# Hazard Communication > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-4826 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** March 26, 2012 - **Citation:** 77 FR 17574 ## Text DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Parts 1910, 1915, and 1926 [Docket No. OSHA-H022K-2006-0062 (formerly Docket No. H022K)] RIN 1218-AC20 Hazard Communication AGENCY: Occupational Safety and Health Administration (OSHA), DOL. ACTION: Final rule. SUMMARY: In this final rule, OSHA is modifying its Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). OSHA has determined that the modifications will significantly reduce costs and burdens while also improving the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. Consistent with the requirements of Executive Order 13563, which calls for assessment and, where appropriate, modification and improvement of existing rules, the Agency has concluded this improved information will enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they may be exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries. The modifications to the standard include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, and requirements for employee training on labels and safety data sheets. OSHA is also modifying provisions of other standards, including standards for flammable and combustible liquids, process safety management, and most substance-specific health standards, to ensure consistency with the modified HCS requirements. The consequences of these modifications will be to improve safety, to facilitate global harmonization of standards, and to produce hundreds of millions of dollars in annual savings. DATES: This final rule becomes effective on May 25, 2012 Affected parties do not need to comply with the information collection requirements in the final rule until the Department of Labor publishes in the Federal Register the control numbers assigned by the Office of Management and Budget (OMB). Publication of the control numbers notifies the public that OMB has approved these information collection requirements under the Paperwork Reduction Act of 1995. The incorporation by reference of the specific publications listed in this final rule is approved by the Director of the Federal Register as of May 25, 2012. ADDRESSES: In compliance with 28 U.S.C. 2112(a), the Agency designates Joseph M. Woodward, Associate Solicitor for Occupational Safety and Health, Office of the Solicitor, Room S-4004, U.S. Department of Labor; 200 Constitution Avenue NW., Washington, DC 20210, as the recipient of petitions for review of this final standard. FOR FURTHER INFORMATION CONTACT: For general information and press inquiries, contact: Frank Meilinger, OSHA Office of Communications, Room N-3647, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, telephone (202) 693-1999. For technical information, contact: Dorothy Dougherty, Director, Directorate of Standards and Guidance, Room N-3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1950. SUPPLEMENTARY INFORMATION: This final rule modifies the Hazard Communication standard (HCS) and aligns it with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) as established by the United Nations (UN). This action is consistent with Executive Order 13563 and, in particular, with its requirement of “retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome.” The preamble to the final rule provides a synopsis of the events leading up to the establishment of the final rule, a detailed description of OSHA's rationale for the necessity of the modification, and final economic and voluntary flexibility analyses that support the Agency's determinations. Also included are explanations of the specific provisions that are modified in the HCS and other affected OSHA standards and OSHA's responses to comments, testimony, and data submitted during the rulemaking. The discussion follows this outline: I. Introduction II. Events Leading to the Revised Hazard Communication Standard III. Overview of the Final Rule and Alternatives Considered IV. Need and Support for the Revised Hazard Communication Standard V. Pertinent Legal Authority VI. Final Economic Analysis and Voluntary Regulatory Flexibility Analysis VII. OMB Review Under the Paperwork Reduction Act of 1995 VIII. Federalism and Consultation and Coordination With Indian Tribal Governments IX. State Plans X. Unfunded Mandates XI. Protecting Children From Environmental Health and Safety Risks XII. Environmental Impacts XIII. Summary and Explanation of the Modifications to the Hazard Communication Standard (a) Purpose (b) Scope (c) Definitions (d) Hazard Classification (e) Written Hazard Communication Program (f) Labels and Other Forms of Warning (g) Safety Data Sheets (h) Employee Information and Training (i) Trade Secrets (j) Effective Dates (k) Other Standards Affected (l) Appendices XIV. Authority and Signature The HCS requires that chemical manufacturers and importers evaluate the chemicals they produce or import and provide hazard information to downstream employers and employees by putting labels on containers and preparing safety data sheets. This final rule modifies the current HCS to align with the provisions of the UN's GHS. The modifications to the HCS will significantly reduce burdens and costs, and also improve the quality and consistency of information provided to employers and employees regarding chemical hazards by providing harmonized criteria for classifying and labeling hazardous chemicals and for preparing safety data sheets for these chemicals. OSHA is required by the Occupational Safety and Health (OSH) Act of 1970 to assure, as far as possible, safe and healthful working conditions for all working men and women. Section 3(8) of the OSH Act (29 U.S.C. 652(8)) empowers the Secretary of Labor to promulgate standards that are “reasonably necessary or appropriate to provide safe or healthful employment and places of employment.” This language has been interpreted by the Supreme Court to require that an OSHA standard address a significant risk and reduce this risk significantly. See Industrial Union Dep't v. American Petroleum Institute, 448 U.S. 607 (1980). As discussed in Sections IV and V of this preamble, OSHA finds that inadequate communication to employees regarding the hazards of chemicals constitutes a significant risk of harm and estimates that the final rule will reduce this risk significantly. Section 6(b)(7) of the Act (29 U.S.C. 655(b)(7)) allows OSHA to make appropriate modifications to its hazard communication requirements as new knowledge and techniques are developed. The GHS system is a new approach that has been developed through international negotiations and embodies the knowledge gained in the field of chemical hazard communication since the current rule was first adopted in 1983. As indicated in Section IV of this preamble, OSHA finds that modifying the HCS to align with the GHS will enhance worker protections significantly. As noted in Section VI of this preamble, these modifications to HCS will also result in less expensive chemical hazard management and communication. In this way, the modifications are in line with the requirements of Executive Order 13563 and its call for streamlining of regulatory burdens. OSHA is also required to determine if its standards are technologically and economically feasible. As discussed in Section VI of this preamble, OSHA has determined that this final standard is technologically and economically feasible. The Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires OSHA to determine if a regulation will have a significant impact on a substantial number of small entities. As discussed in Section VI, OSHA has determined and certified that this rule will not have a significant impact on a substantial number of small entities. Executive Orders 13563 and 12866 require OSHA to assess the benefits and costs of final rules and of available regulatory alternatives. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This rule has been designated an economically significant regulatory action under section 3(f)(1) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget, and the remainder of this section summarizes the key findings of the analysis with respect to the costs and benefits of the final rule. Because this final rule modifies the current HCS to align with the provisions of the UN's GHS, the available alternatives to the final rule are somewhat limited. The Agency has qualitatively discussed the two major alternatives to the proposed rule—(1) voluntary adoption of GHS within the existing HCS framework and (2) a limited adoption of specific GHS components—in Section III of this preamble, but quantitative estimates of the costs and benefits of these alternatives could not reasonably be developed. However, OSHA has determined that both of these alternatives would eliminate significant portions of the benefits of the rule, which can only be achieved if the system used in the U.S. is consistently and uniformly applied throughout the nation and in conformance with the internationally harmonized system. Table SI-1, derived from material presented in Section VI of this preamble, provides a summary of the costs and benefits of the final rule. As shown, the final rule is estimated to prevent 43 fatalities and 521 injuries and illnesses annually. Also as shown, OSHA estimates that the monetized health and safety benefits of the final rule are $250 million annually and that the annualized cost reductions and productivity gains are $507 million annually. In addition, OSHA anticipates that the final rule will generate substantial (but unquantified) savings from simplified hazard communication training and from expanded opportunities for international trade due to a reduction in trade barriers. The estimated cost of the rule is $201 million annually. As shown in Table SI-1, the major cost elements associated with the final rule include the classification of chemical hazards in accordance with the GHS criteria and the corresponding revision of safety data sheets and labels to meet new format and content requirements ($22.5 million); training for employees to become familiar with new warning symbols and the revised safety data sheet format ($95.4 million); management familiarization and other management-related costs as may be necessary ($59.0 million); and costs to purchase upgraded label printing equipment and supplies or to purchase pre-printed color labels in order to include the hazard warning pictogram enclosed in a red-bordered diamond on the product label ($24.1 million). The final rule is estimated to generate net monetized benefits of $556 million annually, using a discount rate of 7 percent to annualize costs and benefits. Using a 3 percent discount rate instead would have the effect of lowering the costs to $161 million per year and increasing the gross benefits to $839 million per year. The result would be to increase net benefits from $556 million to $678 million per year. These estimates are for informational purposes only and have not been used by OSHA as the basis for its decision concerning the requirements for this final rule. BILLING CODE 4510-26-P ER26MR12.000 BILLING CODE 4510-26-C I. Introduction In the preamble, OSHA refers to supporting materials. References to these materials are given as “Document ID #” followed by the last four digits of the document number. The referenced materials are posted in Docket No. OSHA-H022K-2006-0062, which is available at http://www.regulations.osha.gov; however, some information ( e.g., copyrighted material) is not publicly available to read or download through that Web site. All of the documents are available for inspection and, where permissible, copying at the OSHA Docket Office, U.S. Department of Labor, Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210. II. Events Leading to the Revised Hazard Communication Standard The HCS was first promulgated in 1983 and covered the manufacturing sector of industry (48 FR 53280, Nov. 25, 1983). (Please note: The Agency's HCS (29 CFR 1910.1200; 1915.1200; 1917.28; 1918.90; and 1926.59) will be referred to as the “current HCS” throughout this rule.) In 1987, the Agency expanded the scope of coverage to all industries where employees are potentially exposed to hazardous chemicals (52 FR 31852, Aug. 24, 1987). Although full implementation in the non-manufacturing sector was delayed by various court and administrative actions, the rule has been fully enforced in all industries regulated by OSHA since March 17, 1989 (54 FR 6886, Feb. 15, 1989) (29 CFR 1910.1200; 1915.1200; 1917.28; 1918.90; and 1926.59). In 1994, OSHA made minor changes and technical amendments to the HCS to help ensure full compliance and achieve better protection of employees (59 FR 6126, Feb. 9, 1994). The development of the HCS is discussed in detail in the preambles to the original and revised final rules ( See 48 FR at 53280-53281; 52 FR at 31852-31854; and 59 FR at 6127-6131). This discussion will focus on the sequence of events leading to the development of the GHS and the associated modifications to the HCS included in the final rule. The current HCS requires chemical manufacturers and importers to evaluate the chemicals they produce or import to determine if they are hazardous. The standard provides definitions of health and physical hazards to use as the criteria for determining hazards in the evaluation process. Information about hazards and protective measures is then required to be conveyed to downstream employers and employees through labels on containers and through material safety data sheets, which are now called “safety data sheets” (SDS) under the final rule and in this preamble. All employers with hazardous chemicals in their workplaces are required to have a hazard communication program, including container labels, safety data sheets, and employee training. Generally, under the final rule, these obligations on manufacturers, importers, and employers remain, but how hazard communication is to be accomplished has been modified. To protect employees and members of the public who are potentially exposed to hazardous chemicals during their production, transportation, use, and disposal, a number of countries have developed laws that require information about those chemicals to be prepared and transmitted to affected parties. The laws vary on the scope of chemicals covered, definitions of hazards, the specificity of requirements ( e.g., specification of a format for safety data sheets), and the use of symbols and pictograms. The inconsistencies among the laws are substantial enough that different labels and safety data sheets must often be developed for the same product when it is marketed in different nations. Within the U.S., several regulatory authorities exercise jurisdiction over chemical hazard communication. In addition to OSHA, the Department of Transportation (DOT) regulates chemicals in transport; the Consumer Product Safety Commission (CPSC) regulates consumer products; and the Environmental Protection Agency (EPA) regulates pesticides, as well as exercising other authority over the labeling of chemicals under the Toxic Substances Control Act. Each of these regulatory authorities operates under different statutory mandates, and all have adopted distinct hazard communication requirements. Tracking and complying with the hazard communication requirements of different regulatory authorities is a burden for manufacturers, importers, distributors, and transporters engaged in commerce in the domestic arena. This burden is magnified by the need to develop multiple sets of labels and safety data sheets for each product in international trade. Small businesses have particular difficulty in coping with the complexities and costs involved. The problems associated with differing national and international requirements were recognized and discussed when the HCS was first promulgated in 1983. At that time, OSHA committed to periodically reviewing the standard in recognition of an interagency trade policy that supported the U.S. pursuing international harmonization of requirements for chemical classification and labeling. The potential benefits of harmonization were noted in the preamble of the 1983 standard: * * * [O]SHA acknowledges the long-term benefit of maximum recognition of hazard warnings, especially in the case of containers leaving the workplace which go into interstate and international commerce. The development of internationally agreed standards would make possible the broadest recognition of the identified hazards while avoiding the creation of technical barriers to trade and reducing the costs of dissemination of hazard information by elimination of duplicative requirements which could otherwise apply to a chemical in commerce. As noted previously, these regulations will be reviewed on a regular basis with regard to similar requirements which may be evolving in the United States and in foreign countries. (48 FR at 53287) OSHA has actively participated in many such efforts in the years since that commitment was made, including trade-related discussions on the need for harmonization with major U.S. trading partners. The Agency issued a Request for Information (RFI) in the Federal Register in January 1990, to obtain input regarding international harmonization efforts, and on work being done at that time by the International Labour Organization (ILO) to develop a convention and recommendations on safety in the use of chemicals at work (55 FR 2166, Jan. 22, 1990). On a closely related matter, OSHA published a second RFI in May 1990, requesting comments and information on improving the effectiveness of information transmitted under the HCS (55 FR 20580, May 17, 1990). Possible development of a standardized format or order of information was raised as an issue in the RFI. Nearly 600 comments were received in response to this request. The majority of responses expressed support for a standard safety data sheet format, and the majority of responses that expressed an opinion on the topic favored a standardized format for labels as well. In June 1992, the United Nations Conference on Environment and Development issued a mandate (Chapter 19 of Agenda 21), supported by the U.S., calling for development of a globally harmonized chemical classification and labeling system: A globally harmonized hazard classification and compatible labeling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000. This international mandate initiated a substantial effort to develop the GHS, involving numerous international organizations, many countries, and extensive stakeholder representation. A coordinating group comprised of countries, stakeholder representatives, and international organizations was established to manage the work. This group, the Inter-Organization Programme for the Sound Management of Chemicals Coordinating Group for the Harmonization of Chemical Classification Systems, established overall policy for the work and assigned tasks to other organizations. The Coordinating Group then took the work of these organizations and integrated it to form the GHS. OSHA served as chair of the Coordinating Group. The work was divided into three main parts: classification criteria for physical hazards; classification criteria for health and environmental hazards (including criteria for mixtures); and hazard communication elements, including requirements for labels and safety data sheets. The criteria for physical hazards were developed by a United Nations Sub-committee of Experts on the Transport of Dangerous Goods/International Labour Organization working group and were based on the already harmonized criteria for the transport sector. The criteria for classification of health and environmental hazards were developed under the auspices of the Organization for Economic Cooperation and Development. The ILO developed the hazard communication elements. OSHA participated in all of this work, and served as U.S. lead on classification of mixtures and hazard communication. Four major existing systems served as the primary basis for development of the GHS. These systems were the requirements in the U.S. for the workplace, consumers, and pesticides; the requirements of Canada for the workplace, consumers, and pesticides; European Union directives for classification and labeling of substances and preparations; and the United Nations Recommendations on the Transport of Dangerous Goods. The requirements of other systems were also examined as appropriate, and taken into account as the GHS was developed. The primary approach to reconciling these systems involved identifying the relevant provisions in each system; developing background documents that compared, contrasted, and explained the rationale for the provisions; and undertaking negotiations to find an agreed approach that addressed the needs of the countries and stakeholders involved. Principles to guide the work were established, including an agreement that protections of the existing systems would not be reduced as a result of harmonization. Thus, countries could be assured that the existing protections of their systems would be maintained or enhanced in the GHS. An interagency committee under the auspices of the Department of State coordinated U.S. involvement in the development of the GHS. In addition to OSHA, DOT, CPSC, and EPA, other agencies were involved that had interests related to trade or other aspects of the GHS process. Different agencies took the lead in various parts of the discussions. Positions for the U.S. in these negotiations were coordinated through the interagency committee. Interested stakeholders were kept informed through email dissemination of information, as well as periodic public meetings. In addition, the Department of State published a notice in the Federal Register that described the harmonization activities, the agencies involved, the principles of harmonization, and other information, as well as invited public comment on these issues (62 FR 15951, Apr. 3, 1997). Stakeholders also actively participated in the discussions at the international level and were able to present their views directly in the negotiating process. The GHS was formally adopted by the new United Nations Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals in December 2002. In 2003, the adoption 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 U.S. participated in these groups, and agreed to work toward achieving these goals. OSHA published an Advance Notice of Proposed Rulemaking (ANPR) on the GHS in September of 2006 (71 FR 53617, Sept. 12, 2006). At the same time the ANPR was published, OSHA made available on its Web site a document summarizing the GHS ( http://www.osha.gov ). The ANPR provided information about the GHS and its potential impact on the HCS, and sought input from the public on issues related to GHS implementation. Over 100 responses were received, and the comments and information provided were taken into account in the development of the modifications to the HCS included in the September 2009 Notice of Proposed Rulemaking (NPRM) (74 FR 50279-50549, Sept. 30, 2009). A notice of correction was published on November 5, 2009, in order to correct misprints in the proposal (74 FR 57278, Nov. 5, 2009). Over 100 comments were received in response to the NPRM. Commenters represented the broad spectrum of affected parties and included government agencies, industries, professional and trade associations, academics, employee organizations and individuals. Public hearings were held in Washington, DC, from March 2 through March 5, 2010, and in Pittsburgh, PA, on March 31, 2010. Over 40 panels participated in the hearings. The comments, testimony, and other data received regarding this rulemaking were overwhelmingly favorable, and will be discussed in detail later in this preamble. The final post-hearing comment period for further submissions and briefs ended and the record was certified by Administrative Law Judge Stephen L. Purcell and closed on May 31, 2010. Executive Order 13563, emphasizing the importance of retrospective analysis of rules, was issued on January 18, 2011. This final rule is based on Revision 3 of the GHS. The adoption of the GHS will improve OSHA's current HCS standard by providing consistent, standardized hazard communication to downstream users. However, even after the U.S. and other countries implement the GHS, it will continue to be updated in the future. These updates to the GHS will be completed as necessary to reflect new technological and scientific developments as well as provide additional explanatory text. Any future changes to the HCS to adopt subsequent changes to the GHS would require OSHA's rulemaking procedures. OSHA will remain engaged in activities related to the GHS. The U.S. is a member of the United Nations Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labelling of Chemicals, as well as the Sub-committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals, where OSHA is currently the Head of the U.S. Delegation. These permanent UN bodies have international responsibility for maintaining, updating as necessary, and overseeing the implementation of the GHS. OSHA and other affected Federal agencies actively participate in these UN groups. In addition, OSHA will also continue to participate in the GHS Programme Advisory Group under the United Nations Institute for Training and Research (UNITAR). UNITAR is responsible for helping countries implement the GHS, and has ongoing programs to prepare guidance documents, conduct regional workshops, and implement pilot projects in a number of nations. OSHA will also continue its involvement in interagency discussions related to coordination of domestic implementation of the GHS, and in discussions related to international work to implement and maintain the GHS. III. Overview of the Final Rule and Alternatives Considered Based on consideration of the record as a whole, OSHA has modified the HCS to make it consistent with the GHS. OSHA finds that harmonizing the HCS with the GHS will improve worker understanding of the hazardous chemicals they encounter every day. Such harmonization will also reduce costs for employers. OSHA believes that adopting the GHS will result in a clearer, more effective methodology for conveying information on hazardous chemicals to employers and employees. Commenters overwhelmingly supported the revision, and their submissions form a strong evidentiary basis for this final rule. The American Health Care Association stated that the GHS “would enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they might be exposed” (Document ID #0346). The National Institute of Environmental Health Sciences concurred, and added that adopting the GHS “would provide better worker health and safety protections” (Document ID #0347). ( See also Document ID #0303, 0313, 0322, 0324, 0327, 0328, 0329, 0330, 0331, 0334, 0335, 0336, 0339, 0340, 0341, 0344, 0345, 0346, 0347, 0349, 0350, 0351, 0352, 0353, 0354, 0356, 0357, 0359, 0363, 0365, 0367, 0369, 0370, 0371, 0372, 0374, 0375, 0376, 0377, 0378, 0379, 0381, 0382, 0383, 0385, 0386, 0387, 0388, 0389, 0390, 0392, 0393, 0396, 0397, 0399, 0400, 0402, 0403, 0404, 0405, 0407, 0408, 0409, 0410, 0411, 0412, 0414, 0417, 0453, 0456, 0461, and 0463.) Consistent with Executive Order 13563, OSHA has concluded that the revision significantly improves the current HCS standard. Moreover, there is widespread agreement that aligning the HCS with the GHS would establish a valuable, systematic approach for employers to evaluate workplace hazards, and provide employees with consistent information regarding the hazards they encounter. A member of the United Steel Workers aptly summed up the revision by stating that “the HCS in 1983 gave the workers the `right to know' but the GHS will give the workers the `right to understand' ” (Document ID #0403). The American Society of Safety Engineers (ASSE) concurred, stating that adoption of the HCS was “necessary to help this nation's workers deal with the increasingly difficult challenge of understanding the hazards and precautions needed to handle and use chemicals safely in an increasingly connected workplace” (Document ID #0336). Phlymar, ORC, BCI, 3M, American Iron & Steel Institute, and the North American Metals Council (NAMC) all agreed that the adoption of the GHS would improve the quality and consistency of information and the effectiveness of hazard communication (Documents ID #0322, 0336, 0339, 0370, 0377, 0390, 0405, and 0408). ( See also Document ID #0327, 0338, 0339, 0346, 0347, 0349, 0351, 0354, 0363, 0365, 0370, 0372, 0374, 0379, 0389, 0390, 0397, 0405, 0408, and 0414.) The evidence supporting the Agency's conclusions is discussed more thoroughly below in Sections IV, V, and VI; the revisions to the HCS are discussed in detail in Section XIII. This section of the preamble provides an overview of the current HCS and how the adoption of the GHS will change this standard. Moreover, this section will also discuss the alternatives to mandatory implementation and the benefits of the final rule. The specific issues for which OSHA solicited comments in the NPRM will be discussed within their respective sections. 1. The Hazard Communication Standard The HCS requires a comprehensive hazard evaluation and communication process, aimed at ensuring that the hazards of all chemicals are evaluated, and also requires that the information concerning chemical hazards and necessary protective measures is properly transmitted to employees. The HCS achieves this goal by requiring chemical manufacturers and importers to review available scientific evidence concerning the physical and health hazards of the chemicals they produce or import to determine if they are hazardous. For every chemical found to be hazardous, the chemical manufacturer or importer must develop a container label and an SDS, and provide both documents to downstream users of the chemical. All employers with employees exposed to hazardous chemicals must develop a hazard communication program, and ensure that exposed employees are provided with labels, access to SDSs, and training on the hazardous chemicals in their workplace. There are three information communication components in this system—labels, SDSs, and employee training, all of which are essential to the effective functioning of the program. Labels provide a brief, but immediate and conspicuous, summary of hazard information at the site where the chemical is used. SDSs provide detailed technical information and serve as a reference source for exposed employees, industrial hygienists, safety professionals, emergency responders, health care professionals, and other interested parties. Training is designed to ensure that employees understand the chemical hazards in their workplace and are aware of protective measures to follow. Labels, SDSs, and training are complementary parts of a comprehensive hazard communication program—each element reinforces the knowledge necessary for effective protection of employees. Information required by the HCS reduces the incidence of chemical-related illnesses and injuries by enabling employers and employees to implement protective measures in the workplace. Employers can select less hazardous chemical alternatives and ensure that appropriate engineering controls, work practices, and personal protective equipment are in place. Improved understanding of chemical hazards by supervisory personnel results in safer handling of hazardous substances, as well as proper storage and housekeeping measures. Employees provided with information and training on chemical hazards are able to fully participate in the protective measures instituted in their workplaces. Knowledgeable employees can take the steps required to work safely with chemicals, and are able to determine what actions are necessary if an emergency occurs. Information on chronic effects of exposure to hazardous chemicals helps employees recognize signs and symptoms of chronic disease and seek early treatment. Information provided under the HCS also enables health and safety professionals to provide better services to exposed employees. Medical surveillance, exposure monitoring, and other services are enhanced by the ready availability of health and safety information. The modifications that make up this final rule build on these core principles by establishing a more detailed and consistent classification system and requiring uniform labels and SDSs, which will better ensure that workers are informed and adequately protected from chemical exposures. 2. Current HCS Provisions for Classification, Labeling, and SDSs The current HCS covers a broad range of health and physical hazards. The standard is performance-oriented, providing definitions of hazards and parameters for evaluating the evidence to determine whether a chemical is considered hazardous. The evaluation is based upon evidence that is currently available, and no testing of chemicals is required. The current standard covers every type of health effect that may occur, including both acute and chronic effects. Definitions of a number of adverse health effects are provided in the standard. These definitions are indicative of the wide range of coverage, but are not exclusive. Mandatory Appendix A of the current standard lists criteria for specific health effects; however, it also notes that these criteria are not intended to be an exclusive categorization scheme, but rather any available scientific data on the chemical must be evaluated to determine whether the chemical presents a health hazard. Any adverse health effect that is substantiated by a study conducted according to established scientific principles, and reporting a statistically significant outcome, is sufficient for determining that a chemical is hazardous under the rule. Most chemicals in commerce are not present in the pure state ( i.e., as individual elements or compounds), but are ingredients in mixtures of chemicals. Evaluation of the health hazards of mixtures is based on data for the mixture as a whole when such data are available. When data on the mixture as a whole are not available, the mixture is considered to present the same health hazards as any ingredients present at a concentration of 1% or greater, or, in the case of carcinogens, concentrations of 0.1% or greater. The current HCS also recognizes that risk may remain at concentrations below these cut-offs, and where there is evidence that that is the case, the mixtures are considered hazardous under the standard. The current HCS establishes requirements for minimum information that must be included on labels and SDSs, but does not provide specific language to convey the information or a format in which to provide it. When the current HCS was issued in 1983, the public record strongly supported this performance-oriented approach ( See 48 FR at 53300-53310). Many chemical manufacturers and importers were already providing information voluntarily, and in the absence of specific requirements had developed their own formats and approaches. The record indicated that a performance-oriented approach would reduce the need for chemical manufacturers and importers to revise these existing documents to comply with the HCS, thus reducing the cost impact of the standard. 3. GHS Provisions for Classification, Labeling, and SDSs The GHS is an internationally harmonized system for classifying chemical hazards and developing labels and safety data sheets. However, the GHS is not a model standard that can be adopted verbatim. Rather, it is a set of criteria and provisions that regulatory authorities can incorporate into existing systems, or use to develop new systems. The GHS allows a regulatory authority to choose the provisions that are appropriate to its sphere of regulation. This is referred to as the “building block approach.” The GHS includes all of the regulatory components, or building blocks, that might be needed for classification and labeling requirements for chemicals in the workplace, transport, pesticides, and consumer products. This rule only adopts those sections of the GHS that are appropriate to OSHA's regulatory sector. For example, while the GHS includes criteria on classifying chemicals for aquatic toxicity, these provisions were not adopted because OSHA does not have the regulatory authority to address environmental concerns. The building block approach also gives regulatory agencies the authority to select which classification criteria and provisions to adopt. OSHA is adopting the classification criteria and provisions for labels and SDSs, because the current HCS covers these elements. Broad criteria were established for the GHS in order to allow regulatory bodies to apply the same standards to a wide array of hazards. The building block approach may also be applied to the criteria for defining hazard categories. As a result, the GHS criteria are more comprehensive than what was in the current HCS, and OSHA did not need to incorporate all of the GHS hazard categories into this final rule. Under the GHS, each hazard or endpoint ( e.g., Explosives, Carcinogenicity) is considered to be a hazard class. The classes are generally sub-divided into categories of hazard. For example, Carcinogenicity has two hazard categories. Category one is for known or presumed human carcinogens while category two encompasses suspected human carcinogens. The definitions of hazards are specific and detailed. For example, under the current HCS, a chemical is either an explosive or it is not. The GHS has seven categories of explosives, and assignment to these categories is based on the classification criteria provided. In order to determine which hazard class a mixture falls under, the GHS generally applies a tiered approach. When evaluating mixtures, the first step is consideration of data on the mixture as a whole. The second step allows the use of “bridging principles” to estimate the hazards of the mixture based on information about its components. The third step of the tiered approach involves use of cut-off values based on the composition of the mixture or, for acute toxicity, a formula that is used for classification. The approach is generally consistent with the requirements of the pre-modified HCS, but provides more detail and specification and allows for extrapolation of data available on the components of a mixture to a greater extent—particularly for acute effects. Hazard communication requirements under the GHS are directly linked to the hazard classification. For each class and category of hazard, a harmonized signal word ( e.g., Danger), pictogram ( e.g., skull and crossbones), and hazard statement ( e.g., Fatal if Swallowed) must be specified. These specified elements are referred to as the core information for a chemical. Thus, once a chemical is classified, the GHS provides the specific core information to convey to users of that chemical. The core information allocated to each category generally reflects the degree or severity of the hazard. Precautionary statements are also required on GHS labels. The GHS provides precautionary statements; while they have been codified (numbered), they are not yet considered formally harmonized. In other words, regulatory authorities may choose to use different language for the precautionary statements and still be considered to be harmonized with the GHS. The GHS has codified these statements ( i.e., assigned numbers to them) as well as aligned them with the hazard classes and categories. Codification allows the precautionary statements to be referenced in a shorthand form and makes it easier for authorities using them in regulatory text to organize them. In addition, there are provisions to allow inclusion of supplementary information so that chemical manufacturers can provide data in addition to the specified core information. The GHS establishes a standardized 16-section format for SDSs to provide a consistent sequence for presentation of information to SDS users. Items of primary interest to exposed employees and emergency responders are presented at the beginning of the document, while more technical information is presented in later sections. Headings for the sections ( e.g., First-aid measures, Handling and storage) are standardized to facilitate locating information of interest. The harmonized data sheets are consistent with the order of information included in the voluntary industry consensus standard for safety data sheets (ANSI Z400.1). 4. Revisions to the Hazard Communication Standard The GHS uses an integrated, comprehensive process of identifying and communicating hazards, and the GHS modifications improve the HCS by providing more extensive criteria for defining the hazards in a consistent manner, as well as standardizing label elements and SDS formats to help to ensure that the information is conveyed consistently. The GHS does not include requirements for a written hazard communication program, and this final rule does not make substantive changes to the current HCS requirements for a written hazard communication program. Nor does the GHS impose employee training requirements; however, OSHA believes that additional training will be necessary to ensure that employees understand the new elements, particularly on the new pictograms. Therefore, modified training requirements have been included in the final rule in order to address the new label elements and SDS format required under this revised standard. a. Modifications The revised HCS primarily affects manufacturers and importers of hazardous chemicals. Pursuant to the final rule, chemical manufacturers and importers are required to re-evaluate chemicals according to the new criteria in order to ensure the chemicals are classified appropriately. For health hazards, this will involve assigning the chemical both to the appropriate hazard category and subcategory (called hazard class). For physical hazards, these new criteria are generally consistent with current DOT requirements for transport. Therefore, if the chemicals are transported ( i.e., they are not produced and used in the same workplace), this classification should already be done to comply with DOT's transport requirements. This will minimize the work required for classifying physical hazards under the revised rule. Preparation and distribution of modified labels and safety data sheets by chemical manufacturers and importers will also be required. However, those chemical manufacturers and importers following the ANSI Z400.1 standard for safety data sheets should already have the appropriate format, and will only be required to make some small modifications to the content of the sheets to be in compliance with the final rule. Using the revised criteria, a chemical will be classified based on the type, the degree, and the severity of the hazard it poses. This information will help employers and employees understand chemical hazards and identify and implement protective measures. The detailed criteria for classification will result in greater accuracy in hazard classification and more consistency among classifiers. Uniformity will be a key benefit; by following the detailed criteria, classifiers are less likely to reach different interpretations of the same data. b. Specific Changes From the Proposal Based on comments from the rulemaking effort, OSHA has made some modifications from the proposal to the final rule. These changes were the result of OSHA's analysis of the comments and data received from interested parties who submitted comments or participated in the public hearings. The major changes are summarized below and are discussed in the Summary and Explanation Section of this Preamble (Section XIII). Safety Data Sheet In the proposal, OSHA asked interested parties to comment on whether OSHA's permissible exposure limits (PELs) should be included on SDSs, as well as any other exposure limit used or recommended by the chemical manufacturer, importer, or employer who prepares SDSs. After reviewing and analyzing the comments and testimony, OSHA has decided not to modify the HCS with regard to the American Conference of Government Industrial Hygienists (ACGIH) Threshold Limit Values (TLVs) and so will continue to require ACGIH TLVs on SDSs. We have also retained the classification listings of the International Agency for Research on Cancer (IARC) and the National Toxicology Program (NTP) on SDSs. As explained more fully in the Summary and Explanation, OSHA finds that requiring ACGIH TLVs as well as the IARC and NTP classification listings on the SDS will provide employers and employees with useful information to help them assess the hazards presented by their workplaces. Labels As discussed in the NPRM, the GHS gives individual countries the option of using black, rather than red, borders around pictograms for labels used in domestic commerce. OSHA proposed requiring red frames for all labels, domestic and international. The final rule carries forward this requirement. As discussed in Sections IV and XIII, studies showed that there is substantial benefit to the use of color on the label. The color red in particular will make the warnings on labels more noticeable, because red borders are generally perceived to reflect the greatest degree of hazard. Further, while commenters who objected to this requirement cited the cost of printing in red ink as a reason to allow domestic use of black borders, OSHA was unconvinced that the costs involved made the provision infeasible, excessively burdensome, or warranted the diminished protection provided by black borders. ( See Sections VI and XIII below.) One option suggested by commenters was requiring a red label but allowing manufacturers and importers to use preprinted labels with multiple red frames. This would save costs because the preprinted label stock could be used for different products requiring different pictograms. Use of this option, however, would mean that the label for a particular chemical might have empty red frames if the chemical did not require as many pictograms as there were red frames on the label stock. As explained in Sections IV and XIII, OSHA has concluded that a red border without a pictogram can create confusion and draw worker attention away from the appropriate hazard warnings ( See Section IV for more detail). Additionally, OSHA is concerned that empty red borders might be inconsistent with DOT regulations ( See 49 CFR 172.401). Therefore, while OSHA is not opposed to the use of preprinted stock, OSHA has decided not to allow the use of blank red frames on finished labels. Hazard Classification Another change to the final rule is the inclusion of the IARC and NTP as resources for determining carcinogenicity. Commenters generally supported this modification, and OSHA believes the inclusion of this information will assist evaluators with the classification process. Therefore, descriptions of both the IARC and NTP classification criteria have been added to Appendix F, and IARC and NTP classifications may be used to determine whether a chemical should be classified as a carcinogen. Unclassified Hazards OSHA has made several modifications to clarify and specify the definition for unclassified hazards, based on the comments provided. Executive Order 13563 states that our regulatory system “must promote predictability and reduce uncertainty,” and these efforts at clarification are designed to achieve that goal. OSHA included this definition to preserve existing safeguards under requirements of the HCS for chemical manufacturers and importers to disseminate information on hazardous chemicals to downstream employers, and for all employers to provide such information to potentially exposed employees. Inclusion of the definition does not create new requirements. OSHA has made certain changes to clarify application of the definition, and to ensure that the relevant provisions do not create confusion or impose new burdens. In order to minimize confusion, OSHA has renamed unclassified hazards, “hazards not otherwise classified.” More fundamentally, and in response to the majority of the comments on this issue, OSHA has removed from the coverage of the general definition the hazards identified in the NPRM as not currently classified under the GHS criteria. These hazards are: pyrophoric gases, simple asphyxiants, and combustible dust. As described below, OSHA has added definitions to the final rule for pyrophoric gases and simple asphyxiants, and provided guidance on defining combustible dust for purposes of complying with the HCS. In addition, the Agency has also provided standardized label elements for these hazardous effects. Precautionary/Hazard Statements In response to concerns by commenters that, on occasion, a specified precautionary statement might not be appropriate, OSHA modified mandatory Appendix C to provide some added flexibility. Where manufacturers, importers, or responsible parties can show that a particular statement is inappropriate for the product, that precautionary statement may be omitted from the label. This is discussed in more detail in section XIII below. Other Standards Affected Changing the HCS to conform to the GHS requires modification of other OSHA standards. For example, modifications have been made to the standards for Flammable and Combustible Liquids in general industry (29 CFR 1910.106) and construction (29 CFR 1926.152) to align the requirements of the standards with the GHS hazard categories for flammable liquids. Modifications to the Process Safety Management of Highly Hazardous Chemicals standard (29 CFR 1910.119) will ensure that the scope of the standard is not changed by the revisions to the HCS. In addition, modifications have been made to most of OSHA's substance-specific health standards, ensuring that requirements for signs and labels and SDSs are consistent with the modified HCS. Effective Dates In the proposal, OSHA solicited comments regarding whether it would be feasible for employers to train employees regarding the new labels and SDSs within two years after publication of the final rule. Additionally, OSHA inquired as to whether chemical manufacturers, importers, distributors, and employers would be able to comply with all the provisions of the final rule within three years, and whether a phase-in period was necessary. OSHA received many comments and heard testimony regarding the effective dates which are discussed in detail in Section XIII below. First, after analysis of the record, the Agency has determined that covered employers must complete all training regarding the new label elements and SDS format by December 1, 2013 since, as supported by record, employees will begin seeing the new style labels considerably earlier than the compliance date for labeling. Second, OSHA is requiring compliance with all of the provisions for preparation of new labels and safety data sheets by June 1, 2015. However, distributors will have an additional six months (by December 1, 2015) to distribute containers with manufacturers' labels in order to accommodate those they receive very close to the compliance date. Employers will also be given an additional year (by June 1, 2016) to update their hazard communication programs or any other workplace signs, if applicable. Additionally, OSHA has decided not to phase in compliance based on whether a product is a substance or a mixture. OSHA has concluded that adequate information is available for classifiers to use to classify substances and mixtures. Finally, as discussed in the NPRM, employers will be considered to be in compliance with the HCS during the transition period as long as they are complying with either the existing HCS (as it appears in the CFR as of October 1, 2011) or this revised HCS. A detailed discussion regarding the effective dates is in Section XIII. 5. Alternatives of Mandatory Implementation In the NPRM, OSHA proposed several alternatives to mandatory implementation of the GHS in response to concerns raised by commenters through the ANPR (74 FR at 50289). Commenters generally supported the concept of adopting the GHS as it was proposed. However, a few commenters indicated that they were concerned with what they saw as the cost burden on small businesses that are not involved in international trade. To address these concerns, OSHA solicited comments in the NPRM on several options proposed by the Agency regarding alternatives to mandatory harmonization. The following is a discussion of these alternatives; the potential impact and the response from participants in the rulemaking regarding the relative benefit, feasibility, impact on small business; and the impact on worker safety and health. The first alternative OSHA proposed was to facilitate voluntary adoption of GHS within the existing HCS framework, and give manufacturers and importers the option to use the current HCS or the GHS system. This option would have permitted companies to decide whether they wanted to comply with the existing standard or with the GHS. A variation of this alternative was also proposed that would have adopted the GHS with an exemption allowing small chemical producers to continue to use the HCS, even after this GHS-modified HCS is promulgated. The second alternative was a limited adoption of specific GHS components. Under this approach, producers could either comply with the GHS or a modified HCS that would retain the current HCS hazard categories, but require standardized hazard statements, signal words, and precautionary statements. A variation of this alternative would have omitted mandatory precautionary statements. Commenters almost universally objected to both of the alternatives listed above (Document ID #0324, 0328, 0329, 0330, 0335, 0338, 0339, 0341, 0344, 0351, 0352, 0355, 0365, 0370, 0377, 0381, 0382, 0385, 0387, 0389, 0393, 0495, 0403, 0404, and 0412). American Industrial Hygiene Association (AIHA), in a representative comment, stated that “permitting voluntary use of some of the system * * * or exempting certain sectors based on business size or other criteria [would] defeat the purpose of revising this standard and of the GHS” (Document ID #0365). Additionally, the Compressed Gas Association stated they “would not support any alternative approach as it would defeat the goal of global hazard communication coordination” (Document ID #0324). Many commenters argued that a dual system that permitted businesses to opt out of complying with the GHS would undermine the key benefits of implementation. For example, Ferro Corporation stated that “for GHS to be effective and efficient in the U.S., implementation should be consistent and congruent” (Document ID #0363). DuPont Company argued “dual systems would be confusing for employers” (Document ID #0329). ORC also rejected voluntary implementation, reasoning that “consistent requirements for all manufacturers and importers of chemicals [are] needed to maximized efficiency in the chemical supply chain” (Document ID #0370). Additionally, the AFL-CIO cited consistent hazard information for workers and employers as the core objective of this rulemaking (Document ID #0340). The commenters who supported GHS as proposed indicated that consistency was an essential aspect of this rule. Stericycle, Inc., stated that SDSs which “do not follow a consistent format would cause issues in understanding and implementing the controls to limit exposure and protect employee safety and health,” and argued that exemptions from GHS requirements would “shift the burden from the chemical industry to all employers” (Document ID #0338). Additionally, commenters did not support exempting small businesses from adopting the GHS. Ecolab argued that “large and small businesses use each others' products” and are inextricably linked, and they indicated that voluntary adoption “could cause confusion about product hazards if two identical products are labeled differently due solely to the size of the business from which [they are] obtained” (Document ID #0351). OSHA agrees that the first alternative is unworkable as even one business's adoption of one of the alternatives would affect other companies. As stated in the comments above, if small businesses do not adopt the GHS, then large businesses or distributors will either have to generate GHS classifications for chemicals purchased, or request that small businesses supply data and labels using GHS classifications. Likewise, chemical producers often provide their products to distributors who then sell them to customers who are unknown to the original producer. This would lead to a plethora of product labels, a situation that is bound to make hazard communication far more difficult. Commenters specifically cited issues with safety as their basis for rejecting the first proposed alternative. The AIHA (Document ID #0365) stated: If employers and employees cannot have confidence that labels and MSDSs provide a consistent safety message superficial standardization will not improve safety. Safety is also seriously compromised if different hazard communication systems are present in the work area. Effective training is not possible if pictograms and hazard statements are not used in a consistent manner * * *. All of the approaches discussed will create competitive pressures that can affect classification decisions and make good and consistent hazard communication more difficult. North American Metal Council argued that the alternative would penalize workers of small business, and asserted that a “worker's right to know about chemical hazards, should not depend on the source of a chemical or the size of the worker's employer” (Document ID #0337). Moreover, commenters asserted that the benefits derived from the harmonized labeling of chemicals would be significantly diluted if employers were not uniformly required to adopt the GHS. United Steel Workers Union aptly reiterated that the primary benefit of adopting the GHS is not the facilitation of international trade, but rather is the protection of workers, which is “best accomplished through a uniform system of classification leading to comprehensible hazard information” (Document ID #0403). ( See also Document ID #0339, 0351, 0376, 0377, 0382, and 0412.) Several commenters supported the voluntary adoption of the GHS (Document ID #0355, 0389, and 0502). For example, Intercontinental Chemical Corporation supported voluntary adoption for companies not involved in international trade (Document ID #0502). Additionally, Betco supported allowing “small businesses that market domestically” to retain the current HCS and suggested that “voluntary adoption would not be any less protective for employees or create confusion” (Document ID #0389). OSHA acknowledges that small chemical manufacturers will have some burdens associated with the adoption of GHS. However, employees who use products produced by small employers are entitled to the same protections as those who use products produced by companies engaged in international trade. The confusion created by two or more competing systems would undermine the consistency of hazard communication achievable by a GHS-modified HCS. Moreover, whether or not a product will wind up in international trade may not be known to the manufacturer or even the first distributer. A producer may provide a chemical to another company, which then formulates it into a product that is sold internationally. Thus, the original producer is involved in international trade without necessarily realizing it. For these reasons, OSHA has determined that, in order to achieve a national, consistent standard, all businesses must be required to adhere to the revised HCS. OSHA concludes that the rulemaking record does not support adoption of the first alternative. The majority of private industry, unions, and professional organizations did not support this approach, arguing persuasively that piecemeal adoption would undermine the benefits of harmonization. As discussed above, while improvements to international trade are a benefit of this rulemaking; they are not the primarily intended benefit. OSHA believes that implementation of the GHS, without exceptions based on industry or business size, will enhance worker safety through providing consistent hazard communication and, consequently, safe practices in the workplace. However, as indicated above, OSHA does recognize that there are burdens with any change and as discussed in Section XIII, OSHA will use the input OSHA has received to the record to develop an outreach plan for additional guidance. The second alternative, a halfway measure allowing businesses to adopt some of the features of a GHS-modified HCS but not requiring adoption of others, drew little interest or comment from the participants. OSHA has concluded that this alternative, which would have led to even more inconsistencies in hazard communication, is not a viable alternative. OSHA's conclusion is supported by the overwhelming number of commenters who spoke out against the first option and strongly supported the proposed standard. Allowing employers to adopt, say, only the provisions for the labels or safety data sheets will result in inconsistent use of the standardized hazard statement, signal word, and precautionary statement without clear direction on when they would be required, a situation that is sure to compromise safety in the workplace. Therefore, OSHA has concluded that implementation of the GHS is also preferable to the second alternative. Pursuant to its analysis of the entire rulemaking record, OSHA has decided to adopt the GHS as proposed and is not incorporating any of the alternatives into this final rule. The adoption of any of the alternatives would undermine the key benefits associated with the GHS. OSHA has concluded, as discussed in Section V, that the adoption of GHS as proposed will strengthen and refine OSHA's hazard communication system, leading to safer workplaces. IV. Need and Support for the Modifications to the Hazard Communication Standard Chemical exposure can cause or contribute to many serious adverse health effects such as cancer, sterility, heart disease, lung damage, and burns. Some chemicals are also physical hazards and have the potential to cause fires, explosions, and other dangerous incidents. It is critically important that employees and employers are apprised of the hazards of chemicals that are used in the workplace, as well as the associated protective measures. This knowledge is needed to understand the precautions necessary for safe handling and use, to recognize signs and symptoms of adverse health effects related to exposure when they do occur, and to identify appropriate measures to be taken in an emergency. OSHA established the need for disclosure of chemical hazard information when the Hazard Communication Standard (HCS) was issued in 1983 (48 FR 53282-53284, Nov. 25, 1983). As noted in the NPRM (74 FR 50291, Sept. 30, 2009), this need continues to exist. The Agency estimates that 880,000 hazardous chemicals are currently used in the U.S., and over 40 million employees are now potentially exposed to hazardous chemicals in over 5 million workplaces. During the September 29, 2009, press conference announcing the publication of the HCS NPRM, Deputy Assistant Secretary of Labor for Occupational Safety and Health, Jordan Barab, discussed the impact that the HCS has had on reducing injury and illness rates. Mr. Barab stated that, since the HCS's original promulgation in 1983, “OSHA estimates that chemically-related acute injuries and illness [have] dropped at least 42%.” Reiterating information from OSHA's preliminary economic analysis in the NPRM, Mr. Barab also stated: [T]here are still workers falling ill or dying from exposure to hazardous chemicals. OSHA estimates, based on BLS data, that more than 50,000 workers became ill and 125 workers died due to acute chemical exposure in 2007. These numbers are dwarfed by chronic illnesses and fatalities that are estimated in the tens of thousands. OSHA believes that aligning the Hazard Communication Standard with the provisions of the GHS will improve the effectiveness of the standard and help to substantially improve worker safety and health. The GHS will provide a common system for classifying chemicals according to their health and physical hazards and it will specify hazard communication elements for labeling and safety data sheets. Data collected and analyzed by the Agency also reflect this critical need to improve hazard communication. Chemical exposures result in a substantial number of serious injuries and illnesses among exposed employees. The Bureau of Labor Statistics estimates that employees suffered 55,400 illnesses that could be attributed to chemical exposures in 2007, the latest year for which data are available (BLS, 2008). In that same year, 17,340 chemical-source injuries and illnesses involved days away from work (BLS, 2009). The BLS data, however, do not indicate the full extent of the problem, particularly with regard to illnesses. As noted in the preamble to the HCS in 1983, BLS figures probably only reflect a small percentage of the incidents occurring in exposed employees (48 FR 53284, Nov. 25, 1983). Many occupational illnesses are not reported because they are not recognized as being related to workplace exposures, are subject to long latency periods between exposure and the manifestation of disease, and other factors ( e.g., Herbert and Landrigan, 2000, Document ID #0299; Leigh et al., 1997, Document ID #0274; Landrigan and Markowitz, 1989, Document ID #0299). While the current HCS serves to ensure that information concerning chemical hazards and associated protective measures is provided to employers and employees, the Agency has determined that the revisions adopted in this final rule will substantially improve the quality and consistency of the required information. OSHA believes these revisions to the HCS, which align it with the GHS, will enhance workplace protections significantly. Better information will enable employers and employees to increase their recognition and knowledge of chemical hazards and take measures that will reduce the number and severity of chemical-related injuries and illnesses. A key foundation underlying this belief relates to the comprehensibility of information conveyed under the GHS. All hazard communication systems deal with complicated scientific information being transmitted to largely non-technical audiences. During the development of the GHS, in order to construct the most effective hazard communication system, information about and experiences with existing systems were sought to help ensure that the best approaches would be used. Ensuring the comprehensibility of the GHS was a key principle during its development. As noted in a Federal Register notice published by the U.S. Department of State (62 FR 15956, April 3, 1997): “A major concern is to ensure that the requirements of the globally harmonized system address issues related to the comprehensibility of the information conveyed.” This concern is also reflected in the principles of harmonization that were used to guide the negotiations and discussions during the development of the GHS. As described in Section 1.1.1.6(g) of the GHS, the principles included the following: “[T]he comprehension of chemical hazard information, by the target audience, e.g., workers, consumers and the general public should be addressed.” As was discussed in the proposal (74 FR 50291), to help in the development of the GHS, OSHA had a review of the literature conducted to identify studies on effective hazard communication, and made the review and the analysis of the studies available to other participants in the GHS process. One such study, prepared by researchers at the University of Maryland, entitled “Hazard Communication: A Review of the Science Underpinning the Art of Communication for Health and Safety” (Sattler et al., 1997, Document ID #0191) has also long been available to the public on OSHA's Hazard Communication web page. Additionally, OSHA conducted an updated review of the literature published since the 1997 review. This updated review examined the literature relevant to specific hazard communication provisions of the GHS (ERG, 2007, Document ID #0246). Further work related to comprehensibility was conducted during the GHS negotiations by researchers in South Africa at the University of Cape Town—the result is an annex to the GHS on comprehensibility testing ( See GHS Annex 6, Comprehensibility Testing Methodology) (United Nations, 2007, Document ID #0194). Such testing has been conducted in some of the developing countries preparing to implement the GHS, and has provided these countries with information about which areas in the GHS will require more training in their programs to ensure people understand the information. The primary purpose of these activities was to ensure that the system developed was designed in such a way that the messages would be effectively conveyed to the target audiences, with the knowledge that the system would be implemented internationally in different cultures with varying interests and concerns. Another principle that was established to guide development of the GHS was the agreement that levels of protection offered by an existing hazard communication system should not be reduced as a result of harmonization. Following these principles, the best aspects of existing systems were identified and included in a single, harmonized approach to classification, labeling, and development of SDSs. The GHS was developed by a large group of experts representing a variety of perspectives. Over 200 experts provided technical input on the project. The United Nations Sub-Committee of Experts on the GHS, the body that formally adopted the GHS and is now responsible for its maintenance, includes 35 member nations as well as 14 observer nations. Authorities from these member states are able to convey the insight and understanding acquired by regulatory authorities in different sectors, and to relate their own experiences in implementation of hazard communication requirements. In addition, over two dozen international and intergovernmental organizations, trade associations, and unions are represented, and their expertise serves to inform the member nations. The GHS consequently represents a consensus recommendation of experts with regard to best practices for effective chemical hazard communication, reflecting the collective knowledge and experience of regulatory authorities in many nations and in different regulatory sectors, as well as other organizations that have expertise in this area. United States-based scientific and professional associations have endorsed adoption of the GHS since publication of the Advance Notice of Proposed Rulemaking (ANPR) in 2006 (71 FR 53617, Sept. 12, 2006). For example, the American Chemical Society (ACS) indicated its support for the GHS, stating: “The American Chemical Society strongly supports the adoption of the GHS for hazard communication in general and specifically as outlined in the ANPR” adding that “* * * ACS anticipates that OSHA implementation of GHS in the U.S. will enhance protection of human health and the environment through warnings and precautionary language that are consistent across different products and materials as well as across all workplaces” (Document ID #0165). The American Industrial Hygiene Association (AIHA) affirmed its support for modification of the HCS to adopt the GHS. AIHA maintained that standardized labels and safety data sheets will make hazard information easier to use, thereby improving protection of employees (Document ID #0034). While acknowledging that the GHS presents a number of concerns and challenges, the Society of Toxicology has also expressed its support for the GHS, stating that “a globally harmonized system for the classification of chemicals is an important step toward creating consistent communications about the hazards of chemicals used around the world” (Document ID #0304). The American Association of Occupational Health Nurses joined these organizations in advocating adoption of the GHS, arguing that standardization of chemical hazard information is critical to protecting the safety and health of employees (Document ID # 0099). Responders to the 2009 NPRM reiterated their support or, in the case of new commenters, echoed the comments from other scientific and professional associations to the ANPR ( See, e.g., Document ID #0338, 0357, 0365, 0393, and 0410). The positions taken by these organizations point to wide support for the GHS among the scientific and professional communities. Stakeholders representing a wide range of sectors and interests agreed with OSHA that aligning the HCS with the GHS will improve comprehensibility, and thus lead to reductions in chemical source illnesses and injuries. American Society of Safety Engineers, Dow Chemical, and ORC all voiced their support for the proposed rule, citing improved comprehensibility and quality of transmitted information as key benefits (Document ID #0336, 0353, and 0370). Representing union labor, the American Federation of State, County and Municipal Employees (AFSCME) stated that this rulemaking would “allow critical communication about the hazards of chemicals to be understood by all workers, regardless of their literacy level or primary language * * * [and] will in turn lead to safer, more productive workplaces” (Document ID #0414). Many stakeholders asserted that adopting the GHS would lead to safer workplaces. The Chamber of Commerce provided its support for the rulemaking, stating that the GHS could “improve worker safety, and facilitate business growth and international trade” (Document ID #0397). The American Subcontractors Association, Inc. added that consistent hazard communication is critical to having a safe work program (Document ID #0322). Additionally, North American Metals Council (NAMC), which represents the interests of the metals and mining industry, stated that a single, globally harmonized classification and labeling system is of vital interest to its members (Document ID #0233). The position that GHS would increase worker protection was also raised in testimony during the hearings. Elizabeth Treanor of Phylmar Regulatory Roundtable testified that adopting the GHS would “enhance the effectiveness of the hazard communication standard by improving the quality and consistency of chemical hazard information that is provided to employees and employers” (Document ID #0497 Tr. 92). In addition to the endorsement of the GHS by a group of experts with extensive knowledge and experience in chemical hazard communication, support from scientific and professional associations with expertise in this area, and support from industry and labor stakeholders, a substantial body of evidence indicates that the modifications to the HCS will better protect employees. Specifically, this evidence supports OSHA's findings that: (1) Standardized label elements—signal words, pictograms, hazard statements and precautionary statements—will be more effective in communicating hazard information; (2) standardized headings and a consistent order of information will improve the utility of SDSs; and (3) training will support and enhance the effectiveness of the new label and SDS requirements. This evidence was obtained from sources predating the ANPR and from more recent data. OSHA commissioned several studies to examine the quality of information on SDSs (Karstadt, 1988, Document ID #0296; Kearney/Centaur 1991a, 1991b, Document ID #0309 and 0310; Lexington Group, 1999, Document ID #0257); the General Accounting Office (GAO) has issued two reports based on its evaluation of certain aspects of the HCS (GAO 1991 and 1992, Document ID #0271 and 0272); a National Advisory Committee on Occupational Safety and Health (NACOSH) workgroup conducted a review of hazard communication and published a report of its findings (NACOSH, 1996, Document ID #0260); and a substantial amount of scientific literature relating to hazard communication has been published. As mentioned previously, OSHA commissioned a review of the literature, and a report based on that review was published in 1997 (Sattler et al., 1997, Document ID #0191). An updated review was conducted in 2007 (ERG, 2007, Document ID #0246). In addition, OSHA conducted a review of the requirements of the HCS and published its findings in March of 2004 (OSHA, 2004, Document ID #0224). Key findings derived from these sources are discussed below. No commenters questioned the validity of studies presented in the NPRM. Similarly, commenters did not question OSHA's analysis or interpretation of the study findings. Only one commenter suggested that OSHA should adopt more “conservative expectations for the effects that warning format changes can have on the behavior of end users,” adding that “real-world conditions” must be accounted for when determining the actual responses of users (Document ID #0396). However, the commenter did not disagree with OSHA's overall conclusion that this final rule would improve safety. OSHA agrees that external factors may influence the overall benefits of label elements (this will be addressed in Section VI). The studies discussed in the NPRM formed the evidentiary basis for the revised HCS. As such, OSHA infers that commenters generally found the studies, as well as OSHA's analysis, to be sound. OSHA's rationale for adopting the GHS is tied to anticipated improvements in the quality and consistency of the information that would be provided to employers and employees. Hazard classification is the foundation for development of this improved information. Indeed, hazard classification is the procedure of identifying and evaluating available scientific evidence in order to determine if a chemical is hazardous, and the degree of hazard, pursuant to the criteria for health and physical hazards set forth in the standard. Hazard classification provides the basis for the hazard information that is provided in labels, SDSs, and employee training. As such, it is critically important that classification be performed accurately and consistently. The GHS provides detailed scientific criteria to direct the evaluation process. The specificity and detail provided help ensure that different evaluators would reach the same conclusions when evaluating the same chemical. Moreover, the GHS refines the classification process by establishing categories of hazard within most hazard classes. These categories indicate the relative degree of hazard, and thereby provide a basis for determining precise hazard information that is tailored to the level of hazard posed by the chemical. The classification criteria established in the GHS thus provide the necessary basis for development of the specific, detailed hazard information that would enhance the protection of employees. Labels Labels serve as immediate visual reminders of chemical hazards, and complement the information presented in training and on SDSs. The current HCS requires that labels on hazardous chemical containers include the identity of the hazardous chemical; appropriate hazard warnings that convey the specific physical and health hazards, including target organ effects; and the name and address of the chemical manufacturer, importer, or other responsible party. The HCS does not specify a standard format or design elements for labels. In the NPRM, OSHA proposed to improve the HCS by changing the performance requirements for labels to the GHS-specific requirements that labels include four standardized elements: a signal word; hazard statement(s); pictogram(s); and precautionary statement(s) ( See Section XV for a detailed discussion of the requirements). The appropriate label elements for a chemical are to be determined by the hazard classification. OSHA has concluded that these standardized label elements better convey critically important hazard warnings, and provide useful information regarding precautionary measures that will serve to better protect employees than the performance-oriented approach of the current rule. This requirement is different from the current HCS in that it will require consistent and detailed information regarding a chemical based on the hazard classification. The current rule does not specify a standard format or design elements for labels. Rather, all that is required in the current HCS is that the label of the hazardous chemical containers include the identity of the hazardous chemical; appropriate hazard warnings that convey the specific physical and health hazards, including target organ effects; and the name and address of the chemical manufacturer, importer, or other responsible party. Additionally, as discussed in the proposal (74 FR 50291, Sept. 30, 2009), a great deal of literature has been developed that examines the effectiveness of warnings on labels. These studies support OSHA's adoption of standardized warnings on the labels of hazardous chemicals. Although the studies discussed below pertain to prescription and non-prescription medications, alcoholic beverages, or consumer products rather than hazardous chemicals, it does not diminish the importance or relevance of the data. This literature provides a substantial body of information directly applicable and analogous to workplace chemical labels. In spite of the differences in affected populations, workplace chemical labels have many characteristics that are comparable to those found in other sectors. Pharmaceutical labels, for example, are similar to chemical labels in that they often have explicit instructions for use which, if not followed, can cause adverse health effects or death. Designers of pharmaceutical labels also encounter many of the same challenges faced by those who design chemical labels, such as container space limitations and the need to convey information to low-literate or non-English-literate users. In addition, some of the research is not directly related to any particular sector or type of product. Some findings related to use of color, for example, could reasonably be applied to a wide variety of label applications. The studies are discussed below in the specific labeling sections. Signal Words A signal word is a word that typically appears near the top of a warning, sometimes in all capital letters. Common examples include DANGER, WARNING, CAUTION, and NOTICE. The signal word is generally understood to serve a dual purpose: Alerting the user to a hazard and indicating a particular level of hazard. For example, users generally perceive the word DEADLY to indicate a far greater degree of hazard than a term like NOTICE. This final rule requires the use of one of two signal words for labels—DANGER or WARNING—depending on the hazard classification of the substance in question. These are the same two signal words used in the GHS. DANGER is used for the more severe hazard categories, while WARNING denotes a less serious hazard. These signal words are similar to those in other established hazard communication systems, except that some other systems have three or more tiers. For example, ANSI Z129.1 (the American National Standard for Hazardous Industrial Chemicals—Precautionary Labeling) uses DANGER, WARNING, and CAUTION, in descending order of severity (ANSI, 2006, Document ID #0280). A number of studies have examined how people perceive signal words and, in particular, how they perceive signal words to be different from one another. Overall, this research supports the use of signal words on labels, demonstrating that they can attract attention and help people clearly distinguish between levels of hazard. The research also supports the decision to use only two tiers, as many recent studies have found clear differences between DANGER and WARNING, but little perceived difference between WARNING and CAUTION. Wogalter et al. investigated the influence of signal words on perceptions of hazard for consumer products (Wogalter et al., 1992, Document ID #0300). Under the pretext of a marketing research study, 90 high school and college students rated product labels on variables such as product familiarity, frequency of use, and perceived hazard. Results showed that the presence of a signal word increased perceived hazard compared to its absence. Between extreme terms ( e.g., NOTE and DANGER), significant differences were noted. Seeking to test warning signs in realistic settings, Adams et al. tested five industrial warning signs on a group of 40 blue-collar workers employed in heavy industry, as well as a group of students (Adams et al., 1998, Document ID #0235). Signs were manipulated to include four key elements (signal word, hazard statement, consequences statement, and instructions statement) or a subset of those elements. Participants were asked questions to gauge their reaction and behavioral intentions. Overall, 77 percent (66 percent of the worker group) recognized DANGER as the key word when it appeared, and more than 80 percent recognized BEWARE and CAUTION, suggesting that the signal word was generally noticed, and it was recognized as the key alerting element. DANGER was significantly more likely than other words to influence behavioral intentions. Laughery et al. also demonstrated the usefulness of signal words. The authors tested the warnings on alcoholic beverage containers in the U.S., and found that a signal word (WARNING) was one of several factors that decreased the amount of time it took for participants to locate the warning (Laughery et al., 1993, Document ID #0281). Several studies have tested the arousal strength or perceived hazard of different signal words. Arousal strength is a term used to indicate the overall importance of the warning, and incorporates both the likelihood and severity of the potential threat. Silver and Wogalter tested the arousal strength of signal words on college students and found that DANGER connoted greater strength than WARNING and CAUTION (Silver and Wogalter, 1993, Document ID #0308). The results failed to show a difference between WARNING and CAUTION. Among other words tested, DEADLY was seen as having the strongest arousal connotation, and NOTE the least. Griffith and Leonard asked 80 female undergraduates (who were unlikely to have already received industrial safety training) to rate signal words. Results included a list of terms in order of “meaningfulness,” representing conceptual “distance” from the neutral term NOTICE (Griffith and Leonard, 1997, Document ID #0250). From most to least meaningful, these terms were reported to be DANGER, URGENT, BEWARE, WARNING, STOP, CAUTION, and IMPORTANT. Wogalter et al. asked over 100 undergraduates and community volunteers to rank signal words (Wogalter et al., 1998, Document ID #0286). DEADLY was perceived as most hazardous, followed by DANGER, WARNING, and CAUTION. All differences were statistically significant. In a follow-up experiment using labels produced in the ANSI Z535.2 (American National Standard for Environmental and Facility Safety Signs), ANSI Z535.4 (American National Standard for Product Safety Signs and Labels), and alternative formats, the authors found a similar rank order for signal words with all labeling systems. Finally, the authors tested the same terms on employees from manufacturing and assembly plants and found the same general order: DEADLY, then DANGER, then WARNING and CAUTION with no significant difference between the last two terms. In more of a free-form experiment, Young asked 30 subjects to produce warning signs for a set of scenarios, using different sign components available on a computer screen (Young, 1998, Document ID #0289). In roughly 80 percent of the signs, the participant chose to use a signal word. DANGER, DEADLY, and LETHAL were more likely to be used for scenarios with severe hazards; CAUTION and NOTICE for non-severe scenarios. WARNING was used equally in both types of scenarios. The author suggests that these results support a two-tiered system of signal words. In a separate task, users ranked the perceived hazard of signal words, resulting in the following list from most to least severe: DEADLY, LETHAL, DANGER, WARNING, CAUTION, and NOTICE. While these studies have focused on the relative perceptions of signal words, others have sought to evaluate how the absolute meaning of common signal words is perceived. Drake et al. asked a group of students and community volunteers to match signal words with definitions borrowed from consensus standards and other sources (Drake et al., 1998, Document ID #0244). Participants matched DANGER to a correct definition 64 percent of the time, while NOTICE was matched correctly 68 percent of the time. WARNING and CAUTION were matched correctly less than half of the time, suggesting confusion. The authors recommended using WARNING and CAUTION interchangeably. The authors also suggested that a standard set of signal words (but not synonyms) is helpful for users with limited English skills, who can be trained to recognize a few key words. Signal word perceptions are reported to be consistent among some non-U.S. populations, as well. Hellier et al. asked 984 adults in the UK to rate DANGER, WARNING, and CAUTION on a hazard scale from 1 (low) to 10 (high) (Hellier et al., 2000a, Document ID #0252). DANGER was ranked as 8.5, WARNING was ranked as 7.8, while CAUTION was rated as 7.25. These results are consistent with the findings of studies on subjects in the U.S. In a second study published in 2000, Hellier et al. asked a mixed-age group of participants in the UK to rate the arousal strength of 84 signal words commonly used in the U.S. (Hellier et al., 2000b, Document ID #0253). The authors found that DANGER is stronger than WARNING, while WARNING and CAUTION are not significantly different from each other. Similar results were found among workers in Zambia. Banda and Sichilongo tested GHS-style labels using four different signal words (as well as other variables) (Banda and Sichilongo, 2006, Document ID #0237). Among workers in the industrial and transport sectors, DANGER was generally perceived as the most hazardous signal word. WARNING was one of a group of terms that were largely indistinguishable from one another, but distinct from DANGER. The authors support adoption of the GHS, suggesting that having just two possible signal words will lead to “more impact and less confusion about the extent of hazard.” In addition, comparable results were found in South Africa (London, 2003, Document ID #0311). In a large study on SDS and label comprehensibility conducted for South Africa's National Economic Development and Labour Council (NEDLAC), DANGER was generally ranked as more hazardous than WARNING by participants in the four sectors tested: industry, transport, agriculture, and consumers. Cumulatively, these studies provide a clear indication that signal words are effective in alerting readers that a hazard exists, and in conveying the existence of a particular level of hazard. The studies found a generally consistent hierarchy of signal words with respect to perceived hazard. DANGER and WARNING appear to connote different levels of hazard, while the perceived difference between WARNING and CAUTION is often insignificant. In response to the NPRM, OSHA received a comment from Croplife America about the impact of using a two-tiered signal word system on pesticide labels (Document ID #0387). Croplife America explained that they believe a three-tiered system (DANGER, WARNING and CAUTION) provides “a little more distinction in the relative toxicity of a compound” and “if everything says `warning,' we run the risk of diluting the effectiveness of the signal word” (Document ID #0495 Tr. 251). During the informal public hearings, OSHA requested that Croplife America support their position on why a three-tiered warning system is better than a two-tiered system. To support this assertion, Croplife America submitted a late comment containing an additional paper by Hellier et al. which analyzed how signal words are interpreted (Hellier et al., 2007, Document ID #0646). This paper discusses two studies performed in 2007 to analyze if alternative information is communicated with signal words (Hellier et al., 2007, Document ID #0646). Using 17 signal words, 30 undergraduate students were asked to rate the similarities of paired signal words. In the first study, the result ratings revealed that signal words were interpreted by the participants along three dimensions; dimension one: the level of hazard implied by the signal words, dimension two: the extent to which they explicitly implied a risk, and dimension three`: the clarity of the instruction given by the signal word. Using the same signal words as in the first study, the second study explored how these signal words were interpreted by the study participants. Using statistical analysis, the analysis confirmed that the participants were able to discern the levels of hazard implied by the signal words and how it to relates to the explicitness of the implied risk (dimensions one and two). The results of the third dimension were unclear. The studies indicate that the extent to which signal words imply risk is important—people may not respond when repeatedly exposed to warnings that do not explicitly imply a risk. The results support using signal words to denote the level of hazard implied by the situation, and that there might be utility in using signal words to convey both information about a potential risk and the level of hazard. Even if it had been timely submitted, OSHA is not convinced that this study supplies sufficient evidence that using a two-tiered signal word approach will diminish the chemical user's ability to distinguish hazard severity. In OSHA's opinion, if anything, the Hellier study provides additional support for the use of signal words on labels to attract attention and to identify levels of hazard. Indeed, its results show that the signal word “caution” was substantially less connected by participants with communicating hazards than “warning” and “danger,” which supports OSHA's decision not to use “caution” as a signal word. The record supports OSHA's determination that using the signal word in combination with the hazard statement alerts the chemical user to the hazard and allows him or her to distinguish the level of hazard severity posed by hazardous chemicals in the workplace. Commenting on the studies presented in the proposal, Applied Safety and Ergonomics (ASE) agreed that there are benefits associated with the standardization of warning elements. However, they also urged “OSHA to adopt more conservative expectations for the effect that warning format changes can have on the behavior of end users” (Document ID #0396). See Section VI of this final rule for a detailed discussion of the benefits of standardized warning elements. OSHA does not disagree with these comments and has determined that requiring the use of the combined labeling elements (pictograms, signal words, hazard statements, and precautionary statements) will result in a uniform and consistent system of identifying and communicating chemical hazards in the workplace. No other comments were received on the studies OSHA used in its discussion of the need for signal words in this revised HCS. Comments received from stakeholders support the revision of the HCS to include the use of standardized signal words (Document ID #0321, 0338, 0339, and 0349). For example, the Communications Workers of America (CWA) stated: “Clearly, the Rule's requirements regarding revised SDSs and labeling provisions requiring the use of standardized signal words, pictograms, and hazard and precautionary statements would prove invaluable to affected CWA members whom have been exposed to hazardous chemicals and chemical products that have produced negative health effects and medical problems” (Document ID #0349). These comments support OSHA's conclusion that signal words alert chemical users to a hazard and indicate a particular level of hazard. After reviewing the comments received and the evidence presented in the record, OSHA has determined that, in this revised rule, use of the signal words “DANGER” and “WARNING” is appropriate. Pictograms A pictogram is a graphical composition that may include a symbol along with other graphical elements, such as a border or background color. A pictogram is a communication tool and is intended to convey specific information. The proposed rule included requirements for use of eight different pictograms. Each of these pictograms consists of a different symbol in black on a white background within a red square frame set on a point ( i.e., a red diamond). The specific pictograms on a label were to be determined based on the hazard classification of the substance in question. OSHA has found ample evidence to support the requirement for pictograms. A study by Kalsher et al. reported that users preferred labels with pictorials. The authors concluded that pictorials focused the attention of the user, helped users who were unable to read the small font size or print on the labels, and were useful for individuals who did not understand English (Kalsher et al., 1996, Document ID #0256). The presence of the symbol can attract attention to the warnings and are more memorable than written warnings (Parsons et al., 1999, Document ID #0262). Symbols serve several important functions in warning labels. As Wogalter et al. explained (Wogalter et al., 2006, Document ID #0275), symbols may alert the user to a hazard more effectively than text alone: Symbols may be more salient than text because of visual differentiations of shape, size, and color. Usually symbols have unique details and possess more differences in appearance than do the letters of the alphabet. Letters are highly familiar and are more similar to one another than most graphical symbols. Other investigators have examined the benefits of pictograms for those with low literacy levels and those who do not understand the language in which the label text is written. A study by Parsons et al. concluded that nonverbal graphics are especially helpful for ensuring that individuals, who do not speak English or who have limited understanding of English, understand the meaning of the intended warning (Parsons et al., 1999, Document ID #0262). Another study has shown that people with low literacy skills can, with the help of pictographs, recall large amounts of medical information over significant periods of time (Houts et al., 2001, Documents ID #0254). Several researchers have sought to evaluate how people comprehend symbols, including the symbols that were proposed to be required. Several studies have found that the skull and crossbones icon—one of the symbols proposed and included in the final rule—is among the most recognizable of safety symbols. For example, Wogalter et al. asked 112 undergraduates and community volunteers to rank various label elements (Wogalter et al., 1998, Document ID #0244). Among shapes and icons, the skull symbol (in this case, without the crossbones) was rated most hazardous and most noticeable. The skull connoted the greatest hazard among industrial employees as well. Smith-Jackson and Wogalter asked 48 English-speaking workers to rate the perceived hazards of six alerting symbols (Smith-Jackson and Wogalter, 2000, Document ID #0196). The skull was rated significantly higher than all other symbols. Several studies have examined other pictograms included in the final rule. As part of an experiment to see how individuals comprehend warnings on household chemical labels, Akerboom and Trommelen asked 60 university students whether they understood the meaning of several pictograms, including four that are included in the final rule (Akerboom and Trommelen, 1998, Document ID #0236). The authors reported the following levels of comprehension for these pictograms: Flame: 93 percent comprehension; Skull and crossbones: 85 percent comprehension; Corrosion: 20 percent comprehension; and Flame over circle: 13 percent comprehension. Only the flame and skull and crossbones pictograms met the 85 percent comprehension criteria suggested by ANSI Z535.3 (the American National Standard Criteria for Safety Symbols) (ANSI, 2002a, Document ID #0276). The authors recommend that labels present the hazard phrase [statement] and symbol together, along with corresponding precautions, as has been included as a requirement in the final rule. Banda and Sichilongo tested comprehension of labels among 364 workers in four sectors in Zambia (transport, agriculture, industrial, and household consumers) (Banda and Sichilongo, 2006, Document ID #0237). Within this population, the skull and crossbones symbol was widely understood, as was the “flame” symbol. Based on these results, the authors suggest a preference for symbols that depict familiar, meaningful, and recognizable images. London performed a similar study among the same four sectors in South Africa, finding that the skull and crossbones was understood by at least 96 percent of each sector and “flame” by at least 89 percent (London, 2003, Document ID #0311). “Exploding bomb” was correctly comprehended by 44 to 71 percent of each sector. On the other hand, many health-related symbols did not fare well, and six symbols had less than 50 percent comprehension across all four sectors. Outside the transport sector, “Gas cylinder” was the least comprehended symbol. These findings indicate that some of the pictograms included in the final rule are already widely recognized by a general audience. Others, however, are not commonly understood. Therefore, simply adding some of the pictograms on labels will not provide useful information unless efforts are also undertaken to ensure that employees understand the meaning of the pictograms. As Wogalter et al. noted, some studies have found slower processing, poorer recognition, and greater learning difficulties with symbols versus with text—particularly if the symbols are complex or non-intuitive (Wogalter et al., 2006, Document ID #0275). These results emphasize the need to train employees on the meaning of the pictograms that will be included on chemical labels. Where pictograms are used and understood, communication of hazards can be improved. Houts et al. studied long-term recall of spoken medical instructions when accompanied by a handout with pictograms (Houts et al., 2001, Document ID #0254). Nearly 200 pictograms were tested with 21 low-literate adults (less than grade 5 reading level). Immediately after training, participants recalled the meaning of 85 percent of the pictograms, and they recalled 71 percent after 4 weeks. This study found that recall was better for simple pictograms where there is a direct relationship between the image and its meaning—that is, where no inference is required. Another body of literature focuses on the utility of symbols in general. Ganier found that people generally construct mental representations faster with pictures than they do with text, supporting earlier findings on the usefulness of symbols (Ganier, 2001, Document ID #0275). Evans et al. found similar results with a task in which undergraduates were asked to sort items into categories using either text clues, visual clues, or a combination of pictures and text (Evans et al., 2002; Document ID #0192). When categories were fixed ( i.e., sorting instructions were specific), people sorted the cards more consistently with one another when presented with pictures than when presented with text alone. In a follow-up article on the South African study mentioned previously, Dowse and Ehlers found that patients receiving antibiotics adhered to instructions much better when the instructions included pictograms—(54 percent with high adherence, versus 2 percent when given text-only instructions) (Dowse and Ehlers, 2005, Document ID #0243). Pictograms also serve to attract attention to the hazard warnings on a label. To examine factors that influence the effectiveness of pharmaceutical labels, Kalsher et al. asked subjects to rate the noticeability, ease of reading, and overall appeal of labels with or without pictorials (Kalsher et al., 1996, Document ID #0256). A group of 84 undergraduates gave consistently higher ratings to labels with pictorials. A group of elderly subjects had similar preferences, rating labels with pictorials as significantly more noticeable and likely to be read. Laughery et al. found similar results with a timed test on alcoholic beverage labels (Laughery et al., 1993, Document ID #0281). When a pictorial was present to the left of the warning showing what not to do when drinking, the amount of time it took to find the label was significantly reduced. An icon consisting of the alert symbol (an exclamation mark set within a triangle) and the signal word WARNING also decreased response time. The fastest response time came when four different enhancements (including the pictorial and the icon) were included. In a follow-up exercise, an eye scan test found that the pictorial had a particularly strong influence on reaction time, compared with other enhancements. Where chemical labels are concerned, London found that symbols tend to be the most easily recalled label elements (London, 2003, Document ID #0311). In the comprehensibility test of labels among South African workers mentioned previously, symbols were the most commonly recalled elements—particularly the skull and crossbones—and people recalled looking at symbols first. Symbols were also cited as by far the most important factor in determining hazard perception. The author concludes that “Symbols are therefore key to attracting attention and informing risk perception regarding a chemical” (London, 2003, Document ID #0311). Wogalter et al. found factors other than pictorials influenced workers (Wogalter et al., 1993, Document ID #0285). The authors tested the influence of various warning variables on whether subjects wore proper protective equipment during a task involving measuring and mixing chemicals. Warning location and the amount of clutter around the warning had significant effects on compliance, but the presence or absence of pictorials did not. Meingast asked subjects to recall warning content after viewing labels that were considered either high quality (with color signal icons, pictorials, and organized text conforming to ANSI Z535.4, the American National Standard for Product Safety Signs and Labels) or low quality (text only) (Meingast, 2001, Document ID #0210). Pictorials were the items remembered most often, accounting for 48 percent of what viewers of high-quality labels recalled. The author suggests that these pictorials also served the role of dual coding, meaning that they help to improve the retention of corresponding text. Other studies support this dual-coding function of pictorials, finding that symbols tend to be most effective when paired with redundant or reinforcing text. For example, Sojourner and Wogalter asked 35 participants to rate several prescription label formats in terms of ease of reading, ease of understanding, overall effectiveness, likelihood of reading, overall preference, pictorial understanding, and how helpful pictorials are in helping to remember the instructions (Sojourner and Wogalter, 1997, Document ID #0288). The authors found that people prefer fully redundant text and pictorials, which they judged easiest to read, most effective, and preferred overall. Dual-coded pictorials aided understanding and memory more than labels with pictorials only (no text). In a follow-up study, Sojourner and Wogalter gave undergraduates, young adults, and older adults a free recall test after viewing medication labels (Sojourner and Wogalter, 1998, Document ID #0288). Fully redundant text and pictorials led to significantly greater recall than other formats, and were rated most effective by all age groups. Similarly, Sansgiry et al. found that pictograms on over-the-counter drug labels improved comprehension, but only when they were congruent with the corresponding text (Sansgiry et al., 1997, Document ID #0264). The 96 adults who were tested were less confused, were more satisfied, were more certain about their knowledge, and understood more when shown labels that contained congruent pictures and verbal instructions, versus verbal instructions alone. The results were significantly better with congruent pictures and text than with either pictures alone or incongruent pictures and text. Some evidence links use of pictograms directly to safer behavior. Jaynes and Boles investigated whether different warning designs, specifically those with symbols, affect compliance rates (Jaynes and Boles, 1990, Document ID #0290). Five conditions were tested: a verbal warning, a pictograph warning with a circle enclosing each graphic, a pictograph warning with a triangle on its vertex enclosing each graphic, a warning with both words and pictographs, and a control (no warning). Participants performed a chemistry laboratory task using a set of instructions that contained one of the five conditions. The warnings instructed them to wear safety goggles, mask, and gloves. All four warning conditions had significantly greater compliance than the no-warning condition. A significant effect was also found for the “presence of pictographs” variable, suggesting that the addition of pictographs will increase compliance rates. NIOSH submitted an additional study at the informal public hearings that analyzed the use of pictograms on labels. In 1997, Wilkinson et al. (Document ID #0480.6), interviewed 206 farmers in Victoria Australia. Two widely used agricultural herbicides were used for the basis of the research. The researchers developed three “mocked-up” labels for each herbicide—one containing existing warning text, one containing existing text with pictograms of appropriate safety precautions, and one containing text with pictograms that had been tested for recognition and comprehension across a variety of cultures and literacy levels. The interviewees answered questions using a rating scale, which was subjected to a statistical analysis to determine the significance of the responses. The authors concluded that “the labels with added pictograms were perceived by pesticide users as significantly easier to obtain information from than labels containing text only” (Document ID #0480.6). Stakeholders on the whole supported the inclusion of pictograms on the labels of hazardous substances. During the hearings, Chris Trahan of the AFL-CIO voiced support for including pictograms on the labels of hazardous chemicals, and cited construction workers as a group whose safety and health conditions would be greatly improved by OSHA's adoption of “a system of symbols [workers] can then readily use to make decisions on a daily basis” (Document ID #0494 Tr. 8). As discussed in the proposal, a considerable amount of evidence shows that pictograms can serve as useful and effective communication tools. In the final rule, OSHA has decided to adopt the eight GHS pictograms initially proposed in the NPRM. Each of these pictograms consists of a different symbol in black on a white background within a red square frame set on a point ( i.e., a red diamond). The specific pictograms that are required on a particular label are to be determined based on the hazard classification of the substance in question. OSHA finds, based on scores of supporting studies and persuasive testimony that the pictograms will make warnings on labels more noticeable and easier for employees to understand. In particular, symbols will improve comprehension among people with low literacy levels and those who are not literate in the English language. Moreover, pictograms will be used not only in conjunction with other label elements, but also in the context of the hazard communication program as a whole. Training that includes an explanation of labels (included in the final rule) will ensure that the pictograms are understood by employees. Red Borders GHS allows regulatory authorities the option of permitting black pictogram borders for labels on domestic products, and in the proposal OSHA requested comment on this issue. Mandating the use of red borders was supported by stakeholders, who argued persuasively that red borders would make labels more noticeable and would make the warnings appear to be more important (Document ID #0339, 0341, 0365, 0383, 0408, 0410, 0412, and 0456). The National Association of Chemical Distributers, in supporting the use of red borders, reasoned that they would be consistent with the overall goal of the GHS (Document ID #0341). Additionally, the AIHA stated that requiring red borders would promote the safe use of chemicals (Document ID #0365). Several commenters raised economic concerns, suggesting that because red ink is more expensive, the use of black borders should be permitted (Document ID #0318, 0328, 0370, 0377, 0382, 0393, and 0411). Dow Chemical, Troy Corporation, and several other commenters recommended that red borders should only be required on products that were being exported (Document ID #0352, 0353, 0399, 0405, and 0389). Similarly, API argued that in order to remain consistent with the GHS, OSHA should only require exported chemicals to have a red border (Document ID #0376). OSHA finds this argument to be unpersuasive. In order to reap the benefits of consistency in warnings, labels must have a degree of sameness and that includes the colors used. Moreover, OSHA analyzed the impact that the use of red borders would have on production costs. While the use of red borders may increase the cost of printing, OSHA has determined that the cost does not render the rule infeasible. This issue is discussed in greater detail in Section VI. Finally, the GHS does not even state a preference for black borders on labels of domestic products; it simply gives the competent authority discretion to allow black borders when the product will not enter into international commence. Numerous studies have found that substantial benefits exist when color is used on labels. Due to the extensive amount of information that needs to be displayed, warning labels can become cluttered. Swindell found that searching for needed information on a cluttered label is very challenging for the user (Swindell, 1999, Document ID #0284). Her study concluded that minor changes to an extensive warning label, such as the addition of color, can greatly improve the noticeability of the warning, grab the attention of the user faster, and produce quicker reaction times. Swindell also researched the effect that different colors (red, blue, and black) had on the time it took users to locate and respond to a warning. Red was perceived to indicate the highest degree of hazard and was shown to increase the perceived hazard of a word presented in that color ( e.g., DANGER in blue is perceived as less hazardous than WARNING in red). Swindell's findings echo the results reported by Laughery et al., who found that alcoholic beverage labels were located significantly faster when the text was red instead of black (Laughery et al., 1993, Document ID #0281). These studies involve color on label elements other than the pictogram borders, but the presence of color and the particular color is germane to the red borders of labels. The primacy of red as an understandable color denoting danger is also supported by these studies. • Smith-Jackson and Wogalter asked English-speaking community members to rate the perceived hazard of ten ANSI safety colors (Smith-Jackson and Wogalter, 2000, Document ID #0196). Red, yellow, black, and orange were rated the highest (in descending order). Differences were statistically significant except the difference between yellow and black. • Among 80 college students asked to rate colors by Griffith and Leonard, red was rated the most “meaningful” color ( i.e., most distinct in meaning from neutral gray), followed by green, orange, black, white, blue, and yellow (Griffith and Leonard, 1997, Document ID #0250). • Wogalter et al. asked Spanish speakers to rank the perceived hazard of ANSI safety colors (Wogalter et al., 1997b, Document ID #0266). Red was ranked highest, followed by orange, black, and yellow. • Dunlap et al. surveyed 1169 subjects across several different language groups including English, German, and Spanish speakers (Dunlap et al., 1986, Document ID #0191). Subjects rated the color words red, orange, yellow, blue, green, and white according to the level of perceived hazard. The results demonstrated that the hazard information communicated by different colors followed a consistent pattern across language groups, with red having the highest hazard ratings. • Wogalter et al. asked undergraduates and community volunteers to rank various warning components (Wogalter et al., 1998, Document ID #0286). Red connoted a significantly greater hazard than other colors, followed by yellow, orange, and black (in that order). A group of industrial workers ranked the colors from greatest to least hazard as follows: red, yellow, black, orange. • London asked workers in four sectors in South Africa to rank the colors red, yellow, green, and blue in terns of perceived hazard; 95 percent said red represents the greatest hazard, and 58 percent said yellow is the second greatest hazard (London, 2003; Document ID #0311). • Banda and Sichilongo asked workers in Zambia to rate the perceived hazard of various colors used in chemical labels (Banda and Sichilongo, 2006, Document ID #0237). Red was associated with the greatest hazard, followed by yellow. • Among a sample of 30 undergraduates who rated the perceived hazar [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-4826. Public record. Not legal advice.