Ga. Comp. R. & Regs. R. 391-3-4-.15 - Biomedical Waste

(1) All persons subject to regulation under Rule .15 shall, in addition to the requirements of Rule .15, handle biomedical waste in accordance with the provisions of O.C.G.A. 12-8-20, et seq., and the Rules for Solid Waste Management, Chapter 391-3-4 applicable to solid waste.

(2) Biomedical waste shall mean and include the following:

(a) Pathological waste, which means all recognizable human tissues and body parts except teeth which are removed during surgery, obstetrical procedures, autopsy, and laboratory procedures.

(b) Biological waste, which means blood and blood products, exudates secretions, suctionings, and other body fluids which contains free liquids and cannot be or are not directly discarded into a municipal sewer system.

(c) Cultures and stocks of infectious agents and associated biologicals including cultures from medical and pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures.

(d) Contaminated animal carcasses, body parts, their bedding, and other wastes from such animals which are infected with or which have been exposed to infectious agents, capable of causing disease in man.

(e) Sharps, which means any discarded article that may cause punctures or cuts. Such waste includes, but is not limited to, items such as needles, IV tubing and syringes with needles attached, and scalpel blades.

(f) Chemotherapy waste, which means any disposable material which has come in contact with cytotoxic/antineoplastic agents (agents toxic to cells) and/or antineoplastic agents (agents that inhibit or prevent the growth and spread of tumors or malignant cells) during the preparation, handling, and administration of such agents. Such waste includes, but is not limited to, masks, gloves, gowns, empty IV tubing bags and vials, and other contaminated materials. The above waste must first be classified as empty which means such quantity that it is not subject to other federal or state waste management regulations prior to being handled as biomedical waste.

(g) Discarded medical equipment and parts, excluding expendable supplies and materials included in paragraphs (a) through (f) of this Rule, which have not been decontaminated, and that were in contact with infectious agents.

(3) Generation of Biomedical Waste.

(a) Unless otherwise exempted, Rule 391-3-4-.15 shall apply to all persons generating or handling biomedical waste, including but not limited to: ambulatory service centers, blood banks, clinics, county health departments, dental offices, funeral homes, health maintenance organizations (HMOs), hospitals, laboratories, medical buildings, physicians offices, veterinary offices, research and manufacturing facilities, nursing homes, and biomedical waste transportation, storage, treatment, and disposal facilities.

(b) Partial exemption: facilities which generate less than 100 pounds per month of biomedical waste shall be exempt from all provisions of Rule 391-3-4-.15 except that they shall comply fully with the provisions of Rule 391-3-4-.15(4)(a), (4)(b), (4)(b)1., (4)(b)2., (4)(c), (6)(c), and (7)(b). For purposes of this Rule, a facility is defined as one or more persons generating biomedical waste who share common waste management services including, but not limited to, bulk storage containers.

(c) Total exemption: in no case shall a person be generator of biomedical waste if those wastes are generated from single-family residential premises or a single-family dwelling unit in the self-care and treatment of family members living in those premises or units and disposed of as residential solid waste. Home health care organizations or physicians treating patients in a home are not exempt unless otherwise exempted in (b) above.

(d) All requirements of this Rule shall apply to persons or facilities who generate 100 pounds or more biomedical waste per month.

(4) Storage and Containment of Biomedical Waste.

(a) Containment of biomedical waste shall be a manner and location which affords protection from animals, rain and wind, does not provide a breeding place or a food source for insects and rodents, and minimizes exposure to the public.

(b) Biomedical waste shall be segregated by separate containment from other waste at the point of origin.

1. Biomedical waste, except for sharps, shall be placed in containers which are impervious to moisture and have a strength sufficient to preclude ripping, tearing, or bursting under normal conditions of use. The containers shall be securely closed so as to prevent leakage or expulsion of solid or liquid wastes during storage, handling, or transport.

2. Sharps shall be contained for storage, transportation, treatment and subsequent disposal in leakproof, rigid, puncture-resistant containers which are taped closed or tightly lidded to preclude loss of contents.

(c) Rigid containers of discarded sharps and all other disposable containers used for containment of biological waste shall be red or orange in color or clearly identified with the universal biohazard symbol or clearly marked with the word "Biohazard".

(d) Biomedical waste contained in disposable containers as prescribed above, shall be placed for storage, handling, or transport in disposable or reusable pails, cartons, boxes, drums, dumpsters, or portable bins. The containment system shall have a tight fitting cover and be kept clean and in good repair. The containers may be of any color and shall be conspicuously labeled with the universal biohazard symbol and the word "Biohazard" on the sides so as to be readily visible from any lateral direction when the container is upright.

1. Reusable containers used for shipment of biomedical waste shall be thoroughly washed and decontaminated each time they are emptied.

2. Reusable pails, drums, dumpsters or bins used for containment of biomedical waste shall not be used for other purposes except after being decontaminated by procedures as described in (4)(d)1. above and after the universal biohazard symbol and word "Biohazard" are removed.

(5) Transfer of Biomedical Waste to Off-Site Treatment or Disposal Facilities.

(a) Any generator of biomedical waste shall transfer custody of the waste only to a collector who is operating under authority of these Rules.

(b) Biomedical waste shall not be transported in the same vehicle with other solid waste unless the biomedical waste is contained in a separate, fully enclosed leakproof container within the vehicle compartment or unless all of the waste is to be treated as biomedical waste in accordance with the requirements of these Rules.

(c) Biomedical waste shall be delivered for storage, including intermediate transfer, and treatment only to a facility or location for which there is a valid and appropriate operating permit as set forth in these Rules.

(d) Surfaces of transport vehicles that have contacted spilled or leaked biomedical waste shall be decontaminated.

(e) Equipment used to transport waste from the generator to the off-site treatment or disposal facility may not destroy the integrity of the container.

(f) Vehicles used for the transport of biomedical waste shall not be used for transportation of food or food products.

(6) Treatment of Biomedical Waste.

(a) If treated in accordance with the following procedures, the waste shall no longer be considered biomedical waste and may be combined and handled with regular solid waste. Biomedical waste shall be treated by one of the following methods prior to disposal at a permitted waste disposal facility.

1. Incineration in the thermal treatment technology facility which provides complete combustion of waste to render it nonpathogenic.

(i) Biomedical waste thermal treatment technology facilities shall be capable of maintaining a minimum temperature in the primary chamber sufficient to destroy infectious agents and procedure a residue essentially free of odors and unstable organic matter. If chemotherapy wastes are incinerated, the facility must be capable of maintaining a minimum of 1,800 degrees Fahrenheit in the secondary combustion chamber and a minimum residence time of two seconds.

(ii) Atmospheric emissions shall be controlled so as not to exceed air quality standards of the Division.

2. Decontamination by heating with steam under pressure (autoclave) so as to render the biomedical waste noninfectious.

(i) A recording thermometer shall be used during each complete cycle to ensure the attainment of a temperature of 121 degrees Centigrade (250 degrees Fahrenheit) for one-half hour or longer in order to achieve decontamination of the entire load.

(ii) Monitoring of the steam sterilization process shall be required in order to confirm the attainment of decontamination.

(iii) Monitoring may be through the use of biological indicators or other methods as approved by the Director. Indicators used to ensure the attainment of the proper temperature during steam sterilization shall be placed at the point of the load where the rate of thermal penetration is at a minimum.

3. Other methods as may be approved by the Director.

(b) Fluid or semisolid waste specified in (2)(b) of this Rule may be discharged to a sewage treatment system that provides secondary treatment of waste if approved by the agency responsible for the operation of the sewage treatment system.

(c) Biomedical wastes consisting of recognizable human anatomical remains shall not be disposed of by landfilling.

(d) Chemotherapy waste, as defined in (2)(f), shall be treated at a permitted thermal treatment technology facility or other facility approved by the Director. Steam decontamination may not be used for the treatment of chemotherapy waste.

(e) All facilities treating regulated quantities of biomedical waste must, at a minimum, comply with the above criteria. Commercial biomedical waste treatment facilities may not construct or operate a biomedical waste treatment facility without first obtaining a solid waste handling permit under these Rules. On-site biomedical waste treatment facilities are required to obtain a solid waste permit-by-Rule, and must comply with the provisions of paragraph (6)(a)-(d) of this Rule, in addition to Rule 391-3-4-.06. For purposes of this Rule, "Commercial biomedical waste treatment facility" means a facility which accepts over 25 percent of its biomedical waste from other, off-site, facilities, which are not owned by the facility owning the treatment or disposal facility, generally for a fee.

(7) Disposal of Biomedical Waste.

(a) Biomedical wastes treated in accordance with the provisions in Rule 391-3-4-.15(6), shall be properly disposed of at a facility permitted under the authority of these Rules unless otherwise approved by the Director.

(b) Biomedical waste from generators of less than 100 pounds per month shall be properly disposed of at a municipal solid waste landfill or treatment facility permitted under authority of these Rules or other facilities approved by the Director.

(c) The disposal of untreated biomedical waste, from generators of more than 100 pounds per month, by landfilling is prohibited.

Notes

Ga. Comp. R. & Regs. R. 391-3-4-.15

O.C.G.A. Secs. 12-8-20 et seq., 12-8-23.

Original Rule entitled "Biomedical Waste" was F. Jun. 9, 1989; eff. Jun. 29, 1989. Amended: F. Sept. 4, 1991; eff. Sept. 24, 1991. Amended: F. Jun. 7, 1993; eff. Jun. 27, 1993.