Hazardous Waste and Pharmaceutical Waste in



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Hazardous Waste and Pharmaceutical Waste in Veterinary Offices Janine Kraemer, CHMM Environmental Manager Solid and Hazardous Waste Programs Florida Department of Environmental Florida Department of Environmental Protection

Surgeon General s Warning: This presentation ti may cause a lack of oxygen to the brain, which may lead to bouts of yawning and fatigue.

Questions Please minimize questions until end of presentation. Your question may be answered elsewhere in the presentation.

Environmental Rules Clean Air Act (CAA) - 1970 Clean Water Act (CWA) - 1972 Safe Drinking Water Act (SDWA) - 1974 Federal Insecticide, id Fungicide, id and Rodenticide id Act (FIFRA) - 1975 Toxic Substances Control Act (TSCA) - 1976 Resource Conservation and Recovery Act (RCRA) - 1976/1984 Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) - 1980 SARA/EPCRA - 1986 Community Right to Know These environmental laws fall under the jurisdiction of the U.S. Environmental Protection Agency

RCRA Resource Conservation and Recovery Act- 1976 Hazardous & Solid Waste Amendments Act - 1984 Create cradle to grave liability Provide standards for hazardous waste generators, transporters, and treatment, storage and disposal facilities (TSD) Ensure wastes that are land disposed meet either concentration based or treatment based standards No, it is not an acronym for Really Confusing Regulations Act.

Florida s Hazardous Waste Laws Florida Resource and Recovery Management Act-1980 Chapter 403, Florida Statutes (F.S.) - 1980 Rule 62-730 Florida Administrative Code (F.A.C.)-1982

Miscellaneous Florida Laws Discharge of hazardous waste to septic tanks: F.S. 403.161(1)(a), 62-4.030 F.A.C. Discharges of wastes into waters or which will reasonably be expected to be a source of water pollution shall be operated, constructed, or modified with an appropriate and valid permit issued by the Department: 62-620.300620 F.A.C.

What is a Waste? Spent, can t be used again, inherently waste-like, or abandoned

TYPES OF WASTES Trash, Garbage, Yard Waste Regulated Non- Hazardous Wastes Hazardous Wastes

Regulated Non-Hazardous Waste Industrial waste water Sewage Storm water Tires

Solid Waste IS A SOLID WASTE SOLID? Liquids Solids Gases EXEMPTIONS Domestic sewage or if mixed with other wastes discharged d to a POTW Industrial waste discharges regulated under Clean Water Act

Solid Wastes which are not Hazardous Wastes Household Waste Nuclear Waste Bio Medical Laboratory Samples (until testing complete)

Other Non-Hazardous Wastes when Recycled /Reclaimed. Universal Wastes Includes: Light Bulbs Excluding Incandescent Mercury containing devices Certain Pesticides Batteries Excluding Alkaline Pharmaceuticals l (FL) Used Oil Petroleum Contact Water (FL) Used Oil Filters (FL)

IF IT S NOT A SOLID WASTE... IT S NOT A HAZARDOUS WASTE

What is a Hazardous Waste? Must be a solid waste (40 CFR 261.2) Not excluded from regulation (40 CFR 261.4) Characteristic Ignitability Corrosivity Reactivity Toxicity Listed Non Specific Sources Specific Sources Commercial Chemicals

Characteristic Hazardous Waste (D-codes) Ignitability D001: Flash point less than140 o F Greater than 24% alcohol or DOT oxidizer Corrosivity D002: ph less than or equal to 2 or greater than or equal to 12.5 Liquid

Characteristic Hazardous Waste (D-codes) Reactivity it D003: Normally unstable and reacts violently with water or explosive mixtures Toxicity -D004-D043: Concentrations over TCLP levels. Toxicity is determined by TCLP test for presence of 40 chemicals.

TCLP CONCENTRATIONS 40 CFR 261.24 (TABLE 1)

Basic TCLP (Toxicity Characteristic Leaching Procedure) From Tim Townsend, Ph.D., P.E., University of Florida

Hazardous Wastes Characteristic Wastes: Photographic Fixer waste (silver-d011) Spent solvents i.e. isopropyl alcohol (ignitability-d001) Incinerator ash (metals) Caustic/acid solutions i.e. NaOH (corrosivity-d002) Fluorescent lamps (mercury-d009) OTC products i.e. Colloidal Silver (metals, ignitability-d001)

Listed Hazardous Waste F List F001-F028: Wastes from nonspecific sources, i.e. spent solvents. K List K001-K172: K172: Wastes from specific sources i.e. sludges and distillation bottoms from wood preserving and petroleum refining. P (acutely toxic) or U (toxic)list: Pure chemical product that is discarded, spilled, off specification or container residue.

Hazardous Wastes Listed Wastes: Paint/debris related wastes (F001-F005) Spent solvents (F001-F005) F005) Off-spec chemicals (P & U list) i.e Methanol (U154) Formaldehyde (U122) Rags contaminated with listed waste

Universal Pharmaceutical Waste (UPW) 62-730.186, F.A.C. Hazardous Waste Rule: Florida Administrative Code 62-730 Adopted 4/22/07

Benefits of Rule: Simplified and flexible process promotes proper management and reduces illegal disposal Grants longer storage time frames UPW does not count towards generator status T i UPW i hi Transportation as UPW within Florida does not require manifest

Applies to: Hazardous waste pharmaceuticals while managed in Florida Large quantity handlers (LQH) and Small quantity handlers (SQH) of UPW I l d b th ti d i di Includes both routine and episodic handlers

Does Not Apply to: Non-hazardous pharmaceuticals Pharmaceuticals not discarded: Returned with reasonable expectation of credit through reverse distribution system Donated to charitable organization Sold ldfor resell ll( (not discarded) d d) Pharmaceuticals that are biomedical waste Spill residues, cleanup materials, and media contaminated with pharmaceuticals R t i l i di t d i f t Raw materials or ingredients used in manufacture of pharmaceuticals

How it Works: Hazardous waste pharmaceuticals are UPW when managed in accordance with this section. Hazardous waste pharmaceuticals not managed as UPW must be managed as hazardous waste and disposed at a permitted hazardous waste treatment, storage, or disposal facility.

Handlers: Notify DEP and receive an EPA ID Number before accumulating or transporting UPW. Provide initial classroom or on-the-job training, annual refresher, & keep documentation for 3 yrs. Manage UPW to prevent releases. Label containers with UPW and specific HW codes. Accumulation time limits: Small quantity handler no longer than one year from generation date Large quantity handler no longer than six months from generation date

Shipments of UPW: Handlers can send to: another handler, reverse distributor, destination facility, or foreign destination. Handlers that transport UPW must comply with DOT regulations package, label, mark and placard, and prepare p proper p shipping gpapers. p Handlers are advised to meet regulatory requirements of receiving state. Handler keeps record of each shipment and retains records for at least three years

Does My Business Generate Hazardous Waste? Waste Determinations Label Material Safety Data Sheets (MSDS) Process or product knowledge Manufacturer s Technical sheets Laboratory Analysis

Identifying Veterinary Wastes Operating Rooms Vet-Tech Stations Construction Areas Laboratories Radiology Nuclear Medicine Pharmacy Facility Maintenance Areas

Laboratory Wastes Pathology Histology Microbiology Chemistry Serology Gram Xylene Staining Alcohol h l Tissue Alcohol/xylene/stain Preservation Mercury Out dated chemicals Rinsates from cleaning glassware

Radiology Spent t photographic hi fixer containing i silver Leftover barium sulfate Lead aprons

Pharmacy & Vet Tech Station ti Expired i d or damaged d drugs Chemotherapy waste Expired/Off Spec Chemicals, p / p, Reagents, & Standards

Don t Mix Wastes MIXING HAZARDOUS WASTES f Is often DANGEROUS May increase disposal costs

Entities in RCRA Generators Conditionally Exempt Small Quantity Generators (CESQG) Small S a Quantity ty Generators e (SQG) Large Quantity Generators (LQG) Transporters Transfer Facilities Treatment, Storage and Disposal Facilities (TSDF)

Generator Status t by Month Waste counts for the month it was generated in CAN NOT BE AVERAGED Meet standards of generator status for that month

To Determine Generator Size Count Hazardous Waste That: Is Transported Off-Site for Treatment, Storage, or Disposal Is Treated or Disposed of On-Site Is Accumulated Prior to Recycling, Long- Term Storage, Transporting, Treatment or Disposal Don t Count: Spent Lead Acid Batteries sent for reclamation Fluorescent bulbs sent for recycling

Conditionally Small Quantity Generators Generates no more than 100 kg g( (220 lbs) of hazardous waste per month. Approximately half of a 55-gallon drum, or about 25 gallons. Generates less than 1kg (2.2 lbs) of acutely toxic hazardous wastes (P-listed) i.e. arsenic and cyanide compounds) )per month Never accumulates more than 1000 kg (2200lbs) of hazardous waste at any time. ½ drum

Important CESQG Management Standards d Perform Hazardous Waste Determination Ensure Delivery of Hazardous Wastes to Proper Handling Facility. Records Must Be Kept for at Least 3 Years (FL).

Small Quantity Generators Generates more than 100 kg (220 lbs), but less than 1000 kg (220 lbs) of hazardous waste per month. Approximately one half of a drum to 5 drums, or 25 to 250 gallons. Generates less than 1kg (2.2 lbs) of acutely toxic hazardous wastes per month. Never exceeds the 6000 kg (13,200 lbs)/ 180 day storage time limit. ½ drum to 5 drums

Important SQG Management Standards d Obtain FDEP/EPA ID Number Use Manifest System Unless Reclamation Agreement Is Established Keep Records for Three Years Label & Date Hazardous Wastes Properly Have a Modified d Contingency Plan Train Personnel About Proper HW Handling & Emergency Response Meet Satellite Accumulation Requirements Weekly Inspections

Large Quantity Generators Generates more than 1000 kg g( (2200 lbs) of hazardous waste per month. Approximately greater than 5 drums. Generates more than 1 kg (2.2 lbs) of acutely hazardous waste per month. Never stores hazardous waste greater than 90 days. Over 5 drums

Important LQG Management Standards SQG requirements plus.. Do Not Store HW > 90 Days File Biennial Report for HW Shipped Offsite Maintain Emergency Equipment Expanded Contingency Plan Annual Training

So What Do We Look for During an Inspection? Inspectors look at all processes and procedures performed on a contiguous piece of property. Inspectors look at what chemicals are used, how they are used, and the waste streams expected from each process. Inspectors will also usually walk the property.

Unannounced SORRY!!!

How to Keep Inspectors Happy Don t use the term Biodegradable more than 100 times. Don t say The EPA was just here Keep business cards of inspectors who have been to your facility

Housekeeping First impression If housekeeping is poor waste management is often poor, too. Can become a safety issue.

Most Common Violations

Waste Determination ti Failure to perform hazardous waste determination and/or a proper waste determination.

Notification Failure to notify/obtain an EPA ID number Failure to use the correct EPA ID number

Manifests Failure to use a hazardous waste manifest Failure to file an exception report (45/60 days) Missing or incorrect information on manifest. Failure to retain manifests for 3 years. Must use Federal Uniform Manifest-since Must use Federal Uniform Manifest since 9/2006

Manifest Initiation, Movement, & Copy Retention The generator initiates the manifest which travels with the transporter to the broker or final TSD facility. The generator, transporter, and TSD facility each keep a copy and the TSD mails a return copy to the generator. Everybody keeps their copies for 3 years. Process or Cleanup Waste Generator Manifest Copy Transporter (s) Manifest Copy Waste Received from Off-site TSDF Manifest Copy Storage Transporter's) Manifest Copy TSDF Manifest Copy Off-site Treatment/Disposal Treatment System Generator Initiates Manifest Shipped Off-site for Treatment/Disposal Return Manifest Copy TSDF Initiates New Manifest Return Manifest Copy Return Certificate of Disposal by Mail Outbound Manifest travels with Return Manifest by Mail Transporter

Labeling Failure to label drums/containers with the Failure to label drums/containers with the words Hazardous Waste or for satellite accumulation containers label with a description of the contents.

Accumulation Accumulation beyond the 90(180) day limit. Drums/containers not marked with accumulation start dates. Accumulation of too much HW on site.

Container Management Open, rusting or bulging drums No weekly inspection of containers. Failure to maintain aisle space between containers.

Record Keeping Failure to maintain uniform manifest or contractual agreement for 3 years. Failure to retain records of test results, waste analyses, or waste determinations.

Personnel Training Failure to conduct training. Training does not cover all areas.

Preparedness and Prevention No arrangements with local authorities. Arrangements not documented. Failure to have required equipment. Failure to maintain and operate facility to minimize unplanned or sudden release.

Contingency Plan/Emergency Procedures Failure to have a modified contingency plan. Incomplete or outdated contact info. Incomplete reporting after an incident. Failure to report emergency incident (assuming release to the environment) Failure of SQG to post information by telephone.

Land Disposal Restriction FL has NO HW landfills All hazardous waste is PROHIBITED from land disposal in Florida

After the Inspection COMMUNICATE If you agreed to fix something - fix it! If you promised to send inspector something - send it. If you receive a letter - respond within the specified time frame.

The Process In Compliance: Inspection Report Pictures Non-Compliance: Non-Compliance Letter /Warning Letter Inspection Report Pictures Violations Penalties Informal Conference Chance to respond Discuss alleged violations Consent Order

Memorandum of Agreement with USEPA RCRA Program has been delegated to every State except Iowa FDEP has 360 days from the date of the inspection to settle a case EPA requires penalties for certain EPA requires penalties for certain violations

New Gravity Based Component POTENTIAL FOR HARM EXTENT OF DEVIATION MAJOR MOD. MINOR $37,500 $28,330 $21,250250 MAJOR to to to $28,330 $21,250 $15,580 $15,580 $11,330 $7,090 MODERATE to to to $11,330 $7,090 $4,250 $4,250 $2,130 $710 MINOR to to to $2,130 $710 $150

Janine.Kraemer@dep.state.fl.us Phone: 407-893-3329 Helpful Web Sites: www.dep.state.fl.us www.epa.gov/waste/hazard/index.htm