The PharmaStart program takes complete care of pharmaceutical and hazardous waste for hospitals. Hospitals with this program get custom advice on regulatory compliance as well as cost-reducing disposal options.At the start of this program PharmaStart experts conduct a composition analysis as the basis for each hospital’s stream strategy.
This analysis drives cost savings as well as sustainability efforts within pharmaceutical programs. With PharmaStart, hospitals are ablt to meet all regulatory requirements and create a safer work environment so they can focus on their true priority – taking care of patients.
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James: Hi everyone. Welcome to today’s webinar on the new Pharmaceutical Waste Management Rule that has been host by the EPA. My name is James and I’ll be your moderator for today’s event. Before we get started I’d like to give you a brief overview on what this webinar is going to entail.
We’ll start today’s session off with a slide show presentation addressing the various issues that led to the creation of this rule; what this proposed rule entails and what all this means to you. Our speaker today will go over the agenda in more detail.
Following the presentation there will be an open Q and A period. You can ask questions anytime throughout the webinar by typing them into the questions box on the right hand side of your screen.
Please note that everyone’s microphones will be turned off for the entirety of the webinar. But again, if you have a question or if technical issue comes up you can use that questions pane to communicate.
Also, keep in mind you will receive the copy of the slide deck and the webinar recording tomorrow. All the PowerPoint materials will be in your inbox tomorrow and you will receive everything that Steve presents on today.
Today’s speaker is Steve Todisco. He’s the corporate director of Healthcare for Triumvirate Environmental. He oversees Triumvirate’s Healthcare vertical market. He has been at Triumvirate since 2003. After his 13 years in environmental experience he has become an industry expert on the management of highly complex multi-discipline waste management programs. And so with that, I’ll turn things over to Steve. Hey Steve!
Steve: Hey James. How are you? Good afternoon everybody. Thank you very much for attending Triumvirate’s webinar in “Demystifying the New Pharmaceutical Waste Proposed Changes”. I’ve got a great presentation for you today I’ll be driving you through the next 45 minutes.
Here’s our agenda. We’re going to start by spending a moment over viewing recreants sort of power relates to pharmaceutical and healthcare. We will tackle the current issues that exist today and a lot of the things that everybody’s been feeling over the years that relates to pharmaceutical waste management and how the ease implementation – although it’s been streamlined over the years, it’s still difficult for small part of the generators. We’ll dive in to the rule and what the proposed overview looks like. We’ll then take those six current issues and wrap them up with six major solutions or six components to those major solutions and spend a moment on reverse distributions as well. And just talk with you about an action plan and where do we go from here before we wrap it up with question and answer session.
What I like to do is just spend a quick minute on how pharmaceutical waste management actually began. In 2003 the data was pouring in from a prospective of where we find contamination in our water call the supply. The Associated Press, the United States Geological Survey relying on some data points through water quality testing set for those pharmaceuticals were yielding that they were finding material that they were looking for. As our analytics get better, we start measuring things in the parts for quadrillion range and so on, what they’re looking for their finding.
2003 started to take room for pharmaceutical programs and since then we’ve seen all sort sizes and shapes of management programs from all across the states the Triumvirate operates in. Since then we’ve been fortunate enough to built a couple of hundred of those programs across over 20 states.
How this hopes to help you, you ask today? Well to address the next chapter in pharmaceutical waste [0:03:40.7] and really help to prep any program modifications whether they be relevant or part of our programs that we built and rolled up.
Before we begin James our moderator has quick poll question for everybody.
James: Sure. Thanks Steve. The question we’re posing here is trying to get you how concerned you really are about this proposed regulation and how prepared you might be for the changes that may take place. If you could take a few seconds to answer that, we would appreciate it.
Alright Steve. Looks like 53% are somewhat concerned and other 41% are very concerned about this regulation. Hopefully, we clarify some things today with your presentation.
Steve: Great. Thank you very much. Let’s start then. Let’s talk a little bit about RCRA and Healthcare. We’re going to spend a moment on RCRA and how it came to be. As many of you know 1976 is a long time ago. 2016 actually marks 40 years of RCRA subtitle C being promulgated into the EPA legislation of law.
Long time ago, a lot of pharmaceuticals didn’t exist back in 1976. As you can imagine, that has driven some of the issues and some of the pain building pharmaceutical programs. Of course we all know that RCRA is what governs hazardous waste and hazardous waste pharmaceutical falls to that category but this is where it all began. This is where we got to cradle the grave and ultimately, how RCRA made its way into the lives of folks in healthcare.
Next up 1984. HSWA, the Hazardous and Solid Waste Amendment of 1984. For those of you who are familiar with HSWA, it was really enacted largely due to the public’s opposition at the time to current hazardous waste disposal practices. There are a lot of things that weren’t going the way that anybody wanted them to do and things are being disposed off inappropriately to say the least.
HSWA as a subjective opportunity to move RCRA forward is really worth subtitle C left off. It addressed all sorts of things from underground storage tanks and land disposure, restriction notifications. Anytime anybody signs a hazardous waste manifest usually there’s an LDR associated with it.
One of the major components and really how it relates to pharmaceutical waste is it really spoke to regulating small quantity generators. Prior to then, they were sort of off-the-radar screen altogether. We all know that the majority of pharmaceutical issues today really can be derived from SUGs.
All of these regulations of course currently live in 40 CFR. 40 CFR actually refers to the title that protects the environment. Literally, 40 CFR is the protection of the environment. We’ll be able to relate this later to where the new regulations live.
As we move forward, we know that all of three of these components Generators, Transporters and TSDs or Treatment, Storage and Disposal Facilities are regulated under RCRA. Generators are businesses or institutions or even governmental institutions who produce hazardous waste. Transporters, we Triumvirate and another transporter must carry a hazardous waste transport of permit for each state that we pick up waste or we drop off waste.
These permits are issued by the state. In Mass, it’s the Mass DEP, Department of Environmental and Protection. In New Hampshire, it’s DES; so on and so forth. Every state has similar listings for their names but in some cases quite different. Ultimately, Generators that are transporters may not transport their own hazardous waste unless they’re conditionally exempts small quality generator under some state specific guidelines.
Last but not the least the TSDs; they carry a state issued permit to receive waste from generators. They may be permitted to store waste for a year or more. They can treat it. They can dispose it. They can co-mingle it. They can put it together, rip it apart depending on the conditions of their permit is how they operate.
Generators are assuring that their waste is actually shift to it properly permanent TSTF when they allow that material to go off for shipment. As you can see here under 40 CFR, we’ve got part 261 to 271 with a few and between they’re missing. That’s where the existing regulations live today.
Little bit deeper dives that relates to pharmaceuticals; currently there are many types of waste regulated under RCRA. We’ve got some D-List to items F, K, U and P. Just a quick refresher D listed items are characteristic of something. Alcohol have a flash point below 140 degrees Fahrenheit. Corrosivity, I have a PH of two below or 12 ½ and above so on and so forth. A physical characteristic is something that will identify as a D-Listed item.
F-Listed is waste from non-specific source. It comes from a multitude of industries, Healthcare being one of them. You typically see them lab solvents from the histology or microbiology labs, maybe some from hematology and so on. Don’t see a lot of F-Listings when it comes to pharmaceutical waste.
K-Listing as well, these are very, very, very specific generation’s sources. Again, no K-Listings in my 13 years of experience for healthcare very, very specific items.
Then, really what apply mostly to pharmaceuticals is the U and P Listed items. Very clearly they’re listed in the Federal register. They’re listed under 40 CFR. They have to be virgin material that have to be unused. They have to be the sole active ingredient. So the more that you put two things together or multiple things together at some of these cocktails you end up at a place where you really can’t have a U, R, P Listing. Ultimately, they have to be commercial chemical products. If they’re not, they fall out of the regulated range of U and P Listings.
Now the ones that we typically see in the pharmaceutical world that we just mentioned are really the D-Listed items, the U-Listed items and the P-Listed items. The example of the Ds could be the alcohol that’s use as a preservative or rubbing alcohol, isopropyl alcohol, everything that’s a national drug code number.
The U-Listed items some chemotherapy based items so those of you who have a chemotherapy practice, Mitomycin C, Chlorambucil, Cyclophosphamide. From then those pesky U-Listed wastes that relate to the wireframes of the world and the nicotines and the physostigmine and the physostigmine salicylate that cause the majority of the problems which was new law of proposed ruling is working to change.
Next up, we all know about generators statuses. This is federal large, small and conditionally exempt. As a result of the codes federally, this is what we get placed into grouping’s for. They helped to further define the generators involvement in RCRA. There are also states specific differences like here in our appropriate office in Massachusetts. There are also very small quantity generators or VSQGs. Maine has an SQG plus delineations. For the purposes of today we’re going to spend most of the time in the federal world.
Last as the component of a RCRA overview, here are some of the major aspects really of a pharmaceutical program is they are regulated under RCRA. We got a fact finding phase, an operational phase and educational phase. This is an example from a formulary characterization stand point. That’s you’re performing a waste determination. Everybody that generates a hazardous waste is required to perform a waste determination.
Same thing with reverse distribution, it’s the argument versus credible versus non-credible items and so on. The indication upon the tool very based on large, small and conditionally exempt small quantity generators.
As we roll through this a lot of, if not all of Triumvirate’s Pharmaceutical programs will built at the time with the universal pharmaceutical waste regulation sort of looming over head and mind. There’s a lot of similarities here and the vast majority of Triumvirate programs actually took into consideration a lot of these changes that are being propose. So very little effort for folks that have an existing pharmaceutical program with us, some signage and labelling changes and things like that but no major changes really just great support and making the program easier for the end users.
These are the parts that help address questions like what do I have for pharmaceutical? Where is it? Where does it go internally? How do I need to collect those pharmaceuticals and what do I need to collect? And really, who and how do I need to educate those folks so that I have a compliant program under RCRA. Again, today’s RCRA, we’ll get into the future most importantly, the education component.
I’ve said this for years, anytime you ever building a program the goal is to make sure the people collecting what they need to collect and really not more than what they need to collect.
Let’s jump into some current issues. We’re going to discuss the six current major issues when developing any pharmaceutical program. This is under RCRA as it stands today. The way this will work is we’ll be identifying those six issues. We’ll give everybody a few minutes as we review the proposed ruling and then we’ll address those in some of those six proposed solutions.
Let’s jump into it. Issue number one; Large Quantity Generator Status for greater than one kilogram or 2.2 pounds of P-Listed waste. This is the major issue for small quantity generators and conditionally exempt small quantity generators. Anytime you’re going to generate P-Listed waste above that 2.2 pounds per calendar month you are stuck. You are forced at that point, in theory you already are, in a large quantity generator. You then are burdened with all the large quantity generator requirement – the shortened pick up, bi-annual reporting or annual reporting if you’re in New York and smaller other states. Potentially, increases cost, definitely increases training requirements, formal contingency planning and so on.
One thing that’s really seldomly mentioned is that the requirement is based on the waste that you actually generate not the waste that is actually shipped on the manifest although the manifests are what triggers typically our regulator would dive into an inspection related to that material. Issue number one very much so an issue that derived as an issue for small quantity generators.
Issue number two; Residual P-Listed Containers. We know this as a second major issue for many people relating for the collection of empties of P-Listed materials. We’re talking about Warfarin blister packets and the decision to triple rinse versus collect. We all know in healthcare it’s very difficult to even think about triple rinsing anything so that material ends up being forces of collection item unless your state is exempted some of those items. Then tiny, tiny vials; small, small containers the industry was never built, RCRA was never built to think about the 1 milligram vial or the bristoject or some of the delivery mechanisms that we seek today.
This also relates to departmental waste; waste that can be residual like Barium Sulphate. Many time you go to radiology and they make you drink that lovely flavoured drink. There’s Barium Sulphate at that material. Ultimately a D code D005 could apply to your particular brand of Barium Sulphate solution. Every brand has their own NDC number. Every NDC number has their own waste characterization and that’s part of what a formula or characterization process. It’s such an important one in determining what you have and what you don’t have.
Issue number three; our third issue is Manufacture Oriented Regs really imposed at healthcare. Again this is a sign of the times. Think of the 70s. Industrial operations 55 gallon drums, bulk waste streams. RCRA was never really originally designed for these one milligram vials, right?
Hospitals have major hurdles related to these and a lot of these you see on the screen. There are a lot of folks in the hospitals, particularly nursing who get burdened quite a bit with the proper collection of these pharmaceuticals. They need to know what RCRA is and they just don’t have that RCRA knowledge because let’s face it, if I’m in the hospital I want them focusing on patient care and what they need to keep me out of the hospital.
From a pharmacy prospective, these issues vary over timed because formularies change over time, thousands and thousands of variations. We just characterized a pharmaceutical formulary down in mid-Atlantic. It had over 10,000 medications as part of this its formulary, just lots and lots of drugs to identify and manage or track. Some of the biggest location is this satellite accumulation area issues. If you’re in the state that recognizes SAAs there could be hundreds of these locations located throughout the hospital to manage and regulate.
Issue number four; our fourth pharmaceutical waste drain disposal has become a commonly used mechanism for disposal by hospitals and healthcare facilities. This is an interesting fact. One study, did you know that base on that component, that drain disposal actually accounts for about 20% of RCRA pharmaceutical waste disposal? For right, wrong or indifferent, a lot of these materials still end up down in the drain.
Another variant percentage by locations shows that between 25% and 50% ending up in the red bag waste stream. And Triumvirate, in our most endeavor to regulate medical waste management, our recycling process has given us some great data on historically what’s been going into these medical waste streams.
A lot of this is contributed to pharmaceuticals and service in bringing water. We mentioned Associated Press in the United States Geological Surveys. Water quality testing studies has been on-going and continuous. And everywhere they look they find material all end up down in the East Coast, major watershed and across the country.
This issue is one that they really wanted to address because flushing is currently allowed for some pharmaceuticals. This is an opportunity for the EPA and the DEA to play nice in the sand box together. One of the opportunities for this issue.
Issue number five; the intersection of EPA and DEA, The Drug Enforcement Agency. Almost all of us have had a near impossible experience deciphering between these two organizations where the intersection is and where they meet in relationship to pharmaceuticals.
Here are few of the intersection items. There are some DEA items that could carry a RCRA waste code in the event that they either virgin, unused material in the case of Chlorohydrate, and typically the delivery mechanism for some of these others. Those intersections most of us are familiar with them as a wasting process, a double signed off procedure and so on.
Finally, working with a local branch of the DEA to do anything other than wasting. This is that case by case approval status. Any time you want to modify the process even if you have a better process, you have to write a letter and wait for an answer. An opportunity there in disguise to correct something, that is an opportunity for all categories.
Our last major hurdle; the regulatory status of creditable pharmaceuticals. Triumvirate since its very first program, and I remember it well, has always thought of reverse distribution as a really important component managing pharmaceutical waste. All of our programs have incorporated reverse distribution review which again would make it a little bit of an easy transition from existing programs to this new ruling should it become final.
One of the components of this issue is the determination of receiving credit, your pharmacy receiving credit for those pharmaceuticals or not. The general theory has always been if you got an opportunity to receive credit for this, it never became a waste. If it was never a waste, it was never a solid waste. If it was never a solid waste, it was never a hazardous waste, so on and so forth. It falls out of RCRA.
The reality though is the end disposal locations, there are no manifests. There are no land disposal restriction notifications. There isn’t a tracking. An issue with an opportunity to fix. There’s no cradle to grave here. We’ll spend a few minutes later on in the presentation when we get to the solutions as it relates to reverse distribution.
Those are the current issues. Let’s get into the details of the proposed rule in the form of the overview. This is a little bit of an agenda slide. We’re going to address some definitions. Which pharmaceuticals are covered. Who is it covered? Who is it affected by this? Where did these new racks live as it relates to that 40 CFR slide that we address earlier in the presentation?
We’re going to speak to what this means for states and how individual states have options or not in this case. We’re going to go through those six major solutions as a function of those issues that we just covered.
Let’s start by defining some terms. Here’s the definition of a pharmaceutical. Any chemical or biological product that is intended for used in the diagnosis, cure, medication, care, treatment or prevention of disease or injury of a human or animal or any chemical, biological product that is intended to affect structure or function of the body of the human or other animal. This sort of speaks about natural drug code numbers, right? Anything that has a NDC number is going to be regulated as a pharmaceutical. There are some other things outside of that scope that may have yet to actually get their NDC number. That’s one of those components that is a little bit broader than the definition used to be in the past. It really goes further to reflect more of the FDAs look at what a pharmaceutical is unless what the EPA consider as pharmaceutical to be.
Here you can see what is included but it’s not limited to nothing out of the ordinary here. But this also includes the clean up material from the spills of pharmaceuticals. Very similar to what spill debris may have look like as part of the collection process.
More of pharmaceutical definitions; some more inclusions but the real take away from this side is this is broader than what everybody has thought to date to be the universal pharmaceutical waste rule. It had played an important role on states like Florida and Michigan that we’ll discuss a little bit further later on.
It no longer includes waste sharps. There was exemption that we’ll look at at the end of the presentation that addressed this, for all spent for intended purpose, sharps. But it addresses a very clearly here so it no longer include residual material in a sharp, syringe, a glass vial provided that, once the pharmaceutical is spent for its intended purpose.
As we roll through the definitions what’s comes next is really what pharmaceuticals are covered and I really want to put some emphasis on the next couple of slides because they make some important points. I’m going to read this; only pharmaceuticals that already considered hazardous waste. Only RCRA pharmaceuticals that fall into this category are covered under this new rule. It doesn’t regulate additional non-hazardous RCRA, not hazardous pharmaceuticals like the state of New Jersey for example does when they covered NAISH regulated material.
The proposed rule does not propose to increase the number of pharmaceuticals that are considered hazardous waste. I believe that they couldn’t take this rule far off. We’ll talk at the end and how that may change but it only changes how hazardous waste pharmaceuticals must be managed. The EPA did in their presentation a couple of weeks back which to encourage the healthcare facilities manage always pharmaceuticals under the new law as an overarching goal.
More on who is covered after reviewing which pharmaceutical are covered. I’d like to spend a minute looking at who is covered and really as Healthcare facilities the generate hazards waste pharmaceutical. Again, I think it’s important to read this. The proposed definition of a healthcare facility – any person that provides preventative diagnostic, therapeutic, rehabilitative, maintenance, palliative care and counselling or service assessments or procedures with respect to the physical and mental condition of functional status of a human or animal. They highlight human or animal. There wasn’t as much emphasis put in the animal component of this in the past. In order – or that affects the structure or function of the human or animal body. Then, also the secondary definition, sells or dispenses over the counter prescription pharmaceutical.
The story here is lots and lots in people are covered. We’re going to dive into them into a little bit further in this next slide which describes the NAICS codes. Here in the industry sectors under that coding system. As you look at this on the screen, there’s quite a bit here and for those of you who need to be refreshed on NAICS. NAICS stands for the North American Industry Classification System. It’s really a broader coverage than the SIC codes which would have been the Standard Industrial Classification.
The next codes are the newer version of the SIC codes and they have max six digits as opposed to four that’s why you’ll see more groupings and more delineations under the NAICS codes. But you’ve got pharmacies and dentists and hospitals and long term care and reverse distributors so on and so forth. It does not include drug manufacturers. That’s interesting enough. From that prospective, somebody lobbied it successfully.
More on who’s covered. In addition to the typical waste generators reverse distributors also play a part and are now regulated differently, I guess, than they were before under this new proposed rule.
What’s the proposed definition of the reverse distributor? It’s any person that receives and accumulates potentially creditable hazardous waste pharmaceuticals. That’s really the nutshell even though this more here. Everybody knows this is CXP or guaranteed returns. So there’s a lot small players out there in this industry. But I really think it’s important to mention reverse distribution and cover it from a definition stand point because they will be regulated as well and sort of a flip flop of circumstances where healthcare is in a better boat with these new rules. Reverse distributors are more stringent. Similar regulations, they sort of qualify as what was typically a large quantity generator requirement under existing RCRA.
Last but not least, some drug manufacturers may operate as RDs, as reverse distributors.
Talk about 40 CFR where the existing regulations live, we’re going to spend some time now is 40 CFR Part 266, specifically Sub part P. At the beginning of our presentation we started talking about it’s important to understand where these things live within the 40 CFR. The new proposed regs actually are entitled managers and standard for hazardous waste pharmaceuticals. Interestingly enough Part 266 also covers recycling. Who would have thought? That’s an interesting part here.
Let’s take a look at three key points here. The EPA considers this to be more stringent than current regulations. This is one of the more interesting components of the proposed rule. What it does is it really gives an opportunity for the Feds to say, “The states are going to have a choice here. You are required to use this new rule.”
There are a lot of components here that you can feel a little bit more stringent even though they provide some leeway and flexibility for some small quantity generators. But ultimately this is the mechanism to put everyone in a bucket and make them comply. It’s not voluntary. All states will be required to adopt this final rule.
One of the components here is the Sewer Ban under HSWA. It will be effective in all the states once the final rule comes out even before that state adopts it. From a sewer drain disposal component, we’ll talk about what the solution looks like in a few moments. But the states will be required to adopt that as well. As we mentioned a little bit, Florida and Michigan that have some of these existing universal pharmaceutical waste program and I know Connecticut was walking down this road as well about a year ago. They will have to replace their UPW programs to comply with RCRA as it relates to 40 CFR Part 266 sub Part P.
Earlier in the presentation we covered six major issues. Here we’re going to cover review those issues as the six major components or the solutions to those issues. We'll review them in the same order that we went through with them in the beginning.
Solution number one. The issue that we're covering was related to the LQG, a Large Quantity Generator status for that one kg or 2.2 lbs. of P-Listed waste. So, the proposed solution for that issue is hazardous waste pharmaceuticals will no longer count toward an institution's generator status. So think about it from the perspective of everyone has an EPA identification number. That ID number ultimately generated your status whether you're large or small or conditionally exempt. No longer will your weight, your poundage count towards your generated status.
Now, remember this is just pharmaceutical waste, nothing else. So the laboratory waste will continue to be very specific to your generation rate. Your facilities wastes, your universal wastes that fall under RCRA, all of that material will be very specifically and only related to your generated status; no longer pharmaceutical waste.
So, the couple of bullet points here: no monthly generation rate tracking. Under that 220 lbs. per calendar month or 2,200 lbs. per calendar month, the delineation goes away. And all pharmaceuticals that are hazardous under RCRA are managed the same way. One of the biggest incentives here is for folks that want to comingle hazardous and non-hazardous items you won't be penalized by increasing your generation rates because the weight of your haz program is larger.
It will also help to reduce some episodic generation. Meaning these very, very tiny generators that had an influx of something whether it's a year to clean out or formally samples or something like that, it will remove that episodic generation component in total. And it also helps some of those silly rules that P-Listed material couldn't be collected in a container that is larger than a court or would have been regulated as a central accumulation area. Those all go away under this and the comingling of haz and non-haz can make a lot of people happy when it comes to the collection of pharmaceuticals.
Solution number two. If you would refer back to issue number two which was referred to P-Listed waste and the residual waste, the proposed solution now allows residuals. So think of this in the form of RCRA empty. Really, RCRA empty now applies to everything. So you need those containers exempt. Vials up to a liter, a thousand pills exempt.
As long as all the contents were removed, it's now considered RCRA empty. And let's just review what RCRA empty means. RCRA empty means a container that has one inch or less material inside.
If it's a container that's less than 119 gallons which as you can imagine for the vast majority of pharmaceuticals they will all be that. 119 gallons begins the definition of what a bulk container is. It's 3% by weight so if you have any container that's less than 119 gallons and it's less than 3% by weight and less than an inch, you're RCRA empty. And for those if there are any, I don't know if I've come across one yet, if anybody has a container greater than 119 gallons that's 0.3% by weight is RCRA empty.
So, no more issues related to having collect containers that once held P-Listed material – the blister packets for the warfarin; the packed wrappers for the nicotine, etcetera. I know triple rinsing was never an option for healthcare but this exemption really helps solidify and make it very simple so all the "trash" generated on the nursing floors are no longer regulated.
Solution number three. A little bit more of a housekeeping solution in my opinion here. But relating to issue number three, relating to the solution number three, the original issue number three is where the manufacturer oriented regulations were being imposed on healthcare. So mid-70s, healthcare wasn't taking pharmaceutical waste to be regulated. They were thinking more the Ford motor plant type scenario with drums and containers that were larger.
These are very solution sector-specific standard. So that's why they separated it out. And really, the change here is healthcare pharmaceutical waste is no longer regulated under traditional RCRA. It's regulated under Subpart P. And again, we talked about some of these as we've gone through solutions one and two but there's no more small and large quantity generator requirements as it relates to pharmaceuticals.
This really addresses how pharmaceuticals never play the role in the creation of RCRA back in the mid-70s. And you still have a one-time notification. This is how they're going to track ultimately whose pharmaceutical waste generator. Think of it like an EPA ID number for pharmaceuticals.
Satellite accumulation area and the central accumulation area or main accumulation area regs are reduced. And I'm not sure how much of this played a role in the existing regs. But from a pharmaceutical waste, it's not applicable to any biennial reporting.
And those folks live in states who require annual reporting, there won't be specific requirement there as well for pharmaceuticals again, pharmaceuticals and pharmaceuticals only. This does not apply to laboratory waste and does not apply to facilities waste or anything else that's not defined under a pharmaceutical.
Solution number four relates to issue number four which was drain disposal really being commonly used mechanism up to 20% for pharmaceutical waste disposal. And the proposed solution, the new rule bans sewering hazardous waste pharmaceuticals. It applies to all healthcare facilities, reverse distributors. And what's interesting here is it even applies to conditionally exempt small quantity generators which in theory, in previous existing RCRA, really would have been hard to capture some of those regs for CESQG's. So the new rule bans the sewering of hazardous waste pharmaceuticals.
An interesting point and I'm not sure; did anybody listen to the EPA webinar on the same topic a week, week and a half ago? They mentioned in one of their slides that the DEA no longer allows sewering as a means of destroying controlled substance. I'm going to say that again because it took me two days to decide whether or not to put it in this presentation. But the EPA presentation mentions that DEA no longer allows sewering as a means of destroying controlled substances.
Now, we reviewed this at Triumvirate. We reviewed this and we found extreme contradicting language from a guidance document in the federal register and a guidance document online, both resources readily available on the web from some of the more recent DEA updates to laws and rules. So the federal register is basically stating that the DEA does not believe that sewering would render a pharmaceutical controlled substance non-retrievable and that non-retrievable delineation is how they get around that.
So on the one side, they're saying, “Don't bring in narcotics down the drain. Don't waste them. Don't sign up procedure,” and so on. Change that process.
Now, I'm not advocating for a change at the moment because I don't 100% belief that any but they knows what the process should be at the DEA. But there's another component here; that guidance stating that existing mechanisms for disposal were still okay. So, quite a bit of contradiction there because as you can imagine existing mechanisms for disposal include drain disposal via a wasting process. The overall goal of course to prevent diversion and these pharmaceuticals ending up where they shouldn't.
Solution number five. Relatively simple to the confusing regulations that we discussed as the issue or the intersection between the EPA and the DEA. So the solution is hazardous waste pharmaceuticals also regulated by the DEA would be exempt from RCRA.
So if you follow the DEA rules and not the RCRA rules for any of those items that you may have even though a lot of them are really gone by the wayside, predominantly chloral hydrate. We don't see that used quite a bit and more. If you do, it's usually a [0:38:51] cup that is traditionally empty upon completion. But really must be managed in accordance with all DEA regs. You have to combust them at a permitted or an interim status, solid waste combustor or hazardous waste incinerator. Couple of nuances here but ultimately removing the very RCRA regulations from the DEA side of things should streamline that process a little bit.
One quick bullet point here. Authorized collectors of household hazardous waste, so this is just a recent change from the DEA perspective within the last year, including narcotics are exempt from recent DEA law. So again, authorize collector's household hazardous waste, exempt.
Solution number six. Finally, the last major solution to the reversed distribution issue. The point of generation for pharmaceuticals sent to a reverse distributor will now be the healthcare facility and not the reverse distributor. What's important is sort of always or at least since 2007 really been enforced this way with definitely some confusion. It's here. It's right in our face. It's very specific.
Hospitals are the generator of waste. Hospitals are the liable party when material isn't handled correctly as this relates back to sort of our cradle to grave component. So the no education component is very similar to a manifest or an LDR as they exist for the generators. But we'll see more on the next couple of slides related to reversed distribution. So, a really important point here as it relates to building a pharmaceutical program or updating a pharmaceutical program.
Those are the six solutions as they relate to the issues. I'm going to dive couple of slides deeper into reverse distribution. I feel that they're extremely important for people to understand because reverse distribution has always been a component of all the Triumvirate programs. We believe there's really minimal changes related to our programs; related to this proposed rule namely labelling and signage.
So moving forward, we want to be able to spend a few more minutes before wrapping up on this proposal related to reverse distribution. And one of them is the reverse distributors can't knowingly accept non-creditable hazardous waste, sort of the same way as we always thought about it. If we were getting credit for some, they could never fall under RCRA and it was no longer hazardous waste versus the opposite. It should something that expired and we're not getting a monetary credit for it, that material is RCRA.
And those standards are very similar to large quantity generator standards. They have to register for an EPA ID number. They have to make biennial and an annual report that applies to them. They have to inventory those materials. They have to have training and education.
And they can only collect waste for 90 days. Some of them are new ones. Components of the new proposed rule for reverse distribution is they're not required to have a RCRA storage permits.
They don't operate like Triumvirate does; as the TSD or like any other TSD does. They can't store waste for up to a year. They have a much more limited timeline. And we'll walk you through that in a second because it's only 21 days.
Wouldn't be a true webinar if we didn't define reverse distribution so it's potentially creditable. A hazardous waste pharmaceutical that has the potential to be credited really. I mean to receive manufacturer's credit. And this applied on used and un-administered pharmaceuticals and this is kind of interesting. They put a year past the expiration date as the limiting factor for some of this.
The definition does not include evaluated hazardous waste pharmaceuticals. We'll define what evaluated means. It doesn't talk about residues remaining because that's not something that's worked that anybody's going to credit. Doesn't work for PPE or spill debris for the same reasons.
If you remember the term used to be reasonable credit and some of the best understanding of that was, hey if I send something back to credit 10 times that I got credit seven, eight or nine times, can I continue to do that? The answer at that point was yes. But at other end of the spectrum if I've gotten credit for something couple of times out of 10, the answer was typically no because you have no proof that it was ever going to be credited and that would still fall into the hazardous waste realm. So, more here on the definition of potentially creditable.
We talked about what was creditable. Here's what not. Samples, if you try to return a generic; if it's more than a year past expiration; a lot of hospitals remove things from the original containers and repackage those things. Those don't apply. Those are not creditable items.
Again, they further defined this to make it a lot easier not only in the hospitals to say this is or this isn't something that's going back to my reverse distributor or collected here as a hazardous waste but it makes it easier for the reverse distributors as well. It's providing understanding of what someone is going to give credit for. And again, if it was generated during patient care or if used by the patient, something like maybe a chemotherapy dose, someone had a reaction, then the dose have to stop, that's not a creditable opportunity under this ruling item.
Lastly on the reverse distribution, remember that word evaluated? Well, here it is. It's pharmaceuticals must be evaluated by the reverse distributor within 21 days. Within that 21 day period, it's either moving on to another reverse distributor for evaluation. And once it moves out to its second, it can no longer go on with third or it's going to a permitted hazardous waste TSDF.
If they accidentally receive something they're not supposed to, they have to fill out a non-authorized waste report. This is where that tracking comes in which was one of the issues in the beginning, at the beginning of the presentation. It gives the opportunity to the EPA to understand what's happening and what's rolling through. So again, 90 days for accumulating this material like they can't generate it longer than a large quantity generator would and those laws will apply to them just like they do to today under RCRA.
All right. Let's see here. As we begin the wrap-up, many folks are wondering what do I do now? So, let's jump in to those. The publication of the final rule is already in the code of federal regulations. The administrator has already signed the proposed rule back at the end of August. And it was published in the federal register on 9/25.
Originally, there was a 60 day comment period that ended November 24th. There's been a lot of request for extension. So that extension is right before the end of the year for December the 24th, 2015. After that, they'll review that public comment period and they'll begin to finalize the rule.
In the event that you or anybody else in your hospital would like to comment, go to regulations.gov and search docket number epa-hq-rcra-2007-0932. Hope you're all writing that down. This information will ask if you're available or a follow up email that will also include a survey and a link to our presentation.
So again, for those folks who want to comment before the end of the comment period, that docket number will be on this follow up email so that you can go to that link and place your comment. And please do because in the past, I've worked with a lot of hospitals over the last 13 years. And the number one feedback points I've gotten is that traditionally, healthcare hasn't had a voice into finding their own destiny.
So I think this is a good rule. I think this is an opportunity for healthcare to streamline their processes and their pharmaceutical program, make it easier for the end users. And ultimately, the EPA is going to proceed and finalize or they're going to modify. And one of the areas that's a possibility is, depending on the comment period, is they could expand what pharmaceuticals are hazardous and increase the actual number of hazardous pharmaceuticals.
I spoke with the EPA the other day after their presentation and they think that's unlikely and they think that this will be promulgated some time end of Q1 early Q2 as it moves into law. Before we turn over to James for our questions portion, I wanted to say thank you for participating. And we have a couple of slides with some additional information if you want to hang on following the Q and A session. Let's speak a little bit further to some of the previous exemptions and how they'll be applicable. With all of that, I'll turn it over to our moderator, James.
James: Thank you, Steve. I appreciate the guidance there in helping to dissect this rule. And we do have several questions already waiting. So, I think we can jump right in to those.
So, we've got about some 10 minutes left. I do encourage those of you with the question for Steve to go ahead and type that into the questions box and we'll get to as many as we can. In the event that we don't answer your question, just know that we'll follow up individually so every question will get answered whether it's today or in follow up.
So Steve, the first question that's been post is more of an opinion question. In your opinion, what are the chances that this rule will go into effect? I know you've seen similar proposals in the past. What makes this one different?
Steve: That's a great question. I think I got the feeling of the person I know who asked that. I actually think this is the best shot that it's ever had it. I think ultimately they built on this really for almost a decade. And I think the excuse is really to move forward with something that's more like a universal waste program although that program didn't meet all the standards that I think that this is really, really good chance.
After speaking with several regulators last couple of weeks, the EPA, the state, people are excited about this. People think that they've got it right. I don't know that anybody believes that it's perfect but I think ultimately, I think this is a reality. And I think we're going to see this before the second half of 2016.
James: Great. Thanks for the insight there. The next question is a little bit more specific here. We're asking, does this proposal include an educational field like colleges and universities?
Steve: Yes, if you have pharmaceuticals. They left quite a bit of wiggle room for folks that generate pharmaceuticals. There's a little bit of difference between obviously a RCRA regulated pharmaceutical that's used from a clinical trial standpoint versus something that's a research-driven chemical. So, I would anticipate where hospitals seriously have their formulary to begin with to identify what they have and determine what's regulated or not.
I would go to your chemical inventory or folks that have a handle on the items that they're actually using in their laboratories or in their studies related to research for the pharmaceuticals that they have. And again, we go back to those NAICS codes which have quite a bit of leeway for the EPA to commit and inspect. And more so, the states, because they'll be required to adopt this rule know those universities even better than the feds do. So, I think that you'll see probably an increased inspection component here at some point if this does get proposed into law.
James: Got it. Good advice. There are a couple of questions about the solutions you delved into. The first one is about solution number three. And the question asks, can you explain that bullets about SAA and CAA regulations specific to pharmaceuticals? Does this mean I will no longer be required to perform weekly inspections for areas like RCRA pharmaceuticals?
Steve: Great question. Yes. That is correct. So, the bullet point specific to solution number three SAA and CAA. They are regulations specific to pharmaceuticals. This is reducing the reg effectively. So all those regs that exist under RCRA is not to collect the pharmaceuticals the correct pharmaceuticals so you then even how to do that so those regulations are sort of open window as it relates to the SAA and the central accumulation area or main accumulation area. In solution number three there are really referencing sort of how they've made this an industry specific reg it only applies to folks that generate those pharmaceutical wastes but ultimately, yes no more inspection as they apply like they would have a large quantity generator.
James: Thanks and that question comes from Kenneth, so we appreciate that. And another one deals with that solution number one and this bullet being referenced is the one that states what removes the disincentives to manage hazardous and non-hazardous waste separately and I understand that due to the lack of generator status, this is doable. But what about from a cost perspective? How will waste holler classify this?
Steve: That's a great question. Waste hollers really are just part of the mix here. It's really the end dispose the facility. They're accepting the material for the ultimate treatment. So if you think about it these four major treatment standards and the vast majority of pharmaceuticals have not all of them go for an incineration process. Arsenic trioxide really is the only one that I can think of all the top of my head that can't break down chemically the same way as a lot of hazardous pharmaceuticals do so it has to go for process different than incineration. But the component here really is for those folks who already collect non-haz maybe or wish to collect non-haz they probably hadn't because there was small quantity generator. They didn't want their hazardous waste volume to increase. And they get – required to be paying more taxes at the end of the year. So on and so forth.
So, the generator status under current RCRA was always based on the total hazardous waste generation. So if you're generating 3 lbs. of hazardous waste per container and 12 lbs. of non-hazardous waste per container then you're collecting at the same container you've now got 15 lbs. of hazardous waste. That's really what this rule is addressing being able to comingle those not have them relate to your generator status so that there is no burden. From a cost perspective, the process is one and the same. And provided all of them fall under RCRA as they would all the non-hazardous material is going in to the RCRA hazardous materials because there's no separation that material would be sent for incineration the same way. So I would imagine the cost is something that's going to remain the same.
James: Great. Well, all right, Steve. Let's take a couple more questions and then we'll kind of wrap things up here and follow up if we have to. Khristine wants to know how does this affect the labelling, storage and shipping of hazardous pharmaceutical waste?
Steve: Could you say that one more time, James?
James: Yes. How does this rule affect the labelling, both storage and shipping of hazardous pharmaceutical waste?
Steve: That's a really good question. From a labelling perspective, Karen represents you have to have the words out of this waste. You have to have all the constituents with no acronyms, no abbreviations, all spelled out. For anybody who has a Triumvirate program, we typically build this out on the label already so it's just a peel and stick component. But you can have something as simple as waste pharmaceuticals on your label and they can be generic across the board provided that you're education is performance-based and that people know what they're required to collect.
At a lot of cases I've talked to a lot of generators of waste on this new rule for the last couple of months and they've said that they may not change anything because those labels actually do people favors and help them to collect some of the items that they need to collect and not yet and so they don't want to collect.
From the letter of the law perspective, they don't apply the same way. You don't have to worry, have the words necessarily without the acronyms or abbreviations; you can just have something as simple as waste pharmaceuticals which at some states that's allowable right now which is where that came from.
James: Whoa! Thanks for that answer. I think that cleared it up and Paigo wants to know so the new rule is not applicable to the manufacturing industry. He just wants to confirm that and what about analytical laboratories?
Steve: Great question. I'll answer the first one first. The manufacturers from a pharmaceutical waste perspective really doesn't apply that way because it's sort of falls in the commercial chemical product rule at that point so you can't have a waste and until you've generated a product and the manufacturers don't typically use their own products.
So therefore they sort of really generate their own waste The material in which they used as part of their bulk practices for the production of those materials would not apply to these specific rules under Part 266 Sub Part P. So the big pharmaceutical companies of the world that are not the RND facilities that are the manufacturer this will not apply too. And the secondary part of that question, could you repeat the second part of that question? Was that research facilities?
James: Analytical laboratories.
Steve: Oh, that's a good question. At the top of my head I'm not sure that something I can follow back up on with that attendee. I'm not 100% sure if that NAICS code is covered.
James: Okay. No problem. So, let's take one more question. We've got a couple minutes here. We have a few take home points at the end. Kristine wants to know what the waste codes still land on an LDR for the disposal purposes even though the codes wouldn't affect generator status.
Steve: That's a great question. I believe the answer is no but I had to refer back to something and I will get back to Kristine, if that's okay? The LDR is a little bit different type of document even though it's an EPA thing. I believe that the answer is no. But ultimately, the end disposal is still, they still may require some documentation either in that form or another. I'd be happy to follow up on that.
James: No problem at all. So, we'll follow up with both Kristine and Paigo. And if anyone else has a question that you didn't get the chance to ask today, we'll share Steve's information at the end of this PowerPoint. We will be following up with the couple of different emails. One of them contains all the information, survey and information that Steve mentioned. At this time, I just want to take this time to thank Steve for his very informative presentation, giving us some insight into this ruling and what we could expect, a potentially soon as next year. So, I think we wrapped up there. Steve, do you have anything else to add?
Steve: Yes. No thank you very much, James and thank you very much to all of you for joining. I'm watching the attendees literally hover right at the beginning of literally the number of attendees that started are really kicking around the same number now. So, thanks for hanging on to the last hour. Just a couple of slides here on some additional information.
These are all the online memos that were promulgated over the years. A lot of people refer to them as the exceptions right? So it started with epinephrine and the epinephrine salts and what was and what wasn't regulated. All of these things are still applicable. Under the additional reprechanges they'll still not be considered P-Listed waste. The epinephrine example or there's your residual from the syringe standpoint.
And at the time, these were components that each state had to adopt. So again now, it's sort of all across the board as we sort of talk about this. There was a new e-cigarette's one; they determined that was P-75 from the hazardous waste perspective. So, E-cigarettes would still be regulated under RCRA. That was as most recent as May, so on and so forth. These information will all be available on the slide that if anybody has any information and the ripper online memos are something that are easily searchable with those numbers.
Thank you very, very much and we look forward to future webinars and appreciate your attendance.
James: Thank you everyone. Have a great day!