EPA Docket # EPA-HQ-OW-2006-0771

Comments relating to Dental Mercury and Pharmaceuticals

Marshfield Clinic

1000 N. Oak Ave

Marshfield WI 54449

Spokesperson:

Bruce E. Cunha RN MS COHN-S

Manager, Employee Health, Safety and Infection Prevention/Control

715-387-5586

cunha.bruce@marshfieldclinic.org

Dental Mercury

Marshfield Clinic owns and operates three large dental facilities. Each of these facilities 

were designed and built to reduce particulate and mercury in solution from wastewater 

and suction systems. We use filtering systems that collect the mercury and remove it 

from wastewater prior to the water going into the sewer system. The filter cartridges are 

changed per manufacturers instructions and sent to the manufacturer for mercury removal 

and recycling. Annual cost for our mercury filtration runs $600 per year (not including 

the original cost of the equipment). Marshfield Clinic also collects larger chunks of 

amalgam and disposes of these as hazardous waste.

Marshfield Clinic was not required by any local POTW or State regulation to put in the 

filtration systems we have. We believe that we should do what we can to reduce 

pollution and the cost of putting these systems in while the building was being built did 

not add significantly to the cost.

Unused Pharmaceuticals

Marshfield Clinic has spent the last 2 years doing a total inventory of all pharmaceuticals, 

chemicals and other waste products in its facilities. This inventory has allowed us to 

identify exactly what waste streams we needed to set up to handle the various wastes we 

create.

One of the areas of evaluation was how pharmaceuticals are disposed of. We found that 

one of the largest problems we have with pharmaceuticals is that it is very difficult to 

identify how they should be disposed of. Each pharmaceutical has to be reviewed to find 

its primary ingredient and then this compared to the RCRA regulations. In many cases, it 

was very difficult to determine if the pharmaceutical is listed by RCRA.
We eventually found a company that assisted us. PharmEcology 

(www.pharmecology.com) provided us with an on-line computer program that allows us 

to look up each pharmaceutical and find out how it should be disposed of. We dispose 

of hazardous pharmaceuticals through our hazardous waste hauler. We also are able to 

dispose of pharmaceuticals that are not hazardous waste through our hazardous waste 

hauler. The latter category does not require all the cost and paperwork that the hazardous 

pharmaceuticals do, but allows us to assure the pharmaceuticals are properly destroyed. 

Current costs for disposal of nonhazardous materials is $120 for 55 gallon drum, $90 for 

30 Gallon Drum, $7- for 15 gallon drum and $40 for a 5 gallon drum. We currently are 

producing a 5 to 15 gallons of nonhazardous pharmaceuticals per month.

Identification of RCRA Hazardous Pharmaceuticals

On the point of identifying when pharmaceuticals need to be considered as hazardous 

waste. Marshfield Clinic would like EPA to look at easier ways for the individual 

employee to identify at the disposal point what waste category a pharmaceutical should 

go into. We ask that EPA along with FDA and the manufacturers look at creating a color 

code that would correspond to the different waste categories under RCRA (i.e. toxic, 

corrosive, ignitable, etc). If the label or package the pharmaceutical comes in were to 

have a small color stripe that would indicate what RCRA waste it was, it would be much 

easier to teach employees the proper way to dispose of these products. We feel that 

developing a color code for the RCRA hazard categories could be carried over to all 

chemicals. This would make proper disposal much easier and also safer. 

Currently we collect hazardous waste at the user level in plastic containers. We then 

have to go through the containers to separate hazardous waste by category. Because the 

product does not identify the hazard, we end up with incompatible materials in the same 

container.

(1): The main factors that drive current disposal practices are a commitment on the part 

of Marshfield Clinic to do what is right. We understand that EPA and other regulatory 

agencies are taking a closer look at healthcare waste disposal, but regulatory compliance 

is not our sole driving force. We would like to work with EPA to make the process of 

disposal of pharmaceuticals and other chemicals used in the healthcare systems easier and 

less expensive.

(2) We do find that a number of EPA (or other regulatory agency) regulations do make it 

more difficult to properly dispose of pharmaceuticals.

a. Controlled Substances Act.

The controlled substance act does create problems for our system. Our 

providers are asked on a frequent basis if we can accept medications that are 

no longer needed by the patient. We are unable to accommodate all of these 

requests because we are not able to accept controlled substances. This 
typically ends up in us telling the patient to see if their community has a 

pharmaceutical disposal program or if not, for them to put into the garbage or 

flush down the toilet (allowed in Wisconsin, but our least favorite 

recommendation).

We also run into issues with pharmaceuticals that are controlled substances 

and also hazardous waste. Chloral hydrate is a good example. It is listed as 

U032 under RCRA, but is also a controlled substance. In order to dispose of 

this, we have to put in extra work to arrange for a hazardous waste hauler that 

can take both categories.

b. EPA/FDA regulations on manufacturer representatives taking back 

medications.

We are unsure if this is an EPA or an FDA regulation, but our pharmaceutical 

manufacturer representatives tell us that they are unable to take back sample 

medications once they have been signed for by the providers. Marshfield 

Clinic has 775 providers and a number of other practitioners that are routinely 

visited by pharmaceutical manufactures who want to give them sample 

medications. When these medications expire, we are stuck with finding an 

appropriate way to 1) identify if they are hazardous under RCRA, 2) properly 

dispose of them.

With our 45 centers, we literally generate large garbage bags of these expired 

sample medications each month. Each medication has to be looked up to see 

if it is a hazardous waste under RCRA and then properly disposed of. 

We would ask that EPA and FDA consider working with the pharmaceutical 

manufacturers to come up with a voucher program to replace sample 

medications. The voucher would be a slip of paper the provider could give to 

the patient and have a small quantity of the medication dispensed by a 

pharmacy. The pharmacy would be reimbursed for their cost, similar to how 

coupons work in the grocery stores. This would eliminate all the expired 

pharmaceuticals we have to deal with each month. It would also assist in 

patient safety as the pharmacy could double check to see that the sample 

medication did not react with what the patient is already taking.

There are a number of other positives for a voucher system such as samples 

would not have to be shipped reducing potential theft. Samples would not 

have to be hauled around by the market representatives.

c. RCRA Hazardous Waste Regulations

One of the issues that we ask EPA to review is the classification of 

pharmaceuticals under RCRA. We find that the application of regulations that 
were designed for very large volumes of chemicals do not apply well to the 

healthcare arena.

We understand and agree that EPA needs to work to reduce pharmaceuticals 

getting into the environment, but it is very difficult to enforce regulations that 

do not make good sense. I deal with very educated providers and it is difficult 

to get them to understand why a patient can throw away their nicotine 

smoking cessation patch in the garbage at their home, but the provider cannot 

dispose of an expired patch in his trash.

It is hard to get a provider to understand that he/she has to treat an empty 

bottle of coumadin (a blood thinner) as the most hazardous waste category 

there is and yet he/she can go to the hardware store and purchase as much rat 

poison (which contains the same chemical as coumadin) as he/she would like.

We very much appreciate that EPA agrees with the decision from the State of 

Colorado that epinephrine as used in medical systems, is not a P listed waste. 

We would appreciate EPA setting up a review committee to evaluate all 

pharmaceuticals that currently are on the RCRA P list of wastes.

(3) Disposal Systems

a. Take back or reverse distribution systems. 

Manufacturers should be encouraged to have take back or reverse distribution 

systems so that unused pharmaceuticals are all disposed of in a proper way. 

Marshfield Clinic used to be able to return unused influenza vaccinations to 

the manufacturer for credit. This was stopped a few years ago. We were able 

to send the unused vaccinations back last year but without the credit. We are 

unsure if the manufacturer will take back the vaccine this year. If they do not, 

we will have to include the vaccine as part of our hazardous waste as we have 

a large volume of vaccine that contains mercury in the thymerisol 

preservative.

b. Community pharmaceutical clean sweep programs

Marshfield Clinic very much in favor of, and has been a supporter of local 

community pharmaceutical clean sweep programs. The limitation of these 

programs is that they are only done a time or two a year. Patients that have 

pharmaceuticals that they want to get rid of, or family members of expired 

patients, call us and ask that we assist in helping them correctly dispose of 

their medications. We do take non-narcotic medications and dispose of them 

with our hazardous waste hauler. The cost of doing this is not currently a big 

issue, but we do feel that alternative disposal systems could be developed to 

help the public properly dispose of their unused pharmaceuticals. 
Marshfield Clinic is proud to be actively trying to reduce the introduction of 

pharmaceuticals into the environment. We appreciate the opportunity to add out input on 

this topic. 

Yours truly,

Bruce E. Cunha RN MS COHN-S

Manager, Employee Health, Safety and Infection Prevention/Control

715-387-5586

cunha.bruce@marshfieldclinic.org.