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Regulation of Chemo Wastes Under RCRA. John Gorman EPA Region 2 212-637-4008 gorman.john@epa.gov. RCRA Regulated Chemotherapy Wastes. Eight are U-listed: Chlorambucil (Leukeran) (U035) Cyclophosphamide (Cytoxan, CTX, Neosar, Procytox) (U058)

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regulation of chemo wastes under rcra

Regulation of Chemo Wastes Under RCRA

John Gorman

EPA Region 2

212-637-4008

gorman.john@epa.gov

slide2

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

slide3

RCRA Regulated Chemotherapy Wastes

  • One is P-listed:
    • Arsenic Trioxide (Trisenox) (P012)

EPA Region 2

Healthcare Compliance Initiative

slide4

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

bulk trace chemo
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

mixture rule
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

practical application to ppe
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

management of containers
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

empty containers u listed wastes 40 cfr 261 7
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

p listed wastes
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

best management practices
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