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What’s in the Newly Proposed RCRA Subpart P?

Posted on 9/4/2015 by Roger Marks

On August 31, 2015, US EPA proposed new management standards for hazardous waste pharmaceuticals at healthcare facilities.

Click the link above for an overview of the proposed regulations, including important definitions, basic requirements, and how “creditable” and “non-creditable” pharmaceutical hazardous wastes will be treated differently.

Now, and in depth look at EPA’s proposed management standards for hazardous waste pharmaceuticals.

Drain Disposal Prohibited

One rule that will apply to all healthcare facilities is prohibition of “sewering” hazardous waste pharmaceuticals. Under the proposal, disposing of hazardous waste pharmaceuticals in a drain or toilet is now officially prohibited by US EPA.

While many local water treatment works already prohibit sewering this type of waste, the prohibition is now codified in Federal environmental regulations.

Pharmaceuticals managed as hazardous waste in healthcare settings


Accumulation Areas – Neither Satellite Nor Central

As EPA discovered during its 2008 universal waste rulemaking process, healthcare facilities often accumulate hazardous waste in receptacles in different areas of the facility (which RCRA refers to as “satellite areas”). While these facilities may be subject to the 90- or 180- day accumulation rules, they often do not move their pharmaceutical wastes to a centralized storage location, as is typical in other industry settings.

Therefore, EPA has determined that neither the satellite accumulation rules nor the central storage area rules are appropriate for healthcare facilities. In lieu of the satellite accumulation or 90-/180-day rules, healthcare facilities will be subject to unique accumulation time limits and container standards outlined in the proposed rule.

Counting Hazardous Waste Pharmaceuticals

Under the proposed rule, hazardous waste pharmaceuticals will no longer count toward healthcare facilities’ generators status, provided they are managed under the new 40 CFR 266, Subpart P requirements. This rule change may allow some facilities to “move down” to small quantity or even conditionally exempt status by managing pharmaceutical waste under Subpart P.

Items like empty pill bottles, used syringes, and many other dose containers are not considered hazardous waste pharmaceuticals under the new Subpart P.

Labeling Hazardous Waste Pharmaceuticals

For non-creditable wastes, EPA proposes to store them in containers, like other hazardous waste. Generators must mark containers with the words “Hazardous Waste Pharmaceuticals.” Under the proposed rule, EPA will explicitly NOT require personnel to include waste codes on the label/marking.

Accumulation Time Limits for Hazardous Waste Pharmaceuticals

EPA has proposed a one-year accumulation time limit for hazardous waste pharmaceuticals managed under 40 CFR 266, Subpart P.

LDRs for Non-creditable Hazardous Waste Pharmaceuticals

As hazardous waste generators, healthcare facilities must meet Land Disposal Restrictions at 49 CFR Part 268 in order to dispose of their hazardous waste. While most pharmaceuticals are organic in nature and therefore disposed of by incineration, healthcare facilities must segregate organic and non-organic pharmaceuticals in order to prevent those not eligible for incineration from being burned.

Shipping Non-creditable Hazardous Waste Pharmaceuticals

Under EPA’s proposal, off-site shipments of non-creditable hazardous waste pharmaceuticals will require a Hazardous Waste Manifest. That said, RCRA waste codes do not need to be listed on the Manifest. This allowance is not intended to alter or impact any Department of Transportation (US DOT) hazmat shipping rules, which apply to all wastes shipped on a Manifest.

Dealing With Rejected Shipments

In the rare case that a healthcare facility sends waste to a designated facility that’s unable to manage the waste and the waste must be returned to the healthcare facility, the procedures at 40 CFR 262.23(f) will apply. The healthcare facility must:
  • Sign the manifest used to return the waste;
  • Provide the transporter a copy of the manifest, send a copy of the manifest to the designated facility within 30 days; and
  • Retain a copy of the manifest for three years from the date of the delivery of the returned shipment.
RCRA Reporting Requirements for Pharmaceuticals

EPA proposes reporting requirements for healthcare facilities managing hazardous waste pharmaceuticals that reflect the SQG rules—namely the exception reporting requirements at 40 CFR 262.44(b) and the additional reporting requirement at §262.44(c). While large quantity generators are required to submit a Biennial Report to US EPA, generators will no longer be required to include hazardous waste pharmaceuticals on their Biennial Reports.

For exception reporting—as required in cases when the generator does not receive a copy of the Manifest back from the treatment or disposal facility within 60 days—the 40 CFR 262 exception reporting requirements will apply.

RCRA Recordkeeping Responsibilities

EPA proses recordkeeping rules for pharmaceutical waste at healthcare facilities that are similar to those required for regular hazardous waste generators under the 40 CFR 262 rules. Namely, healthcare facilities that generate non-creditable hazardous waste pharmaceuticals must keep a signed copy of each hazardous waste manifest for three years. In addition, healthcare facilities must keep records of any test results, waste analyses, or other determinations made on hazardous waste pharmaceuticals for three years.

Creditable hazardous waste pharmaceuticals will not be regulated as hazardous waste, provided the generator keeps records of all outgoing shipments for at least three years.

Responding to Releases of Non-creditable Hazardous Waste Pharmaceuticals

EPA has proposed basic release responses for hazardous waste pharmaceuticals, the same found under the RCRA Universal Waste program. Accordingly, generators must immediately contain releases of—and residues from—hazardous waste pharmaceuticals.

Secondly, generators must determine whether any material, residue, or debris resulting from the release is or contains a hazardous waste pharmaceutical, and if so, manage it under Subpart P.

RCRA and the DEA

Because hazardous waste pharmaceuticals may have recreational/street value in the “wrong hands,” the RCRA hazardous waste regulations will not extend to waste that’s been received by the Drug Enforcement Agency or an authorized drug collector.

If finalized, these new standards for hazardous waste pharmaceuticals will simplify the compliance requirements for healthcare facilities nationwide. If you have questions about managing your facility’s hazardous waste or training employees who handle, manage, store, and ship waste at your site, visit Lion.com/RCRA-Training for more information.

Tags: disposal, hazardous waste, RCRA, universal waste

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