The Resource Conservation and Recovery Act and California Medical Waste Management Act regulate the disposal of unused pharma ceuticals by hospitals and other large-scale generators of pharmaceutical waste. And finally, the Endangered Species Act and California Endangered Species Act seek to protect marine species that are especially vulnerable to extinction from harmful pollutants contained in POTW effluent. These laws provide a patchwork of protection for marine ecosystems, but as the following Sections illustrate, they are vastly inadequate to prevent flushed pharmaceuticals, illicit drugs, and caffeine from harming marine organisms.Its goal is to “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters.”Under the CWA, it is unlawful for any person to discharge pollutants from a point source into the ocean, contiguous zone, or any other navigable waters of the United States, except in compliance with a National Pollutant Discharge Elimination System permit.The Porter-Cologne Water Quality Control Act is a state law dedicated to protecting water quality and the beneficial uses of waters within California.It implements many CWA provisions, including the NPDES permit program and the national pretreatment program.Pharmaceuticals, illicit drugs, and caffeine contained in wastewater effluent are considered pollutants under the CWA.As point sources, POTWs that discharge effluent into the ocean are therefore required to obtain and comply with individual NPDES permits.A POTW may not obtain an NPDES permit that authorizes the discharge of pollutants if the State Director determines that the discharge “will cause unreasonable degra dation of the marine environment after application of all possible permit conditions . . . .”NPDES permits issued to POTWs establish effluent limitations that are determined using tech nology-based effluent limitations based on secondary treatment standards and water-quality based effluent limitations established by the United States Environmental Protection Agency .
TBELs generally focus on the overall biochemical oxygen demand,vertical farming system total suspended solids, and pH of wastewater. These standards and limitations, however, generally do not specifically address the levels of flushed pollutants in wastewater effluent. The national pretreatment program is designed to prolong the useful lifespan of POTWs and to help POTWs comply with NPDES permit requirements. Pretreatment standards are generally expressed as numeric effluent limitations, narrative prohibitions, and best management practices.All indirect dischargers,including most hospitals, are subject to a set of general national pretreatment standards.Most POTWs are also required to develop local pretreatment programs that indirect dischargers must comply with.Together, the CWA and Porter-Cologne Act provide advocates with the strongest tool for protecting the marine environment against flushed pollutants. This tool, however, is inadequate. The NPDES permit program and the national pretreatment program do not apply to household flushing. NPDES permit conditions for POTWs do not specifically monitor and regulate discharges of pharmaceuticals, illicit drugs, and caffeine.Furthermore, the national pretreatment program fails to impose standards of heightened stringency specifically designed for hospitals and other large, indirect dischargers of pharmaceutical waste. The Controlled Substances Act is the primary federal law regulating the importation, manufacture, distribution, possession, and use of controlled substances.Similarly, the California Uniform Controlled Substances Act prescribes state drug policy.Drugs that are considered controlled substances under the CSA are listed and classified into five schedules.Controlled substances covered by both Acts include pharmaceuticals and illicit drugs such as amphetamines, cannabis, cocaine, MDMA, methadone, methamphetamine, morphine, and prescription opioids.
Under the CSA, it is unlawful for “any person knowingly or inten tionally to possess a controlled substance unless such substance was obtained . . . from a practitioner, while acting in the course of his professional practice . . . .”The Uniform Controlled Substances Act delineates fines and other punishments for possession offenses.Because the mere possession of a controlled substance is often a punishable offense, available methods for legal disposal of unwanted controlled substances are very limited. In an attempt to reduce household flushing of unwanted controlled substances, the Secure and Responsible Drug Disposal Act of 2010 and the Disposal of Controlled Substances Rule amended the CSA to allow for the disposal of over-the-counter prescriptions and controlled substances that are lawfully possessed via take-back events,mail-back programs,and collection receptacles.68 However, only ultimate users and persons legally entitled to dispose of a deceased ultimate user’s property may employ these methods to dispose of controlled substances.An ultimate user is “a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household.”Long term care facilities with authorized collection receptacles may also dispose of certain controlled substances on behalf of an ultimate users who reside or have resided onsite.Because these disposal alternatives are only available to limited individuals and only allow for the disposal of certain controlled substances, they are a step in the right direction, but are far from sufficient. They may help to reduce the flushing of unwanted pharmaceuticals by ultimate users, but do nothing to reduce the flushing of illicit drugs. Limited public awareness of the availability of these disposal alternatives and the relative ease of flushing further diminishes the efficacy of these options. The Resource Conservation and Recovery Act is a federal law that governs the management of non-domestic hazardous solid waste.Under RCRA, healthcare providers and reverse distributors that generate large amounts of pharmaceutical hazardous waste must comply with extensive tracking and reporting requirements as the waste is trans ported to a permitted facility for proper treatment and disposal.
Waste is defined as any substance that is discarded or intended to be discarded.Some pharmaceuticals, including unused nicotine products, are regulated as hazardous waste under RCRA. However, EDCs that are of particular concern in the context of the marine environment are not regulated under RCRA.The California Medical Waste Management Act is a state law governing the management of medical waste that is generated and treated in California.Under the Act, regulated medical waste includes all prescription and over-the-counter drugs that are discarded or intended to be discarded, and are not regulated by RCRA.Medical waste generators include hospitals, clinics, medical and dental offices, research laboratories, and unlicensed health facilities such as hospices and long-term care facilities.Medical waste treatment facilities are those permitted for offsite handling, storage, and treatment of medical waste.The Medical Waste Management Act requires medical waste generators and treatment facilities to ensure pharmaceutical waste is incinerated or disposed of through limited alternative methods.Flushing is not listed as an acceptable method of disposal under the Act.Together, RCRA and the Medical Waste Management Act regulate the disposal of all non-domestic pharmaceutical waste generated in California. However, in practice, vertical farming racks these acts may not be effective at preventing pharmaceutical flushing by healthcare facilities. Navigating two layers of regulation can be extremely complex and hospitals and other large generators of pharmaceutical waste find compliance to be exceedingly onerous and costly.As a result, flushing remains a common method of disposal for unused pharmaceuticals.The Endangered Species Act of 1973 is a federal law devoted to the protection of species that are in danger of extinction or are likely to become in danger of extinction within the foreseeable future.The California Endangered Species Act is a state law that is similarly purposed and designed.Both the ESA and CESA provide protection for listed endangered and threatened species, though the Acts differ in their listing processes and criteria. Over 140 marine species are federally listed as threatened or endangered,and are afforded protection by the ESA.Under the ESA’s take prohibition, it is unlawful for any person subject to the jurisdiction of the United States to kill, harm, harass, pursue, capture, or collect an individual of a listed endangered species, or to attempt to do so, within the United States, the territorial sea of the United States, or upon the high seas.In addition to individuals, this prohibition applies to instrumentalities of the Federal Government and of any State, municipality, or political subdivision of a State.This includes POTWs. Although the ESA’s prohibition on harmful activities affecting listed species is sufficiently broad and the prohibition applies to POTWs, the ESA provides inadequate protection for marine species against potentially harmful pollutants contained in treated wastewater effluent. The CESA is similarly inadequate. The ESA and the CESA only protect listed species, which comprise just a small percentage of known marine organisms. Furthermore, little research has been conducted on the impact that exposure to flushed pollutants has on particular species in the marine environment.Marine ecosystems are also dynamic and complex, and the relationships and inter dependencies between marine organisms are not well under stood.Furthermore, marine organisms generally have larger ranges than their freshwater and terrestrial counterparts.Thus, the distance between an individual marine organism and a particular source of pollution may vary greatly over time, along with the impact that the pollution will have on the individual.
These factors make it exceedingly difficult to show that the take of a listed endangered marine species has occurred as a result of the discharge of pollutants from a POTW into the marine environment. As American consumption of pharmaceuticals, illicit drugs, and caffeine persist, so too will concentrations of these pollutants in effluent discharged from POTWs into the marine environ ment. Although our existing laws and regulations are currently failing to protect the marine environment from flushed pollutants, there is a way forward. In light of the uncertainty surrounding the effects these pollutants have on marine organisms and ecosystems, precautionary solutions are necessary to protect the health of our oceans. The marine environment can be protected by reducing the overall amount of flushed pollutants entering POTWs and by compelling POTWs to remove flushed pollutants from wastewater effluent. These goals can be accomplished through policy reform, the introduction of new legislation, public education, and continued research. The EPA proposed the Management Standards for Hazardous Waste Pharmaceuticals Rule to help healthcare providers under stand and comply with regulations pertaining to the disposal of pharmaceutical waste.The Rule also strives to reduce the amount of unused pharmaceuticals flushed by healthcare facilities including hospitals, pharmacies, long-term care facilities, and pharmaceutical reverse distributors.Healthcare facilities often flush hazardous waste pharmaceuticals that are also DEA recognized controlled substances to avoid having to comply with both RCRA and CSA regulations.96 If finalized, the Rule will prohibit healthcare facilities from flushing hazardous waste pharmaceuticals.The Rule also narrows the household hazardous waste exemption under RCRA to exclude pharma ceutical hazardous waste generated at long-term care facilities.Under the Rule, this waste would be regulated pursuant to RCRA management standards.Because long-term care facilities treat elderly and severely ill individuals, they accumulate large quantities of pharmaceutical hazardous waste.On the national level, keeping this waste out of POTWs would contribute greatly to the protection of the marine environment from flushed pollutants. However, in the context of California, this Rule would mostly reiterate provisions of the Medical Waste Management Act. As of this writing, the Safe Drug Disposal Act of 2009 has also been introduced but has not yet been enacted. The Act is a proposed amendment to the Federal Food, Drug, and Cosmetic Act.It bans drug labeling that recommends disposal by flushing. This simple prohibition would help reduce household pharmaceutical flushing, which is not otherwise regulated. The NPDES permit program and national pretreatment program prescribed by the CWA and implemented by the Porter Cologne Act provide a strong regulatory framework for minimizing the discharge of pollutants into the marine environment. These programs fail, however, to specifically recognize pharmaceuticals, illicit drugs, and caffeine as pollutants of particular concern. This oversight allows flushed pollutants to enter themarine environment undetected, causing harms of unknown scale and severity. To remedy shortcomings in the NPDES permit program, the CWA, and the Porter-Cologne Act should be amended to require the development of TBELs and WQBELS that address pharmaceuticals, illicit drugs, and caffeine. NPDES permit conditions for POTWs and large-scale direct dischargers should also include mon itoring requirements and effluent limitations targeted at flushed pollutants. To remedy shortcomings in the national pretreatment program, categorical pretreatment standards that currently apply to health care facilities that are direct dischargers should be evaluated and amended, if necessary, to minimize the direct discharge of flushed pollutants into the environment. Similarly, equally protective categorical pretreatment standards that specifically address flushed pollutants should be developed for healthcare facilities that are indirect dischargers. This will reduce the concentrations of pharmaceuticals, illicit drugs, and caffeine contained in POTW influent, and therefore effluent.