receiving increased attention from environmental regulators, advocacy groups, and the press. The Food and Drug Administration (FDA) has primary responsibility for regulating pharmaceuticals, and historically the environmental assessments in FDA approval proceedings addressed disposal concerns, even though the FDA’s primary focus is on a drug’s benefits or efficacy. Newer data, however, reflecting measurement capabilities at much lower levels, has heightened visibility of the issue and prompted concerns about the presence of these chemicals in the water supply. In response, regulators worldwide have been studying the science, supporting voluntary take-back programs, and considering whether to adopt additional regulation of pharmaceutical-related contaminants in drinking water.8
EPA’s best practices guidance is likely to encourage the kind of take-back programs the New York settlements embraced, but this is not necessarily easy. Existing RCRA regulations, which EPA is working to streamline,9 make storage, transport, and other management aspects of these wastes cumbersome and costly, and some drugs – those covered by the Controlled Substances Act – must be managed by Drug Enforcement Agency personnel.10 In the meantime, the White House Office of National Drug Control Policy advises consumers who cannot dispose of unwanted prescription drugs at a take-back center to mix them with cat litter or used coffee grounds, put the mixture in a disposable container, and place it in the trash.11
Scientific journals continue to explore concerns that although the chemicals in pharmaceuticals and personal care products – particularly anti-cancer agents, estrogens, psychotropic drugs, and beta blockers – are at low concentrations in the nation’s water supply, they have the potential to cause adverse effects in fish and other aquatic life. These concerns will stimulate efforts like those of New York’s AG, and to the extent hazardous wastes are involved, successful enforcement actions are a likelihood.
Health care facilities of all types and sizes are well-advised to take steps now to ensure they are in compliance with current law and positioned for the rapidly changing developments in this area. Even though there are legal questions about whether disposing of most pharmaceuticals by flushing them down a toilet or drain violates existing law or regulations, health care facilities may find it prudent to develop best practices guidance, which could cover disposal of pharmaceuticals along with other operating policies. Notably, the New York AG enforcement actions were triggered because staff at the facilities admitted they did not follow established disposal procedures. Thus, senior officials at health care facilities should think carefully about adopting a set of practices that are reinforced by training and self-audit programs. This approach will help ensure both compliance and the ability to intervene early and correct problems if needed, reducing the risk of protracted external investigations, negative public relations, costly cleanup efforts, and potential penalties.
Endnotes
1 See “Attorney General Cuomo Announces Groundbreaking Settlements to Stop 5 Healthcare Facilities from Disposing of Pharmaceutical Wastes into the NYC Watershed” (Jan. 12, 2010), available at http://www.ag.ny.gov/media_center/2010/jan/jan12a_10.html.
2 Id., at 1.
3 42 U.S.C. §6901 et seq., 33 U.S.C. §1251 et seq. See, e.g., In the Matter of the Investigation by Andrew Cuomo, Attorney General of the State of New York, of Margaretville Memorial Hospital, Assurance No. 09-155, Assurance of Discontinuance Pursuant to Executive Law § 63(15) (signed Jan. 11, 2010) (Margaretville Memorial Hospital Settlement), available at http://www.ag.ny.gov/media_center/2010/jan/Margaretville%20Final%20AOD.pdf.
4 Id., at paragraphs 6 and 7. Pharmaceuticals are considered safe for use by humans at concentrations that are, in some cases, millions of times higher than those found in the environment and the environmental assessments submitted by pharmaceutical manufacturers as part of their New Drug Applications and other research must address effects on the environment. See “Pharmaceutical Research Manufacturing Association (PhRMA), Statement on Pharmaceuticals in the Environment” (March 10, 2008), available at http://www.phrma.org/news_room/press_releases/phrma_statement_on_pharmaceuticals_in_the_Environment, and “PhRMA Statement on Sustainability and Manufacturing Process” (April 23, 2009), available at http://www.phrma.org/news_room/press_releases/phrma_statement_on_sustainability_and_manufacturing_process.
5 Margaretville Memorial Hospital Settlement, supra note 3, at paragraph 8. There is a significant legal question whether disposal of pharmaceuticals into a sewer system is, in fact, illegal absent proof that the chemicals are classified as hazardous or subject to a pretreatment standard.
6 Id., at paragraph 11.
7 See U.S. EPA, “ Availability of Preliminary 2010 Effluent Guidelines Program Plan, 74 Fed. Reg. 68599, 68,610-11 (Dec. 28, 2009), available at http://edocket.access.gpo.gov/2009/pdf/E9-30625.pdf (EPA 2010 Effluent Guidelines Program Plan), citing the administrative record at EPA-HQ-OW-2006-0771-1694. More generally, see “Pharmaceuticals and Personal Care Products,” available at http://www.epa.gov/ppcp/.
Of course, normal human excretion of medications also reaches a wastewater treatment system. Such systems were not originally designed to filter out the ingredients in pharmaceuticals. However, more research is needed to determine what amount of these pharmaceutical chemicals may, in fact, be treated by these wastewater systems.
8 See. U.S. EPA, “Pharmaceuticals and Personal Care Products in Water,” available at http://www.epa.gov/waterscience/ppcp/.
9 See U.S. EPA, “Pharmaceuticals,” available at http://www.epa.gov/epawaste/hazard/wastetypes/universal/pharm.htm.
10 21 U.S.C. §801 et seq. See, e.g., Keith Ervin, “Finally, a Safe Environmental Way to Get Rid of Old Medicine,” available at http://seattletimes.nwsource.com/html/localnews/2004137723_medicines22m.html.
11 U.S. Office of National Drug Control Policy, “Proper Disposal of Prescription Drugs,” available at http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf.
Jane C. Luxton and William J. Walsh
