Transcript Globally Harmonized System of Classification and Labeling

Globally Harmonized System
of Classification and Labeling
(GHS)
What is the GHS?
 An approach to defining and classifying hazards for chemicals,
including pesticides.
 Labels and MSDS will be changed.
 Affected parties: chemical companies, consumers, pesticide
applicators and workers, transport workers, and emergency
responders.
Timing for Implementation
 Goal of 2008 for most countries.
 EPA will propose regulation changes
 A transition from old to new labels
 EPA seeking input and ideas through Federal
Register 8-25-04 notice white paper. Should
they phase in? Do all at once?
By type of
product? By status in reregistration? Other?
Where we are now:
 The United Nations committee completed their
recommendations in a 2002 document after 10 years of
international negotiations and meetings. Document is
available on the web.
 The U.S. was an active member on the UN committee.
EPA has declared that the GHS will be implemented in
the U.S.
 EPA committee is planning the implementation.
 No new data requirements by USEPA
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
What should be harmonized? The
classification criteria and label
statements for:
 Physical hazards, flammability, etc
 Acute toxicology health hazards
 Certain chronic toxicol. health hazards
 Certain environmental hazards, aquatic
Health Effects
 Acute toxicity, same studies currently required plus
respiratory and skin sensitization.
 Chronic toxicity, reproductive, etc., but EPA will probably
not implement this, yet
What will change on labels?
 Only two signal words:Danger (with skull and
crossbones) or Warning. Some will have none.
 Cut-off points are changed for these two signal
words and the other categories for determining
precautionary statements
 Additional hazard stmts for aquatic hazard.
 Use of pictograms
!
How many labels will change?
 All labels will have to be changed
 USEPA currently has about 20,000
 NYS currently has about 12,200, but ~ 1/2 of these are
distributor labels
 Canada currently has about 8,000
Label Elements
FIFRA
GHS
Trade, Brand, or Product Names
GHS
Ingredient Statement
GHS
Use Classification Statement
No
Type of Pesticide
No
Net Contents
No
Name and Address of Manufacturer
GHS
Emergency Telephone Number
GHS
Registration Numbers
No
Label Elements
FIFRA
Establishment Numbers
Signal Words
GHS
No
Symbols
GHS
GHS
Routes of entry statements
GHS
Specific Action Statements
GHS
Protective clothing and equipment statements
Future GHS
Other precautionary statements
Future GHS
Statement of Practical Treatment
Future GHS
Label Elements
FIFRA
GHS
Environmental Hazards
GHS
Physical or Chemical Hazards
GHS
Restricted Entry Interval (REI)
No
Storage and Disposal
No
Directions for Use
No
GHS LABEL ELEMENTS
 Symbols/pictograms
 Signal Words: Danger, Warning
 Hazard Statements
 [Precautionary information]
 Product identifier/ingredient disclosure
 supplier identification
DECLARATION OF INGREDIENTS
 Substances (Technical)
• chemical identity (name as determined by IUPAC,
ISO, CAS, or technical name)
 Mixtures (Formulations/Inerts)
• chemical identities of all ingredients contributing to
acute toxicity, skin or eye corrosion, germ cell
mutagenicity, carcinogenicity, reproductive toxicity,
skin or respiratory sensitization or TOST
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
Classification criteria for acute toxicity
Acute
Cat
toxicity
1
Oral (mg/kg) 5
Cat Cat
2
3
50 300
Cat
4
2000
Dermal
(mg/kg)
Gases (ppm)
50
200 1000 2000
100
500 2500 5000
Vapours
(mg/l)
Dust and
mists (mg/l)
0,5
2,0
10
20
0,05
0,5
1,0
5
Cat
5
Criteria:
- Anticipated oral LD50
between 2000 and 5000
mg/kg.
- Indication of significant
effect in human
- Any mortality at class 4
- Significant clinical signs
at class 4
- Indications from other
studies
How will New York implement?
 Will partly depend on how USEPA implements.
 Goal is acceptance without data review, but this will need
more discussion.
 New York can comment on USEPA’s Federal Register notice.
PowerPoint References
Pont, R. In Global Harmonization of Hazard Labeling and Impacts, Proceedings of the North American Pesticide
Applicator Certification and Safety Workshop, Honolulu, HI, August 11-14, 2003; U.S. Environmental Protection
Agency: Washington, DC, 2003.