Saccharin; one sweet RCRA listed hazardous waste - Part 1

Woot!  Finally some good news on the RCRA front:

On December 17, 2010, EPA published a final rule to remove saccharin and its salts from the CERCLA list of hazardous substances and the RCRA list of hazardous wastes.

So unless you are in the artificial sweetner business or a RCRA head like me, you might be wondering why the EPA would even have identified saccharin as a hazardous waste in the first place.

What is confusing to most, but completly 'normal' to us in the hazardous waste identification process,  is that what makes something a hazardous waste has nothing to do with wheter or not it poses a hazard.

It's all about the definition.  According to the EPA:

• Saccharin and its salts are listed hazardous wastes [U202 in 40 CFR 261.33(f)], if the waste arises from the discard of commercial chemical products, manufacturing chemical intermediates, off-specification material, container residues or spill residues.

Sounds straightforward enough, but then we have addressed that term discarded before haven't we?  So a generator of a waste that will be discarded that contains saccharin and its salts may need to classify the waste as a hazrdous waste, U202. However, according to the EPA:

• The U-waste code applies only if the chemical is present in a pure or technical grade form, or is the sole active ingredient in the chemical formulation; in addition, the chemical must be unused.

So the manufacturer of saccharin and the user of the pure or technical grade product will end up with U202 waste if they have a unused material they want to get rid of, have a spill, or empty containers with residue.

But what about a company that purchases a product that contains saccharine?  The EPA makes the following statement on that:

• The U202 listing is narrow and does not apply to other discarded materials that merely contain saccharin or its salts, e.g., discarded products that contain saccharin as a sweetening agent. Nor does the listing apply to manufacturing process wastes that may contain saccharin or its salts, except for unused or off-specification saccharin or its salts that are discarded.

So basically what the EPA is saying here is that it does not apply to things that contain saccharine or its salts unless the saccharine is unused and discarded.  So an unopened can of diet soda sweetened with saccharine would not meet this definition, nor would a spill clean up on Isle 3.

Now this last bullet is a bit ambiguous as to the why behind this.  In fact it could be read that the can of soda is not U202 because its a "discarded products that contain saccharin as a sweetening agent."  The use of saccharine as a sweetening agent plays no part in this, nor does the logical "because we will drink it."

RCRA hazardous waste identification for P and U have nothing to do with dose, health hazards, or...well, logic.  It's all about meeting the definition.  When the saccharine is added to the soda or is contained in something, it no longer meets the definition of "technically pure" or "chemically pure" or "sole active ingredient."  Since it does not meet that definition, it is not a hazardous waste.  The saccharine, dose, hazard, quantity, or anything else plays into that.

It's all about meeting the definition.

So what about a business, like a store or restaurant, that wants to get rid of a bottle of unused Necta Sweet tablets?

Do the tablets contain saccharine?  Looking at the ingredients we see:

Is that saccharine "chemically pure" or "technically pure" which according to the EPA means:

• The pure form of a chemical is a formulation consisting of one hundred percent of that chemical.  The technical grade of a chemical is a formulation in which the chemical is almost one hundred percent pure but contains minor impurities 

Well...no.  It has some other stuff in there, plus its only 16.2 mgs of saccharine so its not pure because of that as well.  So that leaves asking if the saccharine in the Necta Sweet is the "sole active ingredient" which according to the EPA means:

• A chemical is the sole active ingredient in a formulation if that chemical is the only ingredient serving the function of the formulation.  

So the question that needs to be answered by the generator (store or restaurant) is this:  Does the sodium bicarbonate, silicon dioxide, povidone, and modified cellulose gum "perform the function of the product, or only serves an ancillary function, such as mobilizing or preserving the active ingredient."  According to the EPA:

• [F]illers, solvent carriers, propellants, and other components with no [active] role are functionally inert in [these] formulations and therefore are not active ingredients.

If I was making the hazardous waste determination, I would have to say that in the case of Necta Sweet, the saccharine is the sole active ingredient would make this product a U202 RCRA Listed Hazardous Waste. (Note: I would find a different avenue for final disposition so as to not generate a hazardous waste, this is for example only).

Now if you are still reading this, you might be asking yourself what about all those pink Sweet'n Low packets that restaurants throw away every day?  Sweet'n Low is saccharine!

Well that's where Sweet'n Low played it smart.  Let's look at the ingredients in a pink package of Sweet'n Low:

Notice what they did to avoid having their customers classify them as a U202 RCRA Listed Hazardous Waste?  They added "Nutritive Dextrose" as an active ingredient (hence the use of the term 'nutritive').

As you can see the Sweet'n Low contains more saccharine (36 mgs) then the Necta Sweet (16.2 mgs) yet it does not meet the definition of a U202 RCRA Listed Hazardous Waste.  Like I said earlier, the saccharine, dose, hazard, quantity, or anything else has anything to do with it being classified as a hazardous waste.  It's all about the definition!

So by adding the nutritive dextrose to their product, Sweet'n Low met the following:

• If a formulation contains more than one active ingredient, the formulation would not be within the scope of the P and U listings in §261.33, regardless of whether only one or both of the active ingredients are listed. (1) 

One could make a reasonable argument that a pill, tablet, or food additive is not a commercial chemical product so the U or P listing would not apply.  The EPA thinks differently on that point as well: 

• The phrase "commercial chemical product" has different meanings in the definition of solid waste and the definition of hazardous waste. As applied to 261.2, the definition of solid waste, EPA interprets the category of commercial chemical products to include all types of unused commercial products, whether or not they would commonly be considered chemicals (e.g., circuit boards, batteries and other types of equipment).

Now you may be shaking your head thinking that there is no way the EPA would regulate a saccharine tablet. That's what they kind of imply in their Federal Register final rule.  But the regulation of low dose food products and medicines as RCRA hazardous waste was an unintended consequence of writing a regulation too broad that it captured all waste streams regardless of quantity or use. 

An example similar to the saccharine tablets are nitroglycerin pills used for heart attacks.  According to the EPA:

• As your letter notes, [medicinal] nitroglycerine in finished dosage forms, such at tablets or capsules, has been regulated under the Resource Conservation and Recovery Act (RCRA) as a 40 CFR 261.33 listed hazardous waste (P081) because it constitutes a formulation containing nitroglycerine as the sole active ingredient.

And people wonder why I like this business of hazardous waste identification.  It's logical aint it?

Next post: Why list a food product as a hazardous waste in the first place?