[Pharmwaste] Input/comment requested on categorical classificationof hazardous waste/PPCP's and "combustibility."

Fri Oct 5 15:21:27 EDT 2007

Hi Steve,

You have both EPA and DOT definitions going on here. Under EPA hazardous waste regulations, if an aqueous solution has an alcohol content of 24% or more and is being disposed, it meets the definition of an ignitable hazardous waste and must be managed as such for reasons of safety for both storage and transportation. It also meets the definition of flammability for DOT. Yes, they will be incinerated and they burn really well. It is the intervening steps that need precautions. The definition for an empty container for these items is that all contents are removed that can be removed and no more than 3% by weight remains. So an empty container that held an ignitable is not hazardous waste. The "empty container rule" you are stumbling over refers to chemicals that are on the P list of acutely hazardous waste in the EPA regulations at 4 CFR 261.33 (e). (Think epinephrine for example.)  These are not considered empty unless they are rinsed with an appropriate solvent and the rinsate disposed as hazardous waste, which is not practical in healthcare. These regulations were written 30 years ago with Love Canal, NY in mind and heavy industrial applications, hence picture a 55 gallon drum or large storage tank. So you are correct, the EPA hazardous waste regulations do not fit pharmaceuticals in consumer or hospital usage well at all, but until there is the political will for EPA to do an in-depth study and a carve out for healthcare, these are the rules for pharmacies, hospitals, and other healthcare facilities. Regarding consumer take back programs, EPA considers these household waste and they are exempt from the federal rules. Each state has the right to manage them more strictly, however. For example, in Wisconsin, they come back under regulation if you are collecting them in a central location. It is also important to know that only 5% of drugs on the market meet the federal definitions of hazardous waste, although more should since the law hasn't been updated in 30 years. Best management practices would involve at least having them incinerated at a facility that can accept non-hazardous pharmaceutical waste, unless you are in a state that brings them back under regulation. Only a very few controlled substances are hazardous waste, except in some states that have stricter rules. 

Having said all that, you might find it helpful to review the H2E Blueprint on Managing Hazardous Waste which reviews all the definitions. You can find it at http://www.h2e-online.org/docs/h2epharmablueprint41506.pdf. Of course, it is designed for hospital use, not for consumer use.  

Regarding the liquor industry, it is my understanding the 24% was the result of the wine and beer lobby. The whisky and brandy folks do need to dispose of unused alcohol as hazardous waste, in the unlikely event that should occur.  Hope this helps.

Best regards, 

Charlotte A. Smith, R. Ph., M.S., HEM

President

PharmEcology Associates, LLC

200 S. Executive Drive, Suite 101

Brookfield, WI 53005

414-292-3959

Cell 414-915-4026

Fax 414-479-9941

csmith at pharmecology.com

www.pharmecology.com

H2E Champion for Change Award Winner

________________________________

From: pharmwaste-bounces at lists.dep.state.fl.us [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Stevan Gressitt
Sent: Thursday, October 04, 2007 4:37 PM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] Input/comment requested on categorical classificationof hazardous waste/PPCP's and "combustibility."

If one of the characteristics to be considered in the disposal of hazardous waste is  flammability

And

The proposed method of "incineration" does indeed involve "burning" explicitly

Then

Why should there not be an exemption for that specific characteristic as a determinant of hazardous status?

The situation arose in a discussion with a non-environmental governmental more law enforcement minded type who was interested in minimizing the disposal costs through either reverse distributors, hazardous waste licensees,   or any of the other commercial avenues.

I am stumped.

Seems there is no reason to apply that standard except in an almost obsessively narrow minded way to that specific category.

I attempted to find an analogy, and without too much caffeine and certainly below toxic espresso levels, I would ask the following:

Some states have liquor monopolies, as in New Hampshire. They sell Rum of 151 proof and absolute ethanol at 195 proof. They collect a state tax on these bottles and a return fee as well. These are flammable liquids. People get burned in restaurants from flare ups of fancy meals known as flambe. 

Empty containers that held hazardous substances are to be considered as needing hazardous waste disposal by "Federal?" regulation ( I saw the citation once but am not familiar with it.) as well as some state regulations ( I have no reference here either except hearsay.)

Hence:

1)      All restaurants that serve "flambé" should be required to dispose of their unused liquor bottles through hazardous waste systems?

2)      All bars that serve over-proof drinks and have empty containers should dispose of them through hazardous waste?

3)      All bottle return facilities should either a) refuse over-proof containers or b)segregate the over-proof containers for hazardous waste disposal

Besides the lunacy of this line of reasoning, I think I must be missing something.

Or is this another case of "unintended consequences" which is my hunch.

Stevan Gressitt, M.D.

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