Managing P-List Hazardous Wastes in Satellite Areas
In a February 17, 2016, letter to industry, US EPA clarified a critical point of waste management for the pharmaceutical industry and other hazardous waste sites that manage commercial chemical products, or CCPs.
Some major pharmaceutical products meet the criteria of an acute hazardous waste, like Warfarin (a P001 waste at concentrations greater than 0.3%), nicotine gums and patches, and others. When pharmacies and medical facilities use or dispense these pharmaceuticals, residue may remain in the containers (bottles, blister packs, etc.). This residue is a P-listed acute hazardous waste.
This affects sites that store these hazardous wastes in two major ways:
First, any facility that generates more than 1 kg of an acute hazardous waste in one calendar month is a large quantity generator under RCRA. Large quantity generators, or LQGs, are subject to the most stringent hazardous waste management requirements, including an annual training requirement for hazardous waste personnel.
In addition, US EPA sets a strict limit on the volume of acute hazardous waste that can be held in a satellite accumulation area. Generators may keep up to 1 quart of acute hazardous waste in a satellite area. [40 CFR 262.34(c)]
EPA Guidance on Counting Acute Hazardous Waste
The question asked of EPA was this: Do the containers—like pill bottles and blister packs—count toward the quantity limit for satellite accumulation areas?
To answer this question, EPA points to a November 2011 letter (RO 14827) in which it clarified that only the residue itself must be considered toward a site’s hazardous waste generator status, not the containers that contain the residue. EPA expands on this point to state that the same principle applies to satellite accumulation areas: Only the residue within the container should be counted toward the 1-quart limit, not the containers themselves.
See the February 2016 EPA letter here.
EPA’s New Rules for Hazardous Waste Pharmaceuticals
Last year, US EPA proposed new standards for managing hazardous waste pharmaceuticals under a new 40 CFR Subpart P. The long awaited new rules for hazardous waste pharmaceuticals include notification requirements, a new category of pharmaceutical facility, standards for counting pharmaceutical hazardous waste, and RCRA training requirements for personnel at healthcare facilities. Read about EPA’s rules for hazardous waste pharmaceuticals here.
What Are Satellite Accumulation Areas?
Satellite accumulation areas are areas of a facility where waste is initially collected and temporarily stored, before being eventually moved to a central accumulation area for management under 40 CFR 262.34
What’s the P List?
The P List refers to the list at 40 CFR 261.33(e) of commercial chemical products listed as hazardous waste due to their acute hazard(s). A “P-listed chemical” is a chemical that is listed as hazardous waste and assigned a P### code by 40 CFR 261.33.
Questions about using RCRA waste codes? Read Simplifying Your Approach to Waste ID.
RCRA Training for Experienced Professionals
Get up to speed with the latest RCRA rules for managing your site’s hazardous waste from cradle to grave under US EPA’s 40 CFR regulations. At the RCRA Hazardous Waste Management Refresher Webinar, meet your annual refresher RCRA training requirement and build a step-by-step approach to keeping your personnel safe and your waste containers in compliance.
Presented live by a full-time Lion instructor, this RCRA refresher webinar blends the convenience of online training with the trusted RCRA curriculum covered in Lion’s nationwide public workshops. Sign up today to fulfill your annual training mandate and protect your site from EPA fines up to $37,500 per day, per violation. Enrollment includes a full year Membership for regulatory updates, support, and exclusive content.
Some major pharmaceutical products meet the criteria of an acute hazardous waste, like Warfarin (a P001 waste at concentrations greater than 0.3%), nicotine gums and patches, and others. When pharmacies and medical facilities use or dispense these pharmaceuticals, residue may remain in the containers (bottles, blister packs, etc.). This residue is a P-listed acute hazardous waste.
This affects sites that store these hazardous wastes in two major ways:
First, any facility that generates more than 1 kg of an acute hazardous waste in one calendar month is a large quantity generator under RCRA. Large quantity generators, or LQGs, are subject to the most stringent hazardous waste management requirements, including an annual training requirement for hazardous waste personnel.
In addition, US EPA sets a strict limit on the volume of acute hazardous waste that can be held in a satellite accumulation area. Generators may keep up to 1 quart of acute hazardous waste in a satellite area. [40 CFR 262.34(c)]
EPA Guidance on Counting Acute Hazardous Waste
The question asked of EPA was this: Do the containers—like pill bottles and blister packs—count toward the quantity limit for satellite accumulation areas?
To answer this question, EPA points to a November 2011 letter (RO 14827) in which it clarified that only the residue itself must be considered toward a site’s hazardous waste generator status, not the containers that contain the residue. EPA expands on this point to state that the same principle applies to satellite accumulation areas: Only the residue within the container should be counted toward the 1-quart limit, not the containers themselves.
See the February 2016 EPA letter here.
EPA’s New Rules for Hazardous Waste Pharmaceuticals
Last year, US EPA proposed new standards for managing hazardous waste pharmaceuticals under a new 40 CFR Subpart P. The long awaited new rules for hazardous waste pharmaceuticals include notification requirements, a new category of pharmaceutical facility, standards for counting pharmaceutical hazardous waste, and RCRA training requirements for personnel at healthcare facilities. Read about EPA’s rules for hazardous waste pharmaceuticals here.
Satellite accumulation areas are areas of a facility where waste is initially collected and temporarily stored, before being eventually moved to a central accumulation area for management under 40 CFR 262.34
What’s the P List?
The P List refers to the list at 40 CFR 261.33(e) of commercial chemical products listed as hazardous waste due to their acute hazard(s). A “P-listed chemical” is a chemical that is listed as hazardous waste and assigned a P### code by 40 CFR 261.33.
Questions about using RCRA waste codes? Read Simplifying Your Approach to Waste ID.
RCRA Training for Experienced Professionals
Get up to speed with the latest RCRA rules for managing your site’s hazardous waste from cradle to grave under US EPA’s 40 CFR regulations. At the RCRA Hazardous Waste Management Refresher Webinar, meet your annual refresher RCRA training requirement and build a step-by-step approach to keeping your personnel safe and your waste containers in compliance.
Presented live by a full-time Lion instructor, this RCRA refresher webinar blends the convenience of online training with the trusted RCRA curriculum covered in Lion’s nationwide public workshops. Sign up today to fulfill your annual training mandate and protect your site from EPA fines up to $37,500 per day, per violation. Enrollment includes a full year Membership for regulatory updates, support, and exclusive content.
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