Virginia Administrative Code › Title 9 - ENVIRONMENT › Agency 20 - VIRGINIA WASTE MANAGEMENT BOARD › Chapter 121 - REGULATED MEDICAL WASTE MANAGEMENT REGULATIONS › Part I - Definitions › Section 9VAC20-121-10 - Definitions

Current through Register Vol. 40, No. 24, July 15, 2024
The following words and terms when used in this chapter
					 shall have the following meanings unless the context clearly indicates
					 otherwise. Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of
					 Virginia defines words and terms that supplement those in this chapter. The
					 Solid Waste Management Regulations (9VAC20-81) define additional words and
					 terms that supplement those in the statutes and this chapter. When the
					 statutes, as cited, and the solid waste management regulations, as cited,
					 conflict, the definitions of the statutes are controlling.
"Approved sanitary sewer system" means a network of sewers
					 serving a facility that has been approved in writing by the Virginia Department
					 of Health, including affiliated local health departments. Such sewer systems
					 may be approved septic tank or drainfield systems and onsite treatment systems,
					 or they may be a part of a collection system served by a VPDES permitted
					 treatment works.
"Ash" means the residual waste material produced from an
					 incineration process or any combustion.
"ASTM" means the American Society for Testing and
					 Materials.
"Autoclave" means a wet thermal treatment process that uses
					 saturated steam under a specified amount of pressure for a specified exposure
					 time and at a specific temperature.
"Bioaerosol" means a suspension of airborne particles,
					 generally comprised of microorganisms (e.g., bacteria, viruses) or materials of
					 biological origin released from humans, animals, plants, soil, water, or other
					 sources. Particles range in size from very small to very large, and could
					 include liquid droplets and materials left behind after such droplets evaporate
					 (known as "droplet nuclei").
"Bioburden" means the degree of microbial contamination,
					 including the type and total population of organisms, the number of spore
					 formers present, and their resistance on any material and in a given amount of
					 waste material prior to undergoing treatment.
"Biohazard" means biological substances that pose a threat
					 to the health of living organisms, primarily that of humans, but can include
					 substances harmful to animals.
"Biological indicator" means a preparation of a specific
					 microorganism of a known concentration and resistance to a specific treatment
					 process or to a known physical or chemical condition and is used to evaluate
					 the capability of a process to effectively treat regulated medical waste.
					 "Biological indicators" include bacterial spores or other microorganisms
					 inoculated onto carriers (such as spore strips), spore suspensions, and
					 self-contained biological indicators.
"Biological toxin" or "toxin" means a poison, especially a
					 protein or conjugated protein produced by certain animals, plants, and
					 pathogenic bacteria that is highly poisonous for other living organisms.
"Biologicals" means any preparations (sera, nonviable
					 vaccines, vaccines attenuated in a manner that prevents propagation, antigens,
					 toxins, and antitoxins) derived from a living organism or its products for use
					 in diagnosis, immunization, or treatment of human beings or animals.
"Blood" means human blood, human blood components (e.g.,
					 serum and plasma), and products made from human blood.
"Bloodborne pathogen" means pathogenic microorganisms that
					 are present in human blood (including human blood components and products made
					 from human blood) that can cause disease in humans.
"Board" means the Virginia Waste Management Board.
"Body fluids" means liquid emanating or derived from
					 humans, including blood; cerebrospinal, synovial, pleural, peritoneal, and
					 pericardial fluids; semen and vaginal secretions; amniotic fluid; and any other
					 body fluids that are contaminated with blood, mixed or combined with body
					 fluids, or suspected by the health care professional in charge of being capable
					 of producing an infectious disease in humans. This term does not include nail
					 and skin clippings, breast milk, sputum, semen, teeth, sweat, tears, urine,
					 vomitus, or saliva that are not contaminated with visible blood unless
					 transmission of an infectious disease is possible as determined by a health
					 care professional.
"Calibration" means the demonstration that a measuring
					 device produces accurate results within specified limits of its operating
					 range.
"Captive regulated medical waste management facility" means
					 a regulated medical waste management facility that is located on property owned
					 or controlled by the generator of all waste managed or disposed of at that
					 facility.
"Category A infectious substance" means an infectious
					 substance in a form capable of causing permanent disability or life-threatening
					 or fatal disease in otherwise healthy humans or animals when exposure to the
					 substance occurs. Category A infectious substances are defined by
					 49 CFR
					 173.134 of the U.S. Department of
					 Transportation Hazardous Materials Regulations.
"Category A waste" means wastes that are contaminated with
					 a Category A infectious substance and must be packaged and transported in
					 accordance with the U.S. Department of Transportation Hazardous Materials
					 Regulations or an applicable Department of Transportation special
					 permit.
"Challenge testing" means periodic monitoring or testing of
					 a regulated medical waste treatment device or system that employs the use of
					 biological indicators to demonstrate continued, effective operation of the
					 device or system.
"Closure" means the act of securing a regulated medical
					 waste management facility and terminating use of the facility for management of
					 regulated medical waste pursuant to the requirements of this chapter.
"Container" means any portable enclosure in which a
					 material is stored, transported, treated, or otherwise handled.
"Contaminated" means the presence or the reasonably
					 anticipated presence of blood or other body fluids, infectious agent,
					 biohazard, or biological toxin on an item or surface.
"Cremains" means the ash or bone shadows that remain after
					 cremation.
"Culture" means an infectious substance containing a
					 pathogen that is intentionally propagated. "Culture" does not include a human
					 or animal patient specimen.
"Cultures and stock" means materials derived from the
					 management (e.g., the systems used to grow and maintain infectious agents in
					 vitro, including nutrient agars, gels, broths, and cell lines) of agents
					 infectious to humans, and associated biologicals, from medical or pathological
					 laboratories, from research and industrial laboratories, or from the production
					 of biologicals and includes discarded live or attenuated vaccines capable of
					 propagation, or culture dishes and devices used to transfer, inoculate, or mix
					 cultures.
"Cycle" means the total operating time required for a
					 device to treat regulated medical waste, and for an autoclave, includes
					 warm-up, residence time, and cool down time.
"D-value" or "decimal reduction value" means the thermal
					 resistance or time in minutes at a specific temperature that is required for a
					 one-log or 90% reduction of a specific microbial population under specified
					 treatment conditions.
"Decontamination" means the use of physical or chemical
					 means to remove, inactivate, or destroy human pathogens on a surface or item to
					 the point where they are no longer capable of transmitting disease and the
					 surface or item is rendered safe for handling, use, or disposal.
"Department" or "DEQ" means the Virginia Department of
					 Environmental Quality.
"Director" means the Director of the Department of
					 Environmental Quality or the director's designee.
"Discard" means to throw away or reject. When a material is
					 soiled, contaminated, or no longer usable, and it is placed in a waste
					 receptacle for disposal or treatment prior to disposal, it is considered
					 discarded.
"Discharge" or "waste discharge" means the accidental or
					 intentional spilling, leaking, pumping, pouring, emitting, emptying, or dumping
					 of regulated medical waste into or on any land or state waters.
"Disinfectant" means an antimicrobial product used on hard
					 inanimate surfaces and objects to destroy or irreversibly inactivate infectious
					 agents, such as bacteria, fungi, and viruses, but not necessarily bacterial
					 spores. There are three types of disinfectants registered by EPA based on the
					 type of efficacy data submitted: limited, general or broad-spectrum, and
					 hospital grade.
"Disinfection" means any procedure that involves the
					 application of an antimicrobial agent (disinfectant) registered with EPA that
					 is consistent with its approved use in accordance with the manufacturer's
					 instructions. Disinfection shall not be considered a form of treatment, and
					 appropriate handling of disinfected materials, as well as health and safety
					 precautions, shall still be required to achieve protection of public health and
					 the environment.
"Disposal" means the discharge, deposit, injection,
					 dumping, spilling, leaking, or placing of any solid waste into or on any land
					 or water so that such solid waste or any constituent of it may enter the
					 environment or be emitted into the air or discharged into any waters, including
					 groundwaters.
"Disposal facility" means a facility or part of a facility
					 at which solid waste is intentionally placed into or on any land or water, and
					 at which the solid waste will remain after closure.
"Domestic sewage" means untreated sanitary wastes that pass
					 through a sewer system.
"Efficacy testing" means testing of a treatment method,
					 system, or device, conducted by a laboratory, independent of the system
					 manufacturer, in conformance with generally recognized scientific principles,
					 microbiologic examinations, or other pertinent assessments of waste material to
					 establish operating parameters for effective treatment of regulated medical
					 waste.
"Effluent" means liquid waste such as spills, wash water,
					 and wastewater emanating from regulated medical waste storage, transfer, and
					 treatment areas.
"Empty" means wastes have been removed from a container
					 using the practices commonly employed to remove materials of that type such as
					 pouring, pumping, or aspirating.
"EPA" means the U.S. Environmental Protection
					 Agency.
"Exposure time" or "residence time" means the length of
					 time at which the treatment method is held at a specific temperature, pressure,
					 irradiation level, or chemical concentration for effective treatment of
					 regulated medical waste.
"Federal agency" means any department, agency, or other
					 instrumentality of the federal government, any independent agency, or
					 establishment of the federal government, including any government corporation
					 and the Government Printing Office.
"Generate" means to cause waste to become subject to
					 regulation. At the point a regulated medical waste is discarded, it has been
					 generated. Timeframes associated with storage and refrigeration are linked to
					 the date the waste is placed in storage, not the date the waste is
					 generated.
"Generator" means any person, by site location, whose act
					 or process produces regulated medical waste identified or defined in this
					 chapter or whose act first causes a regulated medical waste to become subject
					 to this chapter.
"Hazardous material" means a substance or material that has
					 been so designated under 49
					 CFR Parts 171 and
					 173.
"Hazardous waste" means any solid waste defined as a
					 "hazardous waste" by the Virginia Hazardous Waste Management
					 Regulations.
"Health care professional" means a medical doctor or nurse
					 practicing under a license issued by the Department of Health
					 Professions.
"Household sharps" means any needles, syringes with
					 attached needles, lancets, auto injectors, pen needles, and any other devices
					 that are used to penetrate the skin for the delivery of medications that are
					 derived from households through self-care, rather than under the care of a home
					 health care professional or at a health care facility. "Household sharps" are
					 sharps that, except for the fact that they are derived from a household, would
					 otherwise be classified as a regulated medical waste in accordance with this
					 chapter.
"Household waste" means any waste material, including
					 garbage, trash, and refuse, derived from households. Households include single
					 and multiple residences, hotels and motels, bunkhouses, ranger stations, crew
					 quarters, campgrounds, picnic grounds, and day-use recreation areas. "Household
					 waste" does not include sanitary waste in septic tanks (septage) that is
					 regulated by other state agencies. Waste generated by a health care
					 professional or nonstationary health care provider administering care in a
					 household, mobile unit, or commercially operated residence, or outpatient
					 recovery facility that meets the definition of regulated medical waste is not
					 household waste and must be managed as regulated medical waste.
"Inactivated" or "inactivation" means having reached the
					 point, through autoclaving, incineration, or other validated treatment process,
					 where the waste material is no longer infectious, does not pose an infection
					 risk, and is not considered to be a regulated medical waste.
"Infectious agent" means any organism or agent, including a
					 synthetic agent, that causes disease or an adverse health impact in humans or
					 can be transferred to humans, as well as animals that have an economic impact
					 on human society.
"Infectious substance" means a material known or reasonably
					 expected to contain a pathogen, including bacteria, viruses, rickettsiae,
					 parasites, fungi, or prions, that can cause disease in humans or
					 animals.
"Inner packaging" means a packaging that is the primary
					 container, such as a red bag or sharps container, for which an outer packaging
					 is required for transport.
"Nonstationary health care provider" means those persons
					 who routinely provide health care at locations that change each day or
					 frequently. This term includes traveling doctors, nurses, midwives, and others
					 providing care in patients' homes, first aid providers operating from emergency
					 vehicles, and mobile blood service collection stations.
"Offsite" means any site that does not meet the definition
					 of onsite, as defined in this part, including areas of a facility that are not
					 on geographically contiguous property or outside of the boundary of the
					 site.
"Onsite" means the same or geographically contiguous
					 property, which may be divided by public or private right-of-way, provided the
					 entrance and exit to the facility are controlled by the owner or the operator
					 of the facility. Noncontiguous properties owned by the same person but
					 connected by a right-of-way that he controls and to which the public does not
					 have access are also considered onsite property.
"Operating parameters" means the specific conditions of
					 pressure, temperature, residence time, chemical concentration, and other
					 physical or engineering condition established through efficacy testing of a
					 treatment method and verified through validation testing to be effective for
					 treatment of regulated medical waste.
"Outer packaging" means packaging that is the secondary
					 container or the outermost enclosure, such as a disposable or reusable rigid
					 pail, fiberboard carton, drum, or portable bin that is under normal conditions
					 of use leak-resistant, strong enough to prevent tearing or bursting, puncture
					 resistant, impervious to moisture, has leak proof sides and bottom, has a tight
					 fitting cover or is otherwise closable, and is in good repair, of a composite
					 or combination packaging together with any absorbent materials, cushioning and
					 any other components necessary to contain and protect inner packaging.
"Overpack" means an enclosure that is used to provide
					 protection or convenience in handling of a package or to consolidate two or
					 more packages. "Overpack" does not include a vehicle, freight container, or
					 aircraft unit load device. Examples of overpacks are one or more packages (i)
					 placed or stacked onto a load board such as a pallet and secured by strapping,
					 shrink wrapping, stretch wrapping, or other suitable means; or (ii) placed in a
					 protective outer packaging such as a box or crate.
"Packaging" means the assembly of one or more containers
					 and any other components necessary to assure compliance with minimum packaging
					 requirements under Regulations Governing the Transportation of Hazardous
					 Materials (9VAC20-110) or this chapter.
"Parametric controls" or "parametric monitoring device"
					 means real time monitoring instrumentation integral to the treatment unit that
					 is designed to quantitatively measure operational parameters, such as
					 temperature, pressure, or other parameter, and provide an electronic or paper
					 record of measurements that can be correlated to treatment. Parametric controls
					 may be used to regulate or maintain preset operating parameters.
"Pathogen" means a microorganism, including bacteria,
					 viruses, rickettsiae, parasites or fungi, or other agent, such as a
					 proteinaceous infectious particle (prion), that can cause disease in humans or
					 animals.
"Patient specimen" means human or animal materials
					 collected directly from humans or animals and transported for research,
					 diagnosis, clinical or investigational activities, or disease treatment or
					 prevention. "Patient specimen" includes excreta, secreta, blood and its
					 components, tissue and tissue swabs, body parts, and specimens in transport
					 media (e.g., transwabs, culture media, and blood culture bottles) until such
					 time that the patient specimen is discarded.
"Prion" means a pathogenic agent that is able to cause
					 abnormal folding of specific normal cellular proteins called "prion proteins,"
					 which are found most abundantly in the brain. This abnormal folding is
					 associated with neurological disease. Prions are proteinaceous infectious
					 particles that are highly resistant to all but the most destructive methods of
					 inactivation. They require specific inactivation, disposal, and containment
					 procedures.
"Process rate" means the maximum rate of waste acceptance
					 that a regulated medical waste management facility can process for transfer,
					 treatment, or storage. This rate is limited by the capabilities of equipment,
					 personnel, and infrastructure.
"Processing" means preparation, treatment, or conversion of
					 regulated medical waste by a series of actions, changes, or functions that
					 bring about a decided result.
"Regulated medical waste" or "RMW" means solid wastes
					 defined to be regulated medical wastes in Part II (9VAC20-121-90) this chapter.
"Regulated medical waste management facility" means a site
					 used for planned transfer, treatment, or disposal of regulated medical waste. A
					 regulated medical waste management facility may consist of more than one
					 transfer, treatment, or disposal unit. A regulated medical waste management
					 facility is a type of solid waste management facility.
"Regulated medical waste transfer station" means a
					 regulated medical waste management facility where regulated medical waste is
					 received for the purpose of its subsequent consolidation, over-packing,
					 storage, trans-loading, or subsequent transfer to another regulated medical
					 waste management facility for further processing, treatment, transfer, or
					 disposal. Parking a vehicle containing regulated medical waste during
					 transportation for 24 hours or more is considered a regulated medical waste
					 transfer station.
"Regulated medical waste treatment facility" means a
					 regulated medical waste management facility where regulated medical waste is
					 treated so that it no longer constitutes a threat to public health and the
					 environment, and the waste is subsequently managed as solid waste.
"Reusable medical device" means a device, including
					 surgical forceps, endoscopes, and stethoscopes, that is designed and labeled
					 for multiple uses and is reprocessed by thorough cleaning followed by
					 high-level disinfection or sterilization between patients.
"Sanitizer" means a substance, or mixture of substances,
					 that reduces the bacterial population in the inanimate environment by
					 significant numbers, (e.g., 3 log10 reduction) or more but does not destroy or
					 eliminate all bacteria.
"Select agent or toxin" means a subset of biological agents
					 and toxins that the U.S. Department of Health and Human Services and U.S.
					 Department of Agriculture have determined have the potential to pose a severe
					 threat to public health and safety, to animal or plant health, or to animal or
					 plant products. Select agents and toxins are specified under
					 42 CFR §§
											73.3 and
					 73.4,
					 9 CFR §§ 121.3 and
					 121.4, and 7 CFR §
											331.3.
"Sharps" means any object contaminated with a pathogen or
					 that may become contaminated with a pathogen through handling or during
					 transportation and also capable of cutting or penetrating skin or a packaging
					 material. Sharps include needles, syringes, scalpels, broken glass, culture
					 slides, culture dishes, broken capillary tubes, broken rigid plastic, and
					 exposed ends of dental wires. Discarded unused sharps contained in the original
					 liner and outer packaging are excluded from this definition.
"Sharps drop box" means a secure, tamper-proof sharps
					 container for the temporary storage of only household sharps provided for the
					 convenience of individual home generators who choose to transport their own
					 household sharps to the collection point and where collected sharps are
					 packaged, labeled, and managed as regulated medical waste.
"Shipment" means the movement or quantity conveyed by a
					 transporter of a regulated medical waste between a generator and a designated
					 facility or a subsequent transporter.
"Shipping paper" means a shipping order, bill of lading,
					 manifest, or other shipping document serving a similar purpose and containing
					 the information required by the U.S. Department of Transportation Hazardous
					 Materials Regulations.
"Site" means all land or water and structures, other
					 appurtenances, and improvements on them used for treating, storing, and
					 disposing of regulated medical waste. This term includes adjacent land within
					 the facility boundary used for the utility systems such as repair, storage,
					 shipping or processing areas, or other areas incident to the management of
					 regulated medical waste.
"Solid waste" means any of those materials defined as
					 "solid waste" in
					 9VAC20-81-95 of the Virginia Solid
					 Waste Management Regulations. Regulated medical waste that has been treated in
					 accordance with this chapter is considered solid waste.
"Spill" means any accidental or unpermitted discharge,
					 leaking, pumping, pouring, emitting, or dumping of wastes or materials that,
					 when spilled, become wastes.
"Spore" means a dormant form of a microorganism that is
					 more resistant to adverse conditions.
"Sterilize" means to inactivate all microorganisms on
					 materials or waste.
"Storage" means the holding, including during
					 transportation, of regulated medical waste.
"Surrogate waste load" means a load of noninfectious
					 material used in validation test runs of treatment units that represents
					 materials and packaging that would be found in the regulated medical waste
					 stream to be treated by the facility.
"Transportation" or "transport" means the movement of
					 regulated medical waste by air, rail, highway, or water.
"Transporter" means a person authorized in accordance with
					 federal and state regulations and engaged in transportation or movement of
					 regulated waste.
"Treatment" means any method, technology, or process
					 designed to change the character or composition of any regulated medical waste
					 so that it is inactivated and no longer constitutes a threat to public health
					 and the environment. Treatment does not include compaction or
					 disinfection.
"Treatment method" means a process including wet thermal
					 sterilization (such as autoclaving) or dry thermal sterilization, chemical
					 sterilization, combustion or incineration, and alternate technologies used to
					 treat regulated medical waste.
"Thermochemical indicator" means a device (e.g., tape,
					 paper strips, integrators, or small ampoules) that responds to the treatment
					 process parameters in some measurable fashion, such as changing color or
					 becoming striped when subjected to temperatures intended to provide
					 sterilization of materials.
"Thermochemical recording device" means a device (e.g.,
					 thermocouple, wireless data loggers, or chemical monitoring probes) that reacts
					 in response to one or more critical treatment parameters (such as temperature)
					 and yields a quantifiable value that correlates to microbial lethality or
					 predictable inactivation of microbial spore populations.
"Unauthorized waste" means waste that is not authorized by
					 the department to be managed by the regulated medical waste management
					 facility. Examples are site-specific and dependent upon the treatment
					 technology and permit but may include chemotherapeutic, pathological,
					 pharmaceutical, radioactive, chemical, hazardous, or other wastes.
"Used health care product" means a medical, diagnostic, or
					 research device or piece of equipment, or personal care product used by
					 consumers, medical professionals, or pharmaceutical providers that does not
					 otherwise meet the definition of patient specimen, biological product, or
					 regulated medical waste, but is contaminated with potentially infectious body
					 fluids or materials and is not decontaminated or disinfected to remove or
					 mitigate the infectious hazard prior to transportation.
"Validation testing" means procedures conducted at the site
					 of a regulated medical waste treatment facility prior to initial operation of a
					 treatment system or device, the purpose of which is to demonstrate, through
					 established operating parameters, the effective treatment of regulated medical
					 waste.
"Vector" means a living animal, insect, or other arthropod
					 that is capable of transmitting a pathogen or infectious disease from one
					 organism to another.
"VPDES" means Virginia Pollutant Discharge Elimination
					 System, the Virginia system for the issuance of permits pursuant to the Permit
					 Regulation (9VAC25-31), the State Water Control Law (§ 62.1-44.2 et seq.
					 of the Code of Virginia), and § 402 of the Clean Water Act (33 USC §
											1251 et seq.).
"Waste management" means the entire process of managing
					 waste from the point of generation to final disposition. For regulated medical
					 waste, the process includes collection and segregation, characterization,
					 classification, packaging, labeling, processing, staging, storing,
					 decontamination, treatment, transportation, and disposal, as well as monitoring
					 of waste management operations and sites to ensure that the management of these
					 wastes is protective of human health and the environment.
"Waste management facility" means all contiguous land and
					 structures, other appurtenances, and improvements on them used for treating,
					 storing, or disposing of waste.
"Z-value" means the temperature change required for the
					 D-value to change by 1 log (i.e., by a factor of 10) for a specific microbial
					 population under specified treatment conditions.
Statutory Authority: § 10.1-1402 of the Code of
						Virginia; 42 USC §
													6941 et seq.;
						40 CFR Part
						257.