General Regulations, Storage & Record Keeping

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Ethylene Oxide Regulations General Regulations & Standards U.S. Department of Labor Occupational Safety & Health Administration

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1. Ethylene   Oxide   Regulations    General   Regulations   &   Standard s       U.S. Department of Labor Occupational Safety & Health Administration   OSHA    29   CFR   1910.1047(c)(1)      OSHA    29   CFR   1910.1047(c)(2)   “The   employer   shall   ensure   that   no   employee   is   exposed   to   an   airborne   concentration   of   EtO   in   excess   of   1   part   per   million   parts   of   air   ( 1.0   ppm )   as   an   8 ‐ hour   Time   Weighted   Average   (TWA)    Permissible   Exposure   Limit   (PEL)   “The   employer   shall   ensure   that   no   employee   is   exposed   to   an   airborne   concentration   of   EtO   in   excess   of   5   parts   of   EtO   per   million   parts   of   air   ( 5   ppm )   as   averaged   over   a   sampling   period   of   15   minutes.   Excursion   Limit   (EL) OSHA    29   CFR   1910.1047(h)(2)   “Where   there   is   a   possibility   of   employee   exposure   to   EtO   due   to   an   emergency,   means   will   be   developed   to   alert   potentially   affected   employees   to   such   occurrences   promptly” Occupational   Safety   and   Health   Act   of   1970,   Section   5   “Each   employer   shall   furnish   to   each   of   his   employees   employment   and   a   place   of   employment   which   are   free   from   recognized   hazards   that   are   causing   or   are   likely   to   cause   death   or   serious   physical   harm   to   his   employees”   NTIS   Pub   PB ‐ 94 ‐ 195047   (1995)   Immediately   Dangerous   to   Life   or   Health   Concentration   (IDLH)   =   Ethylene   Oxide   800   ppm       ANSI/AAMI    ST:41:1999/(R)   Section   B.3.3.3     Section   B.3.3.2.2   “....Therefore,   for   the   health   and   safety   of   employees,   AAMI   recommends   continuous   monitoring   of   the   workplace   environment.    Monitors   should   be   capable   of   monitoring   the   various   locations   in   which   leaks   or   spills   could   occur.    Therefore,   the   appropriate   monitor   depends   on   the   number   of   points   requiring   this   type   of   monitoring”   “Data   acquisition   (PC   based)   modules   that   can   be   connected   to   area   monitors   to   track   EO   levels   continuously   and   simultaneously   from   each   point......   to   the   lower   detectable   limit   for   EO   of   Less   than   1   ppm ”       Standard   EC.02.02.01   (2009)   Element   of   Performance   #10   Element   of   Performance   #9      “   The   hospital   monitors   levels   of   hazardous   gases   and   vapors   to   determine   that   they   are   in   safe   range.     Note:   Law   and   regulation   determine   the   frequency   of   monitoring   hazardous   gases   and   vapors   as   well   as   acceptable   ranges.”     “The   hospital   minimizes   risks   associated   with   selection,   handling,   storage,   transport,   use   and   disposing   hazardous   gases   and   vapors.    Note:    Hazardous   gases   and   vapors   include,   but   are   not   limited   to,   gluteraldehyde,   ethylene   oxide,   vapors   generated   while   using   cauterizing   equipment   and   lasers,   and   gases   such   as   nitrous   oxide.     Ethylene   Oxide   Record   Keeping   Regulations       U.S. Department of Labor Occupational Safety & Health Administration   29   CFR   1910.1020(d)(1)(ii)   29   CFR   1910.1020(c)(5)(i)   29   CFR   1910.1020   (e)(1)(i)   “Each   employee   exposure   record   shall   be   preserved   and   maintained   for   at   least   thirty   (30)   years ..”   “Employee   exposure   record   means   a   record   containing   any   of   the   following   kinds   of   information:    Environmental   (workplace)   monitoring   or   measuring   of   a   toxic   substance   or   harmful   physical   agent.”   “Whenever   an   employee   or   designated   representative   requests   access   to   a   record,   the   employer   shall   assure   that   access   is   provided   in   a   reasonable   time,   place   and   manner.”       ANSI/AAMI    ST:41:1999/(R)     “Employees   must   be   notified   of   their   personal   monitoring   results   within   15   days   of   when   the   monitoring   report   is   available,   and   a   copy   of   the   monitoring   records   must   be   kept   in   each   employee’s   file.    In   accordance   with   the   OSHA   standard,   these   records   must   be   maintained   by   the   health   care   facility   for   the   duration   of   employment   and   for   at   least   30   years   thereafter.    If   EBZ   (employee   breathing   zone)   monitoring   shows   EO   levels   exceeding   the   PEL   or   EL ,   corrective   actions   must   be   taken   and   documented,   as   required   by   OSHA.    The   results   of   environmental   monitoring   should   be   posted   in   an   area   that   is   readily   accessible   to   employees.      

2.   Ethylene   Oxide   Storage   Regulations     U.S. Department of Labor Occupational Safety & Health Administration   29   CFR   1910.1047   (e)   (1)       29   CFR   1910.1047   (e)   (2)/(3)   The   employer   shall   establish   a   regulated   area   wherever   occupational   exposures   to   airborne   concentrations   of   EtO   may   exceed   the   TWA   or   wherever   the   EtO   concentration   exceeds   or   can   reasonably   be   expected   to   exceed   the   excursion   limit.   Access   to   regulated   areas   shall   be   limited   to   authorized   persons.    Regulated   areas   shall   be   demarcated   in   any   manner   that   minimizes   the   number   of   employees   within   the   regulated   area.   OSHA   CFR   1910.1047   Appendix   B,   Section   VI      Appendix   A,    Section   V     Appendix   A,   Section   VII   A:    Store   EtO   in   tightly   closed   containers   in   a   cool,   well ‐ ventilated   area   and   take   all   necessary   precautions   to   avoid   any   explosion   hazard.   C:    Employers   should   advise   employees   of   all   areas   and   operations   where   exposure   to   EtO   occur   B:    EtO   must   be   stored   in   tightly   closed   containers   in   a   cool,   well ‐ ventilated   area,   away   from   heat,   sparks,   flames,   strong   oxidizers,   alkalines,   and   acids,   strong   bases,   acetylide ‐ forming   metals   such   as   cooper,   silver,   mercury   and   their   alloys.   C:    Existing   aeration   units   must   be   vented   to   a   non ‐ recirculating   or   dedicated   system   or   vented   to   equipment   or   other   room   where   workers   are   not   normally   present   and   which   is   well   ventilated.   Aerator   units   must   be   positioned   as   close   as   possible   to   the   sterilizer   to   minimize   the   exposure   from   off ‐ gassing   of   sterilized   items.   ANSI/AAMI   T:41:1999/(R)2005   Sections    4.8   and   4.8.1   (with   reference   to   NFPA   Code   30    (NFPA   1996b)   “The   healthcare   facility   should   consult   with   the   unit ‐ dose   container   manufacturer   to   determine   how   many   unit   doses   may   be   stored   in   the   sterilizer   area.    In   general,   however,   if   each   dose   contains   50   or   more   grams   of   EO,   only   one   day’s   supply   of   cartridges,   up   to   a   maximum   of   12   cartridges ,   should   be   stored   in   the   immediate   areas   of   the   sterilizer.    If   more   that   48   cartridges   are   to   be   stored   in   one   place   in   inventory,   the   area   should   be   suitable   for   flammable   liquid   storage   and   should   conform   to   NFPA   (1996b)(*).”   Exhaust   ventilation   should   only   be   provided   when   warranted   by   the   materials   in   the   cabinet,   for   example   for   particularly   toxic   or   noxious   materials.    If   provided,   the   manufacturer’s   instructions   should   be   followed.    Typically,   this   will   involve   small   diameter   steel   duct   or   pipe   leading   directly   and   by   the   shortest   route   to   the   exterior   of   the   building.    Exhaust   must   be   taken   from   the   bottom   of   the   cabinet.   DHHS   (DIOSH)   Publication   No.   2007 ‐ 164,   in   conjunction   with   EPA   Publication    No.   550 ‐ F ‐ 99 ‐ 018   • Store   EtO   in   tightly   closed   cylinders   or   tanks   in   a   cool,   shaded,   well ‐ ventilated,   explosion   proof   area.   • Store   cylinders   or   tanks   away   from   heat,   sparks,   flames,   strong   oxidizers,   alkalines,   acids,   and   acetylike ‐ forming   metals   such   as   copper   silver,   mercury   and   their   alloys.    The   storage   room   should   be   explosion ‐ proof   according   to   the   definition   of   the   National   Fire   Protection   Association   (NFPA   560)   [NFPA   1995]   • Do   not   smoke,   use   electrical   devices,   or   create   open   flames   when   EtO   is   handled,   used   or   stored   • Use   non ‐ sparking   tools   when   opening   or   closing   metal   containers   f   EtO   or   whenever   EtO   might   be   present   • Keep   containers   individually   bonded   and   grounded   to   the   earth   when   liquid   EtO   is   poured   or   transferred. Health   Risks     Evaluation   of   Carcinogenic   Risks   to   Humans,   Volume   60   Ethylene   Oxide   is   carcinogenic   to   humans   (group   1)                           National   Toxicology   Program   Report   on   Carcinogens,   Eleventh   Edition,   Profile:   Ethylene   Oxide   CAS   No.   75 ‐ 21 ‐ 8   Ethylene   oxide   is   known   to   be   a   human   carcinogen     Ethylene   Oxide:   o 8   Hour   Time   Weighted   Average   Threshold   Limit   Value   =   1.0   ppm          

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