OSHA Final Rule Status Update – Globally Harmonized System of Classification and Labeling of Chemicals (GHS)

GHS Current Status at US DOL

DOL/OSHA RIN: 1218-AC20 Publication ID: Fall 2010
Title: Hazard Communication
Abstract: OSHA’s Hazard Communication Standard (HCS) requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import, and prepare labels and material safety data sheets to convey the hazards and associated protective measures to users of the chemicals. All employers with hazardous chemicals in their workplaces are required to have a hazard communication program, including labels on containers, material safety data sheets (MSDS), and training for employees. Within the United States (U.S.), there are other Federal agencies that also have requirements for classification and labeling of chemicals at different stages of the life cycle. Internationally, there are a number of countries that have developed similar laws that require information about chemicals to be prepared and transmitted to affected parties. These laws vary with regard to the scope of substances covered, definitions of hazards, the specificity of requirements (e.g., specification of a format for MSDSs), and the use of symbols and pictograms. The inconsistencies between the various laws are substantial enough that different labels and safety data sheets must often be used for the same product when it is marketed in different nations. The diverse and sometimes conflicting national and international requirements can create confusion among those who seek to use hazard information. Labels and safety data sheets may include symbols and hazard statements that are unfamiliar to readers or not well understood. Containers may be labeled with such a large volume of information that important statements are not easily recognized. Development of multiple sets of labels and safety data sheets is a major compliance burden for chemical manufacturers, distributors, and transporters involved in international trade. Small businesses may have particular difficulty in coping with the complexities and costs involved. As a result of this situation, and in recognition of the extensive international trade in chemicals, there has been a long-standing effort to harmonize these requirements and develop a system that can be used around the world. In 2003, the United Nations adopted the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Countries are now adopting the GHS into their national regulatory systems. 

 

Agency: Department of Labor(DOL) Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage
Major: Yes Unfunded Mandates: Private Sector 

 

CFR Citation: 29 CFR 1910.1200; 29 CFR 1915.1200; 29 CFR 1917.28; 29 CFR 1918.90; 29 CFR 1926.59; 29 CFR 1928.21
Legal Authority: 29 USC 655(b); 29 USC 657 

 

Legal Deadline: None 

 

Statement of Need: Multiple sets of requirements for labels and safety data sheets present a compliance burden for U.S. manufacturers, distributors, and transports involved in international trade. The comprehensibility of hazard information and worker safety will be enhanced as the GHS will: (1) Provide consistent information and definitions for hazardous chemicals; (2) address stakeholder concerns regarding the need for a standardized format for material safety data sheets; and (3) increase understanding by using standardized pictograms and harmonized hazard statements. The increase in comprehensibility and consistency will reduce confusion and thus improve worker safety and health. In addition, the adoption of the GHS would facilitate international trade in chemicals, reduce the burdens caused by having to comply with differing requirements for the same product, and allow companies that have not had the resources to deal with those burdens to be involved in international trade. This is particularly important for small producers who may be precluded currently from international trade because of the compliance resources required to address the extensive regulatory requirements for classification and labeling of chemicals. Thus every producer is likely to experience some benefits from domestic harmonization, in addition to the benefits that will accrue to producers involved in international trade. Several nations, including the European Union, have adopted the GHS with an implementation schedule through 2015. U.S. manufacturers, employers, and employees will be at a disadvantage in the event that our system of hazard communication is not in compliance with the GHS.
Summary of the Legal Basis: The Occupational Safety and Health Act of 1970 authorizes the Secretary of Labor to set mandatory occupational safety and health standards to assure safe and healthful working conditions for working men and women (29 U.S.C. 651).
Alternatives: The alternative to the proposed rulemaking would be to take no regulatory action.
Anticipated Costs and Benefits: The estimates of the costs and benefits are still under development.
Risks: OSHA’s risk analysis is under development.
Timetable: 

Action Date FR Cite
ANPRM 09/12/2006 71 FR 53617
ANPRM Comment Period End 11/13/2006
Complete Peer Review of Economic Analysis 11/19/2007
NPRM 09/30/2009 74 FR 50279
NPRM Comment Period End 12/29/2009
Hearing 03/02/2010
Hearing 03/31/2010
Post Hearing Comment Period End 06/01/2010
Final Action 08/00/2011
Regulatory Flexibility Analysis Required: No Government Levels Affected: Local, State
Federalism: Yes
Included in the Regulatory Plan: Yes
RIN Data Printed in the FR: No
Agency Contact:
Dorothy Dougherty
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW., FP Building, Room N-3718,
Washington, DC 20210
Phone:202 693-1950
Fax:202 693-1678
Email: dougherty.dorothy@dol.gov

—————————————————————————————————————————————————————-

A Guide to
The Globally Harmonized System of Classification and Labelling of Chemicals (GHS)


Globally Harmonized System (GHS) of Chemical Classification and Labelling

Acronyms/Abbreviations

The following list presents some acronyms and abbreviations used in this document. The 6.0 – Glossary contains a more complete list.

ANSI: American National Standards Institute
APEC: Asia-Pacific Economic Cooperation
ASTM: American Society of Testing and Materials
CA: Competent Authority
CAS: Chemical Abstract Service
CBI: Confidential Business Information
CFR: Code of Federal Regulations
CG/HCCS: Coordinating Group for the Harmonization of Chemical Classification Systems
CPSC: Consumer Product Safety Commission
DOT: Department of Transportation
EINECS: European Inventory of Existing Commercial Chemical Substances
EPA: Environmental Protection Agency
EU: European Union
FIFRA: Federal Insecticide, Fungicide and Rodenticide Act
GHS: Globally Harmonized System of Classification and Labelling of Chemicals
HCS: Hazard Communication Standard
IARC: International Agency for the Research on Cancer
IFCS: International Forum on Chemical Safety
ILO: International Labor Organization
IOMC: Inter-organization Program on the Sound Management of Chemicals
ISO: International Standards Organization
IUPAC: International Union of Pure and Applied Chemistry
LD50 : Lethal dose 50mg/kg: Milligram per kilogram
MSDS: Material Safety Data Sheet
NAFTA: North American Free Trade Agreement
OSHA: Occupational Safety and Health Administration
OECD: The Organization for Economic Cooperation and Development
QSARs: Quantitative Structure-Activity Relationships
SDS: Safety Data Sheet
SME: Small and medium sized enterprises
TFHCL: Task Force on the Harmonization of Classification and Labelling
TSCA: Toxic Substances Control Act
UN: United Nations
UNCED: United Nations Conference on Environment and Development
UNCETDG: United Nations Committee of Experts on the Transport of Dangerous Goods
UNCETDG/GHS: United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labelling of Chemicals
UNITAR: United Nations Institute for Training and Research
WG: work group
WHMIS: Workplace Hazardous Materials Information System
WSSD: World Summit on Sustainable Development

TABLE OF CONTENTS

1. Background
1.1 What is the GHS?
1.2 Why was the GHS developed?
1.3 What was the International Mandate?
1.4 How was the GHS developed?
1.5 How will the GHS be maintained and updated?
1.6 When will the GHS be implemented?
1.7 What are the benefits?

2. How is the GHS to be applied?
2.1 Are all chemicals covered by the GHS?
2.2 Will all hazardous chemicals require a GHS label and Safety Data Sheet?
2.3 How will the GHS impact existing regulations?
2.4 What is meant by GHS Building Blocks?
2.5 How should the GHS Building Blocks by applied?
2.5.1 Transport
2.5.2 Workplace
2.5.3 Consumer
2.5.4 Pesticides
2.6 How will the GHS impact countries without existing regulations?

3. What is Classification?
3.1 What are the GHS Physical Hazards?
3.1.1 Explosives
3.1.2 Flammable Gases
3.1.3 Flammable Aerosols
3.1.4 Oxidizing Gases
3.1.5 Gases Under Pressure
3.1.6 Flammable Liquids
3.1.7 Flammable Solids
3.1.8 Self-Reactive Substances
3.1.9 Pyrophoric Liquids
3.1.10 Pyrophoric Solids
3.1.11 Self-Heating Substances
3.1.12 Substances Which in Contact with Water Emit Flammable Gases
3.1.13 Oxidizing Liquids
3.1.14 Oxidizing Solids
3.1.15 Organic Peroxides
3.1.16 Substances Corrosive to Metal
3.2 What are the GHS Health and Environmental Hazards?
3.2.1 Acute Toxicity
3.2.2 Skin Corrosion
3.2.3 Skin Irritation
3.2.4 Eye Effects
3.2.5 Sensitization
3.2.6 Germ Cell Mutagenicity
3.2.7 Carcinogenicity
3.2.8 Reproductive Toxicity
3.2.9 Target Organ Systemic Toxicity: Single Exposure & Repeated Exposure
3.2.10 Aspiration Toxicity
3.3 Environmental Hazards
3.3.1 Hazardous to the Aquatic Environment
3.3.1.1 Acute Aquatic Toxicity
3.3.1.2 Chronic Aquatic Toxicity
3.4 What is the GHS approach to classifying mixtures?
3.5 What are bridging principles?
3.6 What testing is required?

4. Hazard Communication
4.1 What factors influenced development of the GHS communication tools?
4.2 Labels
4.2.1 What does a label look like?
4.2.2 USA Examples
4.2.3 International Examples
4.3 What are the GHS label elements?
4.3.1 Symbols (hazard pictograms)
4.3.2 Signal Words
4.3.3 Hazard Statements
4.3.4 Precautionary Statements and Pictograms
4.3.5 Product Identifier (Ingredient Disclosure)
4.3.6 Supplier Identification
4.3.7 Supplemental Information
4.4 How are multiple hazards handled on labels?
4.5 Is there a specific GHS label format / layout?
4.6 What about risk?
4.7 Are workplace containers covered in the GHS?
4.8 What is the GHS Safety Data Sheet (SDS)?
4.9 What is the difference between the GHS SDS and existing MSDSs/SDSs?
4.10 When should SDSs and labels be updated?
4.11 How does the GHS address Confidential Business Information (CBI)?
4.12 Does the GHS address training?

5. References

6. Glossary

7. Appendices
A. Comparison of MSDSs/SDSs Elements
B. GHS MSDS examples

1.0 Background

The purpose of this document is to describe the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), why it was developed, and how it relates to the sound management of chemicals. The full official text of the system is available on the web.

1.1 What is the GHS?
The GHS is an acronym for The Globally Harmonized System of Classification and Labelling of Chemicals. The GHS is a system for standardizing and harmonizing the classification and labelling of chemicals. It is a logical and comprehensive approach to:

  • Defining health, physical and environmental hazards of chemicals;
  • Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria; and
  • Communicating hazard information, as well as protective measures,  on labels and Safety Data Sheets (SDS).
Figure 1.1
GHS Document (“Purple Book”)
Figure 1.1 GHS Document ("Purple Book")

Many countries already have regulatory systems in place for these types of requirements. These systems may be similar in content and approach, but their differences are significant enough to require multiple classifications, labels and safety data sheets for the same product when marketed in different countries, or even in the same country when parts of the life cycle are covered by different regulatory authorities. This leads to inconsistent protection for those potentially exposed to the chemicals, as well as creating extensive regulatory burdens on companies producing chemicals. For example, in the United States (U.S.) there are requirements for classification and labelling of chemicals for the Consumer Product Safety Commission, the Department of Transportation, the Environmental Protection Agency, and the Occupational Safety and Health Administration.

The GHS itself is not a regulation or a standard. The GHS Document (referred to as “The Purple Book”, shown in Figure 1.1) establishes agreed hazard classification and communication provisions with explanatory information on how to apply the system. The elements in the GHS supply a mechanism to meet the basic requirement of any hazard communication system, which is to decide if the chemical product produced and/or supplied is hazardous and to prepare a label and/or Safety Data Sheet as appropriate. Regulatory authorities in countries adopting the GHS will thus take the agreed criteria and provisions, and implement them through their own regulatory process and procedures rather than simply incorporating the text of the GHS into their national requirements. The GHS Document thus provides countries with the regulatory building blocks to develop or modify existing national programs that address classification of hazards and transmittal of information about those hazards and associated protective measures. This helps to ensure the safe use of chemicals as they move through the product life cycle from “cradle to grave.”

1.2 Why was the GHS developed?
The production and use of chemicals is fundamental to all economies. The global chemical business is more than a $1.7 trillion per year enterprise. In the U.S., chemicals are more than a $450 billion business and exports are greater than $80 billion per year.

Chemicals directly or indirectly affect our lives and are essential to our food, our health, and our lifestyle. The widespread use of chemicals has resulted in the development of sector-specific regulations (transport, production, workplace, agriculture, trade, and consumer products). Having readily available information on the hazardous properties of chemicals, and recommended control measures, allows the production, transport, use and disposal of chemicals to be managed safely. Thus, human health and the environment are protected.

The sound management of chemicals should include systems through which chemical hazards are identified and communicated to all who are potentially exposed. These groups include workers, consumers, emergency responders and the public. It is important to know what chemicals are present and/or used, their hazards to human health and the environment, and the means to control them. A number of classification and labelling systems, each addressing specific use patterns and groups of chemicals, exist at the national, regional and international levels. The existing hazard classification and labelling systems address potential exposure to chemicals in all the types of use settings listed above.

Major GHS Progress This Year

A mid-2010 meeting showed how GHS implementation is advancing around the world.

The 20th meeting of the UNECE Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) will take place Dec. 7-9, 2010, in Geneva. While a detailed agenda had not been posted at press time for this issue, the preliminary agenda indicated a U.S. expert may present an analysis requested by the sub-committee in mid-2009 of practices and regulations in place for combustible dust.

Dec. 1, 2010, is also significant because it is the first of two phase-in implementation deadlines for REACH and the date when companies in the European Union must apply CLP, the new European Regulation on Classification, Labelling and Packaging, to chemical substances. A second deadline in June 2015 is set for applying CLP to chemical mixtures. The CLP rule sets a new system in place throughout the European Union for classifying and labeling chemicals that is based on GHS.

At the Geneva meeting, Australia is scheduled to present a final report summarizing the GHS classification lists maintained by each country, their plans for lists to support GHS implementation, how various sectors in different countries use classification lists now, and what future needs there are for such lists.

The mid-2010 meeting showed how GHS implementation is advancing around the world. It became mandatory for chemical substances in the Republic of Korea on July 1, 2010, and will be mandatory for mixtures there on July 1, 2013. Switzerland allowed consumer products classified and labeled in accordance with GHS to be sold as of July 1, 2010, but its reclassification of substances will not be in force until December 2012. Serbia adopted a law implementing GHS on June 29, 2010, that sets a transition period for CLP implementation ending Sept. 1, 2011, for substances and June 1, 2015, for mixtures. Two standards implementing GHS in China took effect May 1, 2010, and a system for coordinating GHS implementation by government and industry is being developed there. Australia expects to release a GHS implementation regulation for public comment in September 2010, and in the United States, OSHA is now drafting its Hazard Communication final rule implementing GHS.

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