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

1. The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Mary Frances Lowe U.S. EPA Office of Pesticide Programs FOSTTA Chemical Information and Management Project Arlington, Virginia October 17-18, 2005

2. What is the GHS? • A common and coherent approach to defining and classifying hazards, and communicating information on labels and safety data sheets. • Target audiences include workers, consumers, transport workers, and emergency responders. • Underlying infrastructure for establishment of national, comprehensive chemical safety programs.

3. Where we are now: • UNCED mandate (1992) • Tripartite negotiations in three focal points for over a decade (completed in December 2002) • UN ECOSOC approval July 2003 • Countries/systems planning for implementation

4. Scope of the GHS • Harmonization of major existing systems for chemicals in transport, in the workplace, pesticides and consumer products—without lowering the level of protection afforded by those systems • Classification based on intrinsic properties/hazards • Scope covers all chemicals • Consistent with U.S. regulatory framework

5. GHS Goals • To promote safer transport, handling and use of chemicals world wide • To facilitate international trade in chemical products by promoting greater consistency in regulatory requirements • To reduce need for testing and evaluation • To assist countries in developing strategies for sound management of chemicals

6. Benefits to U.S. Stakeholders • Greater consistency in information provided to people exposed to chemicals • increase health and environmental protection by providing clear, consistent label messages to users of chemicals, workers and the public • signal words, pictograms, and hazard statements will have the same meaning in all settings/across sectors and internationally

7. Benefits to U.S. Stakeholders (2) • Greater consistency in regulatory requirements U.S. industry must meet, at home and abroad • reduce market barriers and facilitate compliance by eliminating need to learn and comply with multiple hazard classification and communications systems • companies only have to classify once for all authorities that implement the GHS, including other domestic agencies Strategies to minimize the cost of changes and permit smooth transition will be critical

8. What should be harmonized • Classification criteria for physical hazards

10. What should be harmonized • Classification criteria for physical hazards, health hazards,

11. Health Effects • Acute toxicity/lethality (oral, dermal, inhalation) • Skin corrosion/irritation • Serious eye damage/eye irritation • Respiratory sensitization and skin sensitization • Germ cell mutagenicity

12. Health Effects (continued) • Carcinogenicity • Reproductive and developmental toxicity, lactation effects • Specific target organ/systemic toxicity (single and repeated exposure)

13. What should be harmonized • Classification criteria for physical hazards, health hazards, and aquatic toxicity, for chemical substances and mixtures

14. Classification Criteria for Mixtures • Based on the classification criteria for substances • Allows for the use of available data, to serve needs of programs that can/do require data (like OPP) and programs that do not have this authority (like OSHA)

15. Tiered Approach to Classification of Mixtures Generally use test data for the mixture, when available  Use bridging principles, if applicable  Estimate hazards based on the known ingredient information

16. What should be harmonized • Classification criteria for physical hazards, health hazards, and aquatic toxicity, for chemical substances and mixtures • Certain standardized label elements: hazard pictograms,

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18. What should be harmonized • Classification criteria for physical hazards, health hazards, and aquatic toxicity, for chemical substances and mixtures • Certain standardized label elements: hazard pictograms, use of two signal words (danger and warning), and hazard statements for each hazard class and category • [Product identifiers and precautionary statements] • Format and contents for Safety Data Sheets

19. What does not need to change to be consistent with the GHS • Supplemental information • Testing methods and data requirements • Use of risk-based labeling for chronic effects for consumer products in the consumer use setting • Scope of hazards covered by national systems (“building block” approach) • Downstream effects

21. General Implementation Expectations • Voluntary international system—no binding treaty obligations on countries • Intent is that countries with existing systems will harmonize them to be consistent with the GHS and • Countries that do not have systems will adopt GHS as their basic system • To extent that countries adopt GHS into their systems, binding regulatory changes for industry

22. Timing • No international implementation schedule • IFCS, WSSD goal of 2008; APEC goal of 2006 • Different systems/sectors likely to require different time frames • Steps to avoid disruption will need to be considered in transition from old to new labels and data sheets

23. Key U.S. Agencies • Consumer Product Safety Commission • Department of Transportation • Occupational Safety and Health Administration • Environmental Protection Agency Core interagency group coordinates GHS activities and positions for international meetings State, USTR, Commerce also play a role in international and interagency consultations

24. Implementation Planning Tasks • Comprehensive comparison with existing practices • Selection of “building blocks,” resolution of label format and placement issues • Information systems support needed • Internal and external outreach, input • Decisions on implementation mechanism(s) • Consideration of transitional issues • Coordination within USG and internationally

25. What are the implications of GHS for EPA /OPP programs? • Implementation would affect all pesticide labels • Every pesticide user and handler would need to understand the new labels • Other regulations and policies related to classification categories need review

26. EPA/OPP Implementation Planning • Importance of labeling to pesticide regulation: “the label is the law” • Soon after ECOSOC adoption, formed internal working group to coordinate planning and develop recommendations • Representatives of all OPP divisions, other key EPA offices, state regulators and pesticide educators

27. EPA/OPP Implementation Planning • Internal analyses, side-by-side comparisons of GHS with Label Review Manual and 40 CFR 156 • Identification of areas where changes would be needed to be consistent with GHS • Recommendations on “building blocks” and label layouts • Analysis of downstream linkages, e.g. worker protection, container regulations

28. To Implement the GHS: Basic Principles for Pesticides • Cover all pesticides alike (some will be unclassified) • Adopt GHS for all hazard classes for which we now label • In general, limit changes to those required for GHS consistency

29. General Comparison of GHS and OPP Classification and Labeling and Policies • Effects/hazard classes covered • Test methods and requirements, basis of classification, e.g., for mixtures • Symbols/pictograms • Signal words: health,environmental, physical hazards • Hazard statements

30. “Building Blocks”

31. “Building Blocks”

32. Acute Toxicity Summary Comparison (1)

33. Acute Toxicity (2)

34. Product and Supplier Identifiers • Current product and chemical names and registration number requirements satisfy GHS provisions on product identifiers • Ingredient disclosure rules differ for inerts, but GHS provides that CBI rules may override ingredient disclosure provisions • No changes in CBI policies with GHS • Expand supplier contact information (name, address, establishment number) to include telephone number?

35. Key Issues for Consideration in EPA/OPP White Paper • Scope of application • Options for label submission and review: separateapproval process v. “routine business” model • Work-sharing possibilities? Pilot? • Timing • Effective outreach and education strategies

36. Comments received • 1 Federal Agency • 3 State and local government entities • 7 Trade Associations • 6 Individual registrant companies • 2 Professional/educational associations • 1 Consumer/public interest group • 1 Individual expert • Coalition of animal welfare/rights groups

37. Issues in comments • Cost/benefit considerations • Technical/interpretation questions and issues requiring clarification (e.g., to avoid incentives for additional testing) • Pros and cons of implementation options • Education/training/enforcement issues • Scope of coverage issues • Interagency and international coordination issues

38. Next Steps • Work with stakeholders to evaluate/address concerns, continue awareness-raising, evaluate next steps • Interagency coordinating process • Coordination with NAFTA and OECD pesticides groups • Consideration of newer elements of the GHS (e.g., aspiration hazards) and work at the global level to avoid “moving target”

39. OSHA Update • Completed comprehensive comparison of requirements with GHS and guide to GHS • Added GHS to regulatory agenda published 5/16/05 • Plans Advance Notice of Proposed Rulemaking, opportunity for public input on implementation issues • Leads U.S. delegation to GHS Sub-Committee • NAFTA partner discussions, workshop, EU pilot

40. DOT Update • Long history of harmonization with work of UN TDG Sub-Committee, North American counterparts • Existing transport system used in developing GHS • Changes needed to align DOT rules with GHS Aquatic toxicity Acute toxicity Category 3 Flammable aerosols, liquids Revised pictogram for organic peroxides • Aerosol changes complete, expect most other changes by 2007, allowing one year transition to meet 2008 goal (aquatic tox on separate track)

41. CPSC Update • Staff has begun preparing for implementation; formal Commission decision required to implement • Developing comparison of GHS with existing requirements • Continuing participation in OECD work to refine GHS • Coordinating within USG and internationally on implementation • Will be considering use of GHS criteria to classify for health and physical hazards, risk option in GHS for labeling

42. (Source: K. Headrick 6/7/05. See www.healthcanada.ca/ghs for more information)Canadian ImplementationWork Plan Overview with Milestones

43. International Updates • NAFTA: discussions in transport, workplace, pesticides, and consumer sectors • Europe: goal of entry into force at same time as REACH • Japan: revising standards, reclassifying substances, preparing guidance manual, training workshops in Asia • South Africa: preparing model national standard • Latin America: Brazil workshop followup • WHO classification of pesticides, ISO standards for SDS and labeling, APEC, UNITAR capacity building projects, UN Recommendations for Transport of Dangerous Goods, WSSD/IFCS 2008 goal, IPCS/ICSC

44. For more information: • GHS text, UN papers and reports http://www.unece.org/trans/danger/danger.htm • EPA GHS information http://www.epa.gov/oppfead1/international/globalharmon.htm • OSHA GHS information http://www.osha.gov/SLTC/hazardcommunications/global.html • DOT GHS information http://hazmat.dot.gov/regs/intl/globharm.htm

45. For even more EPA information: • EPA White Paper, comparison document, Q’s & A’s: http://www.epa.gov/oppfead1/international/globalharmon.htm • Public Comments: EPA Docket OPP-2004-0205 at http://docket.epa.gov/edkpub/do/EDKStaffCollectionDetailView?objectId=0b0007d4802cc6e6 (or, quick search “globally” in edocket) Other EPA questions? Mary Frances Lowe Deborah McCall lowe.maryfrances @epa.gov mccall.deborah@epa.gov 703 305 5689 703 605 0717