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007.05.7-VIII. Requirements for Commercial Medical Waste Treatment, Storage and/or Disposal fac...

AR ADC 007.05.7-VIIIArkansas 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-VIII
007.05.7-VIII. Requirements for Commercial Medical Waste Treatment, Storage and/or Disposal facilities (TSD) and Commercial Mobile Treatment Systems
Currentness
A. All commercial medical waste treatment, storage and/or disposal (TSD) facilities and commercial mobile treatment/disposal systems shall obtain a permit before construction or modification begins (mobile systems may be already constructed). Commercial medical waste incinerator facilities shall obtain an incinerator permit from the ADEQ. Incineration facilities are not required to have a storage permit (storage requirements will be outlined in the operating license). All other commercial medical waste non-incinerator treatment, storage and/or disposal facilities and mobile treatment/disposal systems shall obtain a permit from the Health Department. In addition, all incineration and non-incineration Treatment, Storage, and/or Disposal (TSD) facilities and mobile medical waste treatment systems shall obtain an annual operating license from the Department before storage, treatment and/or disposal begins (as outlined in Section VIII.T). Facilities that were in operation before the effective date of these regulations shall have ninety (90) days to obtain an operating license after the effective date. Required fees for treatment/disposal shall begin upon issuance of the operating license.
B. Pursuant to the Arkansas Code Annotated Section 20-32-109, a proposed non-incinerator medical waste Treatment, Storage, and/or Disposal (TSD) facility will not be issued a permit for the construction or operation of a facility in which any of the following factors are present:
1. The location of the facility is within a “regulatory floodway” as adopted by communities participating in the National Flood Program managed by the Federal Emergency Management Administration Commission.
2. The location of the facility overlies any portion of a significant surface or subsurface sand aquifer or its primary recharge zone or high yield bedrock aquifer, as defined by the Department.
3. The location of the facility could pose a threat to fisheries, wildlife or other natural resources or a sanctuary, refuge, preserve, critical habitat or fish hatchery.
4. The location of the facility does not comply with zoning regulations of the locality in which the facility is proposed.
5. The location of the facility is within the boundary of a state or federal park or designated wilderness area.
C. At least thirty (30) days prior to submitting a permit application for a TSD facility, the applicant shall have completed the following:
1. A written notification by certified mail to each property owner or resident of any property adjacent to the proposed facility site; a copy must also be provided to the Medical Waste Program.
2. Publication of a public notice in the largest newspaper in each county where the property is proposed for construction and in at least one newspaper with a statewide circulation of the intent to apply for a commercial medical waste treatment, storage or disposal permit to construct and operate the facility; a copy must also be provided to the Medical Waste Program.
3. The Department shall be notified of a facility's intent to apply for a permit application before initiating the requirements of Section VIII.C. 1 and 2.
D. All proposed treatment techniques (with the exception of incineration) shall be approved by the Department and meet the following levels of microbial inactivation.
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.
After the Department approves the proposed technology, on-site treatment efficacy testing is required before an operation license is issued, with the exception of incineration technologies. Total destruction technologies must receive approval from the Department for the type, use, or waiver of efficiency testing. One or more representative surrogate microorganisms from each microbial group shall be used in the treatment efficacy evaluation, unless waivered by the Department. 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 medical waste treatment technologies may be obtained from the Department. The Department shall be notified at least twenty (20) working days before efficacy testing begins.
E. No person may operate a commercial medical waste incineration or non-incineration treatment, storage and/or disposal facility or a mobile system, not to include a POTW, without first obtaining an operating license from the Department. The operating license will be issued for a period of one year. Storage capacity, efficacy testing and operating rates will be outlined in the operating license. The ADEQ may set the operating rates for incineration technologies. Procedures for obtaining an operating license are outlined in Section VIII.T.
F. Commercial medical waste Treatment, Storage, and/or Disposal (TSD) facilities can only accept medical waste from permitted commercial medical waste transporters or primary generators. Mobile treatment systems can only accept medical waste from the on-site generator or its affiliated services, unless authorized by the Department to accept off-site generated medical waste. Commercial medical waste must be accompanied with a tracking paper/manifest that meets the requirements of Section VII.K in order for a medical waste Treatment, Storage and/or Disposal (TSD) facility to accept the waste unless being treated on-site by a mobile treatment system or delivered by the primary generator.
G. Commercial mobile treatment systems shall treat commercial medical waste only on the premises of the generation facility or a designated location as approved by the Department.
H. Permitted storage facilities shall maintain a storage temperature of forty-five (45) degrees Fahrenheit or less for medical waste held for more than seventy-two (72) hours and shall also meet the requirements of Section VI.D.1.2. and 3.
I. Treatment, Storage, and/or Disposal (TSD) facilities must prevent the unknowing entry, and minimize the possibility of the unauthorized entry of persons into the active portion of the facility by either an artificial or natural barrier (e.g., a fence in good repair or a fence combined with a cliff) which completely surrounds the active portions of the facility, and is at least seven (7) feet tall for all facilities approved after the effective date of this rule. Signs with the legend “Danger - Unauthorized Personnel Keep Out” or the biohazard legend as listed in Section VI.C.3.a shall be posted at each entrance to the active portion of a facility and at other locations in sufficient numbers that may be seen from any approach to the active portion. The signs shall be legible from at least twenty-five (25) feet.
J. A fee of five dollars ($5.00) a ton is required for all commercial untreated medical waste that is treated or disposed of in Arkansas. Methods of determining the weight of commercial medical waste and associated fees are as follows.
1. Weight determination - in all cases weights shall be verifiable. Accurate weight tabulation in pounds must be kept monthly on a per vehicle or transporter basis. Estimates of container weights derived from the containers are not permissible. Weights of the medical waste may be determined as follows:
a. Net weights of trailer or vehicle loads may be determined by subtracting the weight of the empty vehicle/trailer from the total weight of the trailer/vehicle and load contents.
b. Net weights of trailer or vehicle loads may be determined by scale tickets, manifest/tracking papers, or other like documentation.
c. The required documentation shall be kept for three (3) years from the time of receipt of the medical waste and shall be made available to the Department upon request.
2. Fees - The commercial medical waste TSD facility shall pay a fee of five dollars ($5.00) per ton of medical waste treated/disposed. The fee is calculated by multiplying the fee per ton by the weight of the waste as determined in Section VIII.J.1.a. or b. in pounds divided by two thousand (2,000). The division should be carried to the second decimal and rounded to the nearest tenth as follows:
Weight of Waste in Pounds x $5.00 = fee
2000 pounds
Weight tabulations and fees are calculated each calendar quarter. Weight tabulations and fee payment for the previous quarter are due forty-five (45) days from the end of the quarter. Quarters are based on the periods January 1 to March 31, April 1 to June 30, July 1 to September 30, and October 1 to December 31. Payments are to be made to the Medical Waste Disposal Program.
K. Logs/tracking papers - TSD facilities shall keep a log of their daily receipts from generators and commercial transporters of medical waste. The log shall show at a minimum, the name and address of the permitted transporter or generator, transporter permit number, date of acceptance, weight (pounds) and the final date of treatment/disposal. Manifests/tracking papers shall accompany all shipments of commercial medical waste. Log records and manifests/tracking papers shall be kept on file for three (3) years and shall be made available to the Department upon request. The commercial medical waste Treatment, Storage and/or Disposal (TSD) facility shall provide the medical waste generator or permitted transporter, which ever delivers the medical waste, with documentation of facility's receipt of the medical waste and/or treatment/ destruction after medical waste has been treated or disposed, if requested.
L. All personnel involved in the management, storage and treatment/disposal of commercial medical waste shall be properly trained in the identification, handling and safety requirements of medical waste for their own protection and others. The commercial medical waste Treatment, Storage and/or Disposal (TSD) facility shall have a written training program. Training shall occur before the initial job assignment and shall be repeated at least annually. Written documentation is required of employee training. This training shall include, but not be limited to, the following:
1. Treatment, Storage, and/or Disposal (TSD) facility's written operation plan/procedure as outlined in Section VIII.T.8.
2. Rules and Regulations Pertaining to the Management of Regulated Medical Waste from Health Care Related Facilities.
3. Mechanisms by which disease transmission may occur.
4. Requirements of OSHA's 29 CFR 1910.1030 Bloodborne Pathogen Standard.
5. Proper use of protective measures to prevent contact with medical waste by both facility personnel and the public.
6. Selection, use, and decontamination/disposal of appropriate protective equipment.
7. Procedures to be taken in the event of an incident involving commercial medical waste, including notification of the appropriate authorities and facility's implementation of their contingency/spill management plan.
M. 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.
N. Commercial medical waste Treatment, Storage and/or Disposal (TSD) facilities and commercial mobile treatment systems shall submit to the Department an annual summary report of their activities from January 1 to December 31 of each year. The report shall be submitted no later than March 1 of the year following the end of the reporting period. The report shall include the following information on forms provided by the Department.
1. Name(s) and address(es), transportation or storage permit numbers, and the amount of waste in pounds deposited/unloaded by each transporter, storage facility or generator that transferred/unloaded medical waste to the facility or commercial mobile system.
2. The amount of waste in pounds treated/disposed on-site by the facility.
3. The amount of medical waste in pounds/tons stored on-site that was not treated/disposed during the reportable year.
O. To apply for a permit, the commercial medical waste Treatment, Storage, and/or Disposal (TSD) facility shall submit each of the following to the Department's Medical Waste Program.
1. A completed and signed application for a commercial medical waste Treatment, Storage, and/or Disposal (TSD) facility or permit including the legal owner, proposed physical facility address and mailing address and organization status of the applicant on forms provided by the Department.
2. The legal description of the property and a plot plan and area map.
3. Written process description and process flow diagram sufficient in detail to provide the Department an understanding of the process. A detailed description of the medical waste treatment equipment, including manufacturer's instructions and equipment specifications, operating procedures and conditions, including as applicable, treatment times, temperatures, pressures, chemical concentrations and irradiation doses, etc.
4. Proposed operating rates including the type and amount of commercial medical waste to be treated, stored or disposed and proposed maximum operating hours per day, hours per month, days per week and weeks per year.
5. Detailed engineering and architectural construction documents and specifications of the facility and equipment. Documents and specifications must be reviewed and bear the seal of an Arkansas registered architect or engineer.
6. Certification forms provided by the Department that the facility will comply with the Arkansas Mechanical Code, the Arkansas Fire Code, the Arkansas Plumbing code and the National Electrical Code.
7. Documentation showing the requirements of Section VIII B, 1-5 and C, 1 and 2 has been met.
8. Documentation demonstrating that the treatment method meets microbial inactivation as outlined in Section VIII. D, 1 and 2 and required testing protocols, including a detailed description of the test procedures and calculations used in fulfilling designated performance standards verifying efficacy of user verification methodology, and of microbial culturing protocols that ensure traceability, purity and concentration on forms provided by the Department.
9. Documentation for occupational safety and health assurance by describing the medical waste treatment equipment's safety systems such as warning signals, operating zone restrictions, lock out procedures and personal protection equipment requirements.
10. Documentation of all point and non-point source discharges from the facility or facility's equipment. Appropriate permit applications for those discharges must be submitted, as applicable, or letters from the ADEQ indicating the applicable permits are not required.
11. A description of waste residues generated (i.e., liquid, solid, shredded, hazardous constituents), waste designation (i.e., general, special, hazardous), disposal mechanisms and recycling efforts, if anticipated.
12. A copy of the facility's proposed closure plan outlining the methods to meet the requirements of Section X.A.4 and B.
13. Other documentation or information as requested by the Department.
The Department may levy up to one hundred dollars ($100.00) per hour not to exceed five thousand dollars ($5,000.00) for permit application processing costs incurred by the Department. All costs imposed by the Department, such as outside consultants, will be documented and submitted on a billing form.
P. Commercial mobile treatment/disposal systems must meet the following requirements to receive a permit.
1. The requirements of Section VIII.D (microbial inactivation).
2. The requirements of Section VIII.O. 4, 5, 9, 10, and 13.
3. Documentation of all point and non-point source discharges from the mobile equipment. Copies of all appropriate permit applications for those discharges must be submitted, as applicable, or letters from the ADEQ or other regulatory agencies indicating the applicable permits are not required.
4. A description of waste residues generated (i.e., liquid, solid, shredded, hazardous constituents), waste designation (i.e., general, special, hazardous), disposal mechanisms and recycling efforts, if anticipated.
5. Other documentation or information as requested by the Department.
Q. Before any substantial changes can be made at a commercial non-incineration medical waste treatment, storage, and/or disposal (TSD) facility or a commercial mobile treatment system, a modification permit application must be issued. Substantial changes include, but are not limited to, change in the treatment/disposal method, major changes to the process rates and equipment, change of ownership or change of location (change of treatment location for mobile systems is not considered a substantial change). Permits are non-transferable. To apply for a permit modification, the commercial non-incineration medical waste Treatment, Storage and/or Disposal (TSD) facility or mobile treatment system owner shall submit each of the following to the Department's Medical Waste Disposal Program.
1. A notice of intent, signed by an authorized representative of the company, on forms provided by the Department.
2. Detailed engineering and architectural construction documents and specifications of all substantial changes to the facility and/or equipment. Documents and specifications must be reviewed and bear the seal of an Arkansas registered architect or engineer.
3. Cases of location change (with the exception of commercial mobile units) will require Section VIII B. 1-5 and C, 1 and 2 to be met.
4. Cases where the treatment or disposal techniques change will require Section VIII.O. 9, 10, 11 and 12 to be met.
5. Other documentation or information as requested by the Department.
The Department may levy up to one hundred dollars ($100.00) per hour not to exceed five thousand dollars ($5,000.00) for permit modification application processing costs incurred by the Department. All costs imposed by the Department, such as outside consultants, will be documented and submitted on a billing form.
R. Before a permit or permit application for a non-incinerator commercial medical waste Treatment, Storage and/or Disposal (TSD) facility is granted, the following conditions will be met by the Department.
1. Notice by certified mail to the mayor of the city and the county judge of the county(ies) where the property is the subject matter of the permit application is located.
2. A public hearing shall be held in the county(ies) in which the facility is to be located.
S. The Department may cancel a permit or modification permit if construction or modifications are not begun within eighteen (18) months from the date of the permit or if construction or modification is suspended for eighteen months or more from the date of permit issuance.
T. To apply for an operating license, the commercial medical waste Treatment, Storage, and/or Disposal (TSD) facility or mobile treatment system shall submit each of the following to the Department's Medical Waste Program.
1. An annual fee of two hundred fifty ($250.00) dollars which includes the operating license annual fee for a mobile treatment system fleet operated by an applicant.
2. A completed and signed application for a commercial medical waste Treatment, Storage and/or Disposal (TSD) or mobile treatment system operating license which includes the legal owner(s), proposed physical facility address, mailing address and organization status of the applicant on forms provided by the Department. For mobile treatment systems, the facility's address where on-site treatment will occur must be included.
3. The legal description of the property and a plot plan and area map, unless previously submitted to the Department or operation as a mobile on-site treatment system.
4. Written process description and process flow diagram sufficient in detail to show the processes used in managing medical waste.
5. Proposed operating rates including the type and amount of medical waste to be treated, stored or disposed and proposed maximum operating hours per day, hours per month, days per week and weeks per year.
6. For a commercial medical waste incinerator Treatment, Storage and/or Disposal (TSD) facility, a copy of an incineration permit issued by the ADEQ.
7. Certification forms provided by the Department of a duly authorized representative of the company stating the company understands and is/will comply with all applicable portions of the following:
a. Department Rules and Regulations Pertaining to the Management of Regulated Medical Waste from Health Care Related Facilities.
b. OSHA 29 CFR 1910.1030 Bloodborne Pathogen Standard, as applicable.
8. A written operating plan/procedure for the handling, treatment, storage and disposal of medical waste. The following plan/procedure shall include the following:
a. A method of receiving and handling medical waste separately from other waste until treatment/disposal which prevents unauthorized persons access to or contact with the waste.
b. A method of unloading and processing the medical waste which limits the number of persons handling the waste and minimizes the possibility of exposure of employees and the public to medical waste.
c. A method of decontaminating emptied reusable medical waste containers, transport vehicles or facility equipment which are or are believed to be contaminated with medical waste. Note - all transport cargo compartments, facility equipment or other items shall be disinfected when contaminated or when it is believed to be contaminated. All disinfectants shall meet the requirements of Section VI.F.3.b.
d. The provision and required use of personal protective equipment for persons manually unloading or handling containers of medical waste. Contaminated protective equipment shall be disposed of as medical waste or cleaned and decontaminated.
e. A description of the means of decontaminating any person having had bodily contact with medical waste while transporting, managing, treating or disposing of the waste.
f. Procedures to be followed in the event an individual(s) has bodily contact with medical waste. These procedures shall include decontamination procedures and procedures for medical care.
g. Procedures to be followed in response to equipment failure, utility failure, fire, explosion, spills, leaks, and/or releases which could threaten public health or the environment.

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-VIII, AR ADC 007.05.7-VIII
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