EPA’s New Pharmaceutical Rule – Origin and Reason for the Rule

EPA Pharmaceutical Rule

The Environmental Protection Agency’s (EPA) long-awaited final rule for managing hazardous waste pharmaceuticals generated by healthcare facilities was finalized and published in the Federal Register on February 22, 2019. This rule had its origins in the EPA’s 2008 Universal Waste proposal for pharmaceutical waste – and perhaps even earlier based on comments to the EPA from retailers.

In December 2008, the Agency proposed to regulate hazardous waste pharmaceuticals under the Universal Waste rule. However, based on the comments received, the Agency decided not to finalize that proposal and, instead, proceeded with a sector-based approach. This means that the rule is written specifically for the healthcare industry (sector) and cannot be used by any other industry type.

This final rule, referred to as Subpart 266 and titled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine,” is a sector-based rule, which is not the common route for EPA regulations. The motivation behind this approach is to address the various concerns raised by stakeholders regarding how difficult it can be to manage hazardous waste pharmaceuticals (HWP) in the healthcare setting under the current hazardous waste rules. This is due to the differences in applying the RCRA Subtitle C hazardous waste regulations to a healthcare (HC) facility as opposed to a manufacturing facility (which healthcare workers can attest to):

  • HWPs in HC settings are generated in small quantities by various employees across the HC facility (as opposed to a larger volume generated at a specific location or process in a manufacturing setting)
  • HC employees’ primary focus is the wellbeing of their patients. They do not have the training or expertise to make a hazardous waste determination
  • The HC facility may have thousands of drugs in their formulary at any one time – and they ever changing. This is much different from a manufacturing site where there are fewer and more predictable waste streams generated
  • There are several pharmaceuticals that are P-listed, or acutely toxic HWPs. The management of these P-listed wastes is quite cumbersome in the HC setting.

The EPA’s new sector-based rule will help alleviate these burdens on HC employees and improve the management and disposal of HWPs across the healthcare facilities.

The bulk of 40 CFR part 266 Subpart P is being finalized under non-HSWA Authority (Hazardous and Solid Waste Amendments). Thus, the amendments promulgated under non-HSWA authority are applicable on the effective date (six months after being published in the Federal Register) only in those states that do not have final authorization of their base RCRA programs (Iowa and Alaska). The new rule is MORE stringent than the current federal standards – so these more stringent provisions MUST be adopted by the other 48 states.

Therefore, authorized states will be required to modify their HW programs to adopt these revisions.

  • Authorized states have until July 1, 2021 to adopt Subpart P
  • Authorized states that require a statutory amendment have until July 1, 2022 to adopt Subpart P

If you have any questions about how this rule may affect you or how to manage your hazardous waste, please contact us.

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Joe Jordan

Director of Hazardous Waste Solutions at Sharps Compliance
Joe Jordan has a Bachelors of Arts degree in Chemistry from Washington and Jefferson College. He is certified in RCRA & DOT, as well as 40 Hour HAZWOPER certified. Joe has been in the hazardous waste industry since 1990 and has managed industrial, healthcare, retail & governmental clients both large & small.
Joe Jordan

Author: Joe Jordan

Joe Jordan has a Bachelors of Arts degree in Chemistry from Washington and Jefferson College. He is certified in RCRA & DOT, as well as 40 Hour HAZWOPER certified. Joe has been in the hazardous waste industry since 1990 and has managed industrial, healthcare, retail & governmental clients both large & small.