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

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

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

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???

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

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

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

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

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

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

Contact Information Pharma-Cycle, Inc. www.pharma-cycle.com 359 Thames St. Newport, RI 02840 Jim Mullowney 617-755-0883 jmullowney@pharma-cycle.com