Transcript Occupational Exposure Banding and Exposure Risk Management

Susan Ripple, MS, CIH, Fellow
Global Manager – Industrial Hygiene
The Dow Chemical Company
Midland, 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)
 How many of you are
familiar with the AIHA
“Exposure Assessment
Strategies” for
performing “qualitative
exposure assessment”?
Hazard
Assessment
 Traditional IH Definition:
 Anticipate
 Recognize
 Evaluate
 Control
Risk Assessment
(Qualitative or Quantitative)
Risk Management

“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.

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
EHS Generalist
Affiliated Professionals
Level of
ERAM
Expertise
Hypothetical Amount of “ERAM Expertise”
for each job type…. (illustration only)
Percent of ERAM
needed in job
IH
Expert
IH Generalist
100%
50-100%
EHS Generalist
5-50%
Affiliated Professionals
1-15%
Exposure Management
Exposure risk assessment knowledge gaps
(Controls & Programs)
HAZARD
Assessment
EXPOSURE
Assessment
<2000 OELs
<2% REACH
Chemicals
with OELs
Occupational
Exposure
Bands (OEBs)
& Exposure
Limits (OELs)
Exposure Risk
Assessment
(modeling,
monitoring,
analogy)
Courtesy of
Elizabeth Pullen
and ERAM
Working Group
Occupational
Health Hazard
Criteria & Process
IH Expertise
Understanding
Exposure & Controls
~21,000,000 commercialavailable chemicals; >107,000
REACH
“Exposure Gap”
~21,000,000 commercially available
chemicals
 107,067 REACH* registrations (1-311) 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
~21,000,000 commercially available
chemicals
 107,067 REACH* registrations (1-311) 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

Hygienists prefer the more official peerreviewed Traditional OELs,
“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
14

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!
MIHS

“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 2012
BOHS OEL-Setting Plenary

OEBs for a chemical provide a range
of acceptable exposure levels based
on expert evaluation of the doseresponse relationships provided
through animal testing.

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).
 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
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 include qualitative, semi-quantitative, and
quantitative data for each toxicological endpoint

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

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

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
Band
A
B
C (default)
D
E
Signal Word
Warning
Warning
Danger
Danger
Danger
> 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
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
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)
OEL Ranges
Examples of Health
Outcomes and
Potency
Considerations
Examples of GHS
Hazard Statements
and Hazard
Categories
Minor, reversible
health effects
occurring at high
doses. Skin and
eye irritation.
May cause
drowsiness or
dizziness
Harmful if inhaled (4).
Harmful in contact with
skin (4).
MIHS
A B
C
D-E
A B C D
A
B C D
Tier 1a—Qualitative
Use GHS Hazard Phrases to identify
chemicals with potential for irreversible
health effects at relatively low doses (Band
D-E) or remain at default Band C
E
Tier 1b—Semi-quantitative
Use GHS Hazard Categories to assign
chemicals into Bands D or E or remain at
default Band C
E
Tier 2—Quantitative
Determine point of departure, factoring
data availability, hierarchy, and quality to
support assigning chemicals into Bands
A, B, or C
A B C D E
Tier 3—Weight of Evidence
Involves integration of all available data
and determining the degree of
conviction of the outcome.
• 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
Tier 1 a & b
Identify Bands D-E from Default Band C
Chemical for
OEB
Authoritative
OEL available?
yes
No OEB
necessary
no
Remain at Band
D-E
yes
no
Health
statements
available?
Need to
define
Band D vs.
E?
no
Band C default
assigned
Review available
Hazard
categories
yes
D or E
statement?
no
Band C default
assigned
E Hazard
categories
?
yes
Assign Band E
no
yes
Band D-E
assigned
Tier 2 process
to determine
Band A or B
D Hazard
categories
?
yes
Assign Band D

Using GHS hazard statements or codes (qualitative
hazard banding), for most criteria, cannot separate
the “D” from the “E” bands

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
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
1-bromopropane

TIER 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 dizziness
TIER 1a outcome: Band D-E
 TIER 1b
 Hazard Category Repro 1B
Tier 1b outcome: Band D: (1-10 ppm)
 TLV: 10 ppm
• OEB based on point of departure (POD) at which adverse
effects are observed
o 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 2
Can Band A or B be considered?
Tier 1 Process
results in Band C
Endpoint PODs
from authoritative
reviews
Does TDS exceed
threshold for
minimum, quality
dataset?
no
Data insufficient
for OEB, “C”
default band
yes
Establish OEB
Score data quality
and relevance
Establish Total
Determinant
Score (TDS)
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.
Total Determinant Score
Endpoint
A
LD50 (Oral)
LD50 (Dermal)
Acute Toxicity
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)
B
Bands
C
D
E
Data
Quality
Relevance
Total
Overall
 Criteria endpoints and band cut
points
 Process
 Decision logic
 Modify based on validation results





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

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
Hazard group
A -Skin and eye irritants
Target airborne
concentration range for
Control Banding
>1-10 mg/m3 dust or >50-500
ppm vapor
R phrases*
36; 38; 36/38; 65;66; All substances
that do not have R phrases in groups
B-E
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
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;
D -Very toxic on single
exposure, reproductive
hazard
< 0.01 mg/m3 dust or < 0 5 ppm
vapor
E - Carcinogen,
occupational asthma
Seek Specialist Advice
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
Muta Cat 3 R40; 42; 42/43; 45; 46;
49; 68
S: Skin and eye contact
Prevention or reduction of skin
and/or eye exposure
MIHS
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
GHS Hazard Classification (class/level)
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
Acute toxicity (lethality), any route, class 4;
Acute toxicity (systemic), any route, class 2
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
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
Mutagenicity class 1 or 2; Carcinogenicity class 1;
Respiratory sensitization
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
MIHS

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 nontoxicologists.
MIHS

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

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.
MIHS
Most Extensive Data Requirements
(human epidemiology studies)
> quality
> certainty
Moderate Data
Requirements
(human data & insight )
> quality
> certainty
multiple
animal
studies
Traditional OELs
• Regulatory, Authoritative
•Health-based
(TLVs, MAKs, WEELs, PELs, MACs,
RELs)
Hierarchy of OELs
As more toxicological and
epidemiological data becomes
available, we move up the
hierarchy of OELs.
Working Provisional OELs
(internal company, trade association, vendor
limits)
Prescriptive Process Based OELs
(REACH DNELs/DMELs)
Hazard Banding Strategies = Occupational Exposure Bands (OEBs)
Least Data
Requirements
(in vitro, SAR (in silico) & few
animal studies)
• Biosafety Levels (1,2,3,4)
• Pharmaceutical Banding
• WEEL-Banding Matrix
EPA SNUR New Chemical Exposure Limits
(NCEL)
Potential
Health Hazard
----------------------------------------------------------
“Most Effective”
Working OEL
DNEL / DMEL
(Prescriptive)
Hazard Banding
Exposure
Controls
Elimination of
Hazards
Engineering
Controls
Administrative
Controls
PPE
Least Effective
Hierarchy of
Exposure
Assessment
Validated Monitoring
Monitoring
Modeling
Qualitative
CERTAINTY of EXPOSURE JUDGMENT
Traditional OEL
Hierarchy of
SUSTAINABILITY of CONTROL
OELs / Banding
Strategies
AVAILABILITY of TOXICOLOGICAL DATA
Hierarchy of
Susan Ripple, MS, CIH
Manager
Industrial Hygiene Expertise Center
The Dow Chemical Co.
Midland, MI
[email protected]
MIHS