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

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

May 18, 2023 319 likes •674 views

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

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Pharmaceutical & Proposed Aerosol Rule Updates

Jim Aycock & Marcus Rivas

Hazardous Waste Program, EPA Region 7

at the 01 May 2019 Iowa SGP Meeting

Federal Hazardous Waste

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SLIDE 2

Rule Topics

Pharmaceutical [Pharma] Pending Aerosol

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01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

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Prepare for Questions/Clarify

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01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

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Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine

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“Pharma” Rule

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 Why & implementation  Sewer prohibition  Impacted (& NOT included) classes  Key rule elements  Planned Outreach  A big deal for RCRA because …

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01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

Pharma Rule

Overview Summary

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 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)

01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

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Pharma Rule

Why & Implementation

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 Eliminate sewering HW Pharmaceuticals

(HWP)

 Reduce overlapping regs  Clarity, certainty & consistency  Regulatory relief

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Pharma Rule

Why & Implementation

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 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]

01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

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Pharma Rule

Why & Implementation

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 Effective 21 August 2019 all States, Indian

Country and Territories

 Coordinated with DEA  Applies to HWP, but ripples

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Pharma Rule

Sewer Prohibition

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 Distribute or sell wholesale or retail  General merchandisers  Veterinary services  Practitioners

continued

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Pharma Rule

Impacted Class

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SLIDE 11

continued

Non-residential care centers –

hospitals & clinics

Residential care centers –

nursing homes, long-term, & hospice

Reverse Distributors

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Pharma Rule

Impacted Class

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NOT included

Pharmaceutical manufacturers –

unless as Reverse Distributor

Farmers, Ranchers, & Fisheries Household usage [household hazardous waste]

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Pharma Rule

Impacted Class

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 Pharmaceutical (& HWP)  Potentially creditable HWP  Non-creditable HWP  Evaluated HWP

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Pharma Rule

Key rule elements

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 Healthcare Facility  Long-term Care Facility  Reverse Distributor  Reverse Logistics

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Pharma Rule

Key rule elements

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 Dispense  Administer

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Pharma Rule

Key rule elements

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 Relax definition of P075 (nicotine)  Redefines “empty” container  Conditional exemptions for HHWP & DEA

collection programs

01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

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Pharma Rule

Key rule elements

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Awareness in Region 7 Iowa – detailed compliance

assistance workshops

Coordinate with professional

associations

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Pharma Rule

Planned Outreach

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Compliance Assistance Website www.epa.gov/ks/pharma

 FAQs  Presentations  Fact Sheets

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Pharma Rule

Planned Outreach

 Archive of webinars  Other? [what do YOU want?]

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 Relax definitions of P075 (nicotine)  Re-defines “empty” container for HWP  Dispositions for HHWP & DEA collection

programs

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Pharma Rule

A big deal for RCRA…

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 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

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Pharma Rule

A big deal for RCRA…

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EPA – Marcus Rivas, 913.551.7669

  • r Rivas.Marcus@epa.gov

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Web support – FAQs & webinar content,

https://www.epa.gov/hwgenerators/final- rule-management-standards-hazardous- waste-pharmaceuticals-and-amendment- p075 Pharma Rule

Why & Implementation

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Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations

01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

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“Aerosol” Rule

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 Critical Dates  Key Elements  Immediate Next Steps  Implementation  Future Contacts

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01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

Proposed Aerosol Rule

Overview Summary

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 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

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Proposed Aerosol Rule

Critical Dates

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01 May 2019 Iowa SGP - RCRA Hazardous Waste Rules 2019

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Assumes cans will be

recycled as scrap metal

Does not include gas

cylinders

Allows handlers (including GEN)

to puncture container

Proposed Aerosol Rule

Key Elements

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Proposed Elements

Puncture waste must

receive HW determination (not UW)

FIFRA allows pesticide

disposal by this method

Proposed Aerosol Rule

Key Elements

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Proposed Elements

P-listed aerosol cans still hazardous

unless triple rinsed

Proposed Aerosol Rule

Key Elements

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EPA workgroup reconciling

comments

Region 7 staff active on workgroup Final Rule expected August 2019

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Proposed Aerosol Rule

Immediate Next Steps

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 When finalized, Rule effective in Iowa,

Alaska, Indian Country & Territories

 When finalized, Rule not effective in

authorized programs until adopted

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Proposed Aerosol Rule

Implementation

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 EPA – Ed Buckner, P.E.  913.551.7621 or

Buckner.Edwin@epa.gov

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Web support –

https://www.epa.gov/hw/increasing- recycling-adding-aerosol-cans-universal- waste-regulations

Once the Rule is final

Proposed Aerosol Rule

Future Contacts

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End Presentation

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Prepare for Questions/Clarify

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Process Questions?

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Bonus Activity

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If you need help getting registered in e-Manifest, we can help you after the close of the workshop today!

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