Global Harmonization System:Global Harmonization System:Impact On OSHA’s Hazard Impact On OSHA’s Hazard Communication StandardCommunication Standard

Adele L. Abrams, Esq., CMSPAdele L. Abrams, Esq., CMSPLaw Office of Adele L. Abrams P.C.Law Office of Adele L. Abrams P.C.

www.safety-law.com301-595-3520301-595-3520

Overview

OSHA has issued final rule to revise 29 CFR 1910.1200 (Hazard Communication Standard) Details released 3/20/12, final rule to appear in 3/26/12 Fed.

Reg. Goal is to integrate components of the UN project’s Global

Harmonization Standard (GHS) into HazCom Rule modifies MSDS requirements, labeling, classifications, and

requires retraining of all employees. Significant opposition to standard from some business groups

due to: Inclusion of “unclassified hazards”- altered in final rule, but

legal challenges possible Some disputed economic impact estimates (costs of training,

revised labels and MSDSs etc.)

Overview

Hazard classification: Provides specific criteria for classification of health and physical hazards, as well as classification of mixtures.

Labels: Chemical manufacturers and importers will be required to provide a label that includes a harmonized signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided.

Safety Data Sheets: Will now have a specified 16-section format.

Information and training: The Final HCS will require that workers are trained within two years of the publication of the final rule to facilitate recognition and understanding of the new labels and safety data sheets.

Global Harmonization ProjectGlobal Harmonization Project

Goal of establishing globally harmonized Goal of establishing globally harmonized system for hazard communication established system for hazard communication established in 1992 at “Rio” Earth Summit.in 1992 at “Rio” Earth Summit.

MandateMandate: “A globally harmonized hazard : “A globally harmonized hazard classification and compatible labelling classification and compatible labelling system, including national safety data sheets system, including national safety data sheets and easily understandable symbols, should and easily understandable symbols, should be available, if feasible, by the year 2000.”be available, if feasible, by the year 2000.”

Global Harmonization ProjectGlobal Harmonization Project

Organization for Economic Cooperation and Organization for Economic Cooperation and Development (OECD) coordinated the development Development (OECD) coordinated the development of environmental and health hazard classification of environmental and health hazard classification criteria.criteria.

UN Committee of Experts on Transport of Dangerous UN Committee of Experts on Transport of Dangerous Goods (UN COE) developed criteria for physical Goods (UN COE) developed criteria for physical hazards (explosives, flammables, reactives).hazards (explosives, flammables, reactives).

International Labour Organization (ILO) served as International Labour Organization (ILO) served as Secretariat for overall coordination.Secretariat for overall coordination.

Global Harmonization ProjectGlobal Harmonization Project

Rationale for U.S. adoption of GHS:Rationale for U.S. adoption of GHS: American companies are major importers of chemicals American companies are major importers of chemicals

as well as exporters, and missing or incomplete as well as exporters, and missing or incomplete information on chemicals we import may lead to information on chemicals we import may lead to reduced protections for workers and public.reduced protections for workers and public.

Large number of varying requirements around the Large number of varying requirements around the world create potential barriers to trade in chemicals, world create potential barriers to trade in chemicals, particularly for small businesses. particularly for small businesses.

A harmonized and consistent approach has benefits A harmonized and consistent approach has benefits both in terms of protection and trade. both in terms of protection and trade.

GHS General PrinciplesGHS General Principles The Globally Harmonized System (GHS) is not in itself a regulation or The Globally Harmonized System (GHS) is not in itself a regulation or

a model regulation. It is a a model regulation. It is a frameworkframework from which competent from which competent authorities may select the appropriate harmonized classification & authorities may select the appropriate harmonized classification & communication elements. communication elements.

Competent authorities will decide how to apply the various elements Competent authorities will decide how to apply the various elements of the GHS within their systems based on their needs and the target of the GHS within their systems based on their needs and the target audience.audience.

OSHA had to adopt through conventional rulemaking (governed by OSHA had to adopt through conventional rulemaking (governed by APA) before it can include components in mandatory HazCom APA) before it can include components in mandatory HazCom standard standard MSHA has not yet placed HazCom revision (30 CFR Part 47) on MSHA has not yet placed HazCom revision (30 CFR Part 47) on

its agendaits agenda The HazCom/GHS includes the following basic elements: The HazCom/GHS includes the following basic elements:

harmonized criteria for classifying substances and mixtures harmonized criteria for classifying substances and mixtures according to their health, environmental and physical hazards; andaccording to their health, environmental and physical hazards; and

harmonized hazard communication elements, including harmonized hazard communication elements, including requirements for labeling and material safety data sheets. requirements for labeling and material safety data sheets.

OSHA Rulemaking – Old Rule HazCom has been in effect for over 25 years; foundation for

building a chemical health and safety program in workplace Addresses needs of employers/employees to obtain information

about chemicals, and worker “right-to-know” about hazards Requires chemical manufacturers and importers to evaluate

hazards and provide info to customers through labels, data sheets and worker training programs

Also addresses trade secret protection Requires all chemicals to be evaluated and incorporates wide

range of hazardous effects to be addressed. OSHA claims HazCom has resulted in 40% decrease in

injuries/illnesses due to chemical exposures

OSHA – Final Rule

GHS specifies warnings and format Method of communication and information

transmitted now varies – GHS makes more consistent

GHS system is based on international negotiations and OSHA plans to learn from implementation experience of other nations

New rule does NOT reduce level of protections afforded under original HazCom standard (29 CFR 1910.1200)

OSHA – Final Rule

Effective Dates: 12/1/13: All employees must be trained on new label

elements and SDS format 6/1/15: Manufacturers and distributors must comply

with all modified provisions except that distributors have until 12/1/15 to provide revised labels for all products shipped.

6/1/16: OSHA enforcement starts: Employers must update all labels and HazCom program, provide additional training for workers on newly identified physical or health hazards

During transition period, employers can comply with old or new standard as far as labels and SDSs.

OSHA – Final Rule

GHS’ “Building block” approach allows competent authorities to choose from regulatory options in terms of which hazard classes and categories are adopted OSHA adopted the same basic BB as the EU …

EXCEPT it will not address environmental hazards (outside jurisdiction) and it adds one more category of the flammable liquid class than EU did.

System has 16 physical hazard classifications and 10 health hazard classifications, which determine label elements, pictograms, hazard statement, signal words and precautionary statement required.

Sample Comments - Union

AFL-CIO “strongly supported” proposal but wanted OSHA to expand exposure limits listed on SDSs to include ACGIH TLVs and NIOSH RELs, because OSHA PELs are outdated

Union also wanted substance-specific standards to be included in SDSs (Sec. 15) to alert workers that there is a comprehensive standard on that chemical

Union supported adding a definition of “unclassified hazards” to make sure that emergent hazards can be included within the scope of HazCom and to address combustible dust hazards.

Sample Comment - Business

US Chamber of Commerce had several meeting with OIRA opposing inclusion of “unclassified hazards” in the rule

It has also challenged the purported cost savings as well as the economic impact analysis prepared by OSHA

Urged switching the compliance deadlines (currently 2 years to train, 3 years to prepare new SDSs) so training can be done after SDSs are available. Another group with significant concerns is the

American Chemistry Council, which also met with OIRA

Sample Comments – ASSE

ASSE endorsed the rule, but was “disappointed” that control banding was ignored in the development of the rule Urged OSHA to incorporate elements of control banding into

HazCom to avoid need to revisit this later Challenged cost estimates for training time Suggested ACGIH TLVs should continue to be listed as well

as NIOSH RELs, and suggested additional references to be considered by end users (AIHA also supports retention of TLVs and RELs)

Advocated a quicker effective date for training but not for phsae in for the SDS and labeling requirements, and recommended significant compliance assistance be made available from OSHA

What’s the Impact?

Rule will impact over 5 million workplaces, and 43 million workers

OSHA claims costs range from $38-$47 per covered entity for one-hour of training This did not add costs for developing new labels, SDSs etc.

According to OSHA: Annualized savings for employers of between $585 mil and

$798 mil Most of this through increased productivity for H&S

managers and logistics personnel Expect 500+ workplace injuries and 43 fatalities to be

prevented annually as a result of change Savings attributed to uniform SDSs and labels accounts for

between $16 mil and $32.2 mil

Safety Data Sheet ImpactSafety Data Sheet Impact

The performance orientation of HazCom’s MSDS will The performance orientation of HazCom’s MSDS will need to be changed. need to be changed. Use ANSI Z400.1 as templateUse ANSI Z400.1 as template

HazCom/GHS requires a 16 section MSDS format HazCom/GHS requires a 16 section MSDS format with specified sequence and minimum required with specified sequence and minimum required contents. contents. OSHA will not enforce elements 12-15 because deal OSHA will not enforce elements 12-15 because deal

with tranport, environmental issues outside jurisdictionwith tranport, environmental issues outside jurisdiction The level of hazardous components can be given as The level of hazardous components can be given as

ranges or concentrations - the values for component ranges or concentrations - the values for component disclosure in mixtures vary by end point. Therefore, disclosure in mixtures vary by end point. Therefore, some changes will be needed for component some changes will be needed for component disclosure. disclosure.

Appendix D – SDS Requirements

1.Identification of the substance or mixture and of the supplier2.Hazards identification3.Composition/information on ingredients Substance/Mixture4.First aid measures 5.Firefighting measures6.Accidental release measures7.Handling and storage8.Exposure controls/personal protection.9.Physical and chemical properties10.Stability and reactivity11.Toxicological 12.Ecological information (non mandatory)13.Disposal considerations (non mandatory)14.Transport information (non mandatory)15.Regulatory information (non mandatory)16.Other information including information on preparation and revision of the

SDS 

Hazard DeterminationHazard Determination

Hazard determination/classification are self-classification Hazard determination/classification are self-classification processes – manufactures and importers must classify each processes – manufactures and importers must classify each chemical, determine appropriate hazard class and category chemical, determine appropriate hazard class and category based on evaluation of full range of available data/evidencebased on evaluation of full range of available data/evidence

No testing is requiredNo testing is required OSHA adopted “one study” rule for findings of hazards. OSHA adopted “one study” rule for findings of hazards.

Appendix A defines health and physical hazardsAppendix A defines health and physical hazards Appendix B includes additional parameters to evaluate Appendix B includes additional parameters to evaluate

health hazard datahealth hazard data Appendix F pertains to carcinogensAppendix F pertains to carcinogens A “floor” of chemicals to be considered hazardous is A “floor” of chemicals to be considered hazardous is

provided by reference to several existing lists of chemicalsprovided by reference to several existing lists of chemicals Added supplemental class: “Hazards not otherwise classified” Added supplemental class: “Hazards not otherwise classified”

and included coverage of combustible dust. and included coverage of combustible dust.

Hazard Class Hazard Category Explosives Unstable

Explosives Div 1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6

Flammable Gases 1 2 Flammable Aerosols 1 2 Oxidizing Gases 1 Gases under Pressure Compressed Gases Liquefied Gases Refrigerated Liquefied Gases Dissolved Gases

1

Flammable Liquids 1 2 3 4 Flammable Solids 1 2 Self-Reactive Chemicals Type A Type B Type C Type D Type E Type F Type G Pyrophoric Liquids 1 Pyrophoric Solid 1 Pyrophoric Gases Single

category

Self-heating Chemicals 1 2 Chemicals, which in contact with water, emit flammable gases

1 2 3

Oxidizing Liquids 1 2 3 Oxidizing Solids 1 2 3 Organic Peroxides Type A Type B Type C Type D Type E Type F Type G Corrosive to Metals 1 Combustible Dusts Single

Category

Physical Hazards

20

Hazard Class Hazard Category

Acute Toxicity 1 2 3 4

Skin Corrosion/Irritation 1A 1B 1C 2

Serious Eye Damage/ Eye Irritation 1 2A 2B

Respiratory or Skin Sensitization 1

Germ Cell Mutagenicity 1A 1B 2

Carcinogenicity 1A 1B 2

Reproductive Toxicity 1A 1B 2 Lactation

STOT –Single Exposure

1 2 3

STOT – Repeated Exposure

1 2

Aspiration 1

Simple Asphyxiants Single Category

Health Hazards

Current HCS versus Modified HCS

"Corrosive:" A chemical that causes visible destruction of, or irreversible alterations in, living tissue by chemical action at the site of contact. For example, a chemical is considered to be corrosive if, when tested on the intact skin of albino rabbits by the method described by the U.S. Department of Transportation in appendix A to 49 CFR part 173, it destroys or changes irreversibly the structure of the tissue at the site of contact following an exposure period of four hours. This term shall not refer to action on inanimate surfaces.

HCS Corrosive definition GHS definition of skin Corrosive

Acute ToxicityAcute Toxicity

Labeling

For labeling, manufacturer/importer must include:For labeling, manufacturer/importer must include: Product identifier Signal word Hazard statement(s) Pictogram(s) Precautionary statement(s) Name, address, and telephone number of responsible party

Once a chemical has been classified, the label preparer can obtain the relevant harmonized information from Appendix C

OSHA is maintaining the flexibility for workplace signs and labels. Use of third party hazard rating systems such as the NFPA

diamonds and HMIS is still a valid approach in the workplace

Comparison of Labeling RequirementsComparison of Labeling Requirements

Old HazCom label requirements are totally Old HazCom label requirements are totally performance -- oriented. performance -- oriented.

The HazCom/GHS labeling requirements are The HazCom/GHS labeling requirements are specified: signal words, hazard statements, and specified: signal words, hazard statements, and pictograms. pictograms. The use of pictograms is a significant change for US The use of pictograms is a significant change for US

labeling. labeling. OSHA has retained NTP/OSHA/IARC carcinogen infoOSHA has retained NTP/OSHA/IARC carcinogen info OSHA has retained references to ACGIH TLVs OSHA has retained references to ACGIH TLVs

Other IssuesOther Issues

Will affect other standards (specific health standards) Will affect other standards (specific health standards) that have incorporated references to 1910.1200.that have incorporated references to 1910.1200.

Health hazard classification also includes specific Health hazard classification also includes specific listing for crystalline silicalisting for crystalline silica

For combustible dust, may need to cross-reference For combustible dust, may need to cross-reference NFPA 654NFPA 654

Listings on SDS could also lead to GDC enforcement Listings on SDS could also lead to GDC enforcement where no PEL established for a chemical, as a where no PEL established for a chemical, as a recognized hazard, as well as enforcement over recognized hazard, as well as enforcement over appropriate PPE/respiratory protection assessment appropriate PPE/respiratory protection assessment (1910.132 and 1910.134)(1910.132 and 1910.134)

Expect OSHA to issue guidance within 6 mo. – many Expect OSHA to issue guidance within 6 mo. – many letters of interpretation are sure to follow!letters of interpretation are sure to follow!

HCS Pictograms and Hazards

Health Hazard

Flame

Exclamation Mark

Carcinogen Mutagenicity Reproductive Toxicity Respiratory Sensitizer Target Organ Toxicity Aspiration Toxicity

Flammables Pyrophorics Self-Heating Emits Flammable Gas Self-Reactives Organic Peroxides

Irritant (skin and eye) Skin Sensitizer Acute Toxicity (harmful) Narcotic Effects Respiratory Tract Irritant Hazardous to Ozone Layer

(Non Mandatory)

Gas Cylinder

Corrosion

Exploding Bomb

Gases under Pressure

Skin Corrosion/ burns Eye Damage Corrosive to Metals

Explosives Self-Reactives Organic Peroxides

Flame over Circle

Environment (Non Mandatory)

Skull and Crossbones

Oxidizers

Aquatic Toxicity Acute Toxicity (fatal or toxic)

GHS Sample Label –GHS Sample Label –HAZARDS (Liquid): flammable liquid, flash point = HAZARDS (Liquid): flammable liquid, flash point =

120°F;  oral LD50 = 275 mg/kg120°F;  oral LD50 = 275 mg/kg

Danger!Danger!

Toxic if swallowedToxic if swallowedFlammable liquid and vaporFlammable liquid and vapor

Contains: XYZContains: XYZ

Do not taste or swallow.  Get medical attention.  Do not take internally.  Wash thoroughly after handling.  Keep away from heat, Do not taste or swallow.  Get medical attention.  Do not take internally.  Wash thoroughly after handling.  Keep away from heat, sparks and flame.  Keep container closed.  Use only with adequate ventilation. sparks and flame.  Keep container closed.  Use only with adequate ventilation.

FIRST AIDFIRST AIDIf swallowed, induce vomiting immediately, as directed by medical personnel. Never give anything by mouth to an unconscious If swallowed, induce vomiting immediately, as directed by medical personnel. Never give anything by mouth to an unconscious person.person.

See Material Safety Data Sheet for further details regarding safe use of this product.See Material Safety Data Sheet for further details regarding safe use of this product.

Company name, Address, Phone numberCompany name, Address, Phone number

GHS Sample Label – Suspected GHS Sample Label – Suspected Carcinogen (inhalation)Carcinogen (inhalation)My ProductMy Product

Warning!Warning!Cause Skin And Eye IrritationCause Skin And Eye IrritationSuspected of causing cancer by inhalationSuspected of causing cancer by inhalationContains: XYZContains: XYZDo not breathe vapors or mist. Use only with adequate ventilation. Avoid contact with eyes, Do not breathe vapors or mist. Use only with adequate ventilation. Avoid contact with eyes, skin and clothing. Wash thoroughly after handlingskin and clothing. Wash thoroughly after handling

FIRST AIDFIRST AIDEYES: Immediately flush eyes with plenty of water for at least 15 minutes. Get EYES: Immediately flush eyes with plenty of water for at least 15 minutes. Get medical attentionmedical attention..SKIN: In case of contact, immediately flush skin with plenty of water. Remove contaminated SKIN: In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Wash clothing before reuse. Get medical attention if irritation develops clothing and shoes. Wash clothing before reuse. Get medical attention if irritation develops and persists.and persists.

Company name, Address, Phone number Company name, Address, Phone number

HAZARDS (Liquid): moderate skin and eye irritant, possible cancer hazard by inhalation HAZARDS (Liquid): moderate skin and eye irritant, possible cancer hazard by inhalation

HazCom/GHS - TrainingHazCom/GHS - Training

Training users of hazard information is integral part of Training users of hazard information is integral part of hazard communication.hazard communication.

Systems should identify appropriate education and Systems should identify appropriate education and training for GHS target audiences who must interpret training for GHS target audiences who must interpret label and/or SDS information and take action in label and/or SDS information and take action in response to chemical hazards.response to chemical hazards.

Training should address: workers, emergency Training should address: workers, emergency responders, and those involved with preparation of responders, and those involved with preparation of labels, SDS and HazCom strategies as part of risk labels, SDS and HazCom strategies as part of risk management systems.management systems.

Systems should also educate consumers in Systems should also educate consumers in interpreting label information on products they use.interpreting label information on products they use.

HazCom/GHS SummaryHazCom/GHS Summary Level of protection offered to workers, consumers, Level of protection offered to workers, consumers,

general public and environment will not be reduced by general public and environment will not be reduced by GHSGHS

Involvement of concerned organizations of employers, Involvement of concerned organizations of employers, workers, consumers and other relevant groups is workers, consumers and other relevant groups is essentialessential

Validated data already generated for classification of Validated data already generated for classification of chemicals under existing systems should be accepted chemicals under existing systems should be accepted when reclassifying the chemicals under Haz/Com/GHSwhen reclassifying the chemicals under Haz/Com/GHS

The new harmonized system may require adaptation of The new harmonized system may require adaptation of existing methods for testing.existing methods for testing.

GHS and Control BandingGHS and Control Banding

GHS establishes an international system of classification and labeling that can be used in control banding.

Control Banding provides an additional impetus for implementation of the GHS as a practical use of the information to control exposures.

GHS adoption does not mean that control banding must be implemented, but . . . US/EU have proposed a pilot project related to the GHS and

control banding, based on 2 high production volume chemicals.

Information on project available at http://www.useuosh.org/

ConclusionConclusion

Training of workers can begin immediately Training of workers can begin immediately As new products are ordered, make sure to keep As new products are ordered, make sure to keep

SDSs in new formatsSDSs in new formats Companies that manufacture products will have to Companies that manufacture products will have to

conform to both employer and manufacturer conform to both employer and manufacturer provisions of revised HazCom ruleprovisions of revised HazCom rule

Litigation is possible over inclusion of “hazards not Litigation is possible over inclusion of “hazards not otherwise classified,” and combustible dust … could otherwise classified,” and combustible dust … could delay effective dates but best to prepare for dates delay effective dates but best to prepare for dates listed.listed.

ConclusionConclusion

Overall benefits of globally harmonized systemOverall benefits of globally harmonized system:: Promotes safer transportation, handling and use of Promotes safer transportation, handling and use of

chemicals;chemicals; Improves understanding of hazards;Improves understanding of hazards; Increases compliance and reduces costs for Increases compliance and reduces costs for

companies involved in international activities;companies involved in international activities; Helps protect workers, consumers and potential Helps protect workers, consumers and potential

exposed populations around the globe.exposed populations around the globe.

Bottom Line: A new OSHA HazCom standard is inevitable . . . Bottom Line: A new OSHA HazCom standard is inevitable . . . Plan ahead!Plan ahead!

QUESTIONS ?QUESTIONS ?

Contact Adele L. Abrams, Esq., CMSPContact Adele L. Abrams, Esq., CMSP

at 301-595-3520 or write to:at 301-595-3520 or write to:

safetylawyer@aol.com