EPA Proposes to Add Pharmaceuticals to Universe of Universal Waste
Relief is insight for the pharmaceutical industry. Today’s U.S. EPA proposal would make it easier for generators to collect, manage, and dispose of pharmaceutical waste while continuing to protect human health and the environment. These rules would apply to anyone who currently manages pharmaceutical wastes, including but not limited to, pharmacies, hospitals, dental and doctor offices, veterinary clinics, residential care facilities and ambulatory health care services.
Under the proposed rules, both non–hazardous pharmaceutical wastes and those pharmaceuticals meeting the definitions of hazardous waste found at 40 CFR 261.3 could be managed as universal waste. The EPA has identified two main reasons to manage pharmaceuticals under the universal waste rules found at 40 CFR 270. The easier regulation would be less cumbersome for those who are currently not aware of the RCRA management standards. It would encourage the development of “pharmaceutical take–back programs” by health care and other such regulated facilities that could then manage pharmaceuticals returned to them by household users.
The universal waste rules as applied to pharmaceutical waste will allow for less stringent rules for accumulating, managing, and transporting in order to encourage participation in the proposed rule. Some of the benefits are as follows:
- Accumulation of universal waste pharmaceuticals for up to one year
- No accumulation limit
- More cost–effective accumulation times and amounts
- No need to separate P–listed and other hazardous waste pharmaceuticals
- Lowered generator status for the facility
As far as management on site of the waste pharmaceuticals are concerned, many of the current universal waste rules will apply as they are currently being utilized for batteries, lamps, mercury–containing equipment, and pesticides. The proposed rules for universal wastes would require:
- The waste to be kept in a container that is structurally sound and compatible with the waste
- Sort or separate the different types of pharmaceuticals that are being accumulated
- Label with the words “universal waste — pharmaceuticals” or “waste–pharmaceuticals”
- Training standards, response to releases, and tracking of shipments are all the same as the current universal waste rules as applicable to small quantity and large quantity handlers
This proposal has not yet been published in the Federal Register. The EPA has made a fact sheet and pre–publication version of the proposed rule available here. The rule must go through formal process of public review and it may be up to a year before a final rule comes into effect.
Additional information on the purpose, scope, and key compliance responsibilities under RCRA are discussed at Lion Technology’s Hazardous/Toxic Waste Workshops provided in easily–accessible cities across the United States.
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