HealthHazardBanding=

OccupationalExposureBanding

SusanD.Ripple,MS,CIH
 TopicsforDiscussion
Backgroundandbigpicture
Valueofoccupationalexposurebands(OEB)
OEBfitintotheIHprocess

OEBprocessforgeneralchemicals
Frameworkanddecisionlogic
Examplesandexercises
 ValueofHealthHazardBanding?
HealthHazardBanding
providesatoolforhygieniststo
doexposureriskassessment
andriskmanagementinthe
workplace.

Byprovidingtherelativehazard
bandsforthesubstancesunder
review,HHBwillservetheIH
communityinthequalitative
aspectsofriskmanagement.
Exposure Risk Assessment Knowledge Gaps

HAZARD EXPOSURE
Assessment Assessment

<2000OELs Chemicals
<2%REACH withOELs

Occupational ExposureRisk
ExposureBands Assessment
(OEBs)& (modeling,
ExposureLimits monitoring, Courtesyof
ElizabethPullen
(OELs) analogy)
andERAM
WorkingGroup

OccupationalHealth ExposureManagement IHExpertise

HazardCriteria& (Controls&Programs) Understanding
Process Exposure&Controls

~21,000,000commercial
availablechemicals;>107,000 Exposure Gap
REACH
 HierarchyofExposureLimits
(Traditional)HealthBasedOELs
KeyFeature usesweightofevidencejudgmentaboutthe
pointofdepartureanduncertaintyfactorsusinganadequate
data
Preliminary/ProvisionalOELs
KeyFeature includesweightofevidencejudgmentaboutthe
PODanduncertaintyfactors(UF),butusinglimiteddata
PrescriptiveorProcessbasedOELs(e.g.,DNELs)
KeyFeature providesalgorithmbasedapproachwithheavy
relianceondefaultdecisions.Requirespointofdeparture
information.
OccupationalExposureBand
KeyFeature enablesuseofhazardclassificationdatato
developOELranges
ProposedbyA.Maier,2012
 NIOSHProjectPlan
1. Establishminimumviabledataset,including
dataqualityrequirements
2. Establishprocessanddecisionlogic
3. Validatedataendpointsandbandcut
points,process,anddecisionlogic
4. Identifydatasources
5. DevelopNIOSHguidance
6. Educatestakeholders
 HazardBanding(OEB)Criteria
Criteriaincludequalitative,semiquantitative,and
quantitativedataforeachtoxicologicalendpoint
Acutetoxicity
Skincorrosion/irritation
Seriouseyedamage/eyeirritation
Respiratoryandskinsensitization
Germcellmutagenicity
Carcinogenicity
Specifictargetorgantoxicity,bothsingleandrepeated
exposure
Reproductivetoxicity
 OSHAGHSLink
OEBtoxicologicalendpointsarealignedwith
GHSclassificationandlabelingsystem*
Importantgoalistorelatepotencyofeach
toxicologicalhazardbandingendpointtoGHS
hazardstatementsandcategories,when
possible

*CLP20081272
 QualitativeCriteriaandGHSInformation
Band A B C (default) D E

GHS Signal Word Warning Warning Danger Danger Danger

> 1,000 g/m3 > 100 and < 1,000 g/m3 > 10 and < 100 g/m3 > 1 and < 10 g/m3 < 1 g/m3
OEL (Control)
Ranges
> 1000 ppm > 100 - < 1000 ppm > 10 - < 100 ppm > 1 - < 10 ppm < 1 ppm

Irreversible organ
Irreversible organ toxicity at low doses, in
Minor, reversible Reversible organ
Examples of toxicity at high doses, vivo genotoxicity, Human carcinogens
health effects toxicity, skin and eye
Health Outcomes irreversible skin and dermal sensitizer at at low doses,
occurring at high corrosion (reversible),
and Potency eye corrosion, dermal low doses, evidence of respiratory
doses. Skin and possible dermal
Considerations sensitizer at mutagenicity, potential sensitization
eye irritation. sensitizer at high doses.
moderate doses. developmental and
reproductive toxicants.

Fatal if inhaled (1).

Fatal if inhaled (2).
Fatal in contact with
Fatal in contact with
skin (1). May cause
skin (1). Causes
cancer (by route of
damage to organs (1).
Toxic if inhaled (3). exposure)1A. May
May cause cancer (by
Examples of Toxic in contact with cause allergy or
May cause Harmful if inhaled (4). route of exposure)
GHS Hazard skin (3). Suspected asthma symptoms or
drowsiness or Harmful in contact with 1A or B. Presumed or
Statements and of causing cancer (2). breathing difficulties if
dizziness skin (4). known human
Hazard Categories May cause damage inhaled (1A resp.).
reproductive toxicant
to organs (2) Known human repro
(1A or 1B). Causes
toxicant (1A). Causes
damage to organs
damage to organs
through prolonged or
through prolonged or
repeated exposure (1)
repeated exposure (1)
 FrameworkforDecisionLogic
Tier1a&b:GHShazardcodeorstatementfromSDSorthe
preferredGHSdatabase(AnnexVI,REACH,GESTIS,etc.).
HazardcategorywillfurtherdefineBandsDandE
User:H&Sgeneralist;mayoverestimaterisk
Warning negativeresultsvs.absenceofdata
Tier2:quantitativedatafromauthoritativesources
User:skilledindustrialhygienist
Tier3:toxicologicalweightofevidence determinethe
criticalstudyfromwhichascientificallysoundpointof
departure(POD)canbedetermined
User:toxicologistorexperiencedindustrialhygienist
OverviewofNIOSHTierApproachtoOEBs
Tier1aQualitative
UseGHSHazardStatementstoidentify
A B C DE chemicalswithpotentialforirreversible
healtheffectsatrelativelylowdoses
(BandDE)orremainatdefaultBandC
Tier1bSemiquantitative
A B C D E UseGHSHazardCategoriestoassign
chemicalsintoBandsDor Eorremain
atdefaultBandC
Tier2Quantitative
Determinepointofdeparture,
A B C D E factoringdataavailability,hierarchy,
andqualitytosupportassigning
chemicalsintoBandsA,B,orC
Tier3WeightofEvidence
A B C D E Involvesintegrationofallavailable
dataanddeterminingthedegreeof
convictionoftheoutcome.
 Tier1 MinimumData
Tier1aQualitative
UseGHSHazardStatementstoidentify
A B C DE chemicalswithpotentialforirreversible
healtheffectsatrelativelylowdoses
(BandDE)orremainatdefaultBandC
Tier1bSemiquantitative
A B C D E UseGHSHazardCategoriestoassign
chemicalsintoBandsDor Eorremain
atdefaultBandC

A B C D E

User:H&Sgeneralist;mayoverestimaterisk
 Tier2 RequiresMoreData

A B C DE

A B C D E
Tier2Quantitative
Determinepointofdeparture,
A B C D E factoringdataavailability,hierarchy,
andqualitytosupportassigning
chemicalsintoBandsA,B,orC
Tier3WeightofEvidence
Involvesintegrationofallavailable
User:skilledindustrialhygienist dataanddeterminingthedegreeof
convictionoftheoutcome.
Tier3 Ideal Robust DataSet

User:toxicologistorexperiencedindustrialhygienists

Tier3WeightofEvidence
A B C D E Involvesintegrationofallavailable
dataanddeterminingthedegreeof
convictionoftheoutcome.
 Datarelevance
Tier1
Relevance:anyGHScriteriacandetermineDor
Eband
 DataQuality
PresenceofGHSstatementsassumes
dataofadequatequalityforclassified
endpoints
AbsenceofGHSstatementsassumes
eitherlackofadequatedataordata
quality
 WherecanIfindTier1data?
GHScompliantSafetyDataSheetorchemicallabel

OSHAHazCom2012:
http://www.osha.gov/dsg/hazcom/ghsfinal
rule.html

ECHAclassificationandlabelinginventory(includes
AnnexVI):http://echa.europa.eu/regulations/clp/cl
inventory
 DefaultBandC
Tier1processbeginsbydeterminingwhether
dataexiststomoveachemicalfromdefault
bandC(>10and<100g/m3)toDorE
band
 Tier1aand1b
Chemicalfor
OEB
Goal:IdentifyBandsDEfromDefaultBandC

Needto
Authoritative yes define no RemainatBand
NoOEB
OELavailable? necessary BandDvs. DE
E?
no yes

Reviewavailable
Health no Hcategoriesor
BandCdefault
statements gotoTier2
assigned
available?

yes
E Hazard yes
no AssignBandE
DorE BandCdefault categories?
statement? assigned
no
yes
Tier2process DHazard yes
BandDE AssignBandD
todetermine categories?
assigned
BandAorB
 Tier1Bands D&E
UsingGHShazardstatementsorcodes(qualitative
hazardbanding),formostcriteria,cannotseparate
theDfromtheEbands
AcutetoxicityHcodes:H300,H330,H310
SensitizationHcode:H334
Germcellmutagenicity:H340
Carcinogenicity:H350
Toxictoreproduction: H360f,H360d,orH360fd
STOT(RE):H372
UsingtheGHShazardcategoryand/oraTierIIprocess
willberequiredtoseparateDfromE
 AcuteToxicity
Band A B C D E
GHS Signal Word Precautionary Warning Danger Danger Danger

--
GHS Hazard
4 3 2 1
Category
Harmful if swallowed.
Toxic if swallowed. Fatal if swallowed. Fatal if swallowed.
GHS Hazard Harmful if inhaled.
Toxic if inhaled. Toxic Fatal if inhaled. Fatal in Fatal if inhaled. Fatal
Statements Harmful in contact
in contact with skin. contact with skin. in contact with skin.
with skin

H Codes H302, H332, H312 H301, H331, H311 H300, H330, H310 H300, H330, H310

Oral Toxicity LD50

Technical Criteria >2000 >300 and 2000 >50 and 300 >5 and 50 5
(mg/kg bodyweight)

Inhalation Vapors
(mg/l) LC50 Technical
>10.0 and 20.0 >2.0 and 10.0 >0.5 and 2.0 0.5
Criteria
(mg/kg bodyweight)

Example:Acetylenetetrabromide
H330(fatalifinhaled)category2(LC50inhalationrat:0.549mg/l/4h)
H319(causesseriouseyeirritation)category2
BandD(OSHAPEL:1ppm)
 SensitizationRespiratoryandSkin
E
Band A B C D Consider Ceiling for
respiratory sensitizers
GHS Signal
Word
Warning Warning Danger Danger
GHS Hazard
Category
1B (skin) 1A (skin) 1B (resp.) 1A (resp.)
May cause allergy May cause allergy
GHS Respiratory or asthma or asthma
and Skin May cause an May cause an
symptoms or symptoms or
Sensitization allergic skin allergic skin
Hazard breathing breathing
reaction reaction
Statements difficulties if difficulties if
inhaled inhaled
Respiratory and
Skin
Sensitization H
H317 H317 H334 H334
Codes

Example:IsopropylGlycidylEther
H332(harmfulifinhaled)category4
H341(suspectedofcausinggeneticdefects)category2
H317(maycauseallergicskinreaction)category1
H334(maycauseallergyorasthmasymptoms)category1
BandDorE(NIOSHREL:50ppmC;IDLH400ppm)
 Carcinogenicity
Band A B C D E
GHS Signal Word Warning Warning Danger Danger
GHS Hazard
2 2 1B 1A
Category
GHS
Suspected
Carcinogenicity Suspected of May cause
of causing May cause cancer
Hazard causing cancer cancer
cancer
statement
Carcinogenicity
H351 H351 H350 H350
H Codes

Example:4Aminobiphenyl

H350(maycausecancer)category1A
H302(harmfulifswallowed)category4(oral)
BandE(FrenchOEL:0.001ppmor7g/m3)
 AdditionalTier1Examples
1bromopropane
TIER1a
Signalword:danger
H360FD:Maydamagefertilityortheunborn
child
H373:Maycausedamagetoorgansthrough
prolongedorrepeatedexposure(STOTRE2)
H319:Causesseriouseyeirritation
H335:Maycauserespiratoryirritation
H315:Causesskinirritation
H336:Maycausedrowsinessordizziness
TIER1aoutcome:BandDE
TIER1b
HazardCategoryRepro1B
TIER1boutcome:BandD:(110ppm)
TLV:10ppm
OSHAGHS:Presumedhumanreproductive TIER1boutcome:BandE:(<1g/m3)or
toxicant
CobaltSulfate
TIER1a
Signalword:danger
H334:Maycauseallergyorasthmasymptoms
orbreathingdifficultiesifinhaled
STOTRE1
H350i:Maycausecancer
H360F:Maydamagefertility
H341:Suspectedofcausinggeneticdefects
H302:Harmfulifswallowed
H317:Maycauseallergicskinreaction
TIER1aoutcome:BandDE
TIER1b
Germcellmutagencategory2
Resp.Sens:1
Carcinogencategory1B
Repro1B
BandD:(1 10g/m3)
TLV:20ug/m3
 Tier1Summary
Alltoxicologicaldatarelevant
Anytoxicologicaloutcome,assumingdataisfrom
anauthoritativesource,canresultinbandDorE
RefertoGHShazardcategorytobetterdefine
Dvs.E
Tier2processisrequiredtodetermineA
andBbands
 Tier2(Quantitative)
Goal:determinewhetherBandsAorBcanbeassigned
OEBbasedonpointofdeparture(POD)atwhichadverseeffects
areobserved
o NOAEL,BMDLorLOAELfortargetorgansystemictoxicity,
developmental/reproductivetoxicity;
o CSFs,IUR,TD05/TC05,NSRLs(CalEPAProp65)oftumorigenic
dosesforcarcinogenicity(stillbeinginvestigated);
o Skinandrespiratorysensitization
o LD50(oralanddermal)orLC50(inhalation)foracutetoxicity
data;
o RD50(inmice)forsensoryirritation;
o Irritationthreshold(mice,ratsorhumanvolunteers)for
irritation
 Tier2DataReliability
Presenceofauthoritativeassessment assumes
dataofadequatequalityforclassified
endpoints
Absent authoritativeassessments,individual
studiesareevaluated
Consulttoxicologist
 Examplesofreliabledatasources
NIOSHPocketGuide:http://www.cdc.gov/niosh/npg/
IUCLID5:http://iuclid.eu/
OECDChemPortal
http://www.echemportal.org/echemportal/index?pageID=0&
request_locale=en
NationalLibraryofMedicineToxNet:
http://toxnet.nlm.nih.gov/
ECHAregisteredsubstancesdatabase:
http://echa.europa.eu/en/informationon
chemicals/registeredsubstances
GESTIS:http://www.dguv.de/ifa/en/gestis/stoffdb/index.jsp
ATSDR:http://www.atsdr.cdc.gov/mrls/mrllist.asp
 Tier2DataWeight
Carcinogenicity
Reproductivetoxicity
15
Specifictargetorgantoxicityrepeatedexposure
Specifictargetorgantoxicity,singleexposure
Germcellmutagenicity(invivo)* 10
Respiratorysensitization**
Acutetoxicity
Skincorrosion/irritation
Seriouseyedamage/eyeirritation 5
Germcellmutagenicity(invitro)*
Skinsensitization**

*useweightofevidence
 Tier2
CanBandAorBbeconsidered?

Tier1Process
DoesTDSexceed no Datainsufficient
resultsinBandC
thresholdfor forOEB,C
minimum,quality defaultband
dataset?

yes
Identifypointsof
departure
TDSreflectsthe
EstablishOEB
availabilityofqualitative
infoand/orquantitative
Scoredata
relevance dataforeachendpoint
underconsideration.
Endpointscoresinclude
EstablishTotal
DeterminantScore
datarelevanceand
(TDS) qualityfactors.TDSis
thesumoftheendpoint
scores.
 TotalDeterminantScore
Assigned
Category Toxicological Endpoint
Weight
Non-systemic, POI, and/or Skin sensitization 5
immunological endpoints Skin/eye irritation 5
Genotox/mutagen (in vitro) 5
Respiratory toxicity/asthma 5
Irreversible non-systemic Skin/eye corrosion 5
Systemic endpoints Acute toxicity/lethality 5
Genotox/mutagen (in vivo) 10
Target organ toxicity SE 10
Target organ toxicity RE 15
Reproductive toxicity 15
Developmental toxicity 15
Cancer 15
Data sufficiency threshold for TDS 20/50
POI=pointofimpact
 NextStepsforNIOSHMatrix:
Validate
Criteriaendpointsandbandcutpoints
Process
Decisionlogic
Modifybasedonvalidationresults