global chemical policy drivers—impact on the way we do business susan d. ripple, ms, cih sr....

Global Chemical Policy Drivers—Impact on the Way We Do BusinessSusan D. Ripple, MS, CIH

Sr. Industrial Hygiene Manager

The Dow Chemical Company

Midland, MI

CIHCCIHC December 2010December 2010

Topics Broader Global Chemical Regulation Drivers

Evolution of OELs

Current status of Chemical Policies

Challenges today


Global Chemical Regulations/Policies

REACh1 – Can’t sell if not registered – puts risk assessment squarely on manufacturer’s shoulders

Green Chemistry – Sustainability - Registrations – following the REACh pathway

EPA – TSCA reform; NCELs2 for the workplace

California – Biomonitoring and PELs

Global Harmonized System (GHS) – Reclassify all chemicals globally (soon to be USA) on MSDSs

1 – NCEL: New Chemical Exposure Limits (NCELs) determined by EPA during the Significant New Use Rules under TSCA 5e consent orders.

2- REACh: EU Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals


eCOSHH – Risk-phrases retiring use GHS phrases which don’t correlate in the Control Banding Tool

OSHA – redirecting funds from Alliances and Voluntary Protection Program to Enforcement

Corporate Citizenship and Responsibility (BP incident) heightened

NIOSH – NORA initiative and Prevention Through Design

Global Chemical Regulations/Policies

1

1 eCOSHH: UK Health and Safety Executive electronic tool for Control Banding under the Control of Substances Hazardous to Health (COSHH)2 NORA: CDC/NIOSH - National Occupational Research Agenda (NORA)


Help on the Horizon: Nanomaterials – Control Bands & Measurement

Techniques Globally Harmonized System for MSDSs “Prevention Through Design” Injury Illness Prevention Programs (I2P2) Increased OSHA Enforcement and Increased Fines REACh Derived No Effect Levels (DNELs) as de

facto OELs Hazard Bands and Control Bands


The Conundrum Exposure Assessment & Control is the

Occupational Hygienist’s core competency Without ‘safe limits’ such as OELs, the

Hygienist has no ‘arsenal’ for discussion Without regulatory OELs, few employers will

do the needed risk assessments or implement controls


Recognition of the Need for OELs Chronology shows many major occupational

chemical exposure problems known for almost 2,000 years

Only the last 100-150 years have seen that these hazards are no longer acceptable

Change in culture started in Europe in late 1880s 50 years later before this cultural change took hold

in the USA


Evolution of EH&S vs Development of OELs

Prior to the development of OELs, insights into industrial hygiene (occupational hygiene) and chemical exposure were developed

ca, 90-20 BC: Roman architect/engineer Marcus Vitruvius Pollio noted lead workers had pale gray complexions

ca, 23-79 AD: Roman Pliny the Elder described workers’ use of sheep bladders as masks to protect from mercury dust and vapors

ca, 1556: Agricola warned of “black lung” in miners (Italian)

ca, 1700: Ramazzini, “father” of occupational medicine recommended hygiene, posture, ventilation and protective clothing for workers (Modena, Italy)

ca, 1736: state of Massachusetts in USA prohibited use of lead in whiskey stills after fatalities of drinking alcohol from the stills.

ca 1840: France issued a policy discouraging the use of lead as a pigment in paint

ca 1912: Kobert of Germany published a list of acute exposure limits for 20 substances


1916 - 1917 U.S. Bureau of Mines published Quartz OEL

10 mppcf

In the late 1920’s a company in West Virginia ignored the 1917 OEL and allowed 2,000 miners to be grossly over exposed to over 98% pure silica quartz dust as they tunneled through a mountain.

>400 workers died within 2 years Almost all remaining workers eventually died of silicosis


In Fact…. 1918 Worker’s Compensation denied an 18-year old

painter’s compensation for exposure to deadly paint fumes and gases 2 days after warming the paint so it would brush onto the building walls

Since lead poisoning was considered usual and customary incident to painters, compensation was denied

Today, lead poisoning would be covered under worker’s compensation in most countries with occupational safety and health legislation.


1920’s U.S. Bureau of Mines published 33 OELs International Critical Tables published 27

OELs


1940’s American National Standards Institute (ANSI) Z-37

published U.S. exposure “standard” for Carbon Monoxide - 100 ppm

Thresholds Committee of ACGIH published first table of 63 ‘Maximum Allowable Concentration” (MACs) – later to be known as “Threshold Limit Values”

Germany outlawed use of asbestos for insulation in ships

India passed the Factories Act with a table of exposure limits

Note that this was 58 years after Germany published the original OEL list in 1912!


1950’s People’s Republic of China published their

first list of exposure standards


1970’s Many countries adopt the latest version of the

ACGIH TLVs® as the basis for their exposure standards and health laws

U.S. Consumer Product Safety Commission outlawed lead in commercial paint

Note that this was 138 years after France outlawedlead in paint in 1840!


1980’s “Control Banding” concept is first proposed U.S. updated OSHA Permissible Exposure

Limits in Table Z-1 (1989)


2000 Global Harmonized System (GHS) for

chemical labeling introduced by the European Union to further chemical safety


Trivia – But are the Hazards really different? Most countries have OELs that date from 2003 or

more recently Except India and USA

G8 countries have active committees to study, develop and update federally-enforceable OELs USA does not

Germany has most advanced system for developing OELs and store all occupational hygiene data in a database. Exposure data used with national health care data system

to look for health effects of chemicals in workers


Is there any wonder we have different OEL values? Some EU countries list an OEL of “0” for certain chemicals –

these are banned chemicals in those countries

Hungary has the most comprehensive OELs for carcinogens and mutagens

Japan differentiates inhalation sensitizers and skin sensitizers

New Zealand adjusts the OELs for respiration rate of the worker

Some countries adjust OELs for altitude, standard temperature and pressure or for a 48-hour work week


Re-Examining the Value of OELs 60 years of developing OELs

Changes during those 60 years include:

Regulatory changes Litigation in some countries Shifting centers of manufacturing growth More global view on issues Better science and testing Better communication of hazards globally Differences in risk tolerance and access to relevant data

results in many OEL values around the world


Where We Go From Here For a global economy to work, the workforce must be valued

and not squandered

All OEL-setting bodies should harmonize worker protection using the same standard of care

The accumulated research globally on OELs is huge

Why are the OELs different in many countries? How do we make available the ‘hazard data’ on materials so that

control strategies and risk management can be prepared?

As shown in this brief overview of the history, the hazards have been known for many chemicals for thousands of years.


~1,500 OELs in North America

Only a modest number of OELs available compared to total list of chemicals

More than 80,000 products in North American commerce


United States OEL-Setting falls within six frameworks:

Occupational Safety & Health Administration (OSHA) National Institutes of Safety and Health (NIOSH) American Conference of Governmental Hygienists

(ACGIH) American Industrial Hygiene Association (AIHA) State OSHA PELs Environmental Protection Agency (EPA) Some manufacturers and employers set limits in the

absence of regulations


Setting OELs: Many Challenges

Prioritization of substances needing OELs Diversity of committee membership Expertise & Experience required Availability of data Perception of committee setting OELs Resources time, data, and finance “Harmonization” of OELs


OEL-Challenges in United States Regulatory OELs (with socio-political influence by

regulation) is a level of “acceptable risk” and not true “threshold of toxic risk”

Litigation in USA precludes development of additional PELs and TLVs and has slowed the AIHA Workplace Environmental Exposure Levels (WEELs)

Lack of Political Support Various political administrations do not support adding government

regulations such as PELs USA budget to NIOSH has slowed the NIOSH REL development

REACh – new default OELs in North America? It will definitely force sharing of data globally


Mission Impossible: Developing more OELs ?

.......or just Mission Difficult?


A Reminder About OELs Variety of OEL sources Very few OELs relative to number of chemicals OELs are based on toxicology and human data and

require robust analysis by experts OELs are built on:

Uncertainty or Safety Factors Margins of Safety Margins of Exposure


In Fact:


TLVs

WEELs

BOEL

MAK

PELs

VendorOELs

NCEL

HazardBands

GHS

MAC

IOEL

REL

DNELDNEL


Why Worry About DNELs? Over 150,000 substances

exist in commerce Only about 1,500 substances

have OELs anywhere around the world

Every substance in commerce in the EU (thus the Rest of World) will have a DNEL

The concern is that risk assessments require some level of ‘safe’ for risk management!

99%

1%

Substances inCommerce

Substances withOEL

DNELDNEL

DNEL

DNELDNEL

DNELDNEL

DNELDNEL

DNELDNEL

DNEL

DNEL

DNEL

DNEL

DNELDNEL

DNELDNEL

DNELDNEL

DNEL

DNEL

DNEL

DNEL

DNELDNEL

DNEL

DNEL

DNEL

DNEL

DNEL

DNEL

DNEL

DNEL

DNELDNEL

DNEL


Simple Comparison

DNELs are: Threshold-based non-cancer

endpoints considered to be “No Effect Levels” for humans based on NOELs and AFs

Worker DNELs are: Calculated from Population

DNELs

Prescriptive & Conservative – not based on judgment

OELs are: Levels of acceptable risk for

workers based on NOAELs and LOAELs with SF (AF)**We target 10 – 50% of the OEL for compliance

OELs Utilize Professional judgment and

‘weight of evidence’ with peer review by experts who draw comparative analogy between animal and human toxicology parameters


DNEL Refresher Manufacturers’ burden to prove use of their

substances is not harmful to human health

After gathering toxicology data and derivation of the DNEL or DMEL, the next step is to assess the risk of use.

Exposure Scenarios determine the risk of use to human health compared to the DNEL.


Hypothesis:

In the Occupational Setting, the DNEL could be construed to be a

de facto OEL.


Concerns & Issues for DNELs vs. OELs

Most chemicals do not have PELs, TLVs, or a unified, codified exposure limit

Can regulators use DNELs to demonstrate non-compliance?

Will EU member-states abandon their current OEL processes and default to the DNELs? Will the EU grab hold of the DNELs and turn them into regulatory OELs?

Will manufacturers derive overly conservative DNELs to shield themselves from liability?

Will manufacturers “adjust” their DNELs to achieve a favorable chemical risk assessment outcome?

Will we see multiple DNELs for the same substance when manufacturers can’t agree?


DNELs vs. OELs Risk Management

Measures (RMMs)*

a. Limit Concentration

b. Ventilation

c. PPE (Specific)

d. Training

e. Limit Duration of Exposure

SDS Section 8

a. OELs listed

b. Ventilation

c. PPE considerations

d. Hazard Awareness

e. Time-specific values

TWA, STEL, Ceiling

DNELs will be presented along with OELs in Section 8 !


Perhaps We Adjust the DNELs for use as OELs

That risk typically not quantified, led to conservatism in IH practice.

Along with statistical conservatism if exposures > 50% OEL.

Also embodied in the < 1/2 to 1/10 OEL concept to prove compliance.


Oh, By the Way DNELs also provide data for:

Standardized hazard assessment for use by IH’s in Risk Management (previously not available for most substances)

Data available to do “Hazard Banding”

OEL development (vs. worker DNELs)

Air sampling methods (or development)

Standardized respirator, body cover and glove material selection


Navigation through Solutions Global Issues USA Issues State Issues Partnerships – Agencies, Manufacturers,

Workers / Employers, Countries Volunteer to be involved at any level that

interests you!

Don’t rely on everyone else or the government to solve the problem…

Be a part of the solution ….


Contact:Susan Ripple, MS, CIH

Manager

Industrial Hygiene Expertise Center

The Dow Chemical Co.

Midland, MI

[email protected]

global chemical policy drivers—impact on the way we do business susan d. ripple, ms, cih sr....

Documents

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usa slide

mi slide

oels chronology

regulatory oels

oels hazard bands

control banding tool

dow chemical company