Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to add hazardous pharmaceutical wastes to the Universal Waste Rule. The Universal Waste Rule, originally promulgated on May 11, 1995, modified the Resource Conservation and Recovery Act's hazardous waste regulations by establishing a set of streamlined requirements for the collection of certain widely dispersed hazardous wastes, called “universal wastes.” This proposed rule would facilitate better management of pharmaceutical wastes by streamlining the generator requirements and encouraging generators of hazardous pharmaceutical wastes to manage them under the provisions of the Universal Waste Rule, which ensures that these hazardous pharmaceutical wastes are properly disposed of and treated as hazardous wastes. In addition, this proposed rule would facilitate the implementation of pharmaceutical take-back programs by removing RCRA barriers in the collection of pharmaceutical wastes from health care and other such regulated facilities, as well as facilitate the collection of pharmaceutical wastes from households, including non-hazardous pharmaceutical wastes.
Comments must be received on or before February 2, 2009. Under the Paperwork Reduction Act, since the Office of Management and Budget (OMB) is required to make a decision concerning the Information Collection Request (ICR) between 30 and 60 days after December 2, 2008, a comment to OMB is best assured of having its full effect if OMB receives it by January 2, 2009.
Submit your comments, identified by Docket ID No. EPA–HQ–RCRA–2007–0932, by one of the following methods:
•
•
•
•
•
Lisa Lauer, Office of Solid Waste (5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: 703–308–7418; fax number: 703–605–0595; e-mail address
This proposed rule could affect up to 634,552 entities in approximately 10 industries involved in health care and/or management of hazardous pharmaceutical wastes, as defined in this proposed rule. This includes 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. Of these entities, EPA's Biennial Reporting System (BRS) indicates that approximately 181 are large quantity generators (LQGs) of hazardous waste. The remainder are likely to be either small quantity generators (SQGs) or conditionally-exempt small quantity generators (CESQGs). Under this proposal, hazardous pharmaceutical waste generators may elect to have their hazardous pharmaceutical waste remain regulated under the current Resource Conservation and Recovery Act (RCRA) generator regulations as set forth in 40 CFR part 262, or may choose to manage their hazardous pharmaceutical wastes under the Universal Waste Rule (UWR). In RCRA-authorized states, the option of managing hazardous pharmaceutical waste under this proposal would be available once it has been adopted by the state.
1.
2.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible.
• Make sure to submit your comments by the comment period deadline identified.
3.
Documents also are available on microfilm. The EPA/DC staff help patrons locate needed documents and operate the microfilm machines. The billing fee for printing microfilm documents is the same as for photocopying documents.
Patrons who are outside of the metropolitan Washington, DC, area can request documents by telephone. The photocopying and microfilming fee is the same as for walk-in patrons. If an invoice is necessary, EPA/DC staff can mail one with the order.
These regulations are proposed under the authority of sections 2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act of 1970, as amended by the Resource Conservation and Recovery Act of 1976 (RCRA), and as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 U.S.C. 6912(a), 6921, 6922, 6923, 6924, 6926, 6927, 6930 and 6937.
This action proposes to add pharmaceutical wastes that are RCRA hazardous wastes to the universal waste system. Similar to other universal wastes, pharmaceutical wastes are produced by a large and diverse community of generators, often in small volumes. As discussed in the economic assessment prepared for this proposed rulemaking, over 600,000 individual facilities in the United States, including approximately 40,000 retail pharmacies, over 7,000 hospitals, and more than 300,000 physicians and dental offices, may be generators of hazardous pharmaceutical wastes. For example, it has been estimated that LQG hospitals in the United States generate a total of 10,600 tons of RCRA hazardous pharmaceuticals waste annually, while a single retail pharmacy may only generate 5 pounds of hazardous pharmaceutical wastes in a year (“Assessment of the Potential Costs, Benefits, and Other Impacts of Adding Pharmaceuticals to the Universal Waste Rule, as Proposed.” October 2008). Within these facilities, hazardous pharmaceutical waste may be generated in a single location (such as a pharmacy), or in multiple locations (such as hospital pharmacies, emergency rooms, operating rooms, and nursing stations) by many individuals. Pharmaceutical wastes may be RCRA hazardous because they contain any of 31 listed hazardous waste chemicals, although many may be identified by a commercial name (rather than a chemical name), making it more difficult to readily identify them as potentially hazardous waste.
Some pharmaceutical wastes are hazardous wastes because they exhibit one or more of the four hazardous waste characteristics. This combination of a large number of individual generators, many with multiple generation points within their facilities, with a substantial number of chemicals potentially rendering pharmaceutical wastes RCRA hazardous, has made implementation of the RCRA hazardous waste regulations difficult for many of these facilities. The universal waste regulations help avoid such mismanagement by streamlining the collection requirements for certain hazardous wastes. The proposed rule may also reduce hazardous waste in the municipal solid waste stream by making it easier for universal waste handlers to collect these items and send them for proper disposal. Thus, expansion of the universal waste system to include hazardous pharmaceutical wastes may lead to better management of these wastes by providing a more streamlined, and effective waste management system. Due to the simplified requirements, this action, if finalized, would also provide regulatory relief to health care facilities, retail pharmacies, veterinary clinics and any other entities that generate hazardous pharmaceutical wastes. Moreover, this proposed rulemaking will alert generators of pharmaceutical wastes to the applicability of the RCRA hazardous waste regulations to their waste streams. Also, we anticipate that waste management systems established under this rule would facilitate the management of other pharmaceutical wastes, particularly those that may pose hazards if not properly managed, but are not regulated as hazardous under RCRA. Finally, the addition of hazardous pharmaceutical wastes to the Universal Waste program would facilitate the management of pharmaceutical wastes via pharmaceutical take-back programs by removing RCRA barriers (e.g., hazardous waste determination, storage accumulation and time limits, etc.) for health care and other such regulated facilities that generate hazardous pharmaceutical wastes, as well as facilitate the collection of pharmaceutical wastes from households.
Any facility that generates RCRA hazardous pharmaceutical waste is subject to the RCRA generator regulations at 40 CFR part 262.
Because RCRA generator status is determined on a monthly basis, it is possible that a generator's status can change from one month to the next, depending on the amount of hazardous waste generated in a particular month. This is commonly referred to as “episodic generation.” If a generator's status does in fact change, the generator is required to comply with the respective regulatory requirements for that class of generators for any hazardous waste generated in that particular month (i.e., LQG, SQG, CESQG).
For the purposes of this proposed rule, “pharmaceutical” refers to “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
In contrast, this definition does
In addition, for the purposes of this rulemaking, the term “pharmaceutical universal waste” means a pharmaceutical that is a hazardous waste as defined in § 261.3, and containers (
The Agency is aware that the definitions in this proposed rule may overlap with similar definitions in other statutes implemented by other agencies. For example, the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Controlled Substances Act both define and regulate aspects of pharmaceuticals, and what the FFDCA considers a “device,” EPA may consider a “container.” Definitions from these other statues should not be confused with those set out in this proposed rule. To avoid confusion, EPA has made an effort to use different terminology (such as “pharmaceutical” instead of the FFDCA term “drug”) and to provide definitions appropriate to waste management under the UWR framework in this proposed rule. Thus, in order to determine whether a particular waste may be managed as a pharmaceutical universal waste, the generator must look to the definitions in this proposed rule, and not rely on the definitions contained in other regulatory programs.
Any person who generates a “solid waste” is required by 40 CFR 262.11 to determine whether such waste meets the definition of RCRA hazardous waste. Proper hazardous waste determination is essential to the success of, and is the foundation of, the “cradle to grave” RCRA hazardous waste program. The hazardous waste determination process can be simplified into several basic steps:
(1) Is the material in question a solid waste (as defined in 40 CFR 261.2)?
(2) Is the solid waste excluded from regulation as a hazardous waste under 40 CFR 261.4?
(3) Is it or does it contain a hazardous waste listed in Subpart D of Part 261?
(4) Does the waste exhibit any of the characteristics defined in Subpart C of Part 261 (ignitability, corrosivity, reactivity or toxicity)?
The RCRA hazardous waste generator regulations are applicable to all pharmaceutical wastes that meet the definition of “hazardous waste” set out in subtitle C of RCRA. Some pharmaceutical wastes are listed hazardous waste under 40 CFR 261.31–33, while some may exhibit one or more of the four chemical or physical characteristics of ignitability, corrosivity, reactivity or toxicity, as defined in 40 CFR 261.21–24. Others may qualify as “mixed waste” when they contain both hazardous waste subject to the requirements of RCRA
• P-listed pharmaceutical wastes
• U-listed pharmaceutical wastes include chloral hydrate (CIV) (U034),
• Characteristic
On the other hand, there are exceptions. Specifically, EPA has interpreted 40 CFR 261.33 to mean that any syringe containing the residue of a P-or U-listed drug is not considered a listed hazardous waste and would be hazardous only if the residue exhibits a hazardous waste characteristic (see “Epinephrine Residue in a Syringe is Not P042,” December 1994, RO #13718). In addition, the P- and U-lists consist of commercial chemical products, which are defined as commercially pure grades and technical grades of the listed chemicals or chemical formulations in which the listed chemical is the sole active ingredient, which has not been used for its intended purpose (
Hazardous pharmaceutical wastes may be generated through a wide variety of activities in a number of different areas within a health care facility. For example, in the health care facility's pharmacy, waste may be generated by: IV preparation; general compounding
At hospitals, pharmacies generally stock thousands of different items, each of which must be evaluated against state and federal hazardous waste regulations to determine whether any of the items would be considered a hazardous waste if discarded.
Doctors' offices, veterinary clinics and other small health care facilities manage their pharmaceutical wastes in a similar manner as hospitals, although on a smaller scale. However, through communications with outside stakeholders, EPA understands that many health care facilities may be unaware of the applicability of the RCRA hazardous waste regulations to their hazardous pharmaceutical waste.
Many times, at health care facilities, pharmaceuticals are sent to a regulated medical waste incinerator (rather than a RCRA-permitted incinerator). Additionally, many health care facilities dispose of their pharmaceutical wastes down the drain.
Pharmacies, such as those found in retail drug stores and health care facilities, including long-term care facilities, may be subject to the RCRA hazardous waste generator regulations. Pharmacies may generate hazardous pharmaceutical wastes via compounding or preparation, or if any portion of their pharmaceutical stock expires, is damaged, or is returned by the consumer. Pharmacies can stock thousands of different items, each of which must be evaluated against state and federal hazardous waste regulations to determine whether the item would be considered a hazardous waste when discarded.
Nursing homes, assisted living centers, and other long-term care facilities also may be subject to the RCRA hazardous waste generator regulations. However, many long-term care facilities may be unaware of the applicability of the RCRA hazardous waste regulations to their hazardous pharmaceutical waste.
Most long-term care facilities generate two types of hazardous pharmaceutical waste. First, the facility itself may generate hazardous wastes as a result of its central management of pharmaceuticals in its pharmacy or pharmacy-like area. These hazardous pharmaceutical wastes would be subject to the RCRA hazardous waste generator regulations since the pharmaceuticals are under the control of the facility, and, thus, the resulting wastes are generated by that facility (
Secondly, patients and residents in long-term care facilities may generate hazardous wastes. Those pharmaceuticals that are under the control of the patient or resident of the long-term care facility, when discarded, would be subject to RCRA's household hazardous waste exclusion (40 CFR 261.4(b)(1)). Hazardous pharmaceutical wastes generated by the resident are excluded from regulation because they are considered to be derived from a household.
Based on information provided by reverse distribution companies, the Agency understands that pharmaceutical manufacturers often offer credit on the return of their unused or expired pharmaceuticals as a financial incentive to pharmacies, hospitals and other health care facilities to stock their products, (since many drugs are expensive and may have short shelf lives). Reverse distributors of pharmaceuticals provide a service to the health care industry by keeping track of the manufacturer return policies and facilitating the return of these unused or expired drugs for potential credit from the manufacturer. In addition, this reverse distribution system for pharmaceuticals helps ensure that unused and expired pharmaceuticals do not get diverted to inappropriate uses, and that the returned pharmaceuticals, are managed appropriately.
Because unused or expired pharmaceuticals are being returned (via the reverse distributor) for possible manufacturer credit, they still have potential value to the pharmacy or hospital and are thus not considered wastes. Therefore, when a health care facility hires a reverse distributor to manage its unused/expired pharmaceuticals, the health care facility can ship the unused or expired pharmaceuticals by using commercial carriers or mail-in services. Once the unused or expired pharmaceuticals reach the reverse distributor, the reverse distributor determines which drugs are eligible for credit from the manufacturer or distributor, and ensures that the health care facility receives the proper credit. Once credit is recorded (for eligible drugs), the manufacturer will instruct the reverse distributor to either dispose of the drug or to ship it back (to the manufacturer's facility). Thus, for those credited pharmaceuticals that the manufacturer has instructed the reverse distributor to dispose of, and for those pharmaceuticals not eligible for credit, reverse distributors must determine which are RCRA solid and hazardous wastes. Then, they must manage all such wastes in accordance with federal, state, and/or local environmental regulations.
The Agency notes that this discussion pertains only to reverse distributors of pharmaceuticals and does not attempt to describe reverse distribution systems that may exist for any other consumer product. EPA requests comment on the
Pharmaceutical take-back or collection programs are periodic or on-going events intended to allow patients and consumers to bring their unused drugs to a central location, such as a local pharmacy or police station for proper management and disposal. Some communities have begun to arrange these programs for their citizens, but they are not widely available. Take-back programs generally facilitate the proper handling and disposal of drugs that may be hazardous wastes under RCRA.
The Agency supports the establishment of these take-back programs as they redirect hazardous and non-hazardous pharmaceutical wastes generated by households, from municipal trash handling systems and sewer systems to hazardous waste management facilities. It should be noted that in establishing and operating pharmaceutical take-back programs, community organizers should seek input from their state and/or local environmental agencies. Additionally, they must seek assistance from the U.S. DEA to ensure the programs comply with federal laws and regulations concerning the handling and management of controlled substances.
While EPA believes that this rulemaking, if finalized, will simplify pharmaceutical take-back programs by streamlining the requirements for handling hazardous pharmaceutical wastes received as part of a take-back program,
In its proposal for the Universal Waste management system, EPA discussed the differences between large industrial or manufacturing facilities' generation of hazardous waste and hazardous waste generation by commercial, non-manufacturing entities (58 FR 8102, February 11, 1993). In that discussion, the Agency expressed concern about the difficulties of implementing the RCRA hazardous waste regulatory program for commercial products that are hazardous when discarded at the end of their useful life, which are widely dispersed in commerce, and which may be generated as waste in relatively small volumes by large numbers of generators nationwide. Pharmaceuticals, when discarded, are such wastes. Specifically, pharmaceutical waste is generated at a large number of facilities nationwide, potentially at several locations within a facility, such as at hospital nursing stations, pharmacies, and patient, emergency and operating rooms, and typically in relatively small quantities. Furthermore, thousands of pharmaceuticals are approved for use, so individual generators of hazardous pharmaceutical wastes may generate hundreds of different types of pharmaceutical waste, some of which may be regulated as RCRA hazardous, and some of which are not.
The Agency's information about pharmaceutical waste management is limited. However, we do know that there are over 7,000 hospitals, and approximately 72,000 long-term-care facilities, 27,000 veterinary care facilities, 40,000 retail pharmacies, and several hundred thousand offices of doctors, dentists and other health care service providers in the United States, all of which are likely to generate some volume of pharmaceutical wastes and many of which will generate some that are RCRA hazardous. Yet, based on the 2005 Biennial Report, only 94 hospitals and 19 pharmacies, for example, reported themselves to be LQGs of hazardous waste, and no long-term care or veterinary care facilities did so. While the vast majority of pharmaceutical waste generators are undoubtedly SQGs or CESQGs, information provided by generators themselves show a low level of knowledge about RCRA and its regulatory requirements, even on the part of some large facilities.
The following sections provide an overview of some of the difficulties that generators of hazardous pharmaceutical waste have expressed concerning the current hazardous waste generator regulations.
As a result of communications with pharmaceutical waste generators, the
Other issues compound these difficulties in making hazardous waste determinations for pharmaceutical wastes. Pharmacists, nurses, and other health care workers generally do not receive training on hazardous waste management during their academic studies, while safety and environmental service managers may not be familiar with the active ingredients and formulations of the hundreds of available pharmaceutical products that may be used at a health care facility to enable them to make hazardous waste determinations.
Failure to comply with the hazardous waste regulations by improperly managing and disposing of such waste can and has resulted in violations of the RCRA hazardous waste regulations, leading to large penalties for all types of health care facilities, from doctors' and veterinarians' offices and clinics, to pharmacies, long-term care facilities, and hospitals (see Profile of the Health Care Industry, EPA Office of Compliance Sector Notebook Project, EPA Publication # EPA/310–R–05–002, also found at
In addition to the hazardous waste regulations, pharmaceuticals are subject to a number of other statutes administered by other federal agencies and their regulatory regimes, and health care facilities have expressed confusion regarding the overlap between these other regulations and the hazardous waste requirements. Examples include pharmaceuticals that are controlled substances and subject to the Controlled Substances Act and DEA regulations; pharmaceuticals that have been prescribed to a patient and are subject to the Health Insurance Portability and Accountability Act (HIPAA) patient privacy requirements; pharmaceuticals with a radioactive component and are subject to the Atomic Energy Act (AEA); and infectious pharmaceutical wastes that are subject to state and local medical waste regulations.
Hospitals and other health care facilities have also reported that their RCRA hazardous waste generator status periodically shifts from CESQG to LQG status due to the acutely hazardous (P-listed) pharmaceutical wastes they generate, since P-listed wastes have a low threshold for triggering a change in generator status (as CESQGs cannot generate or accumulate more than one kilogram per month), and CESQGs could find themselves easily exceeding this threshold to become a LQG. In addition, the requirements that containers once holding P-listed hazardous wastes are themselves considered P-listed hazardous wastes (
Health care facilities and other pharmaceutical waste generators also express concern that the accumulation time limits for hazardous waste generators are not cost-effective with regard to hazardous pharmaceutical wastes. Pharmaceutical wastes are typically packaged and accumulated in relatively small volumes, so it can take a significant amount of time for a health care facility to accumulate enough waste to make offsite shipment using a hazardous waste transporter cost-efficient. Thus, health care facilities have advocated longer accumulation times for hazardous pharmaceutical wastes.
This proposed rule would incorporate hazardous pharmaceutical wastes into 40 CFR part 273, the UWR. The UWR was promulgated on May 11, 1995 (60 FR 25491), modifying the hazardous waste regulations by establishing a set of streamlined requirements for the collection of certain widely-dispersed hazardous wastes, which are called “universal wastes.” The UWR is designed to accomplish three general goals (
• To encourage resource conservation.
• To improve implementation of the current RCRA subtitle C hazardous waste regulatory program.
• To separate universal waste from the municipal waste stream.
The current federal universal wastes system includes hazardous waste batteries, certain hazardous waste pesticides, mercury-containing equipment, and hazardous waste lamps. These wastes share several characteristics (
Under the UWR, handlers and transporters who generate or manage items designated as a universal waste are subject to the management standards under 40 CFR part 273, rather than the full RCRA subtitle C hazardous waste regulations. Universal waste handlers include universal waste generators and collection facilities. The regulations distinguish between “large quantity handlers of universal wastes” (LQHUW; those who handle more than 5,000 kilograms of total universal waste at one time) and “small quantity handlers of universal waste” (SQHUW; those who handle 5,000 kilograms or less of universal waste at one time). The 5,000 kilogram accumulation criterion applies to the quantity of all universal wastes accumulated. The streamlined standards include modified requirements for storage, labeling and marking, preparing the waste for shipment offsite, employee training, responses to releases, and notification.
Transporters of universal waste are also subject to less stringent requirements than the full RCRA subtitle C hazardous waste transportation regulations. The primary difference between the universal waste transporter requirements and the subtitle C transportation requirements is that no manifest is required for the transport of universal waste. The details of the universal waste management standards for both handlers and transporters will be addressed later in this preamble.
Under the UWR, destination facilities are those facilities that treat, store, dispose, or recycle universal wastes. Universal waste destination facilities are subject to all currently applicable requirements for hazardous waste treatment, storage, and disposal facilities (TSDFs), including the requirement to obtain a RCRA permit for such activities. Hazardous waste recycling facilities that do not store hazardous wastes prior to recycling may be exempt from permitting under the federal regulations (40 CFR 261.6(c)(2)).
Finally, states that are authorized to implement the UWR may add wastes that are not federal universal wastes to their lists of universal wastes. Therefore, in some states, hazardous pharmaceutical wastes may already be regulated as universal wastes.
The Agency expects that the addition of hazardous pharmaceutical wastes to the UWR will improve the management of such pharmaceutical wastes by providing a more streamlined waste management system, while ensuring that they are sent to hazardous waste management facilities for final disposal. In addition, this proposed rulemaking would increase the accumulation and storage time limits in comparison to the full RCRA subtitle C hazardous waste regulations for hazardous pharmaceutical wastes, which would allow facilities to accumulate enough waste to make shipment through a hazardous waste hauler more cost-effective. Finally, while not required, this proposed rulemaking could facilitate the management of non-RCRA pharmaceutical wastes as universal wastes. If facilities choose to manage these non-RCRA pharmaceutical wastes as universal wastes, then: (1) Health care and other regulated facilities would no longer need to identify and separate hazardous pharmaceutical wastes from non-hazardous pharmaceutical wastes; and (2) the regulated community could decide to develop drug take-back programs, resulting in a decrease in the disposal of pharmaceutical wastes in municipal solid waste disposal facilities.
EPA considers eight factors when evaluating whether or not it is appropriate to include a particular waste or wastes in the universal waste system. The factors were designed to determine whether regulating a particular hazardous waste under the streamlined standards of the UWR would improve overall management of the waste. These factors, which are codified at 40 CFR 273.81, are: (1) The waste, or category of waste, as generated by a wide variety of generators, should be a listed or characteristic hazardous waste; (2) the waste, or category of waste, should not be exclusive to a particular industry or group of industries, but generated by a wide variety of establishments; (3) the waste, or category of waste, should be generated by a large number of generators and generated frequently, but in relatively small quantities; (4) the systems to be used for collecting the waste, or category of waste (including packaging, marking and labeling practices), should ensure close stewardship of the waste; (5) the risks posed by the waste, or category of waste, during accumulation and transport should be relatively low compared to the risks posed by other hazardous waste, and specific management standards would be protective of human health and the environment during accumulation and transport; (6) the regulation of the waste, or category of waste, under 40 CFR part 273 will increase the likelihood that the waste will be diverted from non-hazardous waste management systems (
The Agency weighed these factors collectively, rather than individually, when deciding to propose to add hazardous pharmaceutical waste to the universal waste system; however, as discussed in the final preamble of the UWR (60 FR 25492, May 11, 1995), it is not necessary for a particular waste or wastes to meet every factor to be classified as a universal waste (see 60 FR 25513). The following section discusses how pharmaceutical wastes meet these factors, and EPA solicits comment on the applicability of these factors to hazardous pharmaceutical wastes.
1.
2.
3.
4.
5.
6.
Additionally, regulation of hazardous pharmaceutical wastes under the UWR will facilitate the collection of commingled hazardous and non-hazardous pharmaceutical wastes at healthcare-related and other such facilities.
7.
For the above reasons, the Agency is proposing to add pharmaceutical wastes to the Universal Waste framework.
EPA believes that hazardous pharmaceutical wastes share the characteristics of other universal wastes discussed above. 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, among others. They also are generated by several different types of personnel at these facilities, including pharmacists, doctors, nurses, and individual consumers. In addition, the RCRA hazardous waste management requirements often are unfamiliar to health care workers, retail pharmacy employees and other generators, prompting them to improperly dispose of hazardous pharmaceutical wastes 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. By proposing to incorporate hazardous pharmaceutical waste in the universal waste regulations, EPA expects the management of hazardous pharmaceutical wastes to improve, while decreasing the regulatory burden for many hazardous pharmaceutical waste generators, large and small.
The UWR also allows handlers to transport such materials with a common carrier that abides by the regulations set forth in Subpart D of the UWR, rather than a hazardous waste transporter, and generally would no longer require a handler to manifest waste to destination facilities.
This proposal would streamline the hazardous waste identification process for pharmaceutical waste generators in a number of ways. Specifically, the universal waste rule does not distinguish between acutely hazardous P-listed wastes and other hazardous wastes. As a result, handlers
As discussed above, handlers of universal waste are eligible for longer on-site accumulation time limits when compared to generators of hazardous waste (non-universal wastes). Also, while SQGs are subject to the hazardous waste generation volume limits of 1,000 kilograms per month, small quantity handlers of pharmaceutical universal waste would be subject to a higher threshold of 5,000 kilograms of all universal waste at any one time.
EPA expects these increased generation volumes and accumulation time limits for pharmaceutical universal
EPA also expects that the longer accumulation times will allow pharmaceutical universal waste handlers to accumulate their waste in volumes large enough to make management of the pharmaceutical universal wastes more cost-effective by allowing handlers more control and flexibility in scheduling the removal of waste from their facility and by reducing the number of shipments. To the extent that this proposed rule results in the co-management of RCRA hazardous and non-hazardous pharmaceuticals with federally controlled substances, compliance with the Controlled Substances Act and DEA regulations might impact accumulation times for those wastes that are controlled substances.
The Agency believes that pharmaceutical wastes meet the criteria for being identified as a universal waste and, thus, inclusion in the universal waste system is appropriate. Similarly, some states have already added hazardous pharmaceutical wastes to their universal waste programs
It should be noted, however, that the inclusion of hazardous pharmaceutical wastes in the universal waste system will not supersede or otherwise amend other laws or regulations and would only become effective if adopted and implemented by individual authorized states. Therefore, any entity involved in the handling or transport of pharmaceutical wastes as universal wastes must continue to comply with all requirements of the Controlled Substances Act and DEA regulations (21 CFR parts 1300–1316) for the handling of Schedule II through V drugs. Furthermore, any entity involved in the handling or transport of pharmaceutical wastes as universal wastes must comply with the U.S. Department of Health and Human Services' HIPAA standards in 45 CFR Parts 160, 162, and 164.
With this proposal, EPA intends to stay within the existing UWR's framework. Therefore, the management requirements for pharmaceutical universal waste in this proposed rule do not significantly differ from the existing requirements for other universal wastes in 40 CFR part 273. By proposing to add hazardous pharmaceutical wastes to the UWR, EPA is not reopening, and does not seek new comment upon, any provisions of the UWR not specifically addressed in this notice.
If finalized, the UWR will regulate only those pharmaceuticals that are RCRA hazardous waste. Under the current federal hazardous waste regulations, until a pharmaceutical is actually discarded, or the decision is made to discard the material, the pharmaceutical is not subject to the RCRA hazardous waste regulations since a material must first be a solid waste before it can be considered a hazardous waste (
EPA is proposing to include within the universal waste system all pharmaceuticals that are hazardous wastes. Under this proposal, entities generating hazardous pharmaceutical wastes would have two options for managing them. Facilities may choose to continue managing these hazardous wastes under the full subtitle C hazardous waste regulations at 40 CFR parts 260 to 268 and 270, or they may choose to manage their hazardous pharmaceutical wastes as universal wastes using the requirements laid out in 40 CFR part 273. It is important to note that only pharmaceutical wastes that are listed or characteristic hazardous wastes (40 CFR 261.21–.33) are required to be managed under either the subtitle C hazardous waste regulations or, where allowed, under the UWR. However, as noted previously, EPA intends the UWR to encourage generators of hazardous wastes to manage the non-hazardous portions of
• Any drug that contains a P-or U-listed chemical, regardless of whether or not that P-or U-listed chemical is the sole active ingredient
• Chemotherapy drugs; and
• Drugs meeting OSHA and NIOSH hazardous drug criteria.
It is important to note that this rulemaking would not apply to any hazardous pharmaceutical waste that also contains a radioactive material component (
The Agency would like this opportunity to reiterate that RCRA, as well as this proposed rulemaking, does not supersede the requirements of the Controlled Substances Act and DEA regulations for the disposal of controlled substances. Thus, any entity generating, collecting, handling or managing a RCRA hazardous pharmaceutical waste that is also a controlled substance in Schedule II–V
Due to the stringent management of pharmaceutical wastes that are both controlled substances and RCRA hazardous wastes and their expected low volumes of generation due to the limited numbers of listed control substances, EPA also is seeking comment on whether or not hazardous pharmaceutical wastes that are also Schedule II-V controlled substances should be included in the federal universal waste program.
The Agency requests information on whether health care facilities, reverse distributors and other hazardous pharmaceutical waste generators will choose to manage their pharmaceutical wastes as universal wastes if this proposed rule is finalized. Specifically, the Agency is requesting information on the likelihood of the following scenarios: (1) Facilities choosing to manage their hazardous and non-hazardous pharmaceutical wastes as universal wastes; (2) facilities choosing to manage their hazardous pharmaceutical wastes and only certain categories (such as certain chemotherapy drugs) of pharmaceutical wastes not currently regulated as hazardous waste as universal wastes; (3) facilities choosing to manage only their hazardous pharmaceutical wastes as universal wastes; and (4) facilities choosing to manage their hazardous pharmaceutical wastes as hazardous wastes, not universal wastes. Furthermore, the Agency requests an explanation of why generators would choose one approach over another. Additionally, the Agency solicits information on the amount of pharmaceutical wastes generated at various health care facilities, as well as these facilities' pharmaceutical waste management practices. Finally, the Agency is seeking any cost information for the aforementioned scenarios.
Currently, under the household hazardous waste exclusion in 40 CFR 261.4(b)(1) of the federal hazardous waste program, hazardous wastes from households are not subject to the hazardous waste regulations, including the UWR provisions. However, EPA encourages “households” to dispose of any pharmaceutical wastes generated in their homes through local household hazardous waste management programs or community take-back programs. Links for finding pharmaceutical take-back programs and donation programs
CESQGs are subject to limited waste management requirements under 40 CFR 261.5. Specifically, CESQGs are not required to obtain an EPA ID number or to comply with the same accumulation and storage, manifesting, or recordkeeping and reporting requirements as SQGs or LQGs. However, CESQGs are required to identify which wastes are hazardous wastes, comply with some accumulation requirements and ensure that their hazardous wastes are properly treated or disposed. Under the existing UWR provisions, CESQGs may choose to manage certain hazardous wastes in accordance with either the CESQG regulations under 40 CFR 261.5 or under the UWR at 40 CFR part 273. In addition, the provision under 40 CFR 273.8(b), which requires any universal waste that is mixed with a household or CESQG waste to be handled as a universal waste in accordance with 40 CFR part 273, will remain unchanged by this proposal, if finalized.
The Agency requests information on whether persons exempted from subtitle C regulation would choose to manage their pharmaceutical wastes under the UWR.
A handler of universal waste can be a person who generates universal waste. A handler can also be a person who receives universal waste from generators or other handlers, consolidates the waste, and then sends it on to other handlers or treatment or disposal facilities. Universal waste handlers accumulate universal waste, but do not treat, recycle or dispose of them. In addition, each location that is generating or collecting universal waste is considered a separate universal waste handler. Therefore, if a company has several locations at which universal waste is generated or collected, each location is a separate handler. Finally, the accumulation threshold that distinguishes between small and large handlers does not refer to
As an example of who may be treated as a universal waste handler, if hazardous pharmaceutical wastes are added to the UWR, a hospital that is currently a LQG under the subtitle C regulations can decide to manage its hazardous pharmaceutical waste as a universal waste, as a universal waste handler.
Under this proposal, most of the existing universal waste requirements currently applicable to SQHUWs and LQHUWs would also apply to handlers of hazardous pharmaceutical wastes. For both SQHUWs and LQHUWs, these requirements include labeling and marking, accumulation time limits, employee training, response to releases, requirements related to off-site shipments, and export requirements. Sections V.B.3.a and V.B.3.b discuss the specific differences between the small quantity handler and large quantity handler requirements for universal wastes.
As defined in 40 CFR 273.9, a SQHUW is a universal waste handler who accumulates less than 5,000 kilograms total of universal waste at any time (e.g., batteries, pesticides, mercury-containing equipment (MCE), lamps and pharmaceuticals (as proposed), calculated collectively). SQHUWs do not need to notify EPA of their universal waste activities (as noted under 40 CFR 273.12) and are not required to obtain an EPA identification number prior to managing universal wastes. In addition, SQHUWs have less stringent requirements for the training of employees (discussed in section V.G.) and for the tracking of universal wastes (discussed in section V.J.) compared to the requirements for LQHUWs. However, if a SQHUW accumulates 5,000 kg or more of universal waste at any one time, that handler must then comply with all LQHUW requirements and must continue to do so for the remainder of the calendar year.
EPA is proposing to maintain and is soliciting comment on maintaining the current SQHUW threshold and notification requirements for those small quantity handlers that would be managing hazardous pharmaceutical wastes as universal wastes. EPA is not soliciting comment on or considering changes to these requirements for SQHUWs of other universal wastes.
A LQHUW is defined in 40 CFR 273.9 as a universal waste handler who accumulates 5,000 kilograms or more of universal waste at any time (
EPA is proposing to maintain the existing LQHUW threshold and notification requirements for those large quantity handlers that would be managing hazardous pharmaceutical wastes as universal wastes and solicits comments on this proposal. EPA is not soliciting comment on or considering changes to these requirements for LQHUWs of other universal wastes.
As used in this proposed rule,
In contrast, the definition of pharmaceutical is not intended to include sharps (
In addition, for the purposes of this rulemaking, the term “pharmaceutical universal waste” means a pharmaceutical that is a hazardous waste as defined in § 261.3, and containers (
The Agency is requesting comment on the proposed definition of “pharmaceutical.” Specifically, EPA is seeking comment on whether the definition of “pharmaceutical” is clear and appropriate, and whether it encompasses the full range of pharmaceuticals available. In addition, EPA is seeking comment on whether this definition inadvertently includes items not intended to be incorporated into the universal waste system, such as dental or medical devices. The Agency is also requesting comment on, in order to add hazardous pharmaceutical wastes to the UWR, whether additional elements not included in this proposal need to be added to this proposed definition. Finally, the Agency requests comment on whether the proposed definition of “pharmaceutical universal waste” is clear and appropriate.
As it is stated in 40 CFR 273.11 and 273.31, all universal waste handlers are prohibited from disposing of universal wastes, or diluting or treating universal waste, except for responding to releases (as provided in 40 CFR 273.17 and 273.37), or managing specific wastes (as provided in 40 CFR 273.13 and 273.33). Handlers of pharmaceutical universal wastes must manage these wastes in a manner that prevents releases of universal wastes or components thereof into the environment (as is required for other universal wastes;
To prevent their release into the environment, the Agency is proposing to require that pharmaceutical universal wastes must be packed into containers
Unlike the container requirements for other universal wastes, the proposed container requirements for pharmaceutical universal wastes do not include the requirement that containers be “closed.” EPA believes that requiring closed containers for pharmaceutical wastes would provide a burden that is unwarranted in these situations as most pharmaceutical universal wastes would be unused and in their original packaging when disposed, and so accumulating these wastes in a larger container would pose little, if any, risk of release through spillage, leakage or emission to the air. Thus, as proposed, accumulation containers for pharmaceutical universal wastes may be open, covered, or sealed, as long as the performance standard to prevent releases is met.
EPA seeks comment on whether the proposed container management standards are appropriate for pharmaceutical universal wastes. Additionally, EPA seeks comment on whether the containers should be required to be “closed” or “covered,” except when waste is being added to or removed from the containers, in order to prevent releases during accumulation. Specifically, EPA is requesting information on scenarios in which a “closed” or “covered” requirement would be appropriate. EPA is not seeking, nor will we respond to, comments on whether to remove the term “closed” from the container requirements of the other types of universal wastes, since that is not the subject being addressed in this proposed rule. Finally, EPA also requests comment on whether handlers of pharmaceutical universal wastes should be required to maintain the pharmaceutical wastes in their original packaging if received as such.
The Agency is proposing specifically to allow, but not require, sorting of pharmaceutical universal wastes. Sorting is currently allowed for handlers of universal waste batteries (
EPA seeks comment on the proposed pharmaceutical universal waste sorting provisions. Specifically, the Agency requests comments on whether sorting of pharmaceutical universal wastes should be required, or whether requiring sorting is unnecessary due to the forms in which pharmaceuticals are typically found. Finally, the Agency requests examples of accidents that have occurred, or may occur, at health care facilities or reverse distributors due to incidents of incompatible hazardous pharmaceutical wastes being stored together.
As a result of sorting activities, solid wastes (both pharmaceutical and non-pharmaceutical) may be generated. It is the responsibility of the handler to determine if the generated solid waste is a listed hazardous waste or exhibits a hazardous waste characteristic (
The Agency is proposing that universal waste handlers managing pharmaceutical universal waste label each individual pharmaceutical universal waste item or accumulating container holding the pharmaceutical universal waste with the words “Universal Waste—Pharmaceuticals,” or “Waste Pharmaceuticals.” These requirements can be found in 40 CFR 273.14(f) and 273.34(f) of the proposed rule. The Agency is requesting comments on the appropriateness of the proposed general labeling requirements for pharmaceutical universal wastes. Specifically, the Agency requests comment on whether, in order for the destination facility to have sufficient information on the pharmaceutical universal wastes they receive, universal waste handlers should be required to include on the label the relevant chemical information or the hazardous waste code.
The existing UWR contains a one year accumulation limit for both SQHUWs and LQHUWs, as well as requirements for demonstrating the accumulation time (
The Agency is proposing to continue to use these accumulation time limits for pharmaceutical universal wastes. The Agency is requesting comments, however, on whether a different time limit is appropriate for handlers of pharmaceutical universal wastes and whether small and large pharmaceutical universal waste handlers should be subject to different accumulation time limits. In addition, the Agency is seeking comment and data on whether any pharmaceutical wastes or mixtures of pharmaceutical wastes tend to become more dangerous with age. EPA is not seeking, nor will it respond to, comments on whether to change the accumulation time limits for handlers of other types of universal wastes, which are not covered in this proposal.
The employee training requirements for small and large quantity handlers of universal waste can be found in 40 CFR 273.16 and 273.36, respectively. The Agency is proposing that the employee training requirements for pharmaceutical universal wastes be the same as the training requirements for other universal wastes.
The Agency is requesting comments on whether this rule should require specialized training for some or all handlers for sorting pharmaceutical universal wastes. EPA is not seeking, nor will the Agency respond to, comments on whether to change the training requirements for handlers of other types of universal wastes which are not covered in this proposal.
The response to releases requirements for small and large quantity handlers of universal waste are found in 40 CFR 273.17 and 273.37. These regulations include basic release responses, including the requirement that handlers immediately contain all releases of, and other residues from, universal wastes. Then the handlers must determine whether any material resulting from the release is hazardous waste and, if so, must manage it under the full RCRA subtitle C hazardous waste regulations. Handlers, however, are not subject to facility-wide corrective action when there is a release of universal waste.
Any releases of universal waste not cleaned up constitutes illegal disposal allowing further action by EPA under RCRA. In addition, any releases of hazardous substances above the reportable quantity (RQ) thresholds must be reported under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) (
This notice does not propose to change any of the existing requirements for responding to releases of hazardous pharmaceutical wastes.
The requirements for off-site shipments under the UWR are included in 40 CFR 273.18 and 273.38. To summarize the off-site shipment requirements of the UWR, handlers of both small and large quantities of universal waste are prohibited from sending or taking universal waste to a place other than another universal waste handler, a destination facility, or a foreign destination. Universal waste handlers can either contract with someone else to transport their universal waste or transport it themselves.
Under the UWR, both the shipper (a small or large quantity handler of universal waste who is shipping the universal waste to another handler or destination facility) and the receiving facility (a small or large quantity handler of universal waste, or destination facility receiving a shipment of universal waste from another universal waste handler) share certain responsibilities for the proper handling of the universal wastes being shipped. For instance, in order to prevent or limit rejected shipments, 40 CFR 273.18(d) and 273.38(d) of the UWR specify that the shipper of the universal waste must ensure that a receiving universal waste handler agrees to receive the shipment prior to the waste being sent. In addition, 40 CFR 273.18(e) and 273.38(e) of the rule specify that if the shipper sends universal waste to another handler or destination facility and the shipment is rejected, the shipping handler must receive the waste back or agree with the receiving facility on a destination facility to which the shipment will be sent. Sections 273.18(f), 273.38(f) and 273.61(b) provide that if an unsuitable shipment containing universal waste is received, the receiving facility, in turn, may reject the full shipment or a portion of the shipment. At that time, the receiving facility must notify the shipper of the rejection and discuss reshipment of the load.
This notice does not propose to change any of the existing requirements applicable to the off-site shipping of universal waste, including pharmaceutical waste managed as universal waste.
Manifests are not required for any shipments of universal waste by small and large quantity handlers of universal waste. Small quantity handlers are not required to track shipments,
For each shipment of universal waste received at or sent by a large quantity handler, the record
This notice does not propose to change any of the existing requirements applicable to the tracking of universal waste shipments, including pharmaceutical waste managed as universal waste.
The export requirements for small and large handlers of universal waste are found in 40 CFR 273.20 and 273.40, respectively. A handler sending universal waste to a foreign destination, without first sending the waste to a consolidation point or destination facility, would be subject to the requirements equivalent to the existing hazardous waste export requirements found at subpart E of 40 CFR part 262, even though a manifest would not be required. Thus, all universal waste shipments would follow procedures for notification and consent which are independent of the manifest procedures. Also, as discussed in the previous section, LQHUW are required to keep records of where they send universal waste, and from where they receive universal waste, including foreign destinations or shippers.
This notice does not propose to change any of the existing requirements applicable to the export of universal wastes, including pharmaceutical waste managed as universal waste.
The requirements for universal waste transporters are found under 40 CFR 273.50 through 273.56. Briefly, universal waste transporters are prohibited from disposing and diluting or treating universal wastes; must handle universal wastes in compliance with all applicable DOT regulations; and must only transport universal wastes to handlers, destination facilities, or to foreign destinations. In addition, transporters may only store universal wastes for ten days or less;
This notice does not propose to change any of the existing requirements applicable to transporters of universal wastes, including pharmaceutical wastes managed as universal wastes.
As described in 40 CFR 273.9 of the existing UWR, a destination facility is “a facility that treats, disposes of, or recycles a particular category of universal waste, except those management activities described in paragraphs (a) and (c) of 40 CFR 273.13 and 273.33. A facility at which a particular category of universal waste is only accumulated is not a destination facility for purposes of managing that category of universal waste.” The standards for destination facilities can be found under 40 CFR part 273, subpart E of the existing UWR, and they are briefly summarized below.
The standards state that destination facilities are subject to all applicable requirements of 40 CFR parts 264, 265, 266, 268, 270 and 124 of Title 40 and, if the destination facility recycles universal wastes without storing them before they are recycled, to 40 CFR 261.6(c)(2). In addition, the notification requirement under § 3010 of RCRA still applies to destination facilities accepting universal wastes.
Destination facilities also have requirements for off-site shipments of
Tracking of universal waste shipments also applies to destination facilities. The UWR requires that the owner or operator of a destination facility keep the same records for receipt of universal waste shipments as those kept by handlers of large quantities of universal wastes (discussed in section of V.J. of this preamble). A record must be kept for each shipment of universal waste received at the facility. The record may be in the form of a log, invoice, manifest, bill of lading or other shipping document, and must include the following information: (1) The name and address of the universal waste handler or foreign shipper from whom the universal waste was sent; (2) the quantity of each type of universal waste received; and (3) the date of receipt of the shipment of universal waste. In addition, destination facilities are required to maintain these records for three years.
This notice does not propose to change any of the existing requirements applicable to destination facilities that manage universal wastes, including pharmaceutical wastes managed as universal wastes.
Pharmaceutical universal wastes entering the country would be subject to the same UWR provisions as any other universal waste. The import requirements for universal wastes are found in 40 CFR 273.70. This section clarifies that universal wastes that are imported from another country must be managed, upon entry into the United States, in compliance with the appropriate universal waste requirements for transporters, handlers, or destination facilities, depending on the universal waste management activities conducted within the United States.
This notice does not propose to change any of the existing universal waste requirements applicable to the import of universal wastes, including pharmaceutical wastes managed as universal wastes.
Pursuant to the Land Disposal Restrictions (LDR) provisions of the Hazardous and Solid Waste Amendments of 1984 (HSWA), all hazardous wastes listed or identified in accordance with RCRA section 3001 are prohibited, on specified timetables, from land disposal unless they are appropriately treated or otherwise meet the specified treatment standard. The regulations for the LDR program in 40 CFR part 268 apply to persons who generate or transport hazardous waste and owners and operators of hazardous waste treatment, storage, and disposal facilities, unless they are specifically excluded from regulation in 40 CFR parts 261 or 268.
As discussed in the preambles for the proposed and final UWR (58 FR 8123—8124, February 11, 1993; 60 FR 25534—25535, May 11, 1995, respectively), handlers and transporters of universal wastes must comply with all of the substantive LDR requirements, but not the administrative requirements. These substantive requirements include: (1) A prohibition on accumulating prohibited hazardous wastes directly on the land (land disposal); (2) a requirement to treat wastes to meet the treatment standards prior to land disposal; (3) a prohibition on dilution; and (4) a prohibition on waste accumulation, except for purposes of accumulating quantities sufficient for proper recovery, treatment or disposal. Destination facilities are required to comply with all of the 40 CFR part 268 LDR requirements for universal waste, which include both the substantive and administrative requirements.
This notice does not propose to change any of the existing requirements with respect to the land disposal restrictions for universal wastes, including pharmaceutical wastes managed as universal wastes.
Under section 3006 of RCRA, EPA may authorize qualified states to administer and enforce the RCRA hazardous waste program within the state. Following authorization, EPA retains enforcement authority under sections 3008, 3013, and 7003 of RCRA, although authorized states have primary enforcement responsibility. The standards and requirements for state authorization are found at 40 CFR part 271.
Prior to enactment of HSWA, a state with final RCRA authorization administered its hazardous waste program entirely in lieu of EPA administering the federal program in that state. The federal requirements no longer applied in the authorized state, and EPA could not issue permits for any facilities in that state, since only the state was authorized to issue RCRA permits. When new, more stringent federal requirements were promulgated, the state was obligated to enact equivalent authorities within specified time frames. However, the new federal requirements did not take effect in an authorized state, until the state adopted the federal requirements as state law.
In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which was added by HSWA, new requirements and prohibitions imposed under HSWA authority take effect in authorized states at the same time that they take effect in unauthorized states. EPA is directed by the statute to implement these requirements and prohibitions in authorized states, including the issuance of permits, until the state is granted authorization to administer the HSWA requirements and prohibitions. States must adopt and be authorized for more stringent HSWA-related provisions to retain final authorization.
Authorized states are required to modify their programs only when EPA enacts federal requirements that are more stringent or broader in scope than the existing federal requirements. RCRA section 3009 allows the states to impose standards more stringent than those in the federal program (
This notice proposes regulations that would not be promulgated under the authority of HSWA. Thus, the standards proposed would be applicable on the effective date only in those states that do not have final authorization. This proposed rule is less stringent than the current hazardous waste standards. Therefore, authorized states would not
Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action.”
Pursuant to the terms of Executive Order 12866, the Agency has determined that this proposed rule is a significant regulatory action because it contains novel policy issues. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.
In addition, EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis is contained in the document entitled,
The following section summarizes the findings from our
The Agency has identified the following facilities potentially affected by the proposed rule: pharmacies, hospitals, physicians' offices, dentists' offices, other health practitioners, outpatient care centers, other ambulatory health care services, residential care facilities, reverse distributors, and veterinary clinics. While the BRS has only limited data for the types of facilities likely to be affected by the proposed rule, it includes sufficient data to develop an approximation of the total tonnage of hazardous pharmaceutical waste generated by hospitals and reverse distributors. In total, the affected hospitals and reverse distributors generated a total of 14,200 tons of hazardous pharmaceutical waste during 2005, based on BRS data. Therefore, it is expected that on the order of 14,000 tons of hazardous pharmaceutical waste could be managed as universal waste each year.
The proposed rule is optional, which means that individual facilities may choose to be regulated under the UWR, or continue to operate under the existing RCRA subtitle C hazardous waste regulations. The assessment assumes that facilities will only choose to be subject to the rule if it is deemed to be in their interest. For purposes of the economic assessment, it is assumed that only facilities that would experience a reduction in hazardous waste management costs would choose to be subject to the proposed rule. The aggregate annualized cost savings associated with the proposed rule are estimated to range from $33.9 to $35.2 million for hospitals and reverse distributors combined. For other types of facilities, the data necessary to support a nationwide estimate of the cost impacts are not readily available. However, based on a 2003 survey by King County, Washington, cost savings associated with ambulatory care facilities, retail pharmacies, and veterinary clinics are estimated to range from $0 to $162.3 thousand for King County. The Agency also evaluated an alternative scenario under which facilities possibly in non-compliance with the RCRA hazardous waste regulations decide to opt into the universal waste system. For more information regarding this alternative baseline, please
EPA anticipates that the proposed addition of hazardous pharmaceutical waste to the UWR will facilitate the environmentally-sound collection and disposal of this waste. Although EPA has not quantified the environmental impacts of the proposed rule, the Agency expects that the rule will reduce the release of pharmaceutically active compounds to the environment and also reduce the incidence of any adverse effects associated with human and ecosystem exposure to these substances.
The information collection requirements in this proposed rule have been submitted for approval to OMB under the
The information requirements established for this proposed rulemaking, and identified in the ICR supporting this action are largely self-implementing. This process would ensure that (1) regulated entities managing hazardous pharmaceutical wastes are held accountable to the applicable requirements; and (2) state inspectors can verify compliance when needed. For example, the universal waste proposal requires LQHUWs and SQHUWs to demonstrate the length of time that hazardous pharmaceutical wastes have been accumulated from the date they were received or became a waste. The proposal also requires LQHUWs and destination sites to keep records of all shipments sent and received. Further, the proposal requires waste handlers and destination facilities to notify EPA under certain circumstances (
EPA will use the collected information in the event of an inspection to ensure that hazardous pharmaceutical waste is being managed in a protective manner. The information aids the Agency in tracking waste shipments and identifying improper management practices. In addition, information kept in facility records helps handlers, processors and destination facilities to ensure that all facilities are managing these wastes properly.
EPA has carefully considered the burden imposed upon the regulated community by the proposed regulations. EPA is confident that those activities required of respondents are necessary and, to the extent possible, has attempted to minimize the burden imposed. EPA believes strongly that if the minimum requirements specified under the proposed regulations are not met, neither the facilities nor EPA can ensure that hazardous pharmaceutical wastes are being managed in a manner protective of human health and the environment.
EPA estimates that the total annual respondent burden for the new paperwork requirements in the proposed rule is approximately 960 hours per year, and the annual respondent cost for the new paperwork requirements in the rule is approximately $54,000. The estimated annual hourly burden ranges from 0.8 to 2.5 hours per respondent for the 1,119 respondents who will likely choose to manage their hazardous pharmaceutical
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, EPA has established a public docket for this rule, which includes this ICR, under Docket ID number EPA–HQ–RCRA–2007–0932. Submit any comments related to the ICR to EPA and OMB.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant
The small entity analysis conducted for this proposed rule indicates that streamlining the requirements for hazardous pharmaceutical wastes would generally result in savings to affected entities compared to the baseline requirements. Under a scenario assuming full compliance, the proposed rule is not expected to result in a net cost to any affected entity. Thus, adverse impacts are not anticipated. Costs could increase for entities that are not complying with the current requirements, but even these costs, which are not properly attributable to the current proposed rulemaking, would not be expected to result in significant impacts on a substantial number of small entities. We have therefore concluded that this proposed rule will relieve regulatory burden for all affected small entities. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.
This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531–1538 for State, local, or tribal governments or the private sector. UMRA generally excludes from the definition of “Federal governmental mandate” (in sections 202, 203, and 205) and from the definition of “federal private sector mandate” duties that arise from participation in a voluntary federal program. If finalized, this rule will be voluntary because it will be less stringent than the current regulations. As a result, state governments will not be required to adopt the change, and the private sector will not be required to participate. In any event, EPA has determined that this proposed rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. The total cost impact of the proposed action results in cost savings estimated to be between at least $33.9 million to $35.2 million per year. Therefore this action is not subject to the requirements of sections 202 and 205 of UMRA.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.”
This proposed rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various
Thus, Executive Order 13132 does not apply to this proposed rule. In the spirit of Executive Order 13132 and consistent with EPA policy to promote communications between EPA and state and local governments, EPA specifically solicits comment on this proposed rule from state and local officials.
Executive Order 13175, entitled “Consultation and Coordination With Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” EPA has concluded that this proposed rule may have tribal implications to the extent that entities generating hazardous pharmaceutical wastes on tribal lands could be affected. However, this proposed rule will neither impose substantial direct compliance costs on tribal governments nor preempt tribal law.
EPA did not consult directly with representatives of Tribal governments early in the process of developing this proposal. However, EPA did conduct outreach with the affected industry. Thus, EPA believes it has captured the concerns that also would have been expressed by representatives of Tribal governmental. EPA solicits additional comments on this proposed rule from Tribal officials.
This action is not subject to EO 13045 (62 F.R. 19885, April 23, 1997) because it is not economically significant as defined in EO 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this proposed action will present a disproportionate risk to children.
This proposed rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that the proposed rule is not likely to have any adverse energy effects.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104–113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This proposed rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.
Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. While the Agency is proposing to streamline the management requirements governing hazardous pharmaceutical wastes, EPA expects that such an action will actually increase compliance with the hazardous waste regulations and reduce exposures to both hazardous and non-hazardous pharmaceutical wastes by the public, including minority populations and low-income populations.
Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Reporting and recordkeeping requirements.
Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping requirements.
Environmental protection, Hazardous waste, Packaging and containers, Security measures, Surety bonds.
Environmental protection, Air pollution control, Hazardous waste insurance, Packaging and containers, Reporting and recordkeeping requirements, Security measures, Surety bonds, Water supply.
Environmental protection, Hazardous waste, Reporting and recordkeeping requirements.
Environmental protection, Hazardous materials transportation, Reporting and recordkeeping requirements.
Environmental protection, Hazardous materials transportation, Hazardous waste.
For the reasons set out in the preamble, title 40, Chapter I of the Code of Federal Regulations, is proposed to be amended as follows:
1. The authority citation for part 260 continues to read as follows:
42 U.S.C 6905, 6912(a), 6921–6927, 6930, 6934, 6935, 6937, 6938, 6939, and 6974.
2. Section 260.10 is amended as follows:
a. By adding the definition of “pharmaceutical” in alphabetical order.
b. By adding the definition of “pharmaceutical universal waste” in alphabetical order.
c. By republishing the introductory text of and revising paragraphs (3) and
(3) Mercury-containing equipment as described in § 273.4 of this chapter;
(4) Lamps as described in § 273.5 of this chapter; and
(5) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
3. The authority citation for part 261 continues to read as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.
4. Section 261.9 is amended as follows:
a. By revising paragraphs (c) and (d).
b. By adding paragraph (e) to read as follows:
(c) Mercury-containing equipment as described in § 273.4 of this chapter;
(d) Lamps as described in § 273.5 of this chapter; and
(e) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
5. The authority citation for part 264 continues to read as follows:
42 U.S.C. 6905, 6912(a), 6924, and 6925.
6. Section 264.1 is amended as follows:
a. By revising paragraphs (g)(11)(iii) and (iv).
b. By adding paragraph (g)(11)(v) to read as follows:
(g) * * *
(11) * * *
(iii) Mercury-containing equipment as described in § 273.4 of this chapter;
(iv) Lamps as described in § 273.5 of this chapter; and
(v) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
7. The authority citation for part 265 continues to read as follows:
42 U.S.C. 6905, 6906, 6912, 6922, 6923, 6924, 6925, 6935, 6936, and 6937.
8. Section 265.1 is amended as follows:
a. By revising paragraphs (c)(14)(iii) and (iv).
b. By adding paragraph (c)(14)(v) to read as follows:
(c) * * *
(14) * * *
(iii) Mercury-containing equipment as described in § 273.4 of this chapter;
(iv) Lamps as described in § 273.5 of this chapter; and
(v) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
9. The authority citation for part 268 continues to read as follows:
42 U.S.C. 6905, 6912(a), 6921, and 6924.
10. Section 268.1 is amended as follows:
a. By revising paragraphs (f)(3) and (4).
b. By adding paragraph (f)(5) to read as follows:
(f) * * *
(3) Mercury-containing equipment as described in § 273.4 of this chapter;
(4) Lamps as described in § 273.5 of this chapter; and
(5) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
11. The authority citation for part 270 continues to read as follows:
42 U.S.C. 6905, 6912, 6924, 6925, 6927, 6939, and 6974.
12. Section 270.1 is amended as follows:
a. By revising paragraphs (c)(2)(viii)(C) and (D).
b. By adding paragraph (c)(2)(viii)(E) to read as follows:
(c) * * *
(2) * * *
(viii) * * *
(C) Mercury-containing equipment as described in § 273.4 of this chapter;
(D) Lamps as described in § 273.5 of this chapter; and
(E) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
13. The authority citation for part 273 continues to read as follows:
42 U.S.C. 6922, 6923, 6924, 6925, 6930, and 6937.
14. Section 273.1 is amended as follows:
a. By revising paragraphs (a)(3) and (4).
b. By adding paragraph (a)(5) to read as follows:
(a) * * *
(3) Mercury-containing equipment as described in § 273.4 of this chapter;
(4) Lamps as described in § 273.5 of this chapter; and
(5) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
15. Add § 273.6 to read as follows:
(a)
(b)
(1) A partially-used pharmaceutical becomes a pharmaceutical universal waste on the date it is discarded.
(2) An unused pharmaceutical becomes a pharmaceutical universal waste on the date the handler decides to discard it.
16. Section 273.9 is amended by adding the definitions of “Pharmaceutical” and “Pharmaceutical Universal Waste” in alphabetical order and by revising the definitions of “Large quantity handler of universal waste,” “Small quantity handler of universal waste,” and by republishing the introductory text and revising paragraphs (3) and (4), and adding paragraph (5), to the definition “Universal waste” to read as follows:
(3) Mercury-containing equipment as described in § 273.4 of this chapter;
(4) Lamps as described in § 273.5 of this chapter; and
(5) Pharmaceutical Universal Wastes as described in § 273.6 of this chapter.
17. Section 273.13 is amended by adding paragraph (e) to read as follows:
(e)
(1) A small quantity handler of universal waste must contain pharmaceutical universal wastes in a container that is structurally sound, compatible with the pharmaceutical universal wastes, and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.
(i) Incompatible wastes must not be placed in the same container, unless in compliance with § 265.17(b) of this chapter.
(2) A small quantity handler of universal waste may sort pharmaceutical universal wastes provided the handler:
(i) Ensures compliance with applicable OSHA regulations; and
(ii) Ensures that employees sorting pharmaceutical universal wastes are thoroughly familiar with proper pharmaceutical universal waste handling and emergency procedures;
(3) A small quantity handler of universal waste who generates a solid waste as a result of the sorting activities under paragraph (e)(2) of this section must determine whether the solid waste exhibits a characteristic of hazardous waste or is a listed hazardous waste identified in 40 CFR part 261, subparts C and D.
(i) If the solid waste is a listed hazardous waste or exhibits a characteristic of hazardous waste, it must be managed in compliance with all applicable requirements of 40 CFR parts 260 through 272. The handler is considered the generator of hazardous waste and is subject to 40 CFR part 262.
(ii) If the solid waste is not hazardous, the handler may manage the waste in a manner that is in compliance with applicable federal, state or local solid waste regulations.
18. Section 273.14 is amended by adding paragraph (f) to read as follows:
(f) Pharmaceutical universal waste, or a container in which the pharmaceutical universal waste is contained, must be labeled or marked clearly with either of the following phrases: “Universal Waste—Pharmaceuticals” or “Waste Pharmaceuticals.”
19. Section 273.32 is amended by revising paragraph (b)(4) to read as follows:
(b) * * *
(4) A list of all the types of universal waste managed by the handler (e.g., batteries, pesticides, mercury-containing equipment, lamps, and pharmaceutical universal wastes); and
20. Section 273.33 is amended by adding paragraph (e) to read as follows:
(e)
(1) A large quantity handler of universal waste must contain pharmaceutical universal wastes in a container that is structurally sound, compatible with the pharmaceutical universal wastes, and that lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.
(i) Incompatible wastes must not be placed in the same container, unless in compliance with § 265.17(b) of this chapter.
(2) A large quantity handler of universal waste may sort pharmaceutical universal wastes provided the handler:
(i) Ensures compliance with applicable OSHA regulations; and
(ii) Ensures that employees sorting pharmaceutical universal wastes are thoroughly familiar with proper pharmaceutical universal waste handling and emergency procedures;
(3) A large quantity handler of universal waste who generates a solid waste as a result of the sorting activities under paragraph (e)(2) of this section must determine whether the solid waste exhibits a characteristic of hazardous waste or is a listed hazardous waste identified in 40 CFR part 261, subparts C and D.
(i) If the solid waste is a listed hazardous waste or exhibits a characteristic of hazardous waste, it must be managed in compliance with all applicable requirements of 40 CFR parts 260 through 272. The handler is considered the generator of hazardous waste and is subject to 40 CFR part 262.
(ii) If the solid waste is not hazardous, the handler may manage the waste in a manner that is in compliance with applicable federal, state or local solid waste regulations.
21. Section 273.34 is amended by adding paragraph (f) to read as follows:
(f) Pharmaceutical universal waste, or a container in which the pharmaceutical waste is contained, must be labeled or marked clearly with either of the following phrases: “Universal Waste—Pharmaceuticals” or “Waste Pharmaceuticals.”