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

?

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 systems Classification based on intrinsic properties/hazards Scope covers all chemicals Consistent with U.S. regulatory framework

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

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

What should be harmonized

Classification criteria for physical hazards, health hazards,

Health Effects

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

Health Effects (continued)

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

What should be harmonized

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

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,

!

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, statements] use of two signal words (danger and warning), and hazard statements for each hazard class and category [Product identifiers and precautionary 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 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

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

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

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 issues Information systems support needed Internal and external outreach, input Decisions on implementation mechanism(s) Consideration of transitional issues Coordination 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 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

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 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

“Building Blocks”

Hazard Class Acute toxicity (lethality) Skin corrosion/irritation Severe eye damage/irritation Respiratory or skin sensitization Germ cell mutagenicity GHS Yes Yes Yes Yes Yes OPP Yes Yes Yes Skin only No

“Building Blocks”

Hazard class Carcinogenicity Reproductive toxicity TOST/single exposure TOST/repeat exposure Aquatic toxicity GHS OPP Yes Yes Yes Yes Yes No No Methanol No Yes acute category 1 only

Acute Toxicity Summary Comparison (1)

Label element GHS Categories 5 OPP/LRM 4, no upper limit Signal words Skull and crossbones symbol and “danger” 2 3 Categories 1-3 (e.g., oral LD 50 <300 mg/kg GHS Cat. 1-2 (OPP Cat I, e.g. oral LD 50 < 50 mg/kg)

Acute Toxicity (2)

Label element Exclamation point symbol, “warning” POISON “Caution” GHS OPP/LRM Cat. 4 (e.g., oral LD mg/kg 50 >300 mg/kg <2000 Not used No symbol, “warning” for oral LD 50 >50 mg/kg <500 mg/kg GHS Cat. 1-2, (OPP I) oral LD 50 < 50mg/kg Not used OPP III, oral LD mg/kg 50 >500 mg/kg <5000

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?

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 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

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 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”

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 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)

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

(Source: K. Headrick 6/7/05. See www.healthcanada.ca/ghs for more information)

Canadian Implementation Work Plan Overview with Milestones

J F M A M J J A S O N D 2004

Technical Consultations

2005

Technical Consultations Economic Analysis Decision

2006 2007 2008

Drafting Regulations & Regulatory Process Regulatory Process & Start of Implementation Implementation

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

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

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 lowe.maryfrances @epa.gov

703 305 5689 Deborah McCall [email protected]

703 605 0717