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Medical Waste Guidance and Interpretations
This document is provided to help you understand the North Carolina medical waste management rules. If you would like further information, please contact the Solid Waste Section in the Department of Environment and Natural Resources (DENR). Contact Bill Patrakis at (919) 707-8290, email: firstname.lastname@example.org. You may also contact a local Waste Management Specialist in one of the seven DENR regional offices.
The Solid Waste Section regulates the packaging, labeling, storage, transportation, treatment and disposal of medical waste in North Carolina. Treatment, storage and disposal facilities that accept waste from outside of the facility cannot operate without a permit from the Solid Waste Section. Please read this entire document. Due to the complex nature of medical waste regulations, failure to read this entire document may result in failure to comply with the rules.
This guide is not intended as legal advice, but as an aid to understanding the current North Carolina medical waste management rules.
The medical waste management rules became effective October 1, 1990. The most recent amendments were made in April 1993.
Link to Section .1200 Rules
Enforcement of the Rules
The medical waste management rules are enforced by the Solid Waste Section and, in some cases, the local law enforcement authority.
Pre-Emption of Local Solid Waste Laws on Medical Waste
These rules pre-empt local solid waste laws on medical waste where local laws are more lenient.
Joint and Several Liability
Under state regulations a solid waste generator is responsible for the storage, collection and disposal of his or her solid waste. The generator is responsible for ensuring that solid waste is disposed at a site or facility that has all applicable permits required to receive waste. (15A NCAC 13B .0106)
Medical Waste Definition
Medical waste means any solid waste which is generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, but does not include any hazardous waste identified or listed pursuant to this Article, radioactive waste, household waste as defined in 40 Code of Federal Regulations § 261.4(b)(1) in effect on 1 July 1989, or those substances excluded from the definition of solid waste in this section. (NCGS 130A-290(a)(18)
Regulated Medical Waste Definition
Regulated medical waste means blood and body fluids in individual containers in volumes greater than 20 ml, microbiological waste, and pathological waste that have not been treated pursuant to .1207. (.1207 is the definition of treatment - see rules on page 22.) Regulated medical waste must be treated prior to disposal. After treatment these wastes may be handled as general solid waste. (.1201(9))
Percentage of the Medical Waste Stream That Is Regulated Medical Waste
Most medical waste may be handled as general solid waste and does not require treatment. Regulated medical waste makes up only a very small portion of the total medical waste stream. The percentage of a facility's waste stream comprised of regulated medical waste is dependant on the activities at that facility. Roughly 9 percent to 15 percent of the waste stream at hospitals is regulated medical waste. Some facilities, such as long-term care facilities, generate medical waste but little or no regulated medical waste.
Microbiological waste means cultures and stocks of infectious agents, including but not limited to specimens from medical, pathological, pharmaceutical, research, commercial and industrial laboratories. (.1201(5))
Pathological waste means human tissues, organs and body parts; and the carcasses and body parts of all animals that were known to have been exposed to pathogens that are potentially dangerous to humans during research, were used in the production of biologicals or in vivo testing of pharmaceuticals, or that died of a known or suspected disease transmissible to humans. (.1201(8))
Blood and Body Fluids
Blood and body fluids means liquid blood, serum, plasma, other blood products, emulsified human tissue, spinal fluids and pleural and peritoneal fluids. Dialysates are not blood or body fluids under this definition. Please note that the definition of regulated medical waste specifies blood and body fluids that are in a liquid state and in a container, such as a suction canister. This does not refer to blood absorbed by materials such as bandages and dressings. (Some waste items contaminated with blood may be subject to OSHA labeling requirements). (.1201(1))
Dressings, Bandages, Sponges, Used Gloves, and Tubing
These items are not included in the definition of regulated medical waste and may be disposed of without treatment. (.1201(9))
Blood and Body Fluids in Individual Containers in Volumes Equal to or Less Than 20 ml
These "containers" are commonly vacuum tubes used for blood samples. If not stored in a secured area, accessible only to authorized personnel, these containers must be packaged either in a container suitable for sharps or in a plastic bag in a rigid fiberboard box or drum. Treatment is not required prior to disposal. (.1202(c))
Urine and Feces
Urine and feces should be disposed of through sanitary sewage or septage disposal practices. Soiled diapers are not regulated medical waste and may be disposed as general solid waste.
Registration of Medical Waste Generators
North Carolina does not require generators of medical waste to register.
Artificial Body Parts and Implants Removed or Replaced During Surgical Procedures
Items such as artificial limbs and pacemakers are considered medical waste. However, they are not generally considered regulated medical waste because they do not fall within a class of regulated medical waste.
Medical Waste Reduction Techniques
Information about medical waste reduction techniques is available from the Solid Waste Section and the Division of Pollution Prevention and Environmental Assistance.
Sharps .1201(10) "Sharps" means and includes needles, syringes with attached needles, capillary tubes, slides and cover slips, and scalpel blades.
Disposal of Sharps
The rules do not require treatment of sharps before disposal. They must be packaged in a container that is rigid, leak-proof when in an upright position and puncture resistant. The package then may be disposed of with general solid waste. (Generators should comply with any relevant OSHA requirements for labeling and packaging). (.1202(b)). Generators should contact local solid waste authorities to confirm that there are no local restrictions against this practice.
Compaction of Sharps
Sharps cannot be processed in small compaction units inside the generating facility. The rule does not prohibit hauling sharps to the landfill on trucks that compact waste. Also, it does not prohibit processing sharps containers in large commercial compactors where the waste will be transported to a disposal facility without being transferred to another container. (.1202(b))
Sharps Generated in Private Households
Household waste is not included in the definition of medical waste and is not subject to the medical waste management rules. However, home users of sharps are urged to place sharps in hard wall containers before disposal in order to protect garbage collectors from needlesticks. A few counties have imposed local restrictions on sharps disposed from private homes. Home healthcare agencies may find it prudent to assist in proper disposal of sharps used to administer care to patients in their homes. This is not specifically required by the rules. Used needles from farms are subject to the rules and are not considered household waste. Such waste is more similar to veterinary waste than household waste.
Packaging Regulated Medical Waste for Off-Site Treatment
Regulated Medical Waste must be packaged in a plastic bag in a rigid fiberboard box or drum in a manner that prevents leakage of the contents. The outer surface must be labeled with a biohazard symbol; the words "INFECTIOUS WASTE" or "MEDICAL WASTE"; the date of shipment; and the name, address and phone number of the generator, transporter, storage facility and treatment facility. The medical waste management rules do not require a biohazard label on the plastic bag or use of red bags. However, generators should be aware that OSHA rules may require labeling of bags containing some types of medical waste. (.1204(a)(1))
Storage of Regulated Medical Waste Prior to Shipment Off Site for Treatment
All medical waste, including regulated medical waste, must be stored in a manner so as not to create a nuisance either by noxious odors or by encouraging the presence of vermin. Regulated medical waste must be maintained in a non-putrescent state. Regulated medical waste must be stored in a manner that maintains the integrity, including labels and markings. Areas used to store regulated medical waste must be accessible only to authorized personnel. Vermin and insects must be controlled. All floor drains in the storage area must discharge directly to an approved sanitary sewer (sewer or septic system). Ventilation must be provided. A plan must be maintained at the facility to ensure proper management of regulated medical waste. (.1206)
Storage of Regulated Medical Waste That Will Be Shipped Off Site for Treatment
A waste generator who stores regulated medical waste that will be shipped off site for treatment must store the waste in a package suitable for transportation. (.1204(a))
Packaging Requirements for Regulated Medical Waste Which Will Be Treated On Site
The packaging requirements in section .1204 only apply to regulated medical waste that is being shipped off site for treatment. There is no packaging requirement for regulated medical waste treated on site.
Storage Requirements for Medical Waste Which Is Not Classified as Regulated Medical Waste
If none of the medical waste being stored is regulated medical waste, the waste is subject to the storage requirements of general solid waste. As with regulated medical waste, non-regulated medical waste must be stored in a non-putrescent state, and vermin and insects must be controlled.
Treatment Facilities for Regulated Medical Waste
Regulated Medical Waste may be treated on site or at a facility that is an integrated part of the generating facility (See .1201(3) for definition of integrated). Otherwise, it must be sent to a medical waste treatment facility permitted by the Solid Waste Section. Many generators choose to ship and incinerate non-regulated medical waste such as gloves, bloody bandages, dressings, and tubing. Generators who incur this expense should be reminded that this is not required by OSHA or any other state agency. Such waste may be landfilled untreated even though it may be designated as regulated waste by OSHA. (.1203(a))
Permitting of Medical Waste Treatment Facilities
Solid waste permits are not required for facilities that treat only waste generated within the facility. Permits are required for facilities that treat medical waste generated off site and not within an integrated medical facility.
>Disposal of Large Volumes of Blood and Body Fluids
Incineration or sanitary sewage are acceptable treatments for blood and body fluids in individual containers in volumes greater than 20 ml. If neither of these options is available on site, a vendor must be obtained to treat the material.
Urine and Feces
Disposal of Items Such as Bloody Gauze, Used Gloves, Tubing, and Dressings. These materials are not regulated medical waste and, therefore, do not have any specific treatment requirement. They may be disposed of as general solid waste. Note that some of these items may be subject to packaging and labeling requirements by OSHA. The Solid Waste Section does not recommend removing these labels at the point of disposal.
Arranging for Incineration of Regulated Medical Waste by a Neighboring Hospital
Any facility treating waste that is generated off site and outside of an integrated medical facility must obtain a permit from the Solid Waste Section. All packaging, labeling, transportation, storage, and treatment requirements apply.
The "50 Pound per Month" Record-Keeping Exemption
This exemption, in Section .1204(b), exempts generators from the record-keeping requirement if they ship less than 50 pounds per month of regulated medical waste.
Rejection of Properly Packaged Sharps or Treated Regulated Medical Waste at the Local Municipal Landfill
Landfill operators have the right to reject any waste for disposal in the landfill, even if state regulations allow landfill disposal of such wastes.
Managing Medical Waste After It Has Been Treated
Treated medical waste is subject to the same requirements as general solid waste. (.1203(c))
Facility "G" (the generator) sends its regulated medical waste to facility "T" for treatment. What packaging, labeling, record-keeping, transportation and treatment requirements apply?
To answer this question, two determinations must be made:
1. whether sites G and T are an "integrated medical facility" (See definition below); and
2. whether G is "on-site" or "off-site" relative to facility T. That is, if you are at one facility, is the other on-site? (See definition below).
After determining whether a facility is an integrated medical facility and/or on or off- site, the table below may be used to find out what requirements apply. See examples.
Exempt from packaging,labeling,storage, and record-keeping requirements.
Exempt from packaging and labeling requirements. Subject to storage and record-keeping requirements. Treatment facility must hold a permit issued by the Solid Waste Section
Exempt from recordkeeping and storage requirements. Subject to packaging, labeling and transportation requirements.
Subject to all packaging, labeling, storage, record-keeping and transportation requirements. Treatment facility must hold a permit issued by the Solid Waste Section.
Integrated medical facility means one or more health service facilities as defined in NCGS 131E-176(9b) that are:
(a) located in a single county or two contiguous counties;
(b) affiliated with a university medical school or that are under common ownership and control; and
(c) serve a single service area. (.1201(3))
"Health service facility" means a hospital; psychiatric facility; rehabilitation facility; long term health care facility; kidney disease treatment center, including freestanding hemodialysis units; intermediate care facility for the mentally retarded; home health agency; chemical dependency treatment facility; and ambulatory surgical treatment facility. (131E-176(9b)) Funeral homes, veterinary hospitals, dental and research labs are not integrated facilities.
On-site means the same or geographically contiguous property which may be divided by public or private right-of-way. (.1201(7))
Off-site means any site which is not on-site. (.1201(6))
The following examples will help to determine what requirements apply under a variety of situations.
Facility G is a hospital sending its pathological and microbiological waste across town to facility T, also a hospital, for treatment. G and T are under common ownership and in the same county but not on a geographically contiguous piece of property. What requirements apply?
Step 1. Are G and T an integrated medical facility?
Yes. G and T meet the three criteria for being an integrated facility - they are under common ownership, serve a single service area and are located in a single county.
Step 2. Are T and G on-site? (Or, if you are at facility T, is G on-site?)
No. The facilities are not on-site because they are not on a geographically contiguous piece of property.
Answer: The table shows facilities that are integrated and off-site are exempt from the record-keeping and storage requirements, but must comply with packaging, labeling and transportation requirements.
Facility G, a veterinary hospital, is sending animal carcasses that are infected with rabies to facility T, a hospital, for treatment. The facilities are not under common ownership and are on separately owned pieces of property that are geographically contiguous. What requirements apply?
Step 1. Are the facilities an integrated medical facility?
No. The facilities are not under common ownership. Furthermore, veterinary facilities are not included in the definition of a health care facility.
Step 2. Are the facilities on-site?
Yes. The facilities are on geographically contiguous property.
Answer: The facilities are non-integrated and on-site. The table shows they are exempt from the packaging and labeling requirements, but are not exempt from the storage and record-keeping requirement. Additionally, the treatment facility must hold a permit issued by the Solid Waste Section.
A university hospital, T, treats waste from a hospital affiliated lab, G, across campus. The campus is a geographically contiguous piece of property. What requirements apply?
Step 1. Are they an integrated medical facility?
Yes. The facilities are located in the same county, affiliated with a university medical school and serve the same area.
Step 2. Are the facilities on-site?
Yes. They are on a geographically contiguous piece of property.
Answer: The facilities are on-site and integrated. The table shows that they are exempt from packaging, labeling, storage and record-keeping requirements.
A pathology laboratory, G, sends regulated medical waste to a local hospital, T, across town. The pathology lab and the hospital are not under common ownership or on geographically contiguous property.
Step 1. Are the facilities integrated?
No. They are not under common ownership.
Step 2. Are the facilities on-site?
No. They are not on the same or geographically contiguous property.
Answer: The facilities are off-site and non-integrated. The table shows that they are each subject to the packaging, labeling, storage, record keeping and transportation requirements. The treatment facility would need a permit issued by the Solid Waste Section.
Impact of the OSHA Bloodborne Pathogen Standards on Medical Waste Disposal Requirements
The new OSHA standards do not address disposal methods, and no changes have been made in state medical waste treatment and disposal rules. OSHA Instruction CPL 2-2.44D states "that while OSHA specifies certain features of the regulated waste containers, including appropriate tagging, the ultimate disposal method (landfilling, incineration, and so forth) for medical waste falls under the purview of the EPA and possibly State and local regulations.
Comparison of the Definition of Regulated Medical Waste with the OSHA Definition of Regulated Waste
There are substantial differences in the two definitions. For example, the OSHA definition of regulated waste may include waste such as bloody gauze, blood-saturated dressings, used gloves, or tubing. These items are not included in the state definition of regulated medical waste and are exempt from treatment requirements. It is essential the generator understand both definitions. Generators who apply the OSHA definition of regulated waste to designate waste for treatment by incineration may unintentionally incur additional expense. The OSHA definition of regulated waste is not intended to designate waste that must be incinerated or otherwise treated before landfilling.
Disposal of Blood and Body Fluids into the Sanitary Sewer
The sanitary sewage treatment system is designed for disposal of body fluids. OSHA regulations do not address disposal and do not prohibit such disposal. Workers disposing blood are of course subject to OSHA requirements, such as wearing protective clothing.
Different Labeling Requirements
Generators must be familiar with both sets of requirements. OSHA may require a red bag or biohazard-labeled bag for some waste that can be safely disposed in the landfill without treatment. That could include properly containerized sharps, used gloves, bloody gauze and dressings, and properly containerized blood and body fluids in volumes of 20 mL or less. State waste disposal regulations require the words "INFECTIOUS WASTE" or "MEDICAL WASTE" on packages of regulated medical waste that are taken off site for treatment and disposal. State medical waste disposal regulations no longer require the use of red bags since the red dyes may contribute heavy metals, such as lead and cadmium, to incinerator ash disposed in landfills. State solid waste goals include reducing the toxicity of landfilled waste. Users of red bags should check with their vendors to ensure they are using bags that do not create toxic residues after incineration.
Disposal of Red Bags That Contain Only Medical Waste Not Classified as Regulated Medical Waste by the State Medical Waste Management Definition
Bags that contain only non-regulated medical waste in accordance with state rules and are labeled as biohazardous in the workplace, are "over-labeled" for disposal purposes. Such labels were previously reserved to designate waste that was banned from the landfill and must be treated. Red bags and biohazard-labeled bags that contain only non-regulated medical waste may be disposed with general solid waste, provided no local rules prohibit it.
The Solid Waste Section has alerted North Carolina landfills to expect increased disposal of non-regulated medical waste in red bags or biohazard-labeled bags as the OSHA rules are implemented. In some counties, landfill operators initially may not accept such bags, even though they had previously accepted the same waste in plain, unlabeled bags. In most cases, this can be worked out through local discussions and better communications with the landfill. Landfill operation is regulated by the Solid Waste Section, and local waste management specialists are available to provide assistance, guidance, and education for landfill operators.
As described in paragraphs (g)(1)(i)(B),(C),(D), and (E) of the OSHA standards, the OSHA labeling requirements can be satisfied by the use of either red bags or bags with a biohazard label. Facilities sending waste to the landfill may find plain bags with the appropriate biohazard label an easy solution.
Risks to Waste Industry Workers
Waste transport and disposal is mechanized, and waste handlers are trained to safely deal with all types of waste that contain human pathogens. To keep things in perspective, it is important to realize that household garbage has on average 100 times more pathogenic microorganisms than general medical waste.
Problems with Using the OSHA Definition of Regulated Waste to Designate Waste That Must Be Treated and Cannot Be Disposed at the Landfill
The OSHA definition designates waste that poses a threat in the workplace, and does not designate waste that should be incinerated or treated by other means. Applying this definition to disposal would constitute imposing treatment requirements to additional categories of medical waste. Requiring treatment of very broad categories of medical waste may increase waste management costs substantially, while providing no benefit for the environment or public health.
Adopting Uniform Definitions for the Department of Labor and Department of Environment and Natural Resources
The rules do not conflict, but they address two entirely different concerns. Federal OSHA rules address waste management in the workplace to ensure worker safety; state solid waste management rules ensure storage, shipping, and disposal practices that protect the environment and public health. Categories of waste that present special infectious hazards in the workplace do not necessarily present the same hazards to the environment or public health once in the disposal process.
means any solid waste which is generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, but does not include any hazardous waste identified or listed pursuant to this Article, radioactive waste, household waste as defined in 40 Code of Federal Regulations § 261.4(b)(1) in effect on 1 July 1989, or those substances excluded from the definition of solid waste in this section. (NCGS 130A-290(18))
Health service facility
means a hospital; psychiatric facility; rehabilitation facility; long term care facility; kidney disease treatment center, including freestanding hemodialysis units; intermediate care facility for the mentally retarded; home health agency; chemical dependency treatment facility; and ambulatory surgical facility. (NCGS 131E-176(9b))
means any method, technique or process, including neutralization, designed to change the physical, chemical or biological character or composition of any hazardous waste so as to neutralize such waste or so as to render such waste nonhazardous, safer for transport, amenable for recovery, amenable for storage or reduced in volume. Treatment includes any activity or processing designed to change the physical form or chemical composition of hazardous waste so as to render it nonhazardous.(NCGS 130A-290(a)(42))