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The Globally Harmonized System of Classification and Labeling of Chemicals (GHS). An Overview with Emphasis on OSHA’s Implementation Bernadette Lindquist, Ph.D., DABT. OUTLINE. GHS – what is it? OSHA Regulatory Status Hazard Communication Elements UN approach As implemented by OSHA
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The Globally Harmonized System of Classification and Labeling of Chemicals(GHS) An Overview with Emphasis on OSHA’s Implementation Bernadette Lindquist, Ph.D., DABT
OUTLINE • GHS – what is it? • OSHA Regulatory Status • Hazard Communication Elements • UN approach • As implemented by OSHA • GHS Label • GHS SDS (formerly MSDS)
What is GHS? - a Worldwide System for Chemical Hazard Communication • GHS is a common and coherent approach to defining and classifying hazards for chemicals, and communicating such information on labels and safety data sheets. • GHS is an international recommendation from the United Nations – initiated 1992; agreed upon 2002; published 2003; updated biennially; and now being adopted into regional regulations. • OSHA adoption 2012 consistent with 3rd revision of GHS • Provides the underlying infrastructure for establishment of national, comprehensive chemical safety programs.
“The Purple Book” • The GHS itself is not a regulation or a standard! • Rather, the GHS document (referred to as “The Purple Book”) establishes agreed upon hazard classification and communication provisions with explanatory information on how to apply the system. • GHS becomes a law when a regulatory authority adopts it as a regulation for a given country/region.
Major Existing Systems (basis for GHS) • UN Recommendations on the Transport of Dangerous Goods • European Union (EU) Directives on Substances and Preparations • Canadian Requirements for Workplace, Consumers and Pesticides • US Requirements for Workplace, Consumers and Pesticides (OSHA HazCom, CPSC and EPA FIFRA)
Why is the GHS needed? • Decisions about how and when to communicate chemical hazards via an SDS or label vary around the world • Worldwide implementation of GHS is expected to minimize differences that impact protection of human health and the environment • Improved consistency in hazard communication • Reduced chemical-related injuries, illnesses, fatalities • Protection of the environment
The GHS Includes: Classification Criteria • Health Hazards • Environmental Hazards • Physical Hazards • Mixtures Hazard Communication • Labels • Safety Data Sheets
Adoption of the GHS by the U.S. Occupational Safety and Health Administration OSHA
OSHA alignment of Hazard Communication Standard (HCS) with GHS • Scope and application are basically the same! • Essential components include: • Evaluation of chemicals • Written hazard communication requirement, i.e. SDS and labels • Employee training • Trade secret provision remains the same
Standardized Hazard Communication Elements included in GHS: • Classification • Pictogram(s) • Signal Word • Hazard Statement(s) • Precautionary Statement(s)* *Not fully harmonized; Annex 3 of GHS provides guidance in selection of appropriate statements Note: Elements 1 – 4 should not be subject to variation and should appear on GHS label as described in the “Purple Book” for each hazard class. (BUT, in HazCom 2012, OSHA has included the Precautionary Statements as required text.)
Elements of the GHS1.ClassificationDetermination of nature and severity of hazardFull range of scientific data is used No testing required
Classification of Physical Hazards Classifications based on United Nations Recommendations on the Transport of Dangerous Goods Explosive Flammable – gases (includes chemically unstable), liquids, solids Aerosol (including flammable) Oxidizing – liquid, solid, gases Self-Reactive Pyrophoric – liquids, solids Self-Heating Organic Peroxide Corrosive to Metals Gases Under Pressure Water-Activated Flammable Gas
Classification of Health & Environmental Hazards Acute Toxicity Skin Corrosion/Irritation Serious Eye Damage/Eye Irritation Respiratory or Skin Sensitization Aspiration Hazard Germ Cell Mutagenicity Carcinogenicity Reproductive Toxicity Target Organ Systemic Toxicity – Single and Repeated Dose Hazardous to the Aquatic Environment Hazardous to the Ozone Layer
In addition to UN GHS hazards, OSHA includes: • Simple asphxiant • Label: Warning. May displace oxygen and cause rapid suffocation. • Pyrophoric Gas • Label: Danger. Catches fire spontaneously if exposed to air. • Hazard Not Otherwise Classified (HNOC) • Does not need to be addressed on labels; has to be addressed on SDS and in training
HNOC "Hazard not otherwise classified (HNOC)" means an adverse physical or health effect identified through evaluation of scientific evidence during the classification process that does not meet the specified criteria for the physical and health hazard classes addressed in this section. This does not extend coverage to adverse physical and health effects for which there is a hazard class addressed in this section, but the effect either falls below the cut-off value/concentration limit of the hazard class or is under a GHS hazard category that has not been adopted by OSHA (e.g., acute toxicity Category 5).
OSHA also includes: • Combustible dust • Covered separately from HNOC • NOT specifically defined • Guidance is to be taken from existing documents: • Directive for the National Emphasis Program • NFPA standards • May apply to solids if processing creates combustible dust • MUST be addressed on label: • Warning. May form combustible dust concentrations in air.
OSHA Definition of Hazardous Chemical “Hazardous chemical” means any chemical which is classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified.”
UN GHS Building Block Approach • Hazard classes and categories of the GHS should be seen as a collection of “building blocks” from which a regulatory approach can be developed. • Needs vary between sectors; regulatory requirements of systems will vary to meet those needs. • All GHS elements do not need to be adopted if not needed. • Transportation sector includes classification and labeling elements for acute and physical hazards, but does NOT include chronic effects. • This allows competent authorities some freedom to take up different hazard classes or categories
Example: Acute Oral Toxicity NOTE: Criteria for classification is acute LD50 or LC50. OSHA did not adopt Category 5 for acute toxicity. Notice that the category numbers go from low to high with lower numbers being more severe.
Example: Flammable Liquids • Criteria for classification is flash point/boiling point. OSHA adopted all categories.
* Individual hazard classes may have more or less than 5 hazard categories, but as numerical category goes from low to high, severity of hazard decreases. ClassificationNumerical categorization
Health Hazard Building Blocks • Acute toxicity Cat 5 and Skin irritation Cat 3: Not adopted by OSHA • OSHA adopted all sub-categories Note:UN GHS allows using single category or sub-dividing certain categories (shown in pink)
Health Hazard Building Blocks (cont’d) †Used for respiratory tract irritants and CNS depressants *Aspiration Category 2: not adopted by OSHA
Environmental Hazard Building BlocksOSHA does not have regulatory authority to address environmental concerns; thus there are no environmental building blocks in OSHA rule * Categories have not been adopted by all regulatory bodies that have adopted GHS, e.g. EU adopted all but Acute Cats 2 and 3.
Summary of OSHA adoption • All health hazards classes adopted; the following categories NOT adopted: • Category 5 for acute toxicity • Category 3 for skin irritation/corrosion • Category 2 for aspiration toxicity • All physical hazard classes/categories adopted except Category 3 aerosol (non-flammable) • No environmental hazard classes adopted
Elements of the GHS2.Signal Words“Danger” or “Warning”Used to emphasize hazard and discriminate between levels of hazard.Note: No use of the signal word “Caution”
Hazard Statements • A single harmonized hazard statement for each level of hazard within each hazard class • Example 1: Flammable liquids • Category 1: Extremely flammable liquid and vapour • Category 2: Highly flammable liquid and vapour • Category 3: Flammable liquid and vapour • Category 4: Combustible liquid • Example 2: Skin Corrosion/Irritation • Category 1: Causes severe skin burns and eye damage • Category 2: Causes skin irritation • Category 3: Causes mild skin irritation
Elements of the GHS5.Precautionary StatementsStandardized but not fully harmonized in GHS, but . . .OSHA has made standardized precautionary phrases mandatory . . .“unless manufacturer, importer or other responsible party can demonstrate that a precautionary statement is inappropriate to a specific substance or mixture . . . ”
Precautionary Information • GHS label should include appropriate precautionary information. • Recommended measures for minimizing or preventing possible adverse effects resulting from exposure to, or improper storage and/or handling of hazardous chemicals. • Standardized precautionary statements associate with specific hazard categories • Five types of precautionary information: • General (Read label before use.) • Prevention (Keep container tightly closed.) • Response • Accidental spills, emergency response, and first aid (Get immediate medical attention.) • Storage (Protect from sunlight.) • Disposal (Refer to manufacturer for information on recycling.)
Key Label Elements • Product identifier - Supplier identifier - Name, address, telephone • Signal words • Pictograms • Hazard statements • Precautionary statements • 5 types; includes 1st aid information Note: supplier label can include additional information, but such information should provide further detail, but should not contradict standard elements or lower standards of protection.
The GHS Label Product Identifier Hazard Pictogram(s) Signal Word Hazard Statement(s) Precautionary Statements Supplier identifier
Label for a Cat. 2 flammable liquid, Cat. 4 acute inhalation hazard, and Cat. 2 specific organ toxicant (repeated exposure)
Role of the SDS in the GHS • The SDS should provide comprehensive information about a chemical substance or mixture. • Primary Use: The Workplace • Employers and workers use the SDS as a source of information about hazards and to obtain advice on safety precautions. • Relates to protection of human health and the environment
SDSFormat: 16 headings 1. Identification 2. Hazard(s) identification 3. Composition/information on ingredients 4. First-aid measures 5. Fire-fighting measures 6. Accidental release measures 7. Handling and storage 8. Exposure control/personal protection
SDS Format: 16 headings (cont.) 9. Physical and chemical properties 10. Stability and reactivity 11. Toxicological information 12. Ecological information 13. Disposal considerations 14. Transport information 15. Regulatory information 16. Other information NOTE: Sections 12,13, 14, and 15 considered non-mandatory under OSHA proposal.