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US Implementation of the Globally Harmonized System. The GHS Journey Continues…. Regulatory Agenda . In the May 16, 2005, semi-annual regulatory agenda, OSHA indicated that it was adding modification of the Hazard Communication Standard to adopt the GHS.
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US Implementation of the Globally Harmonized System The GHS Journey Continues… SCHC, 9/27/2005
Regulatory Agenda • In the May 16, 2005, semi-annual regulatory agenda, OSHA indicated that it was adding modification of the Hazard Communication Standard to adopt the GHS. • The first step is to publish an advance notice of proposed rulemaking (ANPR). SCHC, 9/27/2005
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. SCHC, 9/27/2005
GHS Journey • After many years of negotiations to develop the GHS, the ANPR is the first step in the process to adopt it and make it mandatory in US workplaces. • The US regulatory process includes a number of required activities, as well as analyses to support the process. SCHC, 9/27/2005
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 SCHC, 9/27/2005
Analytical Requirements • Economic Feasibility • Technological Feasibility • Paperwork Burden • Impact on Small Businesses (Small Business Regulatory Enforcement Fairness Act process) • Peer Review SCHC, 9/27/2005
How We Got Here • Commitment in the preamble to the final standard in 1983. • Years of bilateral trade negotiations. • International mandate adopted in 1992. • Negotiations to complete the GHS in several international organizations for the next 10 years. • System now available for adoption. SCHC, 9/27/2005
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 SCHC, 9/27/2005
The GHS Isn’t… • A model regulation or a standard that can simply be adopted. It has criteria or provisions and explanatory text. Countries and authorities will choose those parts of the system that apply to their sphere of regulation, and prepare implementing text consistent with their own requirements. SCHC, 9/27/2005
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. • For example, the GHS does not include training. The HCS does and will continue to do so. SCHC, 9/27/2005
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. SCHC, 9/27/2005
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. SCHC, 9/27/2005
What will OSHA adopt?? Scope will likely be consistent with the HCS to the greatest extent possible. HCS already covers a broad range of both health and physical hazards. 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. SCHC, 9/27/2005
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. SCHC, 9/27/2005
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. SCHC, 9/27/2005
Labels • 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. SCHC, 9/27/2005
Safety Data Sheets • The HCS would likely be modified to include the GHS order of information, as well as the information 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. SCHC, 9/27/2005
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 SCHC, 9/27/2005
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. SCHC, 9/27/2005
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. SCHC, 9/27/2005
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? SCHC, 9/27/2005
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. SCHC, 9/27/2005
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. SCHC, 9/27/2005
Conclusion • The ANPR will provide the public with background on the GHS, possible implementation issues, and other information. • It will also solicit public input and give stakeholders an opportunity to provide necessary information to assist OSHA in the rulemaking process. • We look forward to your comments! SCHC, 9/27/2005