p. 1



# OAR Box 1208
Prepped by Ollie Stewart



### Document

Number: 

# 126 ) ll-E-1 2

Docket Number: 

# A-89-1 0

Printed 5/9/200810:08:24 AM

Sheet 126 of 127P. 2

LA WOPFICS S PHILI PJ

. HARTE R

SUIT E 40 4 230 1 M STREET
. N.W
. WASHINGTON , O. C 2003 7 (202 ) 8S7.I03 3 FAX : (202 ) 887-103 6

Januar y 24 , 199 0 

# mJUUULlii

MEMORAND U

To : EPA Negotiate dRulemaking Committe e o nFugitive Emission s fro

mEquipment

Leak s andInterested " Partie s Fr : Phili p J

. Harter Facilitator Re : Minute s o

f Januar y 17-1 8 Meeting ; Future Meetings ; Workgrou p Meetings ; Miscellaneou s Material s

I enclos e th e minute s o

f th e Januar

y 17-1 8 meetin g tha

t were prepare dby Radia nCorporation

. A s before , the material s tha

t wer e distribute da

t the meeting ar e attached

. I hav e als o includeda nupdated "statement " concernin g the negotiations

. A s I explainedbefore , severa l partie s indicate dtha

t the y ha d receive dcall s abou t

th e negotiations , andi

t seeme dappropriate t o prepare ageneral statement abou t wha t th e Committe e i s doing

. I hop e I capture dth e essenc e o f our deliberation s without

prematurely crystallizing an

y notion s tha

t ar e still tentativ e andfluid

. Us e i t a s yo u se e fit

. I hav e als o encloseda tentativ e agendafo

r the meeting

. Tw o workgroup s hav e bee nscheduledbefore th e next meeting :

o The workgroup tha

t wil l review th e dat abas e andmak e recommendation s concernin g i t to the ful

l committe e wil

l meet a t 10:0 0 o nWednesday , Januar

y 3 1 i nthe 9t hFloor Conferenc e Roomi

n EPA' s Office s inth e Mutua l Building , 41 1 W

. Chapel Hill Street , Durham , NC

.

o Th e BatchProcessing workgroup wil l meet at 10:0 0 o nWednesday , Februar

y 2 1 a t th e office s o

f th e Pharmaceutica

l Manufacturer s Association , 110 0 Fifteent

hStreet NW, Washington , DC ; fo r additiona l information , contac t

Chery l Sutterfieldat

202-835-3548

.
Our meetin g schedul e is :

o FebriMir

y 22-2 3 a

t th e Bristo l Hotel , 243 0 Pennsylvani aAvenu e NW , Washington , DC ; 202-955

- 6400

. CM A made th e arrangement s fo r th e meeting

. Thus , i

f you wisht o book

arooma

t th e hotel , identif

y yourself a s wit hth e CMA EP A Fugitive s meeting

. Marc h27-2 8 a

t th e Picket

t Suit e Hotel , 251 5 Meridia

nParkway , Researc hTriangl e Park , NC ; 919

- 361-4660

. Not

e tha t a s o f Februar y 1 the hotel' s name wil

l b e change dt o "Guest

Quarters; " I a

m tol dtha t everythin g els e wil

l remai n th e same except breakfas t whichwil

l b e upgrade dbut

fo r whic hyou wil

l now b e charged

. Again , whe nmaking reservations , identif y yourself

a s a nEPA Fugitive

.P. 3

• Apri l 25-2 6 a

t Th e Conservatio nFoundation , Suit e 500 , 1250 24t

hStreet NW, Washington , DC

. Since w e wil

l no t b e meetin g at

ahotel , we hav e no t

booke dany room s fo

r thi s meeting

. C Fi s about afiv e bloc k wal k fro mth e Embass y Squar

e Suite s Hote l (202-659-2000 ) where our December meeting wa s held ; i

t i s abou t thre e blocks fro

mthe Bristo l Hotel ; andit i s next doo r t o th e Westi

n (800-228-3000) , the Par

k Hyat t (202-789-1234)

. There ar e bunche s o f other hotel s withinwalking distance

. Since tha

t i s "Eart hWeek" , yo

u ma y b e wel l advisedto mak

e you r reservatio nearly

. Al l the meeting s wil

l begina t 10:0 0 onth e first

da y and9:0 0 o nth e second

. They wil

l rununtil abou t 5:0 0 onth e first

da y andabou t

4:00 onth e second

.JL4

ENVIRONMENTA L PROTECTIO N AGENC Y NEGOTIATIN G COMMITTE E FO R CONTRO L O F FUGITIV E EMISSION S O F VOC s FRO M EQUIPMEN T LEAK S

AGEND A FO RMEETIN G O F FEBRUAR Y 23-2 3
Administrativ e
o Introduction s

° Revie w o

f th e Agenda : additions , subtractions , orde r
o Minute s o

f Januar y meeting : An y major heartburn s Scop e o f th e Standar d

o Source s include di nth e negotiation s
o Source s exclude dfro mthi s standar d
o D e minimi s cutof

f
Dat a

° Repor t

o f th e Dat aWorkgrou p
o Discussio no

f dat a
o Additiona l data : availabilit y an drequirement s
Lea kdefinitio n an d allowabl e leakers : MAC T Conceptua l Approac h t o th e Standar d
o Phasin g
o Incentive s (botto mlin e o f boxes )

o Exi t criteri a(righ t

colum no

f boxes )

° Miscellaneou s point s raise da t prio r meeting s
o Samplin g strategie s
o Procedure s fo r

determinin g equivalen t approache s Repor to f

th e Batc h Processin g Workgrou p
Emissio n Factor s

° Statu s o

f modellin g approac h
o Matri x approac h Approache s t o assessin g th e cos to f th e standar dP. 5

Januar y 25 , 199 0

STATEMEN T CONCERNIN GEPA' S REGULATOR Y NEGOTIATIO N O N CONTRO LO FFUGITIV EEMISSION S O FVOC s FRO M EQUIPMEN T LEAK S
Fugitiv e emission s o

f toxi c chemical s an dvolatil e organi c compound s (VOCs ) fro mequipmen t leak s -

suc ha s valves , pumps , an dflange s - ar e asignifican t sourc e o

f ai r pollution

. Indeed , b y som e estimates , leak s constitut e betwee n on e an dtw o third s of al l routine , non-accidenta l emission s fro mchemica l plants

. Moreover , becaus e the y ar e release dnea r th e ground , EP A believe s thei r impac t ma y b e 10-4 0 time s greate r tha nequa l release s fro mstacks

. Curren t regulation s basicall y requir e tha t equipmen t

b e inspecte dquarterl y fo r leak s withaportabl e hydrocarbo ndetector

. I f concentration s excee d10,00 0 pp mth e sourc e i s identifie da s a"leaker, " an d
maintenanc e i s required

. Thi s approac hi s know na s "lea k detectio nan drepair " (LDAR)

. Th e curren t

LDA Rprogra mca nreduc e uncontrolle demission s b y abou t 60-7 0 percent

. Th e actua l frequenc y rat e an dth e associate demission s vary widely , however

. N o on e i s sur e jus t wha t combinatio n

o f factor s guarantee s lo w emission s no r ho w t o achiev e the mthroug henforceabl e regulations

. Inaddition , curren t

regulator y approache s d o no t provid e th e mean s fo r calculatin g th e leve l o f emis

sions

. Ye t

th e accurat e quantificatio no f fugitiv e emission s fro mequipmen t leak s i s becomin g important

. Specifi c emissio nlevel s ar e necessar y fo r baselin e an dresidua l ris k assessment s fo r

ne w regulations , fo r issuin g permit s fo r

ne w facilities , an dfo r

establishin g appropriat e emissio nfees

. Further , compame s mus t
repor t emission s unde r

"Th e Communit y Righ t T o Kno w Act. "
No t onl y doe s th e curren t

regulator y approac hno t achiev e accurat e estimate s of th e actua l emissions , i t doe s no t provid e incentive s o r

credi t t o firm s fo r

establishin g program s an dfacilitie s t o achiev e th e bes t control

. No r

doe s th e approac hensur e emissio nrate s tha t ar e readil y achievable

. EP A recentl y convene daregulator y negotiatio nt o addres s thes e shortcomings

. Representative s o f EPA ; th e chemical , petroleum , rubber , an dpharmaceutica l industries ; environmenta l organizations ; an dstat e an d
loca l government s ar e workin g togethe r t o develo p aconsensu s on :

o ane w standar dbase dupo nth e maximu mavailabl e contro l technolog y (MACT ) fo r contro l o

fP. 6

fugitive emission s fro

mequipment

leaks ;

o emissionfactor s fo

r fugitive emission s o

f VOC s fro

mequipment

leaks , leadin g to abette r quantifica

tiono f th e magnitude o

f th e leaks ; an d

o aforma

t tha t couidb e usedto implemen t arisk base dstandardfo

r toxic organi c emission s o f hazardou s air

pollutant s fro

mequipment

leaks

. Specific risk

limit s or goal s wil l not b e asubject

o f the negotiations , however

. Thu s far , th e committe e ha s reviewe dconceptua l approache s tha

t wouldprovide incentive s fo r good performanc e anddisincentive s fo r poor performance

. Basically , th e approac hbeing discussedwoulddefine

alea k i nterm s o f s o man y part s pe

r millionanda

n"allowable number

o f leakers" , definedi

nterm s o f a percentag e o

f al l source s o

f fugitive emission s o

f aparticula

r type , suc ha s valves , flanges , or

pumps , wit

ha maximu mnumber

establishe dfo

r smal l plants

. The plan

t wouldthenb e require dt o monitor th e potentia

l

source s o f fugitive emissions , andan y leaker s tha

t ar e discovere dmust

b e repaired

. I

f th e screening show s consistent result s belo w th e allowabl e number o f leakers , th e momtoring couldb e don e les s frequently ; if ,
onth e other

hand , i t demonstrate dleak s i

nexces s o

f th e allowabl e level , momtoring wouldb e require d

mor e often

. Rando msample s couldals o b e usedi nplant s wit

hconsistent

level s belo w th e specifiedlevel

. There ha s beensom

e discussiona s t o aprogra mtha t wouldaddres s plant s tha t chronically fai

l t o meet th e performanc e level

. Th e precis e contour s o f th e approac handho w i t wouldb e phasedinar e still bein g discussed

. Thi s approac hwouldapply most directly t o processe s tha

t operate more o

r les s continuously

. Processe s that operat e only intermittentl y ma y pos e som

e difficulty , however

. Becaus e o f th e uniqu e aspect s o

f thes e batchprocesses , the committe e formedaworkgroup to explore alternativ e regulator y approache s apphcabl e
to them

. Five were suggestedt o th e committee : (1 ) building bagging , i nwhic hall emission s fro

ma n operatio nar e discharge dthroug hasingle vent tha t couldb e measured ; (2 ) pressure testin g o f all line s t o

ensure tha

t they ar e no t

leaking ; (3 ) screening frequencie s base do n"tim e inuse " a s oppose dto th e genera l standard ; (4 ) rando mscreenin g durin g operations ; and(5 ) screenin g onl y thos e component s actually i nus e durin g th e screenin g cycle

. Other regulator y approache s were als o discussed , a s well a s ho w afir man dth e agency coul dasses s other approache s t o determin e whether they wouldb e "equivalent " t o th e generi c standard

.P. 7

The scop e o

f the standardunde

r discussionha s beenbroadene dbeyondthe sourc e categorie s originall y

announce db

y EPA

. The agency intend s to develop generi c standard s tha t wouldb e applicabl e to all chemica l manufacturing facilitie s tha t us e a s ra w material s or

produc e a s intermediates , co-products , o r fina l product s an

y o f the 19 1 chemical s liste dinth e propose damendment s to th e Clea nAir Act

. Th e precis e

source s nee dto b e furthe

r defined

. Th e committe e ha s beenreviewing screenin g dat afro methylen e oxide an dbutadien e plants , a s wel l a s datafro msom e other plants , a s the basi s fo

r the standard

. O nth e committee' s suggestion , th e dataha s beenreformulate dto show the percentag e o f leaker s a t varying lea

k definitions

. Som

e aberration s i

nthe datahav e beennoted , andaworkgroup wil l examine th e datafo

r presentatio na

t the nex t committe e meeting

. The committe e ha s als o considere dacoupl e o f approache s fo

r assessing emissions

. Tha t effor t ha s largely bee nheldi

nabeyanc e pending furthe r development

o f th e conceptua

l approach

. I

t ha s briefly discussedasequentia

l samphng approac htha

t couldb e usedt o accompUs hth e rando msampling aspect s o f th e conceptua

l approach

. Th e committe e als o acknowledgedthe nee dt o examine th e nee dfo r or level o f a "cutoff " o r "d e minimis " level fo

r applicatio no

f th e standard

. While some criteri ahav e bee nmentioned , i t ha s no t yet begunt o define th e lower limit o f applicability

. The committee' s discussions , lik e all negotiations , ar e tentativ e unti l afina l agreement

i s reached

. The committe e ha s expUcitl

y recognizedtha

t man y part s o f th e standarddepen do

nother parts , s o tha

t the specific level s an drequirement s hing e o nother aspect s o f th e deUberations

. Th e committe e i s holding meeting s approximately onc e pe r month , alternatin g betwee nWashingtonand Durham

. Meeting s wil

l b e heldo

nFebruar y 22 and2 3 i

nWashington ; March27 and2 8 i nDurham ; and Apri l 2 5 and2 6 i

nWashington

. They wU l b e announce di

nth e Federal

Register, andmember s o f the pubhc ar e welcom

e t o attend

.P. 8

REGULATOR YNEGOTIATIO N MEETINGO

N FUGITIV E EQUIPMEN T LEAK S JANUARY17-18 , 199 0 PICKET T SUIT E HOTE L DURHAM , NORT H CAROLIN A

DRAF T MEETINGMINUTE S

Thes e meetin g note s summariz e issue s discusse dan dprovid e a

ninforma l recor do f administrativ e an dlogistica l decision s mad e o nschedule s an

dactio n items . Al l presentatio nmaterial s distribute ddurin g th e two-da y meetin g ar e attached : Attachmen t 1 Attachmen t 2 Attachmen t 3 Attachmen t 4 Meetin g Agend a

Attendee s Januar y

17 , 199 0 Revision s t o Decembe r 6- 7 meetin g note s Draf t Repor t t o th e Equipmen t Leak s Regulator y Negotiation s Committee ; Meetin g Minutes-Batc hWor k Grou p Attachmen t 5 : Presentatio nSlides-Alternativ e Lea kDetectio n

Technique s Attachmen t 6 : Handou t "Equivalent " Fugitiv e Emission s Contro l

Program : Conceptua l Basi s Attachmen t 7 : Presentatio nSlides- - Monitorin g Pla nEvaluatio n Attachmen t 8 : Decembe r 2 2 dat a analyse s packag e distribute dt o

committe e b

y Rober t Pahel-Shor t -EPA Attachmen t 9 : Handou t o f condense ddat a package—prepare db y Mr . Majewsk i Attachmen t 10 : Sequentia l Samplin g Handou t Attachmen t 11 : Cost s o f Equipmen t Screening : Lette r fro m Walte r Brenner , Su

nRefinin g an

dMarketin g Co . Minute s o f Previou s Meetin g

Th e minute s o f th e previou s ful l committe e meetin g (Decembe r 6-7 , 1989 ) wer e discussed . Change s inth e minute s approve db y th e Committe e ar e containe di nAttachmen t 3 . Batc hProcessin g

Dr . Jac kKac e reporte do nth e Januar y

4 , 199 0 wor kgrou pmeetin g o nbatc hprocesse s (se e Attachmen t 4) . Dr . Kac e provide d backgroun dinformatio no nth e pharmaceutical s industr y describin g product s tha t ar e manufacture dusin g batc hprocesses . Dr . Kac e describe dsevera l uniqu e difficultie s inapplyin g th e typ e o f LDA R program currentl y

bein g discusse db

y th e committe e t o batc h processes . Amon g th e difficultie s describe dwa s th e schedulin g o f screenin g activitie s a t a time whe nequipmen t wa s "i nservice " fo r on e o r mor e o f th e chemical s o f interest , sinc e th e mi xo f product s wil l chang e durin g an y give nmonth . Further , difficultie s ar e

cao.02 7P. 9

tha t eve nfo r processe s usin g chemical s o f concern , screenin g woul dinvolv e accuratel y timin g al l LDA

Ractivitie s t o coincid e wit hth e stag e o f th e proces s wher e th e chemical s o f concer nar e bein g used . Th e batc hproces s workgrou pidentifie dfiv e possibl e alternativ e lea kdetectio ntechnique s fo r batc hprocesses : 1 ) buildin g bagging , 2 ) pressur e testin g o f al l proces s lines , 3 ) establishin g screenin g frequenc y

base do

n"time-in-use" , 4 ) random screening , an d5 ) screenin g onl y

thos e component s inus e durin g a screenin g cycle . Th e workgrou pplan s t o investigat e th e feasibilit y o f eac h o f th e fiv e alternatives . Th e nex t workgrou pmeetin g i s schedule d fo r 10:0 0 a.m. , Wednesday , Februar y 2 1 a t th e Pharmaceutica l Manufacturer s Association' s office , a t 110 0 Fifteent hStreet , NW , Washingto nDC . Fo r additiona l information , intereste dpartie s shoul dcontac t Ms . Chery l Sutterfiel da t (202 ) 835-3548 . Othe r Equivalen t Regulator y Approache s Mr . Jerr y

Schro y o f Monsant o presente dtwo alternativ e lea k detectio ntechnique s (se e Attachmen t 5) : 1 ) multi-componen t monitorin g achieve dthroug hmonitorin g entir e buildin g exhaus t (i.e. , buildin g bagging) , an d2 ) us e o f industria l hygien e dat a t o determin e workplac e concentratio nlimits . Mr . Schro y state dtha t thes e technique s provid e reliabl e cost-effectiv e alternative s fo r meetin g EPA' s goa l o f reducin g emissions . Mr . Ro nBerglundo f Unio nCarbid e presente da conceptua l program for , th e contro l o f fugitiv e leaks . Th e progra m wa s distinguishe d b y th e us e o f thre e type s o f directe dinspections : 1 ) th e judgemen t inspectio nprogram , whos e purpos e i s t o identif y leakin g components ; 2 ) th e informatio ninspectio nwhos e purpos e i s t o repai r defectiv e components ; an d3 ) th e sourc e inspection , whos e purpos e i s t o preven t component s fro m becomin g leakers . Th e committe e discusse dth e criteri a tha t mus t b e me t t o conside r alternativ e regulator y approache s a s equivalen t t o th e regulator y approac hshoul dbe defined . A proposa l wa s mad e tha t an y approac h recognize da s equivalen t shoul db e base do ntota l emissions . Severa l member s note dtha t usin g tota l emission s a s th e criterio n woul drequir e th e developmen t o f prope r emissio nfactors .
Scop e o f th e Standar d

Mr . Bo bAja xo f EPA

describe dth e regulator y activitie s fo r wastewater , proces s vents , storage , an dtransfe r tha t ar e bein g conducte db

y th e Agenc y

throug hth e conventiona l rulemakin g process . Thes e rules , alon g wit hth e negotiate dequipmen t lea k rule s wil l appl y

t o eac hsourc e categor y tha t wil l b e regulated . Th e Agenc y

intend s t o expan dth e scop e o f th e rule s tha t ar e

cao.02 7P.1 0

Dat a planne dfo r adoptio nwithi nth e firs t two year s afte r passag e CA A revisions . Th e scop e wil l g o beyon dth e thirtee nsourc e categorie s originall y discussed , andi s no w planne dt o includ e al l categorie s o f SOCM I source s tha t produce , an dpossibl y

al l tha t us e (a s raw

materials ) chemical s inth e CA A lis t (e.g. , th e curren t lis t o f 191) . Althoug horgani c chemica l processe s locate d i nrefinerie s o r onrefiner y propert y

woul dbe affected , th e Agenc y doe s no t pla na t thi s time , t o includ e petroleum refiner y processe s amon g th e sourc e categorie s affecte db y thi s initia l phas e o f rules .

Prio r t o th e Januar y

meeting , EPA

distribute dt o al l committe e member s a packag e containin g a nanalysi s showin g th e percen t leaker s b

y componen t typ e fo r variou s lea kdefinition s (Attachmen t 7 ) . Th e analysi s wa s performe donth e ethylen e oxid e an d butadien e screenin g dat a distribute ddurin g October . Mr . Majewsk i distribute da combine dversio no f th e dat a t o th e committe e fo r discussio n(Attachments) . Some committe e member s expresse dconcer nove r th e qualit y o f th e data , notin g evidenc e tha t some dat a appea r t o hav e bee nrounde d dow no r truncated . Committe e member s wer e requeste dt o revie w th e dat a indetai l prio r t o resumin g discussion s onth e qualit y o f dat a an dprio r t o decidin g onth e dat a subse t t o us e in establishin g th e leve l o f th e standard . Frequenc y plot s o f th e dat a wil l b e distribute ddurin g th e wee ko f Januar y 2 2 wit hth e inten t o f discussin g th e dat a i ndetai l ina

ninteri m

workgrou p meeting . Furthe r discussion s o f th e dat a b y th e ful l committe e wa s postpone dunti l th e Februar y meeting . Th e workgrou pmeetin g o ndat a qualit y

i s schedule dfo r Wednesday , Januar y 3 1 a t 10:0 0 a t th e EPA' s Durham

Nort hCarolin a offic e (Mutua l Building) , i nth e 9t hfloo r conferenc e room . Severa l committe e member s sai dther e wa s a sufficien t quantit y o f dat a tha t wer e no t o f questionabl e qualit y t o allo w

position s on th e leve l o f th e standar dt o b e formulated . A suggestio nwa s mad e tha t a lea kdefinitio no f 5 0 pp m an d4 t o 5 percen t lea kfrequenc y wa s supporte dfo r valve s an dflange s takin g int o accoun t tha t some o f th e dat a i s suspect . On e proposa l wa s tha t th e committe e begi n b y considerin g a lea kdefinitio na t th e lowes t practica l concentration , whic hshoul dlogicall y begi na t instrumen t detectio nlevels . Discussion s continue donth e rol e o f cos t indeterminin g MAC T an d th e specifi c languag e an dinten t o f th e CAA . Severa l member s sai d tha t discussio no f th e leve l o f th e standar dshoul dno t b e considere dapar t fro

m costs . Some sai dtha t MAC T discussion s shoul dstar t b

y lookin g a t th e performanc e leve l demonstrate db y th e bes t controlle dplant s an das kwhy

other s canno t duplicat e

cao.02 7P.1 1

tha t performanc e level . Other s sai dtha t th e cos t pe r leve l o f contro l mus t b e considere da s a nintegra l par t o f definin g MACT . Concer nwa s voice dove r extrapolatin g emissio nlevel s tha t ar e achievabl e an

daffordabl e fo r th e butadien e andethylen e oxid e industrie s t o cove r al l othe r affecte dindustries . Conceptua l Approac ht o th e Standar d

A nanalysi s o f th e conceptua l LDA Rapproac hdiscusse dinth e Decembe r meetin g wa s presente dth e compare da monthl y bas e t o a quarterl y

bas e program

(Attachmen t 9) . Specifically , th e analysi s evaluate dtwo element s fo r monthl y an dquarterl y

bas e programs : 1 ) th e probabilit y

o f failin g a

ninspection , an

d2 ) th e numbe r o f inspection s require dpe r year . Durin g th e presentatio nther e wa s discussio nabou t th e numbe r o f program level s a plan t woul dhav e t o fal l bac ki f the y

sample dannuall y

an dfounda

nunacceptabl e lea klevel . Ther e wa s a consensu s tha t a plan t shoul dno t b e require dt o g o al l th e wa y bac kt o th e bas e monitorin g frequenc y inthos e circumstances . Mr . Aja xsummarize dsome o f th e key premise s upo nwhic hth e conceptua l regulator y approac hdiscussion s hav e bee ncentered , i n th e contex t o f th e time schedule s expecte dinth e CA A revision . Th e premise s discusse dinclude dth e us e o f allowabl e limit s a s performanc e standard s an da s a trigge r fo r LDAR , incentive s fo r decrease dmonitorin g frequencies , an dpossibl e penaltie s fo r fina l nonconformance . Mr . Aja xpresente dth e followin g items , whic hinhi s vie w appeare d t o be area s wher e a "genera l sens e o f agreement " exist s amon g severa l o f th e committe e member s wit hrespec t t o th e conceptua l regulator y

approach . 1 . Th e bes t 1 0 o r s o ethylen e oxid e an dbutadien e plant s reflec t th e performanc e o f MACT--recognizin g tha t dat a fo r 3 t o 5 plant s ma y

b e suspect . 2 . T o achiev e MAC T goal s an dbase doncommo nsense , th e lea k definitio nleve l shoul dbe a s low a s practical . 3 . Furthe r evaluatio ni s neede dt o determin e th e lowes t practica l lea kdefinition . 4 . Som e suggeste dtha t discussion s o nth e leve l o f th e standar d fo r valve s an

dflange s shoul dstar t inth e rang e o f 5 0 pp m an d4 t o 5 percen t lea krate s base donth e availabl e data . 5 . A compliance/penalt y

scheme need s t o b e considere dt o brin g int o fina l conformanc e thos e plant s tha t chronicall y fai l t o achiev e th e performanc e leve l define db y th e allowabl e limit . 6 . Random

samplin g i s a desirabl e goa l i f i t i s practical .

cao.02 7P.1 2

Mr . Aja xdistribute da handou t (Attachmen t 10 ) showin g som e example s o f how

sequentia l samplin g coul db e use dt o accomplis h th e goa l o f rando

m sampling . Th e tex t o f th e handou t wa s develope dfo r woodstove s complianc e scheme s bu t th e attache d table s wer e develope dspecificall y fo r scenario s relate dt o thi s equipmen t lea kprogram . Mr . Aja xwalke dthroug ha nexampl e o f th e approac husin g a 50 0 inspectio ncutof f scenari o (pag e EL- 5 o f handout) . Th e key

variable s considere db y th e approac hinclud e "alpha" - whic hi s th e probabilit y o f falsel y

(incorrectly ) identifyin g a plan t a s a leake r (base do nlea kdefinitio no f Ho) , an d"power " - whic hi s th e probabilit y o f trul y

(correctly ) identifyin g a plan t a s a leake r a s compare dt o th e a dho c value (Ha) . I nth e exampl e o

npag e EL-5 , th e "acceptanc e number " identifie s th e allowe dnumbe r o f leaker s fo r a give nnumbe r o f screene dcomponent s tha t woul dconstitut e compliance . Fo r example , i f 11 0 component s wer e screene dan d0 leaker s wer e found (pag e EL-7 ) th e plan t coul dsto psamplin g an db e considere din compliance . I f howeve r 8 leaker s wer e found(the "rejectio n number" ) durin g th e screenin g o f thos e 11 0 component s th e plan t woul db e considere dou t o f compliance .
Emissio nFactor s

CM A reporte dtha t littl e effor t hadbee nspen t onth e conceptua l mode l sinc e th e las t meeting . Th e committe e generall y agree dtha t th e conceptua l mode l ha s a muc hgreate r significanc e inligh t o f th e equivalenc y

issue . CM

A agree dt o tak e th e lea do ndevelopin g informatio nfo r th e emissio nfacto r discussio na t th e nex t meeting . Th e committe e briefl y discusse dth e concep t o f assignin g defaul t emissio nfactor s base dupo nth e LDA Rprogram

"box" . Thi s concep t wa s introduce dinth e Decembe r meetin g an di s outline din Attachmen t 4 o f th e Decembe r meetin g minutes . Approache s fo r Assessin g Cost s

Som e committe e member s sai dtha t many o f th e affecte dsource s wil l hav e n o existin g contro l program inplac e an

dtherefor e th e incrementa l cos t o f contro l fo r those facilitie s woul db e significantl y

greate r tha nfo r industrie s currentl y performin g LDAR . Mr . Aja xsuggeste dtha t a wors t cas e cos t estimat e coul dbe mad e b y comparin g monthl y

LDA Rt o th e SOCM I factor s wit hquarterl y LDAR . Attachmen t 1 1 describin g cos t fo r equipmen t screenin g wa s distributed .

cao.02 7P.1 3

Cutoff s On e suggestio nwa s tha t cos t be use da s anindicato r fo r

determinin g logica l cutoffs . Emissio nmagnitud e andin-lin e concentratio nwer e als o proposeda s possibl e cutof f criteria . Actio nItem s EPA

wil l tak e th e lea dindevelopin g a nannotate doutlin e o f th e conceptua l rule . Th e annotate drul e wil l be anexpansio no f th e "strawman " rul e drawin g o nth e earlie r lis t o f 2 4 issues . EPA wil l distribut e th e outlin e prio r t o th e Februar y meeting , i f possible . CM A wil l tak e th e lea di nth e emissio nfacto r are a andi nth e furthe r investigatio no f th e conceptua l model . CM A wil l distribut e dat a package s fo r discussio ni nth e Januar y 3 1 dat a qualit y

workgrou pmeeting . Pharmaceutica l Manufacturer s Associatio n(PMA ) wil l continu e t o investigat e feasibilit y o f alternativ e approache s fo r batc h processes .

Futur e Meeting s

Dat a qualit y

workgroup : Januar y

3 1 a t 10:0 0 a.m. , EPA/Mutua l Building , 9t hfloo r conferenc e room , Durham NC . Batc hProcesse s workgroup : Februar y 2 1 a t 10:0 0 a.m. , PM A Offices , 110 0 Fifteent hStreet , NW , Washingto nD.C . Th e nex t meetin g o f th e ful l Negotiatio nCommitte e i s schedule dt o be hel dinWashingto nD.C . onFebruar y 22-23 , 1990 . Th e locatio n o f th e meetin g wil l b e identifie di nth e transmitta l memorandum . Marc h2 7 an

d28 ; Durham , N.C.- - Locatio nt o be determined . Apri l 2 5 an

d26 ; Washingto nD.C.- - Locatio nt o be determined .

cao.02 7

# MmC^ftM T 1

ENVIRONMENTA LPROTECTIO N AGENC Y NEGOTIATING

. COMMITTE EFO R CONTRO LO FFUGITIV EEMISSION S O FVOC s FRO M EQUIPMEN T LEAK S

AGEND A FO RMEETIN GO FJANUAR Y 17-1 8 Administrativ e

o Revie w o f the Agenda : additions , subtractions , order

o Minute s o

f December

meeting : .An

y majo r heartburn s
Repor t o f th e Batc hProcessin g Workgrou p

Dat a

° Analysi s o

f ethylen e oxid

e andbutadien e screening datadistribute di nDecember
<* >Statu s o

f agreement

fo r bagging
«* >Additiona

l data : availabiht

y andrequirement s
Conceptua l Approac ht o th e Standar d

o Phasing <* • Incentive s (botto mUn

e o f boxes )
<" > Exi t criteri a(right

colum no f boxes )

o MisceUaneou s point s raise da t prior meeting s

Emissio nFactor s

° Statu s o

f modelling approac h

o Matrix approac h
Conceptua l approac ht o lea k definitio nan dallowabl e leaker s
Approache s t o assessin g th e cos t o f th e standar d

Procedure s fo r

determinin g equivalen t approache s

a JP.1 5



# /OT^C^ftM T

ENVIRONMENTA L PROTECTIO N AGENC Y NEGOTIATIN GCOMMITTE E FOR CONTRO L O F FUGITIV E EMISSION S O F VOC s FRO M EQUIPMEN T LEAK S
ATTENDEE S LIS T FORMEETINGO F JANUAR Y17-18 , 199 0

NAM E Rober t Majewsk i A l Bicku m Gu s VonBodunge n Harve l Roger s Kare nHom e Debora hDalto n Phili pHarte r Bo bAja x Davi dDunn To m Kittlema n Alle nHershkowit z Jac kKac e Larr y Goodhear t Lind a Curra n Meredit hMille r Bruc e Grumstru p Ric kColye r Wal t Brenne r Kare nFidle r E dMorett i Bil l Schikor a Ji m Hes s Charli e Anderso n Mar y AnnGork o Kathy Baile y Jerr y Schro y Davi dMarkword t RonBerglun d A l Weh e Bo bHinkso n Charle s Bennet t Bo bRowlan d Bo bStriete r Elle nSiegle r Scot t Throw e Marti nE . Roc k Miriam Levo n Jame s F . Murphy Kathy Kaufma n GlennRive s Rober t Pahel-Shor t AFFILIATIO N NESCAUM IISRP , Louisian a DEQ-Ai r Qualit y JCAPC D TAC B EPA - Re g Ne g Projec t Facilitatio n U . S . EPA Sterlin g Chemicals , Inc . CM A (DuPont ) NRD C PM A (Roche ) AP I (Chevron ) Amoc o Oi l Fishe r Control s Fishe r Control s EPA/OAQP S SunCo . CM A RadianCorp . - RT P Chevro nCorp . DuPon t Shere xChemica l Co . DuPon t CM A Monsant o EPA/OAQP S Unio nCarbid e EPA/OAQP S Moba y Synthetic s Ashlan dPetroleu

m Co . Pfize r Inc . AP I AP I EPA/OAQPS/SSC D OMN I Envirn . Servic e In c ARC O W.R . Grac e & Company EPA/OAR/OPAR Radia nCor p- RT P EPA/OAQP SP.1 6



# ATTACHMEN T3

REVISION S T O DECEMBE R MINUTE S

Secon d bulle t unde r Conceptua l Approac h (Pag e 2 )
o Unde r Phas e II I o f the conceptua l approach , the progra mwoul d shif t t o a performanc e standard

. Screening result s woul d b e compare d t o the standar d an d i f the leak frequenc yi s foun d t o b e les s tha n the allowabl e limit , monitoring woul d b e allowe d using a randomsampl e o r a les s frequen t approach

. Th e frequenc yo f monitorin g woul d b e base d o n the result s o f previou s screening s (i.e. , les s frequen t monitoring require d fo r plant s tha t consecutivel ydemonstrat e leak rate s les s than , fo r example , hal f the allowabl e limit)

. Th e norma l monitoring frequenc yduring Phas e II I woul d b e quarterl yfo r plant s achieving the allowabl e limit

.

Firs t bulle t unde r Emissio n Facto r (Pag e 4 )

o Attachmen t 9 contain s a handou t showing ba r chart s an d table s showing leak frequencie s an d emissio n factor s fo r the E O an d B D plants

. Attachmen t 1 0 contain s a tabula r summar ylisting the componen t characteristic s (i.e. , valv e type , materia l o f construction , packin g type , etc., ) fo r E O an d B D plant s wit h leak frequencie s o n bot h end s o f the spectrum
.P.1 7



# /OTACCiftM T4

1

Draf t Repor t t o th e Equipmen t Leak s Regulator y Negotiation s Committe e ffeetin g mnute s - Batc hProcessin g Wor k Grou p Januar y 4 , 199 0 - Washington , D.C .

Th e productionoperation s inth e pharmaceutica l industr y wer e summarized . A

nexcerp t fro

m th e USEP A

Effluen t Guidelin e Developmen t Documen t describin g th e fou r industr y subcategorie s wa s distribute d(cop y attached) .

Th e chemica l synthesi s subcategor y o f pharmaceutica l manufacturin g
wa s describe dan

dfurthe r divide dint o thre e groups : continuou s operation s wit hdedicate dequipment , batc hoperation s wit hdedicate dequipment , an d batc hoperatio nwit hmultipurpos e equipment . Bot hbatc hgroup s shar e th e nee dfo r ver y highmanpowe r requirement s t o d o fugitiv e testing . Th e problem

i s mor e sever e inth e multipurpos e equipmen t group . Th e typica l pharmaceutica l produc t take s fiv e step s (o r sequence s o f uni t operations) . Eac hste ptypicall y ha s fiv e majo r piece s o f equipment .

Th e batc hsequenc e i non e majo r piec e o f equipmen t wa s describe d (se e attache dproces s flow diagram

an dproces s instrumentatio ndiagram) . Fugitiv e source s inbatc hproductionoperation s ar e generall y i noperatio n
muc hles s tha ncontinuou s operation s andthu s hav e a lowe r pollutio n potential .

Th e followin g alternativ e lea k testin g technique s fo r batc hprocesse s
wer e discussed :

(1 ) Proces s "Bubble "

Th e tota l fugitiv e losse s fro m th e proces s woul db e determine db y measurin g th e concentratio ni nth e exhaus t ai r fro m a nenclosur e aroun d th e proces s o r b

y us e o f are a monitor s o r simila r techniques . Allowabl e emission s fro

m a batc hproces s wil l b e difficul t t o calculate .P.1 8

(2 ) Pressurize d Testin g

Apar t o f th e proces s woul d b e pressurize d o r place d unde r vacuum and th e pressur e chang e versu s tim e determined

. I f acceptable , n o furthe r testin g i s needed

. I f th e pressur e tes t i s unacceptable , mus t tes t components , repai r leaks , an d retest
. Th e syste mcoul d als o b e teste d wit h a surrogat e (i.e

. helium , nitrogen)

.
(3 ) Tim e i n Us e Rati o

Th e component s woul d b e teste d byscreenin g technique s whil e i n us e a t condition s expecte d t o resul t i n maximu memissions

. Becaus e o f th e hig h manpowe r requiremen t fo r thi s typ e o f testing , and th e fac t tha t thes e source s onl yemi t whe n i n use , source s i n us e with , hazardou s ai r pollutant s woul d b e require d t o b e teste d accordin g t o th e followin g formula :

Proces s Ru

nTim e Fugitiv e Testin g Requiremen t

up t o 876 0 hrs/y r - sam e a s continuou s
u p t o 657 0 hrs/y r - 3/ 4 a s frequentl ya s continuous e
up t o 438 0 hrs/y r - 1/ 2 a s frequentl ya s continuou s
u p t o 219 0 hrs/y r - 1/ 4 a s frequentl ya s continuou s
up t o 109 5 hrs/y r - 1/ 8 a s frequentl ya s continuou s minimu mtestin g requiremen t - every 2 yr s fo r pump s and agitator s
(4 ) Randomize d Approac h

Tes t al l component s i n rando mmanne r independen t o f proces s conditions

. Thi s coul d b e applie d t o al l component s o r onl yflange s and valves

.
(5 ) Component s I n Us e

Tes t al l component s i n servic e a t th e tim e o f th e fugitiv e test
. Repor t percen t leaker s foun d versu s component s i n use .P.1 9

Othe r CoBBgnt s

Component s unde r vacuu mshoul d b e exemp t fro mthes e rule s sinc e thei r emissio n i s regulate d a s a poin t source .

Metho d twenty-on e fo r screenin g i s ver ytim e consuming

. Alternativ e testin g usin g catalyti c tester s (suc h a s Gastra c NGX-600 ) i s sufficien t fo r screenin g purposes .

A50 0 pp mstandar d fo r pump s woul d requir e capita l expenditure s t o upgrad e o r replac e pump s wit h packe d seal s o r singl e mechanica l seals

. Th e cost-benefi t fo r thi s ma yb e unreasonable

.

An yequivalen t approac h shoul d hav e a deadlin e o n USEP Aand Stat e approval

. USEP Ashoul d publis h criteri a b ywhic h the ywoul d judg e a n alternativ e method

. Adefaul t shoul d b e include d whereb yth e equivalen t metho d i s automaticall yapprove d i f USEP Atake s n o actio n i n on e yea r
o r tha t th e sourc e i s no t subjec t t o th e rul e unti l USEP Aact s o n thei r request
.

Th e productio n schedul e fo r a pharmaceutica l plan t wa s distribute d
and discusse d (cop yattached ) t o sho wth e complexit yo f fugitiv e testing

.

OV Amete r reading s ar e likel yt o b e inaccurat e o n batc h processe s tha t emplo ya mi x o f solvent s sinc e th e mete r mus t b e calibrate d t o on e solvent

.

Som e productio n operation s requir e "maximum containment. " T o protec t worker s w e shoul d us e a fugitiv e measuremen t approac h tha t doe s no t requir e th e tester s t o ris k exposure .

Doubl e mechanical , seal s ar e a proble m i n pharmaceutica l applications

. Concer n wa s raise d abou t sea l flui d leakag e int o th e product

.P.2 0

Equipmen t lif e i s longe r i n man ybatc h operation s becaus e th e pump , agitator , etc
. i s onl yi n us e par t o f th e year .
Conclusio n

Th e grou p agree d tha t man ypotentiall yusefu l alternative s wer e discussed

. Thes e alternative s mus t b e develope d further

. I t wa s recommende d tha t th e wor k grou p continu e t o mee t t o complet e thi s task

.P.2 1

Attendee s

Jac k Kac e Tom Whit e Ric k Colye r Harve l Roger s A l Bicku m Davi dDonnige r Davi dDun n Ralp hV . Johnso n Mar y Legatsk i Syntheti c Organi c Chemica l Manufacturer s Assoc , Jo e O'Lai r Willia m J . Barefor d Bo bRowlan d Ji m Haga n Catherin e Ehlhard t Crai g F . Seyfrie d Rober t Baldisserott o Chery l Sutterfiel d Kare nFidle r Hoffmann-L a Roch e 

### PM A EP A Jefferso nCo . APC C Goodyear/11SR P Natura l Resource s Sterlin g Chemical s Dixi e Chemica l Co . Syntheti c Organi c DuPon t - Chamber s DuPon t - Chamber s Pfize r Inc . Inc .

) Defenc e (SOCMA ) Chemica l Work s Work s Smit hKlin e - Frenc h El i Lill y

& Company Wyeth-Ayers t Hoffmann-L a Roch e 

### PM A Inc . Counci l

Manufacturer s



# JP.2 2

DEVELOPMEN T DOCUMEN T FO R PROPOSE D EFFLUEN T LIMITATION S GUIDELINES , NE W SOURC E PERFORMANC E STANDARD S AN D PRETREATMEN T STANDARD S
FO R TH E
PHARMACEUTICA L MANUFACTURIN G POIN T SOURC E CATEGOR Y

ANN E GORSUC H ADMINISTRATO R

FREDERI C A
. EIDSNESS , JR
. ASSISTAN T ADMINISTRATO R FO R WATE R

STEVE NSCHATZO W DIRECTO R OFFIC E O F WATE R REGULATION S AN D STANDARD S

JEFFER Y D
. DENI T DIRECTOR , EFFLUEN T GUIDELINES.DIVISIO N

DEVEREAU X BARNE S ACTIN G CHIEF , ORGANI C CHEMICAL S BRANC H



# y f0i 

# S

Fran k H
. Hund , Ph.D

. Danie l S
. Len t Josep hS
. Vita l i s Proiec t Officer s

Novembe r 198 2

Effluen t Guideline s Divisio n Offic e o f Wate r U.S
. Environmenta l Protectio n Agenc y Washington , D.C
. 2046 0 •P.2 3



### Puert o Ric o ha s clos e t o 1 0 percen t o f th e industryan d i s becomin g a majo r pharmaceutica l manufacturin g center
. Tabl e 11 1 — 2 break s dow n th e industryb ymanufacturin g subcategory

. Thes e process-base d subcategorie s wer e use d fo r a revie wo f th e industry , although thes e distinction s wer e no t carrie d throug h fo r purpose s o f developin g th e newl ypropose d regulations

. Subcategor yD (formulating/mixing / compounding ) i s th e mos t prevalen t pharmaceutica l manufacturin g operation , wit h 8 0 percen t o f th e plant s in th e industryengage d in thi s activity

. Fifty-eigh t percen t o f th e plant s hav e operation s in onl ySubcategor yD
. Th e remainde r als o hav e operation s i n othe r subcategories

. Tabl e III- 3 summarize s th e tota l numbe r o f batch , continuous , an d semi-continuou s manufacturin g operation s b ysubcategor yfo r th e entir e pharmaceutica l industry

. Batch-typ e productio n i s th e mos t commo n typ e o f manufacturin g techniqu e fo r eac h o f th e fou r subcategories

. C
. MANUFACTURING PROCESSE S

On e o f th e mos t importan t generalization s whic h can b e mad e abou t th e wastewater s produce d an d discharge d b

yth e pharmaceutica l industr yi s thei r extreme , diversity

. Products , processes , an d the material s t o whic h wastewate r i s expose d var ygreatly

. Wit h the goa l o f relating thos e discharge s wit h som e commo n characteristics , subcategorie s base d on uni t manufacturin g processe s wer e defined

. Th e broa d manufacturin g processin g area s considere d wer e (a ) fermentation , (b ) biologica l an d natura l extraction , (c ) chemica l synthesis , an d (d ) formulation

. On e characteristi c o f processin g in thi s industryi s tha t th e rati o o f finishe d produc t t o th e quantit yo f ra wmaterials , solvents , an

d othe r processin g material s i s generall yverylow

. Thi s i s mos t apparen t i n natura l extractio n (Subcategor yB) , followe d b

yfermentatio n (A) , synthesi s (C) , an d formulatio n ( D * , respectively

. 1
. Fermentatio n Fermentatio n i s th e usua l metho d fo r producin g mos t antibiotic s an d steroids

. Th e fermentatio n proces s involve s thre e basi c steps : inoculu

m an d see d preparation , fermentation , an d produc t recovery . Productio n o f a fermentatio n pharmaceutica l begin s wit h spore s fro mth e plan t maste r stock

. Th e spore s ar e activate d wit h water , nutrients , an d warmth ; theyar e the n propagate d throug h

3 3P.2 4



### the ycan contribut e t o priorit ypollutan t wast e loads

. Pheno l i s a commonl yuse d disinfectant

.

• o 

### Sometime s a fermentatio n batc h can become infeste d wit h a phage , a viru s tha t attack s microorganisms

. Althoug h phag e infestatio n i s rar e in a well-operate d plant , whe n i t occurs , verylarg e wastewate r discharge s ma yb e necessaryin a shor t perio d o f time

. Usuall yth e batc h i s discharge d earl yan d it s nutrien t pollutan t concentratio n i s highe r than that , o f spen t broth

.

Th e pollutio n contributio n o f th e spen t bee r arise s fro mth e fac t tha t th e bee r contain s substantia l foo d material s suc h a s sugars , starches , protein , nitrogen , phosphate , an d othe r nutrients

. Method s fo r treatin g th e fermentatio n waste s ar e generall y biologica l in nature
. Althoug h th e spent

- beers , eve n in a highl y concentrate d form , can b e satisfactoril yhandle d b ybiologica l treatmen t systems , i t i s les s likel yt o upse t th e syste mi f th e waste s ar e firs t dilute d t o som e degree

. Dilutio n normall y result s fro

m th e equalizatio n o f fermentatio n waste s wit h th e othe r wast e streams
. A s a result , a satisfactory , biologica l reductio n o f th e contaminanti s can b e achieved

. Th e 30 8 dat a show s generall ytha t wastewater s fro m Subcategor yA plant s generall yar e characterize d b yhig h BOD , COD , an

d TS S concentrations , larg e flows , an d a pH rang e o f abou t 4. C t o 8.C
. 2
. Biologica l an

d Natura l Extractio n Man ymaterial s use d a s pharmaceutical s ar e derive d fromsuc h natura l source s a s th e root s an d leave s o f plants , anima l glands , an d parasiti c fungi

. Thes e product s hav e numerou s an d divers e pharmaceutica l application s rangin g fro mtranquilizer s and allerg yrelie f medication s t o insuli n an d morphine

. Als o include d in thi s grou p i s bloo d fractionation , whic h involve s th e productio n o f plasma an d it s derivatives

.

3 5P.2 5



### know n t o b e use d a s precipitatin g agents
. Pheno l wa s identifie d a s a n equipmen t sterlizin g chemica l a s wel l a s an activ e ingredient

. . Otherwise , priorit ypollutant s ar e foun d t o b e use d onl ya s processin g solvents

. Som e identifie d a s solvent s wer e benzene , chloroform , an d 1, 2 dichlorbethane

. Solvent s ar e use d i n two way s in extractio n operations

. First , theyar e use d t o remov e fat s an d oil s tha t woul d contaminat e th e products

. Thes e "defatting " extraction s us e a n organi c liqui d tha t dissolve s th e fa t bu t no t th e produc t material

. Solvent s ar e als o use d t o extrac t th e produc t itself

. Plan t alkaloids , whe n treate d wit h a n alkali , becom e solubl e i n suc h selecte d organi c solvent s a s benzene , chloroform , o r 1, 2 dichloroethane

. Ammoni a i s use d in man yextractio n operation s sinc e i t i s necessaryt o contro l th e p H o f wate r solution s fro mbot h anima l an d plan t source s t o achiev e separatio n o f valuabl e component s fro mwast e materials

. Ammoniu msalt s ar e used a s bufferin g chemical s an

d aqueou s o r anhydrou s ammoni a i s use d a s an alkalizin g reagent
. Th e high degre e o f wate r solubilit yo f ammoniu msalt s prevent s unwante d precipitatio n of* =>-a. c; also , ammoni a doe s no t reac t chemicall ywit h anima l o r plan t tissue

. Suc h basi c material s a s hydroxide s an d carbonate s o f alkal i metal s d o no t hav e thes e advantages

. Th e principa l source s o f wastewate r fro m biological/natura l extractio n operation s ar e (a ) spen t rawmateral s (wast e plasm a fractions , spen t eggs , spen t medi a broth , plan t residues , etc.) ; {b )
. floo r an

d equipmen t washwaters ; (c ) chemica l waste s (spen t solvent s an

d the like) ; an

d (d ) spills

. I n general , th e bul k o f the spen t ra wmaterial s i s collecte d an d sen t t o a

n incinerato r o r landfill

. Likewise , th e nonrecoverabl e portion s o f th e spen t solvent s ar e incinerate d o r landfilled

. However , i

n bot h cases , portion s o f th e residua l material s find thei r wa

yint o a plant' s wastewater
. Floo r an d equipmen t washing s an

d spill s als o contribut e t o the ordinar ywast e discharge

. Althoug h pollutan t informatio n fo r th e biological/natura l extractio n operation s i n th e pharmaceutica l dat a bas e wa s limited , tha t whic h wa s availabl e len t itsel f t o a preliminar y analysis

. Generally , wastewater s fro mSubcategor yB plant s ar e characterize d b

ylo wBOD , COD , an

d TS S concentrations ; smal l flows ; an

d pH value s o f approximatel y6. 0 t o 8.0
. 3
. Chemica l Synthesi s Mos t o f th e compound s use d a s drug s toda yar e prepare d b y chemica l synthesi s (generall yb ya batc h process)
. Th e basi c
3 7P.2 6



### Eac h pharmaceutica l i s usuall ymanufacture d in a "campaign " i n whic h on e o r mor e proces s uni t i s employe d fo r a fe wweek s o r month s t o manufactur e enough compoun d t o satisf yit s projecte d sale s demand

. Campaign s ar e usuall ytightl yscheduled , wit h detaile d coordinatio n extendin g fromprocuremen t o f rawmaterial s t o packagin g an

d labeling o f th e product

. Fo r a variabl e perio d o f time , therefore , a proces s uni t activel ymanufacture s a specifi c compound

. A t th e en d o f thi s campaign , anothe r i s schedule d t o follow

. Th e sam e equipmen t an d operatin g personne l ar e use d t o mak e a completel ydifferen t product , utilizin g differen t ra

wmaterials , executin g a differen t recipe , and creatin g differen t wastes
. Th e syntheti c pharmaceutical s industryuse s a wid e variet yo f priorit ypollutant s a s reactio n an d purificatio n solvent s (43)
. Wate r wa s reporte d t o b e use d mor e ofte n than woul d b e expecte d i n a n industrywhos e product s ar e organi c chemicals

. However , benzen e an

d toluen e wer e th e mos t widel yuse d organi c solvent s sinc e the

yar e stabl e compound s tha t d o no t easil ytak e par t in chemica l reactions

. Simila r ring-typ e compound s (xylene , cyclohexane , pyridine , etc. ) als o wer e reporte d a s bein g use d in th e manufactur e o f synthesize d pharmaceutical s o r resultin g from unwante d sid e reactions

. Solvent s serv e severa l function s in a chemica l synthesis

. The y dissolv e gaseous , solid , o r viscou s reactant s t o brin g al l reactant s int o clos e molecula r proximity

. Theyserv e t o transmi t hea t t o o r fro

mth e reactin g molecules

. B yphysicall yseparatin g molecule s fro

m eac h other , theyslo wdow n som e reaction s tha t woul d otherwis e taft e plac e to o rapidl yan d tha t woul d resul t i n excessiv e temperatur e increase s an d unwante d sid e reactions

. Ther e ar e othe r les s obviou s use s o f solvents , however

. On e o f thes e i s th e us e o f a solven t in th e contro l o f reactio n temperature
. I t i s commo n practic e i n a batch-typ e synthesi s t o selec t a solven t whos e boilin g poin t i s th e same a s th e desire d reactio n temperatur e an d whic h i s compatibl e wit h th e reaction

. Hea t i s the n applie d t o the

. reactio n mas s a t a rat e sufficien t t o kee p th e mixtur e continuousl yboiling

. Vapor s tha t ris e fromth e reactio n vesse l ar e condense d an d th e liquefie d solven t i s allowe d t o drai n bac k int o th e reactio n vessel

. Suc h refluxin g prevent s bot h overheatin g an d overcoolin g o f th e reacto r content s an d can automaticall ycompensat e fo r variation s in th e rat e o f releas e o r absorptio n o f chemica l energy . Essentiall yal l productio n plant s operat e solven t recover y facilitie s tha t purif ycontaminate d solven t fo r reuse . Thes e facilitie s usuall ycontai n distillatio n column s an d ma yals o includ e extractio n facilitie s wher e stil l anothe r solven t i s use d t o separat e impurities

. Man yo f th e waste s fro m th e syntheti c

3 9P.2 7



### Althoug h pharmaceuticall yactiv e ingredient s ar e produce d i n bul k form , theymus t b e prepare d in dosag e for mfo r us e b

yth e consumer . Pharmaceutica l compound s can b e formulate d int o tablets , capsules , liquids , o r ointments

. Tablet s ar e forme d in a table t pres s machin e b yblendin g th e activ e ingredient , filler , an d binder

. Som e tablet s ar e coate d b ytumbling wit h a coatin g materia l an d drying

. Th e fille r (usuall ystarch , sugar , etc. ) i s require d t o dilut e th e activ e medicina l t o th e prope r concentration , a binde r (such a s cor n syru p o r starch ) i s necessar yt o bin d th e table t particle s together

. Alubrican t (such a s magnesiu mstearate ) ma

ybe adde d fo r prope r table t machin e operation

. Th e dus t generate d during

th e mixin g an

d tabletin g operatio n i s collecte d an d i s usuall y recycle d directl yt o th e sam e batch

. Broke n tablet s ar e generall ycollecte d an d recycle d t o th e granulatio n operatio n i n a subsequen t lot

. Afte r th e tablet s hav e bee n coate d an d dried , the yar e bottle d an

d packaged

. Capsule s ar e produce d b yfirs t forming , the hard gelatin e shell

. Thes e shell s ar e produce d b ymachine s tha t di p row s .of rounde d meta l dowel s int o a molte n gelatin e solutio n an d the n stri p the

. capsule s fromth e dowel s afte r th e capsule s hav e coole d an d solidified

. Imperfec t empt ycapsule s ar e remelte d an d reused , i f possible , o r sol d fo r glu e manufacture

. Mos t pharmaceutica l companie s purchas e empt ycapsule s fro m a fe

wspecialis t producers

. Th e activ e ingredien t an d an yfille r ar e mixe d befor e bein g poure d b

ymachin e int o th e empt ygelatin e capsules

. Th e fille d capsule s ar e bottle d an d packaged

. A s i n the cas e o f table t production , som e dus t i s generated

. Although thi s i s recycled , smal l amount s o f wast e dus t mus t b e dispose d of

. Som e glas s an d packagin g wast e fro mbroke n bottle s an d carton s als o resul t from thi s operation

. Liqui d preparation s can b e formulate d fo r injectio n o r ora l use . I n eithe r case , th e liqui d i s firs t weighe d an d the n dissolve d i n water
. Injectabl e solution s ar e bul k sterilize d b yhea t o r filtratio n an

d the n poure d int o sterilize d bottles

. Ora l liqui d preparation s ma

yb e bottle d directl ywithou t th e sterilizatio n steps
. Wastewater s ar e generate d b ygenera l cleanu

p operations , spills , an d breakage

. Bad batche s ma ycreat e a soli d wast e disposa l problem

. Th e primar yobjectiv e o f mixing/compounding/formulatio n operation s i s t o conver t th e manufacture d product s int o a final , usabl e form

. Th e necessaryproductio n step s hav e typicall ysmal lP.2 8

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ATTACHMEN T 1 

## TYPICA L GROTO N PRODUCTIO N DAT AP.3 2



# /OTAOEiftM T Fugitiv e Emission s Negotiate dRegulation s Proposa l Equivalenc e Th e reaso nfor

m y presentatio ni s t o highligh t industry' s nee dfor specifi c equivalen t

method s o

f complianc e to b e incorporate dinth e nex t se t of fugitiv e emissio nregulation s an dt o offe r example s of

possibl e "alternativ e method s o

f emissio nlimitations"

. Th e presentatio nwil l b e mad e by mysel f

andRo nBerglun do

f Unio nCarbide

. Th e method s o f equivalenc e t o b e discusse dare industria l hygiene dat asets , multicomponen t

baggin g (ie. , bag abuilding ) andcluste r monitoring

. I wil l discus s th e firs t

tw o topic s andRonwil l discus s th e late r topic

. Th e existin g fugitiv e emissio nregulation s establishe db y th e EPA fo r specifi c chemical s (eg. , Subpar t J

- Nationa l Emissio nStandardfo r Equipmen t

Leak s (Fugitiv e Emission s Source s o f Benzene ) cal l for

Lea k Detectio nandRepai r

(LDAR ) or

allo w th e owner

t o propos e a

n"alternativ e mean s of emissio nlimitation " (Paragrap h61.242(c))

. However , thi s genera l optio nt o us e "alternativ e mean s o f emissio nlimitation " require s extensiv e tes t

dat afor

eac hsit e propose db y a nowne r (Paragrap h61.244 ) an drequire s th e approva l o f th e Director

. Th e rigorou s requirement s for equivalenc e i nan dof

themselve s inhibi t

th e developmen t

of alternativ e contro l method s whic hcoul dprov e t o b e more effectiv e thancontro l option s suc ha s Leak

Detectio nandRepair

. Th e lac k of guidanc e fo

r thos e implementin g th e rule s o nwhat constitute s a

nequivalen t

metho dals o prevent s initiatio nof

request s for

"alternativ e mean s of

emissio n limitations"

. Th e protoco l give ninth e example , fo r implementin g a

n "alternativ e mean s o

f limitation" , i nSubpart J i s fa r to o restrictiv e and costly

. Th e regulation s shoul dprovid e some approve dalternativ e method s of complianc e t o encourage th e developmen t o f emissio ncontro l technology

. Th e suitability of

Lea k Detectio nan dRepai r

approache s i s als o questionabl e base donth e presen t Syntheti c Organi c Manufacturin g Industry (SOCMI ) emissio nfactor s an dequations

. The y are questionabl e becaus e of

th e hig hemissio nvalue s andth e conservativ e natur e o f th e EPA' s ris k

assessmen t

protocols

. Dat apresente db y th e EPA t o th e committee , andt o th e Nationa l Air Pollutio nContro l Technolog y Advisory Committe e (NAPCTAC ) las t summer , indicat e that

complianc e for

som e chemical s ma

y no t b e possibl e usin g LDARmethodologies

.

Equivalenc e Pag e 1 Jerry M

. Schro y

.^..

. -.

_. •^-....-• ~

### A genera l equivalenc e optio nshoul db e include di nth e regulator y

packag e considere db y thi s committee

. Th e methodolog y shoul db e writte n t o allo w innovativ e approache s t o limitin g equipmen t leak s an d innovativ e proof

s of thos e reductions

. Toda y w e wil l describ e afew option s whic hshoul db e considere dfo r inclusio ninsuc haregulatory package

. T o understan dho w industry deal s wit hfugitiv e emission s th e committe e shoul drealiz e that fugitiv e emission s impac t bot hth e workplac e an dth e environment beyon dth e workplace

. Th e tw o exposur e concern s are inseparable

. Thi s understandin g couple dwithth e realizatio n that concentration s of

specifi c chemical s inth e workplac e are fa r easie r t o detec t thanthos e beyon dth e plan t fenc e line s lead s t o abette r understandin g of

th e specifi c contro l approache s that canminimiz e emissions

. Specifically , th e applicatio nof acontro l practic e depend s onth e ability t o recogniz e that aproble mexist s andth e yardstic k that wil l b e use dt o measur e th e bes t contro l strategies

. Th e Agenc y applie dthi s approac hwheni t

se t th e initia l emissio ncriteri afo r viny l chlorid e becaus e analytica l detectio nlimit s prevente dus e of genera l environmenta l sample s t o demonstrat e compliance

. Th e rule s cal l for controllin g th e source s at level s measure dinth e operatin g uni t no t at th e fenc e line

. Subsequen t viny l chlorid e rule s calle dfo r leak detectio nandrepai r

bu t ther e i s insufficien t

dat aavailabl e t o determine , if th e chang e i nth e rule s resulte d inemissio nreduction

. Th e committe e shoul dals o recogniz e that th e fugitiv e emissio nLeak Detectio nandRepai r

programuse dby th e EPA wa s base dongeneral (VOC ) emissions , no t

th e specifi c toxi c chemical emissions

. Wit hth e presen t CleanAi r

Ac t proposal s th e focu s i s specifi c chemical s an dthei r healt h base dimpacts

. Th e dat areceive db y th e EPA fromindustria l testin g program s demonstrat e that th e SOCM I emissio nfactor s d o no t appl y to al l chemicals

. Th e genera l VO C fugitiv e rule s recognize dth e difference s betwee nth e Chemica l Industr y an drefinerie s whe nth e leak frequencie s wer e established

. Th e emissio nrat e dat aals o showe ddifference s bu t th e Agenc y chos e t o b e conservativ e an dkee p th e refinery emissio nfactors

. Recen t dat apresente dt o th e Agenc y o nbutadiene , ethylen e oxid e an d toluen e diisocyanat e emission s sho w that emission s rate s ar e belo w level s predicte dby th e SOCM I VO C emissio nfactor s an ddifference s i nprocesse s resul t i ndifference s i nemissions

. Similar dat awer e availabl e fo r acrylonitril e whenth e focu s of th e regulation s wer e VOC s bu t th e discussio nof

specifi c chemical s versu s VOC s wa s no t considere drelevant

. I t ha s bee nshow nthat

i t i s possibl e t o achiev e lowe r fugitiv e emissio n level s for som e chemical s base donquantificatio nof specifi c chemica l Equivalenc e Pag e 2 Jerry M

. Schro yP.3 4



### emissions , but

i t i s no t possibl e to sho w complianc e wit hany ris k

base d standar dusin g th e existin g SOCM I fugitiv e emissio nfactor s becaus e th e mas s emissio nestimate s are t o large

. Th e us e of workplac e criteri aare als o no t possibl e for

chemical s sucha s ethylen e o r propan e becaus e workplac e exposur e criteri aar e no t base do nhealthpractices

. Wit hth e mov e t o appl y th e Maximu mAchievabl e Contro l Technolog y (MACT ) followe db y a nassessmen t

o f th e ris k for residua l emission s ther e i s onl y on e issue , specifi c chemical healt himpacts

. T o understan dth e impact s i t

wil l b e necessary for

industry t o determin e th e ris k involve di n applyin g MAC T prio r

to expenditur e o

f any resources . I

f th e risk s are no t understoo da

t th e start

of th e programi t

woul db e possibl e to expen dlarg e quantitie s of

resource s an dthe nhav e t o curtai l operation s becaus e MAC T i s no t sufficien t

t o mee t th e ris k leve l dictate dby th e Agency' s presen t assessmen t

practices

. Th e committe e shoul dunderstan dthat whe n industry deal s wit

hspecifi c chemica l toxicit y issue s for bot hth e workplac e andgenera l environmen t ther e i s onl y on e se t

of contro l option s use dt o minimiz e equipmen t

leaks

. Installatio nof contro l technolog y i s necessary a s demonstrate db y presen t industry practices

. I t

i s no t possibl e t o mee t stric t exposur e criteri ainth e workplace , suc ha s th e viny l chlorid e workplac e exposur e standards , simpl y b y th e wor k practic e of

avoidin g contact

. Thi s i s als o tru e fo r amajorit

y o f othe r specifi c chemical s whic h mus t b e controlle dt o ver

y lo w levels

. Th e contro l of

fugitiv e emission s fo

r specifi c chemical s i s th e goal o f mos t industria l hygien e program s use di nindustry today

. Th e limitatio n of chemica l losse s t o th e workplac e andultimatel y t o th e environment i s on e of th e mos t

positiv e method s of

minimizin g th e exposur e of worker s an dthos e residin g i nth e genera l environmen t an dfo r chemical s whic h hav e very lo w workplac e exposur e limit s i t ma y b e th e onl y method

. Engineerin g control s for achievin g thi s leve l of exposur e contro l includ e workplac e monitorin g programs , analytica l equipmen t whic htake s frequen t sample s fromvariou s part s of a noperatio nuni t

an dus e of engineerin g control s suc ha s quarte r turnvalves , mechanicall y seale d pump s an dagitator s an dproces s samplin g equipmen t that collect s onl y th e quantity o

f sampl e needed

. Fo r

close dbuildings , th e continuou s monitorin g of

buildin g ventilatio nai r and/o r exhaus t stream s make s th e monitorin g of

mas s emissio nrate s easie r andprovid e acleare r

pictur e o

f th e exposur e impact s o nbot hth e worke r

an dgenera l environment

. I t als o make s th e ris k

assessment s easie r

t o quantify

. Th e committe e shoul dtry t o pictur e aproductio nuni t i naclose d buildin g withare amonitorin g device s operatin g ove r aperio dof

several Equivalenc e Pag e 3 Jerry M

. Schro yP.3 5



### years . Th e result s of

suc hmonitorin g effort s yiel daclear pictur e of

th e averag e emissio nrat e fromal l fugitiv e emissio ncomponent , plu s uncontrolle dreleas e point s no t covere db y EPA fugitiv e emissio n categories

. Th e same informatio ni s provide db y are amonitorin g system s inopenstructure s but

wit hles s precision

. Th e are amonitor s provid e a clear pictur e of

averag e condition s ando f period s whenther e i s a n unexpecte dreleas e fromacomponen t failure

. Thes e system s are no t use d inal l processe s becaus e of costs

. However , the y are use dextensivel y in processe s wher e worke r exposur e andlos s to th e genera l environmen t are aconcern . Industria l hygiene monitorin g i nmany chemica l plant s als o offer s th e same pictur e o f averag e an dunexpecte demission s levels

. Whenth e industria l hygien e exposur e limit s o r guideline s (eg. , TLVs ) are se t

the y are base donassessin g th e risk s o f exposure . Thes e standard s therefor e provid e abette r metho do

f limitin g exposur e t o th e worke r an dgenera l environmen t thand o MAC T criteria

. Infact ' th e limit s or guideline s fo

r th e workplac e ar e equivalen t t o level s that

woul db e set by toxicologist s for

genera l environmenta l exposure . Whenconsiderin g . alternativ e mean s of

limitin g emission s th e committe e shoul drecommen d to th e Agenc y that

fo r toxi c chemical s wit

hlo w workplac e exposur e data , complianc e wit

hworkplac e concentration s se t by th e Agenc y usin g th e industria l hygien e dat awoul dconstitut e complianc e wit hfugitiv e limit s establishe db y th e EPA

. W e recommen dth e establishmen t o f ase t o f workplac e concentratio nlimit s a s a nequivalen t

progra musin g industria l hygien e dat afromal l form s of

personne l an dare amonitorin g protocols

. Thi s approac hwil l offe

r astraigh t

forwardmetho do f

dealin g wit

hspecifi c chemical s an dprovid e industr y wit ha nincentiv e t o minimiz e emission s impactin g worker s an dth e genera l environment

. Th e us e of

workplac e industria l hygien e dat aset s for verificatio nof complianc e wit

hAgenc y establishe dcriteri aa s a napproac ht o definin g a n equivalen t

progra mwil l provide : 1 ) rapi drespons e becaus e industria l hygiene dat acollectio nprogram s are inplac e for man y chemical s no t regulate db y an y agency , 2 ) regulatio nof many chemical s unde r th e propose drevisio nt o th e CA A wit hminimu mAgenc y effor t an d3 ) utilizatio nof

dat acollecte dunde r

program s for

complianc e wit

heithe r compan y derive dlimit s o r OSHA establishe dlimit s woul deliminat e duplicat e dat acollectio nprogram s freein g more mone y fo r applicatio nt o contro l technolog y developmen t thu s encouragin g reduc e emissions

.
Equivalenc e Pag e 4 Jerry M

. Schro yP.3 6



### Meetin g Comment s Th e committe e member s indicate dawillingnes s t o conside r "bag a building " approache s t o complianc e testin g if th e methodolog y coul db e demonstrated

. Th e methodolog y i s include dinCMA Fugitiv e Emissio n Guidanc e Documents , Volume 1

. Th e committe e wa s les s willin g to deal wit hth e ope nstructur e are amonitorin g approache s althoug hthe y indicate dawillingnes s t o revie w specifi c proposal s whic har e supporte d by validatio ndata

.

Equivalenc e Pag e 5 Jerry M

. Schro yP.3 7



# ^TOCTftM T

UNIO N CARBID E CORPORATIO N P
. O
. BO X S361
. SOUT H CHARLESTON
. VV
. VA
. 2530 3

Januar y 10 , 198 9

EP A Negotiatin g Committe e fo r Contro l .o f Fugitiv e Emission s o f VO C fro m Equipmen t Leak s (Distributio nLis t Attached )

Subject : "Equivalent " Fugitiv e Emission s Contro l Program :

Conceptua l Basi s

S o fa r i nth e Regulator y Negotiatin g Committe e meetings , a numbe r o f option s fo r a

neffectiv e fugitiv e emission s regulatio nhav e bee noutline dan d discussed ; additiona l idea s wer e solicited , an dth e grou pappear s t o be heade d toward s a concensu s onth e standar dregulatin g format . I nth e interes t o f inducin g continue dfruitfu l discussion s on"equivalent " mechanism s fo r regulator y

contro l o f fugitiv e emission s sources , I a m attachin g a documen t entitle d" A

Tota l Qualit y

Contro l Approac ht o Fugitiv e Emission s Regulatio n an dControl, " whic hi s base do nth e interna l program bein g develope dwithi n Unio nCarbide . Thi s documen t outline s th e conceptua l basi s fo r an "equivalent " approac ht o a fugitiv e emission s regulatio nwhic hi s base do n tota l qualit y

principles . Thi s approac hi s componen t directed , an di s designe dt o focu s th e monitorin g requiremen t toward s component s wit hth e highes t potentia l t o leak , and t o minimiz e th e monitorin g neede dfo r component s whic har e show nt o have a low

potentia l t o leak . Th e approac hi s compatibl e wit hinterna l emissio nreductio nprogram s tha t ar e bein g develope d b y Unio nCarbid e an

dothe r chemica l companies . Yet , i t shoul dstil l assur e tha t fo r th e entir e affecte dindustries , th e regulator y constraint s (a s i n monitorin g requirements ) ar e i ndirec t proportio nt o th e fugitiv e emissio n level s o f thei r respectiv e operations . I woul dlik e fo r th e "equivalency " portio no f an

y new regulatio nt o b e flexibl e enoug ht o includ e alternat e approache s suc ha s thi s one .

I hop e t o b e abl e t o discus s thi s approac ha t th e Regulator y Negotiatio nCommitte e meetin g o nJanuar y

1$ , an dwil l invit e you r comment s a t tha t time . Very trul y yours ,

R . L . Berglun d Attachmen t 3377 mP.3 8

A TOTA L QUALIT YCONTRO L APPROAC H T O FUGITIV E EMISSION S REGULATIO N

ANDCONTRO L

R . L . Berglun d Unio nCarbid e Chemical s an dPlastic s Company

Inc .

Fo r Presentatio nBefor e Th e Environmenta l Protectio nAgenc y Negotiatin g Committe e fo r Contro l o f Fugitiv e Emission s o f VO C Fro m Equipmen t Leak s Januar y 16 , 199 0

Abstrac t
A

fugitiv e emission s regulator y approach , base dupo nTota l Qualit y Contro l (TQC ) principle s i s propose da s 'equivalent ' t o th e standar dLea k Detectio n& Repai r (LD&R ) program s presentl y unde r consideratio nb y th e Fugitiv e Emission s Regulator y Negotiatio nCommittee . Inthi s program , an initia l screenin g o f al l affecte dcomponent s i na proces s uni t (whic hma y represen t severa l quarter s fo r ne w units ) wil l b

e use dt o classif y

th e component s int o two groups . Thos e whic hhav e screenin g value s les s tha nsome deminimu s valu e (sa

y 5 0 ppm) , wil l be classifie da s 'Acceptable, ' an dwil l be monitore dinfutur e quarter s a t som e greatl y

reduce dschedul e (sa y 5% pe r quarter ) t o assur e tha t th e populatio nha s no t changed . Thos e component s whic hhav e screenin g value s abov e th e deminimu s valu e (a s wel l a s specia l proble m components , suc ha s component s wit hdynami c seals ) wil l b e classifie d a s Questionabl e an

dwil l b

e monitore ddurin g al l subsequen t quarter s unti l thes e component s ar e corrected , repaired , o r replaced . Th e expectatio ni s tha t g a th e Questionabl e component s ar e eithe r indicatin g tha t the y hav e some inheren t defec t o r ar e designe dt o allo w som e leakag e inorde r t o operat e properly , whic hgive s them a greate r potentia l t o become "leakers, " whil e th e Acceptabl e component s hav e n o suc happaren t defect , an d(provide dthe system i s no t upse t o r th e component s d o no t wea r out) , therefore , shoul dcontinu e t o functio nfo r a lengthy time withou t becomin g "leakers. " B y focusin g attentio n throug hth e monitorin g activit y toward s th e component s whic hhav e th e greates t potentia l t o leak , rathe r tha ndilutin g thi s monitorin g amon g al l th e component s i nth e proces s uni t regardles s o f thei r lea kpotential , th e operatin g staf f wil l become mor e awar e o f th e potentiall y leakin g sources . Ultimately , historica l trend s o nthes e component s ca nbe studie dan dlong-term solution s developed . I naddition , tigh t unit s wil l b e monitorin g a t a greatl y reduce dschedule , andal l unit s wil l hav e a nincentiv e t o correc t defectiv e component s inth e Questionabl e categor y (t o remov e the

m fro m th e regula r monitorin g list) , eve ni f they ar e no t "Leakers . Th e program i s schematicall y represente di nFigur e 4 an ddevelope do

nth e nex t page .P.3 9

Introductio n

Durin g 198 8 an

d1989 , extensiv e fugitiv e emissio nstudie s wer e conducte dinthe acrolein , butadien e (BD) , ethylen e oxid e (EO ) an dphosgen e productio nindustries (1,2) . I nthes e studies , ove r 93,00 0 valves , flanges , pump s an dothe r piece s o f equipmen t wer e monitored . Th e screenin g result s o f thes e studie s ar e summarize di nFigur e 1 .

Figur e 1 present s th e percentag e o f "Leakers " (component s wit h screenin g value s abov e i0,00 0 ppm ) fo r fou r critica l componen t type s a s observe dinthese industrywid e studies . Clearly , significan t difference s betwee nth e fou r industry group s an

dth e origina l EPA

screenin g result s ca nb e observe dfro

m thi s comparison . Yet , th e critica l questio ntha t arose upo n examinin g these result s was :

Wha t i s th e Differenc e tha t Make s th e Difference " betwee nthes e industries .

T o evaluat e th e differen t "practices " use db y th e fou r industrie s whic hmigh t explai nthes e trends , a surve y wa s prepare dan

ddistribute dt o al l th e participants . Thi s survey wa s focuse do

nth e thre e fundamenta l aspect s o f fugitiv e emission s control : (1 ) program s fo r monitorin g fo r a leak , (2 ) practice s fo r maintainin g o r repairin g th e leak , onc e i t i s detected , an d (3 ) procedure s fo r preventin g th e occurrenc e o f a lea kthroug hspecia l desig n standards . Base dupo nth e aggregatio no f th e qualitativ e response s t o these surve y results , few

generalization s regardin g th e design , monitoring , an d maintenanc e practice s i nth e fou r industrie s coul db e developed . However , severa l apparen t strategi c similaritie s i nth e operatin g philosophie s o f th e plant s wit hth e lowes t emission s (th e "Benchmark " plant s o r industries ) migh t be established . Basically , inth e Benchmar koperations , the uni t staf f ar e traine dt o b e sensitiv e t o leaks , an dhav e reache da poin t where they d o no t tolerat e leaks . A combinatio no f rapi ddetectio no f leakage , continue d maintenanc e o f components , whe ncombine dwit hfocuse ddesig nchanges , ha s allowe dlow

leakag e t o be achieve d(4) . Inconsiderin g thes e operations , severa l critica l caveat s nee dt o b e mad e wit hrespec t t o th e regulator y significanc e o f th e results .
o Today' s performanc e i nth e Benchmar kunit s didn' t jus t happen ; low

fugitiv e emission s ar e th e cumulativ e result s o f year s o f effort .
o Thi s performanc e wa s achieve ddespit e th e fac t tha t th e Benchmar kunit s o r component s wer e ofte nno t unde r a require dfugitiv e emission s regulator y contro l program .
o Lo w fugitiv e emission s i s accomplishe dprimaril y throug h th e us e o f conventiona l technology , rathe r tha nnew technolog y

(bellow s valves , etc.) .
o Ne w technolog y

i s selectivel y

use dwhere i t make s goo d engineerin g sense . Bellow s valve s andsealles s pumps , i f misused , ma y

actuall y

presen t bigge r problem s than the y solve .Overall , th e on e theme tha t pervade s th e operatio no f thes e Benchmar k

industrie s i s that , whil e advance dtechnolog y ca nan dshoul dbe used , th e achievemen t o f low

level s o f fugitiv e emission s i s a direc t resul t o f th e awarenes s t o leak s develope dwithi nth e operation s an dengineerin g staffs . Th e effectiv e fugitiv e emission s contro l program woul dbegi nwhe nth e operation s staf f recognize s it s functio ni nreducin g fugitiv e emissions , it s rol e i nfindin g th e leaks , repairin g the leaks , andrecordin g th e results . Th e program

become s matur e whe nth e dat a i s analyze dan duse dt o modif y

th e desig no f th e uni t an dth e selectio no f component s whic hallo w operatio na t lowe r fugitiv e emission s levels .

Th e key tha t unlock s th e program i s th e inspectio no r monitorin g activity . I

nanoperatio nwhic hmus t rel y o ncomponen t maintenanc e t o achiev e lo w fugitiv e emission s levels , a successfu l monitorin g o r inspectio nprogram wil l b e neede dt o direc t th e maintenanc e activity , an dultimatel y

t o focu s th e desig nchanges . I

naddition , th e monitorin g activit y shoul db e designe dt o enhanc e th e awarenes s o f th e operation s staf f t o fugitiv e emission s fro m equipmen t leaks . Therefore , t o be effective , th e monitorin g program mus t concentrat e o nth e component s posin g th e greates t potentia l t o leak , rathe r tha nbein g disperse damon g al l th e component s inth e proces s unit . Similarly , th e maintenanc e activit y shoul db e directe dt o thos e leak s posin g th e greates t severity . T o develo pa Tota l Qualit y Contro l (TQC ) approac ht o a fugitiv e emission s regulator y

program whic hstrive s fo r continuou s improvemen t (5) , i t wil l be importan t t o understan dth e rol e o f monitorin g o r inspection , an dth e genera l concep t o f equipmen t reliabilit y a s the y

relat e t o fugitiv e emissions .
Monitorin g Functio n

I t i s generall y

acknowledge dtha t inspection s ar e inherentl y wasteful . Preferre dwoul dbe a program t o desig nou t the leakag e defect , o r assur e tha t i t i s no t introduce dint o th e proces s throug hfoo l proofin g o f th e maintenanc e an

dinstallatio noperations . However , accordin g t o Shige o Shing o (6 ) wh o introduce dth e "Pok a Yoke " o r "foolproofing " concept s fo r qualit y program s inOperation s units , sourc e inspection s ar e a necessar y aspec t o f a program strivin g fo r a zer o defec t operation . Shing o ha s propose dthre e differen t type s o f inspections , dependin g upo nthei r purpose . Thes e are :

o Judgemen t Inspection s - - t o discove r defect s Focu s o nquantifyin g defect s
o Informativ e Inspection s - - tha t reduc e defect s Focu s o nclassifyin g andrepairin g defect s
o Sourc e Inspection s - - tha t eliminat e defect s Focu s o ndeterminin g caus e I f inspection s onl y

occu r a s par t o f a regulator y audit , they

wil l generall y

fi t th e firs t category : t o discove r th e defect s (leakage ) fro m th e unit . Suc ha ninspectio nmigh t b e use dt o generat e a SAR A 31 3 estimat e fo r th e unit , o r chec ki f th e component s inth e uni t hav e bee nappropriatel y classified . Th e purpos e o f th e Judgemen t Inspectio ni s simpl y t o findth eP.4 1

leakin g component . B y comparison , th e purpos e o f th e Informativ e Inspectio n i s t o als o transmi t informatio nabou t th e genera l distributio no f defect s and leak s i nth e operatio nbac kt o th e operatio nstaf f whic hthe ntake s actio nt o eliminat e th e leaks . I f record s ar e maintained , trend s studie s an dimprove ment s initiate dwhic hresul t inthe eliminatio no f leakage , the nth e progra m woul dfi t th e fina l category . A Sourc e inspectio nwoul db e describe da s an inspectio nmetho dwhic hrathe r tha nstimulatin g feedbac kan dactio ni n respons e t o leak s i s base donth e ide a o f discoverin g error s or condition s tha t giv e ris e t o leaks , and , b y performin g feedbac kan dactio na t th e defec t stage , kee pthos e defect s fro m turnin g int o leaks , or allo w them t o be quickl y detected . Th e key

t o a successfu l program i s a polic y

tha t reside s inth e absolut e nee dt o contro l th e operatio nsuc htha t onc e th e potentia l fo r a lea k i s detected , i t i s prevente dfro m turnin g int o a sever e occurrence . Th e rol e tha t thes e differen t monitorin g function s ca npla y i na regulator y

program

fo r th e contro l o f fugitiv e emission s ca nb e bette r understoo dfro

m a genera l revie w

o f th e concep t o f equipmen t reliability .
Componen t Reliabilit y

Th e failur e rat e fo r mos t component s follow s th e curv e show ni n Figur e 2 whic hi s calle dthe lif e characteristi c curve , th e failur e rat e curve , o r mor e commonl y th e "bathtub " curv e (7) . Her e ther e ar e thre e type s o f failures , calle db y some , qualit y

failures , stress-relate dfailures , and wearou t failures . Th e su m tota l o f thes e failure s give s th e overal l failur e rat e fo r a populatio no f component s (percentag e o f component s failin g pe r uni t time) . Th e "bathtub " curv e wil l usuall y consis t o f thre e distinc t regions , generall y

dominate db

y on e o f thes e failur e mechanisms . Understandin g eac ho f thes e region s i s importan t fo r developin g aneffectiv e contro l program .
Decreasin g Failur e Rat e Regio n(Qualit y Failures ) Regio nI i s typicall y th e portio nof th e curv e tha t ha s th e larges t percen t contributio nfro m manufacturin g unreliability . Th e regio ni s als o calle dth e decreasin g failur e rat e region , o r th e "break-in " region . Thi s regio no f th e curv e i s wher e mos t productio nandwarrant y failure s occur , and i s ofte ninfluence db y failure s cause db

y mishandlin g or imprope r installa tion . Some o f th e cause s o f failure s durin g th e break-i nperio dar e summarize di nTabl e 1 .

By inspectio ni t ca nbee nsee ntha t a produc t wil l experienc e break-i nfailure s because :

1 . Ther e ar e no well-define dmanufacturin g processe s and installatio nprocedure s tha t wil l assur e low fugitiv e emissions . 2 . Ther e i s no t a system i nplac e t o enforc e conformanc e t o procedure s tha t do exist . 3 . Ther e i s no t a proces s t o detec t an deliminat e th e cause s o f thes e failures .P.4 2

I n general , thi s break-i n portio n o f th e curv e represent s th e earl y failur e o f substandar d equipment , whic h ma yb e du e t o laten t materia l defects , poo r assembl ymethods , an d poo r qualit ycontrol

. Often , a n inspectio n progra m o f component s afte r delivery , and a shor t perio d o f in-plan t lea k testin g ca n b e use d t o eliminat e thes e earl yfailure s fro mth e population

. Similarly , screenin g o f th e entir e populatio n o f component s fo r leakag e woul d b e mos t usefu l whe n th e populatio n i s operatin g i n th e Regio n I portio n o f th e bathtu b curv e [firs t fe wquarter s fo r a ne wuni t (i.e. , NSPS) , o r afte r instal1atio n o f a ne wcomponent]

.

Constan t Failur e Rat e Regio n (Usefu l Lif e Region )

Th e fla t middl e portio n o f th e failur e rat e curv e represent s th e desig n failur e rat e fo r th e specifi c produc t a s presen t durin g it s usefu l lif e i n th e operatin g unit

. Thi s regio n ha s als o bee n calle d th e Constan t Failur e Rat e Regio n whic h implie s tha t durin g thi s useful-lif e portion , representin g th e norma l operatin g period, th e failur e rat e i s relativel yconstant
. But , i t migh t b e decrease d byredesig n o r restrictin g usage . I t ha s bee n suggeste d tha t Regio n I I wil l includ e nonrando m a s wel l a s rando mfailures

. On e exampl e o f a manufacturing-cause d nonrando mfailur e deal s wit h us e o f material s whic h wil l wea r wit h use , i.e. , whos e critica l dimension s d o no t confor mt o th e necessar yspecification

. Unde r som e conditions , thes e coul d b e a valv e stem , o r a bellow s seal

. Als o include d migh t b e th e recurren t failur e o f a repaire d leak

. Tabl e 2 represent s som e o f th e cause s o f unreliabilit yfoun d i n Regio n II
. A s ca n b e noted , th e relativ e contributio n o f problem s whic h are th e responsibilit yo f th e desig n proces s fa r outweigh t thos e whic h ar e manufacturin g o r installatio n controlled

. Ake yassumptio n tha t ca n b e use d i n a fugitiv e emission s contro l progra m i s tha t b

yth e tim e th e component s hav e bee n i n operatio n lon g enoug h t o b e withi n it s "usefu l life " period, thos e tha t hav e an

inheren t potentia l fo r ultimatel ybecomin g a leake r wil l alread yb e givin g som e indicatio n o f leakag e (i.e. , abov e som e deminimu s screenin g value)

.
Increasin g Failur e Rat e Regio n (Wearou t Failures )

Finally , a s product s age , the yreac h a wearou t phas e characterize d by a n increasin g failur e rat e (Regio n III)
. Th e Increasing Failur e Rat e o r "Wearout " regio n i s cause d b yfailur e mechanism s whic h slowl ychang e th e componen t i n a n irreversibl e way , suc h a s corrosion , minera l deposits , friction , fatigue , o r chemica l reaction

. Generally , material s selectio n an d toleranc e o f th e desig n fo r th e us e determin e th e usefu l lif e o f th e component
. Yet , fro ma mor e pragmati c viewpoint , i f manufacturin g defect s wer e present , the ywil l sho wup befor e th e en d o f desig n lif e i s reached

.

Tabl e 3 illustrate s som e o f th e cause s o f failure s durin g th e wearou t phase

. Again , manyo f th e categorie s ar e stil l a functio n o f th e design

. Thi s hold s tru e whethe r on e i s talkin g abou t systems , equipment , components , o r devices

. Ake yter mfirs t introduce d i n explainin g th e Regio n II I wearou t failure s (althoug h implie d i n Regio n I I patter n failures ) i s preventiv e maintenance

. Preventiv e maintenanc e di d no t appea r t o pla ya rol e i n Regio n IP.4 3

o r Regio nI I failures , bu t woul dultimatel y affec t th e Wearou t Failures . I f a nimpendin g failur e wer e properl y diagnosed , th e component , o r part s o f th e componen t woul dhav e bee nreplace dprio r t o fina l failure .
Approac ht o Conceptua l Regulator y Program Usin g qualit y

an dreliabilit y

principles , th e fundamenta l basi s o f thi s fugitiv e emission s contro l program lie s inthe assumptio ntha t a componen t whic hha s bee ni noperatio nthroug ha break-i nperiod , an dha s n o indicatio no f a defec t (belo w th e deminimu s screenin g value ) wil l be Acceptable , andshoul dhav e a lo w probabilit y

o f leakin g durin g th e nea r future . Whereas , a componen t whic hha s som e indicatio no f leakag e o r defec t (screenin g valu e abov e thi s deminimu s value ) wil l be Questionable , an d shoul dhave a highe r probabilit y o f leakin g a t greate r level s inth e future . Monitorin g o f th e entir e populatio nfo r defect s andleak s woul db e mos t effectiv e whe nth e populatio no f component s i s presen t inthe earl y "break-in " perio do f operation , o r th e late r "wear-out " period . Durin g o r followin g th e initia l break-i nperio do f monitoring , i t woul dbe appropriat e t o continu e t o monito r th e remainin g questionabl e component s ona regula r schedule , an dt o monito r the acceptabl e component s a t some reduce d"maintenance " level . A uni t wit ha questionabl e componen t wil l have th e incentiv e t o repai r o r replac e i t s o a s t o remov e i t fro m th e regula r monitorin g list . Continuou s improvemen t progres s ca nbe readil y observe dfro

m th e numbe r o f "leakers " inth e unit , an d b y ho w many component s transfe r fro m th e questionabl e t o acceptabl e list . A neffectiv e fugitiv e emission s detectio nandrepai r program ca nb e develope dfro

m a correc t utilizatio no f th e thre e type s o f inspection , an da n adequat e understandin g o f th e life-cycl e characteristi c curve . Al l thre e o f th e inspectio ntype s ca nbe include dinth e program (se e Figur e 3) . A

n initia l "informative " screenin g o f th e component s i nth e uni t ca nbe use dt o divid e th e component s int o th e tw o categories : thos e whic har e Acceptable , wit hscreenin g value s below th e deminimu s (e.g. , < 5 0 ppm) , an

dthos e whic h ar e Questionable , wit hscreenin g value s abov e thi s deminimu m (e.g.,>5 0 ppm) . A long-term

program

o f continuou s improvemen t wil l focu s th e Monitoring/Repai r actio ntoward s th e questionabl e component s dependin g upo n thei r screenin g value . Al l questionabl e component s wil l be "tagged, " andth e "sources " monitore ddurin g al l futur e monitorin g cycle s (quarterly ) a s lon g a s th e screenin g valu e remain s questionable . Thes e questionabl e component s woul dhav e th e greates t likelihoo do f leakin g andshoul dprovid e the bul ko f th e Unacceptabl e component s o r "leakers " durin g eac hscreenin g cycle . I f the amoun t o f "Leaking " o r Unacceptabl e component s detecte ddurin g th e "Sourc e Inspection " exceed s th e tolerate dlimit , the nth e screenin g cycl e fo r th e "Sourc e Inspection " wil l b e reduce dfro m (fro m quarterl y

t o monthly) . In addition , insight s develope dfro m th e "sourc e inspection " focuse donthes e questionabl e component s ma y allo w th e unit s t o fin

dou t additiona l informatio n o nth e defect s andcause s o f eventua l leakag e a s wel l a s maintai nanawarenes s o f thes e potentia l leakin g source s i nth e operation s staff .

Acceptabl e component s wil l als o b e monitored , bu t a t some greatl y reduce dschedule , a s ina judgemen t inspection . Th e schedul e an dselectio n o f acceptabl e component s t o b e monitore dwil l be statisticall y determine d (perhap s 5%

pe r quarter) , suc htha t an y emergin g trend s wil l be spotte d(e.g. , a whol e populatio no f valve s o na certai nstream tha t begi nt o wea r out) .P.4 4

Component s wil l b e reclassifie dbase dupo nthei r screenin g value s i nthi s inspectio nan

dth e Unacceptabl e component s repaired . I f the amoun t o f leakin g component s detecte ddurin g th e judgemen t inspectio nexceed s th e tolerate dlimit , th e screenin g cycl e fo r judgemen t inspectio nwil l be reduce d (fro m quarterl y

t o monthly) . I f thre e suc hexceedance s occur , the nth e entir e populatio no f acceptabl e component s shoul db e rescreened , an dth e populatio n reclassified .

Overall , th e informativ e screenin g woul db e use dt o initiall y classif y th e component s inth e unit , the sourc e monitorin g woul dbe focuse d o nth e questionabl e component s t o findou t additiona l informatio no nth e defect s an

dcause s o f eventua l leakage , an dth e judgemen t monitorin g woul d b e directe dt o th e acceptabl e component s t o determin e i f th e populatio n distributio nchange s throug hsom e undetecte ddefect , a proces s upset , o r a s some o f th e component s begi nt o wea r out .

I f andwhe nth e lea kdefinitio nchange s fro m th e presen t 10,00 0 ppm , th e definitio no f a nUnacceptabl e componen t ca nchang e t o correspon dt o th e new lea kdefinition . I naddition , th e informatio ngathere dinth e Sourc e Inspectio nmonitorin g shoul dallow a rapi dtransitio nt o th e ne w lowe r lea k definition .

CONCLUSIO N

I nconclusion , thi s Tota l Qualit y Contro l Approac hi s being presente d a s a n"Equivilent " alternativ e t o th e existin g fugitiv e emission s regulatio n an dth e othe r approache s presentl y bein g discusse db

y thi s Regulator y Negotiatio nCommittee . Whil e th e monitorin g requiremen t i nthi s program coul d b e greatl y

reduce dove r tha t i nsom e o f th e presen t proposals , suc hmonitorin g wil l b e reduce donl y

t o the exten t tha t th e uni t i s show nt o have a decreasin g numbe r o f potentiall y leakin g components . Th e monitorin g tha t i s continue d wil l b e focuse doncomponent s wit hth e greates t potentia l t o leak , bu t als o include s a statistica l samplin g o f othe r components . Th e result s o f th e focuse dmonitorin g ca nb e use db y th e proces s uni t operatin g staf f t o striv e fo r continuou s reduction s i nfugitiv e emissio nlevels , andb y regulator y agencie s t o audi t emission s level s fro m a facility . W e recommendtha t th e "equiviiency " portio no f th e propose dregulatio nbe mad e flexibl e enoug ht o includ e alternat e approache s suc ha s thi s one .P.4 5

Reference s 1 . Berglund , R . L. , J . A . Mullins , L . S . Parrett , R . R . Romano , andJ . L . Randail , "Equipmen t Leaks : Result s o f Industrywid e Studie s o f 1, 3 Butadiene , Ethylen e Oxide , an dPhosgen e Productio nFacilities, " pape r #89-120.4 , presente da t th e 82n dAnnua l Meetin g o f th e Ai r andWast e Managemen t Association , Jun e 30 , 1989 , 2 . Berglund , R . L. , D . A . Wood , andT . J . covin , "Fugitiv e Emission s fro m th e Acrolei nProductio nIndustry, " pape r presente da t th e AWM A Internationa l Specialt y

Conference : SAR

A Titl e III , Sectio n313 , Industr y Experienc e i n Estimatin g Chemica l Releases , Apri l 6 , 1989 . 3 . Radia nCorporation , "Fugitiv e Emission s fro m th e Phosgen e Productio n Industry : a Fiel dStudy, " Fina l Report , Jun e 1989 . 4 . Berglund , R . L. , J . A . Mullins , L . S . Parrett , andR . R . Romano , "Fugitiv e Emission s fro

m Equipmen t Leaks : Result s o f Industrywid e Studie s i nth e Butadiene , Ethylen e Oxide , andPhosgen e Productio nIndustries. " Pape r presente da t th e 198 9 Summe r Nationa l AICh E meeting , Augus t 21 , 1989 . 5 . Feigenbaum , A . V . Tota l Qualit y Control , McGra w

Hill , Ne w

York , 1983 . 6 . Shigeo , Shingo , Zer o Qualit y Control : Sourc e Inspectio nandth e Poka-yok e System , Productivit y

Press , Cambridge , MA , 198TT . 7 . Elkins , D . "Reliabilit y i nProduction, " Chapte r 7 i nHandboo ko f Reliabilit y

Engineerin g andManagement , ed . W . G . Ireso nandC . F . Coombs , Jr. , McGra w

Hill , Inc. , flew

York , 1988 .

3414m10. 0

8. 0

6. 0 Averag e Lea k Rat e % 4. 0 EP AStud y(2 4 Plants ) Butadien e Industr y(1 3 Plants ) Ethylen e Oxid e Industr y(1 2 Plants ) Acrolei n Industr y( 2 Plants ) Phosgen e Industr y(1 3 Plants ) Flange s Purftp s Valv© 9 Valve s (Liqui d Service ) (Ga s Service )

Figur e 1 : ACompariso n o f Lea k Frequencie s fo rCritica l Component s I n Acrolein , Butadiene , Ethylen e Oxid e an d Phosgen e industrie s

Relativ e t o th e Original ! EP AStudie sP.4 7

-NEW EQUIPMEN T LEAKAG E 

# t

z C O < U J Q C O

BREAK-I N PERIO D NORMA L OPERATIN G PERIO D WEAROU T PERIO D

TIM E



### FIGUR E 2 : Typica l Lif e Characteristi c Curve Fo r a Populatio n o

fComponent s (Th e 'Bathtub ' Curve )P.4 8

"JUDGEMEN T INSPECTION "
ACCEPTABL E SCREE N AL L COMPONENT S

CLASSIF Y "INFORMATIV E INSPECTION "

"SOURC E INSPECTION "
QUESTIONABL E

STATISTICA L SCREENIN G 100 % SCREENIN G

- Complianc e

- Rando m Leak s

- Upse t

- Wearou t Proble m Area s Trend s Cause s Indicator s



### Figur e 3 : Thre e Type s o f "Inspection"Activitie s I n A Fugitive Emission s Regulatio n An d Contro l Program
.

### FIIGUR E 4 : ATota l Qualit yApproac h T o Fugitiv e Emission s Regulatio n And Contro l

"Judgement " Inspectio n



### U A 

### >X A 

### %4 = = » Initia l Lea k Detectio n & Repai r Audit : Obtai n Screenin g Dat a 'Informative " Inspectio n

Regulator y Progra m ,«*=> > Develo p Emissio n Estimat e * ^ Befor e & Afte r Repair s

USE.ffllfl||ilifM||ulf||§ | EPA : Curve s o r Factor s r ,v * M industry.:SC^^e^"or. ; -Pactor s

Interna l Industr y Progra m

* » U A > X A % < = 3 Time s Rescree n 5 % Of Component s 

# ~^m~ "Source " Inspectio n



### =£ > Rescree n 5 % O f Component s Monthl y 

# 3~r ^
Rescree n Al l Acceptabl e Component s 

# "

F
•ifc-

• * > Questionabl e

>50pp m Unacceptabl e **10,000pp m REPAI R

Rescree n 100 % OfH > W U Q >X Q % Component s QUARTERL Y MONITORIN G

MONTHL Y MONITORIN GP.5 0

Tabl e 1 : Break-I n(Regio nI ) Failur e Cause s

1 . Inadequat e tes t specifications—component s o r engineerin g 2 . Inadequat e Qualit y contro l 3 . Inadequat e manufacturin g processe s o r tooling—unstabl e 4 . Inadequat e Material s 5 . Imprope r handlin g .6 . Margina l component s 7 . Overstresse dcomponent s 8 . Imprope r setupo r installation ' 9 . Imprope r us e procedure s 10 . Inadequat e understandin g o f installatio nenvironmen t 11 . Inadequat e trainin g 12 . Incomplet e fina l tes t 13 . Subsystem

interactio n

Tabl e 2 'Usefu l Life ' (Regio nII ) Failure s
1

. Insufficien t desig n margin s 2

. Misapp l ication--overstres s 3 . Us e inwron g environmen t 4 . Inadequat e desig nmargin s 5 . Caus e 'unknown ' factor s 6 . Predictabl e failur e level s fo r desig n 7 . Inheren t manufacturin g leakag e rate—samplin g errors .

Tabl e 3 : Wearou t {Regio nIII ) Failure s

1 . Scratchin g 2 . Materia l wear , corrosion , frictio n 3 . Agin g 4 . Misalignmen t 5 . Loos e hardwar e 6 . Inadequat e o r imprope r preventiv e maintenanc e 7 . Assembl y

interferenc e fit s 8 . Incipien t stresse s

NOTE : Th e abov e tables , an d man y o f the concept s include dinth e reliabilit y sectio no f thi s analysis , hav e bee nadapte dfro m the Handboo ko f Reliabilit y

Engineerin g an

d Management , edite db y W . Gran t Ireson , an

d Clyd e F . Coombs , Jr. , 1988 .
3375 mP.5 1



# ATTACHMEN T7



# ^^f=LsnfT- ClUR£e7\JT ~


# Monitoring Pla

n Evaluation

D . Berengu

t J . L . Hess T . A . Kittlema

n Januar y 17,199 0P.5 2



# Monitoring Plans
Quarterly Base Monthl y Base

Reference : Minutes of

December6- 7 Meeting , Januar y 2,199 0P.5 3 

# Quarterly Base Plan (Q )

1 Ins j Ba d >ecti o

ctio n 

# Monthly

Inspectio n 

# t 1 Ba d Inspection 1 

# Quarterly Inspectio n

n 2 Consecutive Good Inspection s

2 Consecutive Qsmsi Inspections


# Semianuua

l Inspectio n

) 

### 2 Consecutive Goo d Inspections


# Annua l msp e CUUI 1P.5 4



# Good Performance

GOO D Les s tha

n orequa l the allowable percent leakers
EXCELLENT Les s tha n orequa l one-half the allowabl e percentleakers
BA D Greatertha n the allowable percentleaker

sP.5 5 

# Monthl y Base Pla

n (M)

1 Ba d Inspection 2 Consecutive

Goo d Inspections

1 Ba d Inspection

1 Ba d Inspection l£goj L

bu tnot 

## Excellen t Inspection 

# Quarterly

Inspectio n

2 Consecutive Gj2Qd . Inspections 

# Semiannua

l Inspectio n 1 2 Consecutive ExcellentInspections 

# Annua l Inspectio n 2 Consecutive

ExcellentInspectionsP.5 6



# Th e likelihoo d o

f bein g ata monitorin g frequency ca n b e determined forbot

h plans .

Thi s likelihoo d wil l b e differentfo rdifferentplants dependin g on ho w aplan t performs overtime .

# In othe rwords , characteristics depend

o n th e chanc e o

f aplan texhibitin g good performanc

e overtime . W e looke d attwo characteristic s of monitoring plans

• long ru n chanc e o f falling underagiven inspection frequenc y (eg . monthly , quarterly , etc. )

• Average numbero

f inspections peryearP.5 8 

# Interpretation o

f a"Plan tExhibiting Goo d Performanc

e OverTime "
Tim e PercentLeaker s

1.7%

2.1 %

0.1 %

2.3 %P.5 9 

# Monitoring Pla

n Characteristics

Chance of

Bein g at thi s Monitorin g Frequency : Chance of

: Semi 

# . Pla n £oju l ExcellentMonthl y Quarterly Annua

l Annua

l 

# M 0.5 0 0.25 0.75 0.1 9 0.0 5 0.0 2 Q 0.5 0 —

0.6 9 0.2 3 0.0 6 0.0 2

M 0.7 0 0.3 5 0.5 1 0.2 5 0.1 8 0.0 6 Q 0.7 0 —

0.3 5 0.3 3 0.1 6 0.1 6

M 0.9 0 0.4 5 0.1 9 0.1 5 0.4 9 0.1 6 Q 0.9 0 —0.04 0.1 8 0.1 5 0.6 3

M 0.9 9 0.5 0 0.02 0.02 0.7 2 0.24 M 0.9 9 0.9 8 0.0 2 0.0 2 0.0 2 0.9 4 Q 0.9 9 —0.0 0 0.0 2 0.0 2 0.9 6P.6 0 

# Monitoring Pla

n Characteristics

Chance of

: Average Numbe rof Plan Goo d Excellen

tInspection s Pe rYea r M 0.5 0 0.25 6. 7 Q 0.5 0 —6. 1

M Q

M Q

M M 0.7 0 0.7 0

0.9 0 0.9 0

0.9 9 0.9 9 0.3 5

. . .



# 0.4 5

• *•* •



# 0.5 0 0.9 8 3. 9

2. 9

2. 2 1.3

1.6 1.0 Q 0.9 9 - 1. 0P.6 1



# Conclusion s

Monthly Base Pla

n an d Quarterly Bas e Pla

n ar e notdifferen

tforthos e plant

s leas tabl e t

o mee tthe good performanc

e criteri a
Forplant s able to easily mee

tthe good performanc

e criteria , the Monthl

y Bas e Pla n ca n require amuc

h highermonitoring burde n (1. 5 times ) tha

n the Quarterly Bas e Pla n
Ther e i s agreate rincentive forimproving performanc

e wit h the Quarterly Base Pla

n

## \) t 

## I <ff f 

# MThCUMEMTB *'

UNITE D STATE S ENVIRONMENTA

L PROTECTION AGENC Y Offic e of Ai i Qualit

y Planning an

d Standards Researc h Triangle Park

, Nort h Carolin a2771 1

Decembe r

22 , 198 9

Harve l M

. Rogers , Jr

. Ai r Pollutio nContro l Distric t of Jefferso nCo

. Suit e 30 0 91 4 Eas t Broadwa y Louisville , K Y 4020 4
Dea r Mr

. Rogers : Enclose dpleas e fin dth e analysi s o f th e ethylen e oxid e an dbutadien e screen in g dat ayo u requeste da t th e Equipmen t

Leak Regulator y Negotiation s meetin g o nDecembe r

6-7 , 1989

. Thi s analysi s look s a t th e percen t

o f screenin g value s b y componen t typ e whic har e greate r tha nlea k

definition s a t 10 , 25 , 50 , 75 , 100 , 250 , 500 , 75 0 an d100 0 ppm . Th e analysi s use s th e screenin g valu e dat afor th e twelv e butadien e an dte nethylen e oxid e plant s transmitte dpreviously

. Colum ntitle s ma y nee dalittl e explanation

. Th e combinatio no f "study " an d"epa_no " represent s aplan t (o r unit ) identifier

. Wher e liste d"phase " equal s 1 fo r

equipmen t

i nga s servic e an d2 fo r liqui dservice

. Phas e i s no t liste dfo r flange s an dpumps . Th e las t colum ni s th e percen t leaker s a t differen t lea k definitions , suc htha t

"pleak_10 " i s percent'leaker s a t 1 0 pp m an d"pleak-500 " i s percen t leaker s a t

50 0 ppm . Withi neac hequipmen t typ e an dlea k

definitio ncategory , th e plant s ar e liste di norde r o f ascendin g percen t leakers

. I a mno t currentl y planmn g t o creat e ba r chart s o f

thes e dat afo r

th e nex t meeting

. Pleas e le t

m e kno w i f

yo u feel tha t

ba r chart s ar e necessary . Sincerely , Rober t Pahel-Short , MD-1 3 Standard s Developmen t Branc h Emission s Standard s Divisio n_R£3

_

Enclosure :

cc : Bo b Aja x Alfre dW

. Bicku m Gu s Vo nBodunge n Bruc e V

. Bower s Lind aCurra n Debora hDalto n Davi dDonige r Davi dDun n Thoma s A

. Kittlema n Kare nFidle r Anupo mGangul i Phili p J

. Harte r

(w/ o enclosure ) Alle nHershkowit z Jac k Kac e Bo b Majewsk i Le s Montgomer ystud y

e o e o e o b d b d b d e o e o e o b d e o e o b d b d b d b d e o b d b d e o b d b d stud y e o e o e o e o e o e o e o b d b d e o b d b d e o b d b d b d b d b d b d e o b d b d epa_n o equi p

7 valve s 5 valve s 1 0 valve s 2 valve s 9 valve s 3 valve s 3 valve s 2 valve s 1 valve s 4 valve s 6 valve s 8 valve s 1 1 valve s 1 2 valve s 5 valve s 6 valve s 9 valve s 1 valve s 1 0 valve s 4 valve s 8 valve s 7 valve s epa_n o equi p 1 0 valve s 5 valve s 9 valve s 3 valve s 2 valve s 8 valve s 7 valve s 9 valve s 2 valve s 6 valve s 3 valve s 1 2 valve s 1 valve s 1 1 valve s 4 valve s 1 valve s 5 valve s 1 0 valve s 8 valve s 4 valve s 7 valve s 6 valve s phas e

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 l 1 1 1 1 1 phas e 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 plea k 1 0

0.0 0 0.6 7 1.4 6 1.7 7 2.5 4 3.9 5 4.4 6 5.3 8 5.9 9 6.8 2 8.1 8 8.2 5 14.2 9 17.5 9 19.2 3 20.7 9 23.8 9 32.5 1 33.3 3 35.5 1 49.1 9 83.3 3 pleaJ c 1 0 0.0 0 0.5 2 1.8 6 2.4 4 3.0 3 3.3 9 3.6 0 3.7 3 3.8 8 4.1 9 7.3 9 9.0 2 9.5 2 15.2 9 17.1 7 18.2 7 24.1 2 28.6 8 43.8 9 58.8 1 66.4 3 97.2 4P.6 5



### stud yepa_n o equi p pleak_1 0 e o 7 flang e 0.0 0 b d 9 flang e 0.1 0 e o 1 0 flang e 1.3 7 e o 2 flang e 1.7 1 e o 3 flang e 3.1 7 b d 1 2 flang e 3.8 7 b d l l flang e 4,0 8 e o 8 flang e 4.4 3 e o 1 flang e 5.6 5 b d 1 0 flang e 8.2 3 b d 1 flang e 10.0 0 b d 5 flang e 10.0 4 e o 6 flang e 10.2 7 e o 9 flang e 11.0 3 b d 3 flang e 14.0 0 b d 4 flang e 14.2 9 b d 7 flang e 24.8 2 b d 8 flang e 40.0 0 e o 4 flang e 50.8 4 b d 2 flang e 86.6 7 stud yepan o equi p pleak_1 0 e o 5 pump s 0.0 0 e o 7 pump s 6.6 7 b d 4 pump s 8.5 7 b d 9 pump s 10.3 1 e o 8 pump s 11.7 6 e o 2 pump s 12.5 0 b d 1 1 pump s 16.6 7 e p 6 pump s 25.0 0 b d 1 2 pump s 25.0 0 b d 3 pump s 25.3 7 b d 2 pump s 28.0 0 b d 1 pump s 37.5 0 e o 1 0 pump s 40.9 1 e o 9 pump s 50.0 0 e o 3 pump s 63.6 4 b d 1 0 pump s 66.6 7 b d 5 pump s 66.6 7 e o 1 pump s 68.0 0 b d 8 pump s 83.3 3 e o 4 pump s 90.9 1 b d 6 pump s 100.0 0mot*~vot^'«'"vo<£>^<M"*^^roo^wc^mr~fo©roco<^ >

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• H >>>>>>>>>>>>>>>>>>>>> > 2r4r*r4r-ir4r1r4r4r-lr4r^r~tr4rlr^r4rlr4rlr-4r* H tCTrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdr d Q)>>>> > >>>>>>>>>>>>>>>> > or-inorMo > >rororH(MTtcou>voinrHTi<(siHfr>ocor ^ *, ' C D > . * o d 4-"ooo*o*ao*ooo*ooo'd'd*ao'O r ao'0 , 0 ' 0 nvllii-iAAClAilil'iAClclAAAIliAAOAA A <p<Njcsic\*cs*c\iCN"c\"c\*c\ics*c\"cMCNics"cMc\ics"CMc\*rjcN*CN " M r d

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• H >>>>>>>>>>>>>>>>>>>>> > 2~-1rlr-ir^r4r4r4r4iHr4HiHi-ir{r-lr4l-ir-l>-irs!Hi-i tfrdrdrdcdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdrdr d < D > > > > >* > >>>>>>>>>>>>>>> > O o i n C

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• O d + J o C O 0 ) O'O'O'O'O'O'O'O'O'O'O' O O - O 0 flP.6 7



### stud yepa_n o equi p pleak_2 5 e o 7 flang e 0.0 0 b d 9 flang e 0.1 0 e o 1 0 flang e 1.3 7 b d 7 flang e 1.4 6 b d 1 2 flang e 1.6 6 e o 2 flang e 1.7 1 e o 1 flang e 2.8 2 e o 3 flang e 3.1 7 b d 1 1 flang e 3.4 0 e o 8 flang e 3.8 0 b d 2 flang e 4.6 7 b d 5 flang e 6.0 2 6.9 6 b d 1 0 flang e e o 6 flang e 7.5 3 b d 3 flang e 9.3 3 b d 1 flang e 10.0 0 e o 9 flang e 10.5 4 b d 4 flang e 11.4 3 b d 8 flang e 12.5 9 e o 4 flang e 31.6 0 stud yepa_n o equi p pleak_2 5 e o 5 pump s 0.0 0 b d 4 pump s 2.8 6 e o 7 pump s 6.6 7 b d 9 pump s 10.3 1 e o 8 pump s 11.7 6 e o 2 pump s 12.5 0 b d 1 1 pump s 16.6 7 e o 6 pump s 20.8 3 b d 1 2 pump s 25.0 0 b d 3 pump s 25.3 7 b d 2 pump s 28.0 0 b d 1 pump s 37.5 0 e o 1 0 pump s 40.9 1 e o 3 pump s 45.4 5 e o 9 pump s 50.0 0 b d 5 pump s 50.0 0 e o 1 pump s 52.0 0 b d 6 pump s 61.1 1 b d 1 0 pump s 66.6 7 e o 4 pump s 81.8 2 b d 8 pump s 83.3 3P.6 8



### stud yepa_n o equi p phas e plea k 5 0 

### e o e o e o b d b d 

### eo e o b d b d 

### e o e o e o b d 

### e o b d 

### e o b d b d b d b d b d b d stud y 

### e o e o e o b d 

### e o e o b d 

### e o e o eo e o b d 

### e o b d b d b d b d b d b d b d b d b d 7

5 1 0 2 9 3 1 3 4 2 8 6 6 4 5 9 1 1 1 2 1 7 1 0 8 

### ep a n o 1 0 5 3 2 1 9 7 8 2 6 7 9 4 1 2 3 4 5 1 1 1 1 0 8 6 

### valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s equi p 

### valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s valve s 1

1 1 1 1 1 1 1 1 1 1 1 1 l 1 1 1 1 l l l 1 phas e 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 0.0 0

0.6 7 1.4 6 1.7 7 2.5 4 2.5 7 3.2 4 3.4 8 3.7 1 4.6 2 5.1 5 5.4 5 6.1 0 6.5 4 10.1 0 14.2 9 14.2 9 15.3 4 16.2 6 16.6 7 28.5 7 32.9 7 plea k 5 0 0.0 0 0.5 2 1.3 3 1.3 8 1.3 9 1.4 6 2.1 0 2.4 0 2.6 0 2.8 6 2.8 8 3.7 3 5.9 5 6.5 3 7.3 5 9.1 3 11.0 2 11.6 5 13.3 5 26.0 4 27.5 9 33.1 7P.6 9

f stud y e o b d e o bd e o bd e o b d b d e o e o b d b d b d e o e o e o b d b d b d stud y bd e o b d e o bd e o e o b d e o e o b d bd b d bd e o e o e o b d b d e o bd epa_n o equi p

7 flang e 9 flang e 1 flang e 7 flang e 1 0 flang e 1 2 flang e 2 flang e 3 flang e 1 1 flang e 3 flang e 8 flang e 5 flang e 2 flang e 1 0 flang e 6 flang e 4 flang e 9 flang e 4 flang e 1 flang e 8 flang e epa_n o equi p 1 0 pump s 5 pump s 4 pump s 7 pump s 9 pump s 8 pump s 2 pump s 1 1 pump s 6 pump s 9 pump s 1 2 pump s 3 pump s 2 pump s 1 pump s 1 pump s 3 pump s 1 0 pump s 6 pump s 5 pump s 4 pump s 8 pump s plea k 5 0

0.0 0 0.1 0 0.5 6 0.7 3 1.3 7 1.6 6 1.7 1 2.6 7 2.7 2 3.1 7 3.8 0 3.9 0 4.0 0 5.7 0 6.8 5 7.3 0 9.0 7 10.0 0 10.0 0 11.1 1 plea k 5 0 0.0 0 0.0 0 2.8 6 6.6 7 10.3 1 11.7 6 12.5 0 16.6 7 20.8 3 25.0 0 25.0 0 25.3 7 28.0 0 37.5 0 40.0 0 40.9 1 40.9 1 50.0 0 50.0 0 54.5 5 75.0 0P.7 0



### stud yepa_n o equi p phas e pleak_7 5 e o e o e o b d e o bd 

### e o bd b d 

### e o e o e o b d e o b d b d 

### e o b d b d b d b d b d 

### stud y e o e o e o e o bd 

### e o b d 

### e o e o e o e o e o b d b d b d b d b d b d b d b d b d bd 7

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# ATTOOHIMEINn r1 ©
UNITE D STATE S ENVIRONMENTA L PROTECTIO N AGENC Y

WASHINGTON , O.C
. 2048 0

rC* f OPFIC E OF POLICY , PLANNIN G AN D EVALUATIO N 

## JU L I

MEMORANDUM SUBJECT : Sequentia l Samplin g Pla n fo r th e Woo d Stov e Standar d FROM :

TO : WilliamP
. Smith , Statisticia n

Statistica l Polic yBranc h (PM-223 ) John Rasnic , Chie f Complianc e Monitorin g Branc h (EN-341 )

Th e purpos e o f thi s memorandu mi s t o transmi t m ywor k on a prcpcse d samplin g pla n fo r th e Selectiv e Enforcemen t Audi t (SZA ) cr o cra mo : :h

e Woo d Stov e Standard

. Th e samplin g pla n i s base d o n the

. theor yo f sequentia l analysis

. Thi s metho d o f statistica l inferenc e differ s fro mth e classica l fixe d sampl e siz e tes t procedure s i n tha t th e numbe r o f observation s necessar yt o mak e a decisio n i s no t predetermined

. Th e decisio n t o terminat e o r continue " testin g i s mad e at
. eac h ste p o f th e proces s and depend s o n th e outcom e o f th e previou s steps
. Th e appea l o f sequentia l testin g fo r SE Ai s tha t o n averag e th e numbe r o f stove s tha t mus t b e inspecte d a t a facilit yt o mak e a determinatio n o f complianc e i s appreciabl yles s tha n tha t require d fo r th e mos t efficien t fixe d sampl e procedure

. Testin g wil l terminat e a s soo n a s ther e ar e sufficien t dat a t o suppor t a conclusion

. Th e sequentia l samplin g theorypresente d her e i s base d on th e wor k o f AbrahamWald

. Th e sourc e o f th e followin g discussio n ma yb e foun

d i n AbrahamWald , Sequentia l Analysis

. John Wile y& Sons , 1947
. Th e sequQntia l samplin g plan s wil l b @ USQC £ 

### durin g SEA s a s follows ; Aserie s e £ stev© § ar ®drawn randoml ywithou t replacemen t fro a th

®tota l populatie n © f gtevo s a t th Q faeilit yan d the n

### jt®st®d

. i n tho.ooguonc Q i n whie h tho ywor o ooloetod o A"stage " o f

j the

. proeedur o i o dofino d a o th o eeaplotie n e £ toutin g o f on © jadddtiena l ot©vo
. H runnin g eeunt , a , © f th Q numbe r e f observe d defectiv e \mito (io®. , thes ©ne t i n eompliane e wit h eac h appropriat o osiooie n gtandard ) i s aaintainod

. A t ©ac h stag® , thi s coun t n ea n b o compare d wit h th o compute d acceptanc e an d rejectio n number s fo r tha t stage
. I f a de@ § ne t excee d th e acceptanc e nuabe r th e audi t i s passed

. I f a i s ne t les s tha n th e rejectio n nuaber , th e audi t i s failed

. I f neithe r determinatio n ca n b e made , testin g wil l normall ycontinu®

. j In ' general , th © purpos e o f a Selectiv e Enforcemen t Audi t i s £ o deterain e whethe r P , th e proportio n o f a populatio n o f stove s ho t i n complianc e wit h th e standar d i s greate r tha n some acceptabl e qualit ylevel , PO
. Wha t i s neede d fo r a sequentia l t:est i s a decisio n rul e fo r which ; i 

### i 1
. Th e ris k o f failin g th e procedur©whe n th e tru e failur e rate , P , i s les s tha n o r equa l t o P O doe s no t excee d alpha , th e probabilit yo f makin g a typ e I error , an d i 2
. Th e chanc e o f passin g th e procedur e whe n th e tru e failur e rat e i s greate r tha n som e P l (P l > PO ) doe s no t excee d beta , th e probabilit yo f makin g a typ e I I error . Th e informatio n tha t thi s tes t wil l provid e wil l for mth e statistica l basi s fo r decidin g whethe r th e productio n facilit yi s iij i complianc e wit h th e standard , o r net
. Afacilit yi s i n complianc e i f zh e proportion , P , o f defectiv e woo d stove s (stove s tria t woul d fai l t o mee t th e condition s o f th e standard ) i n th e productio n populatio n doe s no t excee d PO
. Afacilit ycoul d b e definitel yclassifie d a s i n noncomplianc e i f th e proportio n defectiv e wa s greate r tha n som e unacceptabl yhig h value , Pl

. Th e statistica l tes t wil l allo won e t o distinguis h betwee n thes e tw o state s withi n acceptabl e erro r constraints

. I n genera l th e close r th e state s ar ®togethe r th e aor e difficul t the yar e t o distinguish , i.e. , i t woul d b e easie r an d requir e les s testin g t o distinguis h a complianc e rat e o f 0.0 5 fro m0.5 0 tha n fro a 0.20 , bu t yo u hav e les s contre l o f th © typ e I I erro r rat e withi n th e gre yare a betwee n th o tw ©alternatives

. Thi s trad e of f i s eviden t i n th e discussio n o f exhibit s an d figure s tha t follows

. i 

### Discussio n o f JSmsaogAeal outpu t I I Th ©attaeh®

d outpu t consist s o f 1 6 exhibit s an d 1 6 accompanyin g figures

. Thes e exhibit s consis t o f a selectio n o f test s tha t I hav

©investigated ; the yar ®b yn o mean s exhaustive , bu t the ywer e selecte d fro a a brea d spectru mo f condition s tha t wil l likel yexis t i n th ®rea l world

. Ideall y©n o weul d wis h t e optiiaiz ©limite d resource s t e mak e a d®eisie n wit h ainisu a ©rrer
. Soa

® e f th o eritiea l variable s tha t driv o th o £©s*a e f th e i 

### 2RL8 S



### doeisio n proeodur o ar© ; 1
. Sh o eeagliane ®rat d P O 2
. Tho allowabl e erro r ratoo ? 3
. Th o aasfisu s permissibl e sampl e size ; and 4
. Th e Populatio n ©igo

. I f th ©complianc e rat© , PO , i s sa yP0°0.0 5 the n yo u woul d expec t a facilit yi n complianc e t o hav ®a t mos t 5 % o f th ©stove s i n productio n populatio n t o b e defective,e r t e pu t i t anothe r way , th e probabilit yo f a stov e selecte d randoml yfro a thi s populatio n bein g defectiv e i s abou t 1 i n 20
. Th ®decisio n procedur e aay wrongfull ydeclar e a facilit yi n noncoaplianc e e r wrongfull y declar e i t i n coapliance

. Th e specificatio n o f th ®size s (alph

a an d beta ) o f thes e tw o typ ®o f error s i s necessar yt o deterain e a test
. Th e maximu mcut-of f leve l fo r saaplin g i s usuall y specifie d becaus e althoug h th e sequentia l tes t wil l terminat e wit h certainty , i t ma yrequir e infinit ©resource s befor e it.doe s so . Th e specificatio n o f on e othe r parameter , Pl , i s necessary t o completel ydeterain e th e test ; thin k o f thi s paramete r a s neede d t o "peg " th e powe r curv e o f th e tes t —th e powe r curv e wil l g o throug h th e tw o point s (PO,alpha ) an d (Pl , 1-beta )
. Th e populatio n siz e affect s th e error s an d mus t b e considere d separately , i.e. , separat e test s ar e use d fo r eac h rang e o f productio n population

. Exhibits

. 1- 4 ar e fo r P0=0.05 , Pl=0.50 , alpha=0.05 , beta=0.1 , maximu m inspections^lO , an d Pop=10*0, 2 00' , 3 00 , 40 0 c r more . Exhibit s 5- 8 ar e fo r P0=0.05 , Pl=0.20 , alpha=0

. 05' , beta=0.1 , maximu m inspectiohs«25 , an d Pop=lC0,200,300 , 40 0 o r more . Exhibit s 9=1 2 ar e fo r PO-0.05 , Pl-0.20 , alpha=0.1 , beta=0.1 , maximu

minspections= 2 5 , an d Pop=100,200,300 , 4 0 0 o r more . Exhibit s 13-1 6 ar e fo r P0°0.05 , Pl-0.30 , alpha°0.1 , beta-^0.1 , maximu

minspections=20 , and Pop*=>100,200, 3 00 , 40 0 o r aere . Eac h osshibi t contain s tw e tables : Tes t Procedur e an d Tes t Characteriotie s s Th e "Tes t Procedure " tabl ®give s th e decisio n rul e a t eac h j stag e o f th e test
. Fo r exampl e conside r th e sequentia l tes t i shown i n Exhibi t 8
. Thi s tes t procedur e indicate s tha t neithe r i decisio n ca n b e aad ©i n th e firs t 2 stages. ' Apas o doeiaio n ca n I b e aad

© i f th o firs t 1 3 stage s al l pas © (i.o

. ger©failures )
. A j fai l deeise n wil l b o aad o i f th o firs t 3 tost o rooul t i n failure

.
, I n a situatio n i n whie h neithe r decisio n ha s yo t boo n made , e.g. ,P.8 7



### number s ( • a ^numbe ro f failure s i s bet^e n !h. ^ sta 

### * e

### 22) .
. ^~ T **•*•» 1 i s betv»« « ft.. ^ « ««fcwee n th e tw

o der H «.*«. . testin g nu, tb . p.rfori H ' " ° an d 3 

### " «*»? . *•<) , SaaSi^ S

necessar y t o mak e 1 ^_t2?!
- h



### ® avera 

### * « numbe

rof ins 

### S*.. tru e 

### labelle d "Averag

e sampl/^LT " T * i S show 

### * ^ S?*?!^ ! exampl e thes e tw

o propertie s a'r l i ,*,** xaa 

### Pl e i n th e exhibi t ? x » F 

### ^ r e S

A an d 8B P

### TM^i^%^£^curvfs^ U t-t.y^V^Yi ^ SS.^ ^ t o 

### ^l p yo u revie w thes e th e audi t

program . t6St S tha t 

### /<> « »a y wis h t o conside r fl ?
Attachmen t i j 

### cc : Doree n Canto rP.8 8



### ASEQUENTIAL SAMPLIN G PROCEDUR E FOR TH E WOO D STOVE STANDAR D

July'1 , 198 6

PREPARE D B Y WilliamP
. Sait h Statistica l Polic yBranc h Offic ©o f Policy , Planning , and Program U.S
. Envirena®nta l Preteetie n Evaluatio n

### Genera l Th e samplin g plan s propose d fe r th ©Selectiv e Enforcemen t Audi t Program(SEA ) o f th ®Woo d Stev

©standar d ar e base d o n th e theoryo f sequentia l analysis

. Thi s method ' o f statistica l inferenc e differ s fro a th e classica l fixe d sampl e siz e tes t procedure s i n tha t th e nuabe r o f observation s necessaryt o aak ©a decisio n i s no t predetermined

. Th e decisio n t o terminat e o r continu e testin g i s mad e a t ©ac h ste p e f th ®proces s an

d depend s o n the.outcom e o f th e previou s steps
. Th e appea l o f sequentia l testin g fo r SE Ai s tha t o n averag © th e nuabe r o f stove s tha t aus t b e inspecte d a t a facilit yt o mak e a determinatio n o f complianc e i s appreciabl yles s tha n tha t require d fo r th e mos t efficien t fix© d sampl e procedur©

. Testin g wil l terminat e a s soo n a s ther e ar ©sufficien t dat a t o suppor t a conclusion

. Th e sequentia l samplin g theor ypresente d her e i s base d o n th e wor k o f AbrahamWald

. Th e sourc e o f th e followin g discussio n mayb e foun

d i n AbrahamWald , Sequentia l Analysis , John Wile y& Sons, ' 1947
. Th e follows : sequentia l samplin g plan s wil l b e use d durin g SEA s a s

Aserie s o f stove s ar e drawn randoml ywithou t replacemen t fro mth e tota l populatio n o f stove s a t th e facilit yan d the n teste d i n th e sequenc e i n whic h the ywer e selected

. A"stage " o f th e procedur e i s define d a s th e completio n o f testin g of , on e additiona l stove
. Arunnin g count , m , o f th e numbe r o f observe d defectiv e unit s (i.e. , thos e no t i n complianc e wit h eac h appropriat e emissio n standard ) i s maintained

. A t eac h stage , thi s coun t mca n b e compare d wit h th e compute d acceptanc e an d rejectio n number s fo r tha t stage
. I f mdoe s no t excee d th e acceptanc e nuabe r th e audi t i s passed

. I f mi s no t les s tha n th e rejectio n nuaber , th e audi t i s failed

. I f neithe r determinatio n \ ca n b e made , testin g wil l normall ycontinue

.

' A s a n o&aapl e o f th ®applicatio n o f a sequentia l samplin g ! plan , coneide r th e decisio n rul e fo r a n infinit e population , i (Thi s decisio n rul e appear s i n th ®beginnin g o f th

®documen t an

d

, i s presente d i n Exhibi t 8 )
. Thi s tes t procedur e indicate s tha t 1 neithe r decisio n ca n b ® aad ®i n th e firs t 2 stages
. Apas s 1 

### decisio n ca n b

©aad ©i f th e firs t 1 3 stag© s al l pas s (i.e

. zer o | failures )
. Afai l d©eise n wil l b o mad e i f th o firs t 3 tost s I resul t i n failure

. I n a situatio n i n whie h noithoj ? doeioie n ha o

, ye t bee n aado , o.g. , 1 failur o a t stag o If , additi©na l tootin g i o required

. I n thi s latte r example , a pas s doeioie n wil l b o 

### 2P.9 0



### reached , i f th o no3st 3 toot o al l pao o ( 1 Sailur o a t stag o 22) , © r s fai l doeioie n wil l b o roaehe d i f th o noss t 2 te^t s al l fai l ( 3 failuro o a t otag o 22)
. Thuo , whonove r th o nuabe r © f failure s i o betwee n th o tw

©doeisie n number s (o.g. , 1 i s botwee n 0 an d 3 a t stag e 14) , additiona l testin g aus t b e performed

. eoaButatio n o f Aeeeptane ®aad adoptio n Nusfeng g I n general , th

©purpos e o f a Selectiv e Enforcemen t Audi t i s t o deterain

®wh©the r p , th e proportio n o f a populatio n o f stove s no t i n complianc e wit h th e standar d i s greate r tha n som e acceptabl e qualit ylevel , PO
. Wha t i s neede d fo r a sequentia l tes t i s a decisio n rul e fo r which : 1
. Th ® ris k o f failing th e preeadur©wh@ n th ©tru e failur e rate , P , i s les s tha n o r equa l t e P O doe s no t excee d alpha , th e probabilit yo f makin g a typ ©I error , and 2
. Th e chanc e o f passin g th e procedur e whe n th e tru o failur o rat e i s greate r tha n som e P l (P l > PO ) doe s no t excee d beta , th © probabilit yo f makin g a typ e I I error . I f w e conside r p(i,n) , th e probabilit yo f observin g a give n number , m , o f defectiv e (noncomplying)

. stove s a t th e nt h stag e o f testin g whe n p = p(i) , the n

mn- m p(i,n ) - C(n,m)p(i ) (l-p(i) ) fo r a n infinit e populatio n an d C(m,n ) i s th e usua l combinatori c o f munit s take n fro mn unit s withou t replacement

. Asequentia l probabilit yrati o tes t t o tes t th e failur e rat e o f a productio n proces s consider s th e rati o o f p(l,n ) t o p(0,n ) a t eac h stag e o f testing

. Tha t is , th e rati o p(l,n)/p(0,n ) whe n th e populatie n i s ver ylarg e (sa y40 0 o r more) , i s th e tes t statisti c o f interest

. I t shoul d the n b e note d tha t i f P l i s close r t o th o tru e P tha n PO , the n thi s rati o wil l b e high

. Thu s high rati o value s ar e indicativ e o f a hig h failur e rate
. I f P o i s close r t ©th r tru e P , the n th ©rati o wil l b e low , a lo wrati o indicatin g a lo wfailur ©rat®
.P.9 1



### Th o doeXsie n t ©torminat o tootin g wit h a pas s er . fai l e r t e eentinu o tootin g i s base d upo n whetho r
a ) I i s p(l,n)/p(0,n ) b ) A< p(l,n)/p(0,n )

c ) B < p(l,n)/p(0,n ) < (pass) , (fail) , o r (continu e testing)

.
Aan d B ar e chose n t o yiel d th ®appropriat e value s o f alpha an d bet a i n th e followin g manner : Fro a a ) i t ca n b e see n tha t i n a pas s situation , B*p(0,n ) '

_

> p(l,n)

. Thu s th e probabilit yo f observin g a passin g sequenc e whe n P l i s tru e i s a t aos t B tia© s th ©probabilit yo f observin g th e sequenc e whe n P O i s true
. Sinc e thi s inequalit yi s true

- fo r an

ypassin g sequence , i t i s tru e ove r th ©totalit yo f passin g sequences , E
. Tha t is , B 6 

### P(E|P0 ) > P(E|P1 ) wher e P(E|P0 ) an

d P(E|P1 ) ar e th e probabilitie s o f passin g unde r P O an d Pl , respectively

. No wsinc e th e tes t terminate s wit h probabilit y on e w e maystat e tha t fo r passin g sequences , P(E|P0 ) i s equa l t o 1-alpha , th e chanc e o f correctl ypassing , an d P(E|P1 ) i s equa l t o beta , th e ris k o f incorrectl ypassing

. THerefor e i t i s tru e tha t B(l-alpha ) > beta

. Similarl yfro

mb ) on e ca n se e tha t i n a fai l situatio n A*p(0,n ) < p(l,n)

. Thu s th e probabilit yo f observin g a failing sequenc e whe n P l i s tru e i s a t leas t Atime s th e probabilit yo f observin g suc h a sequenc e whe n P O i s true
. A s i n th e cas e o f th e pas s situatio n thi s inequalit yhold s ove r th e totalit yo f failing sequences , F
. Sinc e th e tes t terminate s wit h probabilit yon e w e hav e P(F)+P(E)»1 , an d s o A(alpha ) < 1-beta

. Thu s a lowe r bound fo r B i s B' ! 

### bound fo r Ai s A'-""-(l-beta)/alpha

. •beta/(1-alpha ) an d an uppe r Replacin g Aan

d B wit h thes e bound s doe s alte r th e value s o f alph a an

d beta , bu t difference s ar e small

. fo r smal l value s o f thes e risk s th e
Substitutin g th e bound s fo r Aan d B i n c ) yield s B« < p(l,n)/p(0,n ) < A '
Takin g log s i n th

©abov e inequalit yallow s on e t o stat e tha t th ® sequentia l probabilit yrati o tes t wil l terminat e a t stag e n i fP.9 2

a)
. a 6 ln[PlQ0/(P0Ql) ] + n^lnfQl/QO ] " < ln[B ° 3 (pass )

o r b ) ncin[?lQe/(P0Ql) 3 + n ln[Ql/QO ] > ln[A' ] (fail ) wher ©Q0°1=P 0 an d Q1°1-=P1 -
. Coaputin g formula s fo r th e acceptance , a(n) , an d rejection , r(n) , number s fo r stag e n are : a(n ) « (ln[B« ] + n ln[Q0/Ql] ) / ln[PlQ0/(P0Ql ) ]

an d r(n ) °(ln[A« ] + n ln[Q0/Ql] ) / ln[PlQO/(POQl)]

. I
. ! Nonintege r value s o f a(n ) an d r(n ) ar ©replace d b yth e larges t J intege r les s tha n a(n ) an d th ®smalles t intege r greate r tha n
' r(n) , respectively

. i i Th e abov e theor yi s applicable

. ©ve n whe n observation s ar e J dependent , suc h a s i n th e cas ©o f samplin g fro ma finit e | populatio n withou t replacement

. Sa ytha t o f a productio n i populatio n o f siz e Nt o b e tested , a finit e nuabe r o f units , D , i ar e assuae d t o b e defective

. Testin g th e hypothesi s ! Ho : D S [PO* N+ 0.5 ] ° DO
I versu s ! | HI : D > [P1* N+ 0.5 ] - D l wher e [. ] represent s th e greates t intege r function , i s analygou s to.th e binomia l tes t fo r infinit e populations

. Th e corresponding ' p(0,n ) an d p(l,n ) fo r a observe d defective s a t stag e n o f thi s tes t ar e i p(0,n ) ***

» h(a,n,D0,N ) an d p(l,n ) * » h(a,n,Dl,N ) wher e h(a,n,D,N ) i s th ®usua l hypergeoaetri c probability

. Th e possibl e event s ca n b e define d a t eac h stag e t o be :

Peosibl o laaediat e fvon t Conclusio n Decisio n (1 ) a < n°N-*-D0 D < D O accep t H o (2 ) n-N+D0* i a < n=N->D l D < D l rejec t H I (3 ) n-N+D l

_

s a < D O Tes t rejec t H o (4 ) n-N+D l < a _%D l D > D O rejec t H o (5 ) a > D l D > D l rejec t H e Cas e (1 ) wil l ne t ©eeu r fe r th o truncate d fer a © f th o tos t tha t wil l used , i

. e. , n wil l b o eenstraine d t ©ssal l valuo s typicall y

### les s tha n 2&

- Steves
. ess o (2 ) i o tru o -enl ywhe n th e numbe r © f

observatieno , n , i s greate r tha n N°D1 , th o maximu mnuabe r e f nen = def©etiv o imit o ©n o coul d ebserv o i f a t leas t D l wer e defective

. Thi s iaplio o tha t n°N-«»D l i s th o ainiau a nuabe r e f defectiv e unit s on ®weul i ©bsorv o i f a t leas t D l wer e defective

. Thu s a n observe d a les o tha n n°N-$*D l implie s tha t D aus t b e les s tha n D l an d th e nul l hypothesi s ca n b o accepted

. Cas o (3 ) Bake s sens e onl ywhe n (n-N-s-D0,D0 ) i s a vali d interval , whic h wil l b o th e becaus e n wil l b e smal l relativ o t ©N
. Cas e (3 ) i s th © typica l cas e and wil l b o th ®sequentia l testin g procedur©

. Cas e (4 ) i s true

- onl ywhe n n i s greate r tha n DO , wher e D O i s th e maximu m nuabe r o f defectiv e unit s on e woul d observ e ou t e f n observation s i f th e tru e defectiv e coun t wer e les s tha n o r equa l t e DO
. S e a n observe d m

greate r tha n DO implie s tha t th e tru e numbe r o f defective s i s greate r tha n DO an d th e nul l hypothesi s i s rejected

. I f cas e (5 ) i s tru Q the n D mus t b ©greate r tha n D l an d th e nul l hypothesi s ca n agai n b e rejected

. Th © onl ynontrivia l cas e i s the n cas e (3 ) wher e th ®sequentia l probabilit yrati o tes t wil l b e performe d i n orde r t o aak ®a decision

.
Characteristic s o f Sequentia l Test a Th e powe r functio n o f a sequentia l tes t describe s th e ris k o f failin g th e test ' a s a functio n o f th e tru e proportio n o f defectiv e stove s i n th e productio n a t th ©facilit yfailin g t o mee t th e standard s se t fo r woo d stoves
. Fo r th e propose d SEA samplin g plan s EPAconstraine d thi s ris k o f failur e t o n o mor e tha n 5 1 fo r value s o f P les s tha n 0.10
. Fo r value s o f P greate r tha n 0.20 , i t wa s desire d tha t thi s ris k b e a t leas t 90%
. Thu s whe n usin g th e previou s formula e t o comput e th e acceptanc e an d rejectio n number s o f th e sequentia l tests , th e value s o. f Po,Pl,alpha , an

d bet a ar e a s follows :
P 0 

### P l alph a bet a = 0.1 0

= 0.2 0 » 0.0 5 « 0.1 0 

### Asecond characteristi c o f th e sequentia l procedur e i s th e averag e sampl e nuab® r (ASN ) function , whic h define s th e numbe r o f observatien o necessar yt e reac h a pas s o r fai l decisio n a s a functio n © f th o tru e proportio n o f woo d stove s i n a productio n failin g t©soo t th e standards , i.e. , a s a functio n o f P
. Th o powe r funetie n and AS Ncurve s fe r th e SE Ad©eisi© n rul e ar

®show n fo r a n infinit ©populatio n an d §©vera l finit e population s o f typica l size s tha t ar e execute d t o b e encountered

.



### €

### Ho-amcBfc*.Qafi_fe Q th o Qoelnlef t mian
T ©faeilitat o applicatio n e f th o decisio n rule s develope d above , tw

©modification s wer o made

. First , th e nuabe r o f decisio n rulo o t e b ©use d wa s limite d t e four

. Thi s wa s accomplishe d bypartitionin g th o expecte d rang ®o f woo d stov e productio n t o fou r intervals

. On e decisio n rul ©wa s th© n s©lecte d fo r eac h interva l fo r appliaetie n t e al l volume s withi n tha t interval

. Th e decisio n rul e designe d fo r th e midpoin t o f eac h finit e interval , wil l b e use d fo r tha t interval

. Th e interval s s©lecte d ar ©1=99 , 100-=199 , 200-299 , 300=399 , an d 40 0 an d above

. Base d o n simulation s usin g th e paramete r value s fo r Po , Pl , alpha , an

d bet a define d previously , th ®fi'nit ©populatio n tes t fo r th e las t interva l ha s characteristics

- identica l t o tha t fo r infinit e populations , s o th e infinit © populatio n decisio n rul e was'use d fo r thi s interval

. Second , th e decisio n rule s wer e a t a fixe d endpoin t t o assur e terminatio n o f th e procedur e in ' a reasonabl e numbe r o f tests
. Th e stoppin g poin t chose n fo r eac h procedur e wa s th o stag e whos e inde x equalle d approximatel yon e an d one-hal f t o tw o time s th e highes t valu e o f th e AS No r a se t maximum , whicheve r wa s th e smaller

. A t eac h stoppin g poin t revise d acceptanc e an d rejectio n number s wer e compute d b ytakin g th e greates t intege r functio n o f th e averag e o f thes e tw o number s a s th e ne w acceptanc e number , an d tha t valu e plu s on e a s th e ne wrejectio n number

. Validatio n o f th e Decisio n Rule s Th e decisio n rule s generate d and

. modifie d i n th e abov e manne r wer e validate d usin g Mont e Carl o compute r simulation

. Replicat e experiment s wer e performe d fo r value s o f P , th e noncomplianc e rate , rangin g a s 0.01(0.01)0.99
. Thirty-tw o thousand replication s wer e performe d fo r eac h siz e o f P
. Thes e evaluation s wer e performe d fo r th e endpoint s o f eac h populatio n rang e fo r eac h decisio n rul®

. Tabulatio n an d graph s o f th e powe r an d AS Nfunction s ar ©include d i n thi s document

.P.9 5



### SINOGRAPH Y

Wald , Abraham , Sesuentia l Analysis

. John Wile yand Sens , Inc. , Ne wYork , 1947
. U.S
. EPA , "Analytica l Developmen t o f Samplin g Plan s fo r Selectiv e Enforcemen t Auditin g o f Light°Dut yVehicle s an d Light-Dut y Trucks, " Unpublishe d Interna l Document , Offic e o f Air , Noise , an

d Radiation , U.S
. Environaenta l Protectio n Agency ! 1981
.^WUUUUU.WWOJUlNWWNNNNNNNPHPHI-'l-'PPHh ' O»000vJ(^U14kW*\JHOv0»slWWil»UWHO^C0vl(J>Ulif.UNHOk00SvJ(riUli^WN H

OOOOOOOOOIIIIIIIIIIIIIIIIIIIIIIIIIIIIII I

U1UlU)UlUlUlUlUl_nUl_nUlUlU14i.Ji l (i^^Ji^^*.^4>*.^4i^^ 1 |i^*>^^^ ^ I | | .EC-***** - p j O
»* a "- d

•^ fl) c n r + i-3

*"
. 03 O f 1 o M C D Q>rG rs\ f D<=0.02>=0.04

T 3 ( D O M *
. ' O C D U •- < o »

. . . . o o

. u n o O O l . — n G rf O i- h H i ••
rO Oinspect 

### o cnoo^^^-j^^^^^^CT»o^o>crio^<ria^cT>o^a^aiui'ji*Ji(Ji'ji'_nuiuiui*ki^rf^^rfii^4^ ^ 0^)CO<JO<W^WNHOOO)sl»Ulit>WNHO\l]tBvl(!'Ulit>UI.HOiOCBsllJi|Jli(i.W N

•-'•-••-'•-'•-'•-'•-'•-'•-''-''-'•-'•-'•-''-'OOOOOOOOOOOOOOOOOO
. OOOOOO O

Ui(_nuiLntn(jiuiui(_noiuii_nuiuioi_^uiui(_nm(Jiuiuiuiuitji( ^

r o H3 > (1 ) 0 0 wtr 1 <* + M

" 1 O O a > P i r t 3 C * C D 

### a .P.9 8

TABL E 1 continue d Tes t Procedur e | Numbe r | o f unit s | Inspecte d 1 8 1 | 8 2 | 8 3 | 8 4 | 8 5 | 8 6 | 8 7 | 8 8 | 8 9 | 9 0 1 9 1 | 9 2 1 9 3 | 9 4 1 9 5 | 9 6 1 9 7 | 9 8 | 9 9 | 10 0 Acceptanc e

Numbe r 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 

## 1 4 Rejectio n |

Numbe r |
5 1 5 1 5 | 5 | 5 | 5 1 5 1 5 1 5 | 5 1 5 I 5 I 5 I 5 I 5 I 5 I 5 I 5 I 5 I 1
. 5

EL- 3P.9 9



### BINOMIAL SEQUENTIA L TES T (Cutoff : 10 0 inspections ) Ho : P < = 0.0 2 Ha : P > = 0.0 4 alpha : 0.0 5

power : 0.5 0

TABL E 2 Tes t Characteristic s Percen t o f unit s Defectiv e 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 

### Averag e

Sampl e Siz e 67. 9
. 29. 7 16. 5 11. 5 8. 9 7. 2 6
. 1 5. 3 4. 7 4. 2 

### Probabilit y

Rejecting H O 0.5 1 0.9 9 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0



### EL- 4>^_0(__UJU>_0_0_0_0(_J_0MMMMMNMMMM.-.MMMh-'MK-' M OvO»^Cn_nrf-.U>W.OvjDOT^<" A <_1^_otv--OvO»^C7!Ul^WN
.

I I I I I I I I I I I I I I I I - I I I I I I I I I I I I I I I I I I I I I I I I

a^a>a*o>a^O^<7^o>uienui<^<_i_n_n<_i_nui(_i<_-i_n<_n<_i<_nijnui' ^ I I I I to o

_ . t i

_ C D c n r t

•

_

. . 6
. O f o w ( 0 C - i - c

. ( 0<=0.02>=0.04

T J t_ > O M « : * o a >
__ * i- i *_ •

. . . . o o •• yO O O U l *•_

. n c r t O

.

. •• O l o oinspectionsP. 2

TABL E 1 continue d Tes t Procedur e | Numbe r j o f unit s j Inspecte d 1 4 1 j 4 2 j 4 3 j 4 4 | 4 5 | 4 6 j 4 7 | 4 8 | 4 9 j 5 0 1 5 1 j 5 2 1 5 3 j 5 4 | 5 5 | 5 6 1 5 7 | ' 5 8 1 5 9 | 6 0 1 6 1 j 6 2 1 6 3 | 6 4 j 6 5 j 6 6 1 6 7 | 6 8 1 6 9 | 7 0 

### 1 7 1 j 7 2 1 7 3 1 7 4 1 7 5 1 7 6 1 7 7 | 7 8 j 7 9 j 8 0 Acceptanc e

Numbe r

—

-

- -_

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

- •

-

-

-

-

-

-

-

-

. -

-

-

-

-

-

-

-

-

- Rejectio n j

Numbe r j 6 1 6 I 6 I 6 j 6 I 6 I 6 I 6 I 6 1 6 I 6 1

. 6 | 6 j 6 I 6 I 6 I 6 j 6 I 6 | 6 j 6 I 6 I 6 j 6 I 6 I 6 I 6 I 7 I 7 I 7 j 7 | 7 1 7 I 7 | 7 j 7 | 7 | 7 | 7 | 7 I



### EL- 6HHHh'PI-'HPPHHIl H h l Hh'(-HPHP_____l_»O\___(_00(»a)0000O)(»0( l fsJMM-M..MMMMOOOOOOOOOO>^<»^(X>U1^0-MMOvOCO^O^Ul^O_N> . OvDOOvJWUl^WNI-'OvO(»vlC«Ul 1 M_WH O

OOOOOOOOOOO I I I I I I I I I I I I I I I I I I I I I I I I I I I I I

-J^J^J^J~-J~J-J-J~~J-J^J^J^J^J-J^J^J^-J- J oo<x>oooooooo(soooooocoo.ooooo.ooo.o(iviviv i _ C D c n r t T J

. O O C D 

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. C D H - 3 CC D a• a

a > •_ » 

### c
• P - a C D u o O u W4- > ^ Cfl 

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oooooooooooooooocoooooooooooo o c o c^^(r»(y*o^(rity*o^(r->ff*o\^o>^^o^o^o>ff»(y*r^o\o ^

00000000000000000000000-H_-H-H-H-HrHrH-H-HrHrHr H

_oio_oocno-'NP">-_ H u-><i>.cocri0.r\jcoTi<invor^co<y>o.cvir ^ NNNNNMfnrnfonnrorornn*-f-|i'*^-fTf-f-fTf_i_i_i_i_i_-i_i_iiniri * HHHHHHHHHHHHrlHHHHHHHHHHHHHHHHrlHHHHH H iHrgro-junvO-oocri O r g C M r g C

MOvOvOvOvOvo^vovDvo^oJOoooaoooooooooooovjvivjvjvjvjvjvjvjvioiwo^wwo^ffiaicr iO\000vl0>Ulit-WI_HO»000vl0>U1J-WWIJ O v D C O ~- J OMLn*-OJ[\)l- , OvOOO-J(T>U-|*-U)tN>
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.K)NNNN)NNNNNNNMNNNNNNWNWNNN)WNNJNNMI\)NNNNNNN) W iM*IWWUlUWWUUOJNNN)NNNWNNWI-'HHHHPPI-' p .OOOOOOOO O o_oo•^JWUll^u^)HO_oo^l(^ul^w^J^ J 0_c»^J(JlU1(>u^op0^ooosllJ^ol^u^J^ J

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.

b >P. 7

TABL E 1 continue d Tes t Procedur e | Numbe r | | | o f unit s | Acceptanc e | j Inspecte d | Numbe r j | 24 1 | 3 | 24 2 3 | 24 3 | 3 | 24 4 | 3 j 24 5 | 3 j 24 6 | 3 1 24 7 3 I .24 8 | 4 | 24 9 j 4 | 25 0 | 4 | 25 1 j 4 25 2 j 4 | 25 3 | 4 j 25 4 j 4 | 25 5 ' | 4 | 25 6 j 4 | 25 7 j 4 j 25 8 j 4 j 25 9 j 4 | 26 0 j 4 | 26 1 | 4 | 26 2 | 4 | 26 3 j 4 j 26 4 | 4 | 26 5 | 4 1 26 6 | 4 | 26 7 | 4 j 26 8 | 4 | 26 9 | 4 | 27 0 j 4 j 27 1 | 4 | 27 2 j 4 | 27 3 j 4

. j 27 4 | 4 | 27 5 j 4 | 27 6 j 4 j 27 7 | 4 | 27 8 j 4 | 27 9 | 4 | 28 0 | 4 

# 1 Rejectio n j Numbe r j

i 1 1 2 | 1 2 | 1 2 j 1 2 | 1 2 | 1 2 | 1 2 j 1 2 j 1 2 | 1 2 | 1 2 | 1 2 | 1 2 j 1 2 | 1 2 | 1 2 j 1 2 | • 1 2 j 1 2 j 1 2 j 1 2 | 1 2 | 1 2 | 1 2 j 1 2 | 1 2 j 1 2 j 1 2 | 1 2 | 1 2 | 1 2 | 1 2 j 1 2 j 1 2 | 1 2 | 1 3 | 1 3 j 1 3 | 1 3 | 1 3 |

EL-1 1OJC~l_O_O0J0_0-_O0-_O_U_O_0_O_OU>U>U>U>_O_OMM MNHMHHHHHII HHOOOOOOOOOO_._-0_--__00000000(»0000(»0 0 OvOOOvlWyifrWNHOvOOOvJWUli^ui.HOvOOOvl^Ul^WhOHOkOCOvlOiUli^W'.H '

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.P. 9

TABL E 1 continue d Tes t Procedur e | Numbe r | j o f unit s j j Inspecte d j | 32 1 | 32 2 | 32 3 j 32 4 j 32 5 32 6 j 32 7 I 32 8 | 32 9 | 33 0 | 33 1 | 33 2 | 33 3 | 33 4 | 33 5 I 33 6 | 33 7 I 33 8 33 9 | 34 0 | 34 1 j 34 2 j 34 3 j 34 4 | 34 5 | 34 6 | 34 7 | 34 8 | 34 9 | 35 0 I 35 1 | 35 2 I 35 3 I 35 4 I 35 5 I 35 6 | 35 7 | 35 8 I 35 9 | 36 0 

# 1

Acceptanc e | Numbe r | 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 7 

# 1

Rejectio n | Numbe r j

l 1 1 4 | 1 4 1 4 1 1 4 | 1 4 | 1 4 j 1 4 j 1 4 | 1 4 | 1 4 j 1 4 j 1 4 j 1 4 j 1 4 | 1 4 | 1 4 j 1 4 | 1 4 | 1 4 | 1 4 | 1 4 j 1 4 | 1 4 | 1 4 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 | 1 5 j 1 5 | 1 5 |

EL-1 3P.1 0

TABL E 1 continue d Tes t Procedur e | Numbe r | I j o f unit s | Acceptanc e | j Inspecte d | Numbe r j | 36 1 | 7 | 36 2 | 7 | 36 3 j 7 | 36 4 | 7 | 36 5 | 7 | 36 6 | 7 | 36 7 | 7 | 36 8 j 7 | 36 9 | 7 | 37 0 | 7 1 37 1 j 7 j 37 2 | 7 | 37 3 | 7 | 37 4 j 7 j 37 5 | 7 1 37 6 | 7 37 7 | 7 | 37 8 | 7 | 37 9 | 7 | 38 0 | 7 j 38 1 | 7 | 38 2 • j 7 j 38 3 | 7 j 38 4 | 7 j 38 5 | 7 | 38 6 | 7 | 38 7 j 8 | 38 8 | 8 | 38 9 | 8 | 39 0 j 8 I 39 1 | 8 | 39 2 | 8 | 39 3 j 8 j 39 4 | 8 | 39 5 | 8 I 39 6 j 8 | 39 7 | 8 | 39 8 | 8 | 39 9 | 8 | 40 0 | 8 

# 1 Rejectio n | Numbe r |

1 1 1 5 1 5 15
. 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5

. 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5 1 5

EL-1 4 /

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.P.1 2

TABL E 1 continue d Tes t Procedur e 1 Numbe r | i o f unit s | Acceptanc e | 1 Inspecte d j Numbe r | 1 44 1 | 9 i 1 44 2 | 9 1 1 44 3 | 9 | 1 44 4 j 9 l 1 44 5 j 9 j 1 44 6 j 9 1 1 .44 7 | 9 | 1 44 8 | g j 1 44 9 | g 1 45 0 | g 

# ! 

# Jf 1 

# ! 9 

# ' 45 2 9 , 45 3 9 | 1 45 4 j 9 | 1 45 5 | g i 1 45 6 | i o 1 45 7 | i o | 45 8 | i o 1 45 9 | i o | 46 0 | i o | 46 1 j i o | 46 2 • | i o | 4 6 3 j 1 0 | 1 46 4 j 1 0 | I 46 5 | i o | 46 6 j 1 0 46 7 | 1 0 | 46 8 | i o | 46 9 | i o | 47 0 | 1 0 1 ' 47 1 | 1 0 1 47 2 | 1 0 1 47 3 | 1 0 | 47 4 | i o | 47 5 | i o 1

. 1 47 6 | i o | 47 7 | i o | 47 8 | i o 1 47 9 | i o • | 1 48 0 j ,i o j I 1 Rejectio n j Numbe r j 1 5 1

1 1 5 1

i 1 5 1

1 1 5 |

i 1 5 1

1 1 5 | 1 5 |

1 1 5 1

1 1 5 1

1 1 5 1

f 1 5 1

1 1 5 1

1 1 5 |

1 1 5 I

1 1 5 1

1 1 5 1

1 1 5 |

1 1 5 1

i 1 5 | 1 5 1

1 1 5 1

1 1 5 1

1 1 5 1

1 1 5 1

1 1 5 | 1 5 1

1 1 5 1

1 1 5 1

_ • - » i 1 5 1

i 1 5 1 1 5 1 1 5 1

1 1 5 1

i 1 5 1

1 1 5 1

1 1 5 1

1 1 5 1 * * 1 1 5 1

1 1 5 1

1 1 5 |

EL-1 6in*->f_lt_.>P->{_IP-IP_£-£_iJ_.lt_!j_.4_>£_4_>l(->(_>lf_lJ_ > OvOvOvOvOvOvOvOvOvOvOCOCOCOOOOOOOOOOOO O O-l00vjaiUl*>WNpOv00l)vJOM)l*.Wt- P

*-..l-'..l-'.Mh-'l-'00000000 0

U1U1U1U1U1U1U1U1U1U1U1U1U1UIU1U1U1U1U1U 1 _

_> C D 6 - c n _- • f t M

. 

### o n C D D i r t 3 C C D O iP. M

BINOMIA L (Cutoff :
Ho : P < = 0.0 2 Ha : P > = 0.0 4 SEQUENTIA L TES T 50 0 inspections ) alpha : 0.0 5 power : 0.9 0

TABL E2 

### Tes t Characteristic s Percen t o f unit s Defectiv e 5 1 0 1 5 2 0 2 5 3 0 3 5 4 0 4 5 5 0 5 5 6 0 6 5 7 0 7 5 8 0 8 5 9 0 9 5 10 0 Averag e

Sampl e Siz e 196. 9 63. 5 35. 8 25. 8 20. 3 16. 9 14
. 2 12. 6 11. 2 10
. 1 9. 2 8. 3 7. 8 7
. 1 6. 6 6. 3 5. 9 5. 5 5. 3 5. 0 Probabilit y

Rejectin g H o 

# 1 0.9 8 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1
. } 0 1.0 0 1.0 0

EL-1 84_>_0<j__0_OOJ_OOJ_0_OOJhJNhJtN)tN)MtN)tN)tN>W-..M..
. O^OOslOlUli^UlNHOvOOOsllJiW^UNHOvflt.vlOlUliliWNPOiDOOslOiUlitkUlNr '

..M.*-"
. OOOOOOOOOOOOOOOO O I I I I I I I I I I I I I I I

OiffiWWIJi01(^(7iUlUlUlUllJlWUlW(/lUl(^IJlUlUlU101Uli^J-i^4-J- 1 ^it>.il-*.*. 1 t-i( - I I I

_> _ C D C/ 1 r t Ti >



### . a O I
. o

_ _ C D O
. r c C DHa: ^
VHo: Ti
A
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T3 0 * O
. C O C D 3 *

. 0)
o o c n o O c n C O

—M n 2 c * o r t 2 O M H , > M , E"1

. C/ 1 O M o o 

### c H - t- 1 3 - 2 C O H r t H O

_ 3 M C O O l

—_P.1 6

TABL E 1 continue d Tes t Procedur e | Numbe r j o f unit s j Inspecte d 1 4 1 1 4 2 1 4 3 | 4 4 1 4 5 I 4 6 1 4 7 | 4 8 I 4 9 | 5 0 1 5 1 | 5 2 1 5 3 | 5 4 I 5 5 | 5 6 1 5 7 | 5 8 1 5 9 I 6 0 1 6 1 | 6 2 1 6 3 | 6 4 1 6 5 | 6 6 1 6 7 | 6 8 1 6 9 I 7 0 1 7 1 1 7 2 1 7 3 1 7 4 1 7 5 1 7 6 I 7 7 | 7 8 1 7 9 j 8 0 Acceptanc e

Numbe r 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 Rejectio n j

Numbe r j 6 1 6 I 6 1 6 1 6 1 6 I 6 j 6 | 6 I 7 ' | 7 I 7 | 7 j 7 | 7 I 7 I 7 j 7 | 7 j 7 j 7 | 7 I 7 | 7 | 7 | 7 j 7 | 7 I 7 I
' 7 | 7 | 7 I 7 I 7 | 7 I 7 I 7 I 7 j 7 | 7 |

EL-2 0P.1 7

TABL E 1 continue d Tes t Procedur e | Numbe r | o f unit s | Inspecte d 1 8 1 I 8 2 | 8 3 | 8 4 1 8 5 | 8 6 I 8 7 | 8 8 | 8 9 | 9 0 1 9 1 | 9 2 1 9 3 | 9 4 1 9 5 1 9 6 1 9 7 | 9 8 | 9 9 I 10 0 Acceptanc e

Numbe r 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 1 6 Rejectio n |

Numbe r |
7 | 7 | 7 I 7 I 7 | 7 I 7 | 7 I 7 I 7 I 7 I 7 I 7 | 7 I 7 I 7 | 7 | 7 I 7 | 1 7

EL-2 1P.1 8

BINOMIA L SEQUENTIA L TES T (Cutoff : 10 0 inspections )
Ho : P < = 0.0 4 Ha : P > = 0.0 8 alpha : 0.0. 5 power : 0.5 0

TABL E2 

### Tes t Characteristic s
Percen t o f unit s Defectiv e 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 Averag e

Sampl e Siz e 43. 2 34. 0 18. 1 11. 9 8. 9 7. 2 6. 2 5. 3 4. 7 4. 2 Probabilit y

R e H o jectin g

0.1 6 0.9 2 0.9 8 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0

EL-2 2*WUWW_JCOWWWU)IV)t.N)N)l.tsirON)N)tgHHH.HPH.H M O^OOvlOlUl^WNHOiOOOvlOiUl^WNlHOiDOOvJiTiUli^WNHOiflOOslffiUli^UN )

I I I I I I I I I I I I I I I I I I I I I I I I I I I
. I I I I I I I I I I I I I

•^^^^^0^O^O^O^O^0*0^0>O^0^O\0^0^O*0*(TiO\ISIUIUIUIi^lJ^IJIIJIIJ\UllJIIJ\IJ\{^ I I I I

C O 3 c n T3 C D o r t r t C D c n 

### a o t- h 2 3

o 3 O £C D 5 " r t C D (_ > *- ! 3 O C D

C D C D O r t H O 3 1

_

1 C D
. I c n l r t l
. I T" l > l
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. i - i (_ : i
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t J m O h C 1 3 C D 3 *
•- ( fU

.. .. o o • v O O O O l w

- ~ M n a c o r t s O M

• • M C/ 1 O M o oUENTIALTESTinspections)P.2 0

TABL E 1 continue d Tes t Procedur e | Numbe r j o f unit s j Inspecte d 1 4 1 j 4 2 1 4 3 | 4 4 1 4 5 | 4 6 1 4 7 j 4 8 I 4 9 | 5 0 1 5 1 j 5 2 | 5 3 | 5 4 I 5 5 1 5 6 5 7 | 5 8 1 5 9 | 6 0 1 6 1 | 6 2 1 6 3 | 6 4 1 6 5 | 6 6 1 6 7 j 6 8 1 6 9 I 7 0 1 7 1 I 7 2 1 7 3 1 7 4 1 7 5 1 7 6 1 7 7 1 7 8 1 7 9 1 8 0 Acceptanc e

Numbe r

—

-

-

-

-

-

-

-

-

-

- 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 1 1 1 1 1 1 1 Rejectio n |

Numbe r j 7 | 7 I 7 j 7 I 7 I 7 I 7 | 7 | 7 j 7 I 7 I 7 j 7 I 7 | 7 j 7 I 7 j 7 j 7 | 7 I 7 I 7 I 7 I 7 I 7 | 7 I
' 7 | 7 I 7 I 7 I 7 j 7 | 7 I 7 | 7 I 7 I 7 I 7 | 7 | 7 j

EL-2 4P.2 1

TABL E 1 continue d Tes t Procedur e | Numbe r | o f unit s | Inspecte d 1 8 1 | 8 2 I 8 3 | 8 4 | 8 5 | 8 6 | 8 7 | 8 8 | 8 9 | 9 0 1 9 1 | 9 2 

### 1 9 3 | 9 4 1 9 5 | 9 6 1 9 7 | 9 8 | 9 9 | 10 0 Acceptanc e

Numbe r 1 1 1 1 1 1 l 2 2 2 2 2 2 2 2 2 2 2 2 

### 1 6 Rejectio n |

Numbe r |
7 | 

### 7 1 7 | 

### 7 1 7 | 7 1 7 • I 7 | 7 I 7 | 7 I 7 I 7 I 7 I 7 I 7 I 7 I 7 I 7 I 1 7

EL-2 5P.2 2



### BINOMIAL (Cutoff : Ho : P < = 0.0 4 Ha : P > = 0.0 8 SEQUENTIA L TES T 10 0 inspections ) alpha : 0.0 5 power : 0.9 0

TABL E2 

### Tes t Characteristic s
Percen t o f unit s Defectiv e 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 Averag e

Sampl e Siz e 88. 3 43. 8 22. 8 14. 8 11
. 2 -9. 2 7. 7 6. 6 5. 9 5. 3 Probabilit y

Rejectin g H o 0.2 7 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0

EL-26P.2 3 

### BINOMIAL (Cutoff : SEQUENTIA

L TES T 10 0 inspections ) Ho : Ha : P < = 0.0 4 P > = 0.0 6 alpha :

power : 0.0 5

0.5 0
TABL E1 

### Tes t Procedur e Numbe r o f unit s Inspecte d 1 2 3 4 5 6 7 8 9 1 0 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3 2 4 2 5 2 6 2 7 2 8 2 9 3 0 3 1 3 2 3 3 3 4 3 5 3 6 3 7 3 8 3 9 4 0 Acceptanc e

Numbe r

—

-

-

-

_

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

- 0 0 0 0 0 0 0 0 0 0 Rejectio n

Numbe r

• —

-

-

-

- 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7

EL-27P.2 4 1



### TABL E l continue d Tes t Procedur e 1 Numbe r | 1 o f unit s | Acceptanc e Inspecte d | Numbe r j 4 1 | 0 

### 4 2 | 0 4 3 

### 1 0 4 4 | 0 

### 4 5 4 6 | 0 4 7 

### 1 o 4 

### 8 | 0 4 

### 9 | 0 

### 5 0 | 0 

### 5 1 1 1 5 2 | ! 5 3 | i 5 4 | i 5 5 | i 1 5 6 j ! | 5 7 | i 1 5 8 j 1 ! 5 9 | x 

### 1 6 0 | x 

### ' 6 1 | i 6 2 | ! 6 3 

## 1 1 1 6 4 | 1 

# 1 6 5 

# ' 1 1 6 6 j 1 j 6 7 | i 1 6 8 j 1 | 6 9 | ! 7 0 | x 7 1 

## 1 1 7 2 | 2 7 3 

### 1 2 7 4 

### 1 2 7 5 

### 1 2 7 6 

### 1 2 7 7 

### 1 2 7 8 | 2 7 9 

### 1 2 1 8 0 | 2 1 , 1 1 Rejectio n | 1 Numbe r | 1 7 | 1 7 | 1 7 j 1 7 j 1 7
. |

' 7 

### | 1 ' 7 | 1 7 | 1 7 | 1
. 7 | 1 7 | 1 7 | 1 7 | 1 7 |

' 7 

### | 1 7 | 1 7 | 1 7 | ! 7 

### | 7 | 7 

## I 7 

## I 7 | 7 

## I 7 j 7 | 7 j

" 7 1 7 j 

### 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 

## I 7 j 7 |

EL-2 8h-vOvOvOvOvOvOvOvOvOvOCOCOOOOOOOOOOOCOO O OvOOO~-Jv7iCn*-OJtN).OvOOO-JCTiCn^-OJ[N)
. o

OJOjL-)OJOJOJOJOJtN)tN)tN)tN)tN)tN)"N)tN)tN)rN)IN ) (T

^J-~J^J--J>~J^J--J-J-~J^J-J^J>-J^1^J-~J~J~J^ J
IN ) t o _ C D c n r t •t f

. o O C D H 

## B t
. W (- • o o 3 D , r t C

. C D H - 3 C C D o <P.26

_



### HO : Ha : BINOMIAL

(Cutoff : P < = 0.0 4 P > = 0.0 6 SEQUENTIA L TES T 10 0 inspections ) alpha : 0.0 5 power : 0.5 0

TABL E2 

### Tes t Characteristic s
Percen t o f unit s Defectiv e 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 Averag e

Sampl e Siz e 72. 3 46. 1 27. 8 19
. 3 14. 6 11. 3 9. 3 8. 1 7. 1 6. 3 Probabilit y

Rejectin g H o 0.2 1 0.9 9 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0

EL-3 0H — Cf l w W C

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t- i 3

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_ + J (f l Q J E H

0 4 0 4

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i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i i

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HNrn^_lM3.00ll>OHNM-f_1k0^a3mOHNm-l l _lvO.C00lOHNM-f-1U)>000> ^ .-f-frfrll^^^^f-fln_)lrl^n-lln-^-^lrl-1-^_)_)^o^o^ovovo^Dvo^^.^^^^^r v . o )P.2 9



### TABL E l continue d Tes t Procedur e | Numbe r | o f unit s j Inspecte d 1 8 1 | 8 2 1 8 3 | 8 4 1 8 5 | 8 6 | 8 7 | 8 8 | 8 9 | 9 0 1 9 1 | 9 2 1 • 9 3 | 9 4 1 9 5 1 9 6 1 9 7 | 9 8 | 9 9 | 10 0 Acceptanc e

Numbe r

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

- 

### 1 5 Rejectio n |

Numbe r j 6 1 6 1 6 1 6 1 6 | 6 I 6 I 6 I 6 I 6 I 6 I 6 I 6 I 6 | 6 I 6 I 6 I 6 I 6 I 1 6

EL-3 3P.3 0



### BINOMIAL SEQUENTIA L TES T (Cutoff : 10 0 inspections )
Ho : P < = 0.0 4 Ha : P > = 0.0 6 alpha : 0.0 5 power : 0.9 0



### TABL E 2 Tes t Characteristic s Percen t o f unit s Defectiv e 5 1 5 2 5 3 5 4 5 5 5 6 5 7 5 8 5 9 5 Averag e

Sampl e Siz e 92. 0 39. 7 23. 9 17. 1 13. 2 11. 0 9. 2 8. 0 7. 1 6. 3 Probabilit y

Rejectin g H o 0. 3 3 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0 1.0 0



### EL-3 4. -ST

-



# /OT/.__iJ__ TH.

H P.3 2

Ktarou o W©o

hBoflnory

SMC

. _30_fltr_flD_t3Q5_ l C30(?feO(_lln) g ©®ff5il(pa(nlS 7 P 0 80x42 6 Marcu s Hoo k

P A1906 1 -042 6 

### January12 , 199 0

Mr
. Rober t Aja x U.S
. EPA MD-1 3 Researc h Triangl e Park , NC 2771 1 Dea r Bob , A t th e Decembe r Reg-Ne g meetin g I tol d yo u tha t ou r eguipmen t screening cos t i s $1.75/component

. I hav e sinc e learne d fro

m ou r contracto r (TEAM ) tha t thi s i s onl ya bas e price

. Ou r tru e cost s ar e close r t o $2.75/component

. Fo r example , durin g 198 9 61,75 0 component s wer e screene d a t a cos t o f $169,170

. Thi s come s t o $2.74/component

. I hav e bee n tol d b

yTEA M tha t thi s pric e woul d hol d fo r th e Northeas t fro

mWashingto n t o Norther n Ne w Jersey
. Cos t i n th e Norther n Ne w Jerse yare a i s abou t $4/component

. Th e reaso n fo r th e differenc e betwee n $1.7 5 an d $2.7 5 i s tha t durin g everyscreening sessio n ther e ar e a certai n numbe r o f extraordinaryoperation s tha t mus t b e performed

. Thes e ar e charge d a t a n hourl yrat e an d include : 1
. Replacin g missin g an d damage d tags
. 2
. Addin g an

d removing component s fro mth e program . 3
. Screenin g "inaccessibles'•

. 4
. On-the-Spo t maintenanc e - tighte n packin g an d flanges , plu g o r cap ope n ends , etc
. I hop e thi s informatio n wil l b e o f hel p t o yo u an d yo u wil l u s i t whe n figuring VO C screening costs
. Sincerely , SU NREFININ

G AN D MARKETIN

G COMPAN

Y

Walte r Brenne r Senio r Environmenta l Specialis t

WBser g WB-RA1 2

_ 

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