Comments to the EPA on why we should not Burn Pharmaceuticals at solid waste incinerators.Comment on the Changes to the solid waste Incineration Regulations

1. Presentation by Jim Mullowney
President of
Pharma-Cycle
To the EPA
June15th 2010
Comments on commercial and industrial solid waste
incineration units
EPA – HQ – OAR-2003-0119; FLR-RIN 2060-A012
Drugs are chemicals too.
Some drugs are administered to the patient by burning them
(Marijuana, cigarettes, crack cocaine)
Waste to energy facilities are designed to generate electricity from trash, not to destroy
harmful chemicals. We have been trained to think of industrial chemicals as BAD and
harming the environment and Medicine as GOOD and saving lives, however most
industrial chemicals are designed to not react with the environment and be resistant to the
elements, such as paints adhesives and plastics. Where as Pharmaceuticals are designed
to have a specific effect on the human body and living cells. Both have unintended
consequences when used improperly or released in the environment uncontrolled.
This is not Solid waste
• Drugs
• Pharmaceuticals
• Medicine
• What do they have
in common
They are all chemicals

2. 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.
Solid 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 (RCRA) in 1976. That was 34
years ago, how many chemicals have been invented in the last 34 years, hundreds of
thousands, and it is legal to send these chemicals to a Solid waste incinerator. When was
the last time the EPA regulated a pharmaceutical? Never. There are some
pharmaceuticals that have industrial uses and were regulated under RCRA in 1976.
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 flush
• DEA, Medicare
• Keep away from children
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,

3. DRUGS ARE CHEMICALS TOO.
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 your well and your drinking
water system.
The EPA has done a great job in preventing the flushing of un-used medicine, however
we now have the problem of what to do with the 250 Million pounds of drugs generated
every year, common sense would say to burn it with the trash and it will be gone. We
know this is not the case. There are over 160,000 medicines sent for disposal some
effective at the molecular level and many cause cancer and birth defects. This regulation
is looking at 8 chemicals that come out of the stack as well as particulate matter, what is
particulate matter? A solid waste incinerator is allowed to emit 200,000 times more
particulate matter than Lead or Mercury?
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?
Side Effects
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

4. 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 MUSTARGEN it’ a compound
made by Merck. I picked this out arbitrarily, not to pick on Merck. Does this drug sound
like it may be related to Mustard Gas, a chemical warfare agent used in WWII, well it is.

5. Chemotherapy was invented because of an accidental release of Mustard gas in Italy
near the end of the war. Doctors found that of the thousands of exposed people some who
had cancer showed signs of shrinking tumors. This was the birth of an industry that sold
$80 Billion worth of chemotherapy drugs in 2009.
Like any other pharmaceutical chemotherapy drugs have side effects. The side effects of
this drug are:
Cancer
A 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.
Does that mean genetic damage to my children?
Harm to the unborn child.
It is agreed that this side effect is worse than anal leakage.
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 of Action 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’s why patients on some of these drugs loose their hair.
What are the fastest growing cells, how about
embryonic cells, children being born. A couple
of years 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 spoke along with
representatives from the EPA, the Massachusetts water resources authority (MWRA), and
Dr. Nick Anastas the head of the Massachusetts drinking water program for the
Massachusetts Department of Environmental Protection.
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 then 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. They agreed it is a part per trillion. I asked

6. is a pico-gram per liter smaller than a part per trillion and they said yes. A pico gram per
liter is called a part per quadrillion.
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, and one of those parts per
trillion is injected into the patient and only 1% of the dollar gets into the cells and still
makes the patient’s hair fall out. We should care what happens to a chemical that has
such a severe effect on human body at such a low level.
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,
it looks like you ate your highlighter, that is because only 15% of the vitamin you take
into the body gets absorbed 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.
Dr. Nick Anastas closed the summit stating that he believed cytotoxic drugs are causing
childhood diseases such as autism. Yes he did say that in public.
In March of 2009 Dr Christian Daughton Chief, Environmental Chemistry Branch,
National Exposure Research Laboratory for the US Environmental Protection Agency,
the foremost authority on drugs in the water, published a 25,000 word document on
exposure to drugs in the environment. I recommend everyone read this. He talks about
exposure not only from urine and feces but “transdermal” or touching someone, and
“respiratory exposure” or breathing. He goes as far as saying a person could be exposed
to a cytotoxic drug by going into a public spa or swimming pool where a patient
undergoing chemotherapy has been. I called Dr. Daughton in February of 2008,gave him
my theories and he said “no one is looking at chemotherapy drugs” . A lot can change in
a couple of years.
The EPA is working on the problem and in April of 2009 Dr Michael Firestone Office of
Children’s Health Protection and Environmental Education. US EPA. Published along
with 40 other scientist the EPA’s Strategic plan for evaluating the toxicity of chemicals.
This is the first time the EPA is looking at Pharmaceuticals as pollutants and the first time
the EPA is working with the FDA and OSHA. This is a must read document. The EPA
will be looking at the toxicity of chemicals based on Mechanism of Action and toxicity
pathways based on computer models instead of animal testing. The plan is to look at the
dose/response of drugs and their ability to mutate human genes, this means how a small
amount can change the DNA of future generations. I had called Dr. Firestone in February
of 2008 also.I called Daughton Firestone and Anastas to let them know I was filling out
the application for Nobel Prize. Anastas thought we should do it alphabetically.

7. Chemicals Made by Men in Spacesuits
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.
Prepared like Anthrax
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 Solid waste
incinerators?
I was at Brigham and Women's Hospital in Boston in December of 2008 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.

8. OSHA hazardous drugs
 No safe exposure limit  Carcinogenic, mutagenic  OSHA
recommends the residuals be sent as regulated Solid waste
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 30 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 15 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?

9. 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 in Nevada. 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 Solid Waste
Incinerators that are designed to generate electricity and are not designed to destroy
Chemicals. These Medicines, Drugs, Pharmaceuticals are Chemicals and need to be
disposed of as Chemicals and not be made airborne at electricity generating plants.
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
Solid 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. Drugs are synthetic organic chemicals that will break down over time.
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
chemotherapy 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.

10. The collection of human excrement with
cytotoxic drugs will happen
• Our Solid 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 Solid waste incinerators.
I personally believe that even chemical waste incinerators
are not effective on destroying these chemicals.
Solid 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 Solid 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.
Some other sludges are burned at solid waste incinerators and will be subject to this
regulation
Thanks for listening to me
Sincerely
Jim Mullowney
jmullowney@pharma-cycle.com
Newport, RI 02840
Copyright June 2010