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. What is the GHS ?. - PowerPoint PPT PresentationTRANSCRIPT
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The Globally Harmonized System of Classification and
Labelling of Chemicals (GHS)
Mary Frances LoweU.S. EPA Office of Pesticide Programs
FOSTTA Chemical Information and Management ProjectArlington, 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 products—without lowering the level of protection afforded by those systemsClassification based on intrinsic properties/hazardsScope covers all chemicalsConsistent with U.S. regulatory framework
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GHS Goals
To promote safer transport, handling and use of chemicals world wideTo facilitate international trade in chemical products by promoting greater consistency in regulatory requirementsTo reduce need for testing and evaluationTo 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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PHYSICAL HAZARDS (3)
CORROSIVE TO METALSORGANIC PEROXIDES
OXIDIZING SOLIDSOXIDIZING LIQUIDS
SUBSTANCES which, in contact withwater, emit flammable gases
SELF-HEATING SUBSTANCES
PYROPHORIC SOLIDSPYROPHORIC LIQUIDS
SELF-REACTIVE SUBSTANCESFLAMMABLE SOLIDS
FLAMMABLE LIQUIDSGASES UNDER PRESSURE
OXIDIZING GASESFLAMMABLE AEROSOLS
FLAMMABLE GASESEXPLOSIVES
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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/irritationSerious eye damage/eye irritationRespiratory sensitization and skin sensitizationGerm cell mutagenicity
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Health Effects (continued)
CarcinogenicityReproductive and developmental toxicity, lactation effectsSpecific 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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GHS SYMBOLS
!
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What should be harmonizedClassification criteria for physical hazards, health hazards, and aquatic toxicity, for chemical substances and mixturesCertain 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 requirementsUse of risk-based labeling for chronic effects for consumer products in the consumer use settingScope of hazards covered by national systems (“building block” approach)Downstream effects
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CONFIDENTIAL BUSINESS INFORMATION
• National authorities to establish appropriate mechanisms for CBI
• Competent authority rules for CBI take priority in relation to ingredient declaration
• Principles established, particularly “right-to-know”
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General Implementation Expectations
Voluntary international system—no binding treaty obligations on countriesIntent is that countries with existing systems will harmonize them to be consistent with the GHS andCountries 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 scheduleIFCS, WSSD goal of 2008; APEC goal of 2006Different systems/sectors likely to require different time framesSteps 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 issuesInformation systems support neededInternal and external outreach, inputDecisions on implementation mechanism(s)Consideration of transitional issuesCoordination 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 PlanningImportance 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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Hazard Class GHS OPP
Acute toxicity (lethality) Yes Yes
Skin corrosion/irritation Yes Yes
Severe eye damage/irritation
Yes Yes
Respiratory or skin sensitization
Yes Skin only
Germ cell mutagenicity Yes No
“Building Blocks”
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“Building Blocks”
Hazard class GHS OPP
Carcinogenicity Yes No
Reproductive toxicity Yes No
TOST/single exposure Yes Methanol
TOST/repeat exposure Yes No
Aquatic toxicity Yes Yes-acute category 1 only
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Acute Toxicity Summary Comparison (1)
Label element
GHS OPP/LRM
Categories 5 4, no upper limit
Signal words
2 3
Skull and crossbones symbol and “danger”
Categories 1-3 (e.g., oral LD50<300 mg/kg
GHS Cat. 1-2 (OPP Cat I, e.g. oral LD50< 50 mg/kg)
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Acute Toxicity (2)Label element GHS OPP/LRM
Exclamation point symbol, “warning”
Cat. 4 (e.g., oral LD50
>300 mg/kg <2000 mg/kg
No symbol, “warning” for oral LD50 >50 mg/kg <500 mg/kg
POISON Not used GHS Cat. 1-2, (OPP I) oral LD50< 50mg/kg
“Caution” Not used OPP III, oral LD50
>500 mg/kg <5000 mg/kg
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Product and Supplier IdentifiersCurrent product and chemical names and registration number requirements satisfy GHS provisions on product identifiersIngredient disclosure rules differ for inerts, but GHS provides that CBI rules may override ingredient disclosure provisionsNo changes in CBI policies with GHSExpand 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 received1 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 StepsWork 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 UpdateLong history of harmonization with work of UN TDG Sub-Committee, North American counterpartsExisting transport system used in developing GHSChanges needed to align DOT rules with GHS
Aquatic toxicityAcute toxicity Category 3Flammable aerosols, liquidsRevised 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 UpdateStaff 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 MilestonesJ F M A M J J A S O N D
2004 Technical Consultations
2005 Technical Consultations
Economic Analysis
Decision
2006 Drafting Regulations & Regulatory Process
2007 Regulatory Process & Start of Implementation
2008 Implementation
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International UpdatesNAFTA: 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 informationhttp://www.epa.gov/oppfead1/international/globalharmon.htm
* OSHA GHS informationhttp://www.osha.gov/SLTC/hazardcommunications/global.html
* DOT GHS informationhttp://hazmat.dot.gov/regs/intl/globharm.htm
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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 [email protected] 703 305 5689 703 605 0717