40 CFR 266.504
VSQG Decision - To be or not to be Subpart P? That is the question.
Since VSQG’s (Very Small Quantity Generators) are not required to follow Subpart P, they should consider the impacts of whether or not to manage their pharmaceutical waste under Subpart P. VSQG's not operating under Subpart P are still subject to VSQG requirements (40 CFR 262.14) which may be less than EPA's Subpart P.. Determine your generator status.
If a VSQG operating under Subpart P elects not to continue operating under Subpart P, they must fill out and updated EPA Site Identification Form.
There are more advantages for a VSQG facility not operating under Subpart P (below). Some facilities may find it worth the time to document their generator status to prove they are a VSQG and not follow Subpart P. Refer to VSQG Implementation Plan - Not operating under EPA Subpart P. Each case should be reviewed on an individual basis.
Healthcare Facility Decision Flow Chart
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Generation versus Accumulation
- Healthcare facilities that generate above VSQG limits are SQG's or LQG's and are subject to Subpart P.
- VSQG's that accumulate above VSQG limits are NOT subject to Subpart P.
- Other requirements apply (e.g., waste out in 90 days from start accumulation).
- See § 262.14(a)(3) for accumulating > 1 kg of acute hazardous waste and § 262.14(a)(4) for accumulating > 1000 kg non-acute hazardous waste.
- Recommendation: For VSQGs not opting into Subpart P, avoid accumulating (> 1 kg of acute HW or 100 kg of non-acute HW) at your facility.
SUBPART P - DIFFERENCES FOR VSQG's
| Requirement
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|
Subpart P |
Not Subpart P |
RED Notes |
| EPA notification |
YES |
NO |
EPA audit increase |
| Accumulation time limits |
YES |
NO |
1 year - No extension |
| Training (NC) |
YES |
NO |
Audit issue |
| Containers (NC) |
YES |
NO |
Audit issue |
| Labeling (NC) |
YES |
NO |
Audit issue |
| UHW Manifests (NC) |
YES |
NO |
Audit issue |
| Rejected Shipments (NC) |
YES |
NO |
Audit issue |
| Land Disposal Restrictions |
YES |
NO |
Audit issue |
| Commingling Restrictions |
YES |
NO |
Audit issue |
| Unsuitable for incineration* |
YES |
NO |
Audit issue |
| Exception reporting* |
YES |
NO |
Audit issue |
| Recordkeeping* |
YES |
NO |
Audit issue |
| Spill response* |
YES |
NO |
Audit issue |
| Delivery confirmation* |
YES |
NO |
Audit issue |
| No SAA or CAA |
YES |
YES |
No difference |
| Nicotine relief |
YES |
YES |
No difference |
| Empty containers |
YES |
YES |
No difference |
| Potentially creditable to RD |
YES |
YES |
No difference |
| Sewer ban |
YES |
YES |
No difference |
| DEA/HWP exemption |
YES |
NO |
No difference likely |
| Biennial reporting |
NO |
NO |
No difference |
| Document generator status |
NO |
YES |
Takes time |
| © PharmWaste Technologies |
Copyright Warning
All information found on this website is copyright protected by PharmWaste Technologies, Inc. Do not copy or redistribute without our written permission from PTI or note any reproduction or derivative as copyrighted by PharmWaste Technologies, Inc.
- CAA - Centralized accumulation area
- DEA - DEA controlled substance
- HW - Hazardous waste
- HWP - Hazardous waste pharmaceutical
- NC - Non-creditable hazardous waste pharmaceutical
- SAA - Satellite accumulation area
-
Table comparison is based off of your state adopting Subpart P and Nicotine relief without implementing stricter regulations. Check with you state to see if stricter regulations apply.
- Document generator status - VSQG's document the amount of pharmaceutical and non-pharmaceutical hazardous waste generated on a monthly basis to prove they qualify as a VSQG (except for LTCF's with 20 beds or less). A drug formulary characterization will indicate which drugs are hazardous waste and therefore need to be documented.
-
Unsuitable for incineration - waste that cannot be incinerated and has additional container and storage requirements (e.g., Arsenic trioxide - P012).
-
Exception Reporting - Regarding NCHWPs, there is mandatory reporting to the EPA Administrator if the HCF has not received a signed copy of the manifest within 60 days of the initial transporter accepting the shipment, and the Agency may require a healthcare facility to furnish additional reports regarding the quantity and disposition of NCHWPs.
-
Recordkeeping - Maintain records of waste testing (unless treating all as HWPs), manifests (3 years), site notifications, delivery confirmations, shipping papers and exception reports. All records must be readily available upon request from an inspector.
-
Spill response - Contain immediately and manage appropriately under Subpart P regulations.
-
Delivery confirmation - When shipping PCHWPs to a RD, promptly contact RD if receipt confirmation is not within 35 calendar days of shipment and determine status of shipment
-
VSQG requirements - link to EPA website
Facilities not operating under Subpart P - Recommendations
Literature: VSQG Implementation Plan
- Perform drug waste characterization – PTI Porthole
- Calculate hazardous waste generated and document generator status – PTI Porthole
- Send any potentially creditable HWP's to Reverse distributor – Find Vendor
- Dispose of any non-creditable HWP's - Find Vendor
- Update drug formulary as needed – PTI Porthole
* Although a VSQG may not be operating under subpart P, they are still required to follow regulations as they pertain to the shipping and disposal of HWP's. For example: Potentially creditable HWP's can go back to the RD. Non-creditable HWP's cannot go back to the RD.