‡ Federal Hazardous Waste Pharmaceutical & Proposed Aerosol Rule Updates Jim Aycock & Marcus Rivas Hazardous Waste Program, EPA Region 7 at the 01 May 2019 Iowa SGP Meeting
2 Rule Topics Pharmaceutical [Pharma] Pending Aerosol Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
◊ ‡ Prepare for 3 Questions/Clarify Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
4 Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine “Pharma” Rule Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 5 Pharma Rule Overview Summary Why & implementation Sewer prohibition Impacted (& NOT included) classes Key rule elements Planned Outreach A big deal for RCRA because … Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 6 Pharma Rule Why & Implementation Better fit for healthcare sector Waste- and sector-specific final rule Hazardous Waste Pharmaceuticals (HWP) Healthcare Facilities & Reverse Distributors (HCF & RD) These hazardous wastes and this sector are already regulated under RCRA (changing HOW they are regulated) Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 7 Pharma Rule Why & Implementation Eliminate sewering HW Pharmaceuticals (HWP) Reduce overlapping regs Clarity, certainty & consistency Regulatory relief Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 8 Pharma Rule Why & Implementation Signed 11 December 2018 Promulgated 22 February 2019 84 Federal Register 5816. Effective 21 August 2019 in Iowa, Alaska, Indian Country & Territories [sewer prohibition effective nationwide, see next slide] Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
9 Pharma Rule Sewer Prohibition Effective 21 August 2019 all States, Indian Country and Territories Coordinated with DEA Applies to HWP, but ripples Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 10 Pharma Rule Impacted Class Distribute or sell wholesale or retail General merchandisers Veterinary services Practitioners continued Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 11 Pharma Rule Impacted Class continued Non-residential care centers – hospitals & clinics Residential care centers – nursing homes, long-term, & hospice Reverse Distributors Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
12 Pharma Rule Impacted Class NOT included Pharmaceutical manufacturers – unless as Reverse Distributor Farmers, Ranchers, & Fisheries Household usage [household hazardous waste] Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 13 Pharma Rule Key rule elements Pharmaceutical (& HWP) Potentially creditable HWP Non-creditable HWP Evaluated HWP Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
14 Pharma Rule Key rule elements Healthcare Facility Long-term Care Facility Reverse Distributor Reverse Logistics Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 15 Pharma Rule Key rule elements Dispense Administer Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 16 Pharma Rule Key rule elements Relax definition of P075 (nicotine) Redefines “empty” container Conditional exemptions for HHWP & DEA collection programs Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
17 Pharma Rule Planned Outreach Awareness in Region 7 Iowa – detailed compliance assistance workshops Coordinate with professional associations Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 18 Pharma Rule Planned Outreach Compliance Assistance Website www.epa.gov/ks/pharma FAQs Archive of webinars Presentations Other? [what do YOU want?] Fact Sheets Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
19 Pharma Rule A big deal for RCRA… Relax definitions of P075 (nicotine) Re- defines “empty” container for HWP Dispositions for HHWP & DEA collection programs Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
20 Pharma Rule A big deal for RCRA… Generator’s HWP are solid wastes LQG & SQG storage & transport regs in 40 CFR 266 subpart P Reverse Distributors storage & transport regs in 40 CFR 266 subpart P Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
21 Pharma Rule Why & Implementation EPA – Marcus Rivas, 913.551.7669 or Rivas.Marcus@epa.gov Web support – FAQs & webinar content, https://www.epa.gov/hwgenerators/final- rule-management-standards-hazardous- waste-pharmaceuticals-and-amendment- p075 Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
22 Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations “Aerosol” Rule Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
23 Proposed Aerosol Rule Overview Summary Critical Dates Key Elements Immediate Next Steps Implementation Future Contacts Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
24 Proposed Aerosol Rule Critical Dates Rule Proposed 16 March 2018 83 Federal Register 11654 Comment closed 16 April 2018 EPA Docket EPA-HQ-OLEM-2017-0463 EPA referenced NM, CO, CA, UT and OH state universal waste rules Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
25 Proposed Aerosol Rule Key Elements Assumes cans will be recycled as scrap metal Does not include gas cylinders Allows handlers (including GEN) to puncture container Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
26 Proposed Aerosol Rule Key Elements Proposed Elements Puncture waste must receive HW determination (not UW) FIFRA allows pesticide disposal by this method Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
27 Proposed Aerosol Rule Key Elements Proposed Elements P-listed aerosol cans still hazardous unless triple rinsed Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
28 Proposed Aerosol Rule Immediate Next Steps EPA workgroup reconciling comments Region 7 staff active on workgroup Final Rule expected August 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
29 Proposed Aerosol Rule Implementation When finalized, Rule effective in Iowa, Alaska, Indian Country & Territories When finalized, Rule not effective in authorized programs until adopted Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
30 Proposed Aerosol Rule Future Contacts Once the Rule is final EPA – Ed Buckner, P.E. 913.551.7621 or Buckner.Edwin@epa.gov Web support – https://www.epa.gov/hw/increasing- recycling-adding-aerosol-cans-universal- waste-regulations Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
31 End Presentation Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ Prepare for 32 Questions/Clarify Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 33 Process Questions? Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
‡ 34 Bonus Activity If you need help getting registered in e-Manifest , we can help you after the close of the workshop today! Iowa SGP - RCRA Hazardous Waste Rules 2019 01 May 2019
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