1. Range of Compliance Obligations for Colleges & Universities 1.Resource Conservation & Recovery Act 4. Emergency Preparedness & Community Right to Know 1.Hazardous Waste Management 1.Laboratory Chemical Wastes 5. Federal Insecticide, Fungicide & Rodenticide Act 2.Hazardous Drugs Wastes. 3.Operations & Maintenance 6. Toxic Substances Control Act 4.Student Health Drug Wastes > Import/Export Notification 2.Universal Wastes > Preserving Laboratory Exemptions 3.Underground Storage Tank Standards > PCBs in Equipment 2.Clean Air Act 1.Title V Permit Compliance 1.Steam Plant Permit Compliance 2.Emergency Generators 3.Ethylene Oxide Sterilizers 4.Small Animal Incinerator 2.Section 112r Risk Management Planning 3.Stratospheric Ozone Protection 4.State Permits to Construct and Operate 3.Clean Water Act 1.Spill Prevention Control and Countermeasure Plans 2.Stromwater Management Permits 3.Discharges to local POTW and Pretreatment

2. Emergence of Regulations to Manage Hazardous Wastes Growing awareness of the impact and magnitude of abandoned waste sites on the environment and human health (Love Canal). The exponential growth of manufactured chemicals entering the environment.

3. The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund was enacted by Congress on December 11, 1980. This law created a tax on the chemical and petroleum industries and provided broad Federal authority to respond directly to releases or threatened releases of hazardous substances that may endanger public health or the environment. CERCLA:  established prohibitions and requirements concerning closed and abandoned hazardous waste sites;  provided for liability of persons responsible for releases of hazardous waste at these sites; and  established a trust fund to provide for cleanup when no responsible party could be identified. The law authorizes two kinds of response actions: Short-term removal actions, where actions may be taken to address releases or threatened releases requiring prompt response. Long-term remedial response actions, that permanently and significantly reduce the dangers associated with releases or threats of releases of hazardous substances that are serious, but not immediately life threatening.

4. Resource Conservation and Recovery Act The Resource Conservation and Recovery Act (RCRA) of 1976 was the first substantial effort by Congress to establish a regulatory structure for the management of solid and hazardous wastes.  Subtitle C of RCRA addresses "cradle-to-grave" requirements for hazardous waste from the point of generation to disposal.  Subtitle D of RCRA contains less restrictive requirements for non-hazardous solid waste.

5. RCRA – Cradle to Grave Waste Management

6. Resource Conservation and Recovery Act -1976 A cradle-to-grave system to track and monitor hazardous waste Established management standards for anyone who generates, recycles, transports, treats, stores, or disposes of hazardous waste. Authorized States to implement RCRA programs equal to or more stringent than federal program. Goals – –Ensure that wastes are managed in manner that protects human health and the environment –Reduce/eliminate the amount of waste generated, including hazardous wastes –Conserve energy and natural resources through waste recycling and recovery. Banned open dumping Provided a comprehensive national program to encourage source reduction, recycling, and safe disposal of solid waste. Mandated strict requirements for treatment, storage, and disposal of hazardous waste to minimize present and future risks. First hazardous waste facility permit was issued in October, 1981.

7. RCRA’s Three Interrelated Programs Subtitle D Subtitle C Subtitle I Solid Waste Management Hazardous Waste Management Hazardous Waste Management Underground Storage Tank Program

8. RCRA Hazardous Waste Management Scheme Hazardous Waste Identification Hazardous Waste Recycling and Universal Wastes Standards Governing Hazardous Waste Generators Standards Governing Transporters Standards Governing Treatment, Storage and Disposal Land Disposal Restrictions Hazardous Waste Combustion Permitting of TSD Facilities Corrective Action to Clean Up Hazardous Waste Enforcement of Regulations Authorization of State Programs

9. A Hazardous Waste is: A "solid waste" which because of its quantity, concentration, or physical, chemical, or infectious characteristics may: –Pose a substantial present or potential hazard to human health or the environment when improperly treated, stored or disposed of, or otherwise mismanaged; or –Cause or contribute to an increase in mortality, or an increase in irreversible or incapacitating illness.

10. Defining Hazardous Waste Is the material a solid waste?Is the material a solid waste? –Recycled materials –Secondary materials Excluded wastesExcluded wastes –Some solid wastes –Exempt hazardous wastes –Raw or process wastes –Waste samples Is the waste a listed hazardous waste?Is the waste a listed hazardous waste? –Listed hazardous wastes –Waste listed due to certain characteristics Hazardous Waste CharacteristicsHazardous Waste Characteristics –Ignitibility –Corrosivity –Reactivity –Toxicity Special Wastes –Mixtures –Derived-from rule wastes –Contained-in rule wastes

11. RCRA Hazardous Waste Management Scheme Hazardous Waste Identification Hazardous Waste Recycling and Universal Wastes Standards Governing Hazardous Waste Generators Standards Governing Transporters Standards Governing Treatment, Storage and Disposal Land Disposal Restrictions Hazardous Waste Combustion Permitting of TSD Facilities Corrective Action to Clean Up Hazardous Waste Enforcement of Regulations Authorization of State Programs

12. Requirements for Hazardous Waste Generators Regulated generators –Large Quantity –Small Quantity –Conditionally Exempt Waste identification Registration & ID number Accumulation times Preparation of waste for transport Waste manifests Recordkeeping and reporting Emergency procedures and Contingency planning Personnel training

13. RCRA Hazardous Waste Management Scheme Hazardous Waste Identification Hazardous Waste Recycling and Universal Wastes Standards Governing Hazardous Waste Generators Standards Governing Transporters Standards Governing Treatment, Storage and Disposal Land Disposal Restrictions Hazardous Waste Combustion Permitting of TSD Facilities Corrective Action to Clean Up Hazardous Waste Enforcement of Regulations Authorization of State Programs

14. Hazardous Waste Treatment Oxidation – Strong oxidizing agents breakdown hazardous wastes into less toxic or less mobile constituents. Deactivation – A process that removes the hazardous nature of waste by neutralizing characteristics such as ignitibility, corrosivity, or reactivity. Incineration – High temperature oxidation of waste, usually at temperatures ranging from 1600 to 2500 F. Industrial Furnace – Uses thermal energy to recover energy or materials. Includes cement kilns, lime kilns, coke ovens, blast furnaces, and smelting furnaces. Micro-encapsulation – A process that coats the surface of the waste material with a thin layer of plastic or resin to prevent leaching. Neutralization – A process used to treat corrosive hazardous waste streams. Stabilization – A process that reduces the mobility of hazardous waste constituents. Treatment in Tanks – Mechanical settling, gravity settling, or chemical oxidation to remove hazardous constituents.

15. Hazardous Waste Treatment & Disposal Standards Permits to Operate Performance Standards Recordkeeping & Reporting Requirements Groundwater Protection Corrective Action Emergency Preparedness & Contingency Planning

16. Some Cases - Laboratory Waste Management Healthcare Compliance Initiative Regulated electronic wastes

17. Managing Waste Chemicals

18. Management of Waste Chemicals Generated in Laboratories Large Quantity Generator Waste Management Standards – Part 262 RCRA Best Management Practices – HHMI Proposal Labs can be subject to Satellite Accumulation Standards – Part 262.34

20. Distribution of Wastes Shipped to TSDF – 524,352 lbs Collected

21. Defining Hazardous Waste Management in Academic Laboratories Project XL – New England Laboratory Project – –Evaluated flexible application of generator rules to academic research laboratories. HHMI Report to Congress – October 2001 – –Proposed a set of best practices for the management of laboratory wastes. Nat’l Assoc. of College and University Business Officers – March 2002 – Environmental Excellence in Higher Education –Addressed the application of waste management regulations to the activities of colleges and universities. US EPA Notice for Information on the Effectiveness of RCRA Generator Program and Areas for Improvement – October 2003. –Meeting of agencies and stakeholders on rules flexibility US EPA Memorandum – March 2004 –. –Clarification regarding satellite accumulation practices. US EPA Notice Concerning hazardous waste generator program – April, 2004. US EPA Final Rule – Standards Applicable to Generators of Hazardous Waste; Subpart K – Academic and Research Laboratories – December 2008.

22. Subpart K Changes 1.Container Labeling – 1.Chemicals, products of experiments or other materials no longer needed can be labeled as “unwanted materials. 2.The label must contain a general description of the contents and sufficient information to alert emergency responders. 3.The date of initial accumulation in a container must be recorded. 2.Accumulation Time in the Laboratory – Unwanted materials must be removed once every six months or whenever 55 gallons is accumulated. 3.Point of Hazardous Waste Determination – 1.Waste determinations must be made by a “trained professional” 2.Unwanted material moved to an on-site central accumulation area must be identified as hazardous waste within 4 days. 4.Laboratory Management Plan (LMP)

23. Emerging Issues - Healthcare Compliance –Hazardous Drugs Disposal –Chemotherapeutics Electronic Wastes

28. What’s Regulated as a Hazardous Waste? Certain chemotherapeutic drugs Drugs that are “listed hazardous waste” Drugs that are “characteristic waste” Containers that held regulated drugs

29. Duke Hospitals Formulary

30. Hospital Waste Streams Hazardous Pharmaceutical waste (15%) Non-hazardous pharmaceutical waste (~ 85%) Trace chemotherapeutic waste RCRA Waste (5%) P-listed waste U-listed waste D-listed waste > Ignitable waste > Toxic waste > Corrosive waste > Oxidizers Chemo spill materials RCRA listed chemo agents (residues & bulk) Non-empty - > vials, syringes, IVs Non-RCRA Waste (~ 10%) Non-listed chemotherapeutics NIOSH hazardous drugs Carcinogens Endocrine disruptors Toxic drugs – LD50 < 50 mg/kg Formulations containing listed waste not the sole active ingredient All waste pharmaceuticals in inventory not identified as hazardous Sharps and RMW Empty/trace vials, syringes, IV bags Gowns, gloves, goggles, tubing, wipes Blue bin RMV Red or Sharps Box

31. Municipal Waste Municipal Waste RCRA Hazardous Waste Sewer System Sewer System Pharmaceutical Waste - Regulated medical waste Non- RCRA hazardous drugs Non- RCRA hazardous drugs Sharps Recycle as much paper, glass, plastic as possible Check with local wastewater treatment plant for limits, etc. REGULATED MEDICAL WASTE INCINERATOR FEDERALLY PERMITTED HAZARDOUS WASTE INCINERATOR (HIGH TEMPERATURE) RESIDUE TO LINED HAZARDOUS WASTE LANDFILL RESIDUE TO NON-HAZARDOUS WASTE LANDFILL Sharps Container Bio-Red Bag waste container Hazardous Waste (15%) Collect & Segregate Waste to Energy TREATMENT FACILITY Non-Hazardous Waste (85%) Non-Hazardous Waste (85%) Hazardous Waste Container Waste Management Process Proposal