DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT
Solid and Hazardous Waste Commission/Hazardous Materials and Waste Management Division
6 CCR 1007-2
PART 1 - REGULATIONS PERTAINING TO SOLID WASTE SITES AND FACILITIES

Medical Waste Regulations

1) The existing Section 13 Regulations (Infectious Waste Disposal) are being deleted in their entirety and replaced with new Section 13 Regulations (Medical Waste) to read as follows: 

SECTION 13

MEDICAL WASTE

13.1	Scope and Applicability

13.2	General Provisions

13.3	Certificate of Designation Required

13.4	Standards for Medical Waste Generators

13.5	Standards for Commercial Medical Waste Storage Facilities

13.6	Standards for Medical Waste Treatment 

13.7	Engineering Design and Operation Plan Requirements for 	Commercial Storage and Treatment Facilities

13.8	Operating Requirements for Commercial Storage and Treatment 	Facilities

13.9	Standards for Medical Waste Disposal 

13.10	Transportation Requirements

13.1	SCOPE AND APPLICABILITY

13.1.1	This Section 13 applies to all medical waste generators, transporters and treatment, storage and/or disposal facilities, unless otherwise exempted, that generate, store, consolidate, treat, process, transport or dispose of  non-hazardous (i.e., not regulated under § 25-15-101 et. seq. CRS) medical waste as defined in Section 1.2 of these regulations.   

13.1.2	Household medical waste generators shall be exempt from this Section 13.

13.2	GENERAL PROVISIONS

13.2.1	Under no circumstance shall a site or facility that generates, stores, consolidates, treats, processes, transports or disposes of medical wastes become a health or environmental hazard or allow nuisance conditions as defined in Section 1.2 of these regulations to develop. Medical waste that causes nuisance conditions shall be immediately refrigerated, frozen, treated and/or disposed.

13.2.2	Sites and facilities that generate, store, consolidate, treat, process, transport or dispose of medical wastes must comply with all local, state and federal laws, regulations, ordinances and other requirements.

13.2.3	All records required by this Section 13 must be maintained onsite for three (3) years in an easily retrievable format.

13.2.4	There shall be no compaction of infectious waste before treatment.

13.2.5	Incorporation by Reference.

	(A) References to material incorporated by reference in this Section 13 refer to 2011 editions unless otherwise expressly noted, and do not include any later amendments or editions.

	(B) Information concerning all materials or regulations incorporated by reference may be obtained by contacting:

		Regulatory and Program Authorization Coordinator
	Colorado Department of Public Health and Environment
	Hazardous Materials and Waste Management Division
	4300 Cherry Creek Drive South
	Denver, CO  80246-1530

	(C) Materials or regulations incorporated by reference in these regulations are available for examination at the state publications depository libraries.

13.3	CERTIFICATE OF DESIGNATION REQUIRED  

13.3.1	Exemptions - the following sites and facilities shall be approved sites and facilities for which it shall not be necessary to obtain a Certificate of Designation unless the Department determines that the site or facility may adversely affect human health and the environment:

	(A) Medical waste generators that temporarily accumulate their own medical waste for onsite treatment or offsite shipment to a commercial medical waste treatment, storage or disposal facility, that are in compliance with:

(1) Section 13.4 Standards for Medical Waste Generators. 

(2) Section 13.9 Standards for Medical Waste Disposal.

(3) Section 13.10 Transportation Requirements.

For purposes of this section, “temporarily accumulate” means the generator may:

(i) Store putrescible medical waste onsite for up to thirty (30) calendar days without refrigeration if the waste is packaged consistent with US DOT requirements for infectious substances (49 CFR Part 173.196 or 173.197) prior to being placed in the accumulation area.

(ii) Store putrescible medical waste onsite for up to ninety (90) calendar days if the waste is packaged consistent with US DOT requirements for infectious substances (49 CFR Part 173.196 or 173.197) prior to being placed in refrigeration (45 degrees Fahrenheit or less) or frozen.

(iii) Store non-putrescible medical wastes, such as sharps containers, waste pharmaceutical containers and trace chemotherapy waste, onsite for up to ninety (90) calendar days if the waste is packaged in containers that are taken out of service and are in good condition and secured to prevent unauthorized access.

A Certificate of Designation is required for accumulation and/or storage of medical waste onsite by the generator if all of the requirements of this subpart 13.3.1 (A) are not met. 

(B) Medical waste generators that operate equipment for treatment of medical wastes generated onsite or that is generated through the normal operation of their business at other locations operated by the same business and self-transported by private motor carrier from their other locations for consolidation and/or treatment that are in compliance with:  

(1) Section 13.3.1(A).

(2) Section 13.6 Standards for Medical Waste Treatment.

Such facilities may also treat household medical waste collected as a community service.

	(C) Those entities that conduct medical waste consolidation and storage activities as a community service limited to only households, such as a household medical waste collection program, a sharps collection program or a pharmaceutical take-back program, if they are in compliance with the requirements for medical waste generators in Section 13.3.1(A). Such entities must ensure consolidated wastes are sent to an approved medical waste treatment or disposal facility in compliance with Section 13.9, or other solid waste management program as authorized by the Department.
	
	(D) Those facilities for hazardous waste disposal that have been issued a  Certificate of Designation pursuant to Title 25 Article 15 Parts 1, 2, 3 and 5, CRS, as amended, and are in compliance with 6 CCR 1007-3.

13.3.2	No person, unless exempted under Section 13.3.1, shall operate a medical waste consolidation, storage, treatment, processing or disposal facility without having received a Certificate of Designation in accordance with Section 1.6 of these regulations.

13.3.3	All applications for a Certificate of Designation must be submitted for review and approval by the Department and the local governing body with jurisdiction and include an Engineering Design and Operations Plan prepared in accordance with Section 13.7 of these regulations.  

13.3.4	The owner or operator of an existing solid waste disposal site or facility for which a Certificate of Designation has been issued shall submit an amended Engineering Design and Operations Plan for approval prior to receiving untreated medical waste as a new waste stream for consolidation, storage, treatment, processing or disposal.  

13.4	STANDARDS FOR MEDICAL WASTE GENERATORS 

13.4.1	Medical Waste Generators are required to develop and implement an onsite medical waste management plan for each facility.  At least one employee at the facility must be designated with the responsibility of implementing the medical waste management plan.

	(A) The plan must identify the types of medical waste generated and where each type of medical waste is generated in the facility.  

	(B) The plan must describe how each type of medical waste will be identified, segregated, packaged, stored, treated, transported and disposed.

	(C) The plan must include a contingency plan for responding to spills or loss of containment of medical waste in order to minimize hazards to human health and the environment.  

	(D) The plan must identify medical waste training that will be provided to employees.  

13.4.2	The plan must be maintained onsite in an easily retrievable format and be available for inspection by the regulatory agency, the transporter and the disposal facility. The plan must be updated whenever changes related to medical waste generation or handling occur.

13.5	STANDARDS FOR COMMERCIAL MEDICAL WASTE STORAGE FACILITIES

13.5.1	Commercial medical waste storage facilities shall be used for the consolidation and short-term storage of untreated medical wastes from multiple medical waste generators that will be taken to an approved medical waste treatment or disposal facility. It does not include storage of medical waste for less than seventy-two (72) hours incidental to transportation to an approved treatment, storage or disposal facility.

13.5.2	Commercial medical waste storage facilities must comply with:

(A) Section 13.1 Applicability. 

(B) Section 13.2 General Provisions. 

(C) Section 13.3 Certificate of Designation. 

(D) Section 13.7 Engineering Design and Operations Plan Requirements. 

(E) Section 13.8 Operating Requirements. 

(F) Section 13.10 Transportation Requirements.

13.6	STANDARDS FOR MEDICAL WASTE TREATMENT

13.6.1	Treatment must be appropriate to the type of medical waste.   All waste must be handled in a manner to ensure complete treatment of the waste such that no portion of the container or bulk volume of waste remains untreated.

	(A) Acceptable methods of treatment for infectious wastes shall be those methods that render the waste non-infectious.  Such methods may include but are not limited to thermal (e.g., autoclaving, incineration, heat, microwaving, macrowaving, pyrolysis or gasification), chemical (e.g., chlorine or chlorine derivatives, ozone, enzymes or sodium hydroxide), irradiation, other mechanisms designed for specific medical waste categories (e.g., gas/vapor sterilization), or other methods as approved by the Department that will not present an endangerment to facility personnel or the public.

(1) Infectious waste must be treated to achieve at least a 4 Log10 reduction in Bacillus stearothermphilus, Bacillus subtillis or Bacillus atrophaeus endospores and at least a 6 Log10 reduction in Mycobacterium phlei or Mycobacterium bovis.

(2) Encapsulation, solidification and/or compaction without rendering the waste non-infectious are not adequate forms of treatment.

	(B) Acceptable methods of treatment for trace chemotherapy and waste pharmaceuticals include incineration, encapsulation, stabilization or other method approved by the Department.    

13.6.2	The treatment technology manufacturer must incorporate recognized standards for determining appropriate validation and verification testing methodology and protocols to verify for the Department that the overall technology and the specific equipment perform as designed and are capable of consistently treating the waste to meet at least the minimum treatment standards in 13.6.1 of these regulations.  This information must be made available to the prospective medical waste treater for inclusion in their medical waste management plan or application for Certificate of Designation as applicable.

13.6.3	Unless exempted in Section 13.3.1 of these regulations, medical waste treatment facilities must comply with:

(A) Section 13.1 Applicability. 

(B) Section 13.2 General Provisions. 
 
(C) Section 13.3 Certificate of Designation.

(D) Section 13.7 Engineering Design and Operations Plan Requirements. 

(E) Section 13.8 Operating Requirements.  

(F) Section 13.9 Standards for Disposal.

 13.7	ENGINEERING DESIGN AND OPERATION PLAN REQUIREMENTS FOR COMMERCIAL STORAGE AND TREATMENT FACILITIES

13.7.1 	Prohibited waste.

	(A) Hazardous wastes as defined in Section 25-15-101(6) of the Colorado Revised Statutes and Part 261 of the Colorado Hazardous Waste Regulations (6 CCR 1007-3).

	(B) Radioactive material as defined in the Rules and Regulations Pertaining to Radiation Control (6 CCR 1007-1). 

	(C) Controlled substances as defined by the Controlled Substances Act (21 United States Code (USC) Sec. 802(6)), unless the facility is also a US Drug Enforcement Administration (US DEA) registrant and is authorized to accept and manage these substances. Controlled substances from household medical waste generators are exempt from this Section 13.7.1. 

13.7.2 	Engineering Design and Operations Plan – Commercial medical waste storage and treatment facilities shall provide an Engineering Design and Operations Plan for review and approval to the Department and local governing body having jurisdiction prior to the acceptance of any untreated medical waste. The plan shall describe in detail how the facility will comply with all applicable requirements in these regulations. All engineered features of the facility design shall be reviewed and sealed by a registered Colorado Professional Engineer.

	(A) The Engineering Design and Operations Plan shall contain the following general facility data:

(1) The names, mailing addresses, telephone numbers and e-mail addresses of the facility owners and operators.

(2) The names, addresses, telephone numbers and e-mail addresses of one or more persons having authority to take actions at the facility in the event of an emergency.

(3) The mailing address and physical address of the facility, including the county and legal description as well as the quarter-section, section, township and range.

(4) A general description of the medical waste storage or treatment facility.

(5) A discussion of the facility’s service area, including transportation corridors and surrounding access.

(6) A listing of all permits or construction approvals received by or applied for, including air quality, water quality, local wastewater treatment, and other State or local permits.

	(B) The Engineering Design and Operations Plan shall contain, at a minimum, the following maps:

(1) A vicinity map, drawn at a recognized engineering scale, that has been certified by a registered Colorado Professional Engineer showing access and service roads to the facility; zoning and land use; present land owners; property boundaries; easements; rights of way; residences; wells; location of floodplain boundaries; locations of all springs, lakes, streams, wetlands, constructed or natural drainages, and irrigation ditches; and all man-made or natural features relating to the facility within a 1/2-mile radius.  

(2) A site map, drawn at a recognized engineering scale, that has been certified by a registered Colorado Professional Engineer showing facility boundaries; location, size, and use of existing or proposed structures or other storage units; areas to be used for unloading, storage, and loading of wastes; general process flow; existing or proposed water diversion, collection, conveyance, treatment, storage and discharge facilities; and any other information requested if necessary to complete review of the plan. 

	(C) The Engineering Design and Operations Plan shall contain the following operational information.

(1) A narrative description of the general operating plan for the facility, including hours of operation, daily operations methodology, and expected facility capacity.

(2) Descriptions of the job titles, duties, responsibilities and training requirements of all employees who manage medical waste at the site.

(3) For sites where medical waste treatment is to be conducted, the plan shall also include:

(i) Technology validation process - A detailed description of the technology validation process steps and the waste treatment process including capacity of the unit, composition and volume of waste the technology is designed to treat and the composition and volume of waste representing the worst case scenario for this technology. For infectious waste treatment processes, this shall also include a description of the time intervals and locations for biological indicator samples that were placed in the load, and the procedures for testing the biological indicator samples to determine final concentrations after treatment. This information should be provided by the technology manufacturer.

(ii) Technology verification process – A detailed description of the verification testing procedures to be used on a routine basis by the waste treater to verify for the Department that the technology remains effective onsite under actual operating conditions.

(a) Onsite verification testing must be completed on representative test loads before production startup of a newly installed treatment system at the waste treater’s facility. The waste treater must maintain documentation of onsite verification testing and monitoring results for each test load, including any deviations from the critical limits and corrective actions taken.

(b) For infectious waste treatment processes, verification procedures shall use biological monitoring.  Parametric monitoring may be allowed if the technology manufacturer has successfully demonstrated to the Department that appropriate critical limits are met to achieve adequate biological inactivation and that the parameters to be monitored are directly correlated to biological inactivation.

(c) A description of the treatment technology including manufacturer’s name and equipment model number or description, standard operating procedures which have been proven to be effective, and a description of preventive maintenance procedures.  For infectious waste treatment processes, a description of the required residence time for waste in the treatment zone and a description of the type and frequency of biologic and/or parametric verification monitoring, including calibration of parametric controls, should also be included.  

(d) The waste treater must provide a detailed written operations and maintenance plan that includes the technology manufacturer’s specifications and instructions.

(e) The waste treater must follow the written operations and maintenance procedures provided by the technology manufacturer and maintain documentation of onsite treatment and monitoring results for each waste load, including any deviations from the critical limits and corrective actions taken in the event of a deviation.

(iii) A detailed engineering description of the facility with a flow chart showing the components of the treatment system.

(iv) A description of annual operator training requirements including loading and unloading of the treatment system to minimize occupational exposure and physical injury, emergency procedures for handling malfunctioning systems, and documentation requirements for system failure during operation.

(v) A description of waste loads that can be processed, waste feed capacity and rate, and limitations on waste composition and types.

(vi) A description of control systems including air flow, waste moving/mixing systems, procedures to be used for facility startup and scheduled and/or unscheduled shutdown, warning systems and waste feed cutoff, if applicable.

(4) A waste characterization and acceptance plan, including waste screening methods to be used, waste exclusion procedures and rejection of prohibited wastes, handling methods for wastes that require special or non-standard handling, and a contingency plan for handling prohibited wastes. 

(5) A detailed description of the on- and offsite controls to be used to prevent nuisance conditions, including dust, noise, mud, odors, and control of disease vectors including the attraction, breeding and emergence of insects, birds or rodents.

(6) A waste handling and storage plan, including a detailed description of the unloading, monitoring, handling and storage practices to be used and information on methods to secure access and set up barriers to prevent unauthorized entry to areas where waste is stored. 

(i) All exterior doors, gates or lids to medical waste storage areas shall be marked with the biohazard symbol, if applicable, and the words “Caution – Medical Waste Storage Area – Unauthorized Persons Keep Out”. Letters on signs shall be at least two inches in height and legible. 

(ii) Medical waste shall be stored in a manner and location that maintains the integrity of the packaging and provides protection from water, precipitation and wind. Storage units shall be constructed of easily cleanable materials that are impervious to liquids and resistant to corrosion from disinfectants, have adequate drainage, and are free of standing water.  

(iii) Medical waste shall be stored for no more than fourteen (14) calendar days from the date of receipt at the storage facility before being transported to an approved treatment or disposal facility. 

(iv) If odors or other nuisance conditions develop, the waste shall immediately be placed in an enclosed unit maintained at or below 45 degrees Fahrenheit or transported to an approved treatment or disposal facility. 

(7) A description of the tracking system to be used to maintain control of waste flow.  The system shall include: the source, volume, and types of waste received; the date the waste was received; for storage facilities, the date the waste was shipped to the treatment or disposal facility; for treatment facilities, the date the waste was treated and sent for disposal. Documentation, including copies of waste tracking logs, shipping papers and/or manifests, shall be retained for a minimum of three (3) years from the date the waste was shipped from the facility.

(8) An operational safety, fire prevention and contingency plan to minimize hazards. The plan shall include:

(i) A plan for the alternate management of wastes in the event the facility is not in operation due to equipment failure or closure due to unforeseen circumstances, or if the permitted capacity of the facility will be exceeded.

(ii) Cleanup procedures to be implemented in the event of a loss of containment, spill or release.

(iii) The location and use of all spill response supplies and personal protective equipment and the methods to be used to manage recovered waste and contaminated spill response supplies and personal protective equipment.

(iv) The designated person or persons responsible for implementing the plan.

(v) Spill reporting provisions.

(vi) A fire protection plan in compliance with local fire codes.

(9) A personnel training plan identifying training to be received by each employee based on the responsibilities associated with their job duties. Training shall be conducted, at a minimum: 

(i) When the employee starts a new position or receives additional duties related to medical waste management.

(ii) When new medical waste management procedures are implemented.

(iii) On an annual basis. 

Employee training shall include, but not be limited to: medical waste identification, bloodborne pathogens, waste containment and labeling; storage requirements; equipment operations including equipment startup, shutdown, maintenance, and associated procedures to assure safe operation; and roles and responsibilities when implementing the facility contingency plan. Training for employees that prepare waste for shipment shall be consistent with US DOT requirements.

(10) A closure plan providing information on the actions to be taken at the time of final facility closure, including:

(i) The Department, the local governing body having jurisdiction, and customers serviced by the facility shall be notified in writing at least sixty (60) calendar days in advance of the proposed closure date. If applicable, signs of a suitable size notifying drop-off customers of the site closure shall be placed in a conspicuous area at the entrances to the facility at least sixty (60) calendar days in advance of the proposed closure date.

(ii) The facility shall not accept new or additional waste shipments for storage and/or treatment fourteen (14) calendar days prior to the date of anticipated closure.  All wastes shall be transported offsite to an approved solid waste site or facility within fourteen (14) calendar days of receipt of the final waste load.

(iii) Waste storage units and waste management areas shall be cleaned to disinfect and/or remove visible traces of medical waste.

(iv) Within thirty (30) calendar days of completing closure activities, the owner and operator shall provide written notification to the Department and the local governing body having jurisdiction to document that proper treatment and disposal of all wastes has taken place in accordance with the approved closure plan and that facility closure standards have been achieved.
 
13.7.3 	Fees and financial assurance - All medical waste facilities subject to regulation under this Section 13.7 shall be subject to applicable solid waste fees as required under Section 1.7 and financial assurance as required under Section 1.8 of these regulations.

13.7.4 	Inspections - All medical waste facilities subject to regulation under this Section 13.7 shall be subject to inspection and enforcement requirements in Section1.9 of these regulations.

13.8	OPERATING REQUIREMENTS FOR COMMERCIAL STORAGE AND TREATMENT FACILITIES

13.8.1	Facilities shall notify the Department and the local governing body having jurisdiction in writing of the anticipated date of startup not more than sixty (60) calendar days and not less than thirty (30) calendar days prior to the date of startup.

13.8.2 	Facilities shall be operated in accordance with their approved Engineering Design and Operations Plan and all other applicable permits.

13.8.3 	Facilities shall conduct daily inspections to detect disease vectors, leaks, odors, dust, equipment malfunctions and other site conditions that may cause nuisance conditions to occur.  If problems are found during the inspection, measures to correct the problems shall be implemented immediately. Inspections and any corrective measures taken shall be documented by the facility in an easily retrievable format.

13.8.4 	Access controls shall be used to prevent unauthorized access to areas where wastes are stored, treated or otherwise managed.

13.8.5 	Record Keeping - The facility shall maintain the following records onsite in an easily retrievable format:

	(A) The facility’s Certificate of Designation.

	(B) The facility’s approved Engineering Design and Operations Plan.

	(C) For storage facilities - copies of waste manifests or shipping papers showing incoming volumes of waste, waste types, container types, types of transport, generator names and addresses, dates of waste pick/drop-off, and destinations for waste.

	(D) For treatment facilities - copies of waste manifests or shipping papers showing incoming volumes of waste, waste types, container types, types of transport, generator names and addresses, treatment methods, dates of pickup /drop-off and treatment, copies of all verification testing results and results of treatment system monitoring applicable to the type of treatment, and final disposition of the treated waste.

	(E) Records indicating instances when the facility’s plan to prevent acceptance or treatment of prohibited wastes was put into effect and actions taken, including disposal destinations for such wastes.

	(F) A daily log or equivalent mechanism indicating inspections and necessary actions taken to resolve conditions not in compliance with the approved Engineering Design and Operations Plan.

	(G) For treatment facilities, copies of all verification testing results and results of treatment system monitoring applicable to the type of treatment.

	(H) Copies of personnel training records.	

13.8.6 	The facility shall be closed in accordance with the closure plan in its approved Engineering Design and Operations Plan.

13.9	STANDARDS FOR MEDICAL WASTE DISPOSAL	  

13.9.1	Final disposition of medical waste consisting of recognizable human anatomical remains must be by interment, cremation, incineration or entombment, or by acceptance by a representative of the State Anatomical Board. 

13.9.2	Infectious waste.

	(A) Untreated infectious waste from non-household sources may not be disposed of in a solid waste disposal site or facility unless the facility has an approved Engineering Design and Operations Plan that specifically allows these wastes.

 	(B) Once treated to achieve the required standard of biological inactivation, infectious waste is considered to have been rendered non-infectious and may be discharged into a sanitary sewer system that provides secondary treatment of waste or be disposed of with other non-medical and non-hazardous solid waste as appropriate. 

(C) Discharge to a sanitary sewage treatment system is permitted only if discharged in accordance with the wastewater treatment facility’s requirements, as applicable, and may require notification to and approval from the wastewater treatment authority.

(D) Treated infectious waste must be clearly identified as treated waste or the waste treater must notify the waste transporter and disposal facility in writing that their general solid waste includes infectious waste that has been treated to render it non-infectious.

13.9.3	Trace chemotherapy waste and waste pharmaceuticals.

(A) Trace chemotherapy waste must be disposed of in an approved solid waste disposal site or facility that has an approved Engineering Design and Operations Plan that specifically allows this waste, or may be incinerated at an approved solid or hazardous waste incinerator. 

(B) Waste pharmaceuticals that are not hazardous wastes and that do not contain controlled substances may be:

(1) Sent to a reverse distributor that collects unused, expired and recalled pharmaceuticals for proper disposal or returned to the manufacturer for credit.

(2) Sent to a mail-back service for proper disposal.

(3) Treated to encapsulate or stabilize the waste at an approved medical waste treatment facility prior to disposal in a solid waste disposal site or facility. All activities involved in the disposal of treated pharmaceuticals shall be conducted in a manner that minimizes the potential to release the waste or damage the containers holding the waste.

(4) Incinerated at an approved solid or hazardous waste incinerator.

 or

(5) Must be disposed of in an approved solid waste disposal site or facility that has an approved Engineering Design and Operations Plan that specifically allows this waste.

(C) Hazardous waste pharmaceuticals must be managed in accordance with the Colorado Hazardous Waste Act (Title 25 Article 15 Parts 1, 2, 3, and 5 CRS, as amended) and implementing regulations (6 CCR 1007-3).
(D) Waste pharmaceuticals that contain controlled substances must be managed in accordance with the US DEA requirements in 21 CFR 1307.11 or 1307.21. 

(E) Waste pharmaceuticals that are both hazardous waste and contain controlled substances must be managed in accordance with the Colorado Hazardous Waste Act (Title 25 Article 15 Parts 1, 2, 3, and 5 CRS, as amended) and implementing regulations (6 CCR 1007-3) and the US DEA requirements in 21 CFR 1307.11 or 1307.21.

13.10	TRANSPORTATION REQUIREMENTS

13.10.1	Except as provided for in Section 13.3.1, medical waste may only be transported to an approved commercial medical waste storage, treatment or disposal facility. 

13.10.2	Spills or releases of medical waste which occur during transportation shall be cleaned up immediately by the transporter according to generally accepted procedures. Spills to the environment or those exposing workers or the general public to potential infection shall be reported to the Colorado Department of Public Health and Environment, to the local governing body having jurisdiction, and to the wastewater treatment facility if discharged to the sewer system, within twenty-four (24) hours. A written summary report describing the spill or release and the actions taken to remediate it shall be submitted to the Department within fifteen (15) calendar days of the incident.

2) Section 1.2 is being amended by revising the definitions of “Biohazardous waste” and “Infectious waste” to read as follows: 

“Biohazardous wastes” means all wastes that would otherwise be an infectious wastes but are contaminated with a radioactive or listed hazardous waste solid waste containing or contaminated with organisms or viruses infectious to humans, animals or plants (e.g. parasites, viruses, bacteria, fungi, prions, or rickettsia).

“Infectious waste” means waste containing pathogens or biologically active material which because of its type, concentration and quantity could present a potential hazard to human health when improperly handled, stored, processed, transported or disposed of.  Wastes presumed to be infectious medical waste include blood and body fluids, potentially infectious waste, pathological waste, sharps, trauma scene waste, and any additional waste determined to pose a sufficient risk of infectiousness as determined by the Department on a case-by-case basis.  This also includes any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill of any infectious medical waste.  For purposes of these regulations, it does not include saliva, nasal secretions, sweat, tears, used feminine hygiene products, vomitus, urine or feces unrelated to isolation wastes, uncontaminated disposable bedding or garments, or lightly to moderately contaminated bandages, garments, etc. unless these wastes are soiled to the extent that the generator of the waste determines that they should be managed as infectious waste.  Such wastes remain regulated under the provisions of Parts 1 through 3 of these regulations.  

3) Section 1.2 is being amended by adding the following definitions in alphabetical order to read as follows: 

“Antineoplastic” means acts to prevent, inhibit, or halt the growth of a tumor.

“Blood and body fluids” means all waste unabsorbed human and animal blood or blood products, components of blood or blood products, and other body fluids.  Includes, but is not limited to, human blood; plasma; serum; platelets; other blood components and blood products; body fluids including exudates, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid and amniotic fluid; suction and irrigation fluids contaminated with blood or body fluids; liquid residues or contaminated water resulting from the cleanup of a spill of medical waste; tattoo ink contaminated or potentially contaminated with blood or body fluids; and blood and body fluids from animals known to be infected with diseases that are contagious to humans.  For purposes of this Part 13, it does not include saliva, nasal secretions, sweat, tears, or urine, feces, or vomitus unrelated to isolation wastes unless visible blood is present. 

“Empty container” means a container or inner liner removed from a container that has been emptied by the generator as much as possible using methods commonly used to remove waste or material from containers (e.g., if the material was pourable, then no material can be poured or drained from the container; if the material was not pourable, then no material can reasonably be removed by scraping).  In the case of a container that held an acute hazardous waste, the container is considered empty when the container or inner liner has been triple rinsed using a solvent capable of removing the product, the container or inner liner has been cleaned by another method that has been shown to achieve equivalent removal, or the inner liner that prevented contact of the product with the container has been removed.
“Encapsulation” means coating the surface of a solid waste with material such as resins or plastics to substantially reduce the amount of soluble, miscible or suspended contaminants leached from the waste.

“Household medical waste” means any medical waste generated by households. Does not include medical waste generated at health and residential care facilities regulated under the Standards for Hospitals and Health Facilities (6 CCR 1011-1).

“Isolation waste” means contaminated material from humans or animals that are isolated because they are suspected or known to be infected with an infectious agent capable of causing a highly communicable, possibly lethal disease.  National biosafety guidelines developed by agencies such as the U.S. Department of Health and Human Services, National Institutes of Health or the Centers for Disease Control and other medical professionals should be referenced when making this determination. 

“Medical Waste” means any  infectious, pharmaceutical or trace chemotherapy waste generated in a health care setting in the diagnosis, treatment, immunization, or care of humans or animals; generated in autopsy or necropsy; generated during preparation of a body for final disposition such as cremation or interment, generated in research pertaining to the production or testing of microbiologicals; generated in research using human or animal pathogens; or related to accident, suicide, or other physical trauma.  Medical waste does not include fluids, tissues or body parts removed from the whole body for the purposes of donation, research or other use, or those returned to the person from whom they were removed, or their authorized representative, as long as the material is rendered safe for handling.  For purposes of these regulations, this does not include medications reused in compliance with 6 CCR 1011-1 Chapter II Part 7.200 et. seq. or 6 CCR 1015-10.

“Medical waste generator” means any person, as defined in these regulations, whose act or process produces medical waste.  This includes, but is not limited to, generators at hospitals, clinics (such as medical, dental and veterinary), surgery centers, dialysis centers, blood banks, long term care facilities, hospices, funeral homes, laboratories (such as clinical, diagnostic, pathological, veterinary and biomedical research), pharmacies, body art establishments (such as where  body piercing, tattooing, branding, sculpting and scarification are performed), acupuncture facilities, trauma scene cleanup sites, facilities holding shot clinics or health fairs, other health-related facilities or events, educational and research facilities, and pet shops.

“Medical Waste Management Plan” means a document that must be developed and implemented by medical waste generators that designates all of the medical wastes generated by the facility, waste handling techniques to be used at the facility, contingency plans for spills or releases, staff training requirements, and designation of the person responsible for implementation of the management plan. 

“Medical waste treatment” means any validated method, technique, or process designed to change the biological character or composition of a medical waste so as to minimize its potential to harm human health or the environment. 

“Pathological waste” means all tissues, organs, limbs, products of conception, and other body parts removed from the whole body.  Includes, but is not limited to, tissues; organs; body parts removed during surgery, autopsy or other medical procedures; and human anatomical remains.  Also includes contaminated animal tissue (including animal carcasses and body parts) from animals known to have been exposed to infectious substances during research, production of biologicals, testing of pharmaceuticals, or other exposures and those known or suspected of being contaminated with infectious substances known to be contagious to humans.  This does not include contaminated animal waste that is regulated under Section 14 of these regulations.

“Pharmaceutical” means any prescription or over-the-counter chemical product, vaccine or allergenic that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.  This includes, but is not limited to, drugs, pills or tablets; medicinal gums or lozenges; medicinal liquids, ointments and lotions; intravenous (IV) or other compounded solutions; live vaccines; non-hazardous attenuated vaccines; allergenics; medicinal shampoos; antiseptics; medicinal dermal patches; and any delivery devices with the primary purpose to deliver or dispense a medicinal chemical product, vaccine or allergenic.  

“Potentially infectious waste” means any waste known or suspected to be contaminated with a transmissible infectious agent potentially capable of causing disease or injury.  Includes, but is not limited to, cultures and stocks from pathological, medical, research, and industrial laboratories; wastes from the production of biologicals; devices used to transfer, inoculate, and mix cultures; isolation wastes; biohazardous waste,  contaminated animal bedding from animals known to have been exposed to infectious substances during research, production of biologicals, testing of pharmaceuticals, or other exposures and those known or suspected of being contaminated with infectious substances known to be contagious to humans.  This category also includes items that are capable of releasing blood or body fluids in any form during handling or storage and items that are caked with dried blood or body fluids that could be released during handling or storage; wastes from surgery, autopsy or other medical or laboratory procedures such as visibly contaminated sponges, soiled dressings, drapes, surgical gloves, drainage sets, and dialysis wastes in contact with blood; unbroken blood vials, drainage sets, dialysis wastes, suction canisters, hemovacs, or IV bags and tubing (without needle attached) containing blood or body fluids.  This does not include contaminated animal bedding that is regulated under Section 14 of these regulations.

“Render non-infectious” means to treat infectious waste by inactivating pathogens and other biologically active material to a level that will no longer present a potential hazard of infection when managed, stored or disposed.

“Reverse distributor” means a registrant with the US Drug Enforcement Administration (DEA) who receives controlled substances acquired from another DEA registrant for the purpose of returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer's agent; or 
where necessary, processing such substances or arranging for processing such substances for disposal. 

“Sharps” means any discarded article that may purposely or accidentally puncture or cut the skin or mucosa.  Includes, but is not limited to, used needles; scalpel blades; syringes (with attached needle); pen needles; lancets; pasteur pipettes; broken blood vials; needles with attached tubing; suture needles; razor blades; tattoo pens and toothpicks; broken culture tubes and culture dishes, regardless of presence of infectious substances; broken and unbroken glassware that were in contact with infectious substances (e.g., used slides and cover slips); disposable trocars; and discarded unused or expired hypodermic needles, suture needles, syringes, and scalpel blades.

“Sharps container” means a container that is closable, puncture resistant, leakproof on the sides and bottom, and labeled or color coded in accordance with the Occupational Safety and Health Administration (OSHA) requirements.

“Stabilization” means mixing of a solid waste with Portland cement, or a combination of Portland cement and fly ash or cement kiln dust, to substantially reduce the amount of soluble, miscible or suspended contaminants leached from the waste.  

“Trace chemotherapy waste” means any empty container used to hold an antineoplastic drug (except P-listed hazardous waste), and contaminated items used with these drugs, such as gowns, wipes, or gloves.

“Trauma scene waste” means waste generated by the decontamination of accident scenes, crime scenes, suicides and other scenes of serious human injury or death.  Trauma scene waste is a special category of medical waste that is comprised of other categories of medical waste, including blood and body fluids, pathological waste, pharmaceutical waste, potentially infectious waste and various types of sharps.  This waste stream includes, but is not limited to, contaminated flooring, furniture, drywall, clothing, bedding, cleaning solutions, personal protective equipment (PPE), wipes and absorbents, and sharps contaminated with blood and body fluids or other potentially infectious material.

4) Paragraph (D) of Section 7.1 is being amended to read as follows by removing the term “medical waste”:
 
SECTION 7

REGULATIONS FOR TRANSFER STATIONS

7.1	PURPOSE, SCOPE AND APPLICABILITY:

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(D)  Only residential and commercial waste shall be accepted at transfer stations.  Wastes such as medical waste, asbestos waste and, contaminated soil shall not be accepted at transfer stations unless the transfer station is specifically designed and approved for these wastes.

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