Energy and Environment MonitorU.S. EPA is proposing to add hazardous pharmaceutical wastes to the Universal Waste Rule codified at 40 CFR Part 273. The proposed rule, if finalized and adopted in West Virginia, would affect pharmacies, hospitals, physicians’ and dentists’ offices, other health care practitioners, outpatient care centers, ambulatory health care services, nursing homes and other residential care facilities, veterinary clinics, morgues, and reverse distributors. U.S. EPA published its proposed rule December 2, 2008 (73 Fed. Reg. 73520), and comments are due February 2, 2009.
Under the proposed rule, a pharmaceutical universal waste is a pharmaceutical that is a hazardous waste and any container that held hazardous pharmaceutical waste unless that container is considered “RCRA-empty” under 40 CFR § 261.7. There are approximately thirty-one commercial chemical products listed on U.S. EPA’s P- and U-lists under the Resource Conservation and Recovery Act (RCRA) that have pharmaceutical uses. For example, the following chemotherapy drugs, CTX, Cytotoxan, Neosar, and Procytox are listed as U058 (cyclophosamide). In addition, pharmaceutical wastes may also be hazardous because they exhibit one or more of the following four characteristics of hazardous waste: ignitibility, corrosivity, reactivity, and toxicity. Solutions containing more than 24% alcohol are examples of a pharmaceutical waste that exhibits the ignitibility characteristic. Nitroglycerin is an example of a pharmaceutical waste that may exhibit the reactivity 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 concentrations 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).
Advantages to managing hazardous pharmaceutical waste under the Universal Waste Rule are simplification of the hazardous waste determination process and streamlined standards for “handlers,” defined as any person who generates, receives, consolidates ships or accumulates but does not treat, recycle, or dispose of universal waste, and transporters. For example, handlers of pharmaceutical universal waste would not be required to separate P-listed waste from other hazardous waste for purposes of tracking the volume generated or on-site accumulation volume limits. The proposal would also provide the opportunity for all pharmaceutical waste, hazardous or not, to be managed as a single waste stream, reducing the amount of pharmaceutical waste sent to a regulated medical waste incinerator or disposed of down the drain. In addition, there would be financial benefits. U.S. EPA estimates that the cost savings for hospitals and reverse distributors will range from $33.9 million to $35.2 million per year.
Handlers of pharmaceutical universal waste would have increased generation volumes and longer on-site accumulation time limits as well as modified requirements for storage, labeling and marking, preparing the waste for shipment off site, employee training, responses to releases, and notifications. For example, a small quantity handler of universal waste (SQHUW) may accumulate less than 5,000 kg or 11,000 lb on site at any one time and a large quantity handler of universal waste (LQHUW) may accumulate 5,000 kg or more on site at any one time. Further, the 5,000 kg accumulation limit in U.S. EPA’s proposal refers to all types of universal waste, including batteries, pesticides, mercury-containing equipment, hazardous waste lamps, and, if U.S. EPA’s proposal is finalized, pharmaceuticals.
The RCRA program’s counterpart to “handler” is “generator”. Generator status is determined based upon the quantity of hazardous waste produced each month and those quantities are much lower than for handlers of universal waste: (1) a conditionally exempt small quantity generator (CESQG) generates less than or equal to 1,000 kg or 220 lb per month or less than or equal to 1 kg of acute hazardous waste per month; (2) a small quantity generator (SQG) generates less than 1,000 kg per month; and (3) a large quantity generator (LQG) generates equal to or greater than 1,000 kg per month or greater than 1 kg of acute hazardous waste per month. The quantity of hazardous waste produced each month is significant because as the quantity increases so does the stringency of the applicable regulatory requirements.
A U.S. EPA identification number is not required for small SQHUW but is required for LQHUW, SQGs, and LQGs. The on-site accumulation limits for SQHUW is less than 5,000 kg but for CESQGs the limit is less than or equal to 1,000 kg, less than or equal to 1 kg of acute hazardous waste, or less than or equal to 100 kg of spill residue from acute and for SQGs the limits are less than 6,000 kg. There is no quantity limit for LQHUW or LQGs. The storage time limit without a storage permit would be increased for SQHUW and LQHUW to one year unless for proper recovery, treatment or disposal. If accumulation is solely for accumulating such quantities of universal waste as are necessary to facilitate proper recovery, treatment, or disposal, the proposal would allow accumulation for greater than one year. For SQGs and LQGs, the storage time is less than or equal to 180 days or 20 days, depending upon the transportation distance, and less than or equal to 90 days, respectively. There is no manifest requirement for handlers of universal wastes, whether SQHUW or LQHUW, but a manifest is required for SQGs and LQGs.
Containers must be structurally sound, compatible with the pharmaceutical wastes that will be contained within the container, and lack evidence of leakage, spillage, or damage under reasonably foreseeable conditions, and incompatible wastes may not be placed in the same container. Unlike the RCRA program, there is no requirement that the containers of hazardous pharmaceutical waste be “closed”. Each individual pharmaceutical universal waste item or accumulating container must be labeled with the buzz words “Universal Waste – Pharmaceuticals” or “Waste Pharmaceuticals”
With respect to employee training, LQHUW must insure that all employees are thoroughly familiar with the proper waste handling and emergency procedures related to their responsibilities during normal facility operations and emergencies. SQHUW must provide basic training and inform all employees that handle or have responsibilities for managing universal waste of the proper handling and emergency procedures appropriate to the type(s) of universal waste managed at the facility. This training can be accomplished via verbal communication or through the distribution of pamphlets or other documentation. LQGs by contrast must provide full training to their employees.
In the event of a release, handlers of universal waste must immediately contain all releases of, and other residues from, universal wastes and determine if any material resulting from the release is a hazardous waste and manage it accordingly. Handlers must also report releases of hazardous substances above the reportable quantity threshold.
The proposed rule also addresses off-site shipments. The rule would prohibit handlers from sending or taking universal waste to a place other than another universal waste handler, a destination facility or a foreign destination. If a universal waste being offered for off-site transportation meets the definition of hazardous materials under Department of Transportation (DOT) regulations, the handler of the universal waste must package, label, mark, and placard the shipment in accordance with the DOT regulations and must prepare the proper shipping papers. The shipper is responsible for insuring that a receiving universal waste handler agrees to receive the shipment before shipping the waste. If a 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.
The proposed rule also specifies the receiving facility’s responsibilities. If an unsuitable shipment containing universal waste is received, the receiving facility may reject the full shipment or a portion of the shipment and must notify the shipper of the rejection and discuss reshipment of the load. If a handler receives a shipment of hazardous waste that is not a universal waste, the receiving facility must immediately notify the appropriate regional U.S. EPA office (or the authorized state, when appropriate) of the illegal shipment, provide the name, address, and phone number of the shipper, and manage the hazardous waste pursuant to instructions received from the U.S. EPA regional office or state if applicable. If a handler of universal waste receives a shipment of non-hazardous, non-universal waste, the handler must manage the waste in compliance with applicable federal or state solid waste regulations.
A LQHUW, whether shipping or receiving a universal waste, is required to track shipments. The tracking records must include the name and address of the universal waste handler or foreign shipper to or from whom the universal waste was sent, the quantity of each type of universal waste sent or received, and the date of receipt of the shipment of universal waste.
The requirements for universal waste transporters are essentially the same as the requirements for hazardous waste transporters except no manifest is required for universal waste transporters. Universal waste transporters are prohibited from disposing, or diluting or treating universal waste. They must handle universal waste in compliance with all applicable DOT regulations and transport universal waste to handlers, destination facilities, or to foreign destinations. Universal waste transporters may store universal waste for ten days or less and must respond to releases.
“Destination facilities” are defined as faculties that treat, dispose of, or recycle a particular category of universal waste. Destination facilities are subject to all applicable RCRA requirements. The Universal Waste Rule does not change the requirement for recycling facilities to get a storage permit if they store waste before they recycle it. Also, if a recycling facility does not store waste, the facility still has to comply with the requirements of 40 CFR §261.6(c)(2). Notification requirements under RCRA §3001 also apply to destination facilities accepting universal waste.
Destination facilities may only send or take universal waste to handlers, other destination facilities, or foreign destination facilities. Destination facilities may reject shipments or portions of shipments containing universal waste, but the destination facility owner or operator must notify the shipper of the rejection and arrange for re-shipment. If a destination facilities receives a shipment of hazardous waste that is not a universal waste, the facility must notify its regional U.S. EPA office or authorized state. If the facility receives non-hazardous, non-universal waste in a shipment, the destination facility must manage the waste in any manner that is in compliance with applicable federal or state and local solid waste regulations. Destination facilities must keep a record 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. The content of the record must include the name and address of the universal waste handler or foreign shipper from whom the universal waste was sent, the quantity of each type of universal waste received, and the date of receipt of the shipment of universal waste. The destination facility must retain universal waste shipment records for a period of three years.
Handlers and transporters of universal waste must comply with all the substantive land disposal restrictions (LDR) requirements, but not the administrative requirements. Destination facilities are required to comply with both the substantive and administrative requirements. The substantive LDR requirements include a prohibition on accumulating prohibited hazardous wastes directly on the land (and disposal), a requirement to treat wastes to meet the treatment standards before land disposal, a prohibition on dilution, and a prohibition on waste accumulation, except for purposes of accumulating quantities sufficient for proper recovery, treatment, or disposal.
Because the proposed rule is less stringent than the current hazardous waste standards, West Virginia is not required to modify its program to adopt regulations consistent with and equivalent to U.S. EPA’s proposed standards for hazardous pharmaceutical waste. U.S. EPA’s proposal, if finalized, would be effective in West Virginia only if adopted by the State. Other laws still apply to the regulation of pharmaceutical waste, including the Controlled Substances Act and Drug Enforcement Administration regulations, Health Insurance Portability and Accountability Act, The Atomic Energy Act, and any state and local medical waste regulations. For additional information concerning U.S. EPA’s proposal to add hazardous pharmaceutical waste to the Universal Waste Rule, contact Gale Lea Rubrecht at 304-340-1200 or galelea@jacksonkelly.com.
This article was authored by Gale Lea Rubrecht, Jackson Kelly PLLC. For more information on the author see here.
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