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HomeMy WebLinkAboutRISK MANAGEMENT (3) SAN JOAQUIN CO~IUNITY HOSPITAL RISK I~IANAGEI~ENT AND PREVENTION PROGRAPI FIRE SAFETY ARCHITECTURAL AND ENGINEERING RECEIVED GUIDELINES HAZ. MAT. DIV. FOR THE USE OF ETHYLENE OXIDE AS STERILIZING AGENT WITHIN OSHPD HEALTH FACILITIES October 28, 1993 PREFACE SCOPE OF GUIDELINES: The scope of these guidelines is limited to the fire and life safety aspects of regulatory standards to permit the use of a hazardous material sterilizing agent, ETHYLENE OXIDE (ETO), in health care facilities. This document is intended to provide the architectural and engineering communities with construction and installation guides for fire safety only and does not supersede or control the use of ETO as regulated by other federal, state or local agencies such as but not limited to the; a. California Environmental Protection Agency (CAEPA) for environmental issues, b. California Air Resources Board for air pollution and air quality, c. California Waste Management Board (CAWMB) for the disposition of disposable canisters, and the d. California Occupational Health & Safety Agency (CAL-OSHA) for employee protection, or any other regulatory agency not addressed here. References California Code of Regulations, Title 8, Section 5220 California Building Code (CBC) California Mechanical Code (CMC) California Plumbing Code (CPC) · California Electrical Code (CEC) California Fire Code (CFC) National Fire Protection Association (NFPA) "Ethylene Oxide Use in Hospitals", a manual for Health Care Personnel "Ethylene Oxide Sterilizers in Health Care Facilities", Engineering Controls and Work Practices, by NIOSH Any conflict, duplication and overlap of any building regulations under the regulatory development responsibility of OSHPD and the building standards adoption responsibility of the California Building Standards Commission will be addressed for any safety measures under appropriate standards adoption procedures. In a effort to provide a support base for any recommendations made herein, it is necessary to provide product data and engineering evaluations for all related disciplines. Paramount to our analysis is the recognition of the beneficial and functional use of Ethylene Oxide (ETO) as an antimicrobial chemical sterilizer, albeit, having severe toxic effects to humans when exposed to very limited quantities of gaseous vapors. October 28, 1993 -2- This evaluation of ETO in both 100% pure product "sterilant gas" and diluted mixtures of 12% " ETO with 88% FREON (dichlorodifluoromethane) 'sterilant mixture 12%-88%" will include: 1. The chemical and physical properties of ETO and ETO gas mixtures, 2. Building design for use and storage areas '(Central Supply vs. designated sterilizing areas ) and (gas tanks vs. disposable canisters), 3. Electrical safety wiring methods, 4. Mechanical ventilation of use and storage areas 5. Piping methods for ETO/Freon gas supply and waste disposal via water waste isolation, 6. And fire prevention practices and standards to reduce the risk of ETO use. This guideline incorporates the provisions of the applicable state code adoptions of the 1992 editions of the California Code of Regulations. APPLICATION OF CALIFORNIA FIRE SAFETY STANDARDS: The application of State building regulations (Title 24, Parts 2, 3, 4, 5, 9,& 12 CCR) is based upon the requirements of the principle use of the building (hospitals are Group I, Division 1.1 occupancies) and the accessory use of ETO. Use and/or storage areas, within hospitals, for E-TO are NOT treated herein as a mixed occupancy under the provisions of Chapter 5, CBC. Since the application of the CFC and the CBC stipulate that the examination of the product for all classifications is necessary, it follows that the most restrictive limit of exempt quantity will govern the proper application of these regulations. The most restrictive classifications are the UFC HEALTH HAZARDS, toxic for liquid ETO and toxic for compressed gas, which limits the exempt quantity to ZERO of ETO in 'l" occupancies. The OSHPD modified 'exempt' amount shall be the aggregate of storage and use of ETO. and shall not exceed 6 gallons liquid measure. By limiting the quantities of storage and use of ETO within the 'l' occupancy, OSHPD recognizes the functional needs for the proper administration of health care, yet fulfills its obligation to provide a fire safe environment. Quantities not exceeding 6 gallons liquid measure shall be considered as the 'exempt' amount for the purpose of applying these guidelines. Quantities in excess of this 'exempt' amount shall be used and stored as stipulated in Table 9-A (for physical hazards) and Table 9-B (for health hazards) of Chapter 9 of the CBC. NOTE: THE 'EXEMPT" QUANTITIES LISTED IN THE TABLES ARE LIMITED TO THE AGGREGATE QUANTITIES OF USE AND STORAGE AND SHALL NOT EXCEED THE AMOUNTS SHOWN FOR STORAGE. (SEE NOTE # 2 UNDER TABLE 9-A AND NOTE # 3 UNDER TABLE 9-B). October 28, 1993 -:3- Since the CBC references the safety standards of the CFC, the hazard classifications ' (physical & health) was also used to determine the 'exempt" amounts for each classification as noted in the appropriate tables referenced in the related Section of Chapter 80, Divisions I, II, III and IV of the UFC. Prcduct classifications listed in the classification table are based upon the CBC, Chapter 4 & 9 and the CFC, Articles 9, 74, 79, 80 and Part VIII, Division VI-A. The evaluation of ETO for applicable fire safety requirements is therefore based upon the nature of the materials used and stored within the primary building, (i.e. hospital use). The proper references for ETO, as a flammable liquid (Chapter 79 of the CFC) are in Chapter 10, Section 1008(a) of the CBC, and for other physical and health hazard classifications Chapter 9, Section 901 (a). See Division VII under Chapter 9, CBC. For storage quantities, shown in the appropriate hazardous material tables, in excess of the 'exempt amounts" permitted in "1" occupancies, the provisions of the CBC, Chapter 9 for 'H" occupancies shall apply as welt as the provisions of the CFC. Quantities in excess of this amount, according to the applicable codeS, would require the application of occupancy-separations, Chapter 5, CBC, and mandate the storage and use of ETO in hospital sterilizer moms that are separated from the remainder of the facility by not less than 4 hour occupancy separations. (No openings permitted) The aggregate amount (storage and use) of ETO shall not exceed 6 gallons liquid measure, when the design conditions for all disciplines are provided in compliance with the requirements stated in this guideline. A '1.1.1' occupancy shall have not more than one control area with that portion of the building designated as a hospital. This quantity provides for the functional use of 100% ETO marketed in 5 oz. canisters and 12%-88% ETO/Freon marketed in liquified.gas cylinders. Since the OSHPD modified 'exempt" amount exceeds the regulatory limits of the quantities specified for "exempt~ amounts specified in the CBC and the CFC, applicable provisions for fire safety referenced herein include the requirements intended to be applied for quantities exceeding the specified amounts as referenced in the CFC, Division III, Section 80.301 (a)(2). For aggregate amounts that exceed 6 gallons liquid measure, provision will be made to provide "H" occupancy fire resistive separations (4 hr.) as well as all related design conditions for all disciplines. [CFC 79.202, 80.108(b)] October 28, 1993 -4- PART 2 CCR BUILDING CONSTRUCTION GUIDELINES FOR ETO STERILANT (100% OR 12%/88% GAS MIXES) GENERAL-USE: 1. For purposes of this guideline the 'exempt" amount for ETO shall be the aggregate amount for storage and use of 6 gallons or less, liquid measure. 'H' occupancy separations shall be required/or quantities in excess of 6 gallons liquid measure. [CBC - see Table 9-A, Footnote 2, Chapter 5 - CBC] 2. Storage and use shall mean 'control area' and shall be separated from the remainder of the building by a 1 hr. occupancy separation. [CFC 79.202, 80.103(b), CBC Table 9-A, Footnote 1] 3. All ETO indoor control areas shall be protected with automatic fire sprinklers installed per NFPA 13 for light hazard. [CFC Table 79.203C] 4. Inventory quantities allowed by the guideline shall not be located near exit doorways, stairs, or any location that may.impede egress from the control area. [CFC 79.201 (d)] 5. The term 'ETO System' used in this guideline shall mean the sterilizer, with or without attachment to an aerator and may include direct attachment to vapor emission and/or vapor processing equipment, as designed. 6. No open flame heat source shall be permitted in any use area housing a ETO sterilizer. [CFC 79.114, 79.8050), 80.401(h), 80.301(f)] 7. Ail ETO equipment shall be tested and listed by a nationally recognized testing agency for the type and class of the equipment installed. [CBC 402(r); CFC 79.105 (a), 80.401 (b) (2)] 8. Ail ETO components and equipment shall be enclosed in a room provided with exhaust ventilation required by the mechanical provisions and provided with the installation of electrical equipment and wiring as required by the electrical provisions of this guideline. [CMC 1002(a), CFC 80.108(b) & CBC Table 9-A, Footnote 1] October 28, 1993 USE AREAS FOR 12%-88% ETO SYSTEMS: " A. ETO cylinders located in 12%-88% ETO use areas shall be secured in racks or other means to prevent accidental overturn and discharge. [CFC 74.107(a)] B. Not more than 2 cylinders for primary supply to.a single or manifolded unit may be connected to the sterilizing cabinets in a 'control' area. Each cylinder shall have a capacity not to exceed 140 lbs of 12%-88%gas mix and shall not contain more than 2.55 gallons liquid measure of ETO. GENERAL-STORAGE: (100% OR 12%-80% GAS MIXES) A. No open flame heat source shall be permitted in any ETO storage area of any quantity. [CFC 79.114, 80.301(f)] B. ETO may not be stored with any other incompatable material or chemical. [CFC 80,301 (a)(3)(D) & Table 80.309(a) Footnote] C. Storage of ETO in excess of the exempt amounts in basements or cellars is not permitted. [CBC 901 (e)(3), CFC 79.201(f), 79.203(e), 79.805(b) 80.309(a)(8)] D. A vapor leak detection and monitoring system shall be installed in all ETO indoor storage areas. [CFC 80.301(u)] E. ETO Cylinders located in indoor store rooms shall be secured in racks or other means to prevent accidental overturn and discharge. [CFC 74.107(a)] October 28, 1993 ,-6- CEC , ELECTRICAL CONSTRUCTION GUIDELINES FOR ETO STERILANTS GENERAL: USE AND INTERIOR STORAGE (100% or 12% - 88% Gas Mixes) A. All non-fire emergency monitoring systems for ETO ventilation power supplies for fan units, ETO-leak systems, and any other ETO related emergency monitoring system shall annunciate a AUDIBLE and VISUAL signal at a location continuously attended by Staff. The signals shall not be self restoring. [CFC 80.401(m), 80.301(u)] B. An approved emergency alarm shall be provided in buildings, rooms, and areas used for storage of hazardous materials. Emergency alarm signal device shall be installed outside of each interior exit door of storage building, rooms or area. Activation of the emergency alarm-initiating device shall sound a local alarm to alert occupants of and emergency situation involving hazardous materials. [CFC 80.30~ (u)] C. A power-interlock between ETO systems and the exhaust ventilation system shall be designed to prevent the operation of the sterilizer when the exhaust ventilating system is not operating, or when any aerator and/or emission control device fails to provide the sterilizer with the functions intended by these devices. [CMC 1103(a)] D. Smoke detectors, products of combustion type, shall be installed in all ETO use and storage rooms. Smoke detectors shall be of the 'open area' type and shall be connected to the fire alarm system serving the ETO system area. [CFC 80.301 (v), 80.306(a) (10) 80.402(b)(3)(G) (VI)] E. Emergency power to all ETO fire safety systems shall be interconnected to the 'life safety branch' of the emergency distribution panel of the emergency power generator. [CFC Section 80.401(I) & 80.301 (s); CEC 517-32] F. Emergency power to all equipment of ETO systems and ETO ventilating equipment shall be interconnected to the 'critical branch' of the emergency distribution panel of the emergency power generator. [CEC 517-34(b)(3); CBC 902(g); CFC 80.301(s); CMC 2102(0(4)] G. The operation of all equipment in a ETO system shall be interfaced with all alarm systems such that the ETO system shall be interrupted upon the activation of an alarm. The interruption of any ETO system equipment shall not cause failure of the safety features contained within approved equipment. [CMC 1103(a), CEC 701-2] H. A ventilation alarm shall annunciate the loss of negative duct pressure serving the ETO ventilation system. Ventilation alarms may be activated by pressure differential sensors or sail switches. [CFC 80.401(m); CBC 1005E(e)] I. The presence of ETO vapor in a ETO use or storage area shall cause a vapor detection sensor alarm. [CFC 80.401(m)] October 28, 1993 -7- d. Limit control temperature sensors shall be placed within ETO storage areas and shall , alarm when the ambient temperature exceeds the maximum temperature recommended by the manufacturer or the temperature shown on the MSDS, whichever is lower. [CFC 80.301(t)(3)] K. All fire safety alarm systems (fire alarm and automatic fire sprinkler) shall transmit both audible and visual supervisory annunciation at a constantly attended on-site location. [CFC 80.301 (u)] (12%-88% GAS MIXES) ALL USE AND INTERIOR STORAGE AREAS: A.12%-88% Cylinders and cylinder'racks shall be effectively grounded. [CFC 80,401(i)] B, Loss of power to the ventilating exhaust system shall cause the 12%-88% ETO supply tank motorized ball valves to close automatically, [CFC 80.401(c)(2)(D)] October 28, 1993 -8- CMC (UMC) ,; MECHANICAL HEATING AND VENTILATING GUIDELINES FOR ETO STERILANTS (100% OR 12%-88% GAS MIXES) GENERAL-USE & STORAGE: 1. All rooms containing ETO systems shall have a dedicated exhaust system providing not less than 10 air changes per hr. The ventilation system shall run continuously and shall be of the non-recirculating type. All ETO rooms shall be maintained at a negative air balance. [CMC 2111(a), CMC Table 2110 A] 2. The room ETO ventilation system shall be designed to provide exhaust duct opening with the capacity to exhaust (1/2) half of the required ventilation within 6 inches of the floor level and 1/2 within 12 inches of the ceiling (flat ceiling or highest point of sloped ceilings). [CFC 80.303(a)(6)(c), 80.301(m)(5)] 3. All air from ETO sterilizer equipment and storage rooms shall be exhausted to the outside by a dedicated exhaust system. [CMC Table 2111 (b)] 4. All ETO ducts shall be of the non-flexible type and shall conform to Chapter 10 & 11 of the CMC. For ETO exhaust ducts carrying ETO vapors, (which have not been processed by emission control devices or vapor recovery systems) extending through floors shall be enclosed in a shaft enclosure of fire-resistive construction having the time period set forth in Table No. 17-A of the 1992 California Building Code [CMC 1706]. Steel or copper pipes (up to 4 inch in diameter) may be used in lieu of ducts carrying ETO vapors from the aerator to the emissions control device. Where continuous leak free pipes are utilized, rated shafts will not be required. [CBC, Section 4304] 5. The exhaust fan for the dedicated system shall be located at the discharge point of the system. The discharge point shall be not less than 25 feet from any openable window, air intake, ignition source or exitway. Prevailing wind direction shall be taken into consideration. [CMC 2103 (b), 2111 (c)] 6. Exhaust ducts from emission control devices and/or vapor recovery systems may be located within shafts or chases containing environmental air ducts. When the temperature of the emissions are below 250°F. 7.Fans used on exhaust systems using 100% ETO shall be spark proof, with the motor separate from the blower and located outside of the air stream. [CMC 1103] 8. Ventilating exhaust hoods connected to the proprietary ETO exhaust system shall be located over each, ETO sterilizer chamber and/or aerator, access doors, and ETO gas cylinder manifolds supplying ETO to the sterilizer. Non-proprietary hoods shall extend not less than six(6) inches beyond the area served. Hood exhaust ducts may be manifolded with the room ventilation system. [CMC 2111(d)(2), 1106; CFC 80.402 (b)(3)(c), 80.402(b)(2)(C)] October 28, 1993 -9- 9. Emission control equipment may be installed at exterior locations. Emission control devices located indoors should be placed in the same location as the sterilizer. For the purposes of installation, emission control devices shall be considered as industrial Iow heat appliances and shall comply with the applicable provisions of CMC Chapter 9. The vent (chimney) from emission control systems shall be enclosed within a fire. rated shaft. [CMC 914(a)] 10. Vents (chimneys) handling exhaust over 250°F from emission control devices processing ETO vapor shall be metal and shall be enclosed in a fire resistive shaft as required by CMC Section 914(a)(8). 11. Vents/chimneys for emission control devices shall not be manifolded or interconnected with any other vent or chimney serving any heat producing appliance of any type. EXCEPTION: Vents/chimneys for 2 or more ETO emission control devices may be manifolded. 12. The mechanical exhaust fan shall be controlled by a switch outside of the ETO use area and shall be located adjacent the.use room access door. The switch shall be of the 'break-glass' type and shall be identified as 'exhaust system emergency shut-off'. [CE~C 905(b)] 13.Existing facilities subject to ETO emissions control shall eliminate sterilizer exhaust vacuum pump discharge into wastewater streams. [ARB Staff Report, 3/23/90] 14. Cylinder changes shall be made under a hood and duct connected to the exhaust system. The hood shall be located not more than one (1) foot above the point where the change of cylinders takes place. [CMC 2111 (d)(3)] 15. Motorized ball valves shall be installed on ETO gas supply lines at the point of connection to the ETO gas cylinders to minimize leakage during cylinder exchange. Remote controls should be located at the Fire Control Panel to shut off the cylinders · in case of a spill, and a second switch shall be installed adjacent to the cylinders to be used when exchanging cylinders. [Ethylene Oxide Use in Hospitals - Second Edition, Engineering Controls, UFC 80.401 (c)(3)(D)] October 28, 1993 -'I O' CPC (UPC) ,; PLUMBING AND PIPE GUIDELINES FOR ETO STERILANTS GENERAL: 1. No ETO piping shall pass under any building or be contained in or under concrete floors. [CFC 80.402(b) (3) (B)] 2. No piping carrying ETO as a liquid or as a gas, including pressure relief valve piping from ETO systems shall be installed in any plenums, or any shaft used for elevators, laundry chutes, refuse/trash chutes, chimney or HVAC appliance vent shaft, nor shall any ETO piping pass through any circulating air duct. All sterilizer relief valves shall exhaust directly to the exterior or be connected to the dedicated exhaust system. [CMC 2111 (d)(4)] 3. ETO piping installed in combustible partitions shall be Protected against physical damage by installation within metallic pipe or conduit. Protection for dissimilar metals shall be provided. Openings for piping installed in concealed spaces shall be fire- stopped with construction having a fire resistance equal to or greater than the original construction. [NFPA 99, 4-4.1.2.1(f)] 4. ETO gas piping shall be copper or stainless steel. Fitting connections to pipe or tube shall be brazed or welded. Flared fitting connections for ETO systems are prohibited. [CFC 80.401 ((c)(3) (A)] 5. All exposed ETO piping shall be tagged or signed at 30 foot intervals. Separate floor zone valves for each control area shall be provided and each valve shall be identified 'ETO VALVE'. CFC 80.401(c)(2)(B) 6. All piping, valves and fittings shall be designed from ETO compatible materials and shall be of adequate strength and durability to withstand pressure, structural and seismic stress and exposure to Which they may be subjected. [CFC 80.301(c)] October 28, 1993 -11- RECOGNIZED FIRE PREVENTION PRACTICES 1. All indoor ETO use and storage areas shall contain a sign conspicuously located and visible reading: "ETHYLENE OXIDE IS USED-OR STORED IN THIS AREAl NO SMOKING OR OPEN FLAME PERMITTED. DO NOT INCINERATE OR PUNCTURE LEAKING ETO CARTRIDGES." [CFC 80.304 (d)] 2. For storage and use areas for 100% ETO, a flammable liquid sign reading: ' DANGER. FLAMMABLE LIQUIDS' shall be required. Letters shall 'be not less that 3' high with a .5 inch stroke. [CFC 79.109(b)] 3. Not less than one (1) portable fire extinguisher having a rating of 20 B.C. shall'be located not more than 10 feet from the exit door of an ETO storage room. [CFC 79.205(a)(2)] 4. The connection of the sterilizer to ETO supply cylinders and the transfer of ETO to the sterilizer shall be from factory filled and U.S.D.O.T. approved shipping containers. The transfer of ETO in liquid or gaseous form from factory filled containers to other containment vessels is prohibited. [NFPA-99 4-6.2.1.5] October 28, 1995 -'12- The classifications of ETO based upon the CBC and the CFC are as follows: CLASSIFICATION ·TABLE PRODUCT: CLASSIFICATION: EXEMPT AMOUNT FOR' "H" gCC CLASS FOR 'CODE REFERENCE: · "1"O C ........ ' ' ~" 12%-88% ETO and ' FLAMMABLE LIQUID, ZERO {01 gallons H-3 CBc-g01 la) 100% ETO. Both products meet CLASS lA CFC Table 79.202 and classification's as shown Footnote #2 except 100% ETO also classified as a Flammable Liquid, Class lA. BOTH ' UNSTABLE REACTIVE LIQUID, ZERO (0} LBS except H-2 CBC-901 5 LBS == .5 Gallons for storage. CLASS 3N (non-detonable) CFC Table 80.309(a) and · 1 Gallons in closed system for Footnotes # 1 & 2 use ISee Table gA for Physical Hazardsl 100% ETO when ' ' TOXIC LIQUID ZERO {0} Amount H-7 CBC-901 (a) ingested See Table 80.303-A, Footnote CFC 80.312(a), Exception //1 #2 Isee definition, CFC 9.122 , , . {all 1 2%/88% ' ' COMPRESSED GAS ZERO (0) H-2 CFC Table 80.303-A Same as for 100% ETO BOTH ° ® CARCINOGEN Not Defined in CBC or CFC H-7 CBC-901 (a) Defined under OSHA-IARC-NPT (see Table 9-BI BOTH ° ® IRRITANT 500 LBS = ,50 Gallons H-7 CBC-901 (al (other health hazard) Except toxic classification sets Isee Table 9-B and CFC Table the exempt amount at zero. 80-315-AI :ootnote: Since' the ETo exeml~t amount for both Dhvsical and health hazard Clas.~ific~tinrt_~ i_~'7,~rnlnl quantities in storage cabinets and/or building protected by automatic fire sprinkler systems shall not apply. October 28, 1993 -13- CHEMICAL AND PHYSICAL PROPERTIES OF ETHYLENE OXIDE AND ' ETO GAS MIXTURES: 100% PURE ETO PHYSICAL DESCRIPTION: o ETO is a colorless gas at room temperature above 51 degrees F. o Sweet odor in concentrations between 500-700 ppm. o Molecular weight: 44.06 o Boiling point: 10.7 degrees C. 51 degrees F. at atmospheric temperature and pressure (14 lbs/sq, in. sea level). o Freezing point: minus 168.3 degree's F. o Vapor pressure: 1094 MM of Mercury @ 20 degrees C. = 7.3 pounds per square inch gage (PSlG) o Va~3or t3ressure as determined by the UFC Standard 9-5 iS for flg~mmable liquid,~ only, therefore does not apply to ETO. Vapor pressure more than 40 PSI at 100 degrees F. classed as a compressed gas. (See definitions, compressed gas) [UFC 9.1o5(c)] o Vapor density compared to air: 1.49 (air = 1.0) o Vapor air density: 1.2 @ 100 degrees F. o Soluble in water: 10O% o Specific gravity: 0.87 @ 20/20 C (water = 1) o Volatility: 100% · o Flammable limits (% of gas in air) for_ignitable mixture: 3% to 100% o Flash point (ignition temperature of vapor): 20 degree F. (open cup method) October 28, 1993 -14- CHEMICAL AND PHYSICAL PROPERTIES OF ETHYLENE OXIDE' AND '~, ETO GAS MIXIURES: o Marketed in "unit-dose' canisters/cartridges: wt. per canister range: 67-140 grams wt. capacit~ per canister range: 2.24 oz. - 4.9 oz. vol. capacity per canister range: 2.95 oz. - 5.63 oz. 4.9 oz. (wt) canister .087 gallons (vol) 25 lbs. annual discharge means 81.63 ETO cycles (one canister per cycle) [16/4.9 x 25]. o Sterilizing.cabinet concentrations: 1000 rog/liter of cabinet volume. o ETO cartridge storage temperature: 59 degrees F. to 86 degrees F. o ETO - toxic 1 ppm/million average 8 hour exposure (CAL-OSHA) CLASSIFICATIONS: o Classified as a CLASS I Flammable Liquid by U.S.D.O.T. for packaging and shipping. Also classified as an 'unstable reactive" liquid. o CEC (NEC) Hazardous Atmosphere Classification is equal to Class I, Division 1 or 2. Group 'B' in NEC table of vapors for flammable liquids. o NFPA Hazard Classification for: Fire Protection (requires self-contained breathing unit) Health - 2 Fire Classification. very flammable Fire - 4 Reactivity (detonation/explosive) Reactivity. 3 o UFC Classifications: Class 1 A Flammable Liquid Carcinogen Unstable Reactive - Class 3 Irritant Toxic Liquid Other Health Hazards October 2tg, 1993 -15- 12% - 88% ETHYLENE OXlDE/FREON MIXTURES: , TANKS/CYLINDERS: 12% ETO AND 88 % FREON - by weight 27.3% ETO and 72.7% FREON - by volume ETO Tank capacity (cu.ft.) - 532 cubic feet @ 0 degrees C. UFC Classification: Compressed gas (unstable-reactive) See UFC Appendix VI-A, (2) (a) (2) (H) Carcinogen Irritant Other health hazards D.O.T.classification of ETO gas mixtures: 'non-flammable' gas Capacity of portable tanks (ETO-12%, FREON-88%): 140 lbs. (16 lbs. ETO and 123 lbs. FREON) Net ETO liquid measure = 2.55 gallons 12% - 88% mix = 3.8 cubic feet/lb. 140 lb gas cylinder: ETO; 145 cubic feet and FREON; 387 cubic feet Tank/cylinder use temperature: min. 70 degrees F. Tank/cylinder storage temperature: max. 130 degrees F. Vapor pressure @ 70 degrees F.: 65 lbs/square inch PSIG. [vapor pressure to be determined by UFC Standard 9-5 N/A. UFC Standard 9-5 for Flammable Liquid only. See definitions for compressed gas- UFC ,o~9.105(c)] Boiling point: n/a Freezing point: n/a Specific gravity: 1.24 (water @1.0) Vapor density: 2.82 (air= 1.0) Solubility in water: moderate Gas mixture/cabinet concentrations: 450+ rog/liter of cabinet volume Restricted flow from tank may cause gas mix to become flammable. ETO/Freon mix 'tank spill' may be flammable. October 2g, 1993 -16- FEB I 9 1991 ~ Crawford February 15, 1991 RECEIVED RISK CONTROL SERVICES File No. 905144 T~oF~6~.p FEB ? 7 1991 8o,~,ous BRANCH MANAGER HAZ. MAT. DIV. Ms. Barbara Brenner Hazardous Materials Planning Technician City of Bakersfield Fire Department 2101 "H" Street Bakersfield, CA 93301 Dear Barbara, The San Joaquin Community Hospital and Crawford Risk Control Services/The FPE Group have prepared a Risk Management Prevention Program for the ethylene oxide sterilization system at the Hospital. The Program has been reviewed and commented upon by you, and we thank you for your assistance. We now believe and certify the RMPP to be complete. Sincerely, Dan Cox, PhD', Mr Unit Manager Vice President, Finance Industrial Hygiene San Joaquin Community Hospital and Environmental Health ddc/905144/1 t r/RMPP_Fi nal 3687 MT. DIABLO BLVD., SUITE 200 E] LAFAYETTE, CALIFORNIA 94549 [] (415) 283-8860 FAX (415) 283-5727 The FPE Group 3687 Mt. Diablo Blvd., Ste. 200, Lafayette, CA 94549 (415) 283-8860 Fax: (415) 283-5727 SAN OOAQUIN COMMUNITY HOSPITAL Ethylene Oxide Risk Management and Prevention' Program Job Number 905144 San Joaquin Community Hospital was identified by the Bakersfield Fire Department as a handler of ethylene oxide, which is an acutely hazardous material (AHM). The City of Bakersfield's Fire Department determined that SJCH's operations could pose an acutely hazardous materials accident risk; therefore, it would be required to submit a Risk Management and Prevention Program (RMPP) pursuant to section 25534 of the Health and Safety Code. The purpose of a RMPP is to establish and maintain a comprehensive management program to assess and prevent, to the greatest degree possible, the risk of a release of acutely hazardous materials, in a manner which might cause harm to the safety and health of the community and the environment. San Joaquin Community Hospital is a 162-bed facility and employs approximately 500 employees. The main hospital is 133,289 square feet. The Central Service Department is located in the basement of the main hospital and is 2,160 square feet in area. A. Storage and Quantities Used Currently, SJCH uses Penngas, a 12 percent ethylene oxide (EtO) 88 percent dichlorodifluoromethane gas (CFC-12) for sterilization purposes. CFC-12 is used as a dilutent to render the 12/88 mixture non-flammable and non-explosive. The gas mixture is supplied by Pennsylvania Engineering Company and is shipped in 140-pound, 12" by 38" high cylinders as a liquid under 70 psig. The hospital uses approximately one 140-1b., 12:88 EtO cylinder every three weeks, or approximately 17 cylinders a year. This amounts to approximately 1.4 pounds of EtO used daily and for our purposes discharged daily. Annual use of EtO is calculated to be approximately 500 pounds. !~At any one time there is a maximum of four full cylinders (67.2 pounds of EtO) on hospital property: two behind the sterilizer in the basement' in Central Supply and two currrently outside the main hospital in a gas cylinder storage cabinet on the loading dock. The cylinders are chained to prevent accidental falls and the valves are recessed within a ring- protecting collar to prevent accidental release during a fall. One of the EtO cylinders in Central is "on-line" and connected to the gas sterilizer. About every three weeks, Central Supply notifies engineering the tanks need to be changed; an engineer picks up a reserve tank from the outside storage area with a dolly, transports it to Central and exchanges the tanks in the area behind the sterilizer unit. San Juaquin Community Hospital -1- October 18, 1990 The FPE Group B. Sterilization Process and Emission Releases The sterilization process involves EtO gas, relative humidity (moisture), proper exposure time, and temperature. The relationship of these four elements depends on the sterilizer and materials to be sterilized. After the materials are humidified and gasified, excess gases and moisture are eliminated by vacuum, exhaust, and purge cycles. SJCH has one AMSCO sterilizer, Model No. 2045, which has a 24 cubic foot capacity and an AMSCO Aerator. The AMSCO sterilizer is six years old and it and the aerator are serviced every other month by an AMSCO service technician. In addition to this service, the hospital has Gas Monitoring, Inc. come out quarterly and check the AMSCO sterilizer and AMSCO Aerator for leaks with a Miran lA Spectrophotometer during operation. The hospital currently runs one sterilization load a day for a total cycle period of four hours (actual sterilization time is 1.75 hrs.}, cracks the sterilizer door for 15 mins., moves the load into the aerator for 12 hours and then prepares it for redistribution. Emissions of EtO occur primarily during the latter part of the 1.75-hour sterilization cycle and during transfer of the load to the aerator. Construction workers working in the vicinity of the sterilizer were recently monitored for EtO exposures. All results were Well below the current Cal/OSHA permissible exposure limit {PEL) of 1.0 part per million {ppm). Central Supply employees' short-term exposure levels {STEL) to EtO have been measured in the past and are in the range of 0.49 to 0.75 ppm, which is well below the Cal/OSHA 15 min. STEL of 5 ppm. Estimates of their eight-hour, time-weighted average exposures are well below the PEL of 1 ppm. C. EtO and General Ventilation The hospital is now in the process of modifying the exhaust ventilation system which services the sterilizer area. For your referenCe, addended to this report you will find the reduced blueprints of the modifications to the mechanical system servicing Central Supply. Basically, the exhaust is a dedicated system with a canopy hood installed along the sterilizer and aerator bank, with a exhausted closet for the gas cylinders. The design is to have the sterilization area under negative pressure relative to the rest of Central Supply and the rest of the hospital at all times. The dedicated exhaust duct passes into the adjacent mechanical room and traverses it at ceiling level before penetrating the roof and entering a rooftop blower. The blower output is ducted at rooftop level through a 14" square duct to a point thirty feet above street level and as far away as feasible from any outside intake, operable windows, or routine personnel passage. San Juaquin Community Hospital 2 October 18, 1990 The FPE Group The ventilation design is for the blower to provide a total of 1850 cfm of local exhaust ventilation in sterilizer loading and mechanical areas. When completed the central supply room will have 13 air changes per hour (ach/hr) and the sterilizer equipment room will have 22 ach/hr. An alarm relay system has been installed which alerts personnel in Central to the fact that the sterilizer equipment cannot be operated if the non-recirculating mechanical exhaust system is not operating. D. Accidental Releases SJCH has an EtO Gastech Alarm with four sensors, which alarms at levels greater than 5 ppm. SJCH has had no accidents within the last three years with EtO. However, on 2/26/90, Sensors #1 & #3 alarmed. The AMSCO technician was called and found no leaks. The Gastech alarm is not specific for EtO or Freon, but also reacts to alcohols, perfume, and auto exhaust and that is what apparently happened on this day. The EtO cylinders are designed to resist breakage and leakage. The cylinders are supplied with a welded-ring protecting collar so that the valve is effectively recessed and protected from damage. vThe sterilizer and aerator cannot operate if the mechanical exhaust system fails. A Gastech Alarm system with four remote sensors is activated if leaks of EtO are detected. Employees who may be potentially exposed to ethylene oxide are trained at the time of initial assignment and at least annually on the proper use of the sterilizer, handling techniques and precautions, emergency procedures, and the right to medical surveillance. Attached to this report is a copy of San Joaquin Community Hospital's "Ethylene Oxide: Employee Training and Communications Program," which is a part of their ongoing HAZARDOUS MATERIALS MANAGEMENT PROGRAM. Although ethylene oxide is widely used, serious systemic poisonings from EtO are rare in the literature. Neither Richard Nusbaum of Penngas, who has 25 years experience, nor Tony LaMontagne, who performed literature searches and interviews during the preparation of a comprehensive training manual for Massachusetts hospitals, knew of any fatalities due to ethylene oxide use in hospitals. The Immediately Dangerous to Life and Health (IDLH) level for humans for EtO is listed as 800 ppm, and the odor threshold is listed as 700 ppm, so odor is not a good warning for potentially harmful exposures. High concentrations of EtO gas are both irritating to the mucous membranes and depressing to the central nervous system. Guinea pigs exposed to 51,000 to 64,000 ppm of EtO for 10 minutes died within 24 hours of lung edema. Ethylene oxide is carcinogenic in animal studies and is a suspect human carcinogen. Ethylene oxide is also a suspect reproductive toxin. San Juaquin Community Hospital -3- October 18, 1990 The FPEGroup If a rupture of tubing or valve occurred so that one full cylinder was released in the sterilizer equipment room, essentially all EtO would be confined to the Central Supply and exhausted to the outside air. See attached air dispersion modeling. A release of one full cylinder is a release of 16.8 pounds of EtO or 148 cubic feet at standard temperature and pressure. Using standard industrial hygiene equations for dilution ventilation (see for example page 76 of the NIOSH text), a full release of an EtO tank in five minutes, confined to Central Supply (volume of area is 21,000 ft3) would produce an average concentration in Central Supply increasing to approximately 7,000 ppm at five minutes, which would produce a hazardous condition for all in Central Supply. Thus immediate evacuation and isolation of Central Supply would be imperative. No one would be able to enter the area without the use of a self-contained breathing apparatus (SCBA) and impervious protective clothing (such as polychlorinated ethylene) as £tO is quite irritating to the skin. The dedicated exhaust of 1850 cfm would dilute the EtO in time. The half- life can be calculated to be about 23 minutes. The average concentration would be 800 ppm at about 80 minutes and I ppm at about 310 minutes. In an actual release, concentrations of EtO near the point of release would exceed the average, but the exhaust would also function more as a local exhaust rather than simply as dilution ventilation. The actual half-life for clearance would likely be less than calculated. SJCH has a standby Survivair SCBA outside the immediate Central Supply Area. In order to assure that this emergency equipment is used properly during an EtO spill or rupture, personnel on all three shifts will need to be trained to respond to acutely hazardous materials emergencies by learning how to don protective equipment an operate an SCBA. This first-responder hazardous materials training should be at least 24 hours and be repeated annually. San Juaquin Community Hospital -4- October 18, 1990 · .~ ' ~ '\ January 28, lggl xx.y, Job .No.. 905144/915013/000776 ";~ "~ Oennts Gardner San Joaquin Community Hospital P,O. Box 2615 Bakersfield, CA 93303-2615 'i Dear Dennis, At your request, I have modified my recommendations .to you concerning release of ethylene oxide in the sterilizer equipment, room, in order to limit the number of people at risk. We recognize that the most likely location of release is the sterilizer equipment room. If that ro.om is effectively isolated from the rest of Central Supply, e.g. by hav~n~ an automatically closing door, then the risk ' to Central Supply employees'w~ll be greatly reduced. According to ventilat!on plans, there is 500 cubic feet per minute (cfm) exhaust in. the sterihzer equtpmen~ room and 200 cfm of supply, with a net~ of 300 cfm exhaust. ~he exhaust a~r rate should exceed the supply air rate/ by at least the worst Case release rate. The worst-case release rate for aL~ one-cylinder release is 550 cubic feet of the gas mixture released over / five mtnute~. Thus, an excess of exhaust versus sU'~plY air of at least 110{ cfm is required for Central Supply. The 300 cfm net exhaust appears adequate to exhaust the entire release of mixed gases, with an excess exhaust of lgO cfm. The source of make-up air for the exces~ exhaust lgO cfm {n the sterilizer equipment room will b? Central Supply. With the door b~tween Central Supply and t~e steril3zer equipment room closed, there is abou~ one square foot of open~ng between the two,. Through a 1 square foot opening, the 1gO cfm will provide a control velocity of lgO fpm. : In the'design of ventilation systems, 50-'100 feet per minute (fpm) is o~ten used as the design control velocity, i.e. the face velocity of air required to prevent escape of an air contaminant from an opening or "face". For the sterilizer equipment room to be'isolated from the rest 'of Central Supply, there sh?uld be a minimum control veloc(ty of_50-100 fpm at the opening of the sterilizer equipment room to Central Supply. ~e¢o~mnd~t~on. We recommend that the hospital verify the airflow from Central Supply into the sterilizer equipment room. vt').. ~un'i~ ~o0 D LAFAYEI'i~ OAI~IFORNIA 94~49 C) (41~) ~)~.0~0 FAX (415) ~-67E7 ' Jl':'II"i 38 "91 16::34 FF'E 'SR),.'~_IF'.; LHt- '_.Hi Page 2 The concentration of ethylene oxide vers~s time also had.been . . 'calculated for a full-cylinder release within thestertllzer equipment room, assuming release over five minutes of 148 cubic feet of EtO (16.8 lbs) and an exhaust rate of 500 cfm in a I260 cubic foot space (sterilizer equip~nt mom). Calculations show that the ethylene oxide will be exhausted So 'that the average concentration within the sterilizer equipment room will drop below the IDLH level (800 ppm) in 41 minutes and drop to I ppm in g2 minutes. Recommendation: We recomend the hospital ii,cOrporate this calculated concentration versus time into its'plan for reoccupancy of the steril.lzer equipment room after worstjcase release, In case two full cylinders were released in 5mtnutes;'then the con?ntration would reach 800 ppm in 46 minutes and ! pPm in 98 min~te~. During a release of two Ey!inders, the excess.exhaust would be,BO ~Tm (300 cfm minus 220 cfm), prowd~ng a?ntrol velocity of BO fpm, which ~s slightly less than 100 fpm but l~kely adequate, . ' Although by design the sterilizer equipment ro~ will. be isolated fr~ the rest of Central Supply; evacuation of all Central Supply employees ~en the ala~ sounds is still prudent. Sincerely, Dan.Cox, PhO, ClH Manager, 'industrial Hygiene and Environmental Health ddc/905144/1 t r / DG_O 128g I The FPE Group EARTHQUAKE INFORMATION In our search for earthquake information we contacted the following agencies: San'Francisco Public Library San Francisco Public Library Business & Sciences Dept. Bakersfield Public Library Earthquake Engineering Research Institute US Geological Survey · Earth Scan Office of Emergency Services Office of Emergency Services Natural Disasters Cal Tech UC Berkeley Seismographic Station E. Worst-Case Releases We have used the EPI Code software program to evaluate the atmospheric release of EtO using air dispersion modeling. Attached are modelings based on the release of one full cYlinder either on the loading dock or in Central Supply. The modelings are based on a release of 16.8 pounds of EtO over five minutes, wind speed of 6.4 mph (average for Bakersfield), worst-case stability class, deposition velocity of 0.1 cm/ sec, and worst-~case terrain. The modeling for release in Central Supply uses a release to atmosphere height of 30 feet, the height of the outside exhaust duct outlet. The exposures to receptors at three different heights are included in the modeling. The modeling for release to the atmosphere on the loading dock uses a release height of 8 feet and a receptor height of 8 feet. I. Modeling I. is for a release at the outside exhaust duct outlet, at a height of 30 feet, and predicts the eXposure to a person at street level (breathing zone height 5 feet). There is a maximum predicted concentration of 12 ppm for a receptor 0.03 mile (160 feet) directly downwind from the release. There are no maximum predicted concentrations above the IDLH level (800 ppm). II. Modeling II. is for a release at 30 feet and predicts the exposure to a person whose breathing zone would be at the same height, for example a person working on the roof, or predicts the concentration that could enter through a rooftop air intake. There is a maximum predicted concentration of 13,000 ppm for a receptor within 0.006 mile (32 feet) directly downwind from the release._. Maximum predicted concentrations fall below the IDLH level (800 ppm) at about 0.03 mile (160 feet). The maximum predicted concentration falls off sharply for a receptor not directly downwind. For a receptor 0.005 mile (26 feet) off the direct downwind line, the maximum predicted concentration is 11 ppm, at a distance of 0.05 mile (265 feet). It is possible that a workeron the roof could get a brief exposure above the IDLH level during a worst-case release in Central Supply. Since worst-case release intentral Supply is most likely to happen when an engineer is working in the sterilizer equipment room, a good policy would be to have no one on the roof during that time. It is also possible in this worst-case release that a brief IDLH concentration could enter the hospital through an air intake within 160 feet of the outside exhaust outlet. This is a much less likely occurrence since the air intake would have to be directly downwind from the release. The release point is on the side of the building, which helps direct the release away from the building. It is much more likely that an air intake will be off the direct downwind line, and much lower- concentrations are predicted. Nevertheless, the hospital should be prepared to treat persons exposed to a brief IDLH concentration in case the unlikely were to occur. We are sending the hospital the information San Joaquin Community Hospital -6- October 18, 1990 from a database for physicians concerning the treatment of persons exposed to ethylene oxide. III. Modeling III. is for a release at 30 feet and predicts the exposure to a receptor at height one story above the release (40'~feet), for example a window. There is a maximum predicted concentration of 51 ppm for a receptor 0.01 mile (53 feet) directly downwind from the release, which is'well below the IDLH level (800 ppm). Again, the maximum predicted Concentration falls off significantly for a receptor not directly downwind. For a' receptor 0.005 mile (26 feet) off the direct downwind line, the maximum predicted concentration is 8.5 ppm, at a distance of 0.04 mile (211 feet). IV. Modeling IV. is for a release at 8 feet on the loading dock and predicts the exposure to a person whose breathing zone would be at the same height, for example a person working on the loading dock or a window at 8 feet. There is a maximum predicted concentration of 27,000 ppm for a receptor within 0.006 mile (32 feet) directly downwind from the release. Maximum predicted concentrations fall below the IDLH level (800 ppm) at about 0.04 mile (211 feet). Here again, the maximum predicted concentration falls off sharply for a receptor not directly downwind. For a receptor 0.005 mile (26 feet) off the direct downwind line, the maximum predicted concentration is 2Z ppm, at a'distance of 0.2 mile (1056 feet). Brief concentrations above the IDLH could occur at receptors that happened to be within 211 feet of the release and directly downwind, and brief concentrations above the STEL could occur within 0.7 mile downwind. Recommendation: Work practices should be followed to minimize the likelihood of a release on the loading dock, and moving the storage to another area should be considered. V. A very~difficult release to model, is a worst-case release within the hospital in an area other than Central Supply, which has dedicated exhaust. Anyone near the release would quickly be exposed above the IDLH, ethylene oxide would spread from the point of release in a difficult to predict path. RecJmmendation: Due to the possible consequences of a worst-case release inside the hospital but outside Central Supply, the hospital should develop strict work practices concerning delivery of cylinders to Central Supply, including checking the cylinders for leakage prior to entry into the building and using a buddy system for delivery. VI. Maximum predicted concentrations fall significantly if a 30-minute release period is used in the modeling versus a 5-minute release period. We will continue to try to find additional corroboration of the release period. San Joaquin Community Hospital -7- October 18, 1990 The FPE Group 3687 Mt. Diablo Blvd., Ste. 200, Lafayette, CA 94549 (415) 283-8860 Fax: (415) 283-5727 October 18, 1990 Ms. Barbara Brenner Hazardous Materials Planning Technician City of Bakersfield Fire Department 2101 "H" Street Bakersfield, CA 93301 Dear Barbara, Below is The FPE Group's response to the areas you found incomplete or deficient in our risk analysis of the use of ethylene oxide/freon as a sterilant at San Joaquin Community Hospital. First, we are submitting to you and the hospital a slightly modified version of a general hazard and operability study for ethylene oxide use in hospitals published recently by NIOSH. We are recommending that the hospital follow all the NIOSH recommendations that are feasible. We are providing the hospital with a copy of the NIOSH document (Control Technology for Ethylene Oxide Sterilization in Hospitals). Next are our replies to the points made in your letter of August 6, 1990. 1. We have been unable to find a specific prediction of the likelihood of an 8.3 or similar scale earthquake in Bakersfield. We have been told by Dr. Robert Uhrhammer of the University of California Seismographic Station a quake of this magnitude is very unlikelyf because the active fault in the area is relatively short. You have confirmed that the Bakersfield Fire Department also does not know the probability of an earthquake of this magnitude. The October 27, 1987, issue of The Bakersfield Californian listed the probability of a 6.0 or larger quake occurring in Kern County as 80-100 percent in the next 50 years. If the hospital were near the epicenter of a quake greater than 6.0, significant damage to the hospital could occur. The probability of a quake that causes damage in Kern County in the next 50 years appears high. The probability of the hospital being the target of the significant damage is lower, and the probability of the damage actually being a full-cylinder release of ethylene oxide is even lower. The probability of a worst-case release due to an earthquake is low to medium. Whether the cause of a worst-case release is operating error, equipment failure, or external event (e.g., earthquake), the largest release will likely be the entire contents of a full cylinder of ethylene oxide. Regardless of the cause, the release of the entire contents of a The FPE Group Ms. Barbara Brenner October 18, 1990 Page 2 cylinder could cause serious injury or death to a person or persons near and at some distance from the release point. Therefore, the severity of consequences due to the worst-case AHM release is rated high, although it would not be expected that large numbers of people would be affected. The probability of the worst-case release is certainly not high; worst- case release is simply not a frequent occurrence. The State suggests that records of releases for the past three years be used to identify probable releases. A major release has not occurred in three years and a release approaching worst-case has never occurred at the hospital that any of the staff can remember. Regardless of the cause of the worst-case release, the probability of release is either low or medium. If low, the EPA guideline is that the worst-case release is a concern which may require planning for credible events. If medium, the EPA guideline is that the worst-case release is a situation of major concern. The hospital is treating the worst-case release as a situation of major concern that requires planning for credible events. Through a combination of engineering controls (such as ventilation), required work practices, training, alarm systems, personal protection (respirators and protective clothing), and emergency response and evacuation procedures, the hospital is working both to decrease the likelihood of the worst- case release occurring, as well as to mitigate the severity of the consequences of the worst-case release. It is our hope that the Bakersfield Fire Department will recognize that the hospital is treating the worst-case release (and less significant potential releases) with the proper level of concern. 2. The possible consequences of leaks in lines, fittings, and regulators range from low level exposures to one person (engineering staff changing cylinders or repairing lines, fittings, and regulators) to the consequences of the worst-case release. The hospital has alarm systems to detect low-level but significant leaks (>5 ppm), quarterly leak checks by Gas Monitoring, Inc., and a continuously operated, dedicated exhaust system connected to emergency power to mitigate all releases. Recommendation: We recommend that the engineering staff obtain a portable ethylene oxide monitor to be used for leak detection every time a cylinder is changed. The portable monitor should be used to check cylinder valves, lines, fittings, and regulators for leaks too low to trigger the alarm system. 3. There exists a risk of a cylinder falling, due to a floor-level pipe in the sterilizer equipment room in the path of cylinder delivery. The The FPE Group Ms. Barbara Brenner October 18, 1990 Page 3 cylinders are protected by a welded-ring protecting collar, so that leakage from the fallen tank is not likely to occur. However, the falling cYlinder could damage lines or fittings, even without visible damage, so that they could subsequently leak. Recommendation: We recommend that the hospital cover the pipe with a smooth ramp to prevent accidents during delivery. 4. We inspected the exhaust duct path and found it to be isolated from the general air return system. It is designed to be a dedicated exhaust system, and the design has been approved as such by OSHPOD. However, the duct traverses the boiler room at ceiling level. If both an ethylene oxide release in Central Supply and a duct rupture in the boiler room occurred, the ethylene oxide/freon mixture would spread to the boiler room. This scenario is possible in a major earthquake. Recommendation: We recommend that the hospital assume, in a major earthquake, that both an ethylene oxide release and a duct rupture has occurred. In this case, the boiler room occupants should be included in the emergency response and evacuation plan. 5. Unless the cylinder itself is punctured, which is an extremely unlikely event, the ethylene oxide/freon mixture will be released as a gas in the proportions of 12 percent ethylene oxide and 88 percent freon. Different gases diffuse at the same rate, regardless of molecular weight; so in the absencff of gravity, the proportions of the gaseous mixture will remain the same regardless of the dilution, as the mixture diffuses into the air. Gravity does have an effect on gases, so that a column of gas is more dense at lower than at higher elevation. We have calculated the effect of gravity on a gaseous mixture of ethylene oxide/freon and found that the effect of gravity would be that at a height of 500 meters, the proportions would be 14 percent ethylene oxide and 86 percent freon by weight, rather than the 12 percent and 88 percent at ground level. We contend that this minor change in proportions will have no significant effect on the properties of the mixture. Specifically, the mixture would remain nonflammable even if it were to diffuse upward through the entire height of the hospital. (As we discussed previously, the normal atmospheric reactions of ethylene oxide are not sufficiently rapid to significantly reduce the proportion of ethylene oxide in the mixture.) 6. The exhaust system dedicated to the sterilizer loading area and the sterilizer equipment room is 1850 cfm by design. The FPE Group Ms. Barbara Brenner October 18, 1990 Page 4 The concentration of ethylene oxide versus time has been calculated for a full-cylinder release in Central Supply, assuming release over five minutes of 148 cubic feet of EtO (16.8 lbs) and an exhaust rate of 1850 cfm in a 21,000 cubic foot space (Central Supply}. The calculations show that the ethylene oxide will be exhausted so that the average concentration will drop below the IDLH level (~Q~ ppm) in 78 minutes and drop to 1 ppm in 308 minutes. The actual exhaust rate will likely actually be somewhat greater than that, since the exhaust is located near the release rather than being general dilution ventilation, but this calculation represents a conservative estimate. Recommendation: We recommend the hospital incorporate this calculated concentration versus time into its plan for reoccupancy after worst-case release in Central Supply. Recommendation: We recommend that the hospital proceed with balancing and verification of the performance of the dedicated exhaust system and the ventilation system in Central Supply. The performance check must confirm that Central Supply is at negative pressure relative to the rest of the hospital. The exhaust air rate in Central Supply should exceed the supply air rate by at least the worst-case release rate. The worst- case release rate is 550 cubic feet of the gas mixture released over five minutes. Thus, an excess of exhaust versus supply air of at least 110 cfm is required for Central Supply. 7. Monitoring to compare with the PEL is done to measure the eight-hour time-weighted average exposure. Short-term exposures may exceed the PEL but should not exceed the STEL. A person may have a short-term exposure above the PEL without having an eight-hour time-weighted average exposure above the.PEL. The nature of ethylene oxide exposure in hospitals is such that comparison to both standards is appropriate. Recommendation: We recommend that the hospital proceed with both short- term and full-shift air sampling for ethylene oxide to determine routine exposures of the Central Supply and engineering staff. 8. The risks associated with fire have been considered. The designs for the construction of the sterilizer area of Central Supply and for the ventilation system have been approved by OSHPOD and by the State Fire Marshal. The hospital assures us that the construction materials and sprinkler system were installed to meet code and that no source of ignition exists in Central Supply. Our most experienced fire protection engineer, Ed Vining, assures me that the nonflammable mixture of 12/88 percent ethylene oxide /freon will be nonflammable at any dilution with air. The manufacturer, Penngas, on its material safety data sheet claims that the mixture will The FPE Group Ms. Barbara Brenner October 18, 1990 Page 5 help to extinguish a fire rather than add to the fire. We have no reason to dispute their experience with the mixture. Both Richard Nusbaum of Penngas and Ed Vining of FPE are willing to discuss this issue with you if you wish. Mr. Nusbaum~s phone number is on the MSDS already submitted and Mr. Vining~s number is (415} 283-8860. OFF-SITE CONSEQUENCE ANALYSIS 1. The documentation for EPI Code has been provided and accepted. 2. Our vapor dispersion calculations have been modified to use a five- minute release period for modeling the worst-case scenario. There have been discussions as to the actual release period for a full- cylinder release. Richard Nusbaum of Penngas, the manufacturer of the gas used by the hospital explained to me that the cylinder has a dip tube delivery system that limits the release rate of the contents. The contents of the cylinder are liquid not gaseous. His experience, gained over 25 years, is that full release from an open valve or line takes 30 to 45 minutes. This is why we used 30 minutes in our initial modeling. The NIOSH document referred to a release rate of 5.4 lbs per second, which is a period of 25 seconds for full release. This may have been an error and may have been calculated for a compressed gas rather than for a compressed liquid delivered through a dip tube. Certainly this rapid release rate is strongly denied by the manufacturer. We have chosen to rely on the experience of the manufacturer, but have used five minutes in our calculations as a conservative estimate and to be more in line with EPA and apparently Bakersfield Fire Department guidelines. Richard Nusbaum has offered to talk to you about his experience with release periods as well. 3. Our attached air dispersion modeling has been modified to take into account the possibility of receptors at the height of the elevated exhaust vent {30 feet). 4. See 3. 5. The modeling has been modified to assume a "point" source for the worst- case release. 6. The deposition velocity was documented in the EPI Code.documentation and accepted. The FPE Group Ms. Barbara Brenner October 18', 1990 Page 6 EXISTING OR PROPOSED MEASURES TO MITIGATE POINTS OF CONCERN 1. The ethylene oxide storage area has been moved away from close proximity to the child care facility. The two cylinders not in Central Supply are now stored on the loading dock in a cylinder storage cabinet. We are Concerned that this storage area may allow the cylinders to reach temperatures greater than 100 degrees F. Recommendation: Store all four ethylene oxide cylinders in the sterilizer equipment room. This room is temperature controlled and served by the dedicated exhaust system. The worst-case release in the sterilizer equipment room would continue to be the release of one full cylinder. Cylinders would be transported directly to and from the~delivery truck to the sterilizer equipment room. 2. The roof exhaust outlet has been placed to be as far as possible from openings or air intakes into the building, and its placement was recommended by a Cal-OSHA safety engineer. We have recommended that the windows nearest to the exhaust be sealed from opening. Further discussions of possible consequences are included with our dispersion modeling. 3. The dedicated exhaust .system is attached to the emergency power supply for the hospital, so that a failure of normal power is not sufficient to disable the exhaust. The hospital has revised emergency response and evacuation procedures based on the possibility of high levels of ethylene oxide existing in Central Supply as a result of worst-case release. The alarm panel for ethylene oxide is also attached to the emergency power supply. 4. The hospital has agreed to build a ramp over the pipe. 5. The hospital has sent a letter to Penngas requiring only welded-ring protecting collar (recessed valve tyl~) cylinders be delivered. Penngas assures us that this is their only product today. The hospital will- refuse delivery of any non-protected cylinders. 6. There is a self-closing door between Central Supply and the corridor. Central Supply ventilation is designed to remain under negative pressure relative to the corridor due to the dedicated exhaust sy.stem. The recommendation for balancing and performance checking of the ventilation system applies. The FPE Group Ms. Barbara Brenner October 18, lggO Page 7 7. The hospital does use a variety of cleaning supplies and disinfectants in Central Supply. Recommendation: We recommend the hospital store these items outside Central Supply and that quantities within Central Supply be limited to the amount needed for each task. Containers should be capped immediately after each use. 8. We are providing the hospital with a comprehensive training manual for ethylene oxide developed and tested in hospitals in Massachusetts. A description of the training manual is attached. 9. The hospital has revised their plan and will likely make some additional revisions based on this report. Dan Cox, PhD, CIH/ Sr. Vice President Industrial Hygiene & Environmental Health ddc/docs/9051441tr PAGE 1 SJCH RMPP PUNCH LIST NOTE: AL_L NUMBERED RECOMMENDATIONS REFERENCE TO THE SEVEN PAGE RESPONSE WRITTEN BY THE FPE GROUP AND DAN COX, DATED OCTOBER 18, 1990, ADDRESSED TO BARBARA BRENNER, HAZARDOUS~MATERIALS PLANNING TECHNICIAN, CITY OF BAKERSFIELD. THE DATE AT THE END OF THE PLAN OF ACTION IS 'THE HOSPITAL GOAL FOR COMPLETION OF THE RECOMMENDATION. 2.) RECOMMENDATION: WE RECOMMEND THAT THE 'iENGINEERING STAFF OBTAIN A PORTABLE ETHYLENE OXIDE. MONITOR TO.BE USED FOR LEAK DETECTION _VER~ TIME A CYLINDER IS CHANGED. THE' PORTABLE MONITOR SHOULD BE USED TO CHECK CYLINDER VALVES, LINES, FITTINGS , AND REGULATORS FOR LEAKS TOO LOW TO TRIGGER THE ALARM SYSTEM. SJCH PLAN OF AcTIoN: THE HOSPITAL WILL INSTITUTE A POLICY THAT STATES ALL ENGINEERING STAFF WILL USE A LEAK DETECTOR TO CHECK CYLINDER VALVES, LINES, FITTINGS~ AND REGULATORS FOR LEAKS TOO LOW TO TRIGGER THE ALARM SYSTEM EVERY TIME THEY ARE CHANGING' OR ADJUSIING ETHYLENE OXIDE RELATED E~UIPMENT. JANUARY 7, 1991 3.) RECOMMENDATION: WE RECOMMEND THAT THE HOSRITAL COVER THE PIPE WITH A SMOOTH RAMR TO FR_VENT ACCIDENTS DURING DELIVERY SJCH PLAN OF ACTION: THE HOSPITAL WILL INSTALL A PERMANENT METAL RAMP THAT MAKES THE' EASE OF MOVING THE ETD CYLINDERS TO THEIR DESTINATION MORE SAFELY. JANUARY 7, 1991 4.) RECOMMENDATION: WE RECOMMEND THAT THE HOSPITAL ASSUME, IN A MAJOR EARTHQUAKE, THAT BOTH AN ETHYLENE OXIDE RELEASE AND A DUCT RUPTURE HAS OCCURRED. IN THIS CASE, THE BOILER ROOM OCCUPANTS SHOULD BE 1NCLUDED IN THE EMERGENCY RESPONSE AND EVACUATION PLAN. SJCH PLAN OF .ACTION: THE HOSPITAL WILL INCORPORATE A POLICY THAT INCLUDES THE ENGINEERING STAFF THAT ARE IN THE BOILER ROOM IN THE EMERGENCY RESPONSE AND EVACUATION PLAN. JANUARY 7~ 1~91 6A.) RECOMMENDATION: WE RECOMMEND THE HOSPITAL INCORPORATE THIS CALCULATED CONCENTRATION VERSUS TIME INTO ITS PLAN FOR REOCCUPANCY AFTER WORST-CASE RELEASE IN CENTRAL SUPPLY. S~CH' PLAN OF ACTION: THE HOSPITAL WILL INCORPORATE THIS CALCULATED CONCENTRATION VERSUS TIME INTO ITS PLAN FOR REOCCUPANCY AFTER WORST-CASE RELEASE IN CENTRAL SUPPLY. JANUARY 7, 1991 6B.) RECOMMENDATION: WE RECOMMEND THAT THE HOSPITAL PROCEED WITH BALANCING AND VERIFICATION OF THE PERFORMANCE OF THE DEDICATED EXHAUST sYSTEM AND THE VENTILATION SYSTEM IN CENTRAL sUPPLY. THE PERFORMANCE CHECK MUST CONFIRM THAT CENTRAL SUPPLY IS AT NEGATIVE PRESSURE RELATIVE TO THE REST OF THE HOSF'ITAL. THE EXHAUST AIR RATE IN CENTRAL SUPPLY SHOULD EXCEED. THE SUF'PLY AIR RATE BY AT LEAST THE WORST-CASE RELEASE RATE. THE WORST-CASE RELEASE RATE IS 550 CUBIC FEE'[ OF THE GAS MIXTURE RELEASED OVER FIVE MINUTES. T~US, AN EXCESS OF EXHAUST VERSUS SUPPLY A1R DE AT LEAST 110 CFM Rm.D r~,~, CENTRAl_ SUPF'L¥. PAGE SJCH PLAN OF ACTION: THE HOSPITAL WILL PROVIDE DOCUMENTATION BY A CERTIFIED AIR BALANCE COMPANY THAT THE ETHYLENE OXIDE EXHAUST SYSTEM IS MEETING AT LEAST THE MINIMUM'REQUIREMENTS TO EXHAUST THE WORST-CASE RELEASE RATE. MARCH 15, 1990. 7.} RECOMMENDATION: WE RECOMMEND THAT THE HOSPITAL PROCEED WITH BOTH SHORT-TERM AND FULL-SHIFT AIR SAMPLING FORiETHYLENE OXIDE TO DETERMINE ROUTINE EXPOSURES OF THE CENTRAL suPPL~ AND ENGINEERING STAFF. :I~ S3CH PLAN OF ACTION: THE HOSPITAL WILL PROVIDE DOCUMENTATION THAT IT HAS AND WILL CONTINUE TO TEST AIR SAMPLING FOR ETHYLENE OXIDE TO DETERMINE ROUTINE EXPOSURES OF THE CENTRAL SUPPLY AND ENGINEERING STAFF. 'JANLIARY 7~ 1991 EXISTING OR PROPOSED MEASURES TO MITIGATE POINTS OF CoNcERN 1.) RECOMMENDATION: STORE ALL FOUR ETHYLENE OXIDE CYLINDERS IN THE STERILIZER EQUIPMENT ROOM. THIS ROOM IS TEMPERATURE CONTROLLED AND SERVED BY' THE DEDICATED. EXHAUST SYSTEM. THE WORST-CASE RELEASE IN THE STERILIZER EQUIPMENT ROOM WOULD CONTINUE TO BE THE RELEASE OF ONE FULL CYLINDER. SJCH F'LAN OF ACTION: IN LIGHT OF THE CITY"OF BAKERSFIELD'S CONCERN FOR THE RECOMMENDED STORAGE OF THE ETHYLENE OXIDE CYLINDERS, THE HOSPITAL WILL RESEARCH THE ALTERNATIVES AND FEASIBILITY OF ANOTHER LOCATION. MARCH 15, 1991 7.) RECOMMENDATION: WE RECOMMEND THE HOSPITAL STORE THESE ITEMS OUTSIDE'CENTRAL SUPPLY AND THAT QUANTITIES WITHIN CENTRAL SUPPLY BE LIMITED TO ]'HE AMOUNT NEEDED FOR EACH TASK. 'CONTAINERS SHOULD BE CAPPED IMMEDIATELY AFTER EACH USE. SJCH PLAN OF ACTION: THE HOSPITAL WILL INITIATE A POLICY THAT REQUIRES THAT ALL CLEANING SUPPLIES AND DISINFECTANTS THAT REACT WITH ETHYLENE OXIDE BE STORED OUTSIDE OF THE CENTRAL SUPPLY AREA. JANUARY 7, 1991 CALCULATIONS I. The effect of gravity on gases: The formula for the effect of gravity on the pressure of a gas is: P/Po = e-gy/RT where, g = the gravitational constant = 9.8 m/sec2 (meters per square second) y = vertical distance in meters R = the gas constant = 8.3 joules/mole-deqree (a joule is a newton-meter or a kg-m2/sec2) T = degrees Kelvin (298 at 25 degrees C) P = pressure at vertical distance y above reference height PO TM pressure at reference height The molecular weight of dichlorodifluoromethane is 121 grams or 0.121 kg. The molecular weight of ethylene oxide is 44 grams or 0.044 kg. P/Po = e-(0'004 X MW X y) where MW = molecular weight in kg. At 50 meters, p/pO for freon is 0.976. At 50 meters, p/p0 for ethylene oxide is 0.991. The ratio of freon to ethylene oxide (by weight) at 50 meters is calculated: 88/12 x 0.976/0.991 = 7.2 = 87.8/12.2 At 500 meters, p/pO for freon is 0.79. At 500 meters, p/p0 for ethylene oxide is 0.92. The ratio of freon to ethylene oxide (by weight) at 500 meters is calculated: 88/12 X 0.79/0.92 = 6.3= 86/14 The ratio of freon to ethylene oxide changes only slightly due to gravity. ddc/docs/905144calc II. Concentration versus time after full-cylinder release in Central Supply: During release of a gas, the average concentration in a room versus time is determined by the equation: Ct = (G/mQ)~'(1 - e-(mQ/V)t G = 148 cubic feet/5 minutes (rate of generation or release) m = 0.33 (mixing factor; 0 = no mixing; 1 = perfect mixing) Q = 1850 cubic feet per minute (exhaust rate) v = 21,000 cubic feet (room volume of Central Supply) At t = 1 minute, C = 1,455 ppm. At t = 5 minutes, C = 6,550 ppm After the release ends, the average concentration in a room versus time is determined by the equation: Ct/C0 e-(mQ/v)t = (to = 5 minutes) The time required to reach a given concentration can be determined by solving the above equation for t: t = (-in(Ct/C0))/0.029 The time for the concentration to reach the IDLH level (800 ppm) is- t = (-ln(800/6550))/0.029 = 72.5 minutes, plus 5 minutes, = 77.5 minutes The time for the concentration to reach the PEL (1 ppm) is: t = (-ln(1/6550))/0.029 = 303 minutes, plus 5 minutes, = 308 minutes ddc/docs/905144calc 4.0 S/N 1215~}i The F'PE Group I.D. : ETHYLENE OXIDE (1990:LIBRARY) IMolecular Weioht : 44.0 gram/mole CAS Number: [-~5-21-8] TWA : 1.0 ppm TWA : 1.8 mo/m'"'3 iDLH : 800 ~Dm TERM : 1.7E+01 pounds Release Duration : 5.0E+00 Minutes D.O.T. I$ 1040 HEIGHT-EFFECTIVE: 30 Feet HEALTH : SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0. 100 cm/seconc~ FLAMMABILITY: STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEPTOR HEIGHT (z) : 5 Feet REACTIVITY : LOCATION OF MAXIMUM COIqC. EN]"RATION LEVEl_ ,Distance : < 0.06Mi Level : > 1.6E+01 mg/m'"'3 8.9E+00 PPM MA X I IdUM CONCEN'I"RA'I"ION ARRIVAL. TIME Stabi 1 i tv Dz s~ance-Mi mg / m'"3 ppm ~our s: mi nutes DDDDDDDZ)DD~L),OD DDDDDDDD DDDDDDDL) DDDDDD~)DDDDDD DDD~)DDDDD O. 05 17 10 0: 0 B 0.10 14 7.8 0: 0 C 0.20 9.0 5.0 0: 1 D 0.30 5.9 3.~ 0: i E 0.40 4.5 2.5 0:2 E 0.50 ~.6 2.0 0:2 F 0.60 3.3 1.8 0: 2 F 0.70 2.9 1.6 0:3 F 0.80 2.6 1.4 0:3 F 0.90 2.2 1.2 0:4 F 1.00 2.0 1.1 0: 4 F 2.00 0.85 0.46 0: 8 F 3.00 0.50 0.28 0:12 F 4.00 0.36 0.20 0:16 F 5.00 0.27 0.15 0:20 F 6.00 0.22 0.12 0: 24. F 7.00 0.18 0.10 0:28 F 8.00 O. 15 0. 085 0: 5~; F 9.00 0. 17~: 0. 074. 0: 37 F 10.0 0. 12 0. 065 0:41 F 0 0. 049 0. 027 1:21 F 0 0. 016 0. 0090 2:43 F 60.0 0.010 0.0057 4.: 4 F 80.0 0. 0063 0.00.35 5:25 F 100 0. 0041 0. 0023 6:47 F . =-"~ The FPE Group code 4 0 S/N 121~.. . 3UBSTANCE I.D. : ETHYLENE OXIDE (1990:LIBRARY) ~olecular Weioh{ : 44.0 oram/mole ]'.AS Number: [75-2].-8] YWA : 1.0 ppm TWA : 1.8 mo_/m"'.3 IDLH : .800 prom TERM : 1.7E+01 pounds Release Duration : 5.0E+00 Minutes D.O.T. ~ 1040 HE I GHT-EFFECI' I VE: 30 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0. 100 em/second FLAt¥tMAB I L I TY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD F,.~L~Ei-~LR HEIGHT (z) : 5 Feet REACTIVITY : 3 ,OCATIFiN OF' nm..ildUM Ci"Ji',iC~J::N'IRAT ION LEVEL }istance : < 0.06Mi _evel : > ].. 6E+O1 mo/re'"3 8.9E+00 PPM MAX I MUFi DOWNWIND COiqCENTRATION ARRIVAL TIME Stability X-Mi Y-Mi mo / m'"'5 ppm hours: minutes ?£:'DDDD DDDDDD DD~J?)£)D,.O.D £.~DDS'~DDD ~.~:,D;(;'DDD~}DL)Z~DD DDD:ODDI.)DD 0.0~) { O. 000 1.7E-05 9.3E-06 0: 0 A 0.0t~)7~ 0. 000 1.7E-05 9.5E-06 0: 0 A 0.0~)~ 0. 000 1.7E-05 9.3E-06 0:0 A O. 0~)~ O. 000 1.7E-05 9.5E-06 0: 0 A O. OO~ O. 000 1.7E-05 9.3E-06 0:0 A O. O~D~ O. 000 1.7E-05 9.5E-06 0: 0 A O. 00~ 0. 000 5.5E-F~4 .5.0E-04 0: 0 A 0.0~)~ 0.000 0.011 0.0060 O: 0 A O. O~ 0.000 0. 078 O. 043 O: 0 A O. 01 0. 000 0.31 0.17 0: 0 A O. 02 O. 000 15 8.2 O: 0 A 0.03 0. 000 21 12 0: 0 A 0.04 0.000 18 10 0: 0 A O. 05 O. 000 17 10 0: 0 B 0.06 0.00(> 16 9.1 0: 0 B 0.07 0.000 16 8.7 0: 0 C 0.08 0.000 16 8.8 0:.0 C 0.09 0.000 15 8.4 0: 0 C 0.10 0.000 14 7.8 0: 0 C , Vol, 6 Expires ~.0/31190 ~de 4.0 S/N 12].53 The FPE Group I.D. : ETHYLENE OXIDE (1990:LIBRARY) Molecular Weight : 44.0 oram/mole CAS Number: [75-21-8] ]'WA : 1.0 ~pm TWA : 1.8 mg/m'~5 IDLH : 800 ppm TERM : 1.7E+01 pounds Release Duration : 5.0E+00 Minutes D.O.T. ~ 1040 HEIGHT-EFFECTIVE: 30 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0.100 cm/second FLAMMABILITY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEPTOR HEIGHT (z) : 30 Feet REACTIVITY : 3 LOCATION OF MAXIMUM [>'.'SNCENTRATION LEVEL Distance : < 0.06Mi Level : .~. 2.4E. L~,~ mg/m'""3 1..'-'.E+~'~2 PF'M MAX I MUM ND CONCENTRATION ARRIVAL TIME Stabilitv stance-Mi m~ / m'"'~ p_Dm hours: mi nutes ~.~D~D~/,.)DD~'DDDD DDDDDDL')~, DDDE)DDDD DDDDDP.,'DDD~DDD ' DDDDDDDDD ~-), 05 370 200 0: 0 F 0. 10 94 52 0: 0 F 0,20 25 14 0: i F 0.30 12 6.4 0: 1 F 0,40 6.8 5.8 O: 2 F 0,50 4.7 2.6 0:2 F 0.60 .3.5 1.9 O: 2 F 0.70 ~.o 8 1.6 ¢):_ 3 F 0.80 2.3 1.3 '0:3 F 0.90 2.0 !. I 0: 4 F 1.00 1.8 1.0 0: 4 F ~' 00 0.75 0.42 0: 8 F 3.00 0.46 0.26 0:12 F 4.00 0.34 0.19 0:16 F 5.00 0.26 0.14 0:20 F 6.00 0.~1 O. 12 0:24 F 7.00 ('). 17 0. 10 0:28 F 8.00 0. 15 0.082 0:33 F 9.00 O. 13 O. 071 0:37 F 10.0 0. I i 0.06.3 0:4.1 F 0 0. 048 0. 026 1:21 F 0 0. 016 0, 0089 ~. 43 F ,0 0.010 0,0056 4: 4 F 80.0 0. 0062 0. ()055 5:25 F 100 0. 004.0 0. 0022 6: 47 F 4.0 S/N 12155 The FPE Group I.D. : ETHYLENE OXIDE (1990:LIBRARY) olecul ar : 44.0 oram/mol e Weioht AS Number: [~5-21-8] ~WA : 1.0 ~pm TWA : 1.8 mg/m°~'5  DLH : 800 ppm TERM : 1.7E+01 pounds Release Duration : 5.0E+00 Minutes D.O.T. $~ 1040 HE I GHT-EFFECT I VE: 30 Feet HEALTH : 2 ob~AC~= WIND oFEED :6.4 Miles/hour DEPOSITION VELOCITY: 0.100 cm/second FLAMMABILITY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEPTOR HEIGHT (z) : 30 Feet REACTIVITY : 3 _OCATION OF MAXIMUM CONCENTRATION I_EVEL Distance : '..'. 0.06Mi _evel : > 2.4E+02 mo/m"~5 1.3E+02 PPM MAXIMUM CONCENTRATION ARRIVAL TIME St ability X-Mi Y-Mi mg/m'""3 ppm hours: mi nutes DDDDDD DDDDDD DDDDDDDD DDDDDDDD DDDDDDDDDDDDD DDDDDDDDD 0.01])~ 0. 000 23000 13000 0:0 F 0.0~) 9~ 0. 000 23000 13000 0: 0 F 0. OK) ~ O. 000 25,000 15000 0: 0 F 0.0 D~'~ O. 000 23000 1.3000 0: 0 F 0.00~ 0. 000 23000 13000 O: 0 F 0.0~ (~ O. 000 23000 13000 O: 0 F 0.0~ 0.000 18000 10000 O: 0 F O. 0{])~ 0. 000 14000 7800 0: 0 F O. 0~)~ 0. 000 11000 6200 0: 0 F 0.01 0. 000 9000 5000 0:0 F 0.02 0. 000 2300 1300 0:0 F 0.03 0.000 1000 560 0: 0 F 0.04 0. 000 570 320 0: 0 F 0.05 0. 000 370 200 0: 0 F 0.06 0.000 260 140 0: 0 F 0.07 0.000 190 110 0:0 F 0.08 0.000 150 81 0: 0 F 0.09 0. 000 120 64 0: 0 F 0. 10 0.000 94 52 0: 0 F e4.0 S/N 12153 The FPE ~rouo ~S-T'~NCE I.D. : ETHYLENE OXIDE (I~O:LIBR~RY) ~lolecular Weioht : 44.0 oram/mole ~AS Number: [~5-21-8] ~'  WA : 1.0 ~m TWA : 1.8 mg/m"~'5 DLH : 800 ppm TERM : 1.7E+O1 pounds Release Durmtion : 5.0E+O0 Minutes D.O.T. ~ 1040 HEIGHT-EFFECTIVE: 50 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0.100 em/second FLAMPtABILITY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEPTOR HEIGHT (z) : 50 Feet REACTIVITY : 5 _OCATION OF MAXIMUM CDNCENTRATION LEVEL )istance : < 0.06Mi _evel : > 2.4E+02 mg/m'""3 1.3E+02 F'PM MAX I MUM D CONCENTRATION ARRIVAL TIME St ability X-Mi Y-Mi mg/m'%3 ppm hours: mi nutes >DDDDD DDDDDD DDDDDDDD DDDDDDDD DDDDDD,O. DDDDDD DDDDDDDDD O. 0~ O. 005 6.4E-05 3.6E-05 0: 0 A O. 0~ (~. 005 6.4E-~. ~ .J. - ]= = 6E-05 O: 0 A O. 0~ 0. 005 0. 0016 0. 000B8 0: 0 A 0.0~ 0. O05 0.t~4 0 015 0:0 A O. 0~ 0. 005 0.15 O. 082 0: 0 A 0.01 0.005 0.52 0.29 0:0 A 0.02 0. 005 14 7.8 O: 0 A 0.03 0.005 18 10 0: 0 B 0.04 0.005 18 10 0: 0 B 0.05 0.005 19 11 0: 0 C 0.06 0.005 18 10 0: 0 C 0.07 0.005 18 10 0: 0 D 0.08 0.005 19 10 0: 0 E 0.09 0.005 19 11 0: 0 E 0. 10 0.005 19 11 0: 0 E 0.50 0..005 4.3 2.4 0: 2 F 1.00 0.005 1.7 1.0 0: 4 F 4.0 S/N 12155 The FPE Group 'ANCE I.D. : ETHYLENE OXIDE (1990:LIBRARY) Molecular Weight : 44.0 gram/mole CAS Number: [75-21-8] TWA : 1.0 ppm TWA : 1.8 mg/m^5 IDLH : 800 ppm TERM : 1.7E+01 pounds Release Duration : 5.0E+00 Minutes D.O.T. ~ 1040 HEIGHT-EFFECTIVE: 30 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0. 100 em/second FLAMMABILITY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEF'TOR HEIGHT (z) : 40 Feet REACTIVITY : 3 LOCATION OF MAXIMUM CONCENTRATION LEVEL Distance : < 0.06Mi Level : > 4..3E+01 mg/m^3~.° 4E+01 PPM MAX I MUM IND CONCENTRATION ARRIVAL TIME Stability Di stance-Mi mg / m"~ ppm hours: mi nutes DDDDDDDDDDDDDD DDDDDDDD DDDDDDDD DDDDDDDDDDDDD- DDDDDDDDD O. 05 54. 30 O: 0 D 0. 10 27 15 0:0 E 0.20 15 8.3 O: I F 0.30 9.0 5.0 O: I F 0.4.0 5.9 3.3 0:2 F 0.50 4.1 2.3 O: 2 F 0.60 3.1 1.7 O: 2 F 0.70 2.5 ~ 1.4 O: 3 F 0.80 2. I 1.2 O: 3 F 0.90 1.8 1.0 0:4 F 1.00 1.6 0.87 O: 4 F 2.00 0.69 0.38 0: 8 F 3. O0 O. 44 O. 24. 0: 12 F 4.00 0..32 0. 18 0:16 F 5. O0 0.25 0. 14. 0: 20 F 6.00 0.20 0. 11 0:24 F 7.00 0.17 0. 093 0:28 F 8.00 O. 14 0. 079 O: 3.]; F 9.00 0.12 0. 069 0: .37 F 10.0 0. 11 0.061 0:41 F !0.0 O. 047 0. 026 1: 21 F 0 O. 016 O. 0088 2:43 F 60.0 0.010 0.0056 4:4 F 80.0 0. 0062 0. 0034. 5: 25 F 100 O. 0040 0. 0022 6:47 F ode 4.0 S/N 1215.3 The FPE Grot.to OXIDE ( :1990-' L I.r.. RARY,' ldolecular WeioP, t : 44.0 oram/mole [[;A~ Numb_r: [7o-<1-8] TWA : 1.0 Dom TWA : 1.8 mo/re'%3 IDLH : 800 oom TERM : 1.7E+01 pounds Release Duration : 5.0E+00 Minutes D.O.T. ~ 1040 HEIGHT-EFFECTIVE: 30 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0. 100 em/second FLAMMABILITY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEPTOR HEIGHT (z) : 40 Feet REACTIVITY : 5 =OCATION OF MAXIMLIM CONCENTRATION LEVEL stance : < 0.06Mi '_evel : > 4..3E+01 mg/m'""3 2.4E+C.~1 PPM MAX I MUM DL!NNW I ND CONCEN'f'RAT I ON ARR I VAL TIME Stabi 1 i t y X-Mi Y-Mi mg/m'"'.5 ppm hours: minutes -. ~.)DDDDD D[?DZ>DZ> DD~.)DDDDI_) ,C~D~DDDDD D~.)DDL'DDDDZ)DDD 0.0 ~ ~ 0. 000 42 ~._,~ ~ 0: 0 A O. 0~ O. 000 42 23 O: 0 A 0.0~ 0.000 42 25 O: 0 A 0.0~ 0.000 42 25 O: 0 A 0.0~5 0.000 42 23 0: 0 A 0.00~ 0.000 42 25 O: 0 A 0.0~ 0.000 60 53 0: 0 A 0.0~¢ 0.000 78 43 O: 0 A 0. OD ~ 0. 000 87 49 0: 0 A 0.01 0.000 91 51 O: 0 A 0.02 0.000 73 40 0: 0 B 0.05 0. 000 67 37 0: 0 C 0.04 0.000 65 55 0: 0 D 0.05 0.000 54 30 O: 0 D 0.06 0. 000 45 ~¢~= 0: 0 D 0.07 0.000 36 20 0: 0 D 0.08 0.000 31 17 0: 0 E 0.09 0.000 29 16 0: 0 E 0. 10 0.000 27 15 0: 0 E e 4.0 .S/N 12153 The FF'E Group I.D. : ETHYLENE OXIDE (1990:LIBRARY) 'loiecular- Weioht : 44.0 oram/mole ]AS NumOer: -'75 ~ [/~-~1-8] FWA : 1.0 ppm 'TWA : 1.8 mo/m""~ [DLH : 800 ppm '- TERM : 1.7E+01 pounds Release Duration : 5.0E+00 Minutes D.O.T. ~ 1040 HE I GHT-EFFECT I VE: ~0 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0. 100 em/second FLAMMABILITY: 4 STABILITY CLASS : WORST CASE (A - F') TERRAIN : STANDARD RECEPTOR HEIGHT (z) : 40 Feet REACTIVITY : 3 r'iCATION OF MAXIML;M C[NC~N]RATION LEVEL )istance : < 0.06Mi .~evel : > 4.3E+01 mg/m~'°3 2.4E+01 PPM MA X I NUM CONCENTRATION ARRIVAL TIME S~ability X-Mi Y-Mi mo_ / m'""Z~ ppm hour s: mi nutes )DDDDD DDDDDD DDDDDDDD DDDDDDDD DDDD~)DDDDDDD~" Z;'DDPDDDDD 0.0~ 0. 005 7.9E-06 ~.~ 1E-06 O: 0 A 0.0~ 0.005 3.9E-06 2.1E-06 0: 0 A 0.0~ 0. 005 1.7E-04 9.6E-05 0: 0 A 0.0D~ 0.005 0.0044 0.0025 0: 0 A 0.0~ 0. 005 0. 059 0. 022 0:0 A 0.01 0. 005 0.18 0.10 0: 0 A 0.02 0.005 1! 6.0 0: 0 A 0.03 0.005 13 7.4 0: 0 A 0.04 0.005 15 8.5 O: 0 B 0.05 0.005 14 8.0 O: 0 C 0.0~ 0.006 11 6.0 0:0 C O. 06 O. 005 15 8.2 O: 0 C 0.07 0.005 14 7.7 0: 0 C 0.08 0.005 14. 7.9 O: 0 D 0.09 0.005 14 7.7 0:0 D 0.10 0. 005 13 7.2 0: 0 D 0.20 0. 005 9.2 5.1 .0: 1 F 0.30 0.005 7.3 ~.0 0: i F 0.40 0.005 5.2 2.9 '0: 2 F 0.50 0.005 3.8 2.1 0: 2 F 0.005 3.0 1.6 0: 2 F 0.005 ~.4 1.3 0: 3 F 0.80 0.005 2.0 1. I 0: 3 F 0.90 0.005 1.7 1.0 0: 4 F 4.0 S/N 1215:5 The FPE Grouo SL!BSTANCE I.D. : ETHYLENE OXIDE (1990:LIBRARY) ~olecular Weio. nt : 44.0 gram/mole CAS Number: [75-21-8] /TWA : 1.0 oom TWA : 1.8 mo/m"'"5 '/IDLH : 80i)' o~m ~/ TERM : 1.~E+01 pounds .Release Duration : 5.0E+00 Minutes D.O.T. # 1040 HEIGHT-EFFECTIVE: 8 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0. 100 em/second FLAMMABILITY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEF'TOR HEIGHT (z) : 8 Feet REACTIVITY : 3 ,_OCA]"IOIg OF MAX i?iUM CONCENTRATION LEVEL )istance : < 0.06M.~. ,_,eve]. : > 4.9E+02 mg/m""3 2,,7E+02 PPM MAX I MLJM ~NwiND CONCENTRATION ARRIVAL TIME Stabilitv Di stance-Mi mg/ m'"'5 ppm hours: mi nutes }DDDD,DDDDDDDDD DDDDDDDD DDDDDDDD DDDDDDDDDDDDD-' DDDDDDDDD 0.05 760 420 O: 0 F 0. 10 190 110 0: 1 F O. 20 64 .'56 0: 2 F' 0.30 516 20 0: 3 F O. 40 23 151 O: .3 F O. 50 16 9.1 O: 4 F 0.60 12 6.8 0:5 F 0.70 10 5 · 3 0: 6 F 0.80 7.7 4.3 0: 7 F 0.90 6.4 3.5 0:8 F 1.C)O 5.4 5.0 O: 8 F 2.00 1.9 1.1 0:17 F 5.00 1.0 O. 58 0:25 F 4.00 O· 69 O. 38 O: 34. F 5.00 0.50 0.28 0:42 F 6.00 0.39 0.22 0:50 F 7.00 0·511 0.17 0:59 F 8.00 0.26 0. 14 1: 7 F 9.00 0.22 0.12 1:16 . F 10.0 0. 19 0. 10 1:24 F · 0 O· 056 0. 031 2:48 F 0 0. 014 0. 0075 5:36 F 60.0 O. 0072 O. 0040 8:25 F 80.0 0. 004:Z 0. 0024 11: 13 F 100 0.0028 0.0016 14: i F EPicoUe 4.0 S/N 12153 'l"hm FPE S_BSTANCE I.D. : ETHYLENE OXIDE (1990:LIBRARY) Molecuimr Wmi~ht : 44.0 grmm/mol CAS Number: [75-21-8] TWA : 1.0 ppm TWA : 1.8 m~/m .~, ,... IDLH : 8C)0 mom TERM : 1.TE+OI mounds Release Duration : 5.0E+00 MinL~tem D.O.T. $~ 1040 HE I GHT--EFFECT I VE: 8 Feet HEALTH : 2 SURFACE WIND SF'EED :6.4. Miles/hour DEPOSITION VELOCITY: 0.100 cm/second FLAMMABILITY: 4 STABILITY CLASS : WORST CASE (A - F) TERRAIN : STANDARD RECEPTOR HEIGHT (z) : 8 Feet REACTIVITY : 3 =OCATION OF MAXiMLJM CONCENTRATION LEVEL. Distance.., : < 0.06Mi LeveI : > 4, ~,c'~o'-., ~, ........ mg/m'""3; .~.. 7E+02. _ PPM O. 0~1 0.000 48000 27000 O: 0 F 0.0~]- 0,000 48000 27000 O: 0 F 0.0~] 0. 000 48000 27000 0: 0 F 0.0~)~ 0. 000 48000 27000 0: 0 F 0.0~ ~ 0. 000 48000 27000 0: 0 F 0.0~ 0.000 48000 27000 0: 0 F 0.0~ 0.000 38000 21000 O: 0 F 0.1)~ ~ 0. 000 29000 16000 0: 0 F O. 0~ O. 000 22;000 1~000 O: 0 F 0.01 0.000 19000 10000 O: 0 F O. 02 0.000 470C) 2600 0: 0 F 0.03 0.000 2J. 00 ].200 O: 0 F O. 04 O. 000 1200 650 0: 0 F 0.05 0.000 760 420 0: 0 F 0.06 0. 000 530 290 0: 1 F 0.07 0. 000 390 220 0: i F 0.08 0. 000 ~;0() 170 0: 1 F' 0.09 0. 000 240 130 0: 1 F 0.10 0.000 190 110 0: 1 F' _~ode 4.0 S/N 12153 The FPE Group SUBSTANCE I.D. : ETHYL. ENE OXIDE (1990:LIBRARY) Molecular Weight : 44.0 gram/mole CAS Number: ['75-21-8] TWA : 1.0 ppm TWA : 1.8 mg/m""3 IDLH :- 800 ppm TERM : 1.7E+01 uounds Release Duration : 5.0E+00 Minutes D.O.T. J.~ 1040 HE iGHT-EFFECTIVE: 8 Feet HEALTH : 2 SURFACE WIND SPEED :6.4 Miles/hour DEPOSITION VELOCITY: 0. 100 em/second FLAMMAB:[LITY: 4. STABILITY ULASS : WORST CASE (A- F) TERRAIN : STANDARD R:ECEPTOR HEIGHT (z) : 8 Feet REACTIVITY : 3 LOCATION OF' MAXIMUM uL!"4.¢m~RAflON LEVEL Distance : < 0.06M~. Level.- .." 4..9E+()©.- m~/m'""3 ~.°.7E+02 PF'M ) MAX I MUM OWNWIND CONCENTRATION ARRIVAL TIME St ability X-Mi Y-Mi mg/m'""3 ppm hours: mi nutes ...... r).,n ......onn r)FO:)DDDDDD DDDDDD DDDDDD DDDDDDDD DDDDDDDD 'J' :} :? ;).. ~ .. Z' Z~J'. .......... 0.0 D ~ 0. 005 7.0E-05 5.9E-C25 0: 0 A 0.0~ 0.005 7~0E-05 3.9E-05 0: 0 A 0~0~ 0. 005 0.0017 0.0010 0: 0 A 0.0~ 0.005 O. 027 . 0 C =' . ) t ~ 0: 0 A 0.0~ 0. 005 0.17 0. 093 0: 0 A 0.Or 0.005 0.60 0.33 O: 0 A 0.02 O. 005 23 13 0: 0 A 0.03 0.005 29 16 0: 0 B 0.04 0. 005 .35 18 0: 0 B 0.05 0.0C, 5 32 18 0: 0 C 0.06 0.005 3~; 18 0: 1 C 0.0'7 (). 0()5 5:3 18 0: 1 D 0.08 0.005 34 19 0: I D 0.09 0.005 37 20 0: 1 E O. 10 0.005 38 21 0: 1 E 0,20 0 ()05 4C, ~)9 0: ,~ F 0.:50 0.0C,5 29 16 0: 3 F 0.40 0.()05 20 1]. 0: 3 F' 0.50 0.005 15 8.3 0: 4 F' 0.60 0.005 12 6.4 O: 5 F' 0.005 9. J. 5.0 0: 6 F 0,005 '7.4 4.1 0: 7 i:: ()... 90 0.00~;_ 6.2 E;. 4 ().: c,':' F 1.00 0.005 5.:5 2.9 O: 8 F ~'~. ~")~"~_ . ()_, 005 1 . c;:'. 1. I 0 = ~' '";', F 3.00 0. 005 I. 0 0.58 0 ~', 25 F' APPENDIX B: HAZARD AND OPERABILITY STUDY ... OF AN ETHYLENE OXIDE STERILIZER INTRODUCTION The main body of the present report summarizes a 1984-86 study by NIOSH researchers on controls for continuous or routine emissions of ethylene oxide from sterilizer installations in hospitals. The goals of this study were to evaluate and document effective engineering controls used by the hospitals that were studied. This study involved conducting a series of walk-through surveys to identify hospitals for further study, and week-long industrial hygiene[.. sampling at six facilities that were thought to represent state-of-the-art control. This approach is effective in evaluating the efficacy of controls currently in use, but is less useful for identifying possible causes of infrequent andpotentially catastrophic releases. Unless process or work practice failures were observed during the survey (which is unlikely), they may not have been considered in this type of study. As a follow-up to the field study, a second s~udywas conducted to evaluate the potential for a catastrophic or nonroutine releases of EtO. A ~azard and operability study (HAZOP), a form of process hazard analysis, was conducted on an EtO sterilizer supplied by compressed-gas cylinders. This sterilizer is similar to most of the sterilizers that are currently used in hospitals. ~The sterilizer installation, equipment, and operational procedures were reviewed and recommendations were developed both specifically for the studied installation and for the generic installation of any EtO sterilizer. The success of a HAZOP study depends upon the the knowledge and experience of the personnel involved and on the completeness of the information that is available. A team is assembled drawing from all the areas of interest. In the case of the sterilizer HAZOP, the equipment designers, a manufacturers service representative, the hospital engineering supervisor, and the hospital maintenance supervisor provided the technical expertise on the sterilizer equipment, installation, and procedures. In addition, a team leader and recording secretary were provided on a consulting basis (Technica, Inc., Columbus, Ohio). The team leader was responsible for carrying out the HAZOP in a systematic manner. The HAZOP technique involves studying the operation as a series of separate systems (called nodes). Using the set of guidewords listed in Table B-l, the team leader guides the group through each segment of the operation. Guidewords from the first part of the list relate to deviations in process parameters, such as too much pressure or no flow. For each guideword, the team attempted to identify a cause, or a series of causes. If no cause could be identified, the team moved on to the next guideword. If a cause was found, the team 119 discussed the consequences and plausibility of the deviation. If there were no significant consequences, the team proceeded to the next item. For items with both a plausible likelihood and a significant consequence, recommendations were formulated to eliminate or reduce the likelihood of the process deviation. In some cases, notes for additional study or later action were made. A similar procedure was used for guidewords from the second part of the list in Table B-1. These guidewordsare not related to process deviations, but rather to Specific subject areas or conditions of operation. PROCESS DESCRIPTION The process under study is sterilization of hospital equipment using an ethylene oxide sterilizer. The sterilizer consists of a jacketed chamber and associated pumps, pipes, filters, valves, etc. The actual equipment layout of the sterilizer at the facility of interest is divided into two containment areas: a loading/unloading area, which incorporates the fronts of two aerators and two sterilizer/aerators; and an equipment area, which contains the aerators, piping, ethylene oxide t~nks, and the sterilizer/aerators. The sterilizer chambers are fitted with a safety valve which, depending on the machine design, relieves the chamber at 15 psi or 40 psi; and a jacket safety valve (on steam-heated units), as shown in Figure B-1. The sterilization process begins with a mixture of liquid ethylene oxide and Freon 12 that passes through a steam-heated heat exchanger and is gasified. The gaseous mixture is fed into a preheated chamber, which contains the materials to be sterilized. The materials remain in the gaseous environment for the required amount of time for proper sterilization. Then, the ethylene oxtde/Freon mixture is removed from the chamber by a sequence of exhaust and aeration cycles. A final air wash of the chamber is done to complete the process. The vented gases leave the chamber through a ventilation system where they mix with air to give an acceptable concentration of ethylene oxide before they are exhausted to atmosphere. Aqueous effluent from the sterilizer passes to a disengaging funnel, so that any dissolved ethylene oxide which outgasses from the water can be directed to the ventilation system before the liquid effluent passes to the drain. To aid in understanding the equipment layout, the following definitions were developed: (i) Equipment Room - Room where ethylene oxide sterilizer, tanks, and piping are located. (ii) Loading Room - Contained room in which the sterilizer loading/unloading takes place. The layout of the sterilizer is shown in Figure B-1. An overall piping and instrumentation diagram is given in Figure B-2. 120 The EtO sterilizer system that was evaluated in the HAZOP study was divided into the following components, or nodes, for purposes of the HAZOP: · LayoUt of the EtO sterilizer facility (Figure B-I) Storage, transport, and changing of the EtO/Freon supply cylinder (Table B-2, Figure B-3) EtO piping from the cylinders to the sterilizer (Table B-3, Figure B-4) · Introduction of EtO/Freon into the EtO sterilizer (Table B-4, Figure B-2) · Operation of the EtO sterilizer (Tables B-5 and B-6, Figure B-2) · Utilities and process lines to and from the EtO sterilizer (Tables B-7, B-8, and B-9, Figure B-2) Reliability of the dilution ventilation system (Table B-Il, Figure B-5) · Reliability' of the EtO area monitoring system (Tables B-12 and B-13, Figure B-6) These nodes are discussed in the remainder of Appendix B. ~YOUT OF THE ETO STERILIZER FACILITY The design intention is to assure a safe working area, and to minimize the - chances of EtO exposures. General recommendations for this are as follows: · Ethylene oxide equipment should be isolated from other hospital equipment and should be in a separately enclosed area (containment room). Minimum size and layout should be such that staff and maintenance personnel should have adequate room for working, especially for transportation of ethylene oxide tanks. The ethylene oxide sterilizer and equipment should not be installed in or adjacent to patient areas. · If the machine control panel cannot be seen from outside the loading room, a remote control panel should be used. STORAGE, TRANSPORT, AND CHANGING OF THE ETO/FREON SUPPLY CYLINDERS The design intent is to safely store, transport, and install the EtO/Freon cylinders. Figure B-3 depicts the recommended piping and valving arrangements for the supply cylinders. General recommendations for installing new cylinders are as follows: 121 Supply valve, tank valve¥ vent valve, and needle valve to vent should be labeled (see Figure B-3). The same labeling system should be used in the written operating procedures. Ethylene oxide piping from tank to sterilizer should contain a line to the exhaust ventilation system. The HAZOP analysis for cylinder storage is given in Table B-2. ETO/FREON PIPING FROM THE CYLINDERS TO THE STERILIZER The design intent of this system is to transfer liquid EtO/Freon from the storage cylinders to the sterilizer unit. Figure B-4 shows the arrangement to perform this function. The HAZOP analysis for EtO transport is shown in Table B-3. INTRODUCTION OF ETO INTO THE STERILIZER The design intent of this system is to introduce vaporized EtO/Freon into the sterilizer. This system is a continuation of the EtO/Freon piping in the previous section. The HAZOP analysis is shown in Table B-4, which refers to Figure OPERATION OF THE ETO STERILIZER The design intent of the EtO sterilizer is to provide appropriate sterilization of the reusable hospital supplies without allowing the EtO to escape into the workplace in unacceptable amounts. Table B-5 shows a HAZOP analysis for the routine sterilizer operation. Also, the written operating procedures were reviewed in conjunction with this analysis, and safe practices for these procedures are given. UTILITIES AND PROCESS LINES TO AND FROM THE STERILIZER In addition to EtO, sterilizer operation also involves flows of air, steam, and condensate, as shown in Figure B-2. Consequences of deviation in these flows are considered in this section. Air is used as a vacuum break in between the vacuum cycles that are used to remove the EtO. Table B-7 shows the results of a HAZOP analysis for this air. Table B-8 shows the results of a HAZOP analysis for the steam supply to the sterilizer. The design intent is to provide humidification and some heating during the sterilization cycle. Table B-9 shows the results of a HAZOP analysis for the drain line from the sterilizer. The design intent is to depressurize and evacuate the sterilizer. For later machines, an interlock prevents a high discharge rate through the use of a flow restricter. When the chamber pressure is below atmospheric, a bypass valve opens around the restricter. A HAZOP analysis of the steam supply to the heat exchanger and sterilizer jacket and of the condensate line from.the heat exchanger and sterilizer jacket 122 showed no issues o~ concern. The cOoling water supply and drain also showed no concerns. HAZOP of the pressure relief valve on the sterilizer and of the gas temperature recorder/indicator is shown in Table B-10. The design intent of these items is to maintain proper conditions of temperatures and pressure for sterilization. RELIABILITY OF THE DILUTION VENTILATION SYSTEM The dilution ventilation should be designed in conjunction with the sterilizer equipment. The design intent is to remove EtO that has escaped into the work area and to vent excess heat from the sterilizer. General recommendations are as follows: The equipment room ventilation, lOading room (room in which the sterilizer loading/unloading takes place), ventilation, and machine exhaust should be routed to a dedicated ventilation system, separate from other systems. It should be sized to maintain a negative pressure in equipment room relative to loading room,'~nd a negative pressure in loading room relative to all other areas, if for example, a tank hose were to rupture; (this corresponds to a 5.4 lb/s release). A recirculation ventilation system is not safe for ethylene oxide areas. · Final exhaust fan should be outdoors to keep a negative pressure in the indoor ducts. The loading room ventilation should maintain a pressure lower than that in surrounding areas not containing ethylene oxide. The equipment room ventilation should maintain a pressure below that of the loading room. It is suggested to have separate containment rooms (one for the equipment room, and a second for the loading/unloading room). Where separate loading and unloading rooms are provided, these should both be maintained at a lower pressure than surrounding areas. Efficient ventilation would require a high level supply inlet because of thermal stratification (exhaust above supply). Table B-Ii gives the HAZOP analysis for the dilution ventilation system. ETO AREA MONITORING SYSTEM The .facility that was evaluated used a fixed-point gas chromatograph which rotated between a series of lines that drew air from various locations in the sterilizer area. A HAZOP analysis was done on the transport lines for potentially EtO-laden air from the work areas to the GC. This is shown in Table B-12. 123 ~TE:AM GAS N~ATER ~/': ST£AH ~JPPLY STRAINER ~OL~ND~D VALV~ R~G~ATDR ~z~c~ ~ ......... .......... ~"'~ ................................................... ~ ....... ~ ~ ~ ~LV~ : ~ : ~ ~AM~R ~AT SOLENOID V~VE : : :~' HEAT ~ ~ I ' ~1 ~ .~. * ~ v VAT~R ACT~T~ I ~ "' ~ R~COR~R ~ND]CATOR CH~B~R B~AKER ~ VA~ ~G~ PR~SSU~ SVITCHES ~ ~ 3 VAY S~C~IO I VALVE VITH / ~ ~PLY COOL]~ EATER VALVE TANKS I ~CXC~N~R ~ P~ VAC~ VATER ~ T CO~]~ VATER I ~ASTE VALVE Figure B-2. PiPing and Instrumentation Diagram for the EtO Sterilizer Evaluated in the HAZOP. SUPPLY VALVE )~~ TD VENT VALVE ~ TANK NEE:DLE VALVE VALVE ~co VENT BALi_ VALVE ETHYLENE OXIDE TANK (12~, w/w Ethytene Oxide in Freon) Figure B-3. Labeling of Val~ on the EtO Supply Line. 127 TI] STERILIZER CHECK CHECK  VALVE FILTER I ' L I -I J~' ,l~~ VENT VENT TI] VENT TO ETHYLENE OX1])E TANKS ~' - --- I'~. I 75 pslg I'J (1~'% w/w I~thytene Oxide J J Figure B-4. Piping for Transport of EtO/Freon from the Supply Cylinders to the Sterilizer. A I DTHER RDBMS STERILIZER I Figure B-5. Schematic of a Dedicated Dilution Exhaust for the EtO Sterilizer. 129 CALIBRATIrlN'to 20 ppm ~ ~F~ GAS (15 ppm CARRIER GAS <N2 Ethylene I]xide in Np) I ~7 ~7 ~7 SCHEMATIC FIF MULTIPDRT VALVE I I SAMPLING PUMP I I <~ .PUMP TI] VENT I~ ~~ ~, ~~'T~ Figure B-6. Schematic of Area Monitoring System for EtO. 130 Table B-1. HAZOP Guideword List. PART I - Process Parameters Flow No Flow Reverse Flow More Flow Less Flow Level More Level Less Level Pressure More Pressure Less Pressure Temperature More Temperature Less Temperature Viscosity More Viscosity Less Viscosity PART II - Other Items Composition Change Contamination Pressure Relief Instrumentation Sampling Corrosion/Erosion Service Failure Abnormal Operation Maintenance Static Electricity Spare Equipment Safety 131 Table 1. (NIOSH B-2). HAZOP Analysis of EtO/Freon Supply Cylinders GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION SAFETY High te~erature. Righ pressure. Store tanks in wet[ ventilated area below IO0°F. Follow storage regulations of pressurized ethylene oxide gas (use of caps, etc.). Faulty or damaged cylinder. Ethylene oxide release. Continue to use a transportation route to avoid patient areas, and transport one tank at a time using a cart with a holding strap. Check for leaks from tanks using a halogen leak detector, or other appropriate leak detector, before transporting to equipment room, after transporting, and after connecting to piping. If ethylene oxide tank is dropped, assume leaking, If an audible or visible leakage, assurae a severe leak and leave area imediate[y. Table 2. (NIOSH B-3). HAZOP Analysis of Piping and Valves for EtO Transport from the Storage Cylinders to the Sterilizer Unit (Refer to Figure B-4). GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION NO FLOW Closed valve in line or No hazard. No safety issue. ethylene oxide tank is e~ty. REVERSE FLOW Ethylene oxide tank is not Flow of trapped materia[ into Written procedures should be placed near present and valves A and B equipment room. valve B indicating that the valve should are open, and check va[ve not be open while changing ethylene oxide fails, tanks. HIGH FL~ Broken line or hose due to an Damage to piping or other Instruction to operator must be to leave (CONTINUOUS accidental break, equipment. Chemical burns, the room and initiate emergency procedures. RELEASE) Pool of ethylene oxide forms. Respirator equipment should be close by equipment room (room where ethylene oxide sterilizer, tanks, and piping are located). Equipment room should have two exits. All ethylene oxide tanks ~hou[d be located in one general area. Piping design should follow the code for medical gases and NFPA 9<~ codes (fire codes). NFPA cc~e recommends that copper containing alloys are not suitable for ethylene oxide. This is the case if the ethylene oxide contains acetylene as a con- taminant. Since all U.S. manufacture<~ t\ethy[ene oxide now contains no acetylene, copper piping is considered here to be acceptable. This should specify hard copper tubing, silver solder joints, ar~ adequate supporting. The piping diameter (1/4" min.) and routing should be chosen to minimize' the liquid inventory. Piping should be labeled to identify it as carrying ethylene oxide. The ethylene oxide piping should not be adjacent to steam lines. Table 2. (continued) GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION Operators and maintenance staff should be trained in the hazards of ethylene oxide and Freon 12 according to OSHA regutations. The atmosphere in the equipment room should be monitored to provide a gross Leak alarm in the case of an accidental release. A suitable alarm concentration would be to maximum of 100 ppm. The monitor should be tested periodicaLLy at the manufacturer,s reco~nended frequency or every three n~nths, whichever comes first. An organic vapor detector would be suitable. A sampting point should be Located in the approximate breathing zone in the Loading area, near potential Leak sources. ~The equipment room ventilation, Loading room (room in which the sterilizer Loading/unLoading takes place), ventilation, and machine exhaust should be routed to a dedicated ventiLa 'o~tem, separate fr~ other svstems s,zed to maintain a~ ~e~-e'- equipment room relative to Loading room, and a negative pressure in Loading room relative to aLL other areas, if for example, a tank hose were to rupture. LESS FLOW No hazard. No safety issue. MORE PRESSURE Equipment room temperature EthyLene oxide Leakage around Vent should be sized to ensure that increase warms tank. tank valve. Potymerization in temperature in equipment room should be tank. [ess than 100 °F as specified by ethylene oxide gas distributor. LO~/ PRESSURE No safety issue. Table 2. (continued) GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTION~/QUESTION/RECOMMENDATION HIGH TEMP. High room tenq~erature. High pressure. Same as for more pressure. (NONAMSIENT) Steam Leak onto tank. Possible fusing of fusible When working on pressurized ethylene oxide plug. system, (e.g., when changing cylinders, protective equipment should be worn, including face shield and gloves), facilities should be provided to allow rapid washing off of any spillage or splashing to the skin (e.g., a safety shower). COMPOSITION Composition in tank has pure Explosion or fire. Inspection for correct Labeling (usually by ethylene oxide (no Freon 12). color and sticker) of newly arrived ethylene oxide and Freon tanks should be done. Tanks should be stored in an isolated area. Operator should ensure that the proper ethylene oxide and Freon tank is hooked up to sterilizer. ~A sign saying "Check tank label for proper ethylene oxide and Freon compesition" should be posted in the storage room. CONTAMINATION Dirt contaminates process Filter should remove. No safety issue. stream while making couplings. RELIEF Blocked needle valve in vent No depressurization of hose A system of two isolation valves should be (VENTING) line. and line between valves A and present on ethylene oxide inlet Lines. B (see Figure 2). Addition of a bleed between the two valves would reduce the consequence of Leakage. Alternative[y, addition of a pressure indicator between the valves would allow leak detection. Move or add the pressure indicator to position upstream of valve B. This configuration is shown in Figure S-4. The recommended configuration is shown in Table 2. (continued) GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION MAINTENANCE Leak from valve stems, Low concentrations of ethylene Carry out regular check for leaks around joints, etc. oxide in atmosphere, fittings using an appropriate leak detector (i.e., a halogen or hydrocarbon leak detector). SAFETY Major leaks. High concentration of ethylene Develop a contingency plan for use when a oxide in area. major leak occurs. See Operational Procedure 9 in NIOSH document. (SECURITY) Unauthorized entrance into Equipment misuse. Exposure to Equipment room should be marked, and a equipment room or access ethylene oxide, locked door should be used if bossib[e. area. (HAZARDS OF See recommendations for high flow. PROCESS MATERIAL) (EMERGENCY See recommendations for high flow. EQUIPMENT) Table 3. (NIOSH B-4). HAZOP Analysis of EtO Introduction into the Sterilizer (Refer to Figure B-2.) GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION NO FLO~/ No hazard. No safety issue. REVERSE FLC~/ Not possible. No safety issue. MORE FLOW Solenoid valve opens when Ethylene oxide transport An interlock is required to ensure that the chamber door is open. through piping, ethylene oxide inlet valve (or valves) cannot open unless the chamber door is locked. Regular wear on solenoid Leakage of solenoid valves. A system of two isolation valves should be valves, present on ethylene oxide in[et Lines. Addition of a bleed between the two valves would reduce the consequence of Leakage. In addition, the addition of a pressure indicator between the valves would allow teak detection. Move or add the pressure indicator to position upstream of valve 8 in Figure B-3. MORE FLOW Pressure switch fails. - Relief valve on chamber Chamber relief valve should be routed to lifts, the dedicated ethylene oxide ventilation system. Failed door gasket. Door gasket should be inspected before each use; replace when necessary. LESS FLOW General use. - Longer time to pressurize. No safety issue. Fails after time Limit. ' LESS PRESSURE Steam vent line from heat Higher temperature in ethylene No safety issue. exchanger is blocked, oxide and polymer forms. Table 3. (continued) GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION LOi4 TEMP. IN Hot chant3er contains Liquid - No safety hazard if relief ReLief valve should be sized for maximum ETHYLENE ethy[ene oxide and Freon. valve is adequately sized. Liquid feed rate to hot chamber, assuming OXIDE LINE alt Liquid wiLL evaporate. - Rapid evaporation of ethylene oxide and Freon. - Overpressure in chamber. SERVICE Power failure during - Sequence stops. Manual venting arrangement for power FAILURE sterilization steps, failure should not be used as this could - VaLves close. Lead to ethylene oxide exposure to operator. It is recommended that either the manual vent valve be disabled, or only used under careful management controL. Table 4. (NIOSH B-5). HAZOP Analysis of Routine Sterilizer Operation. GUIDEWORD/ ACTIONS/QUESTION/ STEP DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES RECO~NDATION WARMUP SAFETY Setting temperature higher than Contact burns - alarm sounds at No safety issue. HAZARDS 130°F. 160OF. Misreading of temperature (high Out of limits - won't start. No safety issue. or iow). Misreading of pressure (high or Out of limits - won't start. No safety issue. iow). PREHEAT SAFETY Timer malfunctions. No hazard. No safety issue. HAZARDS EVACUATION SAFETY Air or steam leakage into Causes higher pressure or pumps No safety issue. AND STEAM HAZARDS chamber, work harder. No hazard. PULSING Vacuum switch faulty. - Pressure not achieved. No hazard. - Overpressurize chamber possible, but no hazard. Air in chan~er during No hazard. evacuation. Faulty reading of pressure Too long in cycle - alarm sounds. during evacuation. No hazard. CHARGING WITH NO FLOW Alarm from watchdog timer. No unresolved safety issue. EtO MORE FLOW Leakage in heat exchanger Steam carries ethylene oxide gas No unresolved safety issue. (tubes). to drain. Reverse flow into air line via Ethylene oxide leak to equipment Air inlet to chamber should not leaking valve, room. pick up air from equipment room, but from exhaust duct to reduce risk from reverse leakage of ethylene oxide. Table 4. (continued) GUIDEWORD/ ACTIONS/QUESTION/ STEP DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES RECO~E4ENDATION CHARGING WITH SAFETY Prior evacuation of air was not No hazard to operators - not sure See Operational Procedure 2b in EtO (cont.) HAZARD achieved; begins to charge with of sterility of load. NIOSH document. ethylene oxide and Freon. STERILIZING SAFETY Leakage of ethylene oxide and Notification by computer No unresolved safety issue. PROCESS HAZARD Freon. printouts and alarms if leakage is severe. EVACUATION SAFETY Rapid depressurization of Overloading of vent (exhaust) Maximum exhaust rate of gas from HAZARD chan%ber, system at the plumbing gap. chamber must not exceed ventila- tion system capacity. EVACUATION LEAKAGE OF Faulty pressure switch allows Open door when not actually safe See Operating Procedures 2b and AND AIR WASH ETHYLENE cycle to step on without proper to do so. 2c in NIOSH document. Also, an OXIDE evacuation, interlock is required to ensure that the ethylene oxide inlet valve (or valves) cannot open unless the chamber door is locked. Add a 20-min. air wash procedure if not already on system. Table 5. (NIOSH B-7). HAZOP Analysis of the Air Supply for Vacuum Relief in the EtO Sterilizer GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES -ACTIONS/QUESTION/RECOMMENDATION NO FLOt4 - Valve closed. - Machine hangs up. No hazard. No safety issue. - Fitter plugged. - Machine hangs up. No hazard. Takes too tong, alarm goes off. - Too much vacuum. - Deep vacuum, can't open door. No hazard. REVERSE FLOW Air tine should be connected Air in[et to chamber shoutd not pick up air to vent. from equipment room, but from exhaust duct to reduce risk from reverse [eakage of ethylene oxide. No safety issue. HIGH FLOW LESS FLOW Partial blockage. Takes longer - No hazard. No safety issue. HIGH PRESSURE No hazard. No safety issue. LESS PRESSURE No hazard, flo safety issue. HIGH TEMP. No hazard. No safety issue. LOW TEMP. No hazard. No safety issue. VISCOSITY No hazard. No safety issue. COMPOSITION Draw in contaminated air Concentration is too [ow to No safety issue. (exhaust from other cause hazard. equipment) from vent. Table 5. (continued) GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION CONTAMINATION Biological contamination. Filter takes care of problem. No safety issue. INSTRUMEN- Leaking valve - air leaks in. Chamber doesn't reach required No safety issue. TATION vacuum for function steps. Notified by watchdog alarm - No hazard. Loose water supply to water Can't open valve - system No safety issue. SERVICE actuated valve, hangs. FAILURE Table 6. (NIOSH B-8). HAZOP Analysis for the Steam Supply to the EtO Sterilizer GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION NO FLOW Valve doesn't open. - Cycle won't proceed since it No safety Issue. kooks to see a pressure - No steam, change. PLugged steam tine (due to - If it gets through cycle, cruet), proper sterilization is not achieved. No hazard to emptoyees. HIGH FLOW Vatve sticks open. High pressure in chamber. No safety issue. Unlikely to go above atmospheric pressure because running vacuum - High temperature, pun~o at the same time. - Machine aborts cycle. LESS FLOW Steam kine blockage. Cycle takes longer, No safety issue. HIGH PRESSURE Steam valve stays open. No hazard for kine, No safety issue, LOW PRESSURE No hazard; designed for No safety issue, vacuum. NIGH TEMP. Steam valve doesn't close System designed to handle No safety issue, when supposed to. it. - Damage of toad, printout saying toad is damaged. - If pressure too high, relief vatve opens. - Can't open 'door if this is the case. COMPOSITION No probtem. No safety issue. Table 6. (continued) GUIDEWORO/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/OIJESTION/RECOMMENDATION CONTAMINANTS Boiler fault. System should be able to No safety issue. IN STEAM handle it. - Corrodes at high revels. - Maintenance probtem. RELIEF Piping can withstand max. No safety issue. steam pressure - No hazard. SERVICE No steam. Pressure not achieved; hangs No safety issue. FAILURE up. Table 7. (NIOSH B-9). HAZOP Analysis for the Drain Line from the Sterilizer GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CO~ISEQUENCES ACTIONS/QUESTION/RECOMMENDATION NO FLOW - No water flow. No vacuum [eve[ achieved for No safety issue. additional steps (stops Closed valve in line. cycle). -Pu~ not running. - Ethylene oxide goes to vent. REVERSE FLOW Exhaust valve fails, other Water into chan~er. No hazard. No safety issue. valves fail. MORE FLOW The loading room ventilation should maintain a pressure lower than that in surrounding areas not containing ethylene oxide. The equipment room ventilation should maintain a pressure be[ow that of the loading room, It is suggested to have separate containment rooms (one for the equipment room, and a second for the loading/unloading room). Where separate loading and unloading rooms are provided, these should both be maintained at a lower pressure than surrounding areas. Efficient ventilation would require a high level exhaust out[et and a [ow [eve[ supply in[et because of thermal stratification (exhaust above supply). The minimum ' at the vents  oom ~ t.~~onnecting~e__.~o~a~nd operating ~ movements.-~ e~h-~ust d~d be located above 'each door into each area. A slot hood should be located above the loading /unloading door of the sterilizer. The area ventilation should be to a dedicated exhaust system. Table 7. (continued) GUIDEWORD/ DEV[ATIOM POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION Drain plugs. Water with ethylene oxide on Hospital should have an emergency procedure floor; creates emergency for this case. Avoid continuing cycle if situation, drain is known to be plugged (do this by cutting power to sterilizer). High concentration sensed in equipment room. If interlock is on: Where practical, a dedicated drain section should be used connecting to a main drain - Goes into exhaust cycle, line, to reduce risk of blockage. - Closes ethylene oxide charging valve. - Closes valve S3 to avoid dump. Alarm sounds. If splashes away from funnel, ethylene oxide is picked up by ventilation. No hazard. LESS FLOW Cycle takes longer. No safety issue. HIGH PRESSURE Can handle high pressure. No safety issue. LESS PRESSURE Designed for [ow pressure. No safety issue. HIGH TEMP. Less efficient on cycle. No safety issue. - Pun~ is dry. Damage to pump. No hazard. CONTAMINANTS Line contains contaminants. Strainer removes any (if not - Strainer in chamber should be inspected no flow), before each use. INSTRUMENTA- - Plugged restricter (needle - Hangs up. No safety issue. TION valve). Cycle takes longer. Valve doesn't open. Hange up, watchdog alarm. - Valve doesn't open. Table 8. (NIOSH B-lO). HAZOP Analysis for the Pressure Relief and Temperature Recorder/Indicator on the Sterilizer GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION MORE PRESSURE Overloaded relief valve. Gasket failure - venting into Loading room should not be occup{ed during room. operation. The door to loading room should contain a window for observation. LOW PRESSURE Designed for vacuum. No No safety issue. hazard. (Can, t open door.) HIGH TEMP. Maximum steam temperature No concern. No safety issue. reached. LOW TEMP No concern. No safety issue. CONTAMINANTS Polymerization of ethylene Polymer deposits that could See Operating Procedure 4b in NIOSH oxide in chamber and reaction retain ethylene oxide, document. of this with water. RELIEF Relief valve sticks, or inlet Regular testing of valve Relief valve should be tested periodically. plugged with lint. should solve the problem. (Procedure for test should be carried out according to manufacturer's recommenda- tions). INSTRUMEN- Leakage around temperature Picked up by leak checks. Carry out regular check for leaks around TATION probe, fittings using an appropriate leak detector (i.e., a halogen or hydrocarbon leak detector). Leakage of relief valve. Ventilation system removes Chamber relief valve should be routed to No hazard, the dedicated ethylene oxide ventilation system. CORROSION No safety issue due to materials of construction. SERVICE Steam failure. No warm-up, can't get into No safety issue. FAILURE cycle. SAFETY Manual valve. Manual venting arrangement for power failure should not be used as this could lead to ethylene oxide exposure to operator. It is recommended that either the manual vent valve be disabled, or only used under careful management control. Table 9. (NIOSH B-11). Reliability of the Dilution Ventilation System. GUIDEWORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOHMENDATION NO FLOW Fan at point A stops, (see Back flow from sterilizer Monitoring of pressure with a positive /REVERSE FLOW Figure 4). exhaust into other ventilated indication of failure should be used. areas during exhaust cycle. Pressure should be monitored by a differentia[ pressure switch that is fail- safe, such that a [ack of negative pressure in the exhaust duct sounds an alarm and inhibits the exhaust cycle of the sterilizer. Ventilation system should be sized to keep temperature in area be[ow 100°F. HIGH FLOW No hazard. No safety issue. LOW FLOW Picked up by a differential No safety issue. pressure switch. Possible failure to clear ethylene oxide from area. MORE PRESSURE Fan at point A stops, (see See LOW FLOW. The equipment room ventilation, loading Figure 4). room (room in which the sterilizer loading/unloading takes place), ventilation, and machine exhaust should be routed to a dedicated ventilation system, separate from other systems. It should be sized to maintain a negative pressure in equipment room relative to loading room, and a negative pressure in loading room relative to all other areas, if for example, a tank hose were to rupture. HIGH TEMP. No hazard. No safety issue. LOW TEMP. No hazard - should be No safety issue. controlled for comfort. COMPOSITION No hazard. No safety issue. SERVICE Failure of ventilation No ventilation. Install tow flow switch and alarm (alarm FAILURE system, should be fail-safe) as noted above. Table g.'(continued) GUIDENORD/ DEVIATION POSSIBLE CAUSES POSSIBLE CONSEQUENCES ACTIONS/QUESTION/RECOMMENDATION DISCHARGE Check local codes for location of discharge POINT to prevent reentering of gases into building. A[so, locate for minima[ exposure to passers-by. EQUIPMENT Drain m~st be sea[ed. This wi[[ not violate ROOM p[un~ing codes as the drain piping within the sterilizer provides a p[unt~ing gap which is not sea[ed. Local ventilation should be provided to the plumbing gap. The drain system to which the sterilizer is connected should be fitted with drain traps, to prevent gas flow. If the drain is not likely to be used, it should be capped. The drains [Dca[ to the sterilizer should be [abe[ed, to irx~icate that they may contain ethylene oxide. G~SS~Y AERATOR A device for the removal of ethylene oxide from sterilized materials by the exposure to the circulation of air; aeration is normally accomplishedat an elevated temperature. AIR FLUSH That part of the sterilizer cycle when the vacuum pump operates continuously and a valve opens admitting filtered air into the sterilizer chamber. AMPOULE A small glass vial containing ethylene oxide. ANTISIPHON A device to prevent backflow of contaminated water into the AIR GAP potable water system; the air gap maybe partially enclosed and connected to a local exhaust system. AUTOCLAVE A pressurized, steam-heated vessel used for sterilization. BIOLOGICAL A vial containing bacterial spores used for determination of INDICATOR sterilization. CLF2%NROOM The area within the hospital where washed materials are dried, inspected, and packaged. DECONTAMINATION That area within the hospital where used materials are washed ROOM prior to sterilization; also known as the isolation room. DEDICATED An exhaust system serving only the aerator, sterilizer, EXt~AUST and/or the immediate area. DWELL PERIOD That part of the sterilizer cycle during which sterilization takes place. EVACUATION/ That part of the sterilizer cycle when the vacuum pump runs EXHAUST to remove the bulk of the ethylene oxide from the chamber, followed by the opening of a valve to admit filtered air into the sterilizer chamber, returning it to atmospheric pressure. GENERAL Mechanical ventilation applied to a room or an area for the VENTILATION purposes of climate control and dilution of hazardous chemical concentrations to safe levels. HOOD The point of entry into a local exhaust system. ISOLATION ROOM A separate room containing the sterilizer and the sterilizer loading area. 166 LOADING AREA The area in front of the sterilizer and aer.ator; in some hospitals, the loading area is a separate room with limited access. LOCAL EXHAUST Mechanical ventilation applied at or Close to the source of VENTII2kTION an emission, for the purpose of drawing clean, uncontaminated air past the worker, capturing the emission, collecting it in an exhaust hood, and removing it from the building. MECHANICAL A room into which the mechanical equipment of the sterilizer ACCESS ROOM and aerator are recessed, leaving the front of the equipment flush with the wall; also known as the recess room. NORMAL LOAD The materials sterilized by the hospital. PULSE-PURGE That part of the sterilizer cycle after evacuation/exhaust consisting of repeated cycles of operation of the vacuum pump followed by vacuum relief. RECESS ROOM The mechanical access room. RELIEF VALVE A device to vent the sterilizer in the event the pressure exceeds the chamber design pressure. TEST LOAD A "standard" load used in this study consisting of lengths of latex tubing in a wrapper. 167 ~ U.S.GOVERNMENT PRINTING OFFICEI~989-648--164/OO520 ? ..":,~' PROCEDURE I ' M~nual Number ,. Effective Date Review Date CMMUN~ ETHYLENE OXIDE ~NDLING HOSP~: mg~ o~ ~ 9 T~INING OF PERSONNEL 1. Training shall be done annually. The training of employees who handle ETO shall include: A. ~Methods used to detect ETO in the work area. B. ~Physical and health hazards of ETO. C. Protective measures to include safe work practices, personal protective clothing if required, and equipment. D. Manufacturer's recommendations for working the equipment in use. E. '.~Emergency plan. F. AThe hazard co~unication plan (Including "Material Safety '?Data Sheets"). G. ?..Training of employees who work in an area where ETO is used, ..but do not handle ETO, shall include items E and F. 2. Routine daily inspections and checks. A. ;Daily checks, operator shall visually inspect door gaskets for 'cracks, debris and other foreign objects. B. If debris or foreign objects are observed, clean and start operations. C. . If cracks are observed, call maintenance for service. D. ?~Record observations in Log Book. 3. .Bi-Weekly checks. A. '7~he ventilation alarm system. B. The following using a Fluorocarbon Leak Detector: 'a. ETO entrance port to Sterilizer while tank valve is ~: on, door is open and solenoid valves are closed. '~b. Entire system with Chamber under pressure; areas to '.( check include: Door Gasket Cylinder and Vacuum Piping, Hoses, Filters, Valves and Solenoid Valves. ~'~:~: .,. PROFESSIONAL EDUCATION AND TRAINING CLASS ROSTER . June 12- 14 MM First Name Last Name Title Hospital Address City State Zip Phone Fax Rep Ms Onetta CS RFK 4500 West Hawthorne CA 90250 310-973- 310-219- Kevin Technician Hospital 116th 1711 3728 Mosher Street Ms Polly Fontejon CS RFK 4500 West Hawthorne CA 90250 310-973- '310-219- Kevin Manager Hospital 116th 1711 3728 Mosher Street Ms Carolyn Holiwell Supervisor San 2615 Eye Bakersfield CA 93301 805-395- 805-322- Jim Central Joaquin Street ................ 3000 x2247 8264 Mathers Services Community Hosp Ms Sue Muse Supervisor San 2615 Eye Bakersfield CA 93301 805-395- 805-322- Jim Central Joaquin Street 3000 x2247 8264 ' Mathers Processing Community Hosp Ms Elaine Sikon- Instrument St Margaret 815 Pittsburgh PA 15215 412-784- 412-784- Michelle Brady Processing Memorial Freeport 4000 1670 Bailey Manager Road Mr Bill Geiger St. Alexius 510 Eighth Bismark ND 58501 701-224- Tom ave. 7043 Buckrucker- Mr Brent Veil St. Alexius 510 Eighth Bismark ND 58501 701-224- . Tom Ave. 7043 Buckrucker Ms Nicoletti Joanne Central St. 815 Pittsburgh PA 15215 412-784- 412-784- MicheIle Mascara Supply Margaret Freeport . 4000" 1670. Bailey Supervisor Memorial Road mergrost ., ? Customer 'Education and Training Program June 12- 14, 1995 Headquarters. (33 Technology Drive Irvine, California) Monday, June 12, 1995 INTRODUCTION AND OVERVIEW 8:30 a.m. - 8:45 a.m. Welcome and Overview Kathle. en Demel PLASMA CONCEPTS AND TECHNOLOGY 8:45 a.m. - 9:45 a.m. Science of Physics Sebastian Eulogio States of' Matter Pressure/Vacuum Electromagnetic Spectrum Radio Frequency Hydrogen Peroxide Primary and Secondary Plasma 9:45 a.m. -. 10:00 a.m. Break 10:00 a.m. - 11:00 a.m. Introduction of Participants Joanne Clark J&J and ASP Organization STERRAD* Technology video 11:00 a.m. - 12:00 p.m. Tour of ASP Headquarters Tom Hensley 12:00 p.m. - 1:00 p.m. Lunch *Trademark June 12agn Customer Education and Training Program June 12 ~ 14, 1995 Headquarters (33 Technology Drive Irvine, California) Monday, June 12, 1995 (cont.) STERRAD 100 STERILIZER 1:00 p.m. - 2:00 p.m. STERRAD 100 Sterilizer Demonstration Joanne Clark MICROBIOLOGY 2:00 p.m. - 3:00 p.m. Microorganisms CharlesRoberts Definition of Sterile D Value Sterility Assurance Level Contamination BI Test Pack/TSB/Catalase 3:00 p.m. - 3:15 p.m. Break 3:15 p.m. - 4:00 p.m. Chemical Indicators Mark Espensheid 4:00 p.m. Travel to Embassy Suites 6:30 p.m.- 8:30 p.m. Welcome Reception (Prego's) (Please meet in hotel lobby at 6:00pm for transportation to Prego's) June12agn.doc Page 2 2 Customer Education and Training Program June 12- 14, 1995 Headquarters (33 Technology Drive Irvine, California) Tuesday, June 13, 1995 STERRAD 100 STERILIZER CONSTRUCTION, OPERATION, AND SUBCOMPONENTS DEMO ROOM 8:30 a.m. - 10:30 a.m. 5 Stages of STERRAD Sterilizer Nick Demczuk Vacuum Stage Injection/Diffusion Stage Plasma Stage Vent Stage 10:30 a.m. -10:45 a.m. Break · 10:45 a.m.- 12:00 p.m. Hands-on Practice Nick Demczuk Joanne Clark 12:00 p.m. - 1:00 p.m. Lunch CLINICAL OPERATION, STERRAD 100 STERILIZER LCD / PRINTER ERROR MESSAGES DEMO ROOM 1:00 p.m. - 4:30 p.m. Clinical Applications Joanne Clark Tray Assembly (size) Surgical Instrument Clips and Clamps-JJMI Packaging Materials Polypropylene CSR Wrap Kimbe,rly-Clark, Baxter Supershield June12agn.doc Page.3 3 Customer Education and Training Program June 12- 14, 1995 Headquarters (33 Technology Drive Irvine, California) Tusday, June 13, cont. Peel Pouches Tower Plasti-Peel 3M Steri-Lok Clinical Issues Surface Contact Sterilization Method ... Load Arrangement Wet Loads - Cancellations Paper Linen · Cotton Lot/Load Stickers Lumens 6 mm (1/4") and 31 cm (12") 4:30 p.m. Transport back to hotel 6:30 - 8:30 p.m. Dinner at McCormick and Schmick's Restaurant (this is directly across the street from the hotel - please meet over there for our 6:30pm reservation) June12agn.doc Page 4 4 Customer Education and Training Program June 12- 14, 1995 Headquarters (33 Technology Drive Irvine, California) Wednesday, June 14, 1995 CUSTOMER SUPPORT 8:30 a.m. - 9:00 a.m. Customer Education Joanne Clark Change Process 9:00 a.m. - 9:15 a.m. Customer Support Kathleen number 800 755 - 5900 Demel 9:15 a.m. - 10:15 a.m.' Jeopardy Game 10:15 a.m. - 10:30 a.m. Break 10:30 a.m. - 10:45 a.m. Research & Technology Charles Howlett Sebastian Eulogio Tom McNatt Su Syin Wu pune12agn.doc Page 5 '5 Customer Education and Training Program June 12- 14, 1995 Headquarters (33 Technology Drive Irvine, California) Wednesday, June 14, 1995 (cont.) 10:45 a.m. - 11:15 a.m. Focus Group Julie Ficke Dan Brostoff 11:15 a.m. Adjourn · .- , (Travel. to hotel or airport) The International Association Of Healthcare Central Service Material Management (IAHCSMM) # 00194 has approved 16.0 contact hours for completion of this course. The California Board of Registered Nursing (BRN) # CEP 10868 has approved 16.0 contact hours for successful completion of this course. The Association of Operating Room Nurses has approved 16.0 contact hours for completion of this course. The National Institute for the Certification of Healthcare Sterile Processing and Distribution Personnel #:846Nhas approved 5.1 contact hours for completion of this course. 1RN's: Please add license number to master roster. -June12agn.doc Page 6 6 ~ .ADVANCED STERILIZATION PRODUCTS SERVICES, INC. STERRAD* 100 Sterilization System Alliance* Service Agreement Features Matrix Alliance FEATURES PLATINUM GOLD SILVER BRONZE 500 Cycle P.M. · 'Parts Only Parts Only · 1500 Cycle P.M. · Parts Only Parts Only ·. Product Certification · · · · Product Configuration Report · · · · Account History Report · · ·' · Up-Time Guarantee · · · · Corrective Spare Parts · · · -- Corrective Labor · · -- Product Life Extension · -- -- -- PRICE $8,640 $6,240 $4,500 $2,640 ~ ADVANCED STERILIZATION PRODUCTS' SERVICES, INC. 33 Technology Drive, Irvine, CA 92718 (800) 755-5900 *Trademark ©1994 Advanced Sterilization Products AD-02889-001 12/94 I~.ADVANCED STERILIZATION. PRODUCTS SERVICES, INC. Alliance* SerVice Agreement Program Announcing Advanced Sterilization Products Services, Inc. Program. Alliance sets the indu~t-~gt~i~diit-d ~f6fT6f~il":~0§t~ff6~ t tble only from Advanced Sterilization Products Services, Inc. liance provides the most compr~h~dns~ve ~nvest ~me~nt ~ in the industry. s gned for customers that de end.on the avall~b~t -of sterilization i fipinent and require fast response when support ~S needed. Alliance - your .ax_surance commitment and performance. / . ~.' · 500 Cycle/4 Month, 9 Point leaning, lubrication, adjustments and calibration. Also mctu~erre~On'm, systems as we{I as any recommended corrective action on your STERRAD* tion system. · 1500 Cycle/12 Month, 16 Point Preventive depth preventive maintenance review, designed to eliminate downtime includes repo~ on mechanical and electrical systems as well as any recommended .*ctive action on your STERRAD 100 sterilization system. · Product Certification, Configuration and Advisor ese documents will confirm your STERRAD 100 system meets original instaliati6n SP~ciflC~ions, validate the electrical and mechanical configuration, review product retr~fits/~'~m{les applicable to your unit and report on all corrective and preventive maintenanc6:*acti°ns '~rformed on your STERRAD 100 sterilization, system during the last 12 · Up-Time Guarantee. Advanced Sterilization Products downtime will not exceed 24 consecutive hoursL otherwise, ASPS willl, cost of labor required to return the Equipment to specification at the prevailing · All Replacement parts Supplied at No Charge. Durin~;~he your Alliance Agreement, all replacement parts required to keep your system meeting original installation specifications are supplied at · Corrective Labor Supplied at No Charge. During the Alliance AgreemenL all corrective labor required to keep your STERRAD 100 meeting original '*' installation specifications is supplied at no charge to you. · Product Enhancements. As product upgrades applicable iRRAD 100 Sterilizer configuration become available, ASPS will install them at hq. upgrades developed by ASP applicable to the STERRAD 100 Sterilize~ OhS other than *your configuration will be installed at no charge if determined b~ ASPS to feasible and cost effective to do so. Advanced Sterilization 'ProdUcts Services, Inc. offers Service designed to fit into your express requirements and offer you savings inprocess. See our Service Agreement Matrix for details. · Trademark ~ Defined as not meeting specification for a period greater than 24 consecutive hours, measured from the time ASP is notified by the Customer that the Equipment is not operating properly to the time ASP notifies the Customer that the Equipment again meets specification, excluding time covered by ~Terms and Conditions~ sections six (6), seven (7), and eight (8). FOR EMERGENCY OR PRODUCT ASSISTANCE: CONTACT ADVANCED STERILIZATION PRODUCTS .'(800) 755-5900 1. CHEMICAL PRODUCT/COMPANY IDENTIFICATION " PRODUCT NAME ....................... : HYDROGEN PEROXIDE ' SYNONYMS ................................ : HYDROGEN PEROXIDE SOLUTION (DOT), PERHYDROL, PEROSSlDO DI IDROGENO (ITAMAN), PEROXYDE D'HYDROGENE (FRENCH) WA$$ERTOFFPEROXID(GERMAN) AND WATER-~TOFPEROXIDE (DUTCH) 2. COMPOSITION/INFORMATION ON INGREDIENT~ CAS# AND COMPONENTS ........ : MATERIAL/COMPONENT: HYDROGEN PEROXIDE PERCENT ............................. : 45 TO CAb'~ ..................................... : 7722-84-1 MATERIAL/COMPONENT; WATER PERCENT ............................. : 55 TO 40.5% CAS~ ............................. ~ ....... : 7732-18-5 3. HAZARD IDENTIFICATION EMERGENCY OVERVIEW ......... : OXIDIZER. CONTACT WITH COMBUSTIBLES MAY CAUSE FIRE. DECOMPOSES YIELDING OXYGEN THAT SUPPORTS COMBUSTION OF ORGANIC MATTERS AND CAN CAUSE OVERPRESSURE IF CONFINED. HEALTH EFFECTS ....................... : CORROSIVE TO EYES, SKIN, NOSF~ THROAT, AND LUNGS. MAY CAUSE IRREVERSIBLE TISSUE DAMAGE TO THE EYES INCLUDING BLINDNESS. 4. FIRST AID MEASURES EYES ............................................. : IMMEDIATELY FLUSH WITH LARGE AMOUNTS OF WATER FOR AT LEAST 15 MINUTES, LIFTING UPPER AND LOWER LIDS INTERMITTENTLY. SEE PHYSICIAN OR OPHTHALMOLOGIST. SKIN .............................................. : WASH WtTH LARGE AMOUNTS OF WATER. IF IRRITATION OCCURS, SEE A PHYSICIAN. INHALATION .............................. : REMOVE TO FRESH AIR. IF BREATHING DIFFICULTY OR -, DISCOMFORT OCCURS, CALL A PHYSICIAN. '" INGESTION ................................... ; IF SWALLOWED, DRINK PLENTY OF WATEE IMMEDIATELY TO DILUTE. DO NOT INDUCE VOMITING OR GIVE ANYTHING BY MOUTH TO AN UNCONSCIOUS PERSON. SEE A PHYSICIAN. NOTES TO PHYSICIAN .............. : HYDROGEN PEROXIDE AT THESE CONCENTRATIONS IS A STRONG OXIDANT. DIRECT CONTACT WITH THE EYE IS LIKELY TO CAUSE CORNEAL DAMAGE ESPECIALLY IF NOT WASHED IMMEDIATELY. CAREFUL OPHTHALMOLOGIC EVALUATION IS RECOMMENDED AND THE POSSIBILITY OFLOCAL CORTICOSTEROID THERAPY SHOULD · · BE CONSIDERED. BECAUSE OF THE LIKELIHOOD OF SYSTEMIC EFFECTS, AI-FEMPT~ AT EVACUATING THE STOMACH VIA EME61S INDUCTION OF GASTRIC LAVAGE SHOULD BE AVOIDED. THERE REMOTE POSSIBILITY, HOWEVER, THAT A NASOGAb'FRIC OR OROGASTRlC TUBE MAY BE REQUIRED FOR THE REDUCTION OF SEVERE DISTENSION DUE TO GA~ FORMATION. PAGE: ! OF $. FIRE FIGHTING MEASURES EXTINGUISHING MEDIA....' ...... : PREFERABLY WATER OR WATER FOG. CARBON DIOXIDE AND DRY CHEMICAL MAY ALSO BE USED.. SPECIAL FIRE FIGHTING .......... ; ANY TANK OR CONTAINER SURROUNDED BY FIRE PROCEDURES - SHOULD BE FLOODED WITH WATER FOR COOLING. WEAR FULL PROTECTIVE CLOTHING AND SELF-CONTAINED BREATHING APPARATUS. DEGREE OF FIRE AND .............. :. PRODUCT IS NONCOMBUSTIBLE. ON EXPLOSION HAZARD DECOMPOSITION H202 RELEASES OXYGEN WHICH MAY INTENSIFY RRE. HAZARDOUS DECOMPOSITION: OXYGEN WHICH SUPPORTS COMBUSTION. PRODUCTS 6. ACCIDENTAL RELEASE MEASURES PROCEDURE FOR RELEASE....: DILUTE WITH LARGE VOLUME OF WATER AND OR SPILL ~ HOLD IN A POND OR DIKED AREA UNTIL H202 DECOMPOSES. DISPOSE ACCORDING TO METHODS OUTLINED FOR WASTE DISPOSAl- 7. HANDLING AND BTORAGE HANDLING ................................. : WEAR CUP ~'PE CHEMICAL SAFETY GOGGLES AND/OR FULL FACE SHIELD, POLYESTER OR ACRYLIC FULL COVER CLOTHING AND RUBBER OR NEOPRENE GLOVES AND SHOES. AVOID COI'i'ON, -" WOOL AND LEATHER. AVOID EXCESSIVE HEAT AND CONTAMINATION. CONTAMINATION MAY CAUSE DECOMPOSITION AND GENERATION OF OXYGEN GAS WHICH COULD RESULT IN HIGH PRESSURES AND POSSIBLE CONTAINER RUPTURE. HYDROGEN PEROXIDE SHOULD BE STORED ONLY IN VENTED CONTAINERS AND SHOULD BE TRANSFERRED ONLY IN A PRESCRIBED MANNER. NEVER RETURN UNUSED HYDROGEN PEROXIDE TO ORIGINAL CONTAINER. EMPTY DRUMS SHOULD BE TRIPLE RINSED WITH WATER BEFORE DISCARDING. UTENSILS USED FOR HANDLING HYDROGEN PEROXIDE SHOULD BE MADE ONLY OF GLASS, STAINLESS STEEL, ALUMINUM, OR PLASTIC. VENTILATION ........................ ; PROVIDE MECHANICAL GENERAL AND/OR LOCAL EXHAUST VENTILATION TO PREVENT RELEASE OF VAPOR OR MIST INTO THE' ' ..~ WORK ENVIRONMENT. STORAGE ................................. : STORE DRUMS IN COOL.AREAS OUT OF DIRECT SUNUGHT AND AWAY FROM COMBUSTIBLES. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION CONTROL MEASURES ........... : VENTILATION SHOULD BE PROVIDED TO MINIMIZE THE RELEASE OF H202 VAPORS AND MIST INTO THE WORK ENVIRONMENT. SPILLS SHOULD BE COLLECTED OR CONFINED IMMEDIATELY AND DILUTED FOR DISPOSAL TO PREVENT RELEASE INTO THE WORK AREA. REMOVE CONTAMINATED CLOTHING IMMEDIATELY AND WASH BEFORE REUSE. RECOMMENDED PERSONAL PROTECTIVE EQUIPMENT RF_-~PIRATORY .......... L ....... : IF CONCENTRATIONS IN EXCESS OF 10 PPM ARE EXPECTED USE APPROVED SELF-CONTAINED BREATHING'APPARATUS. DO NOT USE OXIDIZABLE SORBANTB SUCH AS ACTIVATED CARBON. - EYES ................................... :. . USE CUP TYPE CHEMICAL GOGGLES AND/OR FULL FACE SHIELD. PAGE: 2 OF 8 GLOVES ............................. : LIQUID PROOF RUBBER OR NEOPRENE GLOVES, SPECIAl. CLOTHING ....... : POLYESTER OR ACRYLIC FULL CLOTHING. AND EQUIPMENT (AVOID COTTON, WOOL, AND LEATHER)' . FOOTWEAR ...................... : RUBBER OR NEOPRENE FOOT~VEAR. (AVOID LEATHER) 9. PHYSICAL AND CHEMICAL PROPERTIES 4O% 60% ' MELTING/FREEZING POINT....: ~,t.4'C(-42.5'F) -62°C (-62°F) BOILING POINT, ......................... : 110°C (229'F) 114°C (237'F) VAPOR PRESSURF_ ....................: 22 MM HG ~30'C 16.3 MM HG (~ 30°C' VAPOR DENSITY (AIR=I) ....... : NO DATA NO DATA ROOM TEMPERATURF_ .......... ; <---CLEAR TO COLORLESS ..... APPEARANCE AND STATE ODOR ................ : ......................... : < --ODORLESS > SPECIFIC GRAVlI'~ (H20=1)...: 1.16 ~ 20C/4C 1'.19 (~ 20CI4C SOLUBIUTY IN H20 % BY WT: < 100% ... % VOLATILES ........................... : <. 100% EVAPORATION RATE ......... ~...: <. ABOVE 1 .. (BUTYL ACETATE = 1) pH (AS IS) .................................. : <- 1,0 - 3.(~ ........... - pH (1% SOLUTION) ................. : ~ ............ 5.0 - 6.0 - - - > ODOR THRESHOLD ................ ; < ......NOT AVAILABLE. DENSITY (G/ML) ..................... : < NOT AVAILABLE---------~ PARTITION COEFFICIENT....: <-: ..... NOT AVAILABLE. N~CTANOL/VVATER FLASH POINT ......................... : < ........... NON-COMBUSTIBLE - AUTOIGNmON TEMPERATURE: <-----NON-COMBUSTIBLE---> FLAMMABLE LIMIT~ UPPER: < .......NONCOMBUSTIBLE (AIR) LOWER: < .. NON-COMBUSTIBLE .... EXPLOSIVE PROPERTIES ....... : < ...... NOT APPLICABLE.. OXIDIZING PROPERTIES ........ : STRONG OXIDIZER SOLUBILITY ............................. : NO DATA AVAILABLE - FAT SOLUBILITY (SOLVENT - OIL) 10. ~'rABIUTY AND REACTIVITY STABILITY ................................ : STABLE (HEAT AND CONTAMINATION COULD CAUSE DECOMPosmoN) HAZARDOUS POLYMERIZATION: WILL NOT OCCUR CONDITIONS TO AVOID ......... : EXCESSIVE HEAT OR CONTAMINATION COULD CAU&E PRODUCT TO BECOME UNSTABLE. MATERIALS TO AVOID...i ....... ; DIRT, ORGANICS, CYANIDES, AND COMBUSTIBLES SUCH AS WOOD, PAPER, O!1.~, ETC. MAJOR CONTAMINANTS THAT; IRON AND OTHER HEAVY METALS, COPPER ALLOYS CONTRIBUTE TO INSTABILITY ANt) CAUSTIC. INCOMPATIBILITY ................... :- REDUCING AGENTS, WOOD, PAPER AND OTHER COMBUSTIBLES (SEE AaOVE) HAZARDOUS DECOMPO~_ ITION: OXYGEN THAT SUPPORTS COMBUSTION PRODUCT8 SENSITIVITY TO MECH. IMPACT: NO DATA AVAILABLE SENSITIVITY TO STATIC ........ : NO DATA AVAILABLE' DI~HARGE PAGE: 3 OF tl 11. TOXICOLOGICAL INFORMATION EYE CONTACT .......................... : SEVERE IRRITANT/CORROSIVE (RABBIT) (70% H202) REI~. ICG/T- 79.027 SKIN CONTACT ........................ : SEVERE IRRITANT/CORROSIVE (RABBIT) (50% H202) REF. 169-1079 SKIN ABSORPTION ..... , ........... : LOS0 >6.5 G/KG (RABBIT) (70% H202) REF. ICC:d1'-79.027 .. INHALATION ............................ : LCS0>0,17 MG/L (RAT) (50% H202) . REF. 189-1080 INGESTION ............................... : . LD50>225 MG/KG AND <1200 MG/KG (RAT) (50% H202) REF. 186-914 ACUTE EFFECTS FROM ......... : SEVERE IRRITANT/CORROSIVE TO EYES, SKIN AND OVEREXPOSURE GASTROINTESTINAL TRACT.. MAY CAUSE IRREVERSIBLE TISSUE DAMAGE TO THE EYES, INCLUDING BLINDNESS. INHALATION OF MIST OR VAPORS MAY BE SEVERELY IRRITATING TO NOSE, THROAT AND LUNGS. CHRONIC EFFECTS FROM....: THERE ARE REPORT~ OF LIMITED EVIDENCE OF OVEREXPOSURE CARCINOGENICITY OF HYDROGEN PEROXIDE TO (EFFECTS CONSIDERED MICE ADMINISTERED HIGH CONCENTRATIONS IN INCLUDE: THEIR DRINKING WATER (IARC MONOGRAPH SENSITIVITIES, 36,1985). HOWEVER, THE INTERNATIONAL AGENCY CARClNOGENICiTY, FOR RESEARCH ON CANCER CONCLUDED THAT TERATOGENICITY, HYDROGEN PEROXIDE COULD NOT BE CLASSIFIED MUTAGENICITY, AS TO ITS CARCINOGENICITY TO. HUMANS (GROUP ~YNERGISTIC PRODUCTS, I!! CARCINOGEN). AND ANY MEDICAL CONDITIONS GENERALLY RECOGNIZED A~ BEING AGGRAVATED BY EXPOSURE.) 12, ECOLOGICAL INFORMATION ENVIRONMENTAL FATE .......... : H202 IN THE AQUATIC ENVIRONMENT IS SUBJECT TO VARIOUS REDUCTION OR OXIDATION PROCESSES AND DECOMPOSES INTO WATER AND OXYGEN. H202 HALF UFE IN FRESHWATER RANGED FROM 8 HOURS TO 20 DAYS, IN AIR FROM 10-20 HOURS AND IN SOILS FROM MINUTES TO HOURS DEPENDING UPON ,, MIOROBIOLOGICAL ACTIVITY AND METAL CONTAMINANTS. ENVIRONMENTAL EFFECTS...: CHANNEL CATFISH 96 HR LCBO = 37.4 MG/L FATHEAD MINNOW 96 HR LCSO = 16.4 MG/L DAPHNIA MAGNA 24 HR LCS0 = 7.7 MG/L · DAPHNIA PULE 48 HR LCS0 = 2.4 MG/L PHYSA SP. 98 HR LC§0 = 17,7 MG/L (FRESHWATER SNAIL) FOR MORE INFORMATION REFER TO ECETOC 'JOINT ASSESSMENT OF COMMODITY CHEMICALS NO. 22, HYDROGEN PEROXIDE.' ISSN- 0773-6339, JANUARY t993. 15, DIBPO~4,L CONSIDERATION8 WASTE DISPOSAL METHOD...: AN ACCEPTABLE METHOD OF DISPOSAL IS TO DILUTE WITH A LARGE AMOUNT OF WATER AND ALLOW THE HYDROGEN.PEROXIDE TO . DECOMPOSE FOLLOWED BY DISCHARGE INTO A SUITABLE TREATMENT SYSTEM IN ACCORDANCE WITH ALL REGULATORY ., AGENCIES. BECAUSE ACCEPTABLE METHODS OF DISPOSAL MAY PAGE: 4 OF 8 Iri~lllJ MA~.RIAL BA~'~.~Y DATA SHEET - MSDS:, 00t ' I ~ EFFECTIVE: 12/07/94 I VARY BY LOCATION AND BECAUSE REGULATORY REQUIREMENTS. · MAY CHANGE, THE APPROPRIATE REGULATORY AGENCIES SHOULD BY CONTACTED PRIOR TO DISPOSAL. 14. TRANSPORT INFORMATION DOT PROPER SHIPPING NAME: HYDROGEN PEROXIDE, AQUEOUS SOLUTIONS WITH MORE THAN 40 PERCENT BUT NOT MORE THAN 60 PERCENT HYDROGEN PEROXIDE. IATA ............................................. : . HYDROGEN PEROXIDE, AQUEOUS SOLUTIONS WITH MORE THAN 40 PERCENT BUT NOT MORE THAN 60 PERCENT HYDROGEN PEROXIDE. IMDG ............................................ : HYOROGEN PEROXIDE, AQUEOUS SOLUTIONS WITH MORE THAN 40 PERCENT BUT NOT MORE THAN 60 PERCENT HYDROGEN PEROXIDE. DOT CLASSIFICATION ............. : $.1 (OXIDIZER) DOT LABELS .............................. : OXIDIZER, CORROSIVE DOT MARKING .......................... : HYDROGEN PEROXIDE, AQUEOUS SOLUTIONS WITH MORE THAN 40 PERCENT BUT NOT MORE THAN 60 PERCENT HYDROGEN PEROXIDE. UN 2014 DOT PLACARD .......................... : 5.1 (OXIDIZER) UN NUMBER ........................ : ..... : UN2014 HAZARDOUS SUBSTANCE/RQ: NOT APPLICABLE 49 STCC NUMBER ..................... : 4918776 PRECAUTIONS TO BE TAKEN: PROTECT FROM PHYSICAL DAMAGE, KEEP DRUMS IN TRANSPORTATION IN UPRIGHT POSITION. DRUMS SHOULD NOT BE STACKED IN TRANSIT. DO NOT STORE DRUMS ON WOODEN PALLETS. OTHER SHIPPING INFORMATION: ALUMINUM TANKS, DRUM/DOT 420, PACKING GROUP II '. i IS, REGULATORY INFORMATION OSHA EXPOSURE LIMITS SUBSTANCE(S) .................... : HYDROGEN PEROXIDE OSHA PEL-TWA ................ ; I PPM STEL ......................... : NOT APPLICABLE CEIUN{3 ............ ; ...... ; NOT APPLICABLE SKIN DESIGNATION: NOT APPLICABLE ACGIH TLV-TW~ ............... : 1 PPM ~EI, ......................... : NOT APPMCASLE ,, CEILING ................... : NOT APPLICABLE SKIN DESIGNATION: NOT APPLICABLE TARGET ORGAN EFFECTS ....... : SENSORY IRRITATION, EYE, LUNGS AND SKIN CARCINOGENIC POTENTIAL...: HYDROGEN PEROXIDE REGULATED BY OSHA ...... : NO LISTED ON NTP REPORT...: NO IARC GROUP 1, 2~ 2B ........ : NO US EPA REQUIREMENT13 RELEASE REPORTING CERCLA (40 CFR. 302) NOT LISTED LISTED SUBSTANCE(S) ...... : NO RQ ............................... : NOT APPLICABLE CATEI3ORY ............... : NOT APPUCABLE RCRA WASTE NO ........ : NOT APPUCABLE UNUSTED SUBSTANCE(S),,,,: HYDROGEN PEROXIDE 45-59.5% RQ .................................. : 100 LB. CATEGORY .................. : IGNITABILITY, CORROSlVlTY RCRA WASTE NO ...... ...: DO01, DO02 PAGF.: $ Glz 8 ' '--'~rl ~ . EFFECTIVE: '12107/94 ~ I HYDROGEN PEROXIDE (45% - 69.6%) REVISION: · 1 I . , · . 'CR5075 SARA TITLE III SEC 313 (40 CFR 372) .............................. : NOT LISTED LISTED TOXIC CHEMICAL ....... : NOT LISTED REPORTING THRESHOLD ....... : NOT APPLICABLE INVENTORY REPORTING SARA TITLE III SEC 3111312 (40 CFR 370) SUBSTANCE(S) ........................ : HYDROGEN PEROXIDE 450-59,5% HAZARD CATEGORY ............... : FIRE HAZARD IMMEDIATE (ACUTE) HEALTH HAZARD PLANNING THRESHOLD ......... : CONC. > 52% CONC. < 52% 600 LB. 10,000 LB. EMERGENCY PLANNING SARA TITLE iii aEC 302/303 (40 CFR 355) LISTED SUBSTANCE(S) .......... : HYDROGEN PEROXIDE'> 62% RQ ............................................. : I LB. PLANNING THRESHOLD ......... : 1000 LB. US TSCA STATUS .............. : ........... : LISTED CANADA INGREDIENT DISCLOSURE LIST SUBSTANCE(S) ........................ : HYDROGEN PEROXIDE CONTROLLED PRODUCT .............. : YES .. HAZARD SYMBOLS ........................ : CORROSIVE, OXIDIZING, MATERIALS CAUSING OTHER TOXIC EFFECTS CLASS & DIVISION ................... : CLASS C, CLASS D, DIV. 2 SUBDlV. B, CLASS E PRODUCT IDENTIFICATION NO...: 2014 DOMESTIC SUBSTANCE UST ...... : MSTED CEPA PRIORITY LI~T .................... : NOT LISTED CARClNOGENIClTY ACGIH APPENDIX A ................ : NOT LISTED A1 - CONFIRMED HUMAN ...... : NOT APPLICABLE A1 - SUSPECTED HUMAN ...... : NOT APPLICABLE IARC GROUP 1 OR 2 ..................... : NO 'LABEL LANGUAGE (US/CANADA) HEALTH ................................... : DANGER CORROSIVE TO EYES AND SKIN. DIRECT EYE CONTACT MAY CAUSE ... IRREVERSIBLE TISSUE DAMAGE INCLUDING BUNDNE$S. INHALATION OF MIST OR VAPOR COULD CAUSE IRRITATION OF LUNGS, NOSE AND THROAT, USUALLY SUBSIDES AFTER EXPOSURE CEASES. --DO NOT INGEST ,.-CORROSIVE TO GASTROINTESTINAL TRACT. MAY BE FATAL IF ~NALLOWED. ., PHYSICAL .............................. : OXIDIZER-iNITIATES COMBUSTION IN OTHER MATERIALS BY CAUSING FIRE THROUGH RF-t_FA~E OF OXYGEN. HANDLING AND STORAGE..: KEEP CONTAINER IN COOL PLACE (AVOID EXCESSIVE HEAT), AWAY FROM COMBUb~nBLES SUCH AS WOOD, PAPER, OIL~ ETC. STORE ONLY IN VENTED CONTAINERS, 8TORA(3E SHOULD CONFORM TO ~ STANDARDS IN NFPA BULLETIN 43A. ,' AVOID CONTAMINATION-CONTAMINAT~0N COULD CAUSE DECOMPOSITION AND GENERATION OF OXYOEN WHICH MAY ~ RESULT IN HIGH PRESSURES AND PO881BLE CONTAINER RUPTURE. ~' DO NOT RETURN UNUSED MATERIAL TO THE ORIGINAL CONTAINER. PAGE: 6 OF 8 IiTN .q J MA, F..RIAL. SAP. ' DATA SHEET MSDS 001 ~ ' EFFECTIVE: 12/o7/94 WEAR CUP TY'PE CHEMICAL SAFETY gOGGLES AND/OR FU. LL FACE MASK. USE ONLY SUITABLE PROTECTIVE CLOTHING, E.G., RUBBER, NEOPRENE OR SYNTHETIC FIBERS (AVOID COl'tON, VVOOL AND LEATHER}. USE GLASS, STAINLESS STEEL, ALUMINUM OR PLASTIC MATERIALS WHEN HANDLING HYDROGEN PEROXIDE. EMPTY DRUMS SHOULD BE TRIPLE RINSED WITH WATER BEFORE DISCARDING. 'FIRST AID ........................... ;..: · IN CASE OF CONTACT, IMMEDIATELY FLUSH EYES OR SKIN WITH. PLENTY OF WATER FOR AT LEAST'I$ MINUTES WHILE REMOVING CONTAMINATED CLOTHING AND SHOES. SEE A P~IYSlCIAN. WASH CLOTHING BEFORE REUSE. IF SWALLOWED, DRINK PLENTY OF WATER TO DILUTE, DO NOT INDUCE VOMITING, SEE A PHYSICIAN IMMEDIATELY. STATE REGULATIONS ............... : PROPOSITION 65 - CALIFORNIA SAFE DRINKING WATER AND TOXICS ENFORCEMENT ACT OF 1986 REQUIRES THE GOVERNMENT OF CAMFORNIATO DEVELOP A LIST OF CARCINOGENS (A) AND REPRODUCTIVE TOXINS (B). NO PERSONS DOING BUSINESS SHALL KNOWINGLY EXPOSE ANY INDIVIDUAL TO A CHEMICAL ON THIS LIST. 70% HYDROGEN ' PEROXIDE CONTAINS THE INDICATED CONCENTRATION(S) OF USTED CHEMICALS: CADMIUM (A) LESS THAN 0.1ppm; CHROMIUM (B) LESS THAN 0,2 ppm AND LEAD (C) LESS THAN 0.5 ppm. NOTE: PERCENTAGES LESS THAN 70% HYDROGEN PEROXIDE WOULD CONTAIN PROPORTIONATELY LESS. t$. OTHER INFORMATION PRODUCT USES .......................... : - DUROX (TM) 50% REG & LR MEETS FOOD CHEMICAL CODEX REQUIREMENTS FOR ASEPTIC PACKAGING AND OTHER FOOD RELATED APPLICATIONS. - OXYPURE ~) 50% CERTIFIED BY NSF TO MEET ANSI/NSF STD. 60 REQUIREMENTS FOR DRINKING WATER TREATMENT. - HY BRITE $ 50% USED FOR METAL TREATING - STANDARD 50% GRADE MOST SUITABLE FOR INDUSTRIAL BLEACHING, PROCESSING, POLLUTION ABATEMENT AND GENERAL OXIDATION REACTIONS. - , - SEMICONDUCTOR REG & SEG 50% GRADES, CONFORM TO ACS AND SEMI SPECS. FOR WAFER ETCHING AND CLEANING AND APPUCATIONS REQUIRING LOW RESIDUES. - SUPER D ~ 60% COMPLIES WITH PHARMACOPOEIA SPECIFICATIONS SUITABLE FOR PREPARING DILUTE SOLUTIONS FOR PHARMACEUTICAL AND/OR COSMETIC APPLICATIONS. - TECHNICAL 50% ESSENTIALLY FREE OF INORGANIC METALS, SUITABLE FOR CHEMICAL SYNTHESIS. - CHLORATE GRADE 50% SPECIALLY FORMULATED FOR USE IN CHLORATE MANUFACTURE OR PROCESSING. NFPA 704 HEALTH ....................... : 2 FLAMMABILITY ........ : 0 REACTIVITY.......; ...... : 1(GREATER THAN. 52% REACTIVITY IS 3). SPECIAL HAZARD. .... : OX ' (DEGREE OF HAZARD 0" NO HAZARD 4 = SEVERE HAZARD)' PAGE; ? OF 8 THE CONTENTS AND FORMAT OF THIS MSDS ARE IN ACCORDANCE WITH OSHA HAZARD COMMUNICATION STANDARD AND CANADA'S WORKPI. ACE HAZARDOUS INFORMATION SYSTEM (WHMIS). ALL INFORMATION APPEARING HEREIN IS BASED UPON DATA OBTAINED FROM THE MANUFACTURER AND/OR RECOGNIZED TECHNICAL SOURCES. WHILE THE INFORMATION IS BELIEVED TO BE ACCURATE, . ASP MAKES NO REPRESENTATIONS AS TO ITS ACCURACY OR SUFFICIENCY. CONDITIONS OF 'USE ARE' BEYOND ADVANCED STERIMZATION PRODUCTS CONTROL AND THEREFORE USERS ARE RESPONSIBLE TO VERIFY THIS DATA UNDER THEIR OWN OPERATING CONDITIONS TO DETERMINE WHETHER THE PRODUCT IS SUITABLE FOR THEIR PARTICULAR PURPOSES AND THEY ASSUME ALL RISKS OF' THEIR USE, HANDLING, AND DISPOSAL OF THE PRODUCT OR FROM THE PUBLICATION OF USE OF, OR RELIANCE UPON, INFORMATION CONTAINED HEREIN. THIS INFORMATION RELATES ONLY TO THE PRODUCT DESIGNATED HEREIN, AND DOE8 NOT RELATE TO ITS USE IN COMBINATION WITH ANY OTHER MATERIAL OR IN ANY OTHER PROCESS. Reference: HYDROGEN PEROXIDE 40,60% MATERIAL SAFE'W DATA SHEET FROM VAN WATERS & ROGERS INC., VER61ON 003, MSDS# FZ000041 ADVANCED STEB r. ,T ON PRODUC 33 Technology Drive, Irvine, CA. 92718-9824 PAGE: 8 OF 8 APPENDIX A.--THE LIST OF EXTREMELY HAZARDOUS SUBSTANCES AND THEIR THRESHOLD PLANNING QUANTITIES [ AIl~l~b~tie~l Ord.] Repo,'t~le Thresl~old CAS No. Chemical name quanta/' p~nning quantity looun~s) (pounds) 75-88-5 ~ Cyano~min t0 1,000 1752-30-3 Acetone 1 1,000/10,000 107-02--6 1 500 79--06-1 Ac~ ............................... 5,00b 1,000/10,000 107-13-1 Ac~ .................................. 100 10.000 814-68-.6 Acl3~ 1 100 111-69-3 Adtponitrile .............................. 1 1,000 116-06-3 Aidica~ ............................................ 1 100/10,000 309-(X3-2 I 500/10,000 107-1H Ally 100 1,000 107-11-9 1 500 20859-73-8 Aluminum ~ ............. 100 500 54-62-6 1 500/10,000 78.-53-5 Amito~ ............ ; ................... 1 500 3734-97-2 Amiton Oxalate ............................ 1 .100/10,000 7664-41-7 Arm~onia ....................................................................................................................................... 100 500 16919-58-7 1 10,000 3OO-62-9 1 1,000 62-53-3 Aniline.. 5,000 1,000 88-05-1 Aniline, 1 50O 7763-70-2 Antimony I 500 1397-94.-0 Antimycin A 1 1,000/10,000 86-88-4 AN'ILl .......................................... 100 500/10,000 1303-28-2 5,000 1 00/10,000 1327-5.3-3 Arsenou~ 5,000 100/10,000 7784-.34-1 Arsenou~ TricllllOl~e .............. 5,000 500 1 100 7784-42-1 Arsine ............................................................................................................................................. 2642-71-9 Azinpl~Ds-Ethy$ 1 I00/10,000 86-50-0 Azmp~os-Metl~ ................................................................................................. ; .......................... 1 10/10,000 1405-87-4 Baci~'acin ...................................................................................................................................... 1 10,000 98-87-3 Benzai 5,000 500 100-14-1 Benzene, 1-((:::3~omethy~4.Nltro- ................... 1 500/10,000. 98-05-5 Benzenearsorac 1 10/10,000 96-O9-9 Benzenesu~fonyt ~ ........... 100 10 O00 361 5-21-2 Ben~midazole, 1 500/10,000 98-07-7 E~e~zotrJchk~ide ............................................................................................................................. I 100 100.44-7 Benzyl Chlohde ............................................................................................................................ 100 500 140-29-4 Benzyt Cyanide ...................... 1 500 13398 Federel Resister / Vol. 52. No. 77 ! Wednesday, April 22, 1087 ! Rules and Resula~ions APPENDIX A.--THE L.18T O4r EXTP. E~J.Y HAZARDO~ SUBSTANCES AND THEfR THRE~Ot.D ~ QUAmlT~8--Gontinued 534-07-6 8lo(Chlo~ Kotono ....................................................................................... · I 10/~0,00~ 4044-65-0 Bltoocs~te ............................... · 1 500/10,00~ 10294-34-S B~-G.-~ TflchiO~le ............................... · 1 800 7~37.-07-2 Bm'o~ Tdfluo~M ............................................................................................................ · ' I ~00 355-4~-4 Bc~ Trtftuo~M C~lq~nd ~ M~lhyl Elhet' (1:1) · I 1,000 28772-56-7 ~_ · 1 100/10.00( 7726-95-6 Bromine ............................. ~06-99-0 Butadiene ...................................................................................... a, · I 10.000 109-19-3 Butyl I~walerate ............................. ~.., .......................................................... i Ik · 1 10.000 111-34-2 Butyl Vinyl Eltler ...................................................................................................... a, · I 10.000 1306-19-0 Cadmium Oxide ..................................................................................................... · I 100/10,00( 2223-93-0 Cadmium Steamte ....................................................................................................... c. · 1 1,000/10.0~X 777E-'~'~-1 Calcium Amenate ..................................................................................... d I.(XX) 500/10.00( 8001-35-2 Ca~ ........................................................................... d 1 500/10.(XX 56-25-7 Cantharidin ............................................................................................... · I 100/10,00( 51-83-2 Carbachol Chlodde .................................................................. '. ............................................ · 1 500/10.00( 26419-73-8 Cart~untc Acid, Me~, 0.~((2,4.Oimethyl-1, 3-Oilhiolam2-~~)- ........... · I 100/10.0(X t563-68-2 Cart~fumn ............................................................................................................................ 10 10/10,00( 75-15-0 Ca.,'oon Di~ult'Kte ................................................................................................... I I 100 10.000 786-1g-6 C4r~nottdon ............................................................ r ........................................... · 1 500 2244-16-8 Cawone ............................................................................................................................... a, · 1 10.0~0 57-74-9 Chlon~ne ......................................................................................... d 1 1,000 470-90.-6 Chlorfetwirtfo~--_ ............................................................................................................ · 1 500 7782-50-5 Chlogtne .............................................................................................................. 10. 100 24934-91-6 Chlo~ .......................................................................................................... · 1 500 999-8~-$ , C~lormequat 107-20..0 i C~a~etaJOMly(~ ....................................................................................... ., .... · 1,000 10,000 107-.07-3 ~ Chloroelhanol ............................................................................................ · 1 500 627-11-2 Chlomelhyl Chiorokxmate .................................................................................. · 1 1.000 67-66-3 Chloroform ...................................................................................................... d, I 5,000 10,000 542-88-1 Crdoromethyl Ett~w .............................................................. d, h 1 100 107--30-2 Chlorometh~ MettM Ethe~ ............................................... ~, d 1 100 1982-47-4 Chioroxuron · 21923-23-9 (~ , .. , 10025-73-7 Chronic CtlkM4e ............ .~ ............................. · I 1/10,001 7440-48-4 ~ ............................................................... a, · ~ ~0,000 N.N',O.O3-.. 117-52-2 Coumafuryt ........................................................................ a, · 1 10,000 56-72.-4 Co~ ............................. 5a38.-~-3 CoumatmmM .................................................................. 95-48-? Cr,~m, o- ........................................................................................... d %O0O ~,000~0,00 4~ 70-30-9 Cromnal4etW~ ..................................................................................................... ~00 ~,000 50~-78-5 Cyanoge~ Iodide .......................................................... .:. ............................. · 1 1,000/10,00 675-14-8 Cym,ztc Fluodde .......................................................... · 1 100 287-~2-3 Cyclopen~ ................................................................................. ~ ............. & · 1 10,000 633-03.-4 C.I. Ba~k~ Green 1 ................................................................................... a, · I 10,000 17702-41-~ Dec. al~14) ................................................................................... · 1 8065-,1&~ Demeton ................................................................................ · 1 500 0~0-86-8 Demmon*S-Mm~yt ........... · 1 500 J0287-4S-7 f:Xlxxene .......................................................... '- · 84-74-2 ~ Phtheiete ................................................................ ~ · 10 10,000 8023-53-8 DIchk~nz~lkordum ChMflde ........................................................ · ~ 8, · ~ 10.000 Federal Register / Vol. 52, No. 77 / Wednes~iay, April 22, 1987 / Rules and Resulations 13399 APPENDIX A.--THE [JST OF EXTREMELY HAZARDOUS ~JB~TANCES AND THEIR THRESHOLD Pt. NmmG QuANvr;;Es--Co~tinued 149-74-6 I Dichlorornethyl~ .................................................................................................... · 1 1,000 62-73-7I OicNorvos ............................................................................................................................ 10 1,000 141-66-2 I:)icrotO0hO$ ...................................................................................................................... ® 1 100 ~,~-53-S I D~oxyou~ne .............................................. ~ ................................................................... d ~ ~0 814-49-3 Diethy! Chio~ophosDste ......................................................................................................... e, h 1 500 1642-54-2 I Diethy~tmmaz~ne Cilrate ...................................................................................... ~-. · I 100/10,000 93-05-0: Diethy]-p-Pheny~en~:liamine .................................................................................................... ~,e ! 10,000 71-63-6 ' [:)igitoxin ................................................................................................................................ c, · 1 1~0/10,000 2238-07-5 I Dicjlycidyt Ethel .................................................................................................................. · 1 1,000 · 20830.-75-5 I:)igoxin ..................................................................................................................................... e, h ~ 10110.000 115-26-4 I Dimefox .......................................................................................................................... · 1 500 60-51-50imethoate ........................................................ ; ...... ~ ......................................................... 10 500/10,000 2524-03--00imet~t Pho~te ........................................................................ e. I 500 131-11-3 Dim·thy1Phl~talate ..................................................................................................... · S,000 10,000 77-78-10imet'm/t Sulfate ................................................................................................. d t 500 75-18-3 .I Dimetr~ Sulfide ........................................................................................................... . · 1 100 7S-78-5 t ~~oroatane .............................................................................................. e. h 1 SOO 57-14-7 1 Dimethylhy~azlne .................................................................................................. d 1 1,000 99-98-9 ~ Oimel~ · · . ................................................................................ · 1 10/10.00~ 644-64-4 I Dimet~lan .................................................................................. · I 500/10.00~ .534-52-1 '10ini'eocre~ ........................................................................................... 10 10/~0.00~ 88--85-7 I D~:meb ............................................................................................ 1,000 1~0/10.00~ 1420-07-1 I Oirt~m'o .................................................................................................. · I 500/10.0~ 117-84-0 I Dtoctyt Phtha~te ........ ~ ..................................................................... · 6,0~0 10,000 78--34-2 I Dioxalt#on ...................................................................................... · I 500 646-06.-0 I Diox~tane ................................ ~ ............................................................ m, · I 10,000 ' 82--66-6 ~ Diptmcinone ................................................................................... · 1 10/10,01X 152-16-9 I 298-04-4 t Disuffoton ....................................................................................... I 500 - 514-73-8 I ~ Iodide ......................................................................................... · 1 500/10.00( 541-53-7 , Dithiobiuret ............................................................................................. 100 100110.01X 31~-42-? ~ Em·erie, Dihyclroct~ .......................................... 115-29-7 [ Enck~ul/an .......................................................................... 1 10/10,(~X 72-20-8 . Endfln ................................. - ................. I 50G/10,01X 106-89-8 [ EpicNomhycl~ ...................................... -- ............... d, I iA00 1,000 2104-64-5 ~ EPN .................................................................................. · 1 5D-la.-.B | Ergocalciferol ............................................... -- ....... r.. · I 1,000/10,00( 379-7~-3 ! ~e22-32-e / Ettumesu~on~ Ct~rk~ 2-CNom- ............................................... · 1 5OO 10~40~?-~ [ Ethanol, ~2-Dict~mO-, Aeetm~ ......................................... · ~ ~,000 S~3-1~-;, 13~a-4 | E,x~,X~o. ................................................................ · ~ ~,0~0 37 - -o/ ........................ . .............................. 1 107-15--.1 | ~ S~-Se-4 ! Emytermmlm-- ............................................................................... d 1 500 542-g0.-5 ~ EthylltIMel~fll~ ....................................................................... · I 10,000 22224-92-6 ! Fenamll~ ............................................................... .~. ......... · I 10/10.00 122-14-5 | 115-90-2 ! Fenm~k~l~m ..................................................................................... ·, h 1 500 4301-50-2 | Fluefle~ ............................................................................................. · 1 100/10,00 7782-41-4 ~ Fluo~ne .......................................................................................... k 10 500 640-19-7 J Fluoeoacetamk:le ....~ ............................................................. ,J 100 100/10,00 144-49-.0! Fluol'oac~tcActcl ................................................................... · . 1 10/10.00 359-06-8 ~ Fluomace~ Chlo~le .......................................................................... 51-21-8 ~ Fluoroumcit ...................................................................................... · 1 600/10,00 ,~,,, · I ~00 .~-22-e ! Fonofo~ ......................................................................................................... 50-00-0| ~~ .............................................................................................. ~ 07.~e.4 1 ~:omm~c~ 23422-53-e j Fom~et~n~te 2~40-a2-1 | Formomlon ................................................................................ .:. .................... · ! 100 17702-57-7 ~ Formplm~tt .................................................................................................. · 1341111 Federal Register / Vol. 52. No. ?? / Wednesday, April 22, 1987 / Rules and Regulations APPENOIX A.--THE k~ST OF EXTREMELY HAZARDOUS SUBSTANCES AND THEIR THRESHOLD PLANNING QUANTITIES---Continued [Alphabetical Order] Rel:x)rtable Tllresl~old CAS No. Chemical name Notes quantity' planning quantity _, ~ ! (pounds) (pounOs) 3878-19-I Fubendazole .................. ... .............................................................................................................. · 1 100/10,000 100 5O0 , 110-00-9 Furan .............................................................................................................................................. I e 1 500/10,000 13450-90-3 Gallium Tricf'tloride 77-47-4 HexacNo~ocyclopenfadiene ............. 1 100 1335-87-I Hexacnlo~onaphthalene .. 1 10,000 4835-11-4 Hexametl~ylened~amine, N,N'-Dibutyl ............................... 1 500 302-01-2 Hydrazine ........ 1 1,000 74-90-8 HydrocyaniC Acid .............. 10 100 7647-01-0 Hydrogen Chl(xide (Gas Only) 1 500 7664-39-3 Hydrogen Fluoride ............... 100 100 7722-84-1 Hydrogen Peroxide (Conc ~ 52%) 1 1,000 7783-07-5 Hydrogen Selenide ........................ 1 10 7783-06-4 Hydrogen'Sulfide 100 500 123-31-9 Hydroquinone ................... 500/10,000 53-86-1 Im:h:)methacin ........................ 10,000 10025-97-5 Indium Tetrachlork:le ......................... I 10,000 13463-40-6 Iron, Pentac, arbonyl- ....... I 100 297-78-9 Iso~e~an 1 100/10,000 7H2-0 I~nitnle ................................. 1 1,0(30 102-36-3 I cyanic Acid, 3,4-Dichlorophenyl Ester ..... 1 500/10,000 46,5-73-6 Isodnn.. 1 100/10,000 55-91-4 I sofluoq3hate ................. 100 100 4098-71-9 Isol3h(xone Diisocyanate ..................................................................................................... ~. ...... 1 100 108-23-8 Iso0rop~ Chlcxoformate ................ 1 1,000 625-55--8 Isol~ Formate ............... 1 500 119-38--0 Isolxo~thytpyrazolyl Oimet~te ............... 1 500 78-97-7 Lactonit~le ........ 1 1,000 21609-90-5 Leptoohos ..................... 1 500/10,000 541-25-3 Lewisite 1 10 58-69-9 1 1, 7580-87-8 L.itttium 1 100 109-77.-3 MaJononitrile .., 1,000 500/10,000 12108-~3-3 Manganese, Tricarbof~ Metl~lcyciopefltadim~ ......... 1 100 51-75-2 Mectdorett~amine .............. 1 10 950-10-7 1 500 1600-27-7 1 500/10,000 7487-94-7 1 500/10,000 21908-53-2 Merculic O)dde 1 '500110,000 108-67-8 1 10,000 10476-95-6 Methac~ole~n Diaceteto 1 1,000 760-9.3-0 Methacf3~c I 500 126-98-7 Metf~ ............... 1 500 920-48-7 Meb'tac~/loyl 1 100 30674-80-7 Methectytoyfl3xyetf~4 Ilocyanlte ...... 1 100 1026.5-92-8 1 00/10,000 558-25-8 Metl~ Fluodda 1,000 950-.37-8 500/10,000 2032-6.5-7 10 500/10,000 16752-77-5 Mett~omyt ~....; ........................................................................................................................ 100 500/10,000 151-~36-2 ~ Acetate ........ 1 500/t0,000 eo-.e3-7 Met~ 2~ 1 5OO 74-8.3-9 Methyl emlld(ll 1,000 1,000 79-22-1 Meb'W 1,000 500 1 100 624--92-0 Mett~/ 10 500 624-8.3-9 Mett~yl laocyanate ................................................................................................................. 1 500 74-93-1 Mett~ Merc&otan ................................................................................................................ 1 500 3735-23-7 Metl'wl Phenkal~Oa ............................................................................................... : ...................... 1 100 676-97-1 Methyl 1 10,000 556-64-9 1 10 78..1~1-4 I~ V'my~ Ketof~e ........................................................................................ : ................. · 1 500/10,000 502-39.-6 1 50O 75-79--6 Melt~mlatle ............................................................................................................... "- 1 100110 1129-41-5 Meto4ca~o ................................................................................................................................. 10 500 7786-34-7 k4evinl~toa .................................................................................................... ~ ................................ Federal Re~ister ! VoL 52. No. 77 / Wednesday,. April 22. 1987 / Rules and Regulations 13401 · A~NO~x .4L--THE ~ OF ~q"I~ME~Y HAZARDOU~ ..~B~TANC~.~ AND THEm THI~S~tOLD PLANNm OuAHTmE~nued 1~40~ ' '~Federal R~ister / Vol. 52, No. 77 / Wednesday,. April 22, 1987 / Rules and Regulations APPENDIX A.--THE LIST OF EXTREMELY HAZARDOUS SUBSTANCES AND THEIR THRESHOLD PL.ANNIN~ (~UANTITiES.--CoI1Urlued CAS No. _ Chemical name Notes quanta/' planning ClUant~/ (pounds) (pounds) 110-89-4 Piperidirle 1 1,(X)0 5291-13-0 Piprotal 1 100/10,000 23505-41-1 Pi~imifos-Ethyl **...** 1 1,000 10025-65-7 Platinou~ Chloride .................... 1 10,000 13454-96-1 Platinum Tetrachlo~le ............. 1 10,000 10124-50-2 PotaS~um Arsenite ................... 1,000 500/10,000 151-50-8 Potassium Cyanide 10 100 506-61-6 PotaSS4um Silve~ Cyanide ........ 1 500 2631-37-0 Promecarb .................................. 1 500/10,000 106-96-7 Proparg~ Bromide 1 10 57-57-6 Propiolactone, Beta-. ............... "" 1 500 107-12-0 Prol:)~onit~le ....................... 10 500 542-7~-7 Propionitnle, 3-Chloro- ............. 1,000 1,000 70-69-9 PropioDhermne, 4-Amino- ....... * 1 100/10,000 109-61-5 P~ol:~l ' ' I 500 1331-17-5 Propylene Glycol, AIM Ethel ......................... ' ' 1 10,000 75-56-9 Prol~ene Oxide ....................... 100 10,000 75-55-8 1 10,000 ' 2275-16-5 1 100110,000 95-6,.9--6 Pseudocumene ......................... 1 10,000 129-00-0 Pymne ....................................... 5,000 1,000/10,000 140-76-1 Py~idirm, 2-Mett¥-5-V'~M. ....... 1 500 504-24-5 Pyrk:line, 4-Amino. .................... 1,000 500/10,000 1124-33.0 Pyro:line, 4-Nim3-, 1.OxMe ....... 1 500/10,000 53556-25-1 Pyriminii ..................................... 1 100/I0,000 10049-07-7 Rhodium Trlchlo~le.. 1 10,000 14167-18-I Salcomine ............ 1 500/10,000 107-44-8 Satin 1 10 ,~ 7783-0O-8 Semnioua Acid 10 1,000/10,000 7791-23-3 ,Sek~ium Ox~ .......... 563-41-7 SemicaCoazide Hyclrochk=dde. 1 1,000/10,000 3037-72-7 Silane, (4.Amino~)OMtt~oxymetl~ ................................................................. I 1,000 128-56-3 Sodium Anb'tra(Nino~e-l-Sulfo~ate 1 10,000 7631-89-2 1,000 .1,000/10,000 778'~ '~5-$ Sodium Arsenite ...................... 1,000 500/10,000 2662~2.2-e Sodium Az~e IN~(N3)). 1,000 500 124-65-2 Sodium C, acodylate ......................................................... '....:.: ................................................... 1 100/10,000 143-33-g Sod~n Cyank~e (Na(CN)) 10 100 62-74-8 10 10/10,000 131-52-2 Sodium Pe~tacrd~,;~,e~ate 1 100/10,000 13410-01-0 Sodium 1 100/10,000 10102-18-8 , Sodium ,Selenite .................. 100 100/10,000 10102-20-2 Sodium Tetlurit® ....................... 1 500/10,000 900-95-~ 1 500/t0,000 57-24-9 10 100/10,000 60-41-3 Stl~/ct~llnl, 1 100/10,000 3689-24-5 Sulfol~_ 100 5OO 3569-57-1 Su~o3dd~ 3-C~ropro~ Octyt 1 ,5OO 7446-09-5 Su#ur I 500 77~ Sulk~ 1 100 7446-11-9 S~fur 1 100 7664-93-9 S~df~ 1,000 1,000 77-61-6 Talxlrl .................... 1 10 13494-80-9 . 1 500/10,000 7783-80-4 TMIurtum 1 100 107-49-3 TEPP ...................... ~ ..... 10 100 13071 - 79-9 1 1 00 78-00-2 10 100 597-64-8 Tetraell~/tfin ........................... 1 100 7 5-74-1 1 1 00 509-14-8 Tetmnitmmethane ......... 10 500 1314-32-5 Thallic Oxide ................ 100 :10031-59-I Thallium Sulfate ................ 100 100/10,000~ 6583-73-9 Thalloul Cartxmate ............. ~ ..... 100 100/10,000~ 7791-12-0 Thallo~ Chlo~le ..................... 100 100/10,000 Federal Register / Vol. 52. No. 77 / Wednesday. April 22. 1987 / Rule~ and Regulations 13403 APPENDIX A.--THE ~.IST OF EXTREMELY HAZARDOU~ SUBSTANCES AND THEIR THRESI4OI. D I~NIHG C~UANTITIES--'CotltiI~Ued [AIl~h.~ettc~ Order) ~:~ 2757-18-8 Thallous Malormte ................................................................................................................... C, e, 1 100/10,000 h 7446-18-6 Thallous Sulfate .................................................................................................................... 100 100/10,000 2231-57-4 Thiocasl~azide ................................................................. : ......... ; ....................... .'. ................ · 1 1,000/10,000 21564-17-0 ThiocyamC Acid, 2.(Benzotttiazol~io)Methy~ Ester .......................................................... 39196-18--4 Thiofanox ................................................................................................................................ 1(30 100/10,000 640-15-3 Thiometon ........................................................................................................................... a, · 1 10,000 297-97-2 Thionazm ............................................................................................................................ 100 500 108-98-5 Thiol3henol .................................................................... ~ .......................................... .~ ........ 100 500 79-19-6 Thiosemica~.ide ............................................................................................................. 100 100/10,000 5344-82-I Thiourea, (2-Chlorophenyl)- ........................................ ; ..................................................100 100110,000 614-78-8 Thiourea. (2-Mett~)- ....................................... :: ...................................... e 1 7550-45.-0 Titanium Tetrachk3~le ...................................................................................... · 1 100 584-84-9 Toluene 2,4~anate ......................................................................... 100 500 91-08-7 Toluene 2,6-1~te ................................................................ ---.-.- 100 100 110-57-6 Trans. 1,4-DicNorol)utene .................................................................... · 1 500 1031-47-6 Triamighos ...................................................... ~.: .................................. · 1 500110,000 24017-47-8 Triazofos ........................................................... .---.':; ................................. · I 500 76-02-8 Tdchlo~oacety Chloride ..................................... ;; .................................... · 1 500 115-21-9 TricNo~oethytsilane .....; ....................................... ; .................................... I,h 1 500 327-98-0 Tdcflloronate ................................................ ;..;. .................................. e, k 1 500 98-13-5 Trichlomphef~ ...................................... ~--; .................................... e, I~ 1 500. 52-68-6 Tdcttloroghon .................................................................................................... I 100 10,000 1558-25-4 Trichlo~o(Chloro~~ ....................................................................... I 1 100 27137.-85-5 Tdchloro(Dichlo~ .......................... ;...; .................................... · 1 500 998-30-I Triethoxysilane ...................................................................................... · 1 500 75-77-4 Trimethylcfl~....... ..................................... ~-- .............................. · 1 1,000 824-11-3 Tdmet~ ~ ........... : ............................................. e, h 1 100/10,000 1066--45-1 Trtmethyrdn Chlo~de ................... ; ................................................... · 1 500110.000 639-58-7 Tdphenyttin ~ ................ · 1 500/10,(XX) 555-77-'~ I Tds(2-Chloroett~)~ .................................................................. l, h 1 100 2001-95-8I Val~ ...................................................................................... & · 1 1,000/10,000 1314-62-1 Vanadium Pentoxide ........... ; ................................................................... 1,000 100/10,000 108-05-4 Vinyl Acetate Monomer .............................................. . ......................... d, I 5,000 1,000 3048-64-4 V'~/tnodx)meee ................................................................. -- .... I, · 1 10,000 81-81-2 Warfarin ......................................................... ;~ ......................... 100 500110,000 129-06-6 Wmtann 8odium ........................ . , , ........... e, h I 100110.1X3a 28347-13-9 Xy~ ~ ............................... ;~.. ............... ~ .... 1 · ,,i. 1 100/10,000 58270-08-9 Zinc. Dichlom<4,4-Oimett~-6((((~) ~)l.llne~)-,(T.4)-. · 1 100/10,00~ 1314-84-7 Zinc PIx)sphKle .......... b 100 500 'Only the statutoe/o~ final RQ t~ ehown. For mom In~ lee 40 CFR Tlblt 302.4 . '~'.. Notes: c The calculated TPQ changed Iftm' te~hnicll revlew II delcll~d I1~ the .tel~i~ll ~ ~ · Statutory re~.~3m qUml~ kw'lX.l~eee o~ notSacatlm under SARA.