The EPA is considering adding hazardous pharmaceutical waste to the Universal Waste Rule and published its intent in the Federal Register on Dec. 2, 2008.
While this rule specifically applies to only hazardous pharmaceutical waste, it will, if adopted, have a tremendous impact on how waste pharmaceuticals are managed in the future. An open comment period exists until February 2, 2009. We urge all hospitals to carefully read the proposed rule and respond accordingly.
EPA is specifically seeking information that can best be provided by hospitals, such as:
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Any data that may be available regarding the number of generators that generate hazardous pharmaceutical waste, the frequency of generation, and the quantities that are generated.
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How much pharmaceutical waste do health care facilities typically generate per month?
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Of that amount, what percentage is RCRA hazardous waste?
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What method of disposal are health care facilities utilizing for pharmaceutical wastes, including hazardous and non-hazardous?
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What are the costs of collecting and treating hazardous pharmaceutical waste?
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Whether this rulemaking could have unforeseen consequences in the generation, characterization, and management of hazardous pharmaceutical wastes that would potentially increase risks to human health or the environment.
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Information on the volumes of controlled substances that are hazardous wastes disposed of annually.
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Which option would hospitals choose: a. manage all drugs, hazardous and non-hazardous, as universal waste; b. manage RCRA hazardous and select drugs such as chemotherapy as universal waste; c. manage only RCRA hazardous drugs as universal waste; d. manage RCRA hazardous drugs under the full hazardous waste regulations, not as universal waste
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Why would the hospital make the above choice?
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If the facility is already a Conditionally Exempt Small Quantity Generator (CESQG), would it choose to manage pharmaceutical wastes under the Universal Waste Rule? If so, which wastes (see #8 above)?
This is your opportunity to make a difference and have an impact on federal regulations that will impact your facility for the foreseeable future, keeping in mind that your state environmental protection agency will also be determining whether or not to adopt these rules if they are implemented. EPA anticipates implementation no sooner than 2010, depending on the number and nature of the comments received. They must, by law, address and respond to every comment, which will become public record.
To view EPA’s Fact Sheet, go to http://www.epa.gov/epawaste/hazard/wastetypes/universal/pharm-fs.pdf.
To provide comments, go to the Federal Register notification at http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day-02/f28161.htm.
PharmEcology® Associates, LLC of Wauwatosa, WI was founded in 2000 and provides pharmaceutical waste management consulting services to the healthcare industry through seminars, on-site risk assessments, and other custom consulting services, in addition to the PharmE® Waste Wizard and PharmE® Inventory Analysis. For additional information on PharmE® Certification, contact us at 414-292-3959 or email us at info@pharmecology.com.
