Hazardous Waste Proposed Rules Generator Improvements & Pharmaceuticals NAHMMA Conference September 15, 2015 Kristin Fitzgerald, EPA

Outline of Today’s Briefing 2  Part I: Generator Improvements Proposed Rule  Provisions of interest to CESQGs  Part II: Pharmaceuticals Proposed Rule  Brief Overview  Provisions related to Take-Back Programs  Provisions specific to CESQGs

Part I: Hazardous Waste Generator Improvements Proposed Rule 3

Summary  The Agency is: o Proposing 60+ changes to the regulations – some small, some big o Proposing an additional ~30 technical corrections to the program o Taking comment on practically every component of the generator regulatory program 4

Rule Objectives The 2015 HW Generator Improvements Proposed Rule seeks to: 1. Reorganize the regulations to make them more user-friendly and thus enable improved compliance by the regulated community 2. Provide greater flexibility for hazardous waste generators to manage waste in a cost-effective manner 3. Strengthen environmental protection by addressing identified gaps in the regulations 4. Clarify certain components of the hazardous waste generator program to address ambiguities and foster improved compliance 5

Rule Objectives The 2015 HW Generator Improvements Proposed Rule seeks to: 1. Reorganize the regulations to make them more user-friendly and thus enable improved compliance by the regulated community 2. Provide greater flexibility for hazardous waste generators to manage waste in a cost-effective manner 3. Strengthen environmental protection by addressing identified gaps in the regulations 4. Clarify certain components of the hazardous waste generator program to address ambiguities and foster improved compliance 6

1. CESQG Consolidation Problem  Some companies would like to be able to consolidate wastes from multiple CESQG sites for more efficient shipping and hazardous waste management  Reduce liability for company as a whole to ensure proper management of hazardous waste  Sending to a RCRA-designated facility is the most environmentally sound option  Currently an LQG needs a RCRA permit to receive CESQG wastes 7

1. CESQG Consolidation Proposed Solution  Allow consolidation of hazardous waste at an LQG under the control of the same person: o Person – as defined under RCRA o Control – power to direct policies at the facility CESQG Requirements o Marks and labels waste containers with “VSQG Hazardous Waste” o Complies with DOT shipping requirements LQG Requirements o Notifies state on Site ID Form that it is participating in this activity and identifies participating CESQGs; maintains records of each shipment o Manages consolidated waste as LQG hazardous waste o Reports quantities managed as part of Biennial Report submission 8

2. Episodic Generation Problem  Current RCRA rules lack flexibility to address an “episodic” change in a generator’s regulatory category: o Planned event (i.e., periodic maintenance such as tank cleanouts, short-term construction projects) o Unplanned event (i.e., production upset conditions, spill, acts of nature)  As a result, generators must comply with more comprehensive set of regulations for short period of time – difficult to actually comply in practice 9

2. Episodic Generation Proposed Solution  Allow generators to maintain their existing category provided they comply with streamlined set of requirements o Once a calendar year with ability to petition for second event o Notify EPA or state prior to initiating a planned episodic event and have up to 45 days to complete “episodic” event(s) and ship waste off-site; allow for 30 day extension 10

2. Episodic Generation Proposed Solution  Streamlined Requirements for CESQGs: o Obtain RCRA identification number o Notify EPA or state taking advantage of program o Use hazardous waste manifest and transporter to send episodic waste to RCRA- designated facility (TSDF or recycler) o Manage the episodic hazardous waste in a manner that minimizes the possibility of an accident or release o Label episodic waste containers o Identify an emergency coordinator o Maintain records associated with episodic event  SQGs need only notify EPA or state, comply with existing SQG regulations, and maintain records associated with the episodic event 11

QUESTIONS?? Generator Improvements Proposed Rule  Jim O’Leary    Kathy Lett   12

Part II: Hazardous Waste Pharmaceuticals Proposed Rule 13

Flow of HW Pharmaceuticals 14 1 st Reverse Distributor 2 nd Reverse Distributor HW TSDF Healthcare Facility/ Pharmacy Potentially Creditable Pharmacy Drugs

Flow of HW Pharmaceuticals 15 1 st Reverse Distributor 2 nd Reverse Distributor HW TSDF Healthcare Facility/ Pharmacy Non-creditable Floor Waste & Pharmacy Drugs Potentially Creditable Pharmacy Drugs

Flow of HW Pharmaceuticals 16 1 st Reverse Distributor 2 nd Reverse Distributor HW TSDF Healthcare Facility/ Pharmacy Non-creditable Floor Waste & Pharmacy Drugs Potentially Creditable Pharmacy Drugs Sewer Non-Compliant Disposal

3 Problem Areas to Address in Rule 17 1 st RD 2 nd RD HW TSDF Healthcare Facility/ Pharmacy Non-creditable Floor Waste & Pharmacy Drugs Potentially Creditable Pharmacy Drugs Sewer Non-Compliant Disposal

6 Main Issues for Rulemaking 1. Regulatory status of creditable pharmaceuticals 2. Manufacturing-oriented framework of the generator regulations 3. LQG status due to P-listed hazardous waste  Warfarin & nicotine 4. Intersection of EPA & DEA regulations 5. Containers with P-listed pharmaceutical residues 6. Pharmaceuticals being flushed/sewered 18

6 Main Remaining Issues for Rulemaking 1. Regulatory status of creditable pharmaceuticals 2. Manufacturing-oriented framework of the generator regulations 3. LQG status due to P-listed hazardous waste  Warfarin & nicotine 4. Intersection of EPA & DEA regulations 5. Containers with P-listed pharmaceutical residues 6. Pharmaceuticals being flushed/sewered 19

Overview of Proposed Rule 20  Proposed to add hazardous waste pharmaceuticals to the Universal Waste program (2008)  Commenters felt UW was inadequate for pharmaceuticals  Could not address negative comments on proposal without re- proposing  New approach has been to build on the 2008 Universal Waste (UW) proposal by:  Keeping the aspects of the UW proposal that commenters liked  Addressing commenters’ concerns about the UW proposal  Addressing new areas that the UW proposal did not  Coordinating with other federal agencies (e.g., DEA)  Promoting national consistency

Overview of Proposed Rule 21  We are proposing sector-specific standards for the management of hazardous waste pharmaceuticals for:  Healthcare facilities/pharmacies, and  Reverse distributors  The two flows of hazardous waste pharmaceuticals are addressed differently by the rule: 1. Creditable hazardous waste pharmaceuticals that go through reverse distribution to obtain manufacturer’s credit 2. Non-creditable hazardous waste pharmaceuticals that do not and should not go through reverse distribution

Which Pharmaceuticals Will be Covered? 22  Only those pharmaceuticals that are already considered hazardous waste will be covered by the new rule  This rule does NOT propose to expand the number of pharmaceuticals that are considered hazardous waste  We encourage healthcare facilities to manage all waste pharmaceuticals under the new rule

Which Pharmaceuticals are HW? 23  There is no (free) definitive list of all pharmaceuticals that are HW  A few sources to use:     examples-of-hw-pharmaceuticals.pdf examples-of-hw-pharmaceuticals.pdf  azardous/WastePharmListLetter12_07.pdf azardous/WastePharmListLetter12_07.pdf

Examples of Listed HW Pharmaceuticals 24  P-Listed hazardous ACUTE wastes  Warfarin (P001)  Arsenic Trioxide (P012)  Nicotine (P075)  Physostigmine salicylate (P188)  Physostigmine (P204)  U-listed hazardous wastes  Mitomycin C (U010)  Chloral hydrate (U034)  Cyclophosphamide (U058)  Lindane (U129)  Selenium sulfide (U205)

Examples of Characteristic Pharmaceuticals 25  Ignitable (D001):  Preparations with >24% alcohol  Toxicity (D004-D043): if present above certain concentrations in the leachate during TCLP test  Chromium (multi-vitamins)  m-Cresol (preservative in insulin)  Mercury (in the preservative thimerosal)  Selenium (multi-vitamins)  Silver (burn creams)

26 There’s nothing wrong with my eye. It’s a nicotine patch – I’m trying to quit smoking

Who Will be Covered by the Rule? 27  Healthcare facilities  Including pharmacies and long-term care facilities  Excluding CESQGs  The proposed definition of Healthcare facility is: any person that (1) provides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or (2) sells or dispenses over-the-counter or prescription pharmaceuticals.

Who Will be Covered by the Rule? 28  All pharmaceutical reverse distributors - regardless of current generator category  The proposed definition of Pharmaceutical Reverse Distributor is  Any person that receives and accumulates potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer’s credit  Any person, including forward distributors and pharmaceutical manufacturers, that processes pharmaceuticals for the facilitation or verification of manufacturer’s credit is considered a pharmaceutical reverse distributor  Some drug manufacturers may operate as pharmaceutical reverse distributors

6 Main Remaining Issues for Rulemaking 1. Regulatory status of creditable pharmaceuticals 2. Manufacturing-oriented framework of the generator regulations 3. LQG status due to P-listed hazardous waste  Warfarin & nicotine 4. Intersection of EPA & DEA regulations 5. Containers with P-listed pharmaceutical residues 6. Pharmaceuticals being flushed/sewered 29

#6: Sewering Pharmaceuticals Problem 30  Flushing of pharmaceuticals has become a commonly used disposal method by healthcare facilities which  Contributes to pharmaceuticals in surface and drinking water,  Has the potential to present risks to human health and the environment  Are not being treated for by POTWs, except incidentally  Flushing is allowed by current regulation “There’s not some sort of magic process that can remove everything we put down the drain” David Sedlak, Director of the Institute for Environmental Science and Engineering at UC Berkeley

#6: Sewering Pharmaceuticals Proposed Solution 31  Rule bans the sewering of HW pharmaceuticals  Sewer ban applies to all healthcare facilities & RDs, including CESQGs  Otherwise CESQG healthcare facilities are not subject to the proposal  Prevents 6400 TONS of hazardous waste pharmaceuticals from contaminating the water per year  Sewer ban reinforces and highlights EPA’s policy against flushing pharmaceuticals  DEA no longer allows sewering as a means of destroying controlled substances  Several federal agencies, including EPA, have been coordinating to educate consumers to stop flushing pharmaceuticals  EPA would join other jurisdictions with sewer bans for pharmaceuticals, including IL, NJ, DC and CT (proposed)

6 Main Remaining Issues for Rulemaking 1. Regulatory status of creditable pharmaceuticals 2. Manufacturing-oriented framework of the generator regulations 3. LQG status due to P-listed hazardous waste  Warfarin & nicotine 4. Intersection of EPA & DEA regulations 5. Containers with P-listed pharmaceutical residues 6. Pharmaceuticals being flushed/sewered 32

#4: Intersection of DEA & EPA Rules Problem 33  There are a few RCRA hazardous wastes that are also DEA controlled substances  Chloral hydrate (U034)  Fentanyl sublingual spray (D001)  Phenobarbital (D001)  Testosterone gels (D001)  Valium injectable (D001)  These are dually regulated by EPA and DEA – must comply with both sets of regulations

#4: Intersection of DEA & EPA Rules Proposed Solution 34  The following would be exempt from RCRA regulation: 1. Hazardous waste pharmaceuticals that are also DEA controlled substances 2. Authorized collectors of DEA controlled substances that co- mingle them with pharmaceuticals that are exempt household hazardous waste (HHW)  Conditions for both exemptions:  Must be managed in accordance with all DEA regulations  Must be combusted at a permitted/interim status:  municipal solid waste combustor or  hazardous waste combustor

2 Provisions Specific to CESQGs 35  Both provisions encourage CESQGs to manage their hazardous waste pharmaceuticals in an environmentally preferable manner than is required  WIN for CESQGs  reduces liability associated with disposal of hazardous waste  WIN for Environment  hazardous waste that is allowed to be disposed of as non-hazardous gets diverted to hazardous waste management

2 Provisions Specific to CESQGs CESQG healthcare facilities can consolidate hazardous waste pharmaceuticals at an off-site healthcare facility for hazardous waste management, provided the receiving healthcare facility is:  Operating under Part 266 subpart P  Under the control of the same person as the CESQG healthcare facility (e.g., Army); OR the receiving healthcare facility is also the pharmaceutical supplier for the CESQG (e.g., long-term care pharmacies)  Managing the hazardous waste pharmaceuticals it receives from the CESQG under Part 266 subpart P  Keeps records of the shipments

2 Provisions Specific to CESQGs A long-term care facility that is a CESQG may dispose of its hazardous waste pharmaceuticals in an on-site DEA-authorized collection receptacle, provided:  The contents of the collection receptacle are managed in compliance with all DEA regulations

QUESTIONS?? Pharmaceuticals Proposed Rule  Kristin Fitzgerald    Josh Smeraldi    Resources standards-hazardous-waste-pharmaceuticals 38