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This final rule establishes cost- saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.
Importantly, this final rule will make our drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering our waterways by 1,644 to 2,300 tons on an annual basis by prohibiting all facilities subject to the rule from sewering them. This action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.
In addition, under this final rule, Food and Drug Administration-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded, which will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.
EPA presented a webinar about the contents of the final rule on April 2, 2019 and a recording of that webinar is available. Click the "View Archive" button on the webinar webpage to access the recording. Additionally, the presentation slides from the webinar can be found in the "Webinar Slides" tab on this same page.
On August 9, 2023, EPA corrected and clarified technical errors in approximately 50 sections of the hazardous waste regulations. With this rule, EPA fixed typographical errors, incorrect citations, and language that was unintentionally ambiguous in the Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of Solid Waste Rule. EPA also identified several other provisions that needed to be corrected that are located in the same sections of the regulations.
EPA issued a new proposal for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors on September 25, 2015 (80 FR 58014). This proposal responded to the concerns raised on the universal waste proposal as well as feedback from the RCRA Retail Notice of Data Availability (79 FR 8926, February 14, 2014).
EPA significantly engaged states and other interested parties on these issues over the years and carefully evaluated the comments from states, pharmacies, retailers, healthcare facilities, reverse distributors, environmental organizations, and other members of the public. This final rule incorporates certain significant changes from the proposal to address comments and provide additional flexibilities.
There is a growing concern about the occurance of pharmaceuticals in water bodies and in drinking water. Pharmaceuticals get into the water supply via human excretion and by drugs being flushed down the toilet. You might think wastewater treatment plants would take care of the situation, but pharmaceuticals pass through water treatment.
In a 2004 to 2009 U.S. Geological Survey (USGS) study, scientists found that pharmaceutical manufacturing facilities can be a significant source of pharmaceuticals to the environment. Effluents from two wastewater treatment plants (WWTPs) that receive discharge from pharmaceutical manufacturing facilities (PMFs) had 10 to 1,000 times higher concentrations of pharmaceuticals than effluents from 24 WWTPs across the nation that do not receive PMF discharge. The release waters from these two WWTPs were discharged to streams where the measured pharmaceuticals were traced downstream, and as far as 30 kilometers from one plant's outfall.
The source of pharmaceuticals in water is not just from manufacturing plants. You probably know that antibiotics and drugs are used in the livestock industry, and for streams receiving runoff from animal-feeding operations, pharmaceuticals such as acetaminophen, caffeine, cotinine, diphenhydramine, and carbamazepine, have been found in USGS studies. Another source of pharmaceuticals in stream water is you and me. Essentially, drugs that people take internally are not all metabolized in the body, and the excess ends up in our wastewater leaving homes and entering the sewage-treatment plants. It might sound surprising that these drugs could be detected in streams miles downstream from wastewater-treatment plants, but many plants do not routinely remove pharmaceuticals from water.
The USGS South Atlantic Water Science Center has released a podcast titled "Emerging Contaminants, Pharmaceuticals in South Carolina Rivers and Streams". USGS Research Ecologist Dr. Paul Bradley discussed with Ray Douglas the USGS Toxic Substances Research on emerging contaminants in rivers and streams; the information is pertinent to all of the United States, not just South Carolina. Below is a transcript of the podcast.
Dr. Paul Bradley: "There is little doubt that these compounds have been present in the environment for decades and perhaps even more. It's possible that there have been long term ecological consequences that are reaching a critical stage. So while these releases are sometimes alarming. You know, having the information is better than not having the information."
Bradley: "And so we need to begin to correct this problem, we certainly need to understand it. So it is good that this information is coming out, and to do that we have to have release of new information."
Douglas: Paul, it seems seems that we're hearing more and more about emerging contaminants in our rivers and streams across the U.S.. Hopefully you can help us understand where these contaminants are originating, and how they are appearing in our drinking water. But before we get to that, can you tell us what exactly emerging contaminants are?
Bradley: Emerging contaminants is kind of this umbrella term that refers loosely to a wide variety of contaminants which presence in the environment has long been suspected, but which we have only recently verified due to improvements in analytical techniques. The emerging contaminants umbrella covers several broad classes of contaminant compounds that are loosely categorized according to their ecological impacts or their intended function, or their sources. These can include: pharmaceuticals and personal care products, organic wastewater compounds, antimicrobials, antibiotics, animal and human hormones, endocrine disrupting compounds, as well as a variety of domestic and industrial detergents. The critical thing to remember about all of these contaminants is, is that what's emerging about them is our awareness of their potential environmental impacts in the environment and our ability to actually detect the compounds. There is no doubt that many of these contaminants have been in the environment for a long time.
Bradley: Well the USGS Toxic Substances Hydrology Program has been conducting a variety of national surveys over the past decade. And the results of these various studies indicates that, that emerging contaminants are actually widespread in the environment and they are found in rivers and streams across the nation. They are also found in groundwater systems. Not surprisingly you tend to have them in higher frequency near urban centers, but you also find them in rural areas where there is no readily obvious source for them.
Bradley: Well ultimately, they are coming from us. Most of these compounds are produced either naturally or largely manufactured for use in and by people. For health applications like drugs, antibiotics synthetic hormones, you know for personal and domestic use like perfumes, antibacterial soaps and detergents. Everyday ingredients in products, domestic and industrial products. For farming applications, antibiotics and hormones are commonly used in cattle and in livestock operations. So given the wide range of emerging contaminants and the wide range of sources and uses, obviously there are a number of different ways that they can end up getting into the environment, and into the streams and rivers in particular. The obvious source, and the one most people pay attention too is via the human waste stream and municipal wastewater treatment facility outfalls directly into stream systems.
Certainly this is the one most people are aware of but there are a number of other sources out there, for example, industrial wastewater treatment plants also release emerging contaminants into rivers and streams. Septic systems, privately owned septic systems, for example are releasing emerging contaminants into the groundwater system and depending on how close the groundwater system and the release point is to a surface waster body, this groundwater contamination can make its way to rivers and streams. Animal operations, particularly so-called "concentrated animal feed operations," are another poorly recognized but certainly a major concern to the scientific community. Because in contrast to the human waste stream which is fairly closely monitored, animal waste stream is not monitored, and we expect that the contribution to the environment from this source is going to be major, perhaps even greater than the wastewater treatment plants.
Bradley: Well in fact many emerging contaminant compounds, or compounds that we would consider emerging contaminants if we actually detected them in the environment, are actually removed completely in the wastewater treatment plant facilities, at least at the current detection levels, on the other hand many other emerging contaminant compounds that we can detect in the environment, their concentrations are greatly reduced in the wastewater treatment facility as they move along the wastewater stream to eventual release. And decreases in concentrations can be in excess or ninety to ninety-five percent. Unfortunately, many of them are still being released to the environment, at very low concentrations. And this is kind of the point, this is kind of an emerging environmental concern and these wastewater treatment plants were not originally intended to address this type of contamination and in fact are not actually intended to address contaminant concentrations at these part per trillion levels, these very very low concentrations. It turns out that there is evidence that even at these really low concentrations some of these emerging contaminants are actually harmful to the environment.
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