occupational exposure banding and exposure risk management
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Occupational Exposure Banding and Exposure Risk Management
Susan Ripple, MS, CIH, FellowGlobal Manager – Industrial HygieneThe Dow Chemical CompanyMidland, MI
Value of Occupational Exposure Bands (OEB) to supplement other authoritative OELs
Value of OEBs to the industrial hygiene process (ERAM)
OEB Framework
Exposure Risk Assessment & Management (ERAM)
Topics for Discussion
Question!
How many of you are familiar with the AIHA “Exposure Assessment Strategies” for performing “qualitative exposure assessment”?
“Bread and Butter” of Industrial Hygiene
Traditional IH Definition: Anticipate Recognize Evaluate
Control
Hazard
A
ssessm
en
t
Risk Assessment (Qualitative or Quantitative)
Risk Management
– What is it?
ERAM
General Definition of Exposure Risk Assessment and Management (ERAM)
“ERAM is a concise framework to help illustrate the core skills of the industrial hygiene profession. Taken at a high level, ERAM is the anticipation, recognition, evaluation and control of chemical, physical and biological hazards to prevent illness and injury in workers, customers and communities.”
It is the science of understanding and managing human exposure risks.
Strengthen our CORE, Expand our Impact
ERAM is the core competency of IH. Owning the science of ERAM both strengthens our CORE and expands our market opportunities. ERAM is an important skill set needed for parts of…
▪ Sustainability▪ Product Stewardship▪ EHS Management
When we are viewed as being ERAM experts, these Allied Professions will put a higher value on our services. This creates greater need for internal and external IH Consultants
IH Expert
IH Generalist
Affiliated Professionals
EHS Generalist
Level of ERAM
Expertise
ERAM Discipline Under the Umbrella of Public Health
IH Expert
IH Generalist
Affiliated Professionals
EHS Generalist
Hypothetical Amount of “ERAM Expertise” for each job type…. (illustration only)
Percent of ERAM needed in job
100%
50-100%
5-50%
1-15%
<2000 OELs <2% REACH
~21,000,000 commercial-available chemicals; >107,000
REACH“Exposure Gap”
Exposure risk assessment knowledge gaps
Occupational Exposure Bands (OEBs) & Exposure Limits (OELs)
Exposure Risk
Assessment
(modeling, monitoring,
analogy)
Occupational Health Hazard
Criteria & Process
IH Expertise Understanding
Exposure & Controls
HAZARD Assessment EXPOSURE
Assessment
Exposure Management (Controls & Programs)
Courtesy of Elizabeth Pullen and ERAM Working Group
Chemicals with OELs
Scope of challenge to “design-out” chemical hazards
~21,000,000 commercially available chemicals
107,067 REACH* registrations (1-3-11) for >1000 tons production volume or those of high concern
But…only ~ 500 PELs, ~ 650 RELs, ~ 125 WEELs, ~ 650 TLVs
*REACH – Registration, Evaluation, Authorization, and Restriction of Chemicals
Scope of challenge to “design-out” chemical hazards
~21,000,000 commercially available chemicals
107,067 REACH* registrations (1-3-11) for >1000 tons production volume or those of high concern
But…only ~ 500 PELs, ~ 650 RELs, ~ 125 WEELs, ~ 650 TLVs
*REACH – Registration, Evaluation, Authorization, and Restriction of Chemicals
Missed O
pportunity
for E
RAM
The Gap . . . . . . . . . .
Hygienists prefer the more official peer-reviewed Traditional OELs,
But . . . . . . . .
14
“You can’t always get what you want, but if you try some times you might find, you’ll get what you need” – Mick Jaeger
MIHS
. . . . . . . . . . .
Occupational Exposure Banding provides
a mechanism for the evaluation of hazard
and risk to offset the misconceptions by
employers and workers that a substance
must be non-toxic if there is not an OEL!
‘Occupational Exposure’ vs. ‘Control’ Banding
“Hazard banding is simply the first step in the control banding process”
Susan D. Ripple. The Synergist: October 2009
“Occupational Exposure Bands” are a more appropriate description of Hazard Grouping or Hazard Banding
Donna Heidel and Susan Ripple. The Synergist: April 2012BOHS OEL-Setting Plenary
Hazard Bands = Occupational Exposure Bands (OEBs)
OEBs for a chemical provide a range of acceptable exposure levels based on expert evaluation of the dose-response relationships provided through animal testing.
OEBs simply highlight the concept of this model
Objective of “OEBs”
Develop the framework to systematically
evaluate occupational hazards of
chemicals without authoritative OELs
(PELs, RELs, TLVs, etc.) and
communicate the hazards in terms of
occupational exposure bands (OEBs).
Value of Occupational Exposure Banding
Facilitates more rapid evaluation of health risk & provides guidance for many materials without OELs
Highlights areas where data are missing (highlights uncertainties)
Identifies hazards to be evaluated for elimination or substitution
Aligned with GHS for hazard communication Supports the definition of OEL-ranges for families
of materials
Project plan
1. Establish minimum viable dataset,
including data quality requirements
2. Establish process and decision logic
3. Validate data endpoints and band cut
points, process, and decision logic
4. Identify data sources
5. Develop NIOSH guidance
6. Educate stakeholders
Criteria
Criteria include qualitative, semi-quantitative, and quantitative data for each toxicological endpoint
Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory and skin sensitization Germ cell mutagenicity Carcinogenicity Specific target organ toxicity, both single and repeated
exposure Reproductive toxicity
OSHA GHS Link
OEB toxicological endpoints are aligned with GHS classification and labeling system*
Important goal is to relate potency of each toxicological hazard-banding endpoint to GHS hazard statements and categories, when possible
Data quality is also considered
DRAFT Examples of Qualitative Criteria and GHS Phrases
Band A B C (default) D E
Signal Word Warning Warning Danger Danger Danger
OEL Ranges> 1,000 µg/m3 > 100 and < 1,000 µg/m3 > 10 and < 100 µg/m3 > 1 and < 10 µg/m3 < 1 µg/m3
> 1000 ppm > 100 - < 1000 ppm > 10 - < 100 ppm > 1 - < 10 ppm < 1 ppm
Examples of Health Outcomes and
Potency Considerations
Minor, reversible health effects occurring at high doses. Skin and eye irritation.
Reversible organ toxicity, skin and eye corrosion (reversible), possible dermal sensitizer at high doses.
Irreversible organ toxicity at high doses, irreversible skin and eye corrosion, dermal sensitizer at moderate doses.
Irreversible organ toxicity at low doses, in vivo genotoxicity, dermal sensitizer at low doses, evidence of mutagenicity, potential developmental and reproductive toxicants.
Human carcinogens at low doses, respiratory sensitization
Examples of GHS Hazard Statements
and Hazard Categories
May cause drowsiness or dizziness
Harmful if inhaled (4). Harmful in contact with skin (4).
Toxic if inhaled (3). Toxic in contact with skin (3). Suspected of causing cancer (2). May cause damage to organs (2)
Fatal if inhaled (2). Fatal in contact with skin (1). Causes damage to organs (1). May cause cancer (by route of exposure)—1A or B. Presumed or known human reproductive toxicant (1A or 1B). Causes damage to organs through prolonged or repeated exposure (1)
Fatal if inhaled (1). Fatal in contact with skin (1). May cause cancer (by route of exposure)—1A. May cause allergy or asthma symptoms or breathing difficulties if inhaled (1A resp.). Known human repro toxicant (1A). Causes damage to organs through prolonged or repeated exposure (1)
MIHS
Now – A Little “Detail” to Give You Confidence in the OEB Process!
A B C D-E
A B DC E
A B C D E
Tier 1a—QualitativeUse GHS Hazard Phrases to identify chemicals with potential for irreversible health effects at relatively low doses (Band D-E) or remain at default Band CTier 1b—Semi-quantitativeUse GHS Hazard Categories to assign chemicals into Bands D or E or remain at default Band C
Tier 2—QuantitativeDetermine point of departure, factoring data availability, hierarchy, and quality to support assigning chemicals into Bands A, B, or C
A B C D ETier 3—Weight of EvidenceInvolves integration of all available data and determining the degree of conviction of the outcome.
Overview of “Tier Approach” to OEBs
Framework for Decision Logic
• Tier 1 a & b: GHS hazard code or statement from SDS or the preferred GHS database (Annex VI, REACH, GESTIS, etc.). Hazard category will further define Bands D and E— User: H&S generalist; may overestimate risk
Warning – negative results vs. absence of data
• Tier 2: quantitative data from authoritative sources— User: skilled industrial hygienist
• Tier 3: toxicological weight of evidence – determine the critical study from which a scientifically sound point of departure (POD) can be determined— User: toxicologist or experienced industrial
hygienist
Chemical for OEB
Health statemen
ts available
?
D or Estatemen
t?
No OEB necessary
Band C default
assigned
Band C default
assigned
yes
no
no
yes
yes
no
Tier 1 a & b Identify Bands D-E from Default Band
C
Authoritative OEL
available?
Tier 2 process to determine Band A or
B
E Hazard categori
es?
yes
no
Need to
define Band D vs. E?
Remain at Band D-E
Review available
Hazard categories
Assign Band E
D Hazard categori
es?
Assign Band D
Band D-E assigned
yes
no
yes
Tier I “D” vs. “E”
Using GHS hazard statements or codes (qualitative hazard banding), for most criteria, cannot separate the “D” from the “E” bands
Acute toxicity H codes: H300, H330, H310 Sensitization H code: H334 Germ cell mutagenicity: H340 Carcinogenicity: H350 Toxic to reproduction: H360f, H360d, or H360fd STOT(RE): H372
Using the GHS hazard category and/or a Tier II process will be required to separate D from E
Tier 1 Example
1-bromopropaneTIER 1a
Signal word: danger H360FD: May damage fertility or the unborn child (D or E)
▪ OSHA-GHS: Presumed human reproductive toxicant H373: May cause damage to organs through prolonged or
repeated exposure (STOT-RE-2) H319: Causes serious eye irritation H335: May cause respiratory irritation H315: Causes skin irritation H336: May cause drowsiness or dizzinessTIER 1a outcome: Band D-E
TIER 1b Hazard Category Repro 1B Tier 1b outcome: Band D: (1-10 ppm) TLV: 10 ppm
Tier 2 (quantitative)
• OEB based on point of departure (POD) at which adverse effects are observedo LD50 (oral and dermal) or LC50 (inhalation) for
acute toxicity data; o RD50 (in mice) for sensory irritation; o Irritation threshold (mice, rats or human
volunteers) for irritation; o NOAEL, BMDL or LOAEL for target organ
systemic toxicity, developmental/reproductive toxicity; and
o CSFs, IUR, TD05/TC05, NSRLs (CalEPA Prop 65) of tumorigenic doses for carcinogenicity (still being investigated)
Tier 1 Process results in Band C
Establish Total Determinant Score (TDS)
Does TDS exceed threshold
for minimum, quality dataset?
Establish OEB
TDS reflects the availability of qualitative info and/or quantitative data for each endpoint under consideration. Endpoint scores include data relevance and quality factors. TDS is the sum of the endpoint scores.
Data insufficient for
OEB, “C” default band
yes
no
Tier 2Can Band A or B be considered?
Endpoint PODs from
authoritative reviews
Score data quality and relevance
Endpoint Bands Data Total OverallA B C D E Quality Relevance
Acute Toxicity
LD50 (Oral) LD50 (Dermal)
LC50 (Gases) LC50 (Vapors) LC50 (Dusts/mists)
Skin Corrosion / Irritation Serious Eye Damage Eye Damage / Irritation Respiratory Sensitization Skin Sensitization Germ Cell Mutagenicity Carcinogenicity Reproduction Specific Target Organ (Single Exposure)
Specific Target Organ (Repeated Exposure)
TDS
Total Determinant Score
Validate
Criteria endpoints and band cut points
ProcessDecision logicModify based on validation results
Work in progress
Finalize criteria for each band, including weight of evidence and dose-response considerations
Develop process, decision logic, and algorithms
Validate process and tools Develop stakeholder education
materials and guidance document Identify data sources
Expected project outputs
NIOSH guidance
Overall process, including the decision logic
Tools to facilitate finding and evaluating hazard data and assign chemicals to hazard bands
Education materials for H&S professionals, managers, and workers
MIHS
That was deep! What does that mean?
MIHS
Occupational Exposure Bands = OEBs
Hazard group Target airborne concentration range for
Control Banding
R phrases* GHS Hazard Classification (class/level)
A -Skin and eye irritants >1-10 mg/m3 dust or >50-500 ppm vapor
36; 38; 36/38; 65;66; All substances that do not have R phrases in groups B - E
Acute toxicity (lethality), any route, class 5; Skin irritancy class 2 or 3; Eye irritancy class 2; All dusts and vapors not allocated to another band
B - Harmful on single exposure
>01-1 mg/m3 dust or >5-50 ppm vapor
20; 20/21; 20/21/22; 20/22; 21; 21/22; 22; 40/20/21/22;33;67
Acute toxicity (lethality), any route, class 4; Acute toxicity (systemic), any route, class 2
C -Severely irritating & corrosive, skin sensitizers
>0.01-0.1 mg/m3 dust or >0.5-5 ppm vapor
23; 23/24; 23/24/25; 23/25; 24; 24/25; 25; 34; 35; 36/37; 36/37/38; 37; 37/38; 41; 43; 48/20; 48/20/21; 48/20/21/22; 48/20/22; 48/21; 48/21/22; 48/22; 39/23/24/25;
Acute toxicity (lethality), any route, class 3; Acute toxicity (systemic), any route, class 1; Corrosivity, subclass 1A, 1B or 1C; Eye irritancy class 1; Respiratory system irritancy (GHS criteria to be agreed); Skin sensitization; Repeated exposure toxicity, any route, class 2
D -Very toxic on single exposure, reproductive hazard
< 0.01 mg/m3 dust or < 0 5 ppm vapor
26; 26/27; 26/27/28; 26/28; 27; 27/28; 28; Carc Cat 3 R40; 48/23; 48/23/24; 48/23/24/25; 48/23/25; 48/24; 48/24/25; 48/25; 60; 61; 62; 63; 39/26/27/28
Acute toxicity (lethality), any route, class 1 or 2; Carcinogenicity class 2; Repeated exposure toxicity, any route, class 1; Reproductive toxicity class 1 or 2
E - Carcinogen, occupational asthma
Seek Specialist Advice Muta Cat 3 R40; 42; 42/43; 45; 46; 49; 68
Mutagenicity class 1 or 2; Carcinogenicity class 1; Respiratory sensitization
S: Skin and eye contact Prevention or reduction of skin and/or eye exposure
21; 24; 27; 34; 35; 36; 38; 41; 43; 48/21; 48/24; 39/24;39/27;40/21;66;plus R -phrase combinations containing these. Sk
Acute toxicity (lethality), dermal only, class 1, 2, 3 or 4; Acute toxicity (systemic), dermal only, class 1 or 2; Corrosivity, subclass 1A, 1B or 1C; Skin irritation class 2; Eye irritation class 1 or 2; Skin sensitization; Repeated exposure toxicity, dermal only, class 1 or 2
DRAFT
MIHS
MIHS
Limitations of HHB . . . . . Hazard Bands are screening level
hazard groups, often based on limited data.
One of the critical limitations to the use of Hazard Banding has been the lack of standardization of hazard phrases in MSDSs and the lack of expertise to translate those phrases into hazard groups by non-toxicologists.
MIHS
More Limitations . . .
Since Hazard Banding is a preliminary attempt to categorize the relative hazards of the substance to assist OEHS personnel to assign the right controls such as ventilation and PPE, lack of the ability to categorize the hazards can seem insurmountable.
MIHS
Even More Limitations . . . . . But, where this data exists, it is
helpful to compare the relative hazard risk to other more well characterized substances.
Another concern is when a substance is a solid particle or aerosol, the same dilemma exists as often exists for setting an OEL since there is rarely sufficient inhalation toxicology data for these substances.
Traditional OELs• Regulatory,
Authoritative• Health-based
(TLVs, MAKs, WEELs, PELs, MACs, RELs)
Working Provisional OELs(internal company, trade
association, vendor limits)
Hazard Banding Strategies = Occupational Exposure Bands (OEBs)
• Biosafety Levels (1,2,3,4)• Pharmaceutical Banding• WEEL-Banding Matrix
As more toxicological and epidemiological data becomes available, we move up the hierarchy of OELs.
Prescriptive Process Based OELs(REACH DNELs/DMELs)
Most Extensive Data Requirements
(human epidemiology studies)> quality
> certainty
Moderate Data Requirements (human data & insight )
> quality> certainty
Least Data Requirements
(in vitro, SAR (in silico) & few animal
studies)
Hierarchy of OELs
----------------------------------------------------------Control Banding = Hazard Bands + Exposure Risk Assessment + Exposure
Management
PotentialHealth Hazard
Hazard + Process
multiple animalstudies
EPA SNUR New Chemical Exposure Limits (NCEL)
Effective and Efficient Exposure Risk Assessment and
Management
Hierarchy ofOELs / Banding
Strategies
Hierarchy ofExposure Controls
Hierarchy ofExposure
AssessmentTraditional OEL Elimination of
HazardsValidated Monitoring
Working OEL Engineering Controls
Monitoring
DNEL / DMEL(Prescriptive)
Administrative Controls
Modeling
Hazard Banding PPE Qualitative
“Most Effective”
Least Effective
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MIHS
Contact:
Susan Ripple, MS, CIH Manager Industrial Hygiene Expertise Center The Dow Chemical Co. Midland, MI sdripple@dow.com
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