Section 3001 of the Resource Conservation and Recovery Act (RCRA) of 1976, as amended, requires the Environmental Protection Agency (EPA) to identify which solid wastes are hazardous wastes and therefore must be managed as hazardous waste during treatment, storage, or disposal. Under this authority, EPA established four hazardous waste characteristics (toxicity, reactivity, ignitability, and corrosivity), and listed specific wastes that must be managed as hazardous wastes.
EPA is revising the regulations to improve management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify regulation of the reverse distribution mechanism used by healthcare facilities for management of unused and/or expired pharmaceuticals. EPA is adding a new subpart P under part 266. This new subpart is a tailored, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. Healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all reverse distributors, regardless of RCRA generator category, will be required to manage hazardous waste pharmaceuticals under this new subpart P of part 266, in lieu of part 262. That is, the final standards are not an optional alternative to managing hazardous waste pharmaceuticals under part 262, they are mandatory standards.
Healthcare facilities will have different management standards for their non-creditable and potentially creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste pharmaceuticals will be managed on-site similar to how they would have been under the 2008 Universal Waste proposal for pharmaceutical waste. When they are shipped off-site, they must be transported as hazardous wastes and sent to a RCRA interim status or permitted hazardous waste facility. On the other hand, healthcare facilities will continue to be allowed to send potentially creditable hazardous waste pharmaceuticals to reverse distributors for verification of manufacturer credit. EPA is finalizing standards to ensure the safe and secure delivery of the potentially creditable hazardous waste pharmaceuticals to reverse distributors.
EPA is also finalizing standards for the accumulation of the hazardous waste pharmaceuticals at reverse distributors. The standards regard reverse distributors as a new type of hazardous waste entity called reverse distributors. The key provisions of EPAs final rule are: 1)Hazardous waste pharmaceuticals managed under the new rule are not counted toward a facilitys RCRA generator status; 2) Reverse distributors must comply with LQG-like standards regardless of the quantity of hazardous waste pharmaceuticals that they manage; 3) FDA approved over-the-counter nicotine replacement therapies, such as patches, gums, and lozenges, will no longer by managed as hazardous waste; and 4) Sewer disposal of hazardous waste pharmaceuticals is prohibited.
US Code:
42 USC 6901
Name of Law: Resource Conservation and Recovery Act (RCRA)
The requirements covered in this ICR are for the requirements that healthcare facilities (including retail facilities) and reverse distributors managing hazardous waste pharmaceuticals have under 40 CFR part 266 subpart P. The final rule is expected to result in a reduction in paperwork burden for a subset of facilities. For example, EPA expects that many facilities will be able to operate as very small quantity generators (VSQGs) rather than large quantity generators (LQGs) as a result of the exemption for FDA approved over-the-counter nicotine replacement therapies. However, rather than estimating the burden reduction for the affected facilities under this ICR, EPA estimates the total burden to reverse distributors and healthcare facilities for the paperwork requirements under subpart P. In a separate action, EPA will amend the base Hazardous Waste Generator Standards ICR to reflect the burden reduction that results from this final rule. The burden reduction from the final rule is due to the fact that many facilities will experience a change in generator category from LQG to VSQG, and therefore EPA will amend the base Hazardous Waste Generator ICR to remove the facilities from the universe that are no longer expected to comply with the standards for LQGs.
$2,382
No
No
No
No
No
No
Uncollected
Laura Stanley 703 308-7285
Reginfo record details
No
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2486ss02.docx
Management Standards for Hazardous Waste Pharmaceuticals