The Globally Harmonized System of Classification and Labelling of Chemicals GHS

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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

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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.

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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

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Scope of the GHS

• Harmonization of major existing systems for
  chemicals in transport, in the workplace,
  pesticides and consumer productswithout 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

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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

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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

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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

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What should be harmonized

• Classification criteria for physical hazards

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What should be harmonized

• Classification criteria for physical hazards,
  health hazards,

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Health Effects

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

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Health Effects (continued)

• Carcinogenicity
• Reproductive and developmental toxicity,
  lactation effects
• Specific target organ/systemic toxicity (single
  and repeated exposure)

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What should be harmonized

• Classification criteria for physical hazards,
  health hazards, and aquatic toxicity, for
  chemical substances and mixtures

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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)

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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

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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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!
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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

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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

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General Implementation Expectations

• Voluntary international systemno 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

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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

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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

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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

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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

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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

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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

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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

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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

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Building Blocks
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Building Blocks
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Acute Toxicity Summary Comparison (1)
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Acute Toxicity (2)
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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?

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Key Issues for Consideration in EPA/OPP White
Paper

• Scope of application
• Options for label submission and review
  separate approval process v. routine business
  model
• Work-sharing possibilities? Pilot?
• Timing
• Effective outreach and education strategies

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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

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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

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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

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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

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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)

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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

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

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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/globalh
  armon.htm
• OSHA GHS information
• http//www.osha.gov/SLTC/hazardcommunications/glo
  bal.html
• DOT GHS information
• http//hazmat.dot.gov/regs/intl/globharm.htm

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For even more EPA information

• EPA White Paper, comparison document, Qs As
• http//www.epa.gov/oppfead1/international/globalha
  rmon.htm
• Public Comments EPA Docket OPP-2004-0205 at
• http//docket.epa.gov/edkpub/do/EDKStaffCollection
  DetailView?objectId0b0007d4802cc6e6 (or, quick
  search globally in edocket)
• Other EPA questions?
• Mary Frances Lowe Deborah McCall
• lowe.maryfrances _at_epa.gov
  mccall.deborah_at_epa.gov
• 703 305 5689 703 605 0717