## 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 particula te 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 instructio ns 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 thes e 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 build ing 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 allo wed 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 th at 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 pharmaceuti cal 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 ou t 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 req uire 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 crea ting 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 safe r.

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 numb er 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. Thistypically 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. E PA/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 ha ve 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 w ith 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 sl ip 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 expi red 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 c lassification of pharmaceuticals under RCRA. We find that the application of regulations thatwere 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 pharmaceut icals 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 cessatio n 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.

M anufacturers 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 credi t. 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 pharmace utical 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 helpi ng 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 develo ped 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.