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