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

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.

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

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

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

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

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

What should be harmonized

Classification criteria for physical hazards

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

What should be harmonized

Classification criteria for physical hazards, health hazards,

Health Effects

Acute toxicity/lethality (oral, dermal, inhalation)Skin corrosion/irritationSerious eye damage/eye irritationRespiratory sensitization and skin sensitizationGerm cell mutagenicity

Health Effects (continued)

CarcinogenicityReproductive and developmental toxicity, lactation effectsSpecific target organ/systemic toxicity (single and repeated exposure)

What should be harmonized

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

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)

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

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,

GHS SYMBOLS

!

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

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

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”

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

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

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

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

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

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

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

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

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

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”

“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

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)

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

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?

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

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

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

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”

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

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)

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

(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

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

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

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