The Oregon Administrative Rules contain OARs filed through March 15, 2014







Purpose of Infectious Waste Administrative Rules

The purpose of OAR 333-056-0020 through 333-056-0050 is to define terms related to infectious waste and to prescribe acceptable methods of storage and treatment of infectious waste.

Stat. Auth.: ORS 431.110, 433.004 & 459.395
Stats. Implemented: ORS 459.395
Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0040


Definitions Relating to Infectious Waste

As used in OAR 333-056-0010 through 333-056-0050, unless the context requires otherwise, the following definitions apply:

(1) "Act" means chapter 763, Oregon Laws, 1989, codified as ORS 459.386 to 459.405.

(2) "Disposal" means the final placement of treated infectious waste in a disposal site operating under a permit issued by a state or federal agency.

(3) "Disposal site" means land and facilities used for the disposal, handling or transfer of, or resource recovery from solid wastes, including but not limited to dumps, landfills, sludge lagoons, sludge treatment facilities, disposal sites for septic tank pumping or cesspool cleaning service, transfer stations, resource recovery facilities, incinerators for solid waste delivered by the public or by a solid waste collection service, composting plants and land and facilities previously used for solid waste disposal at a land disposal site. “Disposal site” does not include:

(a) A facility subject to the permit requirements of ORS 468.740 [468B.050];

(b) A landfill site which is used by the owner or person in control of the premises to dispose of soil, rock, concrete or other similar non-decomposable materials, unless the site is used by the public either directly or through a solid waste collection service; or

(c) A site operated by a wrecker issued a certificate under ORS 822.110.

(4) "Division" means the Oregon Health Authority, Public Health Division.

(5) "Incineration" means the reduction in volume and weight of waste by combustion.

(6) "Infectious waste" means:

(a) "Biological waste", which includes blood and blood products, excretions, exudates, secretions, suctionings and other body fluids that cannot be directly discarded into the municipal sewer system, and waste materials saturated with blood or body fluids, but does not include diapers soiled with urine or feces. In addition, biological waste does not include articles contaminated with fully absorbed or dried blood, such as gauze, paper towels, and sanitary napkins;

(b) "Cultures and stocks", which includes etiologic agents and associated biologicals, including specimen cultures and dishes and devices used to transfer, inoculate and mix cultures, wastes from production of biologicals, and serums and discarded live and attenuated vaccines. "Cultures" does not include throat and urine cultures;

(c) "Pathological waste", which includes biopsy materials and all human tissues, anatomical parts that emanate from surgery, obstetrical procedures, autopsy and laboratory procedures and animal carcasses exposed to pathogens in research and the bedding and other waste from such animals. "Pathological waste" does not include teeth or formaldehyde or other preservative agents;

(d) "Sharps", which includes needles, IV tubing with needles attached, scalpel blades, lancets, glass tubes that could be broken during handling and syringes that have been removed from their original sterile containers.

(7) "Landfill" means a facility for the disposal of solid waste involving the placement of solid waste on or beneath the land surface.

(8) "Noninfectious" means a state in which a disease causing agent is not capable of causing an infection to occur.

(9) "Saturated Waste" means waste that contains enough body fluid that it would cause dripping of the body fluid from the waste container, with or without compaction.

(10) "Sterilization" means, for purposes of these rules, any process which changes infectious waste so that disease causing agents contained within it are rendered non-infectious at the time the process is completed.

(11) "Storage" means the temporary containment of infectious waste in a manner that does not constitute treatment or disposal of such waste.

(12) "Transportation" means the movement of infectious waste from the point of generation over a public highway to any intermediate point, to the point of final treatment, and to the point of final disposal.

(13) "Treatment" means incineration, sterilization or other method, technique or process approved by the Oregon Health Authority, Public Health Division that changes the character or composition of any infectious waste so as to render the waste noninfectious. Treatment also includes methods of rendering waste noninfectious, which are approved by the Environmental Quality Commission.

Stat. Auth.: ORS 431.110, 433.004 & 459.395
Stats. Implemented: ORS 431.110, 433.004 & 459.395
Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0050; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14


Infectious Waste Treatment

(1) Pathological wastes shall be treated by incineration in an incinerator that provides complete combustion of waste to carbonized or mineralized ash. However, if the Department of Environmental Quality determines that incineration is not reasonably available within a wasteshed, pathological wastes may be disposed of in the same manner provided for cultures and stocks.

(2) Cultures, stocks, sharps and biological wastes must be treated using one of the following methods, as delineated in subsections (2)(a), (b) and (c) of this rule:

(a) Treated via incineration. If incineration is utilized, it shall be done in compliance with all applicable rules established by the Environmental Quality Commission;

(b) Sterilization with saturated steam in a pressurized vessel. If this method is employed, a vessel dedicated to infectious waste treatment must be utilized. Operating procedures which must be developed and implemented shall include at least the following:

(A) Adoption of standard written operating procedures for each steam sterilizer including time, temperature, pressure, type of waste, type of container(s), type of closure on container(s), pattern of loading, and maximum load quantity. The manufacturer's recommendations shall be taken into account;

(B) Methods for monitoring recording or temperature measuring devices during each complete cycle to ensure that the manufacturer's recommended temperature is attained for the recommended amount of time in order to achieve sterilization of the entire load. Temperature measuring devices shall be checked for calibration at least annually;

(C) Methods for using heat sensitive tape or other device designed to indicate attainment of adequate sterilization conditions, for each container;

(D) Methods for at least monthly use of the biological indicator Bacillus stearothermophilus, or equivalent, placed at the center of a load processed under standard operating conditions, to confirm the attainment of adequate sterilization conditions;

(E) Methods for maintenance of records pertaining to paragraphs (2)(a)(A), (B) and (D) of this rule. These records shall be maintained and available for Division review for a period of not less than one year.

(c) Treated by other methods that meet the following criteria:

(A) The specific processes of the method have been tested under the conditions in which the method would be used in Oregon for the treatment of infectious waste. Such testing has demonstrated that the method is effective in rendering infectious agents non-infectious by showing bactericidal efficacy against at least spore-forming bacteria and a Mycobacterium. The testing methodology, test results, and documentation thereof must be considered scientifically valid by the Division. The determination of validity requires, but is not limited to:

(i) The testing methodology follows basic scientific principles or objectivity and is fully documented;

(ii) The results of the testing are fully documented. Raw data are made available to the Division if they are requested by the Division;

(iii) The testing has been done by a scientist(s) with an advanced degree in microbiology and with a record of having published scientific research results in a peer reviewed journal;

(iv) The report of the testing methodology and results, together with the statement "This report is an accurate and complete account of the test methods I performed and the test results I obtained" have been signed by the scientist(s) who performed the testing; and

(B) Any discharges into air or water and any solid waste resulting from the method meet the requirements of the laws and administrative rules of the Oregon Department of Environmental Quality; or

(C) The Environmental Quality Commission has approved the method and has accepted that method by administrative rule.

(3) Liquid or soluble semi-solid biological wastes may be discharged into a sewage treatment system that provides secondary treatment of waste.

(4) After treatment approved by the Division or the Environmental Quality Commission, sharps may be disposed of directly into a permitted land disposal site only if the sharps are in a red, leak-proof, rigid, puncture-resistant container which is taped closed or tightly lidded to prevent loss of the contents. The containers may not be compacted or otherwise broken before placement in the landfill. They must be placed in a segregated area of the landfill.

(5) Methods of treatment which have not been delineated in this rule or approved by the Division or the Environmental Quality Commission, as applicable, are not permitted.

Stat. Auth.: ORS 431.110, 433.004 & 459.395
Stats. Implemented: ORS 431.110, 433.004 & 459.395
Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; HD 20-1991(Temp), f. & cert. ef. 11-8-91; HD 13-1992(Temp), f. & cert. ef. 12-23-92 (and corrected 12-30-92); HD 29-1994, f. & cert. ef. 12-2-94; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0060; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14


Infectious Waste Storage Times and Temperature

(1) Infectious waste shall be segregated from other wastes by separate containment at the point of generation.

(2) Enclosures used for storage of infectious waste shall be secured to prevent access by unauthorized persons and marked with prominent warning signs.

(3) Pathological waste, biological waste and cultures/stocks shall be treated or disposed of pursuant to OAR 333-056-0010 through 333-056-0030 within seven days of generation, unless it is refrigerated (between 33 and 48 degrees Fahrenheit) or frozen (less than 32 degrees Fahrenheit). Refrigerated or frozen infectious waste may be stored 30 days prior to treatment or disposal.

(4) Prior to being treated pursuant to OAR 333-056-0010 through 333-056-0030, sharps contained in a leak proof, rigid, puncture resistant container which is taped closed or tightly lidded to prevent loss of the contents may be stored indefinitely.

(5) Generators that produce 50 pounds or less of infectious waste in any calendar month shall be exempt from the requirements pertaining to storage times and temperatures.

Stat. Auth.: ORS 431.110, 433.004 & 459.395
Stats. Implemented: ORS 431.110, 433.004 & 459.395
Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0070; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14


Exemption for Placenta Removal from a Health Care Facility

(1) Notwithstanding any other provision in these rules, a health care facility or freestanding birthing center, as those terms are defined in ORS 442.015, may release a placenta to the woman from whom the placenta originated, or to her designee, if:

(a) The facility or birthing center has a written policy and procedure to ensure the safe management and transport of placentas;

(b) The woman tested negative for infection by hepatitis B and human immunodeficiency viruses by testing obtained since the beginning of the pregnancy; and

(c) The woman, or her designee, and the woman’s health care provider sign a form that contains at least the following:

(A) The woman’s name, date of birth, address and the name of the health care provider;

(B) An attestation by the woman or her designee that the placenta will not be used for commercial purposes; and

(C) An attestation by the health care provider that:

(i) Since the beginning of the pregnancy the woman tested negative for infection by hepatitis B and human immunodeficiency viruses;

(ii) The woman either tested negative for hepatitis C virus since the beginning of the pregnancy or is not at risk for hepatitis C; and

(iii) To the health care provider’s knowledge, the woman has no infection that poses a threat to persons who handle the placenta.

(2) The health care facility or freestanding birthing center must keep a copy of the signed release form described in subsection (1)(c) of this rule in the mother’s medical record.

(3) Health care facilities and freestanding birthing centers shall make policies and procedures developed in accordance with subsection (1)(a) of this rule available to the Division upon request.

(4) Nothing in this rule prohibits a health care facility or freestanding birthing center from having additional requirements for the removal of a placenta from the facility or center.

Stat. Auth.: ORS 431.110, 433.004, 459.400
Stats. Implemented: ORS 431.110, 433.004, 459.400
Hist.: PH 16-2013, f. 12-26-13, cert. ef. 1-1-14


Prevention of Disease Transmission by Blood-Contaminated Sharp Objects

Any person using sharp instruments (for example, needles, lancets, scalpels) for purposes of drawing blood, administering medication, or medical/surgical procedures on humans, shall dispose of such items in a manner that will protect any other handlers of this waste from injury. The disposal of such waste shall be in accordance with current recommendations of the U.S. Centers for Disease Control and Prevention, and shall include the use of impervious, rigid, puncture-proof containers. This rule applies to but is not limited to blood banks, plasmapherisis centers, medical clinics, dental offices, outpatient care centers, inpatient care facilities, hospitals, and home health agencies.

Stat. Auth.: ORS 431.110, 433.004 & 459.395
Stats. Implemented: ORS 431.110, 433.004 & 459.395
Hist.: HD 4-1987, f. 6-12-87, ef. 6-19-87; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-019-0212; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

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