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.