Home Table of Contents

007.05.7-VI. Identification, Segregation, Packaging, Labeling, Storage, Transport, Treatment an...

AR ADC 007.05.7-VIArkansas Administrative CodeEffective: January 1, 2017

West's Arkansas Administrative Code
Title 007. Department of Health
Division 05. Health Facility Services
Rule 7. Rules and Regulations Pertaining to the Management of Medical Waste from Generators and Health Care Related Facilities
Effective: January 1, 2017
Ark. Admin. Code 007.05.7-VI
007.05.7-VI. Identification, Segregation, Packaging, Labeling, Storage, Transport, Treatment and Disposal of Medical Waste.
This section is applicable as requirements for all generators in Arkansas, except those exempted in Section V.
A. Identification of medical waste.
1. A person who generates a medical waste shall determine if that waste is a medical waste as defined in Section III L.1-9. Any wastes that contain medical waste mixed with general solid waste shall be managed as medical waste if the solid waste has been contaminated by pathological waste, blood or body fluids, contaminated items and/or microbiological waste.
2. Any medical wastes which meet the definition of “hazardous waste”, or which are mixed with hazardous wastes shall be managed as hazardous waste in accordance with the ADEQ's Hazardous Waste Management Code, Regulation 23.
B. Segregation of medical waste.
1. Medical waste must be segregated from other regular waste at the point of its generation in the producing facility.
2. Segregation of medical waste must be made into containers in compliance with the OSHA Bloodborne Pathogen Standard, 29 CFR 1910.1030. Containers (paper or plastic bags, metal or plastic rigid containers) meeting this standard must be closable and constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipment.
3. A non-sharps container (e.g., a step can) of medical waste shall be closed at all times except when actively receiving medical waste.
4. A sharps container with openings large enough to allow entry of any human hand shall be subject to any additional physical and/or administration controls necessary to prevent access by the public during normal conditions of use.
C. Packaging and labeling of medical waste.
1. Medical waste, except for sharps capable of cutting or puncturing, shall be contained for reprocessing at the site of generation in collection containers impervious to moisture, which are leak resistant and have a sufficient strength to preclude ripping, tearing or bursting under normal conditions of usage. Full containers shall be securely closed (fastened, taped or tied) to prevent leakage or loss of solid or liquid wastes.
2. Contaminated sharps shall be packaged for reprocessing at the site of generation in containers that are leak resistant on the bottom and sides, rigid, closable, and puncture resistant. Sharps containers shall be assembled and utilized at all times as intended by the manufacturer. Sharps that have been treated and are still capable of cutting or puncturing must also meet this packaging requirement unless they have been rendered unrecognizable and are no longer capable of cutting or puncturing.
3. a. Warning labels shall be affixed to all bags and containers used for medical waste or affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal. Labels must be water resistant and legible, colored fluorescent orange or orange-red (or predominantly so), with lettering or symbols in a contrasting color, and include the universal biohazard legend.
b. Red bags or red containers shall be labeled as listed in VI.C. 3. a above.
c. Rigid containers for contaminated sharps and treated sharps as outlined in Section VI.C.2. shall be colored or labeled as listed VI.C.3.a. Treated sharps must also be labeled as in Section VI.C.3.a.
d. Individual containers of medical waste that are placed in a labeled container as required in Section VI.E during storage, transport, shipment or disposal are required to be labeled as listed in Section VI.C.3.a. Section VI.C.6 allows for the substitution of the 49 CFR Hazardous Materials Regulation's labeling and packaging requirements during handling and transport of medical waste.
4. When medical waste leaves the facility where it was generated, the name and address of the generator must clearly be marked on the outside of the container. If the waste has been treated using an approved method as outlined in Section VI.F.1-6, then it must also be labeled on the container with the words “TREATED” and “BIOHAZARDOUS WASTE” or “INFECTIOUS SUBSTANCE” or “MEDICAL WASTE” or the universal biohazard symbol. Medical waste that has been treated by an approved method and determined by the Department as rendered unrecognizable, is not required to have special packaging or labeling when transported or disposed as outlined in Section VI.M. The handling and disposal of incinerator ash is regulated by the ADEQ.
5. Treated medical waste cannot be disposed of if it is in a red or orange-red bag or container as outlined in Section VI.C.3.b. and c. It must be further over packed in a different color container (e.g., brown, green, black paper or plastic) and then labeled as required in Section VI.C.4.
6. If medical waste requires labeling, packaging or management under the Code of Federal Regulations, Title 49, Parts 171, 172, 173, 177 and/or 178 of the Hazardous Material regulations, Title 29 Part 1910.1030 of the Bloodborne Pathogen standard or other federal regulations, as applicable, then the generator shall comply with the labeling and other applicable requirements specified in those regulations instead of as outlined in Section VI.C.3.a, b, and c.
7. Mechanical compaction of medical waste shall not be conducted prior to treatment and/or disposal, unless the mechanical compaction and treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated medical waste.
D. Storage
1. Medical waste packaged in disposable containers as described in Section VI.C.1 and 2 shall be placed in disposable or reusable pails, cartons, drums, dumpsters or portable bins. Disposable and reusable systems shall be kept clean and rigid, be designed to prevent leakage of fluids, remain impervious to moisture, and be of sufficient strength to prevent tearing or bursting under normal conditions of use and handling and be kept sealed or closed to prevent leakage. The containers may be of any color and shall be conspicuously labeled as required in Section VI.C.
2. Storage of medical waste shall be in a manner and location which affords protection from unauthorized entry, animals, adverse weather conditions such as rain, snow, ice, sleet, hail and wind, does not provide a breeding place or a food source for insects and rodents and minimizes exposure of employees and the public. When waste is not being actively placed in storage, the area must be secured.
3. The location of the medical waste in storage shall be conspicuously marked with signs which shall include the universal biohazard legend outlined in Section VI.C.3.a.
4. Storage time within the generating facility shall not exceed thirty (30) days once the container has been filled and closed. Storage of medical waste for longer than thirty (30) days must be approved by the Department. Filled containers of medical waste must be held at room temperature (72 degrees Fahrenheit (22 degrees Celsius)) or below in a secure location with limited access (unauthorized entry) as specified in Section VI.D.2. If the generating facility is unable to control odor from its stored waste, the Department may require more frequent removal and further limit the storage time.
E. Transport
1. Generators of medical waste may transport their own waste to an off-site permitted treatment or disposal facility, or satellite facility in a fully enclosed container designed to prevent leakage of fluids as outlined in Section VI.D.1., without having to obtain a transportation permit. Generators that transport their medical waste shall keep a log of all medical waste transported. The log shall include the quantity, the date of transport and the name of the receiving facility. Logs shall be maintained on file at the generator's facility for three (3) years from the date of shipment. Commercial medical waste transportation must comply with Section VII, requirements for transporters of commercial medical waste.
2. Medical waste transported off-site must be labeled as required in Section VI.C.
3. For transport purposes, the generator shall transfer custody of untreated medical waste only to a transporter who has obtained a valid Commercial Regulated Medical Waste Transportation permit from the Department as required in Section VII.A. The Department shall maintain a list of all permitted transporters. The list shall be made available by the Department's Medical Waste Program.
4. The generator of medical waste shall maintain a log of all untreated medical waste transferred to a transporter that is permitted by the Department or a Department permitted treatment, storage and/or disposal facility. The log must include the quantity, the method used to determine the amount, the date the shipment was made and the name and permit number of the transporter or treatment/disposal facility. The logs shall be maintained on file at the generator's facility for three (3) years from the date of shipment or transfer. If the information is listed on the manifest/tracking paper, then the manifest/tracking paper may be substituted for the log.
5. The generator shall obtain from the permitted transporter a signed receipt (manifest or tracking paper) for each shipment of medical waste. The requirements of the manifest/tracking paper(s) are listed in Section VII.K. These manifests/tracking papers shall be maintained on file at the generators facility for three (3) years from the date of shipment.
6. Medical waste cannot be transported in open vehicles or trailers. Tarped loads are not permissible.
7. Medical waste must be physically separated from other materials being transported.
8. Generators that transport large quantities of medical waste (not including commercial medical waste) must sign a letter of agreement provided by the Department ensuring procedures are in place that will assure the medical waste is managed during transport to protect the environment, the waste handlers and the public health. (Large quantity is defined as fifty (50) pounds or more of medical waste transported in a calendar month.).
9. The U.S. Postal Service may be used to transport used and unused sharps for disposal. The generator must retain the original receipt and the returned registered or certified mail receipt. The generator shall retain the manifest/tracking paper for each shipment and they shall be maintained on file at the generator's facility for three (3) years from the date of shipment.
F. Treatment of medical waste shall be by one of the following
1. Incineration - Burning of medical waste in conformance with the standards prescribed by the ADEQ or the EPA. A permit must be obtained from the ADEQ before an incinerator can be installed or operated. Inspection of incinerators shall be conducted by the ADEQ in compliance with the federal Clean Air Act and/or the Arkansas Water and Air Pollution Control Act, or other applicable air regulations.
2. Sterilization Technology - Sterilization is the complete elimination of microbial viability. Procedures utilized must be performed properly and according to the manufacturer's operating instructions (with regard to time, temperature, pressure, waste exposure and capacity), provided the results changes the biological character or composition of the medical waste completely and reliably inactivating bacillus stearothermophilus spores or other appropriate organisms at a 4 Log 10 reduction (99.99%) or greater and meet or exceed the parameters listed below. If a primary container is used, the primary container shall be placed in the sterilization chamber with sufficient space provided between the chamber walls and the container to allow the steam, heat or chemical to surround the container and penetrate all of the medical waste. The primary container shall be sealed loosely enough to allow the steam to penetrate the entire contents of the container, unless a self-venting bag is used. All of the medical waste must be exposed to the temperatures and pressures listed below. Approved procedures are:
a. Steam under pressure (autoclaving) steam at 248 degrees Fahrenheit (120 degrees Celsius) at 15 pounds per square inch (psi) for thirty (30) minutes. Steam auger - steam at 205 degrees Fahrenheit (96 degrees Celsius) at 15 psi for sixty (60) minutes.
b. Dry heat - heat at 320 degrees Fahrenheit (160 degrees Celsius) at atmospheric pressure for two (2) hours.
c. Chemical vapor -- approved EPA chemical mixture at 260 degrees Fahrenheit (127 degrees Celsius) at 20 psi for thirty (30) minutes; and
d. Ethylene oxide - four (4) to five (5) hour cycle using eleven (11) to twelve (12) percent ethylene oxide. Chemical vapor and ethylene oxide sterilization may require an air permit from the ADEQ. Persons interested in applying this technology should contact the ADEQ before installing or operating such equipment.
Quality control of the sterilization process shall be performed at least once a month or after every forty (40) hours of operation, whichever comes later, using physical, chemical, and biological monitors (thermo chemical indicators and integrators such as autoclave tape, spore strips, ampoules, thermocouples, etc.) placed in or on the outside of the waste containers and distributed throughout the load, chamber, or vessel during treatment as listed in Section VI.G to evaluate the effectiveness of the treatment process. Unless the sterilization unit is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, except for treatment using ethylene oxide, the operator of such sterilization equipment shall affix to the medical waste a temperature-sensitive tape which will indicate that the required temperature was reached.
3. Disinfection - a potential less lethal process compared to sterilization that eliminates or inactivates many or all pathogenic microorganisms including viruses, fungi, and bacteria (but not necessarily all their endospores) on inanimate surfaces. Approved procedures are:
a. Thermal Inactivation - procedure must be performed properly as indicated by the equipment manufacturer's operating instructions and the adequacy of disinfection verified by physical, chemical, and biological monitoring (thermo chemical indicators and integrators such as autoclave tape, spore strips, ampoules, thermocouples, etc.) as listed in Section VI.G. Unless the thermal inactivation equipment is equipped to continuously monitor and record temperatures during the entire length of each disinfection cycle, the operator shall affix to the medical waste a temperature-sensitive tape (i.e. autoclave tape) which will indicate that the required temperature was reached. Approved procedures are:
(1) Autoclave
(2) Microwave; and
(3) Dielectric energy.
Thermal inactivation must allow for sufficient heat to access and penetrate the waste. The waste must be packaged according to the recommendations of the manufacturer and loaded into the chamber as to not exceed the capacity limits set by the manufacturer.
b. Chemical - The use of EPA approved chemical agent to significantly reduce microbial activity for waste treatment, e.g., one (1) part freshly prepared solution of free available chlorine (hypochlorite bleach) concentration to no more than ten (10) parts water (1:10 dilution) for at least ten (10) minutes. The chemical agent shall be used according to the manufacturer's instructions. The chemical agent must penetrate all the waste material. If liquid chemical disinfectants or sterilants are used, excess liquid must be drained prior to disposal. Certain chemical disinfectants or sterilants may not be allowed to be discharged to a POTW. Solid waste landfills are prohibited from accepting liquids or wastes containing free liquids and/or infectious waste as outlined in the ADEQ's Solid Waste Management Code, Regulation 22.
4. Discharge of liquid or semi-liquid waste into the collection system of a publicly owned treatment works (POTW) - grinding and/or flushing of waste into a POTW within the generating facility, except as prohibited by the Department, the ADEQ or the superintendent/manager of the POTW.
5. Encapsulation - complete encapsulation of medical waste in a solid matrix (e.g., plaster of paris) which will significantly reduce the possibility of exposure.
6. Other available technology (alternate technology) - technology other than listed above in Section VI.F.1-5 shall be evaluated and approved by the Department. Alternate technologies are usually approved at the manufacturer level. Applications for approval of an alternate technology must be made on forms provided by the Department's Medical Waste Program Criteria used to evaluate alternate technologies will include, but not be limited to:
a. Approval by states other than Arkansas that utilize a performance standards approach to review alternate treatment technologies.
b. Environmental impact.
c. Environmental permit requirements.
d. Potential worker health effects.
e. Manufacturer operating requirements and instructions.
f. Levels of microbial inactivation which includes:
(1) Inactivation of representative samples of mycobacteria, at a level of 6 log 10 (99.9999%) reduction or greater, as determined by the Department.
(2) Inactivation of Geobacillus stearothermophilus endospores or Bacillus atrophaeus endospores at a level of 4 log 10 (99.99%) reduction or greater, as determined by the Department. One or more representative surrogate microorganisms from each microbial group shall be used in treatment efficacy evaluations. The Department shall determine the appropriate microorganisms to serve as representative surrogate microorganisms. Protocols developed for efficacy testing shall incorporate, as applicable, recognized, standard procedures. Guidelines for testing and approval of alternate medical waste technologies may be obtained from the Department's Medical Waste Program.
The Department shall maintain a list of those approved alternate technologies, including manufacturer, product name, model number, or other appropriate identifying information. The list shall be made available by the Department's Medical Waste Program.
G. Quality control of the treatment process must be performed at least once a month or after every forty (40) hours of operation, whichever comes later, using the appropriate physical, chemical, and biological monitors (thermo chemical indicators and integrators such as autoclave tape, spore strips, ampoules, thermocouples etc.) to evaluate the effectiveness of the treatment process, except for discharge into a POTW or encapsulation. The types of biological monitors that shall be used, unless approved by the Department for use of other organisms, are as follows:
Wet heat
Geobacillus stearothermophilus
Dry heat
Bacillus atrophaeus
Gas (ethylene oxide)
Bacillus atrophaeus
(formaldehyde)
Geobacillus stearothermophilus
Radiation
Bacillus pumilus or Bacillus atrophaeus or Geobacillus stearothermophilus
Liquids
Bacillus atrophaeus or Clostridium sporogenes
The Department must approve of biological monitors not listed above used for efficacy (Quality Control) testing. Total destruction technologies must receive approval from the Department for the type, use, or waiver of efficacy testing.
H. Log. For each medical waste treatment unit listed in Section VI.F, a log shall be maintained which contains, at a minimum, the following information for each use.
1. Date.
2. Time.
3. Operator.
4. Type and approximate amount (by weight (pounds)) of medical waste.
5. Sterilization pressure reading, as applicable.
6. Maximum temperature obtained during the process or the results of the temperature sensitive tape, as applicable.
7. The treatment process time.
The log shall be completed during and after all treatment of medical waste in the treatment unit. The log shall also record the required quality control process using biological monitors including the type of organism used as listed in Section VI.G and the results when achieved. The treatment log shall be maintained for three (3) years from the date of last treatment.
I. Equipment such as shredders, choppers, etc., that have the potential to produce aerosols must be fully contained under negative air pressure and exhausted through an HEPA filter. Small medical waste treatment devices may be exempt from this requirement.
J. Disposal of untreated medical waste shall be by one of the following:
1. Discharged from the health care related facility into a POTW.
2. Interment - the disposition of pathological waste by burial or cremation according to standards and practices of the mortuary industry.
3. Other available technology - if approved by the Department and meeting the intent of these rules and regulations.
4. Table 1 describes which methods are approved for treatment and disposal of each specific category of medical waste. Alternate technologies are approved individually for treatment and disposal for each specific category of medical waste. NOTE: Not all methods of treatment and disposal are approved for all categories of medical waste. Medical waste which may no longer serve to transmit an infectious disease and is not recognizable, may be disposed of in the regular solid waste stream and/or in a permitted landfill as outlined in the ADEQ's Solid Waste Management Code, Regulation 22 without any labeling requirements. Section VI.K. outlines the requirements for treated medical waste that is still recognizable.
5. Untreated medical waste cannot be disposed of in a landfill. Treated medical waste may be disposed of in a permitted sanitary landfill in accordance with the ADEQ's Solid Waste Management Code, Regulation 22. Solid waste landfills cannot accept liquid wastes. Treated medical waste, where applicable, must be packaged and labeled as in Section VI.C prior to land filling.
K. If the generator of medical waste has treated the waste by an approved method and it is packaged and labeled as specified in Section VI.C, then the waste may be included in the facility's normal, solid waste stream in accordance with regulations established by the ADEQ or other appropriate regulatory bodies.
L. A health care related facility with an ADEQ permitted incinerator or use of an approved technology as outlined in Section VI.C.1-7 may accept medical waste for treatment/disposal from physicians and surgeons on staff of the health care facility without obtaining a commercial incinerator or non-incinerator technology permit or operating license as outlined in Section VIII. Satellite facilities including additional hospitals, affiliated off-site services and physician offices or other affiliated services owned and managed by the primary generator/treater may accept and treat such medical waste without a non-incineration technology permit or operating license unless the facility is engaged in medical waste disposal for profit. If the ADEQ determines that a facility's incinerator is operating as a commercial medical waste incinerator, then the facility shall obtain an operating license as outlined in Section VIII.
M. Medical waste that has been treated by an approved method and determined by the Department as rendered unrecognizable is not required to have special packaging or labeling when transported or disposed.
N. All incidents involving the release of medical waste to the environment or other incidents that threaten the public health involving medical waste shall be reported verbally as soon as possible but within twelve (12) hours to the Department with a follow-up written report on forms provided by the Department in five (5) working days from the incident. The Department shall be notified at (501) 661-2621 or (501) 661-2000 during working hours and (501) 661-2136 after normal working hours.

Credits

Amended Sept. 5, 2013; Jan. 1, 2017.
Current with amendments received through February 15, 2024. Some sections may be more current, see credit for details.
Ark. Admin. Code 007.05.7-VI, AR ADC 007.05.7-VI
End of Document