Frequent Questions about the Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule
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- Why is EPA proposing management standards for hazardous waste pharmaceuticals?
- What environmental benefits does EPA expect from new management standards for hazardous waste pharmaceuticals?
- Who is affected by this rulemaking?
- What is the definition of healthcare facility under the proposed rule and what is a pharmaceutical reverse distributor?
- What is the definition of pharmaceutical under the proposed rule?
- Which pharmaceuticals are considered hazardous waste?
- Why is management of hazardous waste pharmaceuticals difficult under the RCRA subtitle C hazardous waste generator regulations?
- Why do hazardous waste pharmaceuticals need new management standards?
- How do these proposed regulations differ from the current hazardous waste generator regulations?
- When will this rulemaking go into effect?
- How do I comment on this rule?
- Will EPA be holding a public hearing or other activities to encourage the public to submit comments?
Answer: EPA has two primary reasons for this proposal. First, to address concerns raised by stakeholders regarding the difficulty in implementing the industry-oriented Resource Conservation and Recovery Act (RCRA) hazardous waste regulations for the management of hazardous waste pharmaceuticals generated at healthcare facilities and managed at pharmaceutical reverse distributors. This rule proposes to revise and tailor the hazardous waste regulations to improve the management of hazardous waste pharmaceuticals by the healthcare sector and thereby enhance protection of human health and the environment.
Second, a number of studies have documented the presence of various pharmaceutical active ingredients and metabolic by-products in surface waters and groundwater in the United States. The pharmaceuticals entering the environment, through flushing or other means, are having a negative effect on aquatic ecosystems and on fish and animal populations. These findings highlight the increasing importance of pharmaceutical use and management, leading EPA to propose changes to the hazardous waste management standards for pharmaceuticals.
Answer: EPA is proposing to reduce the risk caused by hazardous waste pharmaceuticals that enter the environment through flushing down the sink or toilet. Specifically, this proposal is projected to prevent the flushing of over 6,400 tons of hazardous waste pharmaceuticals annually by banning healthcare facilities from using this practice to dispose of hazardous waste pharmaceuticals.
With this proposal, EPA strives to improve compliance at healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and pharmaceutical reverse distributors that generate and manage hazardous waste pharmaceuticals in order to improve environmental protection. Additionally, this proposed rule creates an environmentally preferable, convenient and practical management system that EPA encourages the healthcare sector to use for all waste pharmaceuticals.
Answer: Healthcare facilities and pharmaceutical reverse distributors that generate and manage hazardous waste pharmaceuticals will follow these new, tailored standards for managing their hazardous waste pharmaceuticals instead of the industry-oriented hazardous waste generator regulations.
This rule does not apply to pharmaceutical manufacturing, production facilities or other generators of hazardous waste pharmaceuticals.
Answer: EPA is proposing healthcare facility to mean any person that:
- provides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or
- sells or dispenses over-the-counter or prescription pharmaceuticals. This definition includes, but is not limited to, healthcare facilities include hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.
Pharmaceutical reverse distributors are entities that help healthcare facilities calculate and receive credit from pharmaceutical manufacturers when healthcare facilities have unused pharmaceuticals that they no longer need. Reverse distributors generally have contracts with healthcare facilities to help the healthcare facility manage its unused and sometimes expired waste pharmaceuticals.
Healthcare facilities send their unused pharmaceuticals to a reverse distributor they have a contract with and the reverse distributor reviews the unused pharmaceuticals received and works with the pharmaceutical manufacturer to facilitate providing manufacturer credit back to the healthcare facility. Then the pharmaceutical reverse distributor sends the waste pharmaceuticals for disposal.
Answer: The proposed definition of pharmaceutical is “any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal. This definition includes, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act, prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals.”
EPA believes a broad definition of pharmaceutical will benefit the healthcare sector, which has struggled with complying with the industry-oriented framework of the RCRA regulations.
Answer: As thousands of over-the-counter and prescription drugs are currently approved for sale in the United States, it is difficult to provide a precise number of pharmaceuticals that are considered hazardous waste. However, as with any other waste, a solid waste is considered hazardous waste if it meets a listing or exhibits a characteristic described in title 40 of the Code of Federal Regulations Part 261.
There are approximately 30 commercial chemical products listed on the P and U hazardous waste 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 all designated as a U058 hazardous waste for 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. For example, solutions containing more than 24 percent alcohol exhibit the ignitability characteristic. 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).
Answer: Hazardous waste generation and management practices at healthcare facilities 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 waste pharmaceuticals 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.
Answer: Healthcare workers and retail pharmacy employees are often unfamiliar with or confused by RCRA hazardous waste management requirements, prompting them to dispose of hazardous pharmaceuticals as municipal waste or medical waste. This proposed rule would streamline the current regulations governing these wastes, ensuring that larger quantities of hazardous pharmaceutical wastes are managed properly. Additionally, the rule proposes a tailored set of management standards specifically designed to reduce the complexity of the RCRA hazardous waste regulations for hazardous waste pharmaceuticals. 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 waste pharmaceutical would improve and the regulatory burden for many hazardous waste pharmaceutical generators would decrease. This proposal provides a solution to many of the issues facing healthcare facilities. By proposing a convenient and practical system for the management of hazardous waste pharmaceuticals that is easy to comply with, EPA will encourage healthcare facilities to manage all of their pharmaceutical waste - non-hazardous and hazardous - under the rule when finalized.
Answer: Under current requirements any facility that generates hazardous pharmaceutical waste is subject to the RCRA hazardous waste generator regulations. These regulations vary depending on the total amount and type of hazardous waste generated at the site in a calendar month. Many healthcare facilities are considered large quantity generators (LQGs) because they generate more than 1 kilogram (kg) of acute hazardous waste per month. Under the proposed management standards, generators of hazardous pharmaceutical wastes will manage their hazardous waste pharmaceuticals under subpart P of part 266 in title 40 of the Code of Federal Regulations (CFR), instead of the standard RCRA generator regulations found in part 262. Compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits:
- A healthcare facility will not become a LQG, with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
- A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
- The facility will not need to specify hazardous waste codes on manifests;
- The facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
- The facility will have basic training requirements.
Additionally, the proposed standards are tailored to how pharmaceutical reverse distributors operate and will replace the standard generator regulations for the accumulation and management of hazardous waste pharmaceuticals at pharmaceutical reverse distributors.
Answer: As required 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 number and nature of these comments. EPA expects that this rulemaking will be finalized in 2016 and will be effective at the federal level six months after promulgation.
Authorized states will be required to adopt this rule and to modify their RCRA programs in order to retain their authorized status because this rule is more stringent than current RCRA generator regulations. However, generally this rule will not become effective in states authorized for the RCRA program until states have adopted the rule.
The exception to this is the ban on flushing hazardous waste pharmaceuticals. This particular requirement is being proposed under the Hazardous and Solid Waste Amendments. Requirements promulgated under this authority become effective in all states on the effective date of the federal regulation, which is generally six months after promulgation of a final rule.
Answer: The comment period for this rule closed on December 24, 2015.
Answer: EPA encouraged public comment on all aspects of the proposed rulemaking and plans to engage stakeholders and the general public through various means. There are no public hearings planned at this point. EPA held a public webinar to present the main provisions being proposed and to answer some questions on the proposal. The webinar was be held on October 13, 2015 from 2:00 to 3:30 pm EDT. View slides from that webinar.