OSHA, GHS, and Your MSDSs and Labels
The clock is ticking. Companies will have three years from promulgation to come into compliance with the final rule and two years to implement training requirements.
On Sept. 30, 2009, OSHA released its proposal to modify the current Hazard Communication Standard (HCS) to conform with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The proposed OSHA revisions include both philosophical and tactical changes to Hazard Communication that have far-reaching implications for Material Safety Data Sheets (MSDS) and the authoring, publishing, distribution, and management of labels. The proposal also includes revised criteria for the classification of hazardous chemicals, as well as changes to definitions and terms used in the standards and new training requirements for employees. When the final rule is promulgated, companies will face many challenges, including re-evaluating how their substances and mixtures are classified, reissuing MSDSs and labels, and training staff as appropriate.
After having accepted public comments until the end of 2009, OSHA estimates a minimum of 18 months from the Notice of Proposed Rulemaking before the final rule is promulgated. Companies will have three years from promulgation to come into compliance with the final rule and two years to implement training requirements on the final regulation. Once the rule is final, companies can begin implementation. However, in accordance with a letter of interpretation from OSHA on Oct. 6, 2009, companies can begin following the EU GHS label format for their OSHA labels as long as the labels also comply with the current Hazard Communication Standard.
In addition, there are 26 states and territories with their own OSHA-approved plans. These states and territories are Alaska, Arizona, California, Connecticut, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Jersey, New York, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, and Wyoming. They will have six months from promulgation to adopt comparable provisions of the final standard. In the meantime, each individual State Plan will remain in effect until it adopts the required revisions.
Understanding the Impact
Provided the legal process proceeds as planned, companies would be allowed to issue MSDSs and labels for the U.S. market according to the changed rule based on GHS classification no earlier than July 2011, and all existing MSDSs and labels would have to be updated in accordance with the new requirements no later than July 2014. In comparison, the MSDSs for the European market have to be in line with the EU GHS implementation no later than December 2010 for pure substances and by June 2015 for mixtures.
The label requirements will involve changes in the printing process and most likely will require many companies to invest in new label printers. Labels on products that are shipped outside the United States must have the pictograms with a red frame, signal words, and the required hazard and precautionary statements. It is still being determined whether or not empty frames will be accepted on the label, as well as whether or not labels for products that are sold and used only in the United States can have the frame printed in black.
GHS Around the Globe
GHS already has been adopted by countries in regions around the globe. Countries can choose to implement GHS in its entirety or implement only certain parts (otherwise known as the "building block" approach).
The true complexity of the standard is realized when reviewing its implementation status in a sample of countries. For comparison purposes, we have provided a brief overview of the status of GHS in these countries: New Zealand, Japan, Korea, and the European Union.
First, we will examine the adoption of GHS in New Zealand's National Legislature. In New Zealand, hazardous substances are regulated by the Hazardous Substances and New Organisms Act (HSNO), which commenced in July 2001. Hazardous properties are set in the Hazardous Substances Regulations (2001) as follows:
- Explosive (Hazard class 1)
- Flammable (Hazard classes 2, 3, 4)
- Oxidizing (Hazard class 5)
- Toxic (Hazard class 6)
- Corrosive (Hazard class 8)
- Ecotoxic (Hazard class 9)
The HSNO classification description is based on the first version of the UN Purple book and on a class number (e.g., Class 6 -- toxicity), subclass number (e.g., 6.1 -- acute toxicity), and hazard category (e.g., A -- LD 50 ≤ 5mg/kg).
In Japan, the Industrial Safety & Health Law (December 2006) currently details requirements for MSDSs and labels. The ISHL provides a list of substances that are subject to MSDS and label requirements and also provides a classification results list that details the classification of about 1,500 regulated chemicals. Japan's Japanese Industrial Standard (JIS), which specifies the standards used for industrial activities in Japan, also has requirements for labels (JIS Z 7251:2006) and MSDSs (JIS Z 7250:2005). Recently, JIS Z 7252:2009 was published for standard GHS classifications for health and environmental hazards.
Korea's Ministry of Environment (MOE) has created the Toxic Chemical Control Law (TCCL), which incorporates several key principles of GHS. The amendment of the MOE Regulation on the Standard of Classification and Labeling of Toxic Substances (issued Feb. 9, 2009) was the first time MOE provided a GHS classification list on specific toxic chemicals, including hazard categories, signal words, warnings, and hazard and precautionary statements.
The Ministry of Labor (MOL) also has its own requirements, including the Standards for classification and labeling of Chemical Substances and MSDSs (Revised Jan. 1, 2008 and amended through June, 27, 2008). The Ministry of Public Administration and Security (MoPAS) has implemented GHS since Nov. 13, 2008 for classification and labeling of explosives and dangerous goods.
The European Union is currently in a transitional period with regard to GHS. The European Parliament finalized and issued Regulation (EC) No 1272/2008 on classification, labeling, and packaging of substances and mixtures ("CLP Regulation") in late 2008. The CLP Regulation provides the following transitional periods for classifying and labeling hazardous substances and mixtures:
- Substances can be classified, labeled, and packaged according to Directive 67/548/EEC until Dec. 1, 2010.
- Mixtures can be classified, labeled, and packaged according to Directive 67/548/EEC until June 1, 2015.
- Between Dec. 1, 2010, and June 1, 2015, substances should be classified according to both Directive 67/548/EEC and the CLP Regulation.
- Supplemental labeling information in line with the old labeling system's requirements is still applicable under the CLP.
The transitional period for relabeling and repackaging of substances and mixtures placed in the supply chain before Dec. 1, 2010, is postponed until Dec. 1, 2012, and June 1, 2017, respectively.
Companies can do several things now to prepare for OHSA's promulgation of the final rule, including taking stock of their existing compliance tools and associated chemical regulatory information to ensure they address the proposed new requirements.
For example, many companies choose to use reference tools that centralize all global chemical regulatory information into a robust, searchable, easy-to-use database. This provides quick access to official GHS classifications, including substance classifications published by the relevant authorities. Other features supporting GHS compliance include translated GHS classifications, GHS labels, GHS full text, and GHS phrases. Other content tools may be used to feed chemical regulatory data into SAP® EH&S, as well as diverse, custom, open corporate EH&S systems. These integrated data tools provide efficient change management and regular updates as regulations change and new ones are released. Other necessary tools are Expert Rules that not only ensure correct, consistent GHS classification and labeling according to the UN purple book, but also take into consideration national deviations and other national regulations. Document templates for producing MSDSs, labels, and other Hazard Communication documents and multilingual phrase libraries can complete the content suite for efficient production of accurate documents.
Companies also may choose to employ outsourced services for their GHS classification of substances and mixtures as a separate service and/or as a part of outsourcing MSDS and label authoring, for companies that need GHS classification.
In-house MSDS authoring staff may want to adopt an authoring platform that will help generate Hazard Communication documents to meet GHS-related international regulatory compliance and business requirements. Such a platform should provide full support of Hazard Communication, classification, and labeling requirements to generate globally compliant MSDSs and label documents, as well as business-/user-definable documents, such as technical data sheets, product data sheets, hazard summaries, and product stewardship summaries.
The system should use algorithms to accommodate the requirements outlined in the GHS. This consists of the classification of substances and mixtures according to their health, environmental, and physical hazards and HazCom requirements for labeling and MSDSs.
For inbound vendor MSDS management, users will want to search, print, view, and e-mail vendor and raw material MSDSs in a company-specific database via a Web browser interface. As GHS requirements increase the burden of vendor MSDS management, a robust MSDS management system can help to reduce the time and resources necessary for effective compliance management.
Achieving conformance with GHS in the United States is expected to be quite cumbersome. Strong processes, applications, systems, and service providers are needed to support the various aspects of compliance management for GHS. Companies also can seek assistance from providers that are well versed in data and other content and information as it relates to global EH&S regulations and who thoroughly understand the global regulatory environment. These providers will be able to assist in implementing GHS compliance activities into the organization and can help to facilitate compliance with these increasingly complex and changing global chemical regulatory obligations.
Jytte Syska is President of Ariel Operations and Managing Director of 3E Company Europe. Erin McVeigh is Regulatory Research Analyst for 3E Company. Tamie Webber is Director of Product Management for the company. All three can be reached by writing to [email protected] or calling 760-602-8700.