The Environmental Protection Agency (EPA) has been regulating hazardous waste since 1976, but for the nearly 45 years since the EPA first implemented rules around hazardous waste, healthcare facilities have struggled to comply with these regulations as they relate to hazardous waste pharmaceuticals. To combat this issue, in 2015, the EPA released a proposed rule, specifically focusing on healthcare and hazardous waste pharmaceutical management given the challenges they’ve had with the EPA regulations. After three years of consideration, the rule was signed on December 11, 2018 and published in the Federal Register on February 22, 2019.
Since that time, healthcare providers have been working to dissect the rule to understand where changes should be made. While the rule will officially become effective on August 21, 2019, most states will not be adopting it at that time. Let’s dive into some specific details of this rule and how to know if your healthcare facility will need to make changes ahead of August.
Outlining the rule
The rule has three main parts - Subpart P, the Sewer Ban and the Nicotine Exception.
Subpart P is a new addition to the current EPA regulations, specific to disposal of hazardous waste pharmaceuticals by healthcare facilities. This piece of the rule will be effective in Alaska, Iowa, Kentucky, New Jersey, Pennsylvania and Puerto Rico in August – all other states have until either July 1, 2021 or July 1, 2022 to adopt the rule, depending on their state legislative processes.
The sewer ban is a part of Subpart P, and bans drain disposal via flushing or sewering of hazardous waste pharmaceuticals. This part of the rule will be effective in all states on August 21, 2019.
The final part of the rule is the Nicotine Exception, which exempts over-the-counter nicotine replacement therapies such as gums, lozenges and patches, from being P-listed, or defined as acute hazardous waste. This part of the rule does not have an adoption timeline because it’s more lenient than the law currently in place, so states are not required to adopt the new policy.
Overall, the rule is creating easier and safer regulations for healthcare facilities to comply with, and will be more effective in keeping hazardous waste pharmaceuticals out of our environment.
Will your facility need to make changes?
Beyond determining if your state is included in the first round of implementation for the rule in August, there are additional requisites that healthcare facilities should be aware of when considering if the rule applies to them.
Healthcare facilities categorized as small quantity (SQGs) or large (LQGs) quantity generators of hazardous waste are required to follow Subpart P when it’s effective in your state. Very small quantity generators (VSQGs) are not required to follow the Subpart P rule, outside of the Sewer Ban, which applies to all generators. Thus, it is important to review and understand your current hazardous waste generator status so you can know if the rule applies to your facility when the rule is effective in your state.
Differences from current EPA rules and impacts on healthcare facilities
Generator status: The new EPA rule may change some healthcare facilities’ generator status as hazardous waste pharmaceuticals will no longer count toward generator status for this new rule. This means that counting amounts of hazardous waste pharmaceuticals generated will no longer be necessary - good news for many healthcare facilities. Other hazardous wastes such as lab waste and solvents, expired chemicals, cleaning and sterilization products will still count toward generator status.Controlled substances: Hazardous waste pharmaceuticals that are also considered controlled substances will now be exempt from hazardous waste regulation provided that DEA disposal requirements are followed. To manage waste of these controlled substances they can be incinerated at facilities authorized in the rule, but they cannot be drain disposed, as noted in the Sewer Ban.
Waste storage: Hazardous waste storage must be limited to one year. These containers are required to be labeled with the words “hazardous waste pharmaceuticals,” closed at all times, and be in good condition, according to the rule.Pharmaceutical waste categories: The rule created new categories of hazardous waste pharmaceuticals. The first category, ‘potentially creditable hazardous waste pharmaceuticals’ are items that can be returned to a reverse distributor for possible credit and are in the original manufacturer packaging, undispensed, and unexpired or less than one year past the expiration date. The second category is ‘non-creditable hazardous waste pharmaceuticals’ or items that cannot be sent back to a reverse distributor due to there not being a reasonable expectation of credit being received; these items are to be disposed by the generator as hazardous waste pharmaceuticals.What will this mean for healthcare facilities?
It’s essential to understand that until August 21, 2019 all current regulations are applicable and are being enforced. However, it is time to start preparing for changes. The ban on sewering hazardous waste pharmaceuticals applies to all generators and will be implemented in all states on August 21, 2019.
Additionally, healthcare facilities should assess how they are currently disposing of non-creditable and potentially creditable hazardous waste pharmaceuticals to determine if they will need to change methods once the rule is implemented in their state. Finally, healthcare facilities should assess their current generator status to determine if the rule will apply to them, as it applies to all small and large quantity generators, and very small quantity generators have the option of complying with it.
While waiting for your state to adopt the rule, be sure to continue to monitor your current state regulations and get up to speed with the many nuances of both current hazardous rules and this new rule.
