OSHA’s Final Rule to Modify the Hazard Communication Standard

1. OSHA’s Final Rule to Modify the Hazard Communication Standard Aligning Requirements with the United Nations’ Globally Harmonized System for the Classification and Labeling of Chemicals (GHS)

2. Overview Brief overview of the GHS Benefits of revising the Hazard Communication Standard to adopt the GHS Description of some of the major changes to the HCS Guidance Products

3. Why did OSHA align the HCS with GHS? The GHS approach is designed to improve comprehensibility, and thus the effectiveness of the HCS, and help to further reduce occupational illnesses and fatalities

4. Why did OSHA align the HCS with GHS? A common, coherent approach to classifying and communicating chemical hazards Harmonized definitions of hazards Specific criteria for labels Harmonized format for safety data sheets

5. Why did OSHA align the HCS with GHS? The GHS was negotiated to provide appropriate protections and enable existing systems to adopt it The goal of harmonization is best served, and benefits will be enhanced, by aligning with the GHS as negotiated, and minimizing country-specific deviations Covers physical, health and environmental hazards Not a model regulation – contains criteria and text Harmonizes classification and communication of chemical hazards Created as a “building-block” approach Each competent authority adopts those provisions applicable to the sphere of regulation or need

6. Benefits of Adopting the GHS Increase the quality and consistency of information provided to the workers, employers and chemical users Reduce confusion/Increase comprehension of hazards Improve downstream risk management Facilitate training Helps address literacy problems Other benefits include facilitation of international trade in chemicals

7. Development of Final Rule An ANPR to modify to the existing HCS to align it with the GHS was published in 2006  NPRM Published in the Federal Register on September 30, 2009 (74 FR 50280-50549) Public hearings in 2010 The final rule was published in the Federal Register on March 26, 2012

8. Hazard Communication 2012 This final rule aligns OSHA’s Hazard Communication with the GHS, but retains the current protections of OSHA’s existing standard Same basic framework Maintains or enhances the protections provided in the 1994 HCS

9. Principles & Assumptions 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 Written hazard communication program requirements, worker training, and trade secret provisions are all largely unchanged from the existing rule

10. Principles & Assumptions Other aspects of the standard have minimal modifications in terminology to make them consistent with the GHS Bulk of the technical requirements in Appendixes, rather than in the primary paragraphs of the regulatory text

11. Notable changes: Using “hazard classification” rather than “hazard determination” (along with related terms) Labels are more defined and will now require: A product identifier, pictogram, signal word, hazard statement (s), precautionary statement(s), name, address and telephone number

12. Notable changes: • Using “safety data sheet” rather than “material safety data sheet” • Guidance in the GHS (such as decision logics in criteria) has been removed to streamline provisions • May be provided as a separate document to assist compliance later

13. Changes from the Proposal to the Final • Safety Data Sheets • Maintaining inclusion of PELs and TLVs • Retained classification listings of IARC and NTP • Clarified % of unknown toxicity • Labels • Red borders are required for all pictograms • Blank pictograms are prohibited

14. Changes from the Proposal to the Final • Hazard Classification • Classifiers may use IARC and NTP classification for carcinogens in lieu of weight of evidence. • Appendix F is updated to include a classification crosswalk table

15. Changes from the Proposal to the Final • Proposed “Unclassified Hazards” renamed in final rule, “hazards not otherwise classified” • Added hazards not currently classified under the GHS but covered under the 1994 HCS • Definitions were provided for: Simple asphyxiants and pyrophoric gases • The current practice will be maintained for combustible dust (consistent with OSHA’s NEP guidance)

16. Changes from the Proposal to the Final • Final rule requires “hazards not otherwise classified” to be noted on the SDS. • Labeling information about simple asphyxiants, combustible dust, and pyrophoric gases will be communicated both on the label and the SDS • OSHA has provided some accommodations for combustible dust

17. Changes from the Proposal to the Final • Precautionary/Hazard Statements • Modified mandatory Appendix C to provide some added flexibility • For example, where manufacturers, importers, or responsible parties can show that a particular statement is inappropriate for the product, that precautionary/hazard statement may be omitted from the label.

18. 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

19. Appendixes 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 Hazard Classifications re: Carcinogenicity (Non-Mandatory) (NEW)

20. (a) Purpose Maintains the purpose to preempt state laws unless under an OSHA-approved state plan (supported by stakeholder comments) Added that the Agency’s specific intent is to align this rule with the GHS, Revision 3: Replaced the word “evaluated” with “classified” Added clarification language for preemption in (a)(2)

21. (b) Scope and Application Paragraph (b)(1) has been modified to remove the reference to Appendix E The remainder of the scope provisions are unchanged (practical accommodations based on types of exposures; interface with other Federal agency requirements)

22. (c) Definitions Several key changes have been made to update the definitions section. All definitions for the GHS are located at 1900.1200(c) Under this final rule, physical hazard criteria are more detailed and are provided in Appendix B rather than in paragraph (c) Minor edits were made to some of the definitions located throughout this section in order ensure they conformed with the GHS

23. (c) Definitions cont. The following physical hazard terms were removed from the final rules definition section: Combustible liquid; compressed gas;explosive;flammable; flash point; organic peroxide;oxidizer;pyrophoric;unstable (reactive);and water-reactive

24. (c) Definitions, cont. 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; and physical hazard

25. (c) Definitions, cont. 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 information

26. Use of the term “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. OSHA previously used “chemical” to indicate both substances and mixtures OSHA has decided to continue using “chemical” in the final rule as meaning those situations where both substances and mixtures are being addressed

27. Hazards not Otherwise Classified One unique aspect to the OSHA’s final rule is the definition of “hazards not otherwise classified” This definition was added to ensure that hazards currently covered by HCS continue to be covered Changes from current practices are not anticipated (used during literature reviews)

28. 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 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).

29. Hazards not Otherwise Classified Hazard information is required to be provided 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

30. “Simple asphyxiant” means a substance or mixture that displaces oxygen in the ambient atmosphere, and can thus cause oxygen deprivation in those who are exposed, leading to unconsciousness and death. Label: Warning. May displace oxygen and cause rapid suffocation. “Pyrophoric gas” means a chemical in a gaseous state that will ignite spontaneously in air at a temperature of 130 degrees F (54.4 degrees C) or below. Label: Danger. Catches fire spontaneously if exposed to air. Simple Asphyxiant and Pyrophoric Gas

31. Combustible dust is covered separately from HNOC, but is not specifically defined Guidance for defining combustible dust is to be taken from existing documents, including the directive for the National Emphasis Program; the NFPA standards also provide useful information Combustible dust must be addressed on labels where appropriate: Warning. May form combustible dust concentrations in air. Paragraph (f)(4) may apply to materials shipped in solid form, that create combustible dust when processed Combustible Dust

32. Hazard Evaluation: HCS 1994 v. HCS 2012 • Very similar in scope and concept • Provide downstream flow of information • Self-classification • Revised standard builds in additional details and parameters to help to ensure consistency worldwide • Addresses the degree of severity • Assigns categories of hazards within hazard classes • Provides detailed scientific approaches

33. Hazard Determination: HCS 1994 Evaluation of literature and scientific data to determine whether a chemical is hazardous as defined in the HCS For mixtures, the approach for health hazards is to base it on a percentage cut-off of 0.1% for carcinogens, and 1% for all other effects

34. Hazard Classification: HCS 2012 Definitions of health and physical hazards are provided in Appendix A, B, and in the definitions paragraph Appendices A and B provide additional parameters for evaluating health and physical hazard data

35. Hazard Classification: HCS 2012 Chemical manufacturers and importers must classify each chemical they produce or import: Determine the appropriate hazard classes and associated hazard categories Base this on an evaluation of the full range of available data/evidence on the chemical (no testing is required) Use Appendix A for health hazard criteria and Appendix B for physical hazard criteria The introduction to Appendix A provides the general approach to classification, including bridging principles

36. (d) Hazard Classification Each type of hazard covered is considered a “hazard class”—such as acute toxicity, carcinogenicity However, most of these hazard classes are also sub-divided into “hazard categories” to reflect the degree of severity of the effect This is the concept of “classification”—rather than just determining that there is a hazardous effect (carcinogenicity), there is also a finding of how severe that effect might be (Category 1 or 2)

37. Appendix A, Health Hazards OSHA adopted all of the health hazard classes in the GHS—the criteria to define each of these are found in Appendix A However, the Agency did to adopt the following hazard categories: Acute toxicity: Category 5 Corrosion/irritation: Category 3 Aspiration hazard: Category 2

38. Appendix A, Health Hazard Criteria Acute Toxicity Skin corrosion/Irritation Serious eye damage/eye irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity – Single exposure Specific target organ toxicity – Repeated exposure Aspiration hazard

39. Health Hazards

40. Appendix A, Health Hazards cont. • Other Changes • Carcinogens – Classifiers may use IARC/NTP classifications • Updated Appendix F • Skin & Eye changes – technical • Updated tables to reflect text • Was a test scheme – now reflects classification

41. HCS 1994: Mixtures Mixtures For mixtures, the approach for health hazards is to base it on a percentage cut-off of 0.1% for carcinogens, and 1% for all other effects

42. HCS 2012: Mixtures The GHS has a tiered approach to mixtures, with each health hazard class having a specific approach Step 1: Use available test data on the mixture as a whole to classify the mixture based on the substance criteria Step 2: Use bridging principles to extrapolate from other data (e.g., dilution principle) Step 3: Estimate hazards based on known information regarding the ingredients of the mixture (cut-offs may be applied) Except for chronic health hazards Chemical manufacturers and importers may rely on the information provided in ingredient SDSs unless they have a reason to know that it is inaccurate

43. HCS 2012: Mixtures, cont. The approach to mixture classification is found in Appendixes A and B under the particular hazard class The bridging principles that may be applied to a specific hazard class are indicated in each criterion chapter for a hazard class General underlying principles for mixture classification are unchanged E.g. the smaller the concentration of a hazardous ingredient you have in a mixture, the less likely the mixture will pose that hazardous effect

44. HCS 2012: Mixture Cut-offs for Chronic Effects Several of the chronic health effects (e.g., carcinogenicity, reproductive health effects) the GHS provides the competent authority the choice of cut-off for requiring label information on the effect OSHA has selected the lower cut-off in each of these cases to ensure appropriate protection for exposed workers

45. Appendix B, Physical Hazards The physical hazard criteria in Appendix B are based on the UN Recommendations for the Transport of Dangerous Goods, and are already used by the Department of Transportation in hazardous materials regulations OSHA has adopted the GHS criteria for all physical hazards

46. Appendix B, Physical Hazard Criteria Explosives Flammable gases Flammable 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

47. Physical Hazards

48. (e) Written Hazard Communication Program OSHA retained the written hazard communication requirements with only minor technical edits.

49. (f) Labels and Other Forms of Warning • This paragraph has been extensively re-written to incorporate the GHS approach. • This final rule sets forth detailed and specific provisions for container labels.

50. (f) Labels and Other Forms of Warning • Required Elements • Product identifier • Signal words • Hazard statements • Pictograms • Precautionary statements • Name, address, and telephone number of the chemical manufacturer, importer, or other responsible party • A new Appendix C, Allocation of Label Elements, has been provided to indicate the label requirements by hazard class and category