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Pharmaceuticals
The EPA is proposing to add hazardous pharmaceutical wastes to the Universal Waste Rule in order to provide a system for disposing hazardous pharmaceutical wastes that is protective of public health and the environment. The proposed addition will make it easier for generators to collect and properly dispose of these items as hazardous wastes, resulting in a simpler and more streamlined waste management system.
This proposed rule applies to:
- pharmacies,
- hospitals,
- physicians’ offices,
- dentists’ offices,
- outpatient care centers,
- ambulatory health care services,
- residential care facilities,
- veterinary clinics, and
- other facilities that generate hazardous pharmaceutical wastes.
The rule encourages generators to dispose of non-hazardous pharmaceutical waste as universal waste, thereby removing this unregulated waste from wastewater treatment plants and municipal solid waste landfills. The addition of hazardous pharmaceutical waste to the Universal Waste Rule will facilitate the collection of personal medications from the public at various facilities so that they can be more properly managed.
Currently the federal Universal Waste Rule includes batteries, pesticides, mercury-containing equipment, and lamps. Universal wastes are typically generated in a wide variety of settings including industrial settings and households, by many sectors of society, and may be present in significant volumes in non-hazardous waste management systems.
Federal
Register Notice | PDF Version (26 pp, 345K, about PDF) - Proposed Rule - December 2, 2008
Federal Register Notice | PDF Version (1 pg, 61K, about PDF) - Extension of the Comment Period - January 30, 2009
The support materials for this rule and the public comments EPA received on the proposal are available for public review online, as explained below. Please note that proposed rule materials will not be available from Regulations.gov until the rule is published in the Federal Register
Fact Sheet || Fact Sheet (PDF) (1 pg, 61K, About PDF) || Frequent Questions
To use Regulations.gov:
- Select Docket Search.
- Select "Environmental Protection Agency" from the Agency drop-down menu.
- In the Docket ID box, type in the docket number (e.g., EPA-HQ-RCRA-2008-xxxx) and press the "Submit" button to receive search results. Be patient; loading the documents takes time.
Frequent Questions
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How is “pharmaceutical” and “pharmaceutical universal waste” defined under the proposed rule?
For the purposes of this proposed rule, pharmaceutical means any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine or allergenic), not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals; or any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine or allergenic), not containing a radioactive component, that is intended to affect the structure or function of the body in man or other animals. This definition includes products such as transdermal patches, and oral delivery devices such as gums or lozenges. This definition does not include sharps or other infectious or biohazardous waste, dental amalgams, medical devices not used for delivery or dispensing purposes, equipment, contaminated personal protective equipment or contaminated cleaning materials.
Also, in this proposed rule, a pharmaceutical universal waste is defined as a pharmaceutical that is a hazardous waste as defined in § 261.3, and containers (e.g., bottles, vials, IV bags, tubes of ointment/gels/creams, ampules, etc.) which have held any hazardous pharmaceutical waste and which would be classified as hazardous waste under § 261.7. The Agency decided to define “pharmaceutical universal waste” to ensure that any container which has held hazardous pharmaceutical wastes (and thus is also considered a hazardous pharmaceutical waste, unless that container is considered “RCRA-empty”) could also be managed in the universal waste system.
- What pharmaceutical drugs are considered hazardous waste?
There are approximately 31 commercial chemical products listed on RCRA‘s P- and U-lists that have pharmaceutical uses. As the P- and U-lists are based on chemical designations, this number does not completely represent the total number of brand name pharmaceuticals that may actually be listed hazardous wastes. For example, the following chemotherapy drugs, CTX, Cytotoxan, Neosar and Procytox, are U058 (cyclophosamide).
In addition, waste pharmaceuticals may also be hazardous because they exhibit one or more of the four characteristics of hazardous waste: ignitability, corrosivity, reactivity and toxicity. Characteristic pharmaceutical wastes include those that exhibit the ignitability characteristic, such as solutions containing more than 24% alcohol. An example of a pharmaceutical that may exhibit the reactivity characteristic is nitroglycerine. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide. Depending on the concentration in different pharmaceutical preparations, pharmaceuticals may also exhibit the toxicity characteristic because of the use of arsenic (D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), and silver (D011). As thousands of over-the-counter or prescription drugs are currently approved for sale in the U.S., it is difficult to provide a precise number of pharmaceuticals that are listed and/or characteristic under RCRA (for a complete listing of FDA-approved drugs, please see FDA’s Orange Book.
- What facilities generate hazardous pharmaceutical wastes and are they included in this proposal?
This proposed rule applies to hazardous pharmaceutical wastes generated by the following types of facilities: pharmacies, hospitals, physicians’ offices, dentists’ offices, other health care practitioners, outpatient care centers, ambulatory health care services, residential care facilities, veterinary clinics and reverse distributors. This rule does not apply to pharmaceutical manufacturing or production facilities.
EPA understands that many health care facilities may be unaware of the applicability of RCRA hazardous waste regulations to their hazardous pharmaceutical wastes and, thus, EPA anticipates that this proposed rule will also alert generators to the applicability of the RCRA hazardous waste regulations to their waste streams.
- Why is management of pharmaceutical waste difficult under the RCRA subtitle C hazardous waste regulations?
Hazardous waste generation and management practices at health care facilities and other generators of hazardous pharmaceutical wastes differ from practices of industrial hazardous waste generators in several ways that make the application of RCRA Subtitle C hazardous waste regulations difficult. Pharmaceutical waste is typically generated at a large number of points in relatively small quantities across a facility, such as at nursing stations, pharmacies, and patient, emergency and operating rooms. Furthermore, generators of hazardous pharmaceutical wastes tend to generate hundreds of different types of pharmaceutical waste while, in contrast, many industrial generators tend to generate only a few predictable waste streams in large quantities at relatively few generation points. Some of the difficulties that generators of hazardous pharmaceutical wastes have expressed concerning the current hazardous waste generator regulations relate to making the waste determination, generator status upgrade due to generation of acutely hazardous waste, hazardous waste listings, and accumulation time limits.
- Why can pharmaceutical waste be considered a universal waste?
EPA believes that hazardous pharmaceutical wastes meet the factors considered when determining whether a waste is appropriate for inclusion in the Universal Waste Rule. Specifically, most hazardous pharmaceutical wastes present a relatively low risk during accumulation and transport due to their form and packaging, which is typically in small, individually packaged dosages, such as pills or capsules. Hazardous pharmaceutical wastes are frequently generated in a wide variety of settings, including hospitals, pharmacies, long-term care facilities, veterinary offices and by reverse distributors, as well as in households. They also are generated by several different types of personnel at these facilities, including pharmacists, doctors, nurses, and patients. Finally, overall, hazardous pharmaceutical wastes are present in significant volumes in non-hazardous waste management systems. For instance, pharmaceutical wastes are generated by households and, therefore, end up in the municipal waste stream or going to publicly-owned treatment works (POTWs).
In addition, health care workers, retail pharmacy employees and other generators are often unfamiliar with or confused by RCRA hazardous waste management requirements, prompting them to dispose of hazardous pharmaceuticals as municipal or bulk wastes. This proposed action would streamline the current regulations governing these wastes, ensuring that larger quantities of hazardous pharmaceutical wastes are managed properly. Furthermore, this proposed rulemaking will bring to the generators attention that hazardous pharmaceutical wastes are subject to the RCRA hazardous waste regulations.
The UWR is specifically designed to reduce the complexity of the RCRA hazardous waste generator regulations for universal wastes. It streamlines the collection and handling requirements for widely-dispersed hazardous wastes and facilitates their inclusion in the hazardous waste management system. If this proposal is finalized, EPA expects that management of hazardous pharmaceutical wastes would improve and the regulatory burden for many hazardous pharmaceutical waste generators would decrease. This proposal provides a solution to many of the issues facing health care facilities and other hazardous pharmaceutical waste generators today.
- What are the major requirements under the proposed universal waste rule?
The proposed Pharmaceutical Universal Waste Rule is designed to streamline and reduce the complexity of the RCRA hazardous waste collection requirements. EPA expects management of hazardous pharmaceutical wastes to improve, while decreasing the regulatory burden for many hazardous pharmaceutical waste generators, large and small. Specifically, the universal waste program includes modified requirements for storage, labeling, shipment off site, employee training, responses to releases, and notification. For example, the streamlined standards include modified requirements for storage up to a year.
- How do these differ from the current generator regulations?
Under current RCRA requirements any facility that generates RCRA hazardous pharmaceutical waste is subject to the RCRA generator regulations that are applicable to its generator status, which could be a large quantity generator, a small quantity generator or a conditionally-exempt small quantity generator, depending on the total amount of hazardous waste generated at the site in a calendar month. Under the universal waste program, generators of hazardous pharmaceutical wastes will have the option of managing these wastes as “universal wastes.” If a facility opts to manage its hazardous pharmaceutical waste under the universal waste option, then that facility will become a “handler” of pharmaceutical universal waste, rather than a “generator” of hazardous pharmaceutical waste. Compared to a generator of hazardous pharmaceutical waste, a handler of pharmaceutical universal waste will have the following benefits: 1) an increased accumulation threshold; 2) an increased on-site accumulation limit; 3) an increased storage time limit; 4) no manifest requirement; and 5) basic training requirements.
- Should pharmaceutical waste be disposed of down the drain or via sewer systems?
In many instances, at health care facilities and pharmacies, pharmaceuticals are sent to a regulated medical waste incinerator. Additionally, many pharmaceutical wastes are disposed of down the drain. EPA generally considers sewer disposal inadvisable for pharmaceuticals and discourages this practice, unless specifically required by the label on the particular pharmaceutical. More information on proper drug disposal (PDF) (1 pg, 95K, About PDF). In hospitals and other health care facilities, the practice of disposing of pharmaceuticals to sewers has taken place. This has occurred despite the potential adverse effects of introducing waste pharmaceuticals into the environment, and the inability of wastewater treatment plants to treat some pharmaceuticals effectively.
Recent studies have documented the presence of various pharmaceutical chemicals and metabolic by-products in surface waters and groundwater in the United States, and the issue of pharmaceutical use and management has become increasingly important. EPA is conducting research on the presence of pharmaceutical compounds in waterbodies and any ecological effects the compounds may be causing, as well as research directed towards improving water treatment capabilities. Information on EPA’s research in pharmaceuticals and personal care products in the environment. For these and other reasons, pharmaceutical waste management has become an increasingly critical issue in environmental management for health care facilities.
- What is the economic impact of this rulemaking?
This proposed rule does not have any significant economic impacts on the regulated community. In addition, this action does not adversely affect small businesses. EPA estimates that the cost savings of the proposed rule will range from $33.9 million to $35.2 million per year for hospitals and reverse distributors combined. These cost savings largely reflect reduced disposal costs.
- When will this rulemaking go into effect?
As established by the Administrative Procedure Act, this rulemaking must undergo the notice and comment process. Once public comments are received, comments will be reviewed and the proposed rulemaking will be re-evaluated to determine if changes are warranted. This process takes several months to over a year depending on the nature of these comments. We expect that this rulemaking will be finalized in 2010. However, because this rule is less stringent than current RCRA generator regulations, authorized states are not required to modify their programs to adopt this regulation. Therefore, the regulated community cannot choose to manage their pharmaceutical wastes as universal wastes until the rule is adopted in their particular states.
