# Presentation: 489243

## 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

**Notes:**
Scope covers all chemicals;  however, it does not cover pharmaceuticals, food additives or pesticide residues in foods, or cosmetics in the “consumer use setting.”  These types of chemicals are covered in transport and in the workplace.

This is consistent with the U.S. regulatory framework.

In short, the GHS is expected to affect:

All workplaces where there is potential exposure to hazardous chemicals

All hazardous chemicals in transport
Product labels that provide hazard information

Workplace, transport and consumer education and training programs.

## 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

**Notes:**
Implementation should be consistent with the goals of the GHS:  to facilitate

It should also reduce....

## 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

## Slide 9

## 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)

**Notes:**
TOST essentially picks up all acute and chronic effects not covered elsewhere, e.g. liver and kidney damage, neurotoxicity, and so on.

It is possible that some of these effects will be split out into separate endpoints in the future;  however, current U.S. thinking is that this should generally be avoided.

## 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,

## !

**!**

## 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

**Notes:**
Product identifiers and precautionary statements have not been standardized, though they are recognized as essential elements of GHS labels.  

## 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

**Notes:**
Supplemental information on chemical labels that provides more detail or covers additional hazards, provided the supplemental information does not undermine GHS label information.  This point was particularly important to the pesticide program, since pesticide labels now include information that has not been harmonized or covered by the GHS—information we believe is important to prevent loss of protection.

Testing methods and data requirements.  The GHS is testing, and test method, neutral.  Implementation does not require use of any particular test protocols or imposition of any new data requirements. Classification is based on available data, but the GHS acknowledges that agencies with authority to require data will continue to do so.

Use of risk-based labeling for chronic effects on consumer products.  GHS classification criteria are based on intrinsic hazard, not risk.  Classification is essentially equivalent to the hazard identification step in risk assessment paradigms.  A weight of evidence approach is used in making classification determinations based on best available data.

Countries and systems are not obligated to cover all GHS classes and categories (e.g. transport does not cover chronic effects, OPP does not generally label chronic effects based on hazard).  But for those classes and categories that are covered, it is expected that countries will apply GHS classification criteria and require GHS hazard communication elements. 13B

Potentially, there could also be effects on other, “downstream” regulatory policies, to the extent that regulators link them to hazard classification and labeling.  The fact that such downstream effects are now linked to classification and labeling does not mean that they need to remain linked in the future.

## Slide 20

## 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

**Notes:**
Sector-specific considerations also come into play in terms of timing.  For example, pesticide labeling schemes, which generally require review of revised labels by regulatory authorities, will in my view require more time for implementation.

## 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
- 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

## “Building Blocks”

| 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 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 | Drafting Regulations & Regulatory Process |  |  |  |  |  |  |  |  |  |  |  |
| 2007 | Regulatory Process & Start of Implementation |  |  |  |  |  |  |  |  |  |  |  |
| 2008 | 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](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](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		  	Deborah McCall
-     		lowe.maryfrances @epa.gov	   	mccall.deborah@epa.gov
-     		703 305 5689			 	703 605 0717