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The Hazard Communication Standard changes contained in the final rule impact both the chemical manufacturer and imagers. The rule became effective on May 25, 2012; however, implementation with the new provisions will be phased in over several months, with a final implementation date of June 1, 2016.

While manufacturers and employers may opt to comply with either the current standard or the new provisions until effective dates kick in, it is highly recommended that companies start planning now for compliance with all new provisions. When first issued in 1989, the Hazard Communication Standard - or HazCom - provided performance-based standards for the development of labels and material safety data sheets. While a MSDS format was recommended, it was not required, leading to a lack of consistency in the marketplace. This has all changed under the new regulatory provisions. Mirrored after the principles of the Global Harmonization Standard, OSHA sets forth a prescribed format for labeling, and for safety data sheets (SDS), as well as a more robust hazard determination process. In this article, we shall take a look at each of these elements in more detail.

Does this revised standard truly harmonize the US with other countries? The answer is yes, and no. The UN Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labeling of Chemicals adopted the Global Harmonization Standard (GHS) in December 2002. In 2003, GHS was endorsed by the Economic and Social Council of the United Nations. Countries were encouraged to implement the GHS as soon as possible, and have fully operational systems by 2008. This goal was adopted by countries in the Intergovernmental Forum on Chemical Safety, and was endorsed by the World Summit on Sustainable Development. The US participated in these groups, and agreed to work toward achieving these goals. OSHA first proposed revisions to its HazCom standard in 2006.

The scope of this standard is broad. More than 43 million workers who produce or handle hazardous chemicals, in more than five million workplaces across the country, are impacted by these changes. OSHA estimates that, with these changes, American businesses will see more than $475 million in cost savings due to productivity improvements, fewer updates to safety data sheets and labels, as well as simpler hazard communication training. Further, the revisions were made to reduce trade barriers, by harmonizing with systems around the world. There will be benefits as a result of the changes, and there will be growing pains, as manufacturers and employers, alike, struggle to understand and comply, by the implementation deadlines.

Employers have several key deadlines: December 1, 2013; June 1, 2015; and June 1, 2016. Manufacturers have one deadline of June 1, 2015. Each major section - hazard classification, labeling, safety data sheets, and information and training - contains new requirements.

Hazard Classification
The new rule sets forth vastly different requirements and procedures for chemical manufacturers to use when determining the hazards of the chemicals they produce or import. Moving away from a performance-based approach, the new regulations establish specific criteria for each health and physical hazard, along with detailed instructions for hazard evaluation and determinations regarding whether mixtures or substances are covered. The new system creates a building block method, to be used in determining the hazard, as well as the accompanying language to be used on the label. As with the previous requirement, the hazard classification must be based on all available information. For mixtures, there is a tiered approach. The safety data sheet should be provided on the mixture as a whole, and OSHA provides, in mandatory Appendices A and B, the bridging principles used to extrapolate from the available data. The hazard estimate for mixtures is based on all known information of present ingredients.

There are two hazard classes: Physical and health. Each hazard class is further subdivided into hazard categories. These hazard categories are based on the degree of severity. An increase in the hazard category indicates a decrease in the severity of that specific hazard.

As such, Category 1 of any hazard is held to bear the highest level of severity. This is in marked contrast to the Hazard Materials Identification System (HMIS), which is used extensively within our industry sector. Under the HMIS system, Category 4 is denoted as the highest level of severity. It is not recommended that manufacturers or employers continue to use the HMIS system as it is currently constructed. There have been discussions to revise the HMIS system, but no action has been taken to date.

OSHA has introduced a new hazard, known as Hazard Not Elsewhere Classified. Minimally, information must be included in Section 2, Hazards Identification, of the SDS for 'other hazards that do not result in classification (e.g., 'dust explosion hazard') or are not covered by the GHS.' Through this provision, OSHA is seeking to regulate and provide hazard information on simple asphyxiates and combustible dust. This information does not need to be included on the hazard-warning label, but does need to be addressed on the SDS, as well as through employee training.

Labeling Requirements
For the new labeling requirements, the time between May 25, 2012 and June 1, 2015 is considered to be a transitional period. However, employers must begin training their employees on the new label format by December 2013. OSHA believes that new workplace labels will begin to show up long before the 2015 compliance deadline. By June 1, 2015, manufacturers must be in compliance with all modified provisions of the final rule, and by December 1, 2015, distributors must only ship containers labeled under the new regulatory format. By June 1, 2016, employers must update workplace labeling and complete employee training within six months of new hazards becoming known.

The new regulations provide specific information that must be included on each label. The major change includes the use of pictograms. As indicated earlier, the hazard determination process is the beginning of the building blocks. This process determines the information that will be included not only on the SDS, but on the label as well. Labels must now include pictograms within a red border. Further, the labels must be provided in English, and all hazard communication elements must be legible. There are no size formats required for either the label or pictograms.

The new label elements include:

• Product identifier: A product identifier can be a chemical name, trade name, or other designation unique to the substance or product. This designation must be the same across all hazard communication documents and other sources of information.
• Signal word: The signal words to be used are "danger" and "warning." "Danger" is used for the more severe hazards, while "warning" is used for the less severe.
• Hazard statement(s): This is a statement assigned to a hazard class and category that describes the nature of the hazard(s) of a chemical, including, where appropriate, the degree of hazard.
• Pictogram(s): The revisions include eight specific pictograms to be used.
• Precautionary statement(s): A phrase that describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to a hazardous chemical, or improper storage or handling.
• Name, address and telephone number of the chemical manufacturer, importer or other responsible party.

As under the old standard, articles are exempt from, both, the labeling and safety data sheet requirements. However, OSHA added a new section to the final rule for 'Solid Materials.' Solid materials are those materials that, due to downstream use, may creazte a hazard. OSHA is specifically referencing the creation of combustible dust, as well as simple asphyxiates. These solid materials, such as wood, plastic or metal, are no longer included under the definition of an article, and must comply with the label and SDS requirements. Labels are only required with the first shipment of the materials.

The other element of labeling concerns the workplace label programs that must continue to be implemented. As with the container labels, the HMIS system can no longer be utilized as the primary means to communicate hazards to employees, as the rating systems between the OSHA standard and HMIS no longer mesh.

The revised regulation still acknowledges the secondary container rule for workplaces. Essentially, this rule states that if an employee is using a secondary container of materials, it does not have to be labeled unless it is stored for future use or passed to another employee. It is assumed that the employee originally using the container understands the hazards associated with the material.

For workplace labeling programs, it is recommended that employers do not remove original labels from containers, unless immediately re-labeled. For workplace programs, signs, placards, process sheets, batch tickets, operating procedures, or other such written materials can be used in conjunction with written materials, instead of affixed labels. If used, these written materials must be readily accessible to employees in their work area, throughout each work shift.

For workplace labels, employers can opt to use the label elements outlined earlier. Or they can opt to use a combination of signal words, pictograms and product identifiers that provide general hazard information, as long as there is other information, such as an SDS that provides the specific hazard information on the product used.

Safety Data Sheets
OSHA changed the reference from Material Safety Data Sheet to Safety Data Sheet (SDS), which is now required to contain sixteen sections. The sections conform to the layout provided in the consensus standard published by the American National Standards Institute (ANSI Z 400.1). While the SDS will contain 16 sections, OSHA will not enforce sections 12-15. These are the sections that focus on disposal, transport and regulatory information. OSHA believes the information in these sections falls outside the scope of their enforcement authority. Manufacturers may choose to provide information in this section or simply indicate 'not available.'

Manufacturers must complete and provide the data as specified in the format criteria. All headings and subheadings must be followed. A few other major shifts in the provision of information include the requirement to provide threshold limit values as established by the American Conference of Governmental Industrial Hygienists (ACGIH), as well as any carcinogenicity classifications assigned by IARC or NTP. Appendix D of the standard provides the detailed information regarding SDS formatting. By June 1, 2015, all SDS modifications must be in place. The sections of the new SDS are as follows:

More than 43 million workers who produce or handle hazardous chemicals, in more than five million workplaces across the country, are impacted by these changes.

Section 1: Identification of the substance or mixture, and of the supplier
This section contains the product identifier used on the label; other means of identification; recommended use of the chemical and restrictions on use; name, address, and telephone number of the chemical manufacturer, importer, or other responsible party; and the emergency telephone number.

Section 2: Hazards identification
This section classifies the chemical as either a physical or health hazard; includes the signal word, hazard statement(s), symbol(s), and precautionary statement(s); and also includes information on identified hazards not otherwise classified.

Section 3: Composition/Information on ingredients substance/Mixture
This section includes information on the chemical name, including common name and synonyms, the CAS number and other unique identifiers.

Section 4: First aid measures
This section includes a description of necessary first aid measures, subdivided according to the different routes of exposure (e.g., inhalation, skin and eye contact, and ingestion).

Also, the most important symptoms/effects, acute and delayed, must be listed in addition to an indication of immediate medical attention and special treatment needed, if necessary.

Section 5: Firefighting measures
This section delineates information on suitable (and unsuitable) extinguishing media that can be used, as well as specific hazards arising from the chemical (i.e., nature of any hazardous combustion products). Any special protective equipment and precautions for firefighters would also be listed here.

Section 6: Accidental release measures
Personal precautions, protective equipment, and emergency procedures for accidental spills will be outlined in this section. Methods and materials for containment and clean up will also be provided.

Section 7: Handling and storage
Precautions for safe handling and storage will be located in this section.

Section 8: Exposure controls/Personal protection
This section provides chemical specific information. OSHA permissible exposure limits (PEL), ACGIH TLV, and any other exposure limits used or recommended by the chemical manufacturer, importer, or employer preparing the SDS; appropriate engineering controls; and individual protection measures, such as personal protective equipment will be listed here.

Section 9: Physical and chemical properties
This section will provide information such as appearance (physical state, color, etc.), odor, odor threshold, pH, and flashpoint, as well as other physical or chemical properties of the product. While the volatile organic content of the product is not listed as a requirement, many manufacturers do provide the VOC content of a product in this section.

Section 10: Stability and reactivity
This section provides information on the reactivity and chemical stability of the product in question, as well as the possible hazard reactions.

Section 11: Toxicological
While Section 8 provides exposure information, this section details the toxicological profile of the product. The user will find likely routes of exposure; symptoms related to the physical, chemical, and toxicological characteristics; delayed, immediate, and chronic effects from short- and long-term exposure; as well as numerical measures of toxicity.

This section will also inform the use, if the hazardous chemical is listed in the NTP Report on Carcinogens (latest edition), or has been found to be a potential carcinogen in the IARC Monographs (latest edition) or by OSHA.

Section 12: Ecological information (non-mandatory)
This is one of the sections OSHA will not enforce. The preparer has the option of indicating 'No available information' in this section. If information is provided, it will focus on the elements of ecotoxicity (aquatic and terrestrial, where available), persistence and degradability, bioaccumulative potential, mobility in soil, and other adverse effects.

Section 13: Disposal considerations (non-mandatory)
This section will also not be enforced by OSHA. If information is provided, it will focus on a description of waste residues and information on safe handling and methods of disposal, including the disposal of any contaminated packaging.

Section 14: Transport information (non-mandatory)
The provision of transport information, as regulated by the Hazard Materials regulations, is not required. However, if information is provided, it would include the United Nations (UN) number, UN proper shipping name, hazard class/classes, packing group, and whether or not the product is an environmental hazard.

Section 15: Regulatory information (non-mandatory)
Again, this section is not mandatory. It would include safety, health and environmental regulations specific to the products in question. It would be in this section where the preparer of the SDS would include any state-specific information, or other regulatory information pertinent to the product.

Section 16: Other information
This section includes information on preparation and revision of the SDS, including the date of preparation or last revision.

Employer Requirements
For employers, many of the required elements remain the same. The element of a workplace labeling standard has already been addressed, and employers are still required to develop and maintain a written hazard communication program. In addition, the list of hazardous chemicals found in the workplace is still required. When developing this list, employers must use the product identifier included on the SDS.

Employers still must provide training to their employees, so they will recognize the hazards found in the workplace. As mentioned earlier, employers must train their employees to recognize the new warning labels and SDS formats by December 1, 2013. And then, by June 1, 2015, employers must train their employees on any newly identified physical or health hazards.

A Word on Trade Secrets
The section outlining trade secret requirements remains essentially unchanged. It has still been defined to mean any confidential formula, pattern, process, device, information or compilation of information used in an employer's business, and that gives the employer an opportunity to obtain an advantage over competitors who do not know or use it.

Manufacturers can still define what is to be considered trade secret information. The regulations specify the conditions under which this information must be disclosed, to ensure the safety and health of exposed employees.

There is one major change that impacts manufacturers of mixtures. Under the revised trade secret provisions, manufacturers are allowed to claim the composition percentage of mixtures on the SDS as confidential.

Closing Thoughts
While it may appear that there is quite a bit of time for manufacturers to implement the new systems, it is critical that companies start now to understand and incorporate all new elements into their hazard communication system. Many companies are already using the new safety data sheet format, and that is a positive step. However, use of the new SDS format could be considered the easiest transition. Those that supply chemicals to the specialty imaging industry must undertake a new hazard determination process, as well as a labeling system for all existing and new products. This is a daunting challenge.

Marcia Y. Kinter, SGIA's vice president of government and business information, oversees the Association's advocacy program. She represents the specialty imaging community and its associated supplier base before federal and state regulatory agencies and the US Congress on environmental, safety and other issues that directly impact the industry. She is a member and secretary of the Academy of Screen Printing Technology. In 2001, Kinter received the William D. Schaeffer Environmental Award for significant advancement of environmental awareness in the graphic arts industry. marcik@sgia.org

This article appeared in the SGIA Journal, September/October 2012 Issue and is reprinted with permission. Copyright 2013 Specialty Graphic Imaging Association (www.sgia.org). All Rights Reserved.