Pharmaceutical & Proposed Aerosol Rule Updates Jim Aycock - PowerPoint PPT Presentation

‡ 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