pharmaceutical waste management & minimization janet bowen, epa march 26, 2008
TRANSCRIPT
Pharmaceutical Waste Pharmaceutical Waste Management & Management & Minimization Minimization
Janet Bowen, EPAJanet Bowen, EPAMarch 26, 2008March 26, 2008
Overview of PresentationOverview of Presentation
• Environmental impacts of prescription drugs Environmental impacts of prescription drugs • Review of 10-Step Blueprint including Regulatory Review of 10-Step Blueprint including Regulatory
RequirementsRequirements• Federal role: White House disposal guidelines, Federal role: White House disposal guidelines,
research, & policy implicationsresearch, & policy implications• Stewardship activities – state programsStewardship activities – state programs• Region II enforcement summaryRegion II enforcement summary• Additional ProgramsAdditional Programs
11stst National Study Revealed Extent of National Study Revealed Extent of Pharms in WaterwaysPharms in Waterways
• USGS “Reconnaissance” study in 1999-2000 was USGS “Reconnaissance” study in 1999-2000 was 11stst nationwide investigation of pharms, hormones, nationwide investigation of pharms, hormones, & other organic contaminants in 139 streams in 30 & other organic contaminants in 139 streams in 30 states:states:– 82 of 95 antibiotics, prescription & non-prescrip drugs, 82 of 95 antibiotics, prescription & non-prescrip drugs,
steroids, & hormones were found in at least 1 samplesteroids, & hormones were found in at least 1 sample– 80% streams had 1 or more contaminant80% streams had 1 or more contaminant– 75% streams contained 2 or more75% streams contained 2 or more– 54% had more than 554% had more than 5– 34% had more than 1034% had more than 10– 13% tested positive for more than 20 targeted contaminants13% tested positive for more than 20 targeted contaminants
National & International Studies Have National & International Studies Have Shown…Shown…
• Male fish, alligators, frogs, & other species with female organs & Male fish, alligators, frogs, & other species with female organs & eggseggs
• Declines in human sperm counts, rise in female infertilityDeclines in human sperm counts, rise in female infertility• Pharm compounds found at wastewater treatment plantsPharm compounds found at wastewater treatment plants• Anti-cholesterol drug nearly killed test fishAnti-cholesterol drug nearly killed test fish• Cocktail of 13 drugs inhibited kidney cell growthCocktail of 13 drugs inhibited kidney cell growth• Prozac linked to premature release of mussel larvaeProzac linked to premature release of mussel larvae• Associated Press Probe finds drugs in drinking waterAssociated Press Probe finds drugs in drinking water
• National Pharm Listserve National Pharm Listserve http://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwastehttp://lists.dep.state.fl.us/cgi-bin/mailman/listinfo/pharmwaste
How Pharmaceuticals enter the How Pharmaceuticals enter the EnvironmentEnvironment
Two RoutesTwo Routes
• Excretion of unmetabolized medicationsExcretion of unmetabolized medications• Waste of unused medicationsWaste of unused medications
PURPOSEFULPURPOSEFUL INADVERTENTINADVERTENT
Why Can’t We Take the PPCPs out of the Why Can’t We Take the PPCPs out of the Water?Water?
• POTWs are not designed to remove PPCPsPOTWs are not designed to remove PPCPs• Promising technologies include:Promising technologies include:
– OxidationOxidation– OzonationOzonation– UltrasoundUltrasound– Activated carbonActivated carbon– Reverse osmosisReverse osmosis
• Longer retention times (POTWs with nutrient removal) Longer retention times (POTWs with nutrient removal) look promisinglook promising
• Focus on controlling disposal at sourceFocus on controlling disposal at source
Managing Pharmaceutical Waste:10 Managing Pharmaceutical Waste:10 Step Blueprint for Health Care Step Blueprint for Health Care
FacilitiesFacilities
Introduction to a pharmaceutical waste Introduction to a pharmaceutical waste management tool – use it to implement management tool – use it to implement a pharmaceutical waste management a pharmaceutical waste management
system!system!http://www.h2e-online.org/docs/http://www.h2e-online.org/docs/h2epharmablueprint41506.pdfh2epharmablueprint41506.pdf
Review of the 10 StepsReview of the 10 Steps
Step 1Step 1 Getting Started Getting Started– Support from Senior ManagementSupport from Senior Management– Develop a CommitteeDevelop a Committee– Plan for opportunities, challenges and Plan for opportunities, challenges and
financial implications to making changes, financial implications to making changes, improvements in your facility.improvements in your facility.
Step 2: Understanding the RegulationsStep 2: Understanding the RegulationsHazardous Waste BackgroundHazardous Waste Background
What is Hazardous Waste: What is Hazardous Waste: • Waste that is dangerous or potentially harmful to Waste that is dangerous or potentially harmful to
human health or the environmenthuman health or the environment• Can be liquids, solids, contained gases, or sludgesCan be liquids, solids, contained gases, or sludges
Hazardous waste is regulated under the Resource Hazardous waste is regulated under the Resource Conservation and Recovery Act (RCRA):Conservation and Recovery Act (RCRA):• Appears on one of the four hazardous wastes lists Appears on one of the four hazardous wastes lists
(P-list, U-list, F-list, or K-list)(P-list, U-list, F-list, or K-list)• Or exhibits at least one of four characteristics Or exhibits at least one of four characteristics
(Ignitability, Corrosivity, Reactivity, or Toxicity)(Ignitability, Corrosivity, Reactivity, or Toxicity)
Hazardous Waste BackgroundHazardous Waste Background
• In all states, the Environmental Department is the agency In all states, the Environmental Department is the agency authorized to regulate hazardous waste under RCRAauthorized to regulate hazardous waste under RCRA
• A discarded pharmaceutical may be identified as a A discarded pharmaceutical may be identified as a hazardous waste if it appears on a regulatory list of hazardous waste if it appears on a regulatory list of hazardous wastes (P or U) or exhibits one of four hazardous wastes (P or U) or exhibits one of four hazardous characteristics (ignitability, corrosivity, hazardous characteristics (ignitability, corrosivity, reactivity or toxicity)reactivity or toxicity)
Healthcare Environmental Resource CenterHealthcare Environmental Resource Center
www.hercenter.orgwww.hercenter.org
Step 2Step 2 Understanding the Regulations Understanding the Regulations P-Listed WastesP-Listed Wastes
•P-Listed Wastes P-Listed Wastes – Sole active ingredient Sole active ingredient – Unused – drug has not been given to a patientUnused – drug has not been given to a patient
•Empty ContainersEmpty Containers– Empty if triple rinsedEmpty if triple rinsed– Rinsate must be managed as hazardous wasteRinsate must be managed as hazardous waste– Rinsing generally not practical for pharmaceutical Rinsing generally not practical for pharmaceutical
wastewaste
Hazardous Waste: Listed Hazardous Waste: Listed
If the pharmaceuticals you are using appears on these If the pharmaceuticals you are using appears on these lists, the waste must be handled as a hazardous wastelists, the waste must be handled as a hazardous waste
Common P-Listed Pharmaceuticals:Common P-Listed Pharmaceuticals:
• Please note that Please note that this list is not intended to be completethis list is not intended to be complete. The . The full list of all P-listed wastes appear in the Code of Federal full list of all P-listed wastes appear in the Code of Federal Regulations, 40 CFR 261.33. Regulations, 40 CFR 261.33.
Arsenic trioxide P012
Epinephrine P042
Nicotine P075
Nitroglycerin P081
Physostigmine P204
Physostigmine salicylate P188
Warfarin >0.3% P001
Step 2Step 2 Understanding the Regulations Understanding the Regulations Regulatory Interpretation: Regulatory Interpretation:
Epinephrine SaltsEpinephrine Salts
• October 15, 2007 EPA MemoOctober 15, 2007 EPA Memohttp://www.epa.gov/region1/healthcare/pdfs/EpiMemo_Final.pdfhttp://www.epa.gov/region1/healthcare/pdfs/EpiMemo_Final.pdf
• Epinephrine salts are not a P042 listed Epinephrine salts are not a P042 listed waste (federally)waste (federally)
• States are delegated the RCRA program States are delegated the RCRA program and can be more stringentand can be more stringent
Step 2Step 2 Understanding the Regulations Understanding the Regulations Nitroglycerin ExemptionNitroglycerin Exemption
• Medical nitroglycerin removed as a P-listed waste Medical nitroglycerin removed as a P-listed waste – Weak, non-reactive, formulationWeak, non-reactive, formulation
• Some formulations may fail ignitability characteristic Some formulations may fail ignitability characteristic – Waste injectables Waste injectables – AerosolsAerosols
• State may be more stringent (or may be still adopting the State may be more stringent (or may be still adopting the rule) – check with your state on their position on rule) – check with your state on their position on NitroglycerinNitroglycerin
Step 2Step 2 Understanding the Regulations Understanding the Regulations U-Listed WastesU-Listed Wastes
• U-listed Wastes U-listed Wastes – Sole active ingredientSole active ingredient– UnusedUnused
• Empty ContainersEmpty Containers– All contents have been removed that can be All contents have been removed that can be
removed through normal means and no more removed through normal means and no more than 3% by weight remains than 3% by weight remains
– Residues removed from container must be Residues removed from container must be managed as hazardous wastemanaged as hazardous waste
Hazardous Waste: Listed Hazardous Waste: Listed
Common U-Listed PharmaceuticalsCommon U-Listed Pharmaceuticals
• Please note that Please note that this list is not intended to be completethis list is not intended to be complete. The full list of all . The full list of all U-listed wastes appear in the Code of Federal Regulations, 40 CFR 261.33. U-listed wastes appear in the Code of Federal Regulations, 40 CFR 261.33.
Chloral Hydrate (CIV)2 U034 Mitomycin C (chemo) U010
Chlorambucil (chemo) U035 Paraldehyde (CIV)2 U182
Chloroform U044 Phenacetin U187
Cyclophosphamide (chemo)
U058 Phenol U188
Daunomycin (chemo) U059 Reserpine U200
Dichlorodifluromethane U075 Resorcinol U201
Diethylstilbestrol U089 Saccharin U202
Formaldehyde U122 Selenium sulfide U205
Hexachlorophene U132 Streptozotocin (chemo) U206
Lindane U129 Trichloromonofluromethane U121
Melphalan (chemo) U150 Uracil mustard (chemo) U237
Mercury U151 Warfarin <0.3% U248
Hazardous Waste: CharacteristicHazardous Waste: Characteristic
If the pharmaceuticals you are using exhibits one of If the pharmaceuticals you are using exhibits one of four hazardous characteristics, the waste must be four hazardous characteristics, the waste must be handled as a hazardous wastehandled as a hazardous waste
Ignitability - having a flash point less than 60Ignitability - having a flash point less than 60ooCC
• Ignitable Characteristic Pharmaceuticals:Ignitable Characteristic Pharmaceuticals: Any formulations with more than 24% alcohol Any formulations with more than 24% alcohol Oxidizers such as Potassium Permanganate and Oxidizers such as Potassium Permanganate and
Silver Nitrate Silver Nitrate CollodionCollodion
Corrosivity - having a pH less than 2 or greater than Corrosivity - having a pH less than 2 or greater than 12.512.5• Corrosive Characteristic Pharmaceuticals:Corrosive Characteristic Pharmaceuticals:
Compounding Agents such as Glacial acetic acid and Compounding Agents such as Glacial acetic acid and Sodium Hydroxide Sodium Hydroxide
Hazardous Waste: CharacteristicHazardous Waste: Characteristic Reactivity - liable to explode, or react violently or Reactivity - liable to explode, or react violently or
release toxic gases when in contact with water release toxic gases when in contact with water • Reactive Characteristic Pharmaceuticals:Reactive Characteristic Pharmaceuticals:
NitroglycerinNitroglycerin
Toxicity - containing a regulated substance at a Toxicity - containing a regulated substance at a concentration above the limit concentration above the limit • Toxic Characteristic Pharmaceuticals:Toxic Characteristic Pharmaceuticals:
Zinc (some shampoos)Zinc (some shampoos) SeleniumSelenium
How does this apply to Pharmacy?How does this apply to Pharmacy?
Facilities that generate hazardous waste Facilities that generate hazardous waste are regulated as one of the following:are regulated as one of the following:
• Conditionally Exempt Small Quantity Generators Conditionally Exempt Small Quantity Generators (CESQGs)(CESQGs) Generate less than 100 kg of hazardous waste Generate less than 100 kg of hazardous waste per calendar monthper calendar month* *
• Small Quantity Generators (SQGs)Small Quantity Generators (SQGs) Generate between 100 kg and 1000 kg of Generate between 100 kg and 1000 kg of hazardous waste per calendar monthhazardous waste per calendar month**
• Large Quantity Generators (LQGs)Large Quantity Generators (LQGs) Generate greater than 1000 kg of hazardous Generate greater than 1000 kg of hazardous waste per calendar monthwaste per calendar month
* * And no more than 1 kg (2.2 lbs) of acutely And no more than 1 kg (2.2 lbs) of acutely hazardous waste per calendar month counts hazardous waste per calendar month counts weight of containerweight of container
Step 3Step 3 Consider Best Management Consider Best Management Practices (BMPs) for Non-Regulated Practices (BMPs) for Non-Regulated Pharmaceutical WastesPharmaceutical Wastes– Recommendations made for how to manage Recommendations made for how to manage
pharmaceutical waste to protect water bodies, pharmaceutical waste to protect water bodies, aquatic species, human health.aquatic species, human health.
– Incineration (endocrine disruptors, carcinogenic Incineration (endocrine disruptors, carcinogenic drugs, Formulations w/listed active ingredient drugs, Formulations w/listed active ingredient that is not the sole active ingredient, etc.)that is not the sole active ingredient, etc.)
– Eliminate drain disposalEliminate drain disposal– Avoid LandfillingAvoid Landfilling– Use non PVC IV SetsUse non PVC IV Sets
Step 3Step 3 - BMPs - BMPs Managing to the Highest StandardManaging to the Highest Standard
• Hazardous waste regulations have not Hazardous waste regulations have not kept pace with drug development kept pace with drug development
• Approximately 10% of the drugs that are Approximately 10% of the drugs that are not regulated are equally as hazardous. not regulated are equally as hazardous.
• Best management practices encourage Best management practices encourage managing drugs that are equally harmful managing drugs that are equally harmful as hazardous waste when discardedas hazardous waste when discarded
Step 3Step 3 - BMPs - BMPs Dartmouth Hitchcock Medical Center Waste Dartmouth Hitchcock Medical Center Waste
Characterization SummaryCharacterization Summary
84%
11%
5%
FederallyHazardousBMPHazardous
NonHazardous
Step 3Step 3 - BMPs - BMPs Summary BMPsSummary BMPs
• Drugs with more than one active ingredientDrugs with more than one active ingredient• All chemotherapy drugsAll chemotherapy drugs• Drugs meeting OSHA and NIOSH criteriaDrugs meeting OSHA and NIOSH criteria• Drugs on:Drugs on:
– OSHA Technical Manual AppendixOSHA Technical Manual Appendix– DHHS list of carcinogensDHHS list of carcinogens
• Drugs with low oral LD 50sDrugs with low oral LD 50s• Endocrine disruptors Endocrine disruptors • Vitamin and mineral preparationsVitamin and mineral preparations• Contaminated PPE and spill clean Contaminated PPE and spill clean
up materialup material• Eliminate drain disposalEliminate drain disposal
Step 4Step 4 Perform Review of Drug Inventory Perform Review of Drug Inventory
• Obtain purchasing data from Drug Wholesaler Obtain purchasing data from Drug Wholesaler and/or purchasing recordsand/or purchasing records– Identify ingredientsIdentify ingredients– Determine RCRA hazardous waste codeDetermine RCRA hazardous waste code– Consider Compounded Items & ReformulationsConsider Compounded Items & Reformulations
• Gather Drug-Specific Data – national drug Gather Drug-Specific Data – national drug code, brand name, generic name, Mfr, strength, code, brand name, generic name, Mfr, strength, dosage form, package sizedosage form, package size
• Document decision making processDocument decision making process
• Keep the review currentKeep the review current
Step 5Step 5 Minimizing Pharmaceutical Waste Minimizing Pharmaceutical Waste 1.1. Consider lifecycle Impacts in Purchasing ProcessConsider lifecycle Impacts in Purchasing Process
– Longer expiration dateLonger expiration date• Some epinephrine products have longer shelf life than others to Some epinephrine products have longer shelf life than others to
minimize waste from crash carts and other areas where the minimize waste from crash carts and other areas where the drug is stored for emergencies drug is stored for emergencies
– Products with less packaging Products with less packaging • Packaging in contact with RCRA P-listed drugs must be Packaging in contact with RCRA P-listed drugs must be
managed as hazardous waste managed as hazardous waste
– Products without hazardous preservativesProducts without hazardous preservatives
2.2. Maximize Use of Opened Chemotherapy VialsMaximize Use of Opened Chemotherapy Vials3.3. Implement Samples PolicyImplement Samples Policy4.4. Labeling Drugs for Home UseLabeling Drugs for Home Use5.5. Priming & Flushing IV lines w/Saline SolutionPriming & Flushing IV lines w/Saline Solution6.6. Examine Size of Containers Relative to UseExamine Size of Containers Relative to Use
Step 5Step 5 Minimizing Pharmaceutical Waste Minimizing Pharmaceutical Waste (cont’d)(cont’d)
7.7. Replace Prepackaged Unit Dose Replace Prepackaged Unit Dose Liquids w/Patient-Specific Oral SyringesLiquids w/Patient-Specific Oral Syringes
8.8. Try to eliminate generation of controlled Try to eliminate generation of controlled substances that are also hazardous substances that are also hazardous wasteswastes
9.9. Use hard plastic buckets for delivery of Use hard plastic buckets for delivery of chemotherapy drugs to hospital floors – chemotherapy drugs to hospital floors – not brown paper bagsnot brown paper bags
10.10. Monitor dating on emergency syringesMonitor dating on emergency syringes11.11. Review inventory controls to Review inventory controls to
minimize outdatesminimize outdates
Step 5Step 5 Minimizing Pharmaceutical Minimizing Pharmaceutical WasteWaste (cont’d)(cont’d)
• Limitations on less hazardous drug Limitations on less hazardous drug substitutionsubstitution– Hazardous nature of drug often provides Hazardous nature of drug often provides
therapeutic effecttherapeutic effect• Always ask:Always ask:
– What pharmaceuticals are being wasted?What pharmaceuticals are being wasted?– Why are they being wasted?Why are they being wasted?– How can wasting be minimized?How can wasting be minimized?
Step 6Step 6 Assess Current Practices Assess Current Practices
–Conduct Department ReviewsConduct Department Reviews
–Conduct Analyses FrequentlyConduct Analyses Frequently
–Confirm your Generator StatusConfirm your Generator Status
Step 7Step 7 Taking On Communication Labeling Taking On Communication Labeling ChallengeChallenge
• Automating the Labeling ProcessAutomating the Labeling Process
• Manually Labeling in the PharmacyManually Labeling in the Pharmacy
• Providing Guidance on the FloorProviding Guidance on the Floor
• Selecting a Message for the LabelSelecting a Message for the Label
• Advocate that distributors or Advocate that distributors or manufactures label drugs further manufactures label drugs further up the food chainup the food chain
Step 8Step 8 Consider Management Options Consider Management Options
• Segregation at the Point of GenerationSegregation at the Point of Generation
• Centralizing SegregationCentralizing Segregation
• Managing all drug waste as hazardousManaging all drug waste as hazardous– May be simplest and most economical May be simplest and most economical
approach for small facilities with < 50 bedsapproach for small facilities with < 50 beds– May cost large metropolitan facilities in May cost large metropolitan facilities in
excess of $1Mexcess of $1M
Sample Guidance PosterSample Guidance Poster
Step 9Step 9 Getting Ready for Implementation Getting Ready for Implementation
• Locating Your Satellite Accumulation Locating Your Satellite Accumulation AreasAreas
• Evaluating Your Storage Accumulation Evaluating Your Storage Accumulation AreaArea
• Selecting the Right VendorsSelecting the Right Vendors
• Conducting PilotsConducting Pilots
• Putting it all together: Policies and Putting it all together: Policies and ProceduresProcedures
• Preparing for SpillsPreparing for Spills
Locating Satellite Accumulation Locating Satellite Accumulation AreasAreas
• Located at the point of generation and under control of Located at the point of generation and under control of operator operator (check with state)(check with state)
– Soiled utility room in nursing unitSoiled utility room in nursing unit– Sterile processing clean room and other areas of Sterile processing clean room and other areas of
pharmacypharmacy• Hazardous waste labelHazardous waste label• Signage indicating Satellite AccumulationSignage indicating Satellite Accumulation• Keep container covered when not in active useKeep container covered when not in active use• Quantity LimitQuantity Limit
– Up to 1 quart of P listed waste and 55 gallons of combined U Up to 1 quart of P listed waste and 55 gallons of combined U and characteristic wasteand characteristic waste
• Have 3 days to move when limit is reachedHave 3 days to move when limit is reached
Step 10 Launch the ProgramStep 10 Launch the Program
• Educate & Train StaffEducate & Train Staff
• Staging the Roll-outStaging the Roll-out
• Paperwork Requirements: Filling Paperwork Requirements: Filling Out Required FormsOut Required Forms– Hazardous Waste ManifestsHazardous Waste Manifests– Land Disposal RestrictionsLand Disposal Restrictions
• Tracking, Measuring & Tracking, Measuring & Recording ProgressRecording Progress
Federal Role:Federal Role:
Agency InterestsAgency Interests
ResearchResearch
Policy ImplicationsPolicy Implications
Disposal GuidelinesDisposal Guidelines
EPA Regulatory AgendaEPA Regulatory Agenda
• Considering revising Universal Waste Rule Considering revising Universal Waste Rule for inclusion of some waste for inclusion of some waste pharmaceuticalspharmaceuticals
• Office of Water evaluating the healthcare Office of Water evaluating the healthcare sector, including disposal of pharm waste sector, including disposal of pharm waste from institutions, to determine need for from institutions, to determine need for development of WQ criteriadevelopment of WQ criteria
Health Services Industry Study Outreach Health Services Industry Study Outreach January 2008January 2008
What is the Scope of the Study?What is the Scope of the Study?• We are studying the disposal of unused pharmaceutical from the We are studying the disposal of unused pharmaceutical from the
Health Services Industry (hospitals and long-term care facilities) as Health Services Industry (hospitals and long-term care facilities) as part of the EPA’s CWA Effluent Guidelines Programpart of the EPA’s CWA Effluent Guidelines Program
• We are looking to highlight good voluntary best management We are looking to highlight good voluntary best management practices practices
What are We Studying?What are We Studying?• Identifying current management of unused pharmaceuticals at long-Identifying current management of unused pharmaceuticals at long-
term care facilities and hospitalsterm care facilities and hospitals• Summarizing federal, local, and regional requirements, guidance, Summarizing federal, local, and regional requirements, guidance,
and voluntary initiativesand voluntary initiatives• We are soliciting volunteers to fill out a data requestWe are soliciting volunteers to fill out a data requestWhat is our Schedule?What is our Schedule?• August 2008 Preliminary Report of Health ServicesAugust 2008 Preliminary Report of Health Services
EPA’s Health Services Industry Detailed Study
Federal Disposal GuidelinesFederal Disposal GuidelinesFeb. 20, 2007 Feb. 20, 2007
• Federal govt. guidelines for proper disposal of unwanted Federal govt. guidelines for proper disposal of unwanted medicationsmedications– ONDCP issued February 2007ONDCP issued February 2007– Reaches across several Federal agenciesReaches across several Federal agencies– Encourages trash disposal—after drugs made Encourages trash disposal—after drugs made
unusableunusable– Discourages flushingDiscourages flushing
Federal Disposal GuidelinesFederal Disposal Guidelines• Take unwanted meds out of original containers & put Take unwanted meds out of original containers & put
in trashin trash• Mix prescription drugs with undesirable substance, Mix prescription drugs with undesirable substance,
(e.g., used coffee grounds or kitty litter) & put in (e.g., used coffee grounds or kitty litter) & put in impermeable, non-descript containersimpermeable, non-descript containers
• Flush only if label says to do soFlush only if label says to do so– FDA lists 13 pharms that should be flushedFDA lists 13 pharms that should be flushed
• Use community return programs where availableUse community return programs where available
http://www.whitehousedrugpolicy.gov/drugfact/factsht/http://www.whitehousedrugpolicy.gov/drugfact/factsht/proper_disposal.htmlproper_disposal.html
SMARxT DisposalSMARxT DisposalThe SMARXT DISPOSAL campaign is designed to raise awareness about the potential environmental impact from improperly disposed of medications and to provide proactive guidance through proper disposal alternatives.
SMARXT DISPOSAL is a unique public-private partnership between the U.S. Fish and Wildlife Service, the American Pharmacists Association, and the Pharmaceutical Research and Manufacturers of America. This support and involvement is what separates SMARXT DISPOSAL from other initiatives and it will ultimately make this campaign successful.
Website just released! SMARxTDisposal.net
Stewardship ActivitiesStewardship Activities
Types of Stewardship ActivitiesTypes of Stewardship Activities
• 1-time consumer return collections1-time consumer return collections• Household haz waste collectionsHousehold haz waste collections• Permanent collection boxesPermanent collection boxes• Use of police stationsUse of police stations• Pilot use of reverse distributorsPilot use of reverse distributors• Pilot mail-back programsPilot mail-back programs• Many of these programs require Many of these programs require
involvement of a pharmacist (DEA)involvement of a pharmacist (DEA)
EPA Stewardship ActivitiesEPA Stewardship Activities
• EPA’s new PPCP web siteEPA’s new PPCP web site http://www.epa.gov/ppcp/
• 2 recently funded programs in Maine & 2 recently funded programs in Maine & Missouri thru Aging InitiativeMissouri thru Aging Initiative– Mail-back & take-back return programsMail-back & take-back return programs– Inventories of types & quantities of drugs Inventories of types & quantities of drugs
returnedreturned
Northeast Recycling Council grantManagement of Unwanted Pharmaceuticals
• Researching and addressing legal issues with take-back programs,
• Developing drug collection pilots, including one nearby in South Portland, Maine,
• Developing a “Guidebook for Holding Unwanted Medication Collections,”
• Developing Best Management Practices for the end-of-life management of plastic medication containers.
Website – where you can download all materials http://www.nerc.org/projects/completed_projects.html#2006-a
Adapted from Region 2 August 2006Adapted from Region 2 August 2006 4747
Results EPA Region II:Results EPA Region II:Compliance Monitoring & Incentives ProgramsCompliance Monitoring & Incentives Programs
HospitalsHospitals
UniverseUniverse480480
InspectionsInspections4949
Enforcement ActionsEnforcement Actions 3636
Formal Enforcement ActionsFormal Enforcement Actions 11 ($1,523,613)11 ($1,523,613)
SettlementsSettlements 9 ($642,612)9 ($642,612)
Audit AgreementsAudit Agreements 4141
Voluntary DisclosuresVoluntary Disclosures 156 covering 581 facilities ($29,947,688 156 covering 581 facilities ($29,947,688 for 143 resolved)for 143 resolved)
Violations CorrectedViolations Corrected 32233223
Adapted from Region 2 August 2006 Adapted from Region 2 August 2006 presentationpresentation
4848
Healthcare Violations – All R2Healthcare Violations – All R2
Breakout of Violations from Hospital Disclosures
Safe Drinking Water Act -SDWA
Violations0%
Emergency & Planning
Community Right to Know -EPCRA
Violations7%
-Clean Air Act CAA Violations
18%
- Clean Water Act CWA Violations
4%
Toxic Substance Control Act-TSCA
Violations1%
-Hazardous Waste RCRA Violations
70%
Adapted from Region 2 August 2006 Adapted from Region 2 August 2006 presentationpresentation
4949
Top 5 ViolationsTop 5 Violations ( (From 146 Voluntary Disclosures)From 146 Voluntary Disclosures)
RankRank ViolationViolation StatuteStatute FrequencyFrequency
11 ID of Hazardous ID of Hazardous Waste Waste
RCRA – RCRA – Hazardous Hazardous wastewaste
592592
22 Universal WasteUniversal Waste RCRA– RCRA– Hazardous Hazardous wastewaste
446446
33 Container Container ManagementManagement
RCRA– RCRA– Hazardous Hazardous wastewaste
331331
44 LabelingLabeling RCRA– RCRA– Hazardous Hazardous wastewaste
304304
55 CFC Leak Detection CFC Leak Detection Records Records
CAA – CAA – Clean Air ActClean Air Act 264264
Adapted from Region 2 August 2006 Adapted from Region 2 August 2006 presentationpresentation
5050
Healthcare RCRA ViolationsHealthcare RCRA Violations
Breakout of RCRA Violations from Hospital Disclosures
Accumulation Time1%
Manifest 5%
ID of HW 26%
Universal Waste20%
General Facility Standards10%
Container Management30%
UST 3% Generator
Requirements5%
Region II Data – New DataRegion II Data – New Data
• Region II summer intern recently reviewed Region II summer intern recently reviewed disclosures for "failure to identify" and disclosures for "failure to identify" and "mischaracterization of HW" related "mischaracterization of HW" related violations. violations.
• Data based on 100 hospitalsData based on 100 hospitals
ViolationViolation TypeTypeViolation Type
0
20
40
60
80
100
120
140
160
180
200
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mb
er o
f Vio
latio
ns
(fou
nd in
10
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)
Hazardous Waste Hazardous Waste CharacterizationCharacterization
Hazardous Waste Characterization
0
20
40
60
80
100
120
140
160
lab ch
emica
l
met
al
phar
mac
eutic
als
aers
ol ca
ns
chem
other
apeu
tics
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tfilm
alcoh
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54
A voluntary partnership with EPA
ENERGY STAR is…
A strategic approach to energy management
Energy StarPurchasing and Procurement
• Buy Energy Star Products
Product information
Cost saving information, saving calculators
Procurement information, sample language
http://www.energystar.gov/index.cfm?c=bulk_purchasing.bus_purchasing
• Take free on-line procurement training, http://energystar.premiereglobal.com/attendee/ConferenceList.aspx
56
General Resources
Healthcare Environment Resource Centerwww.hercenter.org
Healthcare Without Harmhttp://www.noharm.org/
Sustainable Hospital Projecthttp://www.sustainablehospitals.org/cgi-bin/DB_Index.cgi
Practice Green Health (includes former H2E)http://www.h2e-online.org
General Resources (Cont.)
• Building Healthy Hospitals: Top 5 Green Building Strategies for Healthcare (2007)
• #1 Energy Efficiency • #2 Process Water Efficiency• #3 Sustainable Flooring Material Selection• #4 Indoor Air Quality: Material Selection• #5 Lighting Efficiency
http://www.epa.gov/region09/waste/p2/greenbldg.html
Questions ?
Want to join EPA Region 1’s hospital email group for regular updates on environmental issues?
Janet Bowen, EPA Region 1
617-918-1795