333-056-0030 Infectious Waste Treatment (1) Pathological wastes shall be treated by incineration in accordance with ORS 459.395. (2) Cultures and stocks shall be incinerated as described in ORS 459.395(1) or sterilized by other means prescribed by this rule: (a) Incineration, in compliance with all applicable rules established by the Environmental Quality Commission; (b) Sterilization with saturated steam in a pressurized vessel dedicated to infectious waste treatment. 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; and (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) Treatment by another method that meets 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 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 shall be treated in accordance with ORS 459.395. (4) Sharps shall be treated and disposed of in accordance of ORS 459.395(4). (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. Statutory/Other Authority: ORS 431.110, 433.004, 459.395 & 459.390 Statutes/Other Implemented: ORS 431.110, 433.004, 459.395 & 459.390 History: PH 17-2020, amend filed 03/26/2020, effective 04/06/2020 PH 16-2013, f. 12-26-13, cert. ef. 1-1-14 OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0060 HD 29-1994, f. & cert. ef. 12-2-94 Reverted to HD 15-1990, f. 6-5-90, cert. ef. 7-1-90 HD 13-1992(Temp), f. & cert. ef. 12-23-92 (and corrected 12-30-92) Reverted to HD 15-1990, f. 6-5-90, cert. ef. 7-1-90 HD 20-1991(Temp), f. & cert. ef. 11-8-91 HD 15-1990, f. 6-5-90, cert. ef. 7-1-90