Hazard Communication (HazComm2012) and the Globally Harmonized System (GHS) Mark Banden Banden Safety and Health Services www.bandensafety.com
Plan For the DayHazard Communication (HazComm 2012) and the Globally Harmonized System (GHS) • Brief overview of the GHS • Benefits of revising the Hazard Communication Standard to adopt the GHS • Overview of some major changes to the HCS • Detailed Side-By-Side Review of Changes • Employee Training Program Example • References
Globally Harmonized System of Classification and Labeling of Chemical - GHS An Internationally common, coherent approach to classifying and communicating chemical hazards
What is GHS? • UN system developed to standardize the classification of chemicals and communication of hazards. • Revised every 2 years. Also known as the “Purple Book.”GHS (Rev.3) (2009) – UNECE. • Already adopted in Europe and many other countries (China, Japan, New Zealand, Brazil, etc.). • GHS framework uses a “building block” approach: • countries implement standardized elements they want • still have minor variations, but much less than in the past • Intended to facilitate international trade and improve the quality and consistency of hazard information provided.
GHS • Harmonizes classification, Safety Data Sheets (SDS) and labeling • Not a “model” regulation – contains criteria and text • Specification versus Performance Oriented Approach • Created as a “building-block” approach • Each competent authority adopts those provisions applicable to sphere of regulation or need • Covers physical, health and environmental hazards • OSHA Standard Maintains current exceptions to coverage • Biological Agents • Radioactive elements • Consumer Products • Hazardous Waste • Etc..
OSHA and the GHS • OSHA’s 1983 final HCS included recognition of the importance of international harmonization of such requirements, and a commitment to work towards an international approach • The Agency: • Supported adoption of the international mandate to develop the GHS; • Helped to negotiate the provisions of the GHS; and • Leads the current US delegation to the United Nations’ Committee and Subcommittee on the GHS
Rulemaking History • OSHA published an advance notice of proposed rulemaking (ANPR) on September 12, 2006 • The ANPR described OSHA’s plan to apply the GHS to the HCS; comments were received from over 100 respondents • OSHA published a notice of proposed rulemaking on September 29, 2009, that provided a preamble explanation, as well as the text of the proposed modifications
Rulemaking History, cont. The NPRM established a 90-day period for written comments Public hearings were convened in Washington, DC, and Pittsburgh, Pennsylvania, to receive oral testimony A period for post-hearing comments and briefs was established by the Administrative Law Judge When the public record was completed, OSHA prepared the final rule based on the record, along with various analyses required for such standards The final rule was published in the Federal Register on March 26, 2012 (77 FR 17574 – 17896) The rule will be in effect 60 days later: May 25, 2012
Preliminary Rulemaking Activities Development of the Proposed Rule Publication of the Proposed Rule Analysis of the Rulemaking Record Development of the Final Rule Publication of the Final Rule Site visits Stakeholder meetings RFI or ANPR SBREFA Public Comment Implementation
Why Adopt the GHS? • The primary purpose of the HCS is to reduce chemical source illnesses and injuries • Since the HCS was promulgated in 1983, acute illnesses and injuries from chemicals have decreased 42% • However, there is still a critical need for effective information to protect exposed workers from chemicals—particularly from chronic effects
Why Adopt the GHS, cont. • A key part of the new approach is increased comprehensibility due to the standardized or harmonized approach to information dissemination • Standardized Information includes: • SDS • Labels
Benefits • Enhance worker comprehension of hazards, • especially for low and limited-literacy workers, • reduce confusion in the workplace, • facilitate safety training, • result in safer handling and use of chemicals; • Provide workers quicker and more efficient access to information on the safety data sheets; (emergency sections are always #4, 5, 6) • Result in cost savings to American businesses in productivity improvements, fewer safety data sheet and label updates and simpler new hazard communication training; and • Reduce trade barriers by harmonizing with systems around the world.
What’s the Impact? • Rule will impact over 5 million workplaces, and 43 million workers • 650,000 Chemicals used in the USA • 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 annuallyas a result of change • Savings attributed to uniform SDSs and labels accounts for between $16 mil and $32.2 mil
Penalties for non-compliance are very real • In 2009 & 2010 combined, OSHA citedover 13,000 instances of HCS violations in workplaces across the United States • #3 on OSHA's top 10 list of most frequently violated compliance standards
Major changes to the Hazard Communication Standard 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: Employers are required to train workers by December 1, 2013 on the new labels elements and safety data sheets format to facilitate recognition and understanding.
Principles & Assumptions OSHA has modified only the provisions of the HCS that must be changed to align with the GHS The basic framework of the HCS remains the same Chemical manufacturers and importers are responsible for providing information about the identities and hazards of chemicals they produce or import All employers with hazardous chemicals in their workplaces are still required to have a hazard communication program, and provide information to employees about their hazards and associated protective measures OSHA has maintained or enhanced the overall current level of protection of the HCS
Principles & Assumptions, cont. Other aspects of the standard have minimal modifications in terminology to make them consistent with GHS. The scope and application is basically unchanged, maintaining practical accommodations made by OSHA Written hazard communication program requirements, worker training, and trade secret provisions are all largely unchanged from the existing rule
Other Aspects of the Approach • Maintain consistency with major trading partners where possible • Revise other OSHA standards that will be affected by the changes to the HCS • Minimize country-specific deviations to be as harmonized as possible with GHS provisions
Organization of the Final Rule Keep the regulatory text as simple as possible, adding the detailed specification requirements to Appendices Employers who do not have to classify hazards or prepare labels and safety data sheets (SDSs) do not need to access or be familiar with much of the new text in Appendices A and B
Organization of the Final Rule (a) Purpose (b) Scope and Application (c) Definitions (d) Hazard Classification (e) Written Hazard Communication Program (f) Labels and Other Forms of Warning (g) Safety Data Sheets (h) Employee Information and Training (i) Trade Secrets (j) Effective Dates Appendices A -F
Appendices • Appendix A, Health Hazard Criteria (Mandatory) (NEW) • Appendix B, Physical Hazard Criteria (Mandatory) (NEW) • Appendix C, Allocation of Label Elements (Mandatory) (NEW) • Appendix D, Safety Data Sheets (Mandatory) (NEW) • Appendix E, Definition of “Trade Secret” (Mandatory) • Appendix F, Guidance For Carcinogenicity(Non-Mandatory) (NEW)
Side-by-Side Comparison Of Changes: HazComm 1994 versus HazComm 2012
a) Purpose HazCom 1994 HazCom 2012 All hazards to be classified Other provisions the same, except OSHA added that the rule is consistent with Revision 3 of the GHS (2009 Version) Slight clarifying modification was made to the language regarding preemption Federalism • All hazards to be evaluated • Comprehensive hazard communication program to transmit information • Preempt state laws
Federalism 1910.1200(a)(2) This occupational safety and health standard is intended to address comprehensively the issue of classifying the potential hazards of chemicals, and communicating information concerning hazards and appropriate protective measures to employees, and to preempt any legislative or regulatory enactments of a state, or political subdivision of a state, pertaining to this subject…. Under section 18 of the Act, no state or political subdivision of a state may adopt or enforce any requirement relating to the issue addressed by this Federal standard, except pursuant to a Federally-approved state plan.
b) Scope and Application HazCom 1994 HazCom 2012 Minimal changes except to conform terminology, and remove reference to current Appendix E which has been deleted from the standard. • All chemicals known to be present are covered • Practical accommodations for special situations • Addresses interface with other Federal laws
c) Definitions HazCom 1994 HazCom 2012 • Physical hazard definitions removed from paragraph (c), and placed in a new Appendix B on physical hazard classification criteria • Following terms are also deleted: flashpoint (methods included in Appendix B), hazard warning, material safety data sheets • Some definitions are revised to be GHS-consistent, • New definitions added for classification • Includes specific definitions for terms used in the standard, as well as all physical hazards
Definitions • Terms no longer being defined due to changes in terminology: • Hazard warning; identity; and material safety data sheet (MSDS) • Terms revised to be consistent with the GHS: • Chemical; chemical name;hazardous chemical;health hazard; label; mixture; physical hazard; and trade secret
Definitions The following terms are being added to the definitions section: Classification; hazard category; hazard class; hazard not otherwise classified; hazard statement; label elements; pictogram; precautionary statement; product identifier; pyrophoric gas; safety data sheet (SDS); signal word; simple asphyxiant; and substance These terms are primarily related to the changes in approach to evaluating hazards, and providing label /SDS information
GHS New Terms • Classification – identification and evaluation of relevant data regarding chemical hazards and comparison to GHS criteria • Hazard class– the nature of the physical or health hazard • Hazard category– division of criteria within each hazard class • Hazard statement– statement assigned to a hazard class and category that describes the nature and degree of hazard • Pictogram – symbol plus other graphic elements intended to convey specific information about the hazards • Precautionary statement– phrase that describes measures that should be taken to minimize or prevent adverse effects • Safety data sheet (SDS)= Material Safety Data Sheet (MSDS) • Signal word– indicates the relative level of severity of hazard. Danger is more severe. Warning is less severe.
Definition of “hazardous chemical” ADDED BY OSHA • 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. • OSHA used the “building block” GHS concept to include: • a simple asphyxiant, • combustible dust, • pyrophoric gas, or • hazard not otherwise classified.
Definitions “Hazards Not Otherwise Classified” Classification identifies a hazard, but the evidence does not meet the currently specified criteria covered by HazComm 2012 Example: Static Accumulator, Magnetic, etc.. Example: Toxic at less than 1% concentration
d) Hazard Classification HazCom 1994 HazCom 2012 • Specific and detailed • Concept of “classification” vs. determination in current rule • Each hazard class has detailed criteria to apply to data on the chemical • No floor; based on weight of evidence • Mixture rules are specific to each hazard class • Performance-oriented • Definitions in paragraph (c), Appendices A and B • Appendix B—parameters for evaluating data • “Floor” of chemicals considered hazardous • “One study” rule • Standardized mixture cut-off rules
Hazard Classification Each physical or health hazard is a “hazard class” (e.g., Carcinogenicity is a hazard class) A “hazard class” may be sub-divided in the criteria into several “hazard categories”based on the degree of severity of the hazard Placing a chemical into a “hazard class” , and where necessary, a “hazard category”, is the concept of classification determining not only the hazard, but also the severity of the effect
Hazard Classification Hazard Classification Hazard Type Hazard Class Hazard Severity Hazard Category
Physical Explosives Flammable gases Aerosols Oxidizing gases Gases under pressure Flammable liquids Flammable solids Self-reactive substances and mixtures Pyrophoric liquids Pyrophoric solids Self-heating substances and mixtures Substances and mixtures which in contact with water emit flammable gases Oxidizing liquids Oxidizing solids Organic peroxides Corrosive to metals Health Acute toxicity Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity (STOT SE) – single exposure Specific target organ toxicity (STOT RE) – repeated exposure Aspiration hazard Environmental Hazardous to the aquatic environment Hazardous to the ozone layer GHS Hazard Classes
Physical Explosives Flammable gases Aerosols Oxidizing gases Gases under pressure Flammable liquids Flammable solids Self-reactive substances and mixtures Pyrophoric liquids Pyrophoric solids Self-heating substances and mixtures Substances and mixtures which in contact with water emit flammable gases Oxidizing liquids Oxidizing solids Organic peroxides Corrosive to metals Pyrophoric Gases Combustible Dust Health Acute toxicity Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity (STOT SE) – single exposure Specific target organ toxicity (STOT RE) – repeated exposure Aspiration hazard Simple Asphyxiant Environmental Hazardous to the aquatic environment Hazardous to the ozone layer Hazards Not Elsewhere Classified HazComm2012 GHS Hazard Classes
Hazard Classification • Manufacturers are still responsible for determining the hazards of the chemicals they produce or import • Classification (similar to hazard determination) is based on the full range of available information. • The procedures for determining if the manufacturer has properly performed the hazard classification are provided in Appendix A (health) and Appendix B (physical) • “Single Study” must be used for classification of Carcinogens
Health Hazards(Appendix A) Removed Category 5 OSHA Addition 39
Hazard Categories • Each hazard class has one or more categories of hazard, based on severity, eg.Acute Toxicity: Oral Appendix A used to determine Category for health hazards
Current HCS vs. HazCom 2012 HCS Corrosive definition GHS definition/criteria of skin Corrosive A.2.1.1 Skin corrosion is the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. .Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discoloration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology should be considered to evaluate questionable lesions. "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.
Health Hazards, cont. For carcinogens - OSHA is allowing classifiers to use determinations of IARC/NTP for classification instead of performing their own hazard evaluation New Appendix F Single Study positive findings must be reported -“Where the weight of evidence for the carcinogenicity of a substance does not meet the above criteria, any positive study conducted in accordance with established scientific principles, and which reports statistically significant findings regarding the carcinogenic potential of the substance, must be noted on the safety data sheet.”
Physical Hazards(Appendix B) ADDED BY OSHA ADDED BY OSHA
Significant OSHA Decisions The addition of Pyrophoric gas, Simple Asphyxiants and Combustible dust to the Physical and Health hazards is very significant as these are not hazards as defined by GHS
Hazards not Otherwise Classified • One unique aspect to the OSHA’s final rule is the definition of “hazards not otherwise classified” (HNOC) • This definition was added to ensure that hazards currently covered by HCS continue to be covered • Combustible Dust has its own hazard class • Nanomaterials? • Emerging Hazards….
Hazards not Otherwise Classified “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 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 been adopted by OSHA (e.g., acute toxicity Category 5, “simple asphyxiant”).
Hazards not Otherwise Classified Information will be required on the safety data sheets in Section 2 Hazard information on the label, is not mandatory, but can be provided under supplementary information Such hazards must also be addressed in worker training