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August 21, 2019 updates – Pharmaceuticals rule

Sewer ban effective today

Effective today, August 21, 2019, the sewer ban prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW; see 40 CFR §266.505). This is the only provision of EPA’s “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” rule effective in Hawaii. Other provisions of the rule do not become effective until they are adopted in state law.

Save the date – Public presentation September 20

The Hazardous Waste Program is planning a presentation on the federal rule “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” for September 20, 2019, 9-11am. Confirmation and details to follow. Note that the sewer ban is the only provision of the federal rule effective in Hawaii. Other provisions of the rule do not become effective until they are adopted in state law. This presentation will cover the federal rule only.

More information on the federal rule

40 CFR §266.505 prohibits all healthcare facilities and reverse distributors from discharging any hazardous waste pharmaceuticals to a sewer system that passes through to a publicly owned treatment works (POTW). This includes hazardous waste pharmaceuticals that are also controlled substances under the Drug Enforcement Administration (DEA) regulations and collected household pharmaceuticals (see 40 CFR §266.506). Although the sewer prohibition applies to healthcare facilities and reverse distributors with respect to hazardous waste pharmaceuticals, EPA strongly discourages sewering of any pharmaceutical in any setting (with few exceptions, such as sterile water, 0.9 percent sodium chloride (saline) and Ringer’s lactate solution).

 

 

 


 

Ban on sewer disposal of hazardous waste pharmaceuticals goes into effect August 21, 2019

As many of you probably know, EPA finalized its “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine rule,” a.k.a. “The Pharmaceuticals Rule,” on February 22, 2019.

The only part of the rule adopted under federal Hazardous and Solid Waste Amendments of 1984 (HSWA) authorities is a prohibition on sewering of hazardous waste pharmaceuticals that applies to all healthcare facilities,** including very small quantity generators. The sewer ban becomes effective nation-wide on the effective date of the federal rule, August 21, 2019 [see the new 40 CFR section 266.505]. EPA discourages sewer disposal of any pharmaceutical waste by any entity, although the legal ban will only apply to hazardous waste pharmaceuticals and healthcare facilities.

**Definitions of “healthcare facility,” “pharmaceutical,” and “hazardous waste pharmaceutical” are found in the new 40 CFR section 266.500.

The rest of the rule does not become effective in the State of Hawaii until the provisions are adopted into State regulations. This long and complex rule will be a future topic of discussion.

For more information, including a copy of the rule and a link to a recorded EPA webinar summarizing the various provisions, go to: https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075


“Safe Management of Recalled Airbags” EPA interim final rule

On November 30, 2018, EPA published an interim final rule to facilitate the prompt removal of defective Takata airbag inflators from vehicles by dealerships, salvage yards, and other locations for safe and environmentally sound disposal. The rule will exempt the collection of airbag waste from hazardous waste requirements so long as certain conditions are met, and the airbag waste is ultimately disposed of at a facility designated to dispose of hazardous waste.

 

The Hawaii Department of Health will allow airbag waste handlers to manage airbag waste under the conditional exclusion immediately, and plans to adopt the exclusion into state regulations as soon as possible.

To find out more about the interim final rule: https://www.epa.gov/hw/interim-final-rule-safe-management-recalled-airbags
To find out more about the Takata airbag recall: https://www.nhtsa.gov/equipment/takata-recall-spotlight