Printed in the Suffolk Lawyer
The disposal of pharmaceuticals is a growing area of concern in our over-medicated society. According to Citizens Campaign for the Environment, nearly 4 billion prescriptions are filled in the U.S. each year, of which about one third, or 200,000 pounds, are unused. Trace amounts of these drugs enter our surface and ground waters from various sources, including landfill leachate, animal feedlots, aquaculture, land application of organic materials, pharmaceutical manufacturing facilities, and deliberate flushing. Most ubiquitous of all, the pharmaceuticals pass through our bodies and are secreted, ending up in cesspools and sewage treatment plants, neither of which are equipped to filter or treat them. Studies relating to the impacts of these substances and of personal care products are still few and far between. However, according to Douglas Feldman, Chief of the Office of Water Resources of the Suffolk County Health Department, some of these compounds are known to mimic naturally occurring hormones and affect normal hormone activity. A limited number of studies have reported disruptions of the endocrine system in animals and the “feminization” of fish.
At this time, there are no mandatory regulations requiring any particular method of pharmaceutical disposal by members of the public. The New York State Department of Environmental Conservation (DEC) has focused its efforts on a public awareness program advising people not to flush their unused or expired medications. Instead, the public is urged to return them to collection events, where available, or mix them with something such as coffee grounds, cat litter or dirt, seal them in containers, and put them in the garbage. In fact, pursuant to New York’s Drug Management and Disposal Act of 2009, pharmacies, retail businesses that sell drugs, and veterinary offices are required to conspicuously display a poster to this effect. In addition, people can bring their unused medications and deposit them in drop boxes installed in police stations statewide or to municipal collection events. The current process for getting approval for a household pharmaceutical collection event is somewhat cumbersome. The DEC requires an applicant to fill out three forms identifying the location, date and time of the event, the law enforcement presence, a chain of custody from collection through destruction and pre-approval for destruction via a witnessed burn at a permitted medical solid waste combustion facility in New York State. The program requires the further approval of the New York State Department of Health, Bureau of Narcotic Enforcement (BNE) and notice to the U.S. Department of Justice Drug Enforcement Administration (DEA). After the event, the organizer must submit to DEC a chain of custody report and another form which reports the weight of pharmaceuticals collected. See 6 NYCRR 373-4 et seq. ; http://www.dec.ny.gov/chemical/68554.html. The DEC is considering new regulations to streamline this process.
A new option for Long Island residents is to bring the drugs to 11 local King Kullen pharmacies, which accept everything, except for narcotics (use this link to find participating police and supermarket locations: http://www.citizenscampaign.org/campaigns/pharmaceutical-disposal/nassau-suffolk-locations.asp). About half a million pills were collected in the first five months of the King Kullen program and sent to a hazardous waste incinerator in Texas. A recent grant will enable the store to continue the program for the next three years.
Pharmacies and hospitals usually send back their unused or expired medications to reverse distributors. However, if the drugs have the characteristics of hazardous substances (e.g. warfarin, nicotine, alcohol, mercury, acids) and are classified as waste, then the State hazardous waste regulations apply to their disposal (6 NYCRR Parts 364, 370-373). Last year, the DEC created an audit program for pharmacies, allowing them 12 to 18 months to come into compliance and deferring inspections and enforcement. See http://www.dec.ny.gov/docs/remediation_hudson_pdf/rcraaudits12182014.pdf. In addition, new hazardous waste regulations from the U.S. Environmental Protection Agency are expected to be issued in this month.
A separate effort is being made for the collection of unused medications from long-term care facilities, such as nursing homes. For a long time, the preferred method of disposal was flushing. In fact, it is still approved for controlled substances by BNE. This is because BNE imposes restrictions on the movement of narcotics, and nursing homes may not return them to the pharmacies that issued them or dispose of them as solid waste, but rather, are required to render them totally “unrecoverable and beyond reclamation” (10 NYCRR Part 80). In recent years, there has been an effort to curtail the practice of flushing. The DEA used to conduct national collection events for controlled substances, ie. narcotics. Unfortunately, these have recently been discontinued. The DEC has picked up where the DEA left off, organizing special collection events. The first such event on Long Island took place in February 2015, yielding 52 boxes of waste medications collected for proper disposal by DEC’s Region 1 environmental enforcement personnel. A more permanent solution is expected to come soon when BNE issues regulations implementing the October 2014 rules of the DEA. These rules expand disposal options for ultimate users, such as long term care facilities, by allowing them to participate in mail back programs or use collection receptacles by DEA approved pharmacies for the return of unused drugs.
The Suffolk County Department of Health Services (SCDHS), which collects water samples from public and private wells and from groundwater monitoring wells, currently analyzes for about 30 pharmaceuticals and personal care products. To date, 25 of these have been detected in very small concentrations (less than 1 microgram per liter), with the most detections being in private wells. At this time, there is no regulatory standard for these compounds, so the standard applied is the catch-all 50 parts per billion for unregulated contaminants. According to Amanda Comando of the Suffolk County Water Authority (SCWA), the SCWA, which operates 550 wells, currently tests for 26 pharmaceutical compounds of concern and hopes to expand the list to 47 by the middle of this year.
Several legislative initiatives in Suffolk County have begun to address the issue of waste pharmaceuticals. Resolution No. 181-2011 requires hospitals, nursing homes, and long term-care facilities to file a written plan with the SCDHS for the disposal of unused or expired medications in a safe manner. Resolution No. 762-2008 established a program which allows residents to deposit unused/expired medications County police precincts 24 hours a day, 7 days a week. A companion program uses a ¼% sales tax to support the collection of unused medications for the five East End towns.
A lot of questions still remain. What are the cumulative impacts on animals, fish and humans of trace levels of pharmaceuticals in our surface waters and in drinking water? Should there be specific standards? What about compounds for which there is no current testing? How can the efforts of individual groups and municipalities be combined for greater efficiency and impact? What is the proper balance between ensuring that narcotic drugs do not get into the wrong hands and convenient disposal alternatives that are also safe for the environment? What filters or treatment methods are being developed to purify the water for human use? Hopefully, some of these questions will be answered as more public attention is focused on this emerging health and environmental issue.