How will the proposed EPA Universal Waste Rule change your program?

It is important to point out that the proposed universal waste rule for pharmaceuticals has not been passed. In the event that the rule is passed, it will still need to be adopted by individual states before these regulations can be implemented at your facility.

With the increased regulatory oversight on healthcare pharmaceutical collection, management and disposal, healthcare facilities have been tasked with developing regulatory compliant programs often with dated regulations. The Environmental Protection Agency (EPA) had an open comment period for the proposed regulations allowing the healthcare industry to voice their concerns and guidance around the subject matter.

In reviewing the proposed universal waste rule, some of the notable regulatory items of interest are as follows:

• “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 262, or may choose to manage their hazardous pharmaceutical wastes under the universal waste rule.”1

• “Specifically the universal waste rule does not distinguish between acutely hazardous P-listed wastes and other hazardous wastes.”1 This would allow generators the ability not to track P-listed weights and therefore not be concerned about if they are generating 2.2 pounds or greater per month.

• With the choice of managing pharmaceutical wastes under the universal waste rule, small quantity handlers would be able to generate 5,000kg or 11,000 pounds of all universal waste at one time.

• “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.”1 Manifesting, accumulation time limits, training and reverse distribution are also outlined within the proposed universal waste rule.

The proposed rule can be found at:

1 Federal Register / Vol. 73, No. 232 – pgs 73520 - 73544