P. 1 

# OAR Box 

# 1846 Prepped by Ollie Stewart
Document

Number: 

# 43 ) ll-E- 3 Docket Number: 

# A-90-0 7

Printed 11/18/20087:30:16

AM Sheet 43 of 93P. 2

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# US B UNITE D STATE S ENVIRONMENTA L PROTECTIO N AGENC Y V . ^ AN N ARBOR . MICHIGA N 4810 5 OFFIC E O F AI R AN O RADIATIO N FE B 2 1 138

2 MEMORANDU

M SUBJECT : Meetin g Betwee n EPA , AP I an d CM ARegardin g Draf t FF A Registratio n Regulation s Caroly n Krueger , Chemica l Enginee r U#- A> ' v ' ^ ) ^ Standard s Developmen t an d Suppor t Branc h FROM : TO : THRU : Docke t No . A-90-0 7

Glen n W . Passavant , Senio r Projec t Manage r Standard s Developmen t an d Suppor t Branc h O n Wednesday , Septembe r 19 , 1991 , representative s fromEPA , th e America n Petroleu mInstitut e (API ) an d th e Chemica l Manufacturer s Associatio n (CMA ) me t a t EPA' s Moto r Vehicl e Emission s Laborator yi n An n Arbor , Michigan . (Se e Attachment s fo r lis t o f attendees. ) EP Abriefe d AP I and CM Ao n th e genera l descriptio n o f th e draf t Fuel s an d Fue l Additive s Registratio n Notic e o f Propose d Rulemaking . (Se e Attachment s fo r a copyo f th e briefin g presented. ) Topic s discusse d wer e th e scop e o f th e healt h an d welfar e effect s provisions , th e assessmen t o f suc h effects , th e propose d treatmen t o f conventiona l fuels , and provision s fo r emissio n contro l syste mevaluation . Apotentia l groupin g methodologyand treatmen t o f smal l businesse s wer e als o covered . Attachment sP. 3

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PARAMIN S C . A . KELLER , Ph.D . Head . Environmenta l an d Regulator y Affairs ' EXXO N CHEMICA L COMPAN Y RO . Bo x 53 6 Linden . N.J . 0703 6 Tel . (201)474-597 0 FA X (201 ) 474-679 7P. 4



## FUEL S AN

D FUE L ADDITIVES REGISTRATIO

N PROGRA

M Potentia l Issue s for Regulator y Negotiation Washington , D.C . Ma y 2,199 1
Emissio n Control Technolog y Divisio n Offic e of Mobil e Source s Offic e o f Ai r and Radiatio n 

### U.S . Environmenta

l Protectio n Agenc

y 

# mP.5 _ OVERVIEW Backgroun d Statutory Provision s Timeline s Fuel s an d Fue l Additive s Registratio n Databas e Program Component

s • Scop e o f

Healt h Effect s Provision s • Scop e o f

Welfare Effect

s Provision s Treatmen to f

Conventional Fuel s Assessmen to f

Health/Welfare Effect

s Emissio n Control System Provision s Othe r Program Issue s • Groupin g o f

Fuel s an d Fue l Additive s Smal l Busines s Provision s Important

Note: This document

outlines EPA's current

perspectives on some of

the issues involved

in the development

of new regulations forthe registration of motorvehicle fuels and fuel additives. These views are presented forthe purpose of

initiating constructive discussion, and should not be construed

as final decisions or

formal rulemaking proposals. - 2 -P. 6



## BACKGROUN

D

- 3 -P. 7 STATUTOR

Y PROVISION S Clean Ai r Ac t

Section s 211(b)(2 ) and 211(e ) Specifie s registratio n requirement s fo r new motor

vehicl e fuel s and fue

l additive s (F/FAs ) Applicabl e t o bot

h current and new F/FA s Grant s authorit

y t o EP A to collec t

informatio n o n potential advers e effect s of F/FA s

- Regulator

y contro l base don such informatio n woul drequir e follow-o n rulemakin g under

Sectio n 211(c ) Require s manufacturer s t o assess :

- Compositio n of

F/F A emission s

- Effect s of

F/F A emission s o n designate d healt h parameter s

- Impac t of F/F A emission s o n th e publi c welfar e

- Effect s of

F/FA s o n emissio n contro l systemperformanc e Authorize s specia

l provision s for :

- Smal l businesse s

- Cost-sharin g arrangement s

- Avoidanc e o

f duplicativ e informatio n

- 4 -P. 8 TIMELINE S Rulemakin g Deadline s (pe r ConsentDecree ) Notic e o f Propose dRulemakin g (NPRM ) du e Januar y 1 , 199 2
• Final rule s du e Jun e 1 , 199 3 Complianc e deadline s (pe r Statute )
• For F/FA s alread

y registere d when fina

l rule s published : thre e year s fro mfina l rulemakin g (June , 1996 )
• Fo r ne w products : prio r

t o registratio n

- 5 -P. 9 FUEL S AN

D FUEL ADDITIVE S REGISTRATIO N DATABAS E Fuel s
• 2,23 5 gasoline an

d diese l fuels registere

d b y 76 4 manufacturer

s • 2,13 9 contai

n additives , 9 6 contai

n n o additive

s • Include s 1,30 4 no-lea d gasolines , 71 8 leade

d gasolines , 5 9 # 1 diese

l fuels , an d 154 # 2 diese

l fuels • Registratio

n fo r alternativ

e fuels i s planne

d fo r th e nea r futur e Additive s Classification Bul k Aftermarke

t Bot h Tota l Numbe r o f Manufacturer

s 18 0 93 0 _5 0 1,16 0 Numbe

r o f Additives 1,67 3 2,42 9 13 4,11 5

- 6 -P.1 0



## PROGRAM COMPONENT S

- 7 -P.1 1 SCOP E O F HEALT H EFFECT S PROVISION S Genera l Approac h • Establis h requirement s tha t ar e bot h reasonabl e an

d necessar

y fo r regulator y decision-makin g • Fin d appropriat

e balanc e between informatio n need s and tech nical/economi c constraint s • Us e tiere d testin g approach , emphasizin g relativel y short-ter m screenin g wit

h allowanc e fo

r more rigorou s studie s a s require d Focu s o n effect s o f

F/F A emission s onl y • Consistent

wit h specifi c statutor

y intent o f Sectio n 21 1 and general objective s o f

Clea n Ai r Ac t a s awhol e (per

current interpretatio n fro

m EPA' s Offic e of

Genera l Counsel ) • Include s assessment

o f effect s o f inhalatio n exposur

e t o combustio n emission s an d evaporative/refuelin g emission s • Assessment

o f effect s o f

oral/derma

l exposur e t o "raw " F/FA s i s i n th e domai n of

other programs , e.g. , TSC A Rol e o f atmospheri c transformatio n products • Som e o f thes e product s ma

y pos e sigmfican

t healt h risk s • Reasonabl e t o requir

e analyti c assessment , but

actua l la b tes t require ment s preclude d b y scientifi c and technica l limitation s • Mor e definitiv e evaluatio n ma y b e neede d i n th e futur

e - 8 -P.1 2

SCOP E O F HEALT H EFFECT S PROVISION S

(Continued ) Specifi c Healt

h Endpoint

s to be Addressed
• Minimumstatutor

y requirements :

- Carcinogenicit

y

- Mutagenicit

y

- Teratogenicit

y
• Planne d i n addition :

- Extensio n o

f teratogenicit

y testin g (in-utero effects ) t o include stud y of adult reproductiv e effects

- Pulmonar

y toxicit y Topic s Fo r Discussio n • Man y other healt h endpoint s ma

y b e of concern , e.g. , neurotoxi c effects , renal effects , chroni c inhalatio n effect s • Whic h (if

any ) ar e reasonabl e to include a s genera l progra mrequire ment s and necessar

y fo r regulator y decision-making ?

- q -P.1 3

SCOP E O F WELFAR E EFFECT S PROVISION S Planne d Approac h • Focu s o n publi c welfar

e and environmenta

l effect s o f air pollutio n • Assessmen

t expecte d t o rely on literatur e researc h an

ddat aanalysi s rather tha n laborator

y testing , because :

- Statut e call s fo r "reasonabl e an

d necessary " informatio n on welfar e effects , without

specifi c requirement

to conduc t

test s

- Limite dscientifi c testin g experienc e

- Lac k o f practical screenin g approache s

- Significan

t overla p between healt

h an denvironmenta

l effects

- Overla p wit h other EP A program s assessin g contributio n o f F/FA s t o majo r environmenta

l problem s such a s aci d rai n an d globa l warmin g Topic s fo r Discussio n • I s thi s approac h adequat e to fulfil l th e statutor

y requirements ? • Ar e there specifi c welfar

e issue s whic h shoul d b e mor e definitively addresse d withi n th e program ? I f so , how ?

-10 -P.1 4

TREATMEN T OF CONVENTIONA L FUEL S AN D ADDITIVE S Background • Th e ter m"conventional " refer s to gasolin e and diese l F/FA s which :

- Mee t EPA' s criteri afo

r categorizatio n as "substantially similar " to th e respectiv e certificatio n fue l (alread y in effec t fo r gasoline , no w unde

r development

fo r diesel )

- D o no t contai n compound s othe

r tha n thos e typically i

n 199 0 gasolin e or diese l fuels , no r

unusua l concentration s o

f suc h compound s • Sectio n 21 1 (e)(3 ) give s authorit y to allo w progra

mexemption s fo

r F/FA s i f EP A find s tha

t "additiona

l testin g o f such fue l or fue l additiv e woul d b e duplicativ e o

f adequat e existin g testing "

- Existin g informatio n o n conventiona l fuel s (andtheir

additives ) i s extensive : adequat

e t o justif y current an d planne d mobil e sourc e regulation s

- Exception : Significan

t informatio n ga

p regardin g potential teratogeni c an d other reproductiv e effect s o

f gasolin e and diese l emission s Planne d Approac

h • Exemp t conventiona

l F/FA s fro

mal l progra

mrequirements , assumin g satisfactor y completio n o

f teratolog y an

d reproductiv e studie s to b e specifie d b y EP

A • Retai n authorit

y t o requir

e additiona

l testin g t o addres s new concern s whic h ma y aris e in th e futur

e
-11 -P.1 5

TREATMEN T O F CONVENTIONA L FUEL S AN D ADDITIVE S (Continued ) Topic s fo r Discussio n • Ar e ther e additiona

l informatio n gap s i n regardto th e healt h effects o

f gasolin e and/o r

diese l fuel s which mus t

b e fille d to provide adequat e informatio n fo

r regulator y decision-making ? • Shoul d EPA mak

e afinding whic h exempt s thes e product s fromprogra m requirement s or , alternatively , shoul dth e producer s of conventiona

l F/FA s b e require dt o supply dat ademonstratin g th e existenc e o f "adequat e information" ?

-12 -P.1 6

ASSESSMEN T O F HEALTH/WELFAR E EFFECT S

Overvie w o

f Tie r Structur e Tier l • Emissio n speciatio n • Literature search fo

r existin g informatio n o n healt h an d environmenta

l testin g • Dataanalysi s andexposur e modelin g Tie r 2 • Short-ter

mlaborator

y testin g fo

r designate d healt

h effects • Tier 2 require donly to th e extent tha t the result s o

f well-conducte d comparabl e test s ar

e no t foun ddurin g Tier

1 activitie s Tie r 3 • Additiona

l testin g a

t EPA' s discretion , base d o n specifi c informatio n need s indicate d b y result s of Tier s 1 an

d 2

-13 -P.1 7

ASSESSMEN T O F HEALTH/WELFAR E EFFECT S

Tie r 1 : Emissio n Speciatio n Function s • Satisfie s statutor

y provisio n t o "determine the emissions " o f F/FA s • Provide s inventor

y o f potentiall y hazardou s motor vehicl e emissions , an

d provide s basi s fo

r analytica l and modelin g studie s Require d Speciatio n Procedure s • EP A benc h procedure s fo

r CO , C0 2 , total hydrocarbon , methane , NOx , and total particulate s (whe n applicable ) • Protocol s develope d b y th e Auto/Oi l Study , includin g ga s chromatogra ph y (GC ) fo

r C 1- C 1 2 hydrocarbon s an d alcohol s and HPL C for aldehyde s • Identificatio n o f

polycycli c aromati c hydrocarbon s (PAHs ) i n bot h vapor phas e an d particulate phas e of exhaus t emission s • Determinatio n o f

th e chemica

l fat e of element s o f

specia l concern , e.g. , metals , halogen s • Possibl e additiona

l compound-specifi c analyse s fo r designate d air

toxic s Special Consideration s fo r Additive s • T o approximat

e in-us e conditions , additive s mus t b e mixe d wit

h the ap propriate parent

fue l prio r t o generatio n and analysi s o f emission s

- Additiv e concentration s ma y b e "doped up " to enhanc e detectabilit y • T o determin e additive' s contributio n to speciate d products , th e emission s profil e o f th e parent

fue l mus t b e subtracte d fromthe emission s profil e o f th e additive/fuel mixtur

e -14 -P.1 8

ASSESSMEN T O F HEALTH/WELFAR E EFFECT S Tie r 1 : Emissio n Speciatio n (Continued ) Topic s fo r Discussio n • Regarding combustio n emissions :

- Wha tvehicle s an

d operating condition s ar e appropriat

e fo r generating th e emissions ?

- Ar e the planned speciatio n procedures reasonable ? Ar e they ade quate ?

- T o wha

textentshoul d mas s spectroscop y b e required i n conjunctio n wit h ga s chromatography ? • Regarding evaporativ e emissions :

- Wha tprocedure s shoul d b e use d fo r generatin g an d speciatin g evaporativ e emissions ?

- Wha tcriteri a (e.g. , V P o r RV P limits ) shoul d b e establishe d fo r deter minin g whethe r evaporativ e emission s ar e pertinen tfo r a give n F/FA ?

- Ca n evaporativ e emission s b e accurately predicte d base d o n physica l an d chemica l characteristics o f the liqui d F/FA , as a

n alternative t

o actua l chemica l analysis ? • Regarding additives :

- Wil l artifact

s b e created b y "dopin

g up " additiv e concentrations ?

- Wha tparen tfue l specification s shoul d b e used ?

- I s side-by-sid e testin g o f th e paren

tfuel an d th e additive/fuel mixtur

e required? -15 -P.1 9

ASSESSMEN T O F HEALTH/WELFAR E EFFECT S Tie r 1 : Informatio n Searc h and Analysi s Component

s • Compar e emissio n product s o

f th e F/F A to publishe d list s of

air toxic s • Searc h publi c and in-hous e source s fo r informatio n about

th e healt h an d welfar e effect s of

th e F/FA' s emission s • Us e analyti c method s (suc h a s th e CARB/Carte r scale ) t o estimate the chemica l reactivit y o f emitte d compound s and thei r predicte d contribu tio n t o atmospheri c ozon e • Us e modelin g method s (suc h a s th e Ingalls/Garb e approach , SA E Tech nical Paper

820787 ) t o estimate concentration s of th e speciate d emission s in typica

l exposur e scenario s Evaluatio n o f

Informatio n "Adequacy " • I f th e informatio n gathere dabov e include s th e result s of test s tha t ar e comparabl e t o thos e i n Tier 2 , the n th e Tier

2 test s wil l no t

b e require d

- Suc h studie s mus t

tes t F/F A emissions . Fo r

example , whol e aerosol ize d fuel s are no t

equivalent

t o evaporativ e emission s • Existin g test s mus t

b e wel l documente dan dmus t b e conducte d i n accordanc e wit h establishe d scientifi c an d technica l standard s • EPA wil l b e fina

l judg e o f adequac y o f

existin g tests , and wil l reserv e authorit y t o require additiona

l testin g

-16 -P.2 0

ASSESSMEN T OF HEALTH/WELFAR E EFFECT S Tie r 2 : Short-Ter

m Laborator

y Testin g Background • Minimumbatter

y o f screenin g test s fo

r the previously designate d endpoint s are liste d belo w • Ame s batter

y make s us e o

f particulate extrac t

(whe n applicable) , whil e al l other test s involv e exposur

e o f animal s t o whol e emission s • When testin g additives , th e effect s o f emission s generate d fromth e additive/fue l mixtur

e ar e compare dto th e effects of emission s fromthe parent fue l alon e Require d Tests • Carcinogenicit

y (C ) an dmutagenicit

y (M ) screens :

- AME S Revers e Mutatio n Assa y ( C and M )

- Unschedule d DN

A Synthesi s (C )

- Bone-Marro w Micronucleu s Assa y (C )

- Wit h Chromosoma

l Aberration s (C )

- Wit h Sister Chromati dExchang e (M ) • Teratogenicit

y screen :

- Inhalatio n exposur

e o f female rodent s durin g Day s 6-1 5 o f pregnanc y

- Analysi s o

f uterin e content s o n Da

y 2 0 • Reproductiv e an d pulmonar y toxicit y screens :

- 28-da y inhalatio n exposur

e o f mal e an d female rodent s

- Morphologic , histologic , an dfunctiona

l analyse s o

f relevant structure s -17 -P.2 1

ASSESSMEN T O F HEALTH/WELFAR E EFFECT S Tie r 2 : Short-Ter m Laborator y Testin g (Continued ) Topic s fo r Discussio n
• Ar e thes e Tie r 2 requirement s adequate ? Ar

e they reasonable ? • Shoul d product

s wit h hig h potentia

l risk o f exposure (e.g. , fuel s an d som e oxygenates ) b e teste d mor e rigorously a

tTie r 2 tha

n thos e wit

h relativel y lo w exposure potential ?

- For example , shoul d the routine tes trequirement s fo r fuel s includ e subchroni c o r eve n chroni c inhalatio n exposure studies , instead o f leavin g such testin g to Tie r 3 ? • Wha tvehicle s an

d operating conditio n shoul d b e require d i n generatin g combusio n emission s fo r testing ? • Shoul d F/FA s wit

h lo w vapo r pressur

e b e excuse d from tes tre quirement

s fo r evaporativ e emissions ? • Shoul d evaporativ e emission s b e subjec tto th e same routine healt h testin g requirements as combustio n emissions ? • Int o wha tparen tfuel formulations (e.g. , industr y average o r certification typ e fuels ) shoul d additive s b e mixe d fo r testing ? • I s side-by-sid e testin g o f th e additive/fuel mixtur e an d the paren

tfuel required ? • Ca n testin g programs b e coordinated betwee n manufacturer s o f fuel s an d manufacturer

s o f related additives ?

-18 -P.2 2

ASSESSMEN T OF HEALTH/WELFAR E EFFECT S Tie r 3 : Additiona

l Testin g Requirement

s
• EP A retain s authorit

y to requir

e additiona

l testin g base d on result s o f Tier s 1 and 2

- Coul d include subchroni c (9 0 day ) and/or chroni c ( 2 year

) inhalatio n studies , usin g anima

l subject s

- Woul d b e tailore d t o specifi c concern s identifie d in earlier tier s • Exercise d a

t EPA' s discretio n o n acase-by-cas e basis , e.g. :

- Persuasiv e qualitativ e evidenc e o f emissions-base d toxicit

y exists , but mor e definitiv e informatio n i s neede dfo r regulator y decision-makin g

- Result s o

f Tier 2 test s ar

e negativ e (i.e. , apparently non-toxic) , but EP A believe s inadequat

e la b techniqu e interfere d wit

h result s

- EP A disagree s about

"adequacy " o

f Tier 1 informatio n

-19 -P.2 3 OVERVIE W O F EVALUATIO N TIER S 

# I "Conventional " Gasolin e o rDies e Fuel s an d Fue l Additive s

Testin g t o fil l specified ] informatio n gaps STAR T 

# 1 D C

Non-"Conventional " Fuel s an d Fue l Additive s 

# D I ra SL. Emission s Speciatio n Dat a searc h an d analysis : Revie w o f previou s testin g Analysi s o f chemica l reactivit y an d exposur e potentia l "Adequate " Existin g — Informatio n "Indequate " Existin g Informatio n

* Tie r2 Short-ter m laborator y testin g fo r carcinogenic , mutagenic , teratogenic , reproductiv e an d pulmonar y effect s 

# J Tie r3 : Additiona l Testin g Longe rterm , antmal-base d testin g wil l b e prescribe d a t EPA' s discretion , e.g. , whe n ther e i s persuasiv e qualitativ e evidenc e of emissions-base d toxicity , an d bette rris k quantificatio n i s require d ^ \

EN D

* "Adequate " Implie s tha t th e existin g informatio n Include s th e result s o f test s comparabl e t o thos e require d i n Tie r2 . -20 -P.2 4

EMISSIO N CONTRO L SYSTE M PROVISION S Background • Sectio n 211(b ) authorize s testin g to determin e F/F A impac t on the abilit y o f EC S equipmen

t t o comply wit

h emissio n standard s • Significan

t overla p wit h Sectio n 211(f

) rales implemente d in 197 7

- Establishe s criteri afo

r F/FA s considere d "substantially similar " to certificatio n fuel s

- Fo r F/FA s tha

t ar e no t "sub-sim" , require s EC S testin g t o obtai n a waive r allowin g introductio n into commerc e • Applicabilit

y o f Sectio n 211(f

)

- In th e past , applie d only to unleade d gasolin e and it s bul k additive s

- 199 0 CA

A Amendment s extende d211(f ) authorit y to othe r F/F A types , e.g. , diese l and "alternative " fuel s

- Under "grandfathering " provision , stil l doe s no t appl y to non-gasolin e F/FA s and aftermarke

t gasolin e additive s introduce d pre-199 0 Planne d Approac

h
• Develo p "sub-sim " rule s fo r diese l andothe

r fue l type s • Continu e 211(f

) jurisdictio n fo

r EC S testin g • T o addres s concem s about grandfathere dF/FAs , EP

A ma y (a t it s discre tion ) require waive

r applicatio n fo

r particula r F/FA s upo n petitio n o

f vehicl e manufacturer s or

othe r intereste dpartie s -21 -P.2 5

EMISSIO N CONTROL SYSTE M PROVISION S (Continued ) Topic s fo r Discussio n • I s thi s approac h adequat e to addres s concern s about th e impac t

o f F/FA s on EC S function ? • I n existin g aftermarke

t additive s (and othe

r F/FA s which hav e previousl y bee n outside th e jurisdictio n o f Sectio n 211[f]) , ar

e ther e component s know n to hav e advers e effects on EC S performance ?

-22 -P.2 6



## OTHE RPROGRAM ISSUE S

-23 -P.2 7

GROUPIN G OF FUEL S AN D FUE L ADDITIVE S Objective s • Enabl e manufacturer s o f chemically simila

r products , o n avoluntar

y basis , to shar

e cost s o f progra mcomplianc e • Minimiz e duplicativ e efforts an dredundan

t informatio n • Eas e deman don limite dlaborator y capacit y • Decreas e volum

e o f materia l fo r EP A revie w an

d analysi s Planne d Approac

h • EP A wil l develo p groupin g criteri aaccordin g to chemica l compositio n o f ra w F/FAs , sinc e compositio n o f emission s no t

yet know n

- Group s likel y to b e narrowly defined , base do n characteristic s such a s aromati c content , presenc e of specifi c metal s an

d halogens , etc .

- Groupin g systemwil l b e update da s neede dto properl y accommodat e variabilit y o f futur e F/FA s • Formation , organization , and operatio n of group s preferably brokere d by participatin g manufacturer s themselve s • Withi n eac h group , one o r mor e representativ e F/FA s wil l b e selecte d a s subject s fo

r require d test s

- Selectio n of

representatives ma

y b e done by EPA , or

ma y b e done b

y manufacturer s under

EP A guideline s

- Tes t results fo r representative s wil l b e applie dt o al l grou p member s -24 -P.2 8

GROUPIN G OF FUEL S AN D FUE L ADDITIVE S (Continued ) Topic s Fo r Discussio n • Group definition s an

d selectio n criteri afo

r grou p representative s • Qualit y o f dat ai n current

F/F A Databas e • Formatio n and organizatio n o f group s • Financia

l factors :

- Cos t sharin g mechanism s fo

r group s o f existin g F/FA s

- "Buy-in " arrangement s fo r manufacturer s seekin g first-time registra tio n of product s which ar

e simila r t o individua

l F/FA s o r F/F A group s tha t hav e alread

y satisfie d progra

mrequirement s

- Lengt h o f tim e such provision s shoul d b e i n effec t

-25 -P.2 9 SMALL BUSINES S PROVISION S Authorit y • Unde r Sectio n 21 1 (e)(3) , EP

A ma y modif y the F/F A registratio n require ment s fo r smal l businesse s • "Small business " i s to b e definedwithi n the regulation s Planne d Approac

h • EP A doe s no t

pla n to exercis e thi s authority , i n consideratio n o f the following factors :

- Propose d exemptio n fo

r conventiona

l F/FA s i s expecte d t o reduc e th e testin g burde n fo

r man y currently-registere d product s

- Opportunit

y fo r cos t sharin g

- Relativel y modes t

requirement s planne d throug h Tier 2

- Additional , more costl y testin g i s t o b e require d only when significan t hazar dpotential ha s been identifie d

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