1. Jim Mullowney Pharma-Cycle Inc. December 5, 2012
Presentation to the Rhode Island Special Legislative Commission to Study Pharmaceutical Contamination in the Water Supply
Jim Mullowney
Pharma-Cycle Inc.
December 5, 2012

2. Industry Expert for Managing Hazardous Waste
Environmental industry chemist for over 25 years
Started the largest Household Hazardous Waste Program in New England.
Owner of a RCRA waste facility
Expert witness on managing hazardous pharmaceuticals in human excreta
Presented to EPA in North Carolina, DC and Boston
Presented to New England hospitals and regional Department of Environmental Protection
Presented to the American Chemical Society Regional meeting in October 2012

3. Hazardous Chemicals Require Careful Management
Goals are to keep hazardous chemicals out of our water and environment
Over 25 years, I developed and instituted guidelines and procedures
Not one of my employees have been hurt on my watch
Safely clean inside cyanide tanks
Safely remove PCB’s
Safely collect and dispose of Mercury, Arsenic and other hazardous materials

4. Many Chemotherapy Drugs are Extremely Hazardous Chemicals AFTER Patients
In 2007, started managing the disposal of unused cytotoxic chemotherapy drugs and was shocked at the danger
Extremely hazardous
Many directly attack DNA
Cause cancer and birth defects
Must provide my employees with more protection than ever before (Level A suit)
Had to develop methods to manage cytotoxic chemotherapy contaminated bodily fluids
Learned that as much as 90% of certain hazardous drugs exit patients intact
How can I keep my employees safe when they clean a toilet at a cancer hospital???

5. Chemotherapy Drugs Dangers Not Confined to Hospitals
In 2008, my mother developed breast cancer
She required surgery, radiation and CHEMOTHERAPY
Sent home with Hazardous Drugs in her body but
NO information
NO protective equipment
Danger of hazardous drugs contaminating her home
My daughter was THREE
I was struggling to figure out how to keep my employees safe and then I needed to keep my daughter safe from her grandmother ???
How many other families are struggling with these dangers???
85% of chemo treatments are out-patient - receive hazardous chemicals and sent home
What is happening to their homes and water??? 5 5

6. Strict Government Oversight for all Employees Working with Hazardous Drugs
Multiple Government agencies have strict guidelines for how to protect employees at all stages of handling Hazardous Drugs
NIOSH 2012 Hazardous Drug List – 167 drugs
Definition – Toxic, Carcinogenic, Mutagenic or Terotogenic
i.e. can cause cancer, DNA mutations and birth defects
OSHA safety requirements tolerate ZERO exposure for workers
“effects that can be irreversible even after low-level exposures”
In Practice:
Drugs produced with robots (no human intervention)
Pharmacists diluting drugs require specialized safety cabinets and procedures
Oncology Nurses required to wear top level Personal Protection Equipment and use special IV connectors
Nurses working with cancer drugs had a 4.7-fold increase in birth defects (OSHA technical manual).
Special equipment and practices to handle bodily fluids and items (bedding etc.) that may be contaminated with bodily fluids

7. Don’t Put Hazardous Chemicals Down the Drain
Clean Water Act (1972) established better methods to keep water safe by forbidding the disposal of hazardous chemicals into water
6.1.5 It is the policy of the state not to permit the introduction of pollutants into the groundwaters of the state in concentrations which are known to be toxic, carcinogenic, mutagenic, or teratogenic.
Unused Chemotherapy Drugs and trace contaminated materials handled as RCRA waste since 1990.
Some Chemotherapy drugs exit patients in quantities that are known to be toxic, carcinogenic, mutagenic, AND teratogenic
In addition, the chemicals destroy Septic Systems and can poison wells

8. Must Create a Solution for Rhode Island Families
Keep Hazardous Chemotherapy Drugs out of water
Don’t flush wastes containing Hazardous Chemicals down toilet
Pharma-Cycle Solution
Give patients simple way to collect bodily fluids during dangerous excretion period (2-5 days after infusion)
Method must include way to safely transport chemicals in waste
Pharma-Cycle Inc., Newport RI

9. Pharma-Cycle Family Safe System
Mission - to help Chemotherapy patients protect their loved-ones and everyone’s drinking water supply from the toxic chemicals that pass through their body.
At Hospital:
At Home:
Pharma-Cycle:
For 2 days patient uses Pharma-Cycle Family Safe supplies
Arranges collection from Patient’s home to Pharma-Cycle’s central location
Provides responsible safe environmental disposal
Treatment (85% outpatient)
Collection kit (or sent to home)
Kit - 16” discrete cube contains supplies need to create safety barriers around contaminated wastes
Urine, feces and vomit collection devices
Disposable sheets, gloves, utensils, straws etc.
Disposable washing supplies
Additional containment supplies

10. Outcome: Family, home, and environment is safe
Using Pharma-Cycle Family Safe System
Pharma-Cycle wants to make the difficult process of helping cancer patients keep their home safe from dangerous cytotoxic chemicals as easy as possible
Family Safe System is discretely delivered to patients' home and collected after use
Safe to ship as Non-DOT material
Same day delivery in Rhode Island
Collection devices automatic sequester contaminated bodily wastes
All liquids are turned to solids within minutes
Biologic pathogens rapidly neutralized
Chemically sequestered within hours
Additional supplies help reduce common sources of contamination in homes and water
For 2-5 days after each infusion, the patients use the materials, pack everything back in the shipping box and Pharma-Cycle handles the rest.
Outcome: Family, home, and environment is safe

11. Contact Information
Pharma-Cycle, Inc.
359 Thames St.
Newport, RI 02840
Jim Mullowney