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US Implementation of the US Implementation of the Globally Harmonized Globally Harmonized

SystemSystem

The GHS Journey Continues…The GHS Journey Continues…

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Regulatory AgendaRegulatory 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).

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What is an ANPR?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.

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GHS JourneyGHS 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.

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Regulatory ProcessRegulatory Process

• Rulemaking Steps– ANPR – Notice of Proposed Rulemaking

• Public Comment Period• Public Hearing• Post-hearing Comment Period

– Final Standard– Phase-in Period for Compliance

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Analytical RequirementsAnalytical Requirements

• Economic Feasibility

• Technological Feasibility

• Paperwork Burden

• Impact on Small Businesses (Small Business Regulatory Enforcement Fairness Act process)

• Peer Review

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How We Got HereHow 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.

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GHS RequirementsGHS 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

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The GHS Isn’t…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.

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What That Means for HCS…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.

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Impact on OSHA RequirementsImpact 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.

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Other Standards Also AffectedOther 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.

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What will OSHA adopt??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.

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Example: Acute ToxicityExample: 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.

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Environmental InformationEnvironmental 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.

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LabelsLabels

• 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.

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Safety Data SheetsSafety 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.

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Information Needed from the PublicInformation 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

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Other InputOther 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.

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TimingTiming

• 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.

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Other Phase-In IssuesOther 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?

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Technical IssuesTechnical 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.

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Compliance AssistanceCompliance 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.

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ConclusionConclusion

• 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!