Kay Rowntree, CIH - WMC

Kay Rowntree, CIH

Industrial Hygiene Sciences, LLC

� The Globally Harmonized System of Classification and Labeling of Chemicals

� A system for standardizing and harmonizing the classification and labeling of chemicals

� Not a regulation, not a treaty obligation

� Roots in a 1992 UN mandate

� Builds on the best of existing regulations in the US, EU, Canada and the UN Transport Regulations

� Defining the health, physical and environmental hazards of chemicals;

� Classifying hazards

� Communicating hazard information and protective measures on labels and Safety Data Sheets (SDS)

� not reduce current employee protection

� establish agreed upon hazard classification and communication provisions and provide an explanatory system for applying them

� allow countries to use the criteria and implement them into their own regulatory structure

� result in changes to the HCS when OSHA adopts GHS

� Different hazard definitions leads to classifying something as hazardous in one country but not in another

� Differences in required information makes it more difficult to prepare labels and safety data sheets

� Reduce need for testing & evaluation against multiple classification systems

From: http://www.schc.org/pdf/fact_sheets/SCHC_GHS_FS2_Flammable_

Liquid.pdf

From: http://www.schc.org/pdf/fact_sheets/SCHC_GHS_FS2_Flammable_

Liquid.pdf

� Safer work environment◦ Consistent, simplified information on hazards and safety procedures/practices

◦ Better information on potential severity of hazards

◦ Easier to train employees

◦ Easier for employees to recognize hazards and take appropriate actions

� Reduced regulatory costs for hazard communication

� Issued a NPRM in September, 2009� Proposed a number of changes in the current HCS to align it with GHS

� The basics of HCS will NOT change◦ Chemical manufacturers, distributors & importers are responsible for disclosing information about hazards◦ Employers using chemicals must have a HCP and provide info about hazards and protective measures to employees

� The requirements to have a written program, obtain SDSs and train employees will NOT significantly change

� Unclassified hazards still covered (CD, simple asphyxiants)

� Exceptions for solid metals and articles will not change

� Other OSHA standards will be updated to make the consistent with GHS◦ Flammable liquids

◦ Substance specific standards- labeling, hazard communication

� Hazard determination will be called hazard classification◦ Specific GHS criteria for classification of health and physical hazards as well as classification of mixtures will be adopted

� The technical data for SDSs and label preparers will likely move to Appendices, making the Standard itself easier to read for chemical users

� Safety Data Sheets◦ Material Safety Data Sheets (MSDSs) will be renamed Safety Data Sheets (SDSs)

◦ Must be in a specified specified 16 part format

� Labels must have….◦ a harmonized warning signal word

◦ a prescribed pictogram

◦ a hazard statement for each hazard class and category

◦ precautionary statements

� SDSSDSSDSSDS◦ Safety Data Sheet

� Product IdentifierProduct IdentifierProduct IdentifierProduct Identifier◦ Product name

� Hazard groupHazard groupHazard groupHazard group◦ Health◦ Physical◦ Environmental.

� Building BlocksBuilding BlocksBuilding BlocksBuilding Blocks◦ Classes and categories make up building blocks◦ Countries can choose which building blocks will be used in their regulatory framework

◦ Once a block is chosen, the GHS rules and classification apply.

� ClassClassClassClass◦ Describes the intrinsic hazard(s)◦ Within each classes there are rules to classify the hazard(s)◦ Each hazard group has its own list of classes.

� CategoryCategoryCategoryCategory◦ Describes in more detail the nature of the hazard(s) within a class◦ Each category has rules or criteria for classification

� Hazard StatementHazard StatementHazard StatementHazard Statement◦ A short statement about the hazard

◦ Standardized language

◦ Based on the classification

◦ Must appear on the label and on the SDS

◦ Numerical codes describe hazards but these are not a substitute for written information

� Precautionary StatementPrecautionary StatementPrecautionary StatementPrecautionary Statement◦ Phrases and/or pictograms that describe what measures should be taken to prevent adverse effects

◦ Includes personnel, storage or handling related protection

◦ Numerical codes describe statements but these are not a substitute for written information

� Signal word Signal word Signal word Signal word ◦ Communicates the level of hazard◦ 2 signal words- Danger and Warning◦ Based on the classification◦ Found on labels and SDSs ◦ There are classifications in which no signal word is required

� PictogramPictogramPictogramPictogram◦ A standardized visual symbol that conveys the potential hazard(s)◦ Found on the label and SDS◦ Based on the classification◦ There are classifications for which no pictogram is required

You will have to learn a new lingo to train employees and prepare MSDSs

and labels

� All hazardous chemicals� No complete exemptions for a particular type of chemical or product

� “Chemical" is a broad term and includes◦ substances◦ products◦ mixtures◦ preparations◦ or any other terms used by existing systems

� Pharmaceuticals, food additives, cosmetics and pesticide residues in food will be covered where workers may be exposed and in transport

� Target audiences for the GHS include consumers, workers, transport workers, and emergency responders

� The heart of the program� Applies only to intrinsic hazards� Requires a ID of hazards, review of existing data and a classification of hazards using that data

� For many hazard classes semi-quantitative or qualitative criteria and expert judgment is used to interpret the data for classification purposes

� This is one area where there are significant differences with the current HCS

� Weight of evidence approach◦ For some hazards, the classification is totally data driven◦ For others, classification may be based on using all of the information together; OSHA refers to this the “full range of available evidence) and can include in vitro tests, relevant animal data and human experience (epidemiological and clinical studies, well-documented case reports & observations.

� Explosives� Flammable Gases� Flammable Aerosols� Oxidizing Gases� Gases Under Pressure� Flammable Liquids� Flammable Solids� Self-Reactive Substances

� Pyrophoric Liquids� Pyrophoric Solids� Self-Heating Substances

� Substances which, in contact with water emit flammable gases

� Oxidizing Liquids� Oxidizing Solids� Organic Peroxides� Corrosive to Metals

Criteria for Chemicals Which, in Contact With Water, Emit Flammable Gases

CategoryCategoryCategoryCategory CriteriaCriteriaCriteriaCriteria

1 Any chemical which reacts vigorously with water at ambient temperatures and demonstrates generally a tendency for the gas produced to ignite spontaneously, or which reacts readily with water at ambient temperatures such that the rate of evolution of flammable gas is equal to or greater than 10 liters per kilogram of chemical over any one minute.

2 Any chemical which reacts readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 20 liters per kilogram of chemical per hour, and which does not meet the criteria for Category 1.

3 Any chemical which reacts slowly with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 1 liter per kilogram of chemical per hour, and which does not meet the criteria for Categories 1 and 2.

� Acute toxicity (OSHA may not adopt all categories)� Skin corrosion/irritation (OSHA may not adopt all categories)

� Serious eye damage/eye irritation (OSHA may not adopt all categories)

� Respiratory or skin sensitization� Germ cell mutagenicity� Carcinogenicity� Reproductive toxicity� Specific target organ toxicity- single exposure� Specific target organ toxicity - repeated exposure� Aspiration hazard (OSHA may not adopt)

CategoryCategoryCategoryCategory CriteriaCriteriaCriteriaCriteria

Definition A substance is classified as a respiratory sensitizer: (a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and/or (b) if there are positive results from an appropriate animal test.

1A Substances showing a high frequency of occurrence in humans; or a probability of occurrence of a high sensitization rate in humansbased on animal or other tests. Severity of reaction may also beconsidered.

1B Substances showing a low to moderate frequency of occurrence in humans; or a probability of occurrence of a low to moderate sensitization rate in humans based on animal or other tests. Severity of reaction may also be considered

Hazard Category & Sub-Categories for Respiratory Sensitizers

Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for respiratory sensitizers. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table A.4.1 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals.

� Hazardous to the aquatic environment (acute and chronic)

� Hazardous to the ozone layer

� If you manufacture, generate, import, distribute chemicals covered under GHS you will have to classify your substances

� This classification process is highly prescribed. Since the required elements of SDSs & labels depend on proper hazard classification, you must be able to competently do this.

� You may need to have your products tested if you don’t have reliable existing data

� Must be careful in just updating existing SDSs-many contain errors

� Need to understand the potential legal ramifications of preparing inadequate SDSs

� Need to determine the appropriate◦ Hazard Statements

◦ Precautionary Statements

◦ Pictograms

� Must used the standardized statements on SDSs and labels

� 72 individual and 17 combined

� Will replace EU “R” phrases seen on European SDSs

� Causes eye irritation� Causes mid skin irritation� Causes serious eye damage � Causes serious eye irritation � Causes severe skin burns and eye damage

� Causes skin irritation� Combustible liquid� Contains gas under pressure; may explode if heated

� Contains refrigerated gas; may cause cryogenic burns or injury

� Explosion; fire, blast or projection hazard

� Explosion; mass explosion hazard

� Explosion; severe projection hazard

� Extremely flammable aerosol � Extremely flammable gas � Extremely flammable liquid and vapour

� Fatal if inhaled � Fatal if swallowed� Fatal in contact with skin � Fire or projection hazard � Flammable aerosol� Flammable gas� Flammable liquid and vapour� Flammable solid� Harmful if inhaled� Harmful if swallowed

� Types of PS◦ General

◦ Prevention

◦ Response in case of spill or exposure

◦ Storage

◦ Disposal

� 116 individual & 33 combined PS

� There are also PS Pictograms which may or may not be used

� Obtain special instructions before use� Do not handle until all safety precautions have been read and understood

� Keep away from heat/sparks/open flames/hot surfaces – No smoking

� Do not spray on an open flame or other ignition source� Do not allow contact with air� Keep away from any possible contact with water, because of violent reaction and possible flash fire

� Protect from moisture� Keep container tightly closed� Ground/bond container and receiving equipment� Use only non-sparking tools� Take precautionary measures against static discharge� Do not breathe dust/fume/gas mist/vapours/spray� Use only outdoors or in a well-ventilated area

� Required Elements◦ Pictograms◦ Signal Words◦ Hazard statements◦ Precautionary statements◦ Product identifier◦ Supplier information

� There is a specified preference order for label elements � In-plant labeling systems will have to be consistent with GHS

� OSHA requires that labels be in English� Exemption for labeling “portable” containers and allowing alternative labels for stationary equipment will likely be maintained

� Labels have to be updated within 3 months after new info about hazards is found

� Three years to convert to new format

What is It?What is It?What is It?What is It? PictogramPictogramPictogramPictogram Hazard Class/CategoryHazard Class/CategoryHazard Class/CategoryHazard Class/Category

Exploding Bomb

Unstable explosives Explosives of Divisions 1.1, 1.2, 1.3, 1.4 Self reactive substances and mixtures, Types A,BOrganic peroxides, Types A,B

Flame Flammable gases, category 1Flammable aerosols, categories 1,2Flammable liquids, categories 1,2,3Flammable solids, categories 1,2Self-reactive substances and mixtures, Types B,C,D,E,F Pyrophoric liquids, category 1 Pyrophoric solids, category 1 Self-heating substances and mixtures, categories 1,2Substances and mixtures, which in contact with water, emit flammable gases, categories 1,2,3 Organic peroxides, Types B,C,D,E,F


Flame over a Circle

Oxidizing gases, category 1 Oxidizing liquids, categories 1,2,3

Cylinder Gases under pressure: - Compressed gases - Liquefied gases - Refrigerated liquefied gases- Dissolved gases

Corrosion Corrosive to metals, category 1Skin corrosion, categories 1A,1B,1CSerious eye damage, category 1

Skull & Crossbones

Acute toxicity (oral, dermal, inhalation), categories 1,2,3


Exclamation Point

Acute toxicity (oral, dermal, inhalation), category 4 Skin irritation, category 2 Eye irritation, category 2 Skin sensitisation, category 1 Specific Target Organ Toxicity – Single exposure, category 3

Health Hazard

Respiratory sensitization, category 1Germ cell mutagenicity, categories 1A,1B,2 Carcinogenicity, categories 1A,1B,2 Reproductive toxicity, categories 1A,1B,2 Specific Target Organ Toxicity – Single exposure, categories 1,2 Specific Target Organ Toxicity – Repeated exposure, categories 1,2 Aspiration Hazard, category 1

Dead fish and tree

Hazardous to the aquatic environment - Acute hazard, category1 - Chronic hazard, categories 1,2

� 16 part format essentially same as ANSI

� Several sections will not be mandatory (Sections 12-15) since they do not deal with workplace H & S but most SDS authors will include this info because SDSs are used for more than workplace safety

� Unclassified hazards go in Section 2

� Three years to convert to new format

�� Section 1Section 1--Product Product InfoInfo◦ Product identifier.◦ Other means of identification.◦ Recommended use of the chemical and restrictions on use.◦ Supplier's details (including name, address, phone number, etc.).◦ Emergency phone number

�� Section 2Section 2--Hazards Hazards IdentificationIdentification◦ GHS classification◦ GHS label elements, including precautionary statements pictograms◦ Other hazards which do not result in classification (e.g., dust explosion hazard) or are not covered by the GHS.

�� Section 3: Section 3: Composition/information on Composition/information on ingredientsingredients◦ Substance Chemical identity.◦ Common name, synonyms, etc.◦ CAS number, EC number, etc.◦ Impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance.

◦ For mixtures, the chemical identity and concentration or concentration ranges of all ingredients which are hazardous within the meaning of the GHS and are present above their cutoff levels.

�� Section 4: First Aid MeasuresSection 4: First Aid Measures◦ Description of necessary measures, subdivided according to the different routes of exposure, i.e., inhalation, skin and eye contact, and ingestion.

◦ Most important symptoms/effects, acute and delayed.

◦ Indication of immediate medical attention and special treatment needed, if necessary.

�� Section 4: Fire Fighting Section 4: Fire Fighting MeasuresMeasures◦ Suitable (and unsuitable) extinguishing media.

◦ Specific hazards arising from the chemical (e.g., nature of any hazardous combustion products).

◦ Special protective equipment and precautions for firefighters.

�� Section 6: Accidental Section 6: Accidental Release MeasuresRelease Measures◦ Personal precautions, protective equipment and emergency procedures.◦ Environmental precautions.◦ Methods and materials for containment and cleaning up.

�� Section 7: Handling and Section 7: Handling and Storage Storage ◦ Precautions for safe handling.◦ Conditions for safe storage, including any incompatibilities.

�� Section 8: Exposure Section 8: Exposure controls/personal controls/personal protectionprotection◦ Control parameters, e.g., occupational exposure limit values or biological limit values.◦ Appropriate engineering controls.◦ Individual protection measures, such as personal protective equipment.

�� Section 9Section 9-- Physical and chemical Physical and chemical propertiesproperties◦ Appearance (physical state, color, etc.).

◦ Odor.◦ Odor threshold.◦ pH.◦ melting point/freezing point.◦ initial boiling point and boiling range.◦ flash point.◦ evaporation rate.◦ flammability (solid, gas).◦ upper/lower flammability or explosive limits.

◦ vapor pressure.◦ vapor density.◦ relative density.◦ solubility(ies).◦ partition coefficient: n-octanol/water.◦ autoignition temperature.◦ decomposition temperature.

�� Section 10: Stability and Section 10: Stability and Reactivity Reactivity ◦ Chemical stability.◦ Possibility of hazardous reactions. ◦ Conditions to avoid (e.g., static discharge, shock or vibration).

◦ Incompatible materials.◦ Hazardous decomposition products.

�� Section 11: Toxicoilogy InfoSection 11: Toxicoilogy Info◦ Concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects, including: information on the likely routes of exposure (inhalation, ingestion, skin and eye contact);

◦ Symptoms related to the physical, chemical and toxicological characteristics;

◦ Delayed and immediate effects and also chronic effects from short- and long-term exposure;

◦ Numerical measures of toxicity (such as acute toxicity estimates).

�� Section 12: Ecological InfoSection 12: Ecological Info◦ Ecotoxicity (aquatic and terrestrial, where available).

◦ Persistence and degradability.◦ Bioaccumulative potential.◦ Mobility in soil.◦ Other adverse effects.

�� Section 13: Disposal Section 13: Disposal ConsiderationsConsiderations◦ Description of waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging.

�� Section 14Section 14--Transport InfoTransport Info◦ UN Number.◦ UN Proper shipping name.◦ Transport Hazard class(es).◦ Packing group, if applicable.◦ Marine pollutant (Yes/No).◦ Special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside their premises.

�� Section 15: Regulatory InfoSection 15: Regulatory Info◦ Safety, health and environmental regulations specific for the product in question.

�� Section 16: Other Section 16: Other information including information including information on preparation information on preparation and revision of the SDSand revision of the SDS

� Nuts and bolts are the same

� Requires updated training in the new elements (labels and SDSs)

� Must be completed within 2 years after final rule is issued

� No major changes in this section

� Called Confidential Business Information in GHS

� Percentages of ingredients is required on SDS under GHS but these may be considered CBI and not specifically disclosed on the SDS

� Only chemical names and percentages can be considered to be CBI-all other parts of GHS must be met

� GHS has a 3 step procedure for classifying mixtures◦ Use mixture as whole data◦ Use bridging principles to extrapolate data◦ Estimate hazards based on known info regarding ingredients

� Manufacturers/importers still responsible for accuracy of info even if relying on info provided by their suppliers

� OSHA will retain the low cut-off points for mixtures

� You are going to have to obtain new SDS within 3 year after the standard is finalized◦ Start now by weeding out you old MSDSs and keeping your chemical inventory up-to-date

� You will need to ensure that labels meet GHS requirements

� You will need to train your employees to read the new SDSs and labels◦ This is actually going to be easier than before!!

Thank You!

Kay Rowntree, CIH

Industrial Hygiene Sciences, LLC

602 Fox Knoll Drive

Waterford, WI 53185

262-534-2554

[email protected]

www.ihsciences.com

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Kay Rowntree, CIH - WMC