1. Regulation of Chemo Wastes Under RCRA John Gorman EPA Region 2 212-637-4008 gorman.john@epa.gov

2. RCRA Regulated Chemotherapy Wastes • Eight are U-listed: • Chlorambucil (Leukeran) (U035) • Cyclophosphamide (Cytoxan, CTX, Neosar, Procytox) (U058) • Daunomycin (Daunorubicin, Cerubidine, DaunoXome, Rubidomycin, Liposomal Daunorubicin) (U059) • Diethylstilbestrol (Diethylstilbesterol, DES, Stilbestrol, Honvol, Stilbesterol)(U089) • Melphalan (Alkeran, L-PAM) (U150) • Mitomycin C (Mitomycin, Mutamycin) (U010) • Streptozotocin (Streptozocin, Zanosar) (U206) • Uracil Mustard (U237) EPA Region 2 Healthcare Compliance Initiative

3. RCRA Regulated Chemotherapy Wastes • One is P-listed: • Arsenic Trioxide (Trisenox) (P012) EPA Region 2 Healthcare Compliance Initiative

4. Chemotherapy Wastes (Cont’d) • Other listed chemicals used in cancer research or treatment; but not FDA approved: • Azaserine (U015) • Chlornaphazin (U026) • Ethyl Carbamate (U238) • 3-Methylcholanthrene (U157) EPA Region 2 Healthcare Compliance Initiative

5. Bulk & Trace Chemo • These terms do not exist in the federal regulatory program • Mixture rule applies to listed chemo wastes (see 40 CFR §261.3(a)(2)(iv)) • No minimum quantity or concentration to exit regulatory system EPA Region 2 Healthcare Compliance Initiative

6. Mixture Rule • A solid waste is a hazardous waste if: • It is a mixture of a solid waste and a hazardous waste not listed solely because it exhibits a characteristic EPA Region 2 Healthcare Compliance Initiative

7. Practical Application to PPE • HW only if contaminated with listed chemo wastes • Solid waste if uncontaminated • Signs of contamination include: shiny sheen, change in color, change in texture or feel of the PPE, or seeing the material on the PPE • Note: NIOSH & OSHA recommend handling all PPE as contaminated EPA Region 2 Healthcare Compliance Initiative

8. Management of Containers • Containers may also be regulated • If the container is not “empty” and • if they formerly held a hazardous waste • Different rules for P-listed and U-listed wastes EPA Region 2 Healthcare Compliance Initiative

9. Empty Containers – U-Listed Wastes (40 CFR §261.7) • Containers, IV bags, vials and inner liners that have held U-listed hazardous waste are deemed empty when: • All the wastes have been removed that can be removed, and • No more than one inch of residue remains on the bottom of the container or inner liner, or • No more than 3 percent by weight of the total capacity of the container remains in the container or inner liner if the container is less than or equal to 110 gallons in size. • Any residues removed from the container are managed as listed HW. EPA Region 2 Healthcare Compliance Initiative

10. P-Listed Wastes • Not subject to the empty container rule • Containers, IV bags, vials and inner liners that have held P-listed hazardous waste are a HW unless triple rinsed with an appropriate solvent • The rinse water must be managed as a hazardous waste. EPA Region 2 Healthcare Compliance Initiative

11. Best Management Practices • Handle all chemo wastes as HW • Reverse distribution • Pharmacy as accumulation area • Special marking on regulated chemo containers • Develop standard policy for PPE EPA Region 2 Healthcare Compliance Initiative