Attachment J-6 Glossary of Abbreviations and Acronyms75F40123R00003.pdf

Attachment J-6 Glossary of Abbreviations and Acronyms

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

AEA Atomic Energy Act CBER Center for Biologics Evaluation and Research CDER Center for Drug Evaluation and Research CDRH Center for Devices and Radiological Health CFSAN Center for Food Safety and Applied Nutrition CO Contracting Officer COR Contracting Officer's Representative CPK1 College Park Harvey W. Wiley Building CPK2 University Station CVM Center for Veterinary Medicine DEA Drug Enforcement Administration DOT Department of Transportation FDA Food and Drug Administration FRC Federal Research Center – White Oak GCSL Gulf Coast Seafood Laboratory IATA International Air Transport Association ICAO International Civil Aviation Organization MCTR Moffet Center, Summit Argo, IL MDE Maryland Department of the Environment MODI Module I

MODII Module II MPW Medical Pathological Waste MRC Muirkirk Road Complex OAGS Office of Acquisitions and Grants Services ORA Office of Regulatory Affairs SOW Statement of Work TSDRF Treatment, Storage, Disposal or Recycling Facility UN / DOT United Nations / Department of Transportation USDA United States Department of Agriculture WO 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 designated waste coordinators. Designated waste coordinators for a specific facility will be identified in the task order awarded for that facility.

Devices: Implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

i. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

ii. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

iii. Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term 'device' does not include software functions excluded pursuant to section 520(o)."

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.

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 an 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.