Globally Harmonized System and the Hazard Communication Standard. What You Might Expect
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1 Globally Harmonized System and the Hazard Communication Standard What You Might Expect PRESENTED BY: Keith D. Hass Assistant Area Director Atlanta East Area Office
2 How We Got Here Commitment in the preamble to the final standard in 1983 to review the standard regularly to address international harmonization. Years of bilateral trade negotiations. International mandate adopted in Negotiations to complete the GHS in several international organizations for the next 10 years. OSHA chaired coordinating group
3 Hazard Communication Tuesday, September 12, 2006, ANPR to modify the Hazard Communication Standard to align with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
4 What is an ANPR? An ANPR is a document in the Federal Register that describes what the Agency is working on, and gives the public an opportunity to provide input in the form of written comments. The US regulatory process includes a number of required activities, as well as analyses to support the process.
5 Regulatory Process Rulemaking Steps ANPR Notice of Proposed Rulemaking Public Comment Period Public Hearing Post-hearing Comment Period Final Standard Phase-in Period for Compliance
6 Analytical Requirements Economic Feasibility Technological Feasibility Paperwork Burden Impact on Small Businesses (Small Business Regulatory Enforcement Fairness Act process) Peer Review
7 Scope of GHS Four primary U.S. regulatory agencies OSHA, EPA, DOT and CPSC GHS designed to allow regulatory agencies to choose provisions building block approach OSHA would choose the provisions of the GHS that are necessary for the protection of employees, but would not adopt others that address other types of protection e.g. aquatic life protection
8 GHS Requirements Health, physical and environmental hazard criteria for substances and for classification of mixtures Provisions for communicating information on labels (including harmonized pictograms, hazard statements, and signal words) A 16-section safety data sheet
9 Impact on OSHA Requirements Hazard Communication Standard includes the primary affected requirements. OSHA has more requirements affected by the GHS than other US agencies: Cover all acute and chronic hazards. Have requirements for labels and safety data sheets. Cover over 7 million workplaces and 945,000 hazardous chemical products.
10 What That Means for HCS The framework of the HCS will remain the way it is currently promulgated, i.e., those provisions not affected by the GHS will remain the same. Adoption of the GHS by OSHA would affect general industry, construction shipyards, long shoring and maritime.
11 What That Means for HCS The scope of GHS very similar to HCS. However, it does not include requirements for a written hazcom program or for employee training. OSHA will maintain training requirements. OSHA also expects to propose some additional training to ensure understanding of the new approach regarding labels and SDSs in the GHS.
12 Health Hazards Both the HCS and GHS have a broad range of health effects, including both acute and chronic effects. For HCS, any type of adverse health effect that is reported and substantiated by a scientific study is covered. Under GHS, hazard classes are generally sub-divided into categories of hazard. The definitions of hazards are much more specific and detailed than what is in the HCS.
13 What will OSHA adopt?? Scope will likely be consistent with the HCS to the greatest extent possible. Therefore, it is likely OSHA will adopt all of the health and physical hazard criteria. However, the Agency may not adopt all categories of each criterion.
14 Example: Acute Toxicity OSHA covers acute toxicity in the current rule. Since the GHS includes criteria for consumer protection in addition to worker protection, the criteria are more extensive than HCS. It is not likely that OSHA will adopt all of the categories of acute toxicity when aligning with the GHS.
15 Health Hazards HSC Carcinogens Toxic or highly toxic agents (all routes of entry) Reproductive toxins Irritants Corrosives Sensitizers Hepatotoxins Nephrotoxins Neurotoxins Agents which act on the hematopoietic system Agents which damage the lungs, skin, eyes, or mucous membranes GHS Acute toxicity (any route of entry) Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitizer Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ systemic toxicity--single exposure Specific target organ systemic toxicity--repeated use Aspiration hazard
16
17 Physical Hazards With regard to physical hazards, the current definitions in the HCS are drawn from other standards that address such chemicals (e.g., flammable chemicals), or from what were the DOT criteria for physical hazards at the time OSHA promulgated the HCS. DOT has since changed their criteria
18 Physical Hazards HSC Combustible liquid Compressed gas Explosive Flammable (aerosol, gas, liquid, solid) Organic peroxide Oxidizer Pyrophoric Unstable (reactive) Water-reactive GHS Explosives Flammable (aerosol, gas, liquid (including combustible liquid), solid) Oxidizing (liquids, solids, gases) Gases under pressure Self-reactive substances and mixtures Pyrophoric (liquid, solid) Self-heating substances and mixtures Substances and mixtures which in contact with water emit flammable gases Organic peroxide Corrosive to metals
19 Physical Hazards One issue of concern is whether OSHA should also propose to change the physical hazard definitions in other standards e.g. definition of flammable liquids in the flammable liquids standard What is the impact beyond classification and labeling? Area that needs to be further explored in terms of impact and possible consequences.
20 Labeling The HCS minimal information on labels At the time the standard was promulgated, OSHA focused on requiring information that was not generally present on most labels in use by industry. e.g. identity that could be traced to more detailed information, and specific information about both the health and physical hazards. Performance oriented approach
21 Labeling The HCS would change to adopt the label provisions of the GHS for harmonized pictograms, hazard statements, and signal words. Identification of the chemical and supplier and precautionary information would also be included.
22 Labeling Advantages May improve communication for those who are not functionally literate, or who are not literate in the language written on the label. Having the core information developed already, translated into multiple languages, and readily available, will eliminate the burden of chemical manufacturers and importers developing and maintaining their own such systems.
23 GHS Labeling Symbols (hazard pictograms): Convey health, physical and environmental hazard information, assigned to a GHS hazard class and category.
24 GHS Labeling Signal Words: "Danger" or "Warning" are used to emphasize hazards and indicate the relative level of severity of the hazard, assigned to a GHS hazard class and category.
25 GHS Labeling Hazard Statements: Standard phrases assigned to a hazard class and category that describe the nature of the hazard. e.g. Fatal if swallowed Toxic if swallowed Harmful if swallowed
26 GHS Labeling Other GHS label elements include: Precautionary Statements and Pictograms: Measures to minimize or prevent adverse effects. Product Identifier (ingredient disclosure): Name or number used for a hazardous product on a label or in the SDS. Supplier identification: The name, address and telephone number should be provided on the label. Supplemental information: non-harmonized information.
27 GHS Labeling
28 Safety Data Sheets The HCS specifies what information must be included on the MSDS, but does not specify a format or order of information. Chemical manufacturers in the U.S. developed a voluntary industry consensus standard that included an order of information for safety data sheets (ANSI Z400.1). In negotiating the GHS, it was decided that this format should be adopted there as well.
29 Safety Data Sheets The HCS would likely be modified to include the GHS order of information reversing the order of sections 2 and 3 so the hazard information appeared earlier in the sheet than information on chemical composition. Adopt title descriptions. However, it would not include mandatory requirements for sections dealing with issues that are not under OSHA s jurisdiction, e.g., transport and environment.
30 Safety Data Sheets HCS Identification of the chemical or hazardous ingredients of a mixture Physical and chemical characteristics Health hazards, including signs, symptoms, and medical conditions that could be aggravated by exposure The primary routes of entry The OSHA permissible exposure limit, ACGIH Threshold Limit Value, and any other recommended exposure limits Whether the chemical is considered to be a carcinogen by OSHA, the International Agency for Research on Cancer, or the National Toxicology Program Precautions for safe handling and use Control measures Emergency and first aid procedures Date of preparation of the safety data sheet Contact information for the responsible party GHS Identification Hazard identification Composition/information on ingredients First aid measures Firefighting measures Accidental release measures Handling and storage Exposure controls/personal protection Physical and chemical properties Stability and reactivity Toxicological information Ecological information Disposal considerations Transport information Regulatory information Other information
31 Environmental Information GHS includes criteria for classifying aquatic toxicity. The GHS SDS also includes information related to the environment. OSHA has no authority in these areas and therefore will not be adopting the parts of the GHS that are relevant to environmental protection.
32 Other Standards Also Affected Will likely need to change hazard communication provisions in substance-specific standards to be consistent. May also need to address parts of other standards that have criteria for hazard definitions, such as flammable liquids.
33 Information Needed from the Public Assistance in defining the scope of the changes needed: Requesting information about the numbers of products to be reevaluated under the new criteria, and new labels, SDSs prepared Also information about the time it takes to do these activities and the qualifications of those who perform them
34 Other Input OSHA will need to assess the costs and benefits and will be soliciting information from the public on these topics. The availability of electronic tools and their relationship to compliance activities will also need to be assessed.
35 Timing Labels and SDSs are normally updated on a regular cycle. OSHA wants to establish a phase-in period for compliance that will take advantage of this regular cycle and reduce costs as a result. Input on updating time frames is needed.
36 Other Phase-In Issues OSHA will consider other suggested approaches to phasing in if supported by evidence: The Europeans are considering phasing in substances first and then mixtures will this work in the US? What other approaches to staging or phasing would be effective and reduce burdens?
37 Technical Issues Input will also be requested on any technical GHS issues that need to be considered in implementation. One example would be the appropriate categories of acute toxicity to adopt. Another would be to suggest any hazards that might not be adequately covered.
38 Compliance Assistance OSHA wants to identify what compliance assistance tools would facilitate the transition to the GHS so such outreach can be made available when the rulemaking is completed. Public suggestions will be sought to identify these tools.
39 HCS Conclusion Greatest impact on chemical manufacturers, importers, and employers who produce or distribute hazardous chemicals as currently covered under the HCS. More consistency and better communication Significant phase-in period Frequently asked questions document
40
41 Call for Additional Assistance Keith Hass (770) Jonathan Worrell Compliance Assistance Specialist (770)
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