Presentation by Jim MullowneyTo the EPA

January 15th 2009Comments on Medical Waste Incinerator Regulations

Regulated medical wastes areBlood-borne pathogens, blood,

viruses, human tissue etc.Regulated medical waste is a blood-borne pathogen's, blood, viruses, human tissue, AIDS virus. Regulated medical waste incinerators are very effective at destroying these compounds; they die at about 200°F. Medical waste incinerators are very important part of our society, and are very effective at controlling disease.

This is not regulated medical waste

They are all chemicalsWhat is not regulated in a medical waste, Pharmaceuticals, Drugs, and Medicine.What do they all have in common? They are all Chemicals and some of the most dangerous chemicals we manufacture today are Pharmaceuticals, Drugs, and Medicines. Medical waste incinerators are not Chemical waste incinerators and are not designed to destroy chemicals. Does anyone know the last time the EPA regulated a Chemical as a Hazardous waste? How about the Resource Conservation and Recovery Act in 1976. That was 32 years ago, how many chemicals have been invented in the last 32 years, hundreds of thousands, and it is legal to send these chemicals to a medical waste incinerator.

• Drugs

• Pharmaceuticals

• Medicine

• What do they have in common

Health facility/estimated 250,000,000 pounds of drugs a year are flushed down the drain. This is from an article in USA Today at September 14, 2008. “Treating the toilet as a trashcan is not a good option.” That is a quote from Ben Grumbles EPA's top water administrator. Mr. Grumbles may be one of for your bosses.Why do you flush drugs down the toilet? The DEA says we have to flush them. Medicare and Medicaid both mandate that we flush the unused drugs, and the reason is to keep them away from children, That is why we have childproof caps on medicines. If a child gets into a medicine they tell us to call the poison control center, because it is a poison, DRUGS ARE CHEMICALS TOO. If a person gets the medicine and takes too much of it they may die. The reason they may die is because they took too much of the chemical.Most people think the waste water treatment plant destroys the chemicals, they don’t. The drugs pass thru the treatment plant and into the water system, and if you are on a septic system the chemicals go into your leaching field and in to the drinking water system.

che·mo· ther·a·py : the use of chemical agents in the treatment of a medical condition

Chemo-therapy. The definition of Chemotherapy is the use of a Chemical agent in the treatment of a medical condition, which means that all medicine is Chemotherapy. I can't watch television without finding a new disease that I didn't know I had. A commercial of a guy that's always in the bathroom is on a boat is missing out on his life because he has to pee too much. Personally I think he was drinking too much beer. At the end of this commercial it says side effects may include dizziness, shortness of breath and anal leakage. Anal leakage does not sound like a fun thing to have as a side effect. Then there is that commercial for a drug that has a side effect that causes an erection for four hours. Why does that commercial only come on when my daughter walks into the room?

Health facilities flush estimated 250M pounds of drugs a year.

USA Today September 14 2008

Treating the toilet as a trash can isn't a good option," says Ben Grumbles the EPA's top water administrator

Why do we flushDEA, Medicare Keep away from children

This Medicine has some serious side effects.

Material Safety Data Sheet for Common Chemotherapy Drug

This Drug May Cause:• Cancer • Heritable Genetic Damage • Harm to the Unborn

Child • Very toxic by inhalation and if swallowed

Cytotoxic agent

This is a material safety data sheet. Are all of you familiar with the Material Safety Data sheet (MSDS)? Under a Regulation called The Right to Know, workers must be notified of the Chemicals that they are working with and the dangers they pose if exposed. Drugs Pharmaceuticals, and Medicines, are all Chemicals and there are material safety data sheets for these Chemicals. This slide shows a MSDS for MUSTERGEN it’ a compound made by Merck. I picked this out arbitrarily, not to pick on Merck. As of any other drug this has side effects. The side effects of this drug are cancer a pretty serious side effect. 30 % of breast cancer survivors develop a secondary cancer from the drugs, it is well known that cytotoxic drugs cause cancer.Hereditable genetic damage. Harm to the unborn child. It is agreed that this side effect is worse than anal leakage. Very toxic by inhalation and if swallowed.Cytotoxic agents does anybody know what a cytotoxic agent means. It means it is toxic to the cell. Does anyone know how they work? The mechanism by which these cytotoxic agents work by breaking into the blood cells attacking the DNA and breaking off the chromosomes so when the cells splits it's a different cell hence, mutated. They attack cancerous as well as non cancerous cells and they tend to work on fast growing cells such as hair cells, that is why patients on some of these drugs loose their hair.

What are the fastest growing cells, how about embryonic cells, children being born. About a year ago a study came out that Autism is a genetic disorder that is not hereditary, how do you have a genetic disorder that is not hereditary? You mutate the genes. What class of Chemicals are designed specifically to mutate human genes? Cytotoxic Chemotherapy drugs. Do you think this drug is regulated by the EPA as a waste, No it is not.I gave a longer version of this speech on November 20th 2008 to 100 people in New England. We had every large hospital represented; we had Yale New Haven, Dartmouth Hitchcock, Mass General. Brigham and Women's, Beth Israel, the Hartford

hospitals, the Providence hospitals, and the Worcester hospitals. I asked the audience if they knew what cytotoxic agents were and for the most part they said yes. I asked the audience if there were any Pharmacists the room. There were a few. I had one in the front row. I asked the Pharmacist in the front row, have you ever made drugs in a dose of a nano-gram per liter and he said yes of course. I asked have you ever made a drug in a pico-gram per liter and he said sure. So I asked the audience if a nano-gram per liter was a part per trillion. And they said yes it is a part per trillion and I asked is a pico-gram per liter smaller than a part per trillion and they said yes.If you take a trillion one dollar bills and stack them like a deck of cards, turn them sideways, they would reach from Boston to the middle of Ohio. Then I asked the pharmacist if the absorption rate of a typical cytotoxic chemotherapy drug was 100% or was it more like 1% and his answer was more like 1%. I asked the audience if anyone knew what absorption rate was? Then I said if you take a vitamin, two

hours later you go to the bathroom and you look in the toilet your urine is bright yellow, that is because only 5% of the vitamin you take the body absorbs in the cells.The rest of it the passes through your body in your feces, urine, sweat glands, and through your breath. Sometimes you take a vitamin and the smell stays on your breath for hours. The same thing happens with cytotoxic drugs except your breath stinks for as long as the drugs remain in the body.Look up chemo breath on the Internet and you will find advertisements for special mints because your breath smells terrible, as well as your whole body smells. Chemicals are smells, what you're smelling are the chemotherapy drugs. Perfumes are chemicals.We are all worried about second hand smoke, how about second hand Chemotherapy drugs that dangerous at levels that you could smell them.

This is a picture of a man manufacturing a chemotherapy drug notice he's in a spacesuit. Do you think if you have to make this drug in a spacesuit it can be pretty harmful? He is wearing a spacesuit because of OSHA regulations. I took this picture from the June 2008 Chemical and Engineering News the basis of the article was that the drug companies are subcontracting the manufacture of Active Pharmaceutical ingredients or API’s, because of the liability of exposure to their employees.

He is protected by OSHA regulations from this chemical what about the rest of us, who protects us? Do you think this Chemical is regulated by the EPA? Once the drug is made is shipped in little vials to a pharmacy where it is compounded in different doses sometimes with drugs.

This is how these drugs are prepared. Does the woman in the hood look protected from the Chemotherapy drugs. She has to be according to OSHA. She is preparing a nanogram per liter, how do you measure nano-gram? Do you use a scale with the chemical on one side and a nano-gram on the other? No you start with a known amount of the drug and do a series of dilutions. What happens to the dilutions with a much higher concentration of the drug, do they get sent to Medical waste incinerators?I was at Brigham and Women's Hospital before Christmas and they paid $500,000 for robot to prepare the drugs because they are too dangerous to a pharmacist to be exposed to. They don't use the robot because the nurses are wondering if they are protected. That's a good question.

OSHA hazardous drugs

OSHA is designed to protect workers and they do. In fact they have a 30 page document describing the dangers of cytotoxic agents and that there is zero exposure allowed. The scary part of the document is all the research that they've done and the references to studies that have been done over the last 20 plus years. I love the study where the volunteers were scratched on the arm with cyclophpsphomide, a cytotoxic agent and then checked for chromosomal aberrations in their urine, sound like a James Bond movie.In 1985 they did a study of a nurses that were working on oncology floors they found nurses had a spontaneous abortion rate of 4.7. That is 4.7 times the national average just working with these chemicals. That's what prompted this document OSHA's guide to handling hazardous drugs in 1995 that was 14 years ago.OSHA cites carcinogenic and the mutagenic effects of these drugs they also note that heavy concentrations of these drugs may be excreted by patients through their urine and their feces as well as through their skin and breath. If one percent is absorbed by the body what happens to the rest of it? Does anyone remember high school physics, the law of conservation of mass?

• No safe exposure limit • Carcinogenic, mutagenic • OSHA recommends the residuals be sent as regulated medical waste

Drug Portal to the World. I took this picture from EPA a gentleman named Christian Daughton who is the Chief of research and development of the EPA. We already talked about the guy in the left and how to solve that problem by not dumping drugs down the drain but we don't want to do is put these chemicals into Medical Waste Incinerators

that are designed to kill germs and are not designed to destroy Chemicals. These Medicines, Drugs, Pharmaceuticals are Chemicals and need to be sent to Chemical waste incinerators.The guy on the right is a bigger problem what we do about him. We really don't care how much aspirin is in the water or Tylenol, Prozac. We do care how many cytotoxic agents that are effective on a molecular level are released into the environment through the excrement of the patient on chemotherapy drugs. I know it sounds crazy but we need to collect the waste from these patients. We need to make sure this waste is not sent to a Medical Waste Incinerator. What should we do with the human excrement from patients on Chemotherapy? Collect it, chemically bind it and send it to Canada. Maybe not Canada, we should send it to a landfill in the desert that gets little rainfall and is far from a drinking water source. We know who is on these drugs, how long they stay in the body, and how to collect it.OSHA has a list of these drugs; they are called Hazardous Drugs or HD’s. These Drugs are too dangerous for human exposure; there are about 60 of them mostly cytotoxic drugs. NIOSH has another list that is more updated with another 140 Chemicals used as drugs and together there are about 200 medicines.We know long a drugs stays in a human body, it is written on the prescription and is mandated by the FDA. Sometimes it's four hours sometimes it's three days it varies by drug but we do know that information and with only 1% of the drug that nearly kills the patient 99% of it going down the toilet into a septic system we as a society need to care where that 99% goes. It is well known that Chemotherapy Drugs kill the bacteria in a septic system, these are chemicals they are not alive. They go through the septic system and go into the water system. If you're on a septic system you probably on a well therefore it's going directly into your drinking water. If you're on town drinking water these cytotoxic agents are going into the water system that feeds the town drinking water so you are giving chemotherapy to everyone that drinks the water, takes a shower or otherwise uses the water.

The collection of human excrement with cytotoxic drugs will happen

• Our medical waste incinerators are not capable of destroying these chemicals

Eventually we will be collecting the excrement from patients on chemotherapy drugs and we need to make sure that this excrement is not sent to medical waste incinerators. I personally believe that even chemical waste incinerators are not effective on destroying these chemicals.Medical waste incinerators do not look like this. Just

because you can't see the smoke does not mean that the chemicals are not there. I believe the safest way to handle it is to mix with a binding agent, seal up and send to a secure landfill in the area that has no groundwater and little rainwater. I as well as others know that cytotoxic drugs are causing childhood diseases such as Autism, and are the major cause of cancer in this generation.Are there any questions?

Q. How is this problem affecting our food supply?A. Good question, I live in the Boston area and we may have the highest concentration of patients on chemotherapy drugs in the world, all the waste from Boston sewers goes to the waste treatment plant on Deer Island in Boston Harbor. This plant, like a Medical waste Incinerator is designed to destroy germs, not chemicals. Some of the drugs are concentrated in the sludge and the rest are sent into the Atlantic Ocean. The sludge is sent across the harbor to Quincy via barge to be dried and converted to fertilizer to be sold to farmers all over the USA to make our food. Yummy.

Thanks for listening to me

SincerelyJim MullowneyNewport, RICopyright February 2009Edited by Briana Whitt