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Global HarmonizationGlobal Harmonization
System:System:
Impact On OSHA’s HazardImpact On OSHA’s Hazard
Communication StandardCommunication Standard
Adele L. Abrams, Esq., CMSPAdele L. Abrams, Esq., CMSP
Law Office of Adele L. Abrams P.C.Law Office of Adele L. Abrams P.C.
www.safety-law.comwww.safety-law.com
301-595-3520301-595-3520
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 harmonizedGoal of establishing globally harmonized
system for hazard communication establishedsystem 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 labellingclassification and compatible labelling
system, including national safety data sheetssystem, including national safety data sheets
and easily understandable symbols, shouldand 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 andOrganization for Economic Cooperation and
Development (OECD) coordinated the developmentDevelopment (OECD) coordinated the development
of environmental and health hazard classificationof environmental and health hazard classification
criteria.criteria.
 UN Committee of Experts on Transport of DangerousUN Committee of Experts on Transport of Dangerous
Goods (UN COE) developed criteria for physicalGoods (UN COE) developed criteria for physical
hazards (explosives, flammables, reactives).hazards (explosives, flammables, reactives).
 International Labour Organization (ILO) served asInternational 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 chemicalsAmerican companies are major importers of chemicals
as well as exporters, and missing or incompleteas well as exporters, and missing or incomplete
information on chemicals we import may lead toinformation 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 theLarge 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 benefitsA 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 regulationThe Globally Harmonized System (GHS) is not in itself a regulation
or a model regulation. It is aor a model regulation. It is a frameworkframework from which competentfrom 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 elementsCompetent authorities will decide how to apply the various elements
of the GHS within their systems based on their needs and the targetof the GHS within their systems based on their needs and the target
audience.audience.
 OSHA had to adopt through conventional rulemaking (governed byOSHA had to adopt through conventional rulemaking (governed by
APA) before it can include components in mandatory HazComAPA) before it can include components in mandatory HazCom
standardstandard
 MSHA has not yet placed HazCom revision (30 CFR Part 47) onMSHA 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 mixturesharmonized criteria for classifying substances and mixtures
according to their health, environmental and physical hazards;according to their health, environmental and physical hazards;
andand
 harmonized hazard communication elements, includingharmonized 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 willThe 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 formatHazCom/GHS requires a 16 section MSDS format
with specified sequence and minimum requiredwith specified sequence and minimum required
contents.contents.
 OSHA will not enforce elements 12-15 because dealOSHA 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 asThe level of hazardous components can be given as
ranges or concentrations - the values for componentranges 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 componentsome changes will be needed for component
disclosure.disclosure.
Appendix D – SDS Requirements
1.Identification of the substance or mixture and of the supplier
2.Hazards identification
3.Composition/information on ingredients Substance/Mixture
4.First aid measures
5.Firefighting measures
6.Accidental release measures
7.Handling and storage
8.Exposure controls/personal protection.
9.Physical and chemical properties
10.Stability and reactivity
11.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-classificationHazard determination/classification are self-classification
processes – manufactures and importers must classify eachprocesses – manufactures and importers must classify each
chemical, determine appropriate hazard class and categorychemical, 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 evaluateAppendix 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 isA “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 totallyOld HazCom label requirements are totally
performance -- oriented.performance -- oriented.
 The HazCom/GHS labeling requirements areThe HazCom/GHS labeling requirements are
specified: signal words, hazard statements, andspecified: signal words, hazard statements, and
pictograms.pictograms.
 The use of pictograms is a significant change for USThe 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 TLVsOSHA 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 specificHealth hazard classification also includes specific
listing for crystalline silicalisting for crystalline silica
 For combustible dust, may need to cross-referenceFor combustible dust, may need to cross-reference
NFPA 654NFPA 654
 Listings on SDS could also lead to GDC enforcementListings on SDS could also lead to GDC enforcement
where no PEL established for a chemical, as awhere no PEL established for a chemical, as a
recognized hazard, as well as enforcement overrecognized hazard, as well as enforcement over
appropriate PPE/respiratory protection assessmentappropriate PPE/respiratory protection assessment
(1910.132 and 1910.134)(1910.132 and 1910.134)
 Expect OSHA to issue guidance within 6 mo. – manyExpect 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 swallowed
Flammable 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 AID
If swallowed, induce vomiting immediately, as directed by medical personnel. Never give anything by mouth to an unconsciousIf 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 – SuspectedGHS Sample Label – Suspected
Carcinogen (inhalation)Carcinogen (inhalation)
My ProductMy Product
Warning!Warning!
Cause Skin And Eye IrritationCause Skin And Eye Irritation
Suspected of causing cancer by inhalationSuspected of causing cancer by inhalation
Contains: XYZContains: XYZ
Do 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 AID
EYES: Immediately flush eyes with plenty of water for at least 15 minutes. GetEYES: 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 contaminatedSKIN: 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 developsclothing and shoes. Wash clothing before reuse. Get medical attention if irritation develops
and persists.and persists.
Company name, Address, Phone numberCompany name, Address, Phone number
HAZARDS (Liquid): moderate skin and eye irritant, possible cancer hazard by inhalationHAZARDS (Liquid): moderate skin and eye irritant, possible cancer hazard by inhalation
HazCom/GHS - TrainingHazCom/GHS - Training
 Training users of hazard information is integral part ofTraining users of hazard information is integral part of
hazard communication.hazard communication.
 Systems should identify appropriate education andSystems should identify appropriate education and
training for GHS target audiences who must interprettraining for GHS target audiences who must interpret
label and/or SDS information and take action inlabel and/or SDS information and take action in
response to chemical hazards.response to chemical hazards.
 Training should address: workers, emergencyTraining should address: workers, emergency
responders, and those involved with preparation ofresponders, and those involved with preparation of
labels, SDS and HazCom strategies as part of risklabels, SDS and HazCom strategies as part of risk
management systems.management systems.
 Systems should also educate consumers inSystems 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 bygeneral 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 isworkers, consumers and other relevant groups is
essentialessential
 Validated data already generated for classification ofValidated data already generated for classification of
chemicals under existing systems should be acceptedchemicals 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 ofThe 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 immediatelyTraining of workers can begin immediately
 As new products are ordered, make sure to keepAs new products are ordered, make sure to keep
SDSs in new formatsSDSs in new formats
 Companies that manufacture products will have toCompanies that manufacture products will have to
conform to both employer and manufacturerconform to both employer and manufacturer
provisions of revised HazCom ruleprovisions of revised HazCom rule
 Litigation is possible over inclusion of “hazards notLitigation is possible over inclusion of “hazards not
otherwise classified,” and combustible dust … couldotherwise classified,” and combustible dust … could
delay effective dates but best to prepare for datesdelay 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 ofPromotes safer transportation, handling and use of
chemicals;chemicals;
 Improves understanding of hazards;Improves understanding of hazards;
 Increases compliance and reduces costs forIncreases compliance and reduces costs for
companies involved in international activities;companies involved in international activities;
 Helps protect workers, consumers and potentialHelps 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.comsafetylawyer@aol.com

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Global Harmonization System by Safety Law

  • 1. Global HarmonizationGlobal Harmonization System:System: Impact On OSHA’s HazardImpact On OSHA’s Hazard Communication StandardCommunication Standard Adele L. Abrams, Esq., CMSPAdele L. Abrams, Esq., CMSP Law Office of Adele L. Abrams P.C.Law Office of Adele L. Abrams P.C. www.safety-law.comwww.safety-law.com 301-595-3520301-595-3520
  • 2. 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.)
  • 3. 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.
  • 4. Global Harmonization ProjectGlobal Harmonization Project  Goal of establishing globally harmonizedGoal of establishing globally harmonized system for hazard communication establishedsystem 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 labellingclassification and compatible labelling system, including national safety data sheetssystem, including national safety data sheets and easily understandable symbols, shouldand easily understandable symbols, should be available, if feasible, by the year 2000.”be available, if feasible, by the year 2000.”
  • 5. Global Harmonization ProjectGlobal Harmonization Project  Organization for Economic Cooperation andOrganization for Economic Cooperation and Development (OECD) coordinated the developmentDevelopment (OECD) coordinated the development of environmental and health hazard classificationof environmental and health hazard classification criteria.criteria.  UN Committee of Experts on Transport of DangerousUN Committee of Experts on Transport of Dangerous Goods (UN COE) developed criteria for physicalGoods (UN COE) developed criteria for physical hazards (explosives, flammables, reactives).hazards (explosives, flammables, reactives).  International Labour Organization (ILO) served asInternational Labour Organization (ILO) served as Secretariat for overall coordination.Secretariat for overall coordination.
  • 6. 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 chemicalsAmerican companies are major importers of chemicals as well as exporters, and missing or incompleteas well as exporters, and missing or incomplete information on chemicals we import may lead toinformation 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 theLarge 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 benefitsA harmonized and consistent approach has benefits both in terms of protection and trade.both in terms of protection and trade.
  • 7. GHS General PrinciplesGHS General Principles  The Globally Harmonized System (GHS) is not in itself a regulationThe Globally Harmonized System (GHS) is not in itself a regulation or a model regulation. It is aor a model regulation. It is a frameworkframework from which competentfrom 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 elementsCompetent authorities will decide how to apply the various elements of the GHS within their systems based on their needs and the targetof the GHS within their systems based on their needs and the target audience.audience.  OSHA had to adopt through conventional rulemaking (governed byOSHA had to adopt through conventional rulemaking (governed by APA) before it can include components in mandatory HazComAPA) before it can include components in mandatory HazCom standardstandard  MSHA has not yet placed HazCom revision (30 CFR Part 47) onMSHA 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 mixturesharmonized criteria for classifying substances and mixtures according to their health, environmental and physical hazards;according to their health, environmental and physical hazards; andand  harmonized hazard communication elements, includingharmonized hazard communication elements, including requirements for labeling and material safety data sheets.requirements for labeling and material safety data sheets.
  • 8. 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
  • 9. 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)
  • 10. 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.
  • 11. 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.
  • 12. 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.
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. Safety Data Sheet ImpactSafety Data Sheet Impact  The performance orientation of HazCom’s MSDS willThe 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 formatHazCom/GHS requires a 16 section MSDS format with specified sequence and minimum requiredwith specified sequence and minimum required contents.contents.  OSHA will not enforce elements 12-15 because dealOSHA 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 asThe level of hazardous components can be given as ranges or concentrations - the values for componentranges 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 componentsome changes will be needed for component disclosure.disclosure.
  • 17. Appendix D – SDS Requirements 1.Identification of the substance or mixture and of the supplier 2.Hazards identification 3.Composition/information on ingredients Substance/Mixture 4.First aid measures 5.Firefighting measures 6.Accidental release measures 7.Handling and storage 8.Exposure controls/personal protection. 9.Physical and chemical properties 10.Stability and reactivity 11.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
  • 18. Hazard DeterminationHazard Determination  Hazard determination/classification are self-classificationHazard determination/classification are self-classification processes – manufactures and importers must classify eachprocesses – manufactures and importers must classify each chemical, determine appropriate hazard class and categorychemical, 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 evaluateAppendix 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 isA “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.
  • 19. 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. 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
  • 21. 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
  • 23. 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
  • 24. Comparison of Labeling RequirementsComparison of Labeling Requirements  Old HazCom label requirements are totallyOld HazCom label requirements are totally performance -- oriented.performance -- oriented.  The HazCom/GHS labeling requirements areThe HazCom/GHS labeling requirements are specified: signal words, hazard statements, andspecified: signal words, hazard statements, and pictograms.pictograms.  The use of pictograms is a significant change for USThe 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 TLVsOSHA has retained references to ACGIH TLVs
  • 25. 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 specificHealth hazard classification also includes specific listing for crystalline silicalisting for crystalline silica  For combustible dust, may need to cross-referenceFor combustible dust, may need to cross-reference NFPA 654NFPA 654  Listings on SDS could also lead to GDC enforcementListings on SDS could also lead to GDC enforcement where no PEL established for a chemical, as awhere no PEL established for a chemical, as a recognized hazard, as well as enforcement overrecognized hazard, as well as enforcement over appropriate PPE/respiratory protection assessmentappropriate PPE/respiratory protection assessment (1910.132 and 1910.134)(1910.132 and 1910.134)  Expect OSHA to issue guidance within 6 mo. – manyExpect OSHA to issue guidance within 6 mo. – many letters of interpretation are sure to follow!letters of interpretation are sure to follow!
  • 26. 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)
  • 27. 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 swallowed Flammable 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 AID If swallowed, induce vomiting immediately, as directed by medical personnel. Never give anything by mouth to an unconsciousIf 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
  • 28. GHS Sample Label – SuspectedGHS Sample Label – Suspected Carcinogen (inhalation)Carcinogen (inhalation) My ProductMy Product Warning!Warning! Cause Skin And Eye IrritationCause Skin And Eye Irritation Suspected of causing cancer by inhalationSuspected of causing cancer by inhalation Contains: XYZContains: XYZ Do 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 AID EYES: Immediately flush eyes with plenty of water for at least 15 minutes. GetEYES: 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 contaminatedSKIN: 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 developsclothing and shoes. Wash clothing before reuse. Get medical attention if irritation develops and persists.and persists. Company name, Address, Phone numberCompany name, Address, Phone number HAZARDS (Liquid): moderate skin and eye irritant, possible cancer hazard by inhalationHAZARDS (Liquid): moderate skin and eye irritant, possible cancer hazard by inhalation
  • 29. HazCom/GHS - TrainingHazCom/GHS - Training  Training users of hazard information is integral part ofTraining users of hazard information is integral part of hazard communication.hazard communication.  Systems should identify appropriate education andSystems should identify appropriate education and training for GHS target audiences who must interprettraining for GHS target audiences who must interpret label and/or SDS information and take action inlabel and/or SDS information and take action in response to chemical hazards.response to chemical hazards.  Training should address: workers, emergencyTraining should address: workers, emergency responders, and those involved with preparation ofresponders, and those involved with preparation of labels, SDS and HazCom strategies as part of risklabels, SDS and HazCom strategies as part of risk management systems.management systems.  Systems should also educate consumers inSystems should also educate consumers in interpreting label information on products they use.interpreting label information on products they use.
  • 30. 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 bygeneral 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 isworkers, consumers and other relevant groups is essentialessential  Validated data already generated for classification ofValidated data already generated for classification of chemicals under existing systems should be acceptedchemicals 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 ofThe new harmonized system may require adaptation of existing methods for testing.existing methods for testing.
  • 31. 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/
  • 32. ConclusionConclusion  Training of workers can begin immediatelyTraining of workers can begin immediately  As new products are ordered, make sure to keepAs new products are ordered, make sure to keep SDSs in new formatsSDSs in new formats  Companies that manufacture products will have toCompanies that manufacture products will have to conform to both employer and manufacturerconform to both employer and manufacturer provisions of revised HazCom ruleprovisions of revised HazCom rule  Litigation is possible over inclusion of “hazards notLitigation is possible over inclusion of “hazards not otherwise classified,” and combustible dust … couldotherwise classified,” and combustible dust … could delay effective dates but best to prepare for datesdelay effective dates but best to prepare for dates listed.listed.
  • 33. ConclusionConclusion Overall benefits of globally harmonized systemOverall benefits of globally harmonized system::  Promotes safer transportation, handling and use ofPromotes safer transportation, handling and use of chemicals;chemicals;  Improves understanding of hazards;Improves understanding of hazards;  Increases compliance and reduces costs forIncreases compliance and reduces costs for companies involved in international activities;companies involved in international activities;  Helps protect workers, consumers and potentialHelps 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!
  • 34. 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.comsafetylawyer@aol.com