Attachment_1_-_Statement_of_Work_(SOW)_Final.docx

Attachment 1 - Statement of Work (SOW) 16-223-SOL-00016

Statement of Work

HAZARDOUS WASTE

CONTRACT

CHEMICAL, RADIOACTIVE

MEDICAL PATHOLOGICAL WASTE COLLECTION, MINIMIZATION AND DISPOSAL SERVICE, DANGEROUS GOODS SHIPPING AND MULTI-HAZARDOUS MATERIAL INVENTORY MANAGEMENT SERVICES

Table of Contents

Section I Background & Work Statements

Section I Background & Work Statements

Section I.1 Background Information

The Food and Drug Administration (FDA) is responsible for arranging for proper disposal of chemical, medical pathological, radioactive and mixed wastes generated by the research laboratory activities within FDA facilities nationwide, including Puerto Rico. Our laboratory operations include the use and generation of diversified chemical, radioactive, and medical pathological wastes of varying toxicities and quantities.

FDA recognizes its responsibilities to ensure that its facilities are in compliance with existing and proposed regulations imposed upon entities which generate, transport, store, treat, and dispose of hazardous chemical compounds. The Agency acknowledges however, that the field of hazardous waste disposal services is a dynamic and ever changing industry, which is significantly impacted by State and Federal regulations and by the influx of new technological advancements.

To fully support this task the Contractor shall provide necessary full time employees with the applicable credentials as specified in the SOW, to support environmental services for the FDA service locations as scheduled by the COR.

The Contractor shall provide, either directly or through qualified sub-Contractors, all aspects of a comprehensive, cradle to grave chemical, radiological and medical pathological waste management service for FDA.

Section I.1.2 Definition of Terms and Acronyms

The following acronyms and definitions are used throughout this Statement of work:

COR Contracting Officer's Representative

FRC Federal Research Center – White Oak

Aqueous Waste: Liquid Radioactive waste that is potentially suitable for discharge to the sanitary sewer in accordance with FDA permits and licenses. This does not include liquid wastes that contain chemical wastes not suitable for discharge in accordance with applicable FDA permits and regulatory requirements.

Biological Safety Level (BSL): the level of biocontainment precautions required to work with hazardous biological agents and toxins in an enclosed laboratory. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health through the Biosafety in Microbiological and Biomedical Laboratories (BMBL, 5th edition) have specified the requirements for each of these levels.

Bulking: A process that consists of consolidating compatible wastes from multiple containers into a single container or fewer containers.

Byproduct Material: Radioactive materials defined as such in Title 10 CFR 20.3.

Certificate of Final Disposition (CFD): A form that documents the final disposition of a waste container issued by the facility executing the final disposal of the waste.

CFR: Code of Federal Regulations Chemical Waste: Any discarded chemical including hazardous and non-hazardous compounds: items defined as Hazardous Wastes (40 CFR 261), Hazardous Substances (40 CFR 302.4), Hazardous Materials (49 CFR 171.8), Controlled Hazardous Substances (26 COMAR 13.02.06); biologically derived toxins and venoms; any item containing or contaminated with chemically hazardous components; antineoplastic drugs; injectables; intravenous solutions and other pharmaceutical chemicals requiring assured destruction; petroleum products; batteries (all types); lead metal scrap; any empty container that previously contained a pesticide or acutely hazardous chemical and has not been decontaminated in accordance with 40 CFR 261.7; all empty drums and other chemical containers with a capacity of five gallons or more; gas cylinders and lecture bottles (full or empty) which cannot be returned to the manufacturer; pressurized containers such as aerosol cans; and residues from clean-up of spills or releases of chemical wastes.

COMAR: Code of Maryland Regulations.

Contracting Officer (CO): An officer of the FDA authorized to take action to enter into, terminate, or change a contractual commitment on behalf of the Government or the FDA.

Controlled Hazardous Substances (CHS): Chemical, radioactive and mixed wastes as defined in 26 COMAR 13.02.03 Controlled Substance: Narcotics, drug formulations, and listed precursors subject to regulation under the Federal Controlled Substances Act (84 Stat 1242; 21 U.S.C. 801) or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951) as amended; or subject to State or local narcotics control laws and regulations. Excluded Non-narcotic Substances listed in 21 CFR 1308.221; Exempt Chemical Preparations listed in 21 CFR 1308.23; and Exempt Prescription Products listed in 21 CFR 1308.32 shall not be considered Controlled Substances in this Contract.

COR: Contracting Officer’s Representative: The Government's representative to the Contractor for monitoring specific aspects of Contractor performance including technical matters, performance and cost, or an FDA employee designated by the COR to represent and act for the COR in his or her absence. An overall COR will be assigned to the contract and facility-specific COR’s will be assigned through task orders.

Decontamination: To eliminate or reduce to acceptable levels the chemical, biological, or radioactive contamination of an area, object, waste, or person through an appropriate treatment method such as disinfection, neutralization, remediation or radioactive decay.

De Minimis: Low level radioactive wastes defined in Title 10 CFR 20.2005 that may be shipped, treated, or disposed without regard to their radioactivity.

Designated Waste Coordinator: An individual identified by the COR, who has the appropriate qualifications, training and authority to manage hazardous waste at a specific facility. This individual may manage one, two or all three waste streams at a facility or may share this responsibility with additional waste coordinators. Waste coordinators for a specific facility will be identified in the task order awarded for that facility.

Emergency Responder: The entity designated by the local jurisdiction to provide the first response to a fire, explosion or other emergency incident.

Environmental Media: Surface water, groundwater, sewage, soil and air.

Facility: A defined area within an installation that is authorized by the provisions of a license, final permit, interim status or consent decree issued by the EPA, NRC or an authorized state to store, treat, or dispose of regulated hazardous or radioactive wastes.

Final Disposition: The last step in the management process for a waste such as the beneficial reuse or reprocessing of a recycled waste into a useful product; burial in a secure landfill; terminal treatment which renders the waste in a form that may not be released to an environmental media; or placement into secure long term storage until recycling, final treatment or disposal can be completed.

General Solid Waste: Solid wastes that do not contain components which are listed as or exhibit characteristics of hazardous waste, medical pathological waste, radioactive waste or mixed waste and may be discarded as regular trash. General solid waste includes office trash, garbage, treated solid MPW (except sharps), uncontaminated glass, and empty chemical containers with a capacity less than five gallons that have been processed in such a manner that they are not regulated as a hazardous waste or controlled hazardous substance.

Glassware Disposal Box: A fiberboard box used at the FDA to facilitate safe handling and disposal of discarded glass and plastic ware.

Generator: An FDA employee, FDA Contractor or an off-site FDA installation representative that generates wastes or discards of chemicals to be managed under this contract.

Hazardous Waste: All hazardous materials as defined in 40 CFR 261 et. seq:, all Controlled Hazardous Substances as defined in 26 COMAR 13.02.06; similar wastes defined in statutes and regulations of other states serviced by this contract; and chemical wastes that are not currently regulated under federal regulations as hazardous, but have toxic or hazardous waste characteristic(s) or which may meet criteria for listing as hazardous waste in 40 CFR 261.11.

Health Rx: Inventory Management System used on FDA Campuses.

Vaporized Hydrogen Peroxide: Biological decontamination method for Biological Safety Level 3 laboratories and equipment.

Lab Pack: A shipping container that contains internal containers of compatible chemical or mixed wastes.

Low Level Radioactive Waste (LLRW): All radioactive waste not designated as high-level radioactive waste under the provisions of 10 CFR 62.2.

Mixed Waste (Multi Hazardous Waste): Waste that contains any combination of a hazardous waste component regulated under Subtitle C of RCRA; a radioactive component consisting of source, special nuclear, or byproduct material regulated under the AEA; or a biological agent.

NRC: The U.S. Nuclear Regulatory Commission.

NRC License: A license, which places control mechanisms on a site for the acquisition, utilization, storage and disposal of radioactive materials.

OSHA: The Occupational Safety and Health Administration of the U.S. Department of Labor.

Recycling: Use of a waste for its original purpose or other beneficial purpose that does not constitute disposal. Accumulation, storage or processing of wastes to render them suitable for recycling is not considered recycling.

Resource Conservation and Recovery Act (RCRA): The federal Resource Conservation and Recovery Act of 1976 (RCRA) and all amendments and regulations adopted pursuant thereto.

Sharps: A type of SMW or MPW that includes all discarded hypodermic needles, syringes, Pasteur pipettes, scalpels, blades, lancets or other sharp objects used in human patient or animal care; or in treatment of animals, or in contact with humans or animal blood and body fluids or otherwise contaminated.

Special Medical Waste (SMW): Special Medical Waste includes materials that may contain potentially infectious agents, biological materials, or meet the definition of regulated medical wastes. These wastes include cultures, laboratory animal carcasses, human blood products and cells, discarded etiological agents, and used or unused sharps (needles, syringes, or Pasteur pipettes). This is more commonly known as Medical Pathological Waste (MPW).

Treatment, Storage and Disposal Facility (TSDF): A facility permitted by the USEPA or RCRA authorized State for the receipt, recycling, treatment, storage or disposal of RCRA regulated hazardous wastes. For radioactive wastes, any facility authorized to treat or dispose of low level radioactive waste by the Nuclear Regulatory Commission or a NRC agreement State.

Universal Wastes: Universal wastes are specific hazardous wastes that are commonly generated by households, businesses, and industries. These include pesticides, thermostats, batteries and fluorescent lamps.

Waste Characterization: Determination of the composition, properties, regulatory status, management requirements and profile of a waste by knowledge, sampling and analysis, or other regulatory approved methods.

Waste Profile: A computerized FDA document that serves as a characterization record of all management information for a specific, discrete type of waste or waste stream.

Section I.1.3 General Requirements

To provide hazardous chemical, radioactive and medical pathological waste disposal services, dangerous goods shipping and inventory management services to FDA research laboratories. This shall involve the following:

1) The collection, sorting, packaging, manifesting, transportation, and off-site storage, recycling, treatment and/or disposal of such wastes, including any materials or equipment required to perform this service;

2) Sampling and analysis of the waste stream to identify and characterize chemical, radiological, and multi-hazardous wastes for storage, transportation, treatment or disposal;

3) Characterization of unknown chemicals, radioactive materials, and gases;

4) Identification of controlled substances for disposal;

5) Emergency response/remediation/removal of spills, leaks, or other environmental releases involving hazardous waste or materials including items that is potentially explosive and extremely toxic.

6) Relocation of hazardous materials to other facilities;

7) Biological decontamination of laboratory suites and equipment in conjunction with industry methods for validating the effectiveness of the decontamination process

8) Chemical and radioactive decontamination, remediation and decommissioning services for facilities.

9) Consultation and administrative services on waste management issues regarding waste to be handled by the subContractors.

10) Dangerous goods packaging services and training, per DOT and IATA.

11) Temporary Temperature Controlled Trailer Storage

12) Surplus Environmental Equipment Pickup form MCTR and GCSL line item 20 C & D

13) Multi-Hazardous Material Inventory Management Services

14) Technical engineering evaluation of waste storage areas to facilitate waste handling

Section I.1.4 Government Responsibilities

The generator (the person that creates the waste) is responsible for properly identifying and labeling wastes and surplus chemicals prior to removal by the Contractor.

The FDA will provide training to all new permanent contract staff on the FDA Contingency Plan and Emergency Procedures as required by 40 CFR 265.16. Annual updates of this training will also be provided.

Section I.1.5 Scheduling

The Contractor shall provide the services described in this contract during routine working hours, 7:00AM – 4:00 PM, Monday through Friday. If the Contractor is scheduled to work all day at an FDA facility to pick-up waste, one half hour shall be allocated for lunch. All Federal holidays will be observed and the Contractor shall not be required to provide routine services on Federal holidays or on days when the government facility is closed for inclement weather.

Unscheduled, rapid response services may be required for emergency response activities. This will be the exception and not the rule. If necessary, arrangements will be coordinated through the COR or designated dangerous goods shipping coordinator.

Non-routine and emergency services may be required for emergency response activities, or to accommodate unusual workloads. The COR is the authorized individual who may request the additional services. Emergency response to a spill or release shall take top priority. The Contractor shall be available for remediation of spills, to conduct emergency waste removals, and other emergency activities. The Contractor must respond to emergency spill situations or emergency waste removal requests within four hours (4) of notice.

Section I.1.6 Compliance

The Contractor shall comply with all applicable sections of the laws and regulations listed below and any other applicable laws and regulations that are not listed:

1. U.S. Environmental Protection Agency (EPA): Title 40 CFR.

2. U.S. Department of Transportation (DOT): Title 49 CFR.

3. U.S. Department of Labor (DOL): Title 29 CFR.

4. U.S. Nuclear Regulatory Commission (NRC): Title 10 CFR 19 and 20, 30, 40 and 70.

5. U.S. Drug Enforcement Administration (DEA): Title 21 CFR.

6. U.S. Public Health Service (PHS): Title 45 CFR.

7. Applicable State Environmental Regulations: MD, IL, AL, MA, MO, AR, PA, MI, OH, NY, KS, WA, CA, GA, CO and Puerto Rico.

8. Hazardous waste receiving states: The Contractor shall, when shipping hazardous wastes to another state for disposal, comply with all receiving state requirements regarding the shipping, receiving, storage, treatment, and disposal of such waste.

9. Recycling, treatment, disposal, and storage facilities: The Contractor shall comply with all requirements for waste packaging, etc. imposed by TSDFs that accept FDA wastes and surplus chemicals.

7. Maryland Department of the Environment: Title 26 COMAR.

8. Treatment and disposal facilities: The Contractor shall comply with all requirements for waste packaging, etc. imposed by the treatment and disposal facilities that accept FDA wastes

9. Title 42 Code of Federal Regulations, Public Health

10. IATA, Dangerous Goods Regulations

11. ICAO, Technical Instructions for the Safe Transport of Dangerous Goods by Air

12. Carrier specific rules and instructions (FEDEX, DHL, UPS, USPS, Commercial Airlines, etc.)

Secondary Company References

13. The Contractor shall meet the Department of Transportation Emergency Response Communication Standards (49 CFR 171 and 172.604) applicable to the shipment of hazardous waste. This regulation requires that a comprehensive emergency response service be in place with a 24-hour emergency telephone number, DOT Emergency Response Guide information, and the provision of two technical names for generic N.O.S. descriptions on all hazardous waste shipping papers.

14. The Contractor shall comply with all existing FDA permits, licenses, and decrees listed below, any revisions thereto, and any other future permits and licenses which become effective during the term of the contract.

Environmental Compliance

FDA realizes its responsibility of being a good steward to the environment and maintains a proactive relationship with all regulatory agencies to fulfill this responsibility. It is FDA’s goal to achieve compliance at all facilities by having a proactive environmental management program in place. Contractors that work for FDA must realize how important environmental management is to the agency, and in turn, must act as an active partner in FDA’s environmental management program. It is extremely important for the FDA to have a sound environmental management program that fully supports its regulatory and research missions.

The Contractor shall comply with all federal, state, interstate, and local laws, regulations, ordinances, and FDA facility operating permits and licenses applicable to activities and services performed under this contract. Failure to comply with all applicable Federal, State, and local hazardous waste regulations may result in the termination of the contract.

The Contractor shall have all trucks maintained in good operating condition; shall have all stickers, permits, and licenses required by federal, state, interstate and local authorities for the transportation of wastes and hazardous materials in commerce; and shall have vehicles suitable for the task of safely transporting, loading, and unloading such wastes and materials at the FDA facilities. The Contractor shall have certified drivers using certified transport vehicles (vehicles which have passed a DOT examination) to transport wastes via trucks in route to EPA permitted hazardous waste transfer, storage, and disposal facilities (TSDRF). The Contractor shall placard all vehicles hauling hazardous wastes or materials on the open highway in accordance with DOT regulations.

The Contractor shall have all applicable licenses and permits necessary to perform the work required under this contract prior to the start of the work.

The Government will not be liable to the Contractor for the cleanup of spills, accidental releases to the environment, or potential exposures of contract personnel, due to the fault of the Contractor or their Subcontractors.

Chemical / Regulatory Compliance

The Contractor shall compile and assist the COR to file Federal and state hazardous waste activity reports when and where required. For example, the Code of Maryland Regulations (COMAR 26.13.03.06B requires the filing of a report on hazardous waste generation once every two years.)

The Contractor must inform the COR as soon as possible about any regulatory issues actually or perceptually involving FDA's waste which may result from Federal, State, or local inspections of the Contractor's waste handling facilities.

The Contractor shall notify the COR within five days of any such incidents or regulatory issues by means of a full, written report.

Radioactive / Regulatory Compliance

The Contractor shall provide all aspects of a comprehensive, cradle-to-grave chemical/ radioactive and mixed waste service for the FDA. The Contractor shall perform all contract operations in compliance with applicable occupational health and safety, transportation, environmental protection and radiation control regulations.

Medical Pathological / Regulatory Compliance

The agencies and regulatory titles listed below constitute the primary regulatory framework under which waste management operations described in this contract must be carried out. The Contractor shall comply with all applicable sections of the laws and regulations listed below and any other applicable laws and regulations that are not listed:

Dangerous Goods Shipping / Regulatory Compliance

This dangerous goods service will be exercised by the site specific COR.

Multi-Hazardous Material Inventory Management / Regulatory Compliance

The Contractor shall comply with applicable federal, state, and local laws, regulations, ordinances, and proposed FDA Safety Management Guide (SMG) for activities and services performed under this contract. This hazardous material inventory management service will be exercised by the site specific COR.

Section I.1.7 Integration of Services

The Contractor shall integrate the chemical, radioactive and medical pathological waste services, Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management Services where possible to maximize effective use of personnel, equipment and supplies. Extreme care shall be taken to minimize the potential for cross contamination of radioactive, biological and chemical wastes by use of separate containment within collection vehicles, carts and or/trucks. Management of daily activities must be coordinated between the Contractor's operational supervisors. Incorporation of the Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management for FDA Nationwide.

Section I.1.8 OSHA Requirements

The Contractor is responsible to address OSHA's requirements in 29 CFR 1910.120 for hazardous waste operations and emergency response for such operations, as they relate to the health and safety of the Contractor's employees.

Section I.1.9 Emergency Response and Remediation of Spills

The Contractor shall ensure that all contractual personnel fully understand and comply with the contingency and spill prevention control and countermeasures plans of each FDA facility.

Section I.1.9.1 Hazardous Material Emergency Response

The Contractor shall provide emergency spill response and cleanup services to the FDA facilities nationwide to mitigate any hazardous material spills or releases. The Contractor shall respond to any situation where there is a release or spill of hazardous materials within four (4) hours of telephone notice by the COR.

Section I.1.9.2 Dangerous Goods Shipping Emergency Response

A person who offers a hazardous material for transportation must provide an emergency response telephone number, if required, (including the area code or international access code) for use in the event of an emergency involving the hazardous material.

1. FDA has registered with CHEMTREC to provide emergency response information. CHEMTREC was founded by members of the Chemical Manufacturers Association and is the nation's premier hazardous material emergency response source. CHEMTREC specialists have access to over 1.5 million SDSs and can ensure that emergency personnel at the scene of an accident or spill have the assistance they need.

2. All shippers will use the CHEMTREC telephone number as the emergency contact number for domestic shipments. The CHEMTREC number is (800) 424-9300.

3. If the package is shipped outside the USA then you must also add the international telephone number (703) 527-3887.

4. Certified shippers must keep, on file, available for inspection, shipping documentation (air bills, shipper’s declarations, and bill of lading) for two (2) years after the acceptance of the material by the initial carrier. Shippers must also keep current copies of vendor package

Section I.1.10 Housekeeping and Maintenance Responsibilities

The Contractor shall provide all labor, materials, and equipment necessary to maintain the waste marshalling area in the same condition as when the Contractor arrives. Acceptable housekeeping includes proper placement of wastes, containers, materials, and equipment so as to provide a safe, healthful, clean, neat, and well organized working environment within all of the FDA facilities.

Section I.1.11 Security Requirements

The Contractor shall take all reasonable precautions to ensure that the security of all FDA personnel, research programs, facilities, property, data, records, and materials are not jeopardized by contract operations.

Contractor must comply with both physical and personnel FDA security requirements including the immediate reporting of suspicious individuals in FDA facilities. FDA security will provide a briefing on requirements upon award of the contract.

Section I.2 Chemical Waste Scope of Work

The Contractor shall supply all labor, materials, manifests, shipping papers/forms/labels, containers, equipment, vehicles, and managerial services, as needed and necessary, to safely accomplish under the specifications of this contract the pickup of hazardous chemicals or chemical/biological wastes at individual laboratories and/or waste storage areas. Such wastes shall then be segregated, packaged, labeled, manifested, transported, and stored, recycled, disposed of or treated off-site by the Contractor. It is anticipated that pickups shall be made at any laboratory or storage area within FDA facilities, as directed by the waste coordinator and/or designated safety representative at each facility.

In addition, the Contractor shall have access to a treatment, storage and disposal facility (TSDRF) capable of receiving and managing a majority of the hazardous waste generated by FDA. The Contractor shall have access to a treatment, storage and disposal facility (TSDRF) capable of receiving FDA wastes to supplement any storage-only facilities. All operations of this facility are to be monitored by the Contractor to ensure compliance with all applicate federal and state regulations.

In addition, the Contractor shall provide an emergency spill response and cleanup service to the FDA facilities within the metropolitan Washington, DC area to mitigate any chemical spills or releases. The Contractor shall be able to respond to any release or spill of hazardous materials within four (4) hours of telephoning the Contractor.

Section I.2.1 Pickup Sites / Estimated Volumes See attachment 3

Section I.2.2 Types of Chemical Waste

Wastes generated by FDA are summarized below:

Highly Reactive, Explosive or Unstable Chemicals

FDA laboratories generate small quantities of shock sensitive, potentially explosive wastes. Several bottles may become inadvertently outdated or contaminated, dehydrated, or result from experimental research activities. The Contractor engaged in chemical waste collection must be trained to recognize highly reactive and explosive materials. If the Contractor discovers a chemical at a pickup location or waste storage area that is potentially explosive or unstable, he shall determine if the chemical presents an imminent hazard (i.e., the chemical may spontaneously explode, undergo violent reaction, or cause an uncontrolled release of hazardous constituents when moved or otherwise handled.) Examples of such situations are: dried out picric acid, trinitrobenzene, N-methyl-N-nitro nitrosoguanidine, N-nitrosomethyl urea, or ethers with peroxide crystals formed within the liquid or lid.

If the Contractor finds that the item does not present an imminent hazard under normal conditions of storage, removal, and transportation, the Contractor shall remove the item and transport it in accordance with general procedures for waste.

The Contractor shall be expected to move any explosive or otherwise reactive materials, which is deemed safe to handle to a location specified by the COR or the waste coordinator. The Contractor may be required to provide part or all of the response action, depending on the nature of the incident, available on-site facilities, and the Contractor's capabilities to handle the material. The Contractor may be required to provide available off-site facilities to manage and dispose of some reactive materials.

Un-identified Chemicals

In the event the chemicals are not completely identified by name or concentration of materials in spent mixtures (if concentration data is required for transportation, redistribution, storage, treatment, or disposal), the Contractor shall notify the COR or the Center Safety Officer of the waste in question, the location, and any further information pertinent to the identity of the waste or the generator of the waste.

Waste Solvents

Any liquid material with a flash point less than 60 °C (140 °F) or, when ignited, burns so vigorously that it creates a hazard. Examples of organic solvents (ether, xylene, toluene, etc.), alcohols (methanol, ethanol, butanol, etc.), paint thinners, and many cleaning compounds.

Controlled Substances

Controlled substances may comprise only a very small proportion of the chemical wastes generated for disposal within FDA facilities. Unused quantities of Controlled Dangerous Substances, as defined in Title 21, CFR, Part 1308, are sometimes discovered in inventories of hazardous waste when they expire or are no longer needed. The Contractor shall be able to identify these controlled substances and recognize on which DEA schedule they are listed.

The Contractor shall have expertise in dealing with controlled substance disposition and DEA regulations. FDA frequently works with such compounds and other pharmaceuticals. The Contractor shall provide detailed technical assistance to FDA researchers with proper disposition of controlled substances and shall be capable of disposal of DEA substances.

Chemical and Biological Wastes

The Contractor may be asked to dispose of chemically contaminated biological waste. FDA will treat some of this combination type of waste by autoclaving or chemical treatment prior to disposing of the waste. Some of these combination wastes, however, cannot be treated to remove the regulated medical waste label. Animal carcasses, sharps, etc. containing test materials, traces of heavy metals, or other substances classified as hazardous waste (in accordance with 40 CFR 261) cannot be handled by routine biological waste treatment methods and are accordingly classified as chemical/biological because more than one hazard is present. The FDA presently has a mechanism in place to handle all purely biological waste. However, the Contractor shall make special arrangements for disposing of this combination waste in accordance with the EPA requirements for both regulated medical waste and hazardous waste.

Asbestos

FDA laboratories generate small waste items containing asbestos. Examples of sources of asbestos are: gloves, insulation tape for condensers, heating mantles, and insulation from equipment. Small asbestos items shall be collected by the Contractor with the chemical wastes and placed in plastic bags or other appropriate containers and labeled in accordance with 29 CFR 1910.1001 (g)(2)(ii) before removal from the location of waste pick up.

Larger amounts of asbestos waste may be generated from abatement and/or decommissioning projects. The Contractor may be required to dispose of such wastes. Qualified subContractor use for such asbestos-related services will be acceptable with approval by the COR.

Universal Waste

FDA laboratories generate universal waste in the form of batteries, pesticides, thermostats, waste oils and fluorescent lamps. The Contractor shall be responsible to manage universal waste within required annual storage limits.

a. Batteries

FDA facilities generate, on occasion, small nickel-cadmium, lithium, mercury and larger lead, acid and alkaline batteries. The Contractor shall remove spent or waste batteries from the facilities and transport them to designated areas for accumulation and subsequent off-site for recycling, treatment, or disposal. Appropriate spill kits shall be carried while transporting batteries containing liquid electrolytes.

b. Fluorescent Lamps

FDA facilities generate a large volume of fluorescent lamps. FDA or its agent will collect the fluorescent lamps during preventative maintenance. Fluorescent lamps will be turned over to the Contractor for processing. Processing of fluorescent lamps involves packaging and shipping them off site for recycling.

c. Motor Oil

The FDA generates used motor oil from tractors and other agricultural equipment. Used oils are also generated as a result of operating and maintaining building systems and equipment.

Empty Drums

The Contractor shall remove any empty drums or other chemical containers with a capacity of five gallons or greater and deliver them to designated off-site disposal or recycling facilities. All containers shall be emptied, that is, the wastes or hazardous materials shall be removed using practices commonly employed to remove materials. The containers will then be rinsed three times, the rinsate collected as hazardous wastes, and the containers collected accumulatively for disposal or recycling.

Empty Reagent Containers & Laboratory Glassware

The Contractor shall process reagent containers and laboratory glassware via recycling or disposal facilities.

The Contractor shall collect empty reagent, bar coded containers which previously contained reagents for inventory control by FDA or its agent at applicable locations. Empty reagent containers shall be turned over to the Contractor for processing. Processing of empty reagent containers by the waste Contractor involves sorting and disposal of plastic and metal containers via the sanitary refuge. Glass containers are to be recycled, where possible, employing the government glass crusher.

Any reagent containers that are either full or contain waste shall require removal of barcode information prior to processing. These containers have to be handled as waste and disposed of as such due to the nature of the hazard. Barcode information shall be collected by the waste Contractor and turned over to the COR or the facility’s designated inventory control representative.

A specific policy for empty containers for each FDA facility shall be provided to the Contractor in facility-specific task orders. Waste containers previously used for accumulation of wastes in the laboratories shall be rinsed, inspected and, if found in good condition, shall be returned to the generators for reuse.

Halogenated Dibenzo-P-Dioxins and Furans

The Contractor shall supply appropriate waste disposal for halogenated dibenzo-p-dioxins and furans. The Contractor shall pack the dioxin waste in containers acceptable for different disposal methods (landfill or incineration).

Other Liquids, Gases and Solids

The Contractor shall supply waste disposal for an assortment of waste items, to include corrosive liquids, solid hazardous waste, contaminated materials, used column packings, pump oils, compressed gas cylinders, lecture bottles, etc. Some of these items require special packing and arrangements for disposal. Chemically contaminated laboratory articles such as gloves and pipettes contaminated with hazardous chemicals and other solid chemical wastes shall be packaged in containers which safeguard against sharp objects protruding through the package, prevents leaks, and allows visual inspection.

Some materials may contain contamination from the manufacturing process, which will cause the materials to be classified as hazardous waste when disposed. One example is the presence of any chemicals on the Toxicity Characteristic (TC) waste list. The Contractor shall keep informed whenever such common materials are found to contain TC wastes at regulated levels and advise the COR of such issues. The COR will also notify the Contractor whenever any materials are suspected of or found to have contamination of TC wastes. Once notified, the Contractor shall handle all such materials as hazardous waste until further notification from the COR.

Surplus and Un-used or Un-opened Chemicals

Surplus and otherwise unused chemicals shall be collected by the Contractor with waste chemicals during routine waste pick-ups.

Waste for Recycling

Any waste which is stored on site for recycling may be stored in the waste marshalling area for accumulation, but the storage time is limited to the time periods allowed under 40 CFR 262.34 for accumulation time if the material is a RCRA defined hazardous waste.

(a) Recovery of Precious Metals The Contractor may collect unused or surplus chemicals that contain gold, silver, platinum, palladium, iridium, osmium, rhodium, ruthenium, or any compound or combination of these metals with waste chemicals during routine waste pick-up activities. FDA will designate the location, preferably a locked cabinet, within the waste marshalling area for storage of precious metals. The Contractor shall date the container as it is received and immediately place such materials in the designated location. The Contractor shall notify the COR or the waste coordinator, who will review the contents of the cabinet. If an economically significant amount of precious metals have accumulated in the storage cabinet to warrant shipment, the COR will request the Contractor to ship the metals to an approved off-site metals recovery facility. If the COR finds a chemical in the storage cabinet to be unsuitable for storage as precious metals, he will direct the Contractor to handle the metal as hazardous waste. The Contractor shall then dispose of the material or chemical according to procedures specified in this contract for wastes.

(b) Recovery of Mercury The Contractor shall collect all mercury waste during routine waste pick-up activities. Routine laboratory waste contaminated with mercury where the mercury cannot be readily or safely separated from the waste materials, mercury salts, and organic mercury will be handled as RCRA hazardous waste and handled in accordance with the provisions of this contract. Metallic mercury, which can be separated from laboratory waste, shall be segregated from the other waste in the waste marshalling area and stored in an area designated by FDA for mercury storage. An example of such separable mercury is mercury from broken thermometers and mercury from electrodes in equipment.

(c) Recoverable Lead Items FDA generates lead pigs, which have been used to ship radioactive materials to FDA. The FDA radiation safety officer or designee will survey the pigs prior to removal from the waste collection area and certify via an accompanying memo that the pigs are free of contamination from radioactive materials. The Contractor shall pick-up the pigs and store them in the accumulation area until sufficient quantity is ready to ship as scrap lead to a recycling firm.

Section I.2.3 Pickup Procedures

The COR or the designated waste coordinator will notify the Contractor when there is sufficient quantity of waste to schedule a waste pickup.

If the Contractor believes certain waste to be an imminent hazard, the Contractor must notify the COR immediately, and steps will be taken by both the COR and the Contractor to alleviate the hazard. Such waste must be removed for disposal as soon as possible.

Certain areas within FDA facilities are restricted and entry by contract personnel into such areas is prohibited unless certain rules or policies are followed. The COR will inform the contract personnel at the start of the contract, which areas are prohibited from routine entry, such as corridors, elevators, laboratories, rooms, etc. and under what circumstances such areas may be accessed. The Contractor shall ensure all personnel are informed once the guidelines are established. If the Contractor is not certain about the status of a particular area, he shall consult the COR before entering.

The Contractor shall wear all protective clothing and equipment necessary to safely handle and move chemicals.

The Contractor shall furnish the expertise to evaluate the waste marshalling facility at each FDA facility to ensure that the Contractor employees are working in an area which meets the Occupational Safety and Health Administration (OSHA) requirements for such facilities. The Contractor shall evaluate what safety equipment and personnel protection is required to meet OSHA standards.

Section I.2.4 Transporting Wastes

Waste chemicals shall be collected, segregated, packaged, and manifested at a site designated by the COR at each facility and shipped directly to the Contractor's recycling, treatment, storage, or disposal (TSDRF) facility.

If a release or incident involving FDA waste in transit occurs during transit, the Contractor shall notify the COR and/or the Contracting Officer as soon as possible and shall work under the direction of the local regulatory authority responding to the incident. The Contractor shall be responsible for cleanup and shall dispatch its own remedial resources to perform the cleanup operation, or may use services as provided by or acceptable to regulatory authorities. The Contractor shall not ship any site cleanup residues for storage, treatment, or disposal without the prior knowledge of the COR or the Contracting Officer unless the Contractor is unable to contact either officer or emergency response requirements dictate immediate shipment.

Section I.2.5 Marshalling and Handling of Collected Wastes

For marshalling areas the Contractor shall be responsible for weekly inspections unless otherwise directed. At the smaller FDA facilities the designated waste coordinator will be responsible for weekly inspections.

All chemical wastes collected according to the procedures stated above, shall be transported to the appropriate FDA storage marshalling areas. Upon arrival wastes will be segregated per specific handling practices for each of the categories of material identified below:

For all facilities with waste storage areas, the general time frames are as follows: (1) the Contractor shall pack all drums and prepare all contents sheets for the full drums to be transported, (2) leave the drums described on the contents sheets on-site until the COR or the designated waste coordinator can review the paperwork, and (3) return within one week to prepare the manifest and transport the drums after the contents sheets have been reviewed and approved by FDA. The manifest and associated paperwork should be submitted to the COR as early in the day as possible to allow sufficient time for review (maximum of two hours), and the Contractor shall be available to answer any questions. All fully packed drums shall be removed from the FDA facilities within their respective accumulation time limits (90 day / 180 day).

Section I.2.6 Preliminary Processing Procedures

The Contractor shall bulk or consolidate compatible wastes from multiple containers into single or fewer containers. All bulking operations shall be carried out in special waste marshalling areas, as designated by the COR. Flammable solvents shall only be bulked at those sites, which have such special facilities. At other FDA locations, the Contractor shall lab-pack the solvents for disposal to minimize any exposures.

The Contractor shall perform all sampling and analysis of incompletely identified wastes necessary to accurately identify the waste in accordance with EPA and DOT requirements, the terms of this contract, and the requirements of the recycling facility or TSDF. If on-site analysis will be performed, the method of analysis will be approved by the COR. The Contractor shall notify the COR of the presence of unidentified waste in the daily report of unprocessed waste and other issues which is submitted before departure. The Contractor shall complete the characterization of the waste within 45 days after sample collection.

Infrequently, waste is generated which is both biological and hazardous chemical waste, and it is not possible to autoclave or chemically treat the waste to inactivate the biohazardous nature of the waste. Some chemical waste may volatilize or undergo violent decomposition under heat, steam, or pressurized conditions. Examples of such waste are animal carcasses contaminated with TCLP waste, and Ames plate cultures containing carcinogens. It is anticipated that the bulk of such wastes will involve animal carcasses contaminated with regulated levels of TCLP wastes. Biohazardous wastes containing hazardous chemical constituents will be subject to all provisions applicable for handling, treatment, and disposal of chemical waste. Each chemical and biohazardous waste will be reviewed by the COR and the Contractor to determine the proper course of action on a case-by case basis. The Contractor shall have available a facility to handle such waste on occasion.

Section I.2.7 Specifications for Packaging, Labeling and Marking of Waste Storage…