[Federal Register: September 30, 2009 (Volume 74, Number 188)] [Proposed Rules] [Page 50279-50549] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr30se09-14] [[Page 50279]] ----------------------------------------------------------------------- Part II Department of Labor ----------------------------------------------------------------------- Occupational Safety and Health Administration ----------------------------------------------------------------------- 29 CFR Parts 1910, 1915 and 1926 Hazard Communication; Proposed Rule [[Page 50280]] ----------------------------------------------------------------------- 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), Department of Labor. ACTION: Proposed rule; request for comments. ----------------------------------------------------------------------- SUMMARY: OSHA is proposing to modify its existing Hazard Communication Standard (HCS) to conform with the United Nations' (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS). OSHA has made a preliminary determination that the proposed modifications will improve the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. The Agency anticipates 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 proposed 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, requirements for employee training on labels and safety data sheets. OSHA is also proposing to modify provisions of a number 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. DATES: Written comments. Written comments, including comments on the information collection determination described in Section VIII of the preamble (OMB Review under the Paperwork Reduction Act of 1995), must be submitted by the following dates: Hard copy: Comments must be submitted (postmarked or sent) by December 29, 2009. Facsimile and electronic transmissions: Comments must be sent by December 29, 2009. Informal public hearings. The Agency will schedule an informal public hearing on the proposed rule. The location and date of the hearing, procedures for interested parties to notify the Agency of their intention to participate, and procedures for participants to submit their testimony and documentary evidence will be announced in the Federal Register. ADDRESSES: Written comments. You may submit comments by any of the following methods: Electronically: You may submit comments electronically at http:// www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow the instructions on-line for making electronic submissions. Fax: If your submissions, including attachments, are not longer than 10 pages, you may fax them to the OSHA Docket Office at (202) 693- 1648. Mail, hand delivery, express mail, messenger or courier service: You must submit three copies of your comments to the OSHA Docket Office, Docket No. OSHA-H022K-2006-0062, U.S. Department of Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210. Deliveries (hand, express mail, messenger and courier service) are accepted during the Department of Labor's and Docket Office's normal business hours, 8:15 a.m.-4:45 p.m., E.T. Instructions: All submissions must include the Agency name and the docket number for this rulemaking (Docket No. OSHA-H022K-2006-0062). All comments, including any personal information you provide, are placed in the public docket without change and may be made available online at http://www.regulations.gov. Therefore, OSHA cautions you about submitting personal information such as social security numbers and birthdates. Docket: To read or download comments submitted in response to this Federal Register notice, go to Docket No. OSHA-H022K-2006-0062 at http://www.regulations.gov or to the OSHA Docket Office at the address above. All comments are listed in the http://www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through that Web page. All comments, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Electronic copies of this Federal Register document are available at http://regulations.gov. Copies also are available from the OSHA Office of Publications, Room N-3101, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693- 1888. This document, as well as news releases and other relevant information, are also available at OSHA's Web page at http:// www.osha.gov. FOR FURTHER INFORMATION CONTACT: For general information and press inquiries, contact Jennifer Ashley, Office of Communications, Room N- 3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-1999. For technical information, contact Maureen O'Donnell, 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: I. Introduction The preamble to the proposal to modify the Hazard Communication Standard includes a review of the events leading to the proposal, a discussion of the reasons why OSHA believes these modifications are necessary, the preliminary economic and regulatory flexibility analysis for the proposal, and an explanation of the specific provisions set forth in the proposed standard. The discussion follows this outline: I. Introduction II. Issues III. Events Leading to the Proposed Modifications to the Hazard Communication Standard IV. Overview and Purpose of the Proposed Modifications to the Hazard Communication Standard V. Need and Support for the Proposed Modifications to the Hazard Communication Standard VI. Pertinent Legal Authority VII. Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis VIII. OMB Review Under the Paperwork Reduction Act of 1995 IX. Federalism X. State Plans XI. Unfunded Mandates XII. Protecting Children From Environmental Health and Safety Risks XIII. Environmental Impacts XIV. Public Participation XV. Summary and Explanation of the Proposed 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 [[Page 50281]] (h) Employee Information and Training (i) Trade Secrets (j) Effective Dates (k) Other Standards Affected (l) Appendices XVI. References XVII. Authority and Signature XVIII. Proposed Amendments In the preamble, OSHA references a number of 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). The documents are also available at the OSHA Docket Office (see ADDRESSES section above). For further information about accessing documents referenced in this Federal Register notice, see Section XIV (Public Participation--Notice of Hearing). II. Issues OSHA requests comment on all relevant issues, including economic impact and feasibility, environmental impact, effects on small entities, proposed revisions to the HCS, and subsequent modifications to other standards. OSHA has received many comments on the issues raised in the Advance Notice of Proposed Rulemaking (ANPR) (71 FR 53617, September 12, 2006), and the Agency has considered those comments in the development of this proposal. This section identifies issues on which the Agency seeks additional information and comment to supplement that received in response to the ANPR, as well as new topics related to this proposal. While new comments are welcome, OSHA requests that comments submitted in response to the ANPR not be resubmitted as they are retained in the rulemaking record and reconsidered throughout the process. OSHA is including these issues at the beginning of the document to assist readers as they consider the comments they plan to submit. However, to fully understand the questions and provide substantive input in response to them, the parts of the preamble that address these issues in detail should be read and reviewed. These include Section VII, which addresses the impacts of the NPRM, and thus provides the background related questions 2 through 5. Section XV provides the Summary and Explanation of the proposed regulatory text, and Section XVII is the text itself. These are key to understanding questions 6 through 26. It should be noted that the Federal Register's required format for a modification of an existing standard does not allow the Agency to provide the full text of the rule, i.e., the regulatory text in this document only addresses those paragraphs that OSHA is proposing to change. Therefore, the Agency is putting a marked up version of the text of the current rule on its web page to help readers understand the proposed changes in context. The marked up text will be found on www.osha.gov under Hazard Communication in the subject index. OSHA requests that comments be organized, to the extent possible, around the following issues and numbered questions. Submitting comments in an organized manner and with clear reference to the issue raised will enable all participants to easily see what issues the commenter addressed and how they were addressed. This is particularly important in a rulemaking such as GHS which affects many diverse industries. Many commenters, especially small businesses, are likely to confine their interest (and comment) to the issues that affect them, and they will benefit from being able to quickly identify comment on their issues in others' submissions. Of course, OSHA also welcomes relevant comments concerning the proposal that fall outside the issue questions raised in this section. However, the Agency is particularly interested in receiving public responses, supported by evidence and reasons, to the following questions: Need and Support for the Standard 1. OSHA has made a preliminary determination that the proposed modifications to the HCS would increase the quality and consistency of information provided to employers and employees. Specifically, OSHA believes that standardized label elements would be more effective in communicating hazard information; standardized headings and a consistent order of information would improve the utility of SDSs; and training would support and enhance the effectiveness of the new label and SDS requirements. Is this assessment correct? OSHA requests information that reflects on the effectiveness of the proposed modifications to the HCS in protecting employees from chemical hazards in the workplace. Economic Impacts and Economic Feasibility 2. The preliminary economic analysis in Section VII raises a variety of specific questions and issues with respect to the preliminary economic analysis. OSHA would appreciate it if you could place answers to these issues as heading 2 in your comments and further organize comments on the preliminary economic analysis (PEA) as follows: a. Industrial profiles. This covers issues concerning how many employees, establishments and products would be affected by the proposed standard. OSHA welcomes comments on all aspects of the industrial profile and is particularly interested in comments on the number of affected employees, and the number of SDSs that would need revision, by industry. b. Issues with respect to estimated benefits of the proposed standard. OSHA considers three kinds of benefits in this preliminary analysis: Benefits associated with preventing injuries, illnesses, and fatalities through clearer and more accessible information; benefits associated with reducing the time that safety and health managers and logistics and emergency response personnel spend on hazardous chemicals through clearer and easier-to-find information; and benefits associated with reducing the time needed to develop and review SDSs because of international harmonization. OSHA is particularly interested in comments on the scope of these benefits; the extent to which they are already being achieved by existing practices; and the extent to which they depend on other countries following the harmonization effort. c. Issues with respect to the costs and range of costs of the proposed standard. OSHA preliminarily estimated the principal costs of the standard to chemical producers for reclassification of chemicals; remaking SDS's; and redoing labels; and to chemical users for familiarization and program changes for managers and for training exposed employees. OSHA welcomes comments on all aspects of the costs, and is particularly interested in comments on the extent to which chemical producers may have already met some of the requirements of the standard and the time and professional skills needed for the activities the standard would require. d. Issues with respect to economic impacts and feasibility of the proposed standard, including the sensitivity of OSHA's economic feasibility determination with respect to various assumptions. OSHA welcomes comments on all aspects of the economic impact and economic feasibility analyses. e. All other issues with respect to the PEA. Effects on Small Entities 3. OSHA has certified that the proposed standard will not have a [[Page 50282]] significant impact on a substantial number of small entities. Nevertheless, because of the number of small entities affected, OSHA has prepared a voluntary initial regulatory flexibility analysis, the results of which are described in Section VII of the proposed rule. Do you consider the estimated costs and impacts on small entities presented there to be reasonable? Why or why not? 4. Are there alternatives to the rule as a whole or specific requirements of the rule that reduce impacts on small entities while still protecting the health of employees and meeting the broad goal of a globally harmonized system? Environmental Impacts 5. OSHA has preliminarily determined that the proposed standard will not have any adverse effects on the environment, and may have positive effects on the environment. OSHA welcomes comments on this determination. Hazard Classification 6. OSHA is proposing to adopt all of the physical and health hazard classes in the GHS. Among the physical and health hazard classes, OSHA is proposing to include all hazard categories in the GHS except Acute Toxicity Category 5 for oral, dermal, or inhalation exposures; Skin Corrosion/Irritation Category 3; and Aspiration Hazard Category 2. If you believe that the exclusion of these hazard categories is not consistent with the scope and/or level of protection provided by the current HCS, please describe any recommended changes to this proposal and the reasons you think these changes are necessary. 7. OSHA has proposed a definition for unclassified hazards be added to the HCS to ensure that all hazards currently covered by the HCS--or new hazards that are identified in the future--are included in the scope of the revised standard until such time as specific criteria for the effect are added to the GHS and subsequently adopted by OSHA. Will this approach provide sufficient interim coverage for hazards such as combustible dust? Are there other hazards for which criteria should be developed and added to the GHS? Please provide information regarding these hazards, and the information available to characterize them. 8. OSHA believes it may be more appropriate to add specific coverage for simple asphyxiants to the standard in the final rule to ensure everyone properly addresses their coverage rather than addressing them under the unclassified hazard definition. This effect is simple and straightforward, and could be addressed in a definition that does not involve extensive criteria. OSHA is requesting comment on this approach. A possible definition would be as follows: ``Simple asphyxiants'' are substances that displace oxygen in the ambient atmosphere, and can thus cause oxygen deprivation in exposed workers that leads to unconsciousness and death. They are of particular concern in confined spaces. Examples of asphyxiants include: nitrogen, helium, argon, propane, neon, carbon dioxide, and methane. OSHA would also like to solicit comments on specific label elements for simple asphyxiants. No symbol would be required, but the signal word ``warning'' would be used, with the hazard statement ``may be harmful if inhaled''. In addition, a precautionary statement such as the following would be required: May displace oxygen in breathing air and lead to suffocation and death, particularly in confined spaces. All other requirements of the standard that apply to hazardous chemicals would also apply to chemicals that meet this definition. These substances would generally be covered already under the proposed rule as compressed gases, and may also pose other effects such as flammability that would have to be addressed as well. They are also already covered under the existing HCS. Is the definition suggested by OSHA sufficient to cover this effect? Do you have suggestions for modifying this definition? Are the label elements suggested appropriate? 9. In order to help to ensure that health hazard determinations are properly conducted under a performance-oriented approach, the HCS includes a ``floor'' of chemicals that are to be considered hazardous based on several cited reference lists. In addition, the existence of one toxicological study indicating a possible adverse effect is considered sufficient for a finding of hazard for any health effect. Under the GHS, there is no floor of chemicals cited, nor is there an across-the-board provision such as the one-study criterion. Instead, specific, detailed criteria are provided for each type of health hazard to guide the evaluation of relevant data and subsequent classification of the chemical. The proposed modifications to the HCS would align the standard to the GHS approach, and thus do not include the floor of chemicals nor the universal one-study rule. Would the proposed detailed criteria provide sufficient guidance for a thorough hazard evaluation? 10. OSHA has edited the chapters in the GHS for classification of physical and health hazards to remove material not directly related to classification and to otherwise streamline the text. OSHA anticipates providing the decision logics separately to serve as guidance, but has not included them in the regulatory text. Are there any additions, subtractions, or clarifications of the classification criteria from the GHS that OSHA needs to consider? 11. Certain physical hazard classification criteria (i.e., for self-reactive chemicals, organic peroxides, self-heating chemicals, explosives) either directly reference packaging or quantity, or rely on test methods that reference packaging or quantity. The criteria were developed for transport concerns. Clearly, quantity and packaging can greatly affect safe transport of chemicals that pose hazards such as those listed above. However, OSHA seeks comments on whether the criteria as stated in the GHS are appropriate for the workplace. Does use of these criteria present any obstacles to classification or create any difficulties for suppliers or users of chemicals? Describe any difficulties these criteria may present and any suggestions for addressing these issues, particularly recommendations that would be consistent with the GHS and maintain the GHS level of safety for these chemicals. 12. The GHS gives countries guidance on a cut-off or concentration limit for chemical mixtures containing target organ toxicity hazards. In Appendix A, Section A.8.3, OSHA is proposing to make the suggested 20% concentration limit mandatory so that label preparers are clear on what needs to be done. Please comment on whether this mandatory concentration limit is appropriate. If you have an alternative, please provide it along with the rationale. Labels 13. The proposal would require pictograms to have a red frame. As discussed in Section V, OSHA believes that use of the color red will make warnings more noticeable and will aid in communicating the presence of a hazard. However, the GHS gives competent authorities such as OSHA the discretion to allow use of a black frame when the pictogram appears on a label for a package which will not be exported. For packages that will not be exported, should the modified standard allow black frames on pictograms, or should the pictogram frame be required to be presented in red? [[Page 50283]] 14. In addition to the pictograms, signal word and hazard statements, GHS labels must include precautionary statements. OSHA is proposing to require the text in the precautionary statements in the GHS to be on HCS labels. As discussed in Section XV Summary and Explanation of the Proposed Standard, these statements are codified under the GHS, meaning that numbers have been assigned to them. In addition, the appropriate statements to use for each hazard class and category have been indicated in the GHS annexes. This means that label preparers will know exactly what precautionary statements to apply once they complete their hazard classification, and chemical users will see consistent language on labels to indicate the necessary precautionary measures. However, the statements are not yet considered to be part of the harmonized text like hazard statements are; rather they are included in the GHS as an suggested language. OSHA expects that other countries may adopt the codified precautionary statements when they put GHS in place. For example the EU has required that labels use the GHS codified precautionary statement text in adapting the GHS. Since OSHA did not previously require the use of precautionary statements, and had no such recommended statements to provide, the Agency is proposing to use those currently in the GHS as the mandatory requirements with the option of consolidating statements where appropriate (See Appendix C). OSHA anticipates this approach will provide the maximum benefit. OSHA is also seeking comment on whether any of these statements should be modified or if other precautionary statements should be included. In addition, as discussed in Section IV, OSHA has presented other alternatives with regards to precautionary statements, and OSHA is soliciting comment on these options as well. Specifically, OSHA is seeking feedback on whether the Agency should include the GHS precautionary statements as nonbinding examples, through a non mandatory appendix or guidance, rather than as required statements, or whether OSHA should allow label preparers to develop their own precautionary statements rather than specifying the text to be used. 15. OSHA has not proposed to require the exploding bomb pictogram or specific precautionary statements for Division 1.4S ammunition and ammunition components because the specified GHS label elements may not accurately reflect the hazards of these materials. Is this sufficiently protective? Are any adjustments to the label elements for Division 1.4S ammunition and ammunition components necessary? Describe any requested changes and explain why such revisions are necessary. 16. In the current HCS, OSHA has a provision that requires labels to be updated within three months of obtaining new and significant information about the hazards. The Agency has not been enforcing this provision for many years, and there has been an administrative stay on enforcement. OSHA is including the provision in this proposal, and inviting comment on it with the intention of including it in the final rule and lifting the stay. Is three months the appropriate time interval for updating? Are there any practical accommodations that need to accompany this limit (for example, related to stockpiles of chemicals)? Provide any alternatives you consider appropriate, as well as documentation to support them. Safety Data Sheets (SDSs) 17. As discussed in Section XV, the Agency is proposing to require that OSHA permissible exposure limits (PELs) be included on the SDS, as well as any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the safety data sheet. OSHA welcomes comments on this approach, along with an explanation of the basis for your position. 18. OSHA is proposing that Section 15 of the SDS be non-mandatory. As indicated in Appendix D, Section 15 addresses regulatory information concerning the chemical. OSHA is considering requiring the substance specific standards be referenced in this section, which would make Section 15 mandatory. Would employers and employees benefit from having this information in this section of the SDS? Other Standards Affected 19. OSHA is proposing to align the definitions of the physical hazards to the requirements of the GHS categories in safety standards for general industry, construction, and maritime standards, which either directly reference the HCS or provide information pertinent to the Safety Data Sheets (SDSs). In most cases OSHA has modified the standards to maintain scope and protection. However, the changes in definitions for flammable liquids Category 1 and 2 and flammable aerosols appear to be more than simply rounding to the nearest significant number. [cir] Flammable liquids Category 1 and 2: The boiling point cut-off for Category 1 is reduced from 100 deg F (37.8 deg C) or less to 95 deg F (35 deg C) or less, which could shift some liquids from Category 1 to Category 2. [cir] Flammable aerosols: OSHA is proposing to adopt the GHS method to determine flammability rather than the method defined by the Consumer Product Safety Commission (CPSC). OSHA's decision to change these definitions to be consistent with the GHS is based not only upon harmonizing its standards with those of other countries that have adopted or may adopt the GHS, but OSHA is also concerned with making its standards internally consistent. OSHA believes the methods used to classify these physical hazards are similar enough so that substances that are currently regulated by OSHA would continue to be regulated and that few, if any, changes would result in a shift in regulatory coverage. Would the proposed changes have any impact on your operations? If so, describe the anticipated effects. 20. OSHA is proposing to eliminate the term ``combustible liquid'' in 29 CFR 1910.106. 1910.107, 1910.123, 1910.124, 1910.125, and 1926.155 for liquids with a flashpoint above 100 [deg]F. To reflect consistency with the revised HCS where appropriate, OSHA is proposing to add the specific flashpoint criteria. This will maintain equivalent protection. Are there other standards that OSHA should update with the new terminology? 21. OSHA is proposing to modify the language required on signs in substance-specific health standards. The Agency developed the proposed language to reflect the terminology of the revised HCS while, at the same time, providing adequate warning through language that is consistent with the current sign requirements for these chemicals. An added benefit is the hazard warnings on signs specified for these standards will now be consistent throughout OSHA standards. For example, all carcinogens will now bear the hazard statement ``MAY CAUSE CANCER''. OSHA believes that providing language that is consistent on both signs and labels will improve comprehension for employees. Does the proposed language on signs accurately convey the hazards? 22. OSHA is proposing to revise the substance-specific health standards' provisions on labeling for producers and importers of chemicals and substances. Currently in the substance-specific standards OSHA requires specific language on labels for certain chemicals. OSHA is proposing to change these labeling requirements by referring those responsible for labeling to the modified HCS and including in each substance- [[Page 50284]] specific standard a list of health effects that must be considered for hazard classification. The modified HCS will dictate the specific language (i.e., signal word, hazard statement(s), and precautionary statement(s)) that is required on labels through the classification process. However, OSHA is proposing to maintain specific language for labels on contaminated clothing and waste/debris containers to ensure adequate hazard communication for the downstream recipients. How would the removal of required language for labels from substance-specific standards affect your work place? Are there hazard warnings that will be lost that do not have an equivalent hazard or precautionary statement? Are there alternatives to OSHA's approach for the substance- specific standards that will assure information is disseminated in a manner that is consistent with the modified HCS labeling requirements? 23. In determining the health hazards that need to be considered by manufacturers, importers and distributors when classifying chemicals regulated by the substance-specific standards, OSHA is proposing to primarily rely on the determinations made by the Agency in each rulemaking, the NIOSH Pocket Guide to Chemical Hazards (2005) and the International Chemical Safety Cards, and use as a secondary source the health effects identified by the European Commission (2007). OSHA is proposing to include a health hazard only if it is identified as such by two or more of these organizations. Are there other sources of information that OSHA should consult? 24. As detailed in the Summary and Explanation section of this document, OSHA is not proposing in this rulemaking to update the electrical standards (general industry 1910 subpart S and construction 1926 subpart K) or Explosives and blasting agents (general industry 1910.109 and construction 1926.914). These subparts are ``self- contained'' in that they do not rely on other OSHA standards for regulatory scope or definitions, but reference external organizations (such as the National Fire Protection Association [NFPA]). OSHA believes that these standards could be updated when the referenced external organizations adopt applicable GHS elements. If OSHA were to change these standards to comply with the GHS, how would this impact your operations? Effective Dates 25. OSHA has proposed to require that employers train employees regarding the new labels and safety data sheets within two years after publication of the final rule to ensure they are familiar with the new approach when they begin to see new labels and SDSs in their workplaces. Is the proposed time appropriate? 26. OSHA has proposed that chemical manufacturers, importers, distributors, and employers be required to comply with all provisions of the modified final rule within three years after its publication. Does this allow adequate time to review hazard classifications and amend them as necessary, and to revise labels and safety data sheets to reflect the new requirements? Would a shorter time frame be sufficient? 27. Are there any other factors that should be considered in establishing the phase-in period? Compliance Assistance and Outreach 28. OSHA received many comments in response to the questions in the ANPR regarding compliance assistance and outreach and is seeking additional comment in this proposal. However, comments already submitted need not be resubmitted. Please refer to the discussion in Section XV. Specifically, OSHA is interested in your responses to the following: What types of materials or products would best assist employers in understanding and complying with the modified HCS? OSHA seeks input to identify the tools that would be most useful to employers and employees, the subjects of greatest interest (e.g., classification criteria, labels, safety data sheets), and the best means of distributing these materials. 29. OSHA received a number of comments that suggested that a data base of chemical classifications should be developed and maintained to assist chemical manufacturers and importers in performing hazard classifications. This approach has been adopted in some other countries. Would such a data base be helpful? Who would be responsible for doing the classifications and maintaining them? How would the data base be kept aligned with other countries' classifications? Alternative Approaches 30. OSHA has described alternatives to the scope and application of the proposed rule in the preamble, Section IV. These include consideration of allowing voluntary implementation of the GHS; exemptions based on size of the business; adopting some components of the GHS but not others; and not adopting all of the required label elements. The Agency requests comments on these alternatives, with data to support the views expressed. Suggestions and support for other alternatives are requested as well. III. Events Leading to the Proposed Modifications to the Hazard Communication Standard OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200; 1915.1200; 1917.28; 1918.90; and 1926.59) was first issued in 1983 and covered the manufacturing sector of industry (48 FR 53280, November 25, 1983). In 1987, the Agency expanded the scope of coverage to all industries where employees are potentially exposed to hazardous chemicals (52 FR 31852, August 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 covered by OSHA since March 17, 1989 (54 FR 6886, February 15, 1989). In 1994, OSHA made a number of minor changes and technical amendments to the HCS to help ensure full compliance and achieve better protection of employees (59 FR 6126, February 9, 1994). The development of the HCS is discussed in detail in the preambles to the original and revised final rules (see 48 FR 53280-53281; 52 FR 31852-31854; and 59 FR 6127-6131). This discussion will focus on the sequence of events leading to the development of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the modifications to the HCS included in this proposed rule. The HCS requires chemical manufacturers and importers to evaluate the chemicals they produce or import to determine if they are hazardous. The rule 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 safety data sheets. 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. (Note: The HCS uses the term ``material safety data sheet'' or ``MSDS'', while the GHS uses ``safety data sheet'' or ``SDS''. For convenience and for consistency with the GHS, safety data sheet or SDS is being used throughout this document and that term would replace MSDS in the modified HCS.) To protect employees and members of the public who are potentially exposed to chemicals during their production, [[Page 50285]] 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. These laws vary with regard to 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 between the various 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's HCS, 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 having other authority over labeling under the Toxic Substances Control Act. Each of these regulatory authorities operates under different statutory mandates, and has adopted distinct hazard communication requirements. Tracking 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 may 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 issued in 1983. The preamble to the final rule included a commitment by OSHA to review the standard regularly to address international harmonization of hazard communication requirements. OSHA was asked to include this commitment 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: * * * [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 53287) OSHA has actively participated in a number of 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 also 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 Labor Organization (ILO) to develop a convention and recommendations on safety in the use of chemicals at work (55 FR 2166, January 22, 1990). On a closely related matter, OSHA published an 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 SDS 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 labelling 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 to complete. 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 Subcommittee 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, there were a number of other agencies [[Page 50286]] 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 e-mail 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, April 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. The GHS will be updated as necessary to reflect new technology and scientific developments, or provide additional explanatory text. This proposed rule is based on Revision 3 of the GHS, published in 2009. Countries have been encouraged to implement the GHS as soon as possible, and established a goal to 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. While much progress was made by the U.S. and other countries by the end of 2008, most are still in the process of implementing the GHS. OSHA published an Advance Notice of Proposed Rulemaking (ANPR) on the GHS in September of 2006 (71 FR 53617, September 12, 2006). 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 this proposed rule. At the same time the ANPR was published, OSHA made a document summarizing the GHS available on its Web site (http://www.osha.gov). OSHA remains engaged in a number of activities related to the GHS. The U.S. is a member of both the United Nations Committee of Experts on the Transport of Dangerous Goods and the Globally Harmonized System of Classification and Labeling of Chemicals, as well as the Subcommittee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals. 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 and EPA also 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 also continues to be involved 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. IV. Overview and Purpose of the Proposed Modifications to the Hazard Communication Standard The intent of the HCS is to ensure that the hazards of all chemicals are evaluated, and that information concerning chemical hazards and associated protective measures is transmitted to employers and employees. The standard 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. The three information components in this system--labels, SDSs, and employee training--are all 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. OSHA believes that the comprehensive approach adopted in the HCS-- requiring evaluation of chemicals and the transmittal of information through labels, SDSs, and training--is sound. The proposed modifications to the rule do not alter that approach. Rather, the proposed modifications to the rule are intended to improve the effectiveness of the HCS by enhancing the quality and consistency of the information provided to employers and employees. OSHA believes this can be accomplished by modifying the requirements of the standard to conform with the more specific and detailed provisions of the GHS for classification, [[Page 50287]] labeling, and SDSs. OSHA's rationale for this belief is summarized below. The evidence supporting this preliminary conclusion is presented in Section V of this preamble, and the proposed revisions to the HCS are discussed in detail in Section XV. HCS Provisions for Classification, Labeling, and SDSs The 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 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. 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 provided as 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 HCS also recognizes that risk may remain at concentrations below these cut-offs, and where there is evidence that is the case, the mixtures are considered hazardous under the standard. The current definitions of physical hazards in the HCS were derived from other OSHA standards that address such chemicals (e.g., flammable chemicals), or from the DOT criteria for physical hazards at the time OSHA promulgated the HCS. DOT subsequently changed their criteria to be consistent with the internationally harmonized transport requirements, and the HCS criteria for classification of physical hazards are generally not consistent with current DOT requirements. The 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 HCS was issued in 1983, the public record strongly supported this performance-oriented approach (see 48 FR 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. In recognition of the work that had been voluntarily completed, OSHA decided to allow labels and SDSs to be presented in any format desired, as long as the minimum information requirements of the standard were met. 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 a new system. The GHS is designed to allow regulatory authorities to choose provisions that are appropriate to their particular 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. Regulatory authorities such as OSHA adopt the provisions of the GHS that are appropriate for their particular regulatory sector, but do not need to adopt all of the criteria and provisions of the GHS. For example, the GHS includes criteria for classifying chemicals for aquatic toxicity. Since OSHA does not have the regulatory authority to address environmental concerns, OSHA would not adopt the GHS criteria for aquatic toxicity. The building block approach may also be applied to the criteria for defining hazards. For example, the acute toxicity criteria in the GHS are much broader than those currently found in the HCS. This is to allow consumer product authorities the ability to address the protection of children and other vulnerable populations. OSHA would not need to adopt all of the acute toxicity categories to maintain protection of employees in the workplace. The building block approach can also be applied when a regulatory authority decides which parts of the system to adopt. For example, the GHS includes classification criteria and provisions for labels and SDSs. While OSHA is proposing to adopt all of these elements because the current HCS cover labels and SDSs, consumer product and transportation authorities are not expected to require SDSs. 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. The definitions of hazards are more specific and detailed than those currently in the HCS. For example, under the HCS, a chemical is either an explosive or it is not. Under the GHS, there are seven categories of explosives, and assignment to these categories is based on the classification criteria provided. The GHS generally applies a tiered approach to evaluation of 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 which is used for classification. The approach is generally consistent with the current requirements of the 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) are 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 of severity of the hazard. Precautionary statements are also required on GHS labels. The GHS provides example precautionary statements, but they are not yet [[Page 50288]] considered formally harmonized. In other words, it would be possible for regulatory authorities to use different language for the precautionary statements. However, it appears likely that the language in the examples will become the harmonized text of the GHS on precautionary statements in the near future. The most recent revision to 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 reference to them 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 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 later. 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). Advantages of the Proposed Modifications to the Standard OSHA believes that the detailed and specific classification requirements of the GHS would result in better, more consistent information being provided to employers and employees. Classification under the revised criteria would not only indicate the type of hazard, but would generally give an indication of the degree of severity of the hazard as well. This information would be helpful to both employers and employees in understanding chemical hazards and identifying and implementing protective measures. The detailed criteria for classification are also expected to result in greater accuracy in hazard classification and more consistency among classifiers. By following the detailed criteria, classifiers are less likely to reach different interpretations of the same data. OSHA also believes that standardized presentation of information on labels and safety data sheets would improve the comprehensibility of chemical hazard information. Employers and employees would be given the same core information on a chemical regardless of the supplier. Use of standardized pictograms would complement and reinforce the information provided through signal words and hazard statements. Pictograms are also anticipated to improve communication for those who are not functionally literate, or who are not literate in the language used on the label. The standardized format for SDSs is expected to make the information easier for users to find, with the information employees and emergency responders need most appearing in the beginning of the document for easy identification and reference. Standardized requirements for labels and SDSs are also expected to increase the accuracy of chemical hazard information. With consistent presentation of information, the task of reviewing SDSs and labels to assure accuracy would be simplified. Individuals preparing and reviewing these documents should find it easier to identify any missing elements, and OSHA enforcement personnel should be able to more efficiently examine SDSs and labels when conducting inspections. Another advantage that will result from adopting a system that has harmonized hazard statements in it relates to the use of ``control banding,'' a guidance approach to recommending control measures for chemical exposures. The approach uses information that is readily available to small and medium-sized employers with chemicals in their workplaces to provide them with workplace-specific control recommendations. Basically, the system uses such information to estimate the degree of severity of the hazard and the amount of chemical present, and relates that to the degree of control needed. The control banding approach relies on harmonized hazard statements to allow the system to estimate the degree of severity of the hazard. Initially based on the European hazard classification system, it has now been converted to the GHS phrases. The use of control banding to provide guidance for chemical safety and health approaches in U.S. workplaces cannot be accomplished until harmonized hazard statements are readily available. Adoption of the GHS and its phrases would open up the possibility that control banding guidance can be used in the U.S. to help small and medium-sized employers select and implement appropriate control measures. For more information on control banding, please see http://www.cdc.gov/niosh/topics/ctrlbanding/. OSHA is proposing modifications to the HCS that are necessary for consistency with the GHS. The GHS does not include requirements for a written hazard communication program or for employee training. OSHA is not proposing any substantive changes to the requirements for a written hazard communication program. However, OSHA believes that additional training would be necessary to ensure that employees understand some elements of the new system. In particular, some training and familiarization would be needed for pictograms to be effective. The Agency is therefore proposing modified training requirements to address the new label elements and SDS format that would be required under the revised standard. The GHS leaves certain matters to the competent authority (i.e., the regulatory authority with jurisdiction over that sector) to determine. OSHA would maintain its current approaches in these situations. For example, the scope and application provisions in the HCS address the interface of the OSHA requirements with requirements of other agencies. These scope provisions would remain unchanged under the proposed rule. The proposed modifications to the HCS primarily affect manufacturers and importers of hazardous chemicals. Chemical manufacturers and importers would be required to re-evaluate chemicals according to the new criteria in order to ensure they are classified appropriately. For health hazards, this will necessitate placing the chemical in the appropriate hazard category as well as the hazard class. For physical hazards, however, the 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 for physical hazards for purposes of complying with DOT's transport requirements. This should minimize the additional work required for classification of physical hazards. Preparation and distribution of modified labels and safety data sheets by chemical manufacturers and importers would also be required. Those chemical manufacturers and importers already following the ANSI Z400.1 standard for safety data sheets should already have the appropriate format, and would only be required to make some small modifications to the content of the sheets to be in compliance. Compliance requirements for chemical users would be limited. Workplaces where chemicals are used would need to integrate the new [[Page 50289]] approach into their hazard communication program, assuring that employees understand the pictograms and other information provided on labels and SDSs. Employers who use chemicals, and exposed employees, would benefit from receiving labels and safety data sheets presented in a consistent format. The information should be easier to find and comprehend, allowing it to be used more effectively for the protection of employees. Changing the HCS to make it conform to the GHS will also make it necessary to modify a number of other OSHA standards. Modifications are proposed 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. A modification to the Process Safety Management standard (29 CFR 1910.119) is proposed to ensure that the scope of the standard is not changed by the proposed modifications to the HCS. In addition, modifications to most of OSHA's substance- specific health standards are proposed to ensure that requirements for signs and labels are consistent with the modified HCS. OSHA's preliminary determination to modify the HCS is based on its assessment of the potential to improve employee safety and health by adopting the GHS approach to hazard communication. However, GHS implementation is also expected to accomplish a number of other objectives, and produce additional benefits. By providing an internationally comprehensible system for hazard communication, the GHS is anticipated to enhance the protection of the environment and of human health in all sectors, not only the workplace. The GHS provides a framework for developing a hazard communication system for those countries without an existing system, thus protecting employees around the world and helping to ensure that the appropriate information is received with chemicals imported into American workplaces. Implementation of the GHS is also expected to reduce the need for testing and evaluation of chemicals, since classification would be based on existing data and would only need to be performed once for each substance. In addition, implementation of the GHS is expected to facilitate international trade in chemicals, as the need to identify and comply with diverse and complex hazard communication requirements in different countries would be reduced or eliminated. Alternative Approaches In this section OSHA presents several alternatives to the proposed GHS modification to the HCS to respond to concerns raised by commenters through the ANPR. OSHA provides the following discussion of these alternatives and their potential impacts and requests comments regarding their relative costs, benefits, feasibility, impact on small businesses, impact on worker safety and health, and any other issues on which commenters may wish to provide feedback. This rulemaking seeks to improve employee protections by adopting an internationally harmonized approach to hazard communication issues. While the current HCS provides protections for exposed workers by disseminating information about chemicals in their workplaces, OSHA believes, as discussed in Section V, that the adoption of GHS strengthens and refines the system, and gives OSHA the opportunity to improve worker safety by improving hazard communications. The GHS has the same general concept of an integrated, comprehensive process of identifying and communicating hazards, but provides more extensive criteria to define the hazards in a consistent manner, as well as standardizes label elements and SDS formats to help to ensure that the information is conveyed consistently. Additionally, the Agency believes that adoption of the GHS as proposed will simplify implementation insofar as OSHA's preferred alternative would clearly be considered ``harmonized'' with other regulatory authorities in the world, and thereby acquire the full benefits of harmonization. This is in line with the GHS, which anticipates that countries will adopt the hazard classification criteria and required label elements, as well as SDS requirements in workplaces. As stated in the introduction to the GHS (3rd revision): 1.1.3.1.3 In the workplace, it is expected that all of the GHS elements will be adopted, including labels that have the harmonized core information under the GHS, and safety data sheets. It is also anticipated that this will be supplemented by employee training to help ensure effective communication. As addressed in Section XV, many commenters supported the concept of OSHA moving forward to adopt the GHS (Document ID s 0003, 0007, 0047, 0050, 0052, 0062, 0106, 0011, 0033, 0038, 0123, 0130, 0151, 0163, and 0171). While others objected to adoption, OSHA has identified and responded to their concerns in Section XV as well. In addition, there were several commenters who noted that small chemical manufacturers that are not in international trade of chemicals would have a large burden associated with adopting the GHS, and questionable benefits due to their lack of international trade. (Document ID 0022). Others simply noted that they believed there would be high costs and limited benefits for such employers, or that it would be costly and difficult to adopt (Document ID #s 0015, 0026, 0178, and 0144). There was no discussion in any of these comments about potential alternatives. It should be noted that it appears that all of these commenters assumed the primary benefits of adopting the GHS would be in facilitating international trade. As has been addressed in Section VII, OSHA has based the benefits of this action on improved communication to workers and has provided initial estimates of a range of benefits that would be achieved in this area; trade benefits which, while recognized, have not been quantified. Therefore, grandfathering or other exemptions related to this rule might result in workers in those facilities receiving lower benefits of increased comprehensibility relative to workers in other types and sizes of workplaces; OSHA considers this a serious concern that could potentially exclude a group of workers exposed to hazardous chemicals from the increased benefits associated with clearer and more specific classification criteria, as well as standardized label elements. Alternatives: In order to respond to the concerns raised in these comments, OSHA solicits comment on several options: 1. The first option is designed to facilitate voluntary adoption of GHS within the existing HCS framework. Specifically, this approach would involve recognition and adoption of the GHS, with minimal changes to the current HCS. Under this approach, entities could opt to adopt GHS or continue to follow their current practice under HCS. Therefore, companies would decide whether they would continue complying with the existing standard, or comply with the GHS. This would reduce the costs for those companies that choose to remain in compliance with the existing HCS, and allow those companies that foresee the benefits of GHS compliance from a trade perspective to adopt its provisions. Another version of this option would be to exempt small chemical producers from complying. 2. A second option that OSHA is seeking to solicit comment on would [[Page 50290]] make modifications to the current HCS in order to improve hazard communication through adoption of components of the GHS. Under this option OSHA would add requirements for standardized hazard statements, signal words, and precautionary statements being added to the current HCS, but otherwise would follow the approach outlined in Alternative 1 above. Since the standardized labels are relatively inexpensive to implement, while reviewing classifications is more costly, this has the potential to reduce the overall cost of implementation of the revised rule. A variation on this alternative would entail incorporation of some, but not all, of the label elements. In particular, the Agency would not adopt the precautionary statements since these are not yet considered to be ``harmonized'' under the GHS--they are provided for guidance and reference, but competent authorities may choose to implement other statements. The precautionary statements could be adopted later when they are harmonized under the GHS. Or, alternatively, OSHA could either allow label preparers to use whatever precautionary statements they deem appropriate or develop its own set of statements to require. From OSHA's perspective, a key issue regarding the alternative approaches presented is that the classification criteria in the GHS are different from the hazard definitions in the current HCS. In general, as discussed in Section XV, they cover the same scope of hazard so these differences do not result in significant differences in the chemicals covered. But the GHS criteria divide most of the hazard classes into hazard categories that convey the severity of the effect, while few of the hazard classes in the current HCS take this approach. The standardized label elements are associated with these specific hazard categories, i.e., the harmonized pictograms, signal words, and hazard statements are assigned by hazard category and reflect the degree of hazard it presents to those exposed. Likewise, the precautionary statements assigned are also reflective of the degree of hazard, with responses related to these presumed hazard levels. Additionally, with regard to the first alternative, there will be chemicals that will be classified in different hazards classes under the GHS classification scheme versus the HCS hazard determination step. In addition, these chemicals will also be assigned to hazard categories under GHS where there are none now. This is particularly true for the classification of mixtures for all hazards, except the chronic health hazards, since the hazard determination scheme in the current HCS is based solely on concentration limits and the GHS classification scheme is based on bridging principles. Under the alternatives presented workers might be given different hazard information when exposed to a chemical purchased from two different suppliers. OSHA notes that this would be similar to the situation under the current performance- oriented HCS, but this approach may forego an opportunity to make the system more consistent. OSHA is interested in comments related to the alternatives addressing the extent to which differences in classification between the GHS and HCS might create confusion or otherwise result in problems. OSHA is further interested in comments addressing the classification of mixtures under the alternatives discussed, given the differences in classification under HCS and GHS applicable to mixtures. Given the current variability in MSDS and labels under the performance based HCS, OSHA believes that this approach might not have a negative impact on safety and health relative to our current HCS. However, the Agency anticipates that components of the GHS would confer benefits external to producers (e.g., the benefits associated with clearer and more specific classification criteria, as well as labels or other changes that could potentially make easier for users to locate and understand the information they are seeking), adoption of this alternative could result in foregone benefits. In addition, a small number of chemicals or mixtures might be labeled differently due to differing categorization results between the existing HCS and GHS. OSHA is generally seeking comment on the possible cost impacts associated with the alternatives on the chain of chemical suppliers. OSHA notes that large and small producers are not mutually exclusive so that a large business or distributers engaged in international trade cannot simply and straightforwardly choose to implement the GHS regardless of their suppliers. Small businesses sell to large businesses. If small businesses do not adopt the GHS, then the large businesses or the distributor would either have to generate GHS classifications for chemicals they buy from them 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 unknown to the original producer. Thus knowing whether or not a product will wind up in international trade may be questionable in some situations. A producer may provide a substance to another company, who then formulates it into a product that is sold internationally--thus the original producer is involved in international trade without necessarily realizing it. In theses cases, costs would be incurred for the conversion to GHS. This issue was raised in comments regarding the effective dates for the rule, when many suggested it was not appropriate to differentiate dates based on the size of the business. For example, ORC Worldwide, Inc. stated (Document ID 0123): OSHA should consider a company's place in the manufacturing supply chain, not size, in determining how the phase-in is implemented. It would be sensible to start with producers of raw materials and basic chemicals. The technical information, classification and categorization they perform will be useful downstream for the intermediate chemical producers and specialty chemical manufacturers. Lastly, the end user will benefit from the influx of information developed by the upstream professionals. OSHA solicits comment on whether a voluntary system, or a system based on business size, could be successfully implemented given the structure of the supply system. OSHA seeks comment on how companies that use chemicals, but don't produce them, would be affected under an alternative approach. Rather than potentially simplifying compliance and improving comprehensibility, the user of chemicals would continue to see variation in labels on purchased chemicals. This would be further complicated by the fact that the underlying criteria for these labels may be different as well, and thus the warnings would be too. If there is no requirement for such employers to be familiar with the new system, and train their employees, then there will be new pictograms and signal words with no structure for ensuring they are understood and the appropriate precautions are implemented. Regarding Alternative 2, under OSHA's proposed approach the label provisions are relatively cost-efficient to adopt given that the GHS assigns the various required elements by hazard class and category and once the classification or re-classification has been accomplished, the GHS provides the specific information for the label. OSHA solicits comment on whether requiring this standardized approach to labeling under the HCS, without the infrastructure of the GHS will be burdensome for the chemical [[Page 50291]] manufacturer to accomplish OSHA further solicits comment on whether confusion may result from labels that may look the same but which actually reflect different classification criteria. Under this approach, chemical producers will have to assess their current determinations and attempt to relate them to the established hazard classes and categories. Alternatively, OSHA could create a regulatory system assigning HCS categories to each GHS label elements; comments are welcomed on the impact on benefits and costs, and the feasibility of such an approach. OSHA believes it is unlikely that this component of Alternative 2 would provide significant savings over reviewing classifications for purposes of putting the chemicals into GHS classes and categories. OSHA is concerned that chemical producers following this approach might not be able to use their labels in other countries where the GHS has been adopted. OSHA is further concerned that adopting only some elements of the GHS label may be confusing and may fail to provide useful information regarding the possible hazardous effects of exposure. Delaying adoption of the precautionary statements may also reduce the effectiveness of the labels significantly, and reduce the appropriate information on the SDSs as well. A variation on this alternative--to simply require precautionary statements, but not to specify what they are, may generate significant variation due to the performance-oriented approach that allows the label preparer to determine what they are or if they are included. One communication advantage of providing the information in the same language from label- to-label is that workers and other users can be assured that the same action is required. If you take a simple preventive measure such as ``wash your hands,'' but convey it in several different ways, the reader of the label will think you mean something different. This is one of the advantages of providing the text for these statements in the revised HCS. In addition, since these precautionary statements will be translated, this should make it easier for those participating in international trade to produce and use labels. Thus, OSHA solicits comment on a range of alternative approaches to regulatory adoption of GHS and welcomes comments on these options. The costs and benefits are further addressed in Section VII. V. Need and Support for the Proposed 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 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 HCS was issued in 1983 (48 FR 53282-53284). 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. 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). 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; Leigh et al., 1997; Landrigan and Markowitz, 1989). The HCS currently serves to ensure that information concerning chemical hazards and associated protective measures is provided to employers and employees. However, OSHA's experience, along with information acquired since the HCS was issued, indicates that modifications to the standard may be appropriate. The Agency believes that the proposed changes, based on the GHS, will substantially improve the quality and consistency of the information provided to employers and employees. OSHA further believes the proposed revisions to the HCS will enhance workplace protections, because better information will enable employers and employees to take measures that would result in a reduction in 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 issue 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.'' 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. Prepared by researchers at the University of Maryland, the document entitled ``Hazard Communication: A Review of the Science Underpinning the Art of Communication for Health and Safety'' (Sattler et al., 1997) has also long been available to the public on OSHA's Hazard Communication web page. More recently, 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). [[Page 50292]] 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 related to comprehensibility testing (see GHS Annex 6, Comprehensibility Testing Methodology) (United Nations, 2009). 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. Also among the agreed principles that were established to guide development of the GHS was that the level of protection offered by an existing hazard communication system should not be reduced. 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 32 member nations as well as 17 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. A number of United States-based scientific and professional associations have endorsed adoption of the GHS. The American Chemical Society indicated its support for the GHS, stating: ``The American Chemical Society (ACS) 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). In comments submitted in response to the ANPR, 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). The American Society of Safety Engineers also indicated its support for the GHS rulemaking (Document ID 0139). 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'' (SOT, 2007). 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). The positions taken by these organizations point to wide support for the GHS among the scientific and professional communities. In addition to the endorsement of the GHS by a group of experts with extensive knowledge and experience in chemical hazard communication and support from scientific and professional associations with expertise in this area, a substantial body of evidence indicates that the proposed modifications to the HCS will better protect employees. Specifically, this evidence supports OSHA's belief that: (1) Standardized label elements--signal words, pictograms, hazard statements and precautionary statements--would be more effective in communicating hazard information; (2) standardized headings and a consistent order of information would improve the utility of SDSs; and (3) training would support and enhance the effectiveness of the new label and SDS requirements. This evidence was obtained from a number of sources. OSHA has commissioned several studies to examine the quality of information on SDSs (Karstadt, 1988; Kearney/Centaur 1991a, 1991b; Lexington Group, 1999); the General Accounting Office (GAO) has issued two reports based on its evaluation of certain aspects of the HCS (GAO 1991, 1992); 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); 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). An updated review was published in 2007 (ERG, 2007). In addition, OSHA conducted a review of the requirements of the HCS and published its findings in March of 2004 (OSHA, 2004). Key findings derived from these sources are discussed below. 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 that 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. [[Page 50293]] Labels Labels provide a brief, conspicuous hazard summary at the work site where a chemical is used. Labels serve as an immediate visual reminder of chemical hazards, and complement the information presented in training and on SDSs. The HCS currently 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. OSHA is proposing a requirement that labels include four new, standardized elements: a signal word; hazard statement(s); pictogram(s); and precautionary statement(s) (see Section XV for a detailed discussion of the proposed requirements). The appropriate label elements for a chemical would be determined by the hazard classification. OSHA believes that these standardized label elements would better convey critically important hazard warnings, and provide useful information regarding precautionary measures that would serve to better protect employees. A great deal of literature has been developed that examines the effectiveness of warnings on labels. However, some important limitations must be recognized in applying this information to workplace labels for hazardous chemical products. Most studies have examined labels for prescription and non-prescription medications, alcoholic beverages, or consumer products. Relatively few studies pertain specifically to labels for hazardous chemicals in the workplace. Much of the literature is also characterized by the use of research subjects such as college students or consumers. Such subjects may not be representative of workplace populations, as these subjects may differ from typical employees in terms of product knowledge, hazard perception, perceptual abilities, and safety motivation. In addition, some studies involve non-U.S. populations that may not be representative of the U.S. workforce. Nevertheless, the literature provides a substantial body of information applicable 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. Relevant finding from the literature are presented in the sections that follow. 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. The proposal prescribes 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 order of descending severity (ANSI, 2006). A number of recent 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 in 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). 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). 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). 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). 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 [[Page 50294]] term NOTICE (Griffith and Leonard, 1997). 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). 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). 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). 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). 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).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). 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). 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 have 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. 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 includes 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 that are required on a label would be determined based on the hazard classification of the substance in question. OSHA believes that the proposed pictograms would make warnings on labels more noticeable and easier for employees to understand. In particular, symbols are expected to improve comprehension among people with low literacy and those who are not literate in the English language. It should be remembered that pictograms would be used not only in conjunction with other label elements, but in the context of the hazard communication program as a whole. Training that includes an explanation of labels (included in the proposed rule) would ensure that pictograms are understood by employees. A considerable amount of evidence supports the belief that pictograms can serve as useful and effective communication tools. In reviewing this evidence, it should be noted that some sources offer distinct definitions for ``pictogram,'' ``pictorial,'' ``symbol,'' and other terms describing graphical elements. For example, Rogers et al. state that: ``Pictorials refer to pictures that represent the concept of interest (e.g., a picture of a fire extinguisher). Symbols are more abstract representations of a concept, the meaning of which must be learned (e.g., the use of a skull and crossbones to denote poison)'' (Rogers et al., 2000). ANSI and others combine these terms in the definition of ``symbol,'' however, and for the purposes of discussing the literature on this subject, these terms are used interchangeably. Symbols serve several important functions in warning labels. As Wogalter et al. explain, 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 [[Page 50295]] alphabet. Letters are highly familiar and are more similar to one another than most graphical symbols (Wogalter et al., 2006). Symbols also can bolster a text message and improve label comprehension among individuals with low literacy, and those who do not understand the language in which the label text is written (Parsons et al., 1999). Several researchers have sought to evaluate how people comprehend symbols, including those symbols that are incorporated in the proposed rule. Some studies have found that the skull and crossbones icon--one of the symbols included in the proposed rule--is among the most recognizable safety symbols. For example, Wogalter et al. asked 112 undergraduates and community volunteers to rank various label elements (Wogalter et al., 1998). 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). The skull was rated significantly higher than all other symbols. Some research has examined other pictograms included in the proposed 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 proposed rule (Akerboom and Trommelen, 1998). 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). The authors recommend that labels present the hazard phrase [statement] and symbol together, along with corresponding precautions, as would be required under the proposed rule. Banda and Sichilongo tested comprehension of labels that included the proposed pictograms among 364 workers in four sectors in Zambia (transport, agriculture, industrial, and household consumers) (Banda and Sichilongo, 2006). 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). ``Exploding bomb'' was correctly comprehended by 44 to 71 percent of each sector. 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 well comprehended symbol. These findings indicate that some of the pictograms included in the proposed rule are already widely recognized by a general audience. Others, however, are not commonly understood. Therefore, simply adding some of the proposed 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). These results emphasize the need to train employees on the meaning of the pictograms that would 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). 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). 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). 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). 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). 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). 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. As far as chemical labels are concerned, London found that symbols tend to be the most easily recalled label elements (London, 2003). 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. Overall, the author concludes that ``Symbols are therefore key to attracting attention, and informing risk perception regarding a chemical.'' [[Page 50296]] Wogalter et al. found less encouraging evidence on pictorials, however (Wogalter et al., 1993). 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). 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 recent 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). 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). 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). A group of 96 adults were less confused, more satisfied, 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, 1993). 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. In addition to the evidence pertaining to the other graphical elements in pictograms, research indicates that the use of the color red in pictograms will serve to make warnings more noticeable. Red is also generally perceived to reflect the greatest degree of hazard, and is thus well-suited to identifying serious chemical hazards in the workplace. In their review of the literature on warning effectiveness on behavioral compliance, Kalsher and Williams summarize several studies that examined the effects of adding color to warnings (Kalsher and Williams, 2006). Overall, Kalsher and Williams suggest that adding color can influence both the noticeability and effectiveness of warnings. In a test on the noticeability of warnings, Swindell measured the amount of time it took subjects to locate warning text that had been embedded in medication instructions (Swindell, 1999). Warnings were found significantly faster when the icon and signal word were presented in either red or blue, causing the warning to stand out from the black text. 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). While these studies involve color on label elements other than the pictogram border, they provide a general indication that color attracts the attention of label users. A number of researchers have investigated the hazard connotations of different colors. These investigations indicate that red is generally perceived to reflect the greatest degree of hazard. Yellow, orange, and black reflect a lesser degree of hazard. In a review of the literature, Parsons et al. suggest that the red-orange-yellow hierarchy generally matches people's perceptions of risk, including perceptions among native Spanish speakers (Parsons et al., 1999). Experimental results that support the conclusion that red generally connotes the highest degree of hazard include: [dec221] Smith-Jackson and Wogalter asked English-speaking community members to rate the perceived hazard of ten ANSI safety colors (Smith-Jackson and Wogalter, 2000). Red, yellow, black, and orange were rated the highest (in descending order). Differences were statistically significant except the difference between yellow and black. [dec221] 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). [dec221] Wogalter et al. asked Spanish speakers to rank the perceived hazard of ANSI safety colors (Wogalter et al., 1997b). Red was ranked highest, followed by orange, black, and yellow. [dec221] Dunlap et al. surveyed 1169 subjects across several different language groups including English, German, and Spanish speakers (Dunlap et al., 1986). 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. [dec221] Wogalter et al. asked undergraduates and community volunteers to rank various warning components (Wogalter et al., 1998). 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. [dec221] 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). [dec221] Banda and Sichilongo asked workers in Zambia to rate the perceived hazard of various colors used in chemical labels (Banda and Sichilongo, [[Page 50297]] 2006). Red was associated with the greatest hazard, followed by yellow. [dec221] Among a sample of 30 undergraduates who rated the perceived hazard of 105 signal word/color combinations, Braun et al. reported that red conveyed the highest level of perceived hazard followed by orange, black, green, and blue (Braun et al., 1994). These reports are consistent in indicating that red is commonly understood to be associated with a high level of hazard--the highest of any color. OSHA anticipates that by using the color red on labels for hazardous chemicals, labels will be more effective in communicating hazards to employees--both by drawing the attention of employees and indicating the presence of a hazard through non-verbal means. Hazard and Precautionary Statements Hazard statements describe the hazards associated with a chemical. Precautionary statements describe recommended measures that should be taken to protect against hazardous exposures, or improper storage or handling of a chemical. The HCS currently includes a performance- oriented requirement for ``appropriate hazard warnings'' on labels. The proposed rule would require specific hazard statements and precautionary statements on labels. The statements would be determined based on the hazard classification of the chemical. Standardized requirements for hazard and precautionary statements would provide a degree of consistency that is currently lacking among chemical labels. This lack of consistency makes it difficult in some instances for users to understand the nature and degree of hazard associated with a chemical, and to compare chemical hazards. For example, Beach relates experiences from the perspective of a doctor treating occupationally exposed patients (Beach, 2002). The author noted that different suppliers use different risk phrases for the same chemical, making it difficult for users to compare relative risks. ANSI standard Z129.1 was developed to provide a consistent approach to labeling of hazardous chemicals. This standard gives manufacturers and importers guidance on how to provide information on a label, including standardized phrases and other information that can improve the quality of labels. Because it is a voluntary standard, however, the ANSI approach has not been adopted by all chemical manufacturers and importers. As a result of the diverse formats and language used, consistent and understandable presentation of information has not been fully achieved. A preference for hazard statements was shown in EPA's Consumer Labeling Initiative (Abt Associates, 1999). This study asked consumers about their attitudes toward labels on household chemical products. Overall, consumers indicated that they like to have information that clearly connects consequences with actions, and they prefer to know why they are being instructed to take a particular precaution. A clear hazard statement can provide this information. In some cases, clear and concise precautionary information is necessary to enable employees to identify appropriate protective measures. For example, Frantz et al. examined the impact of flame and poison warning symbols prescribed in certain regulations by the Canadian government (Frantz et al., 1994). The results suggest that although the generic meanings of these two symbols are well understood, people may have difficulty inferring the specific safety precautions necessary for a particular product. Other reports have indicated that users prefer information that includes both an indication of the hazard and the recommended action (i.e., the precautionary statement). Braun et al. examined statements in product instructions for a pool treatment chemical and a polyvinyl chloride (PVC) adhesive, asking subjects to rate the injury risk posed by each product (Braun et al., 1995). The experimenters manipulated the instructions to include either recommended actions only, actions followed by consequences, consequences followed by actions, or a simple restatement of the product label. The authors found that actions paired with consequences led to significantly higher risk perception than a restatement of the label or actions alone. Although the preferred wording was longer than the alternatives, subjects did not feel that the instructions were too complex, suggesting that they appreciate having actions and consequences paired together. Freeman echoed these findings in a discussion on communicating health risks to fishermen and farmers, noting that to be useful, risk statements should be balanced with equally strong statements of ways to reduce or avoid the risk (Freeman, 2001). Explicit precautionary statements may make it more likely that employees will take appropriate precautions. Bowles et al. asked subjects to review product warnings, then either decide what actions they should take or evaluate whether someone else's actions were safe, based on the warning (Bowles et al., 2002). In general, situations that required the user to make inferences about a hazard--particularly when they had to come up with their own ideas for protective actions--led to decreased intent to comply. By providing clear precautionary instructions on the label, the proposed rule would eliminate the need for users to infer protective actions. Some evidence indicates that using key label elements together can improve warning performance, compared with labels that only contain a subset of these elements. This is the approach taken in the proposed rule, which would require the signal word, pictogram(s), hazard statement(s), and precautionary statement(s) together on the label. In one study, Meingast asked students to recall information from two variations of warning labels: enhanced warnings with color, signal icons, pictorials, and organized text (following the ANSI Z535.4 standard); and warnings with text only (Meingast, 2001). The authors reported that the enhanced warnings were more noticeable, led to significantly greater recall, and made people report a higher likelihood of compliance. Other findings agree that improving all label elements can improve warning performance. For example, Lehto tested information retrieval from three chemical label formats and found that subjects generally did best with an ``extensive'' format that included pictograms, paragraphs, and horizontal bars indicating the degree of hazard (Lehto, 1998). Subjects were able to answer more questions correctly when the label included a range of content--particularly information on first aid and spill procedures. Wogalter et al. reported similar results in a test of four different signs that discouraged people from using an elevator for short trips (Wogalter et al., 1997a). Three signs were text-only. The fourth sign had a signal word panel, icons, a pictorial, and more explicit wording indicating the desired behavior (i.e., ``use the stairs''). Subjects rated the enhanced sign as more understandable, and a field test found that it significantly increased compliance over the other options. The effectiveness of a combination of elements was also investigated in a study of warnings on alcoholic beverage containers (Laughery et al., 1993). Laughery et al. tested warnings to determine which elements influenced noticeability. The authors manipulated labels by adding a pictorial, adding an alert symbol with a signal word, making the text red, and/or adding a border around the warning. The warning was [[Page 50298]] located fastest when all four of these modifications were present, suggesting that the best designs include a combination of enhancements. These findings support the belief that the proposed label elements, in combination, would likely be more effective in communicating hazard information than the individual elements would be if presented alone. Although the warnings examined in these studies are different than those included in the proposed rule, they indicate that enhancements such as color and symbols can increase the effectiveness of a label, and that presenting hazard information and corresponding precautions together may improve understanding. OSHA therefore believes that this evidence substantiates its belief that the proposed labeling requirements will result in more effective transmittal of information to employees. Overall, the presentation of information on labels through standardized signal words, hazard statements, pictograms, and precautionary statements would provide clearer, more consistent, and more complete information to chemical users. Comments received in response to the ANPR support this view (e.g., Document ID s 0054, 0032, 0124, 0124, and 0158). For example, the Refractory Ceramic Fibers Coalition (Document ID 0030) pointed to the benefits of this approach, stating: Employers and employees would be given the same information on a chemical regardless of the supplier. This consistency should improve communication of the hazards. It may also improve communication for those who are not functionally literate, or who are not literate in the language written on the label. In addition, having the core information developed already, translated into multiple languages, and readily available to whomever wishes to access it, should eliminate the burden on manufacturers and users to develop and maintain their own such systems. Thus the specification approach should be beneficial both to the producers and the users of chemicals. Labels are intended to provide an immediate visual reminder of chemical hazards. Whereas labels currently may be presented in a variety of formats using inconsistent terminology and visual elements, labels prepared in accordance with the proposed requirements would be consistent. Standardized signal words and hazard statements would attract attention and communicate the degree of hazard. Pictograms would reinforce the message presented in text and enhance communication for low-literacy populations. Precautionary statements would provide useful instructions for protecting against chemical-source injuries and illnesses. Safety Data Sheets The HCS requires chemical manufacturers and importers to develop an SDS for each hazardous chemical they produce or import. SDSs serve as a source of detailed information on chemical hazards and protective measures. Each SDS must indicate the identity of the chemical used on the label; the chemical and common name(s) of hazardous ingredients; physical and chemical characteristics; physical and health hazards; the primary route(s) of entry; exposure limits; generally applicable precautions for safe handling and use; generally applicable control measures; emergency and first aid procedures; the date of preparation of the SDS; and the name, address and telephone number of the party preparing or distributing the SDS. The HCS does not require this information to be presented in any particular order or to follow a specific format. Since the HCS was adopted in 1983, access to chemical information has improved dramatically due to the availability of SDSs. While the effectiveness of SDSs is evident, there are concerns regarding the quality of information provided. In particular, concerns have been raised regarding the accuracy (i.e., the correctness and completeness of the information provided) and comprehensibility (i.e., the ability of users to understand the information presented) of information provided on SDSs. OSHA is proposing a requirement that the information on SDSs be presented using consistent headings in the sequence specified in the GHS (see Section XV for a detailed discussion of the proposed requirements). The Agency believes that a standardized order of information would improve the utility of SDSs by making it easier for users to locate and understand the information they are seeking. A standardized format would also be expected to improve the accuracy of the information presented on SDSs. A number of studies have demonstrated the benefits provided by SDSs. In May 1992, the General Accounting Office (GAO) issued a report presenting the findings of an examination of difficulties small employers were said to experience in complying with the HCS, as well as issues relating to the costs of compliance (GAO, 1992). The findings were based on the results of a national survey of construction, manufacturing, and personal services providers. A total of 1,120 responses were received from employers. One very important finding of the GAO survey was that almost 30% of employers reported that they had replaced a hazardous chemical with a less hazardous substitute because of information presented on an SDS. With regard to the HCS as a whole, GAO found that over 56% of employers reported ``great'' or ``very great'' improvement in the availability of hazard information in the workplace and in management's awareness of workplace hazards. Forty-five percent of those in compliance with the HCS considered the standard to have a positive effect on employees, compared with only 9% who viewed the effect as negative. The results indicate that when chemical hazard information is provided, the result is generally recognized as beneficial to employees. A number of other studies support this conclusion. For example, in a survey of 160 workers at a large national laboratory, more than 90 percent of respondents said that SDSs are satisfactory or very satisfactory in providing protective information and answering questions (Phillips et al., 1999). Conklin demonstrated the utility of SDSs among employees of a multinational petrochemical company (Conklin, 2003). Across three countries (the U.S., Canada, and the United Kingdom), 98 percent felt that the SDS is a satisfactory information source (the percentage was similar across all three countries). Seventy-two percent said they would request an SDS all or most of the time when introduced to a new chemical, although 46 percent of workers said that SDSs are too long. The author notes, however, that this sample did not include any workers with low literacy. A number of investigations have raised concerns that, in some cases, the information on SDSs is not comprehensible to employees. In 1991, OSHA commissioned a study that evaluated the comprehensibility of SDSs by a group of unionized employees in manufacturing industries located in the State of Maryland (Kearney/Centaur, 1991). The study assessed the ability of these employees to understand information regarding the route of entry of the substance, the type of health hazard present, appropriate protective measures, and sources of additional help. Each of the 91 participating workers was provided with and tested on four different SDSs. The workers answered the test questions based on information [[Page 50299]] supplied on each of the SDSs. It should be noted that the employees who volunteered for this study understood that it relied on reading comprehension. This created a selection bias, as employees with reading difficulties would not be likely to volunteer for the study. The results of the tests indicated that workers on average understood about two-thirds of the health and safety information on the SDSs. The best comprehension was associated with information providing straightforward procedures to follow (e.g., in furnishing first aid, dealing with a fire, or in using personal protective equipment) or descriptions of how a chemical substance can enter the body. Workers had greater difficulty understanding health information addressing different target organs, particularly when more technical language was used. Workers also reportedly had difficulty distinguishing acute from chronic effects based on information presented in the SDSs. A similar result was reported by Conklin in a study involving employees of a multinational petrochemical company (Conklin, 2003). After viewing information on an unfamiliar chemical in a variety of SDS formats, a questionnaire was administered to workers to gauge their comprehension of the material presented. The workers reportedly answered 65 percent of the questions correctly. A study that examined the comprehensibility of SDS to master printers was reported by the Printing Industries of America in 1990 (PIA, 1990). The subjects had an average of 13.9 years of formal education, or approximately two years beyond high school. In this study, 27 SDSs were selected and analyzed for reading levels using a software program, finding an average reading grade level of 14. The investigators found that employees with 15 years of education or more understood 66.2% of the information presented. Some of the difficulty workers experience in understanding information presented on SDSs may be due to the vocabulary used in the document. Information presented at a reading level that exceeds the capability of the user is unlikely to be well understood. An example of this situation was reported by Frazier et al. (Frazier et al., 2001). The authors evaluated a sample of SDSs from 30 manufacturers of toluene diisocyanate, a chemical known to cause asthma. Half of the SDSs indicated that asthma was a potential health effect. One SDS made no mention of any respiratory effects, while others used language (e.g., allergic respiratory sensitization) that the authors believed may not clearly communicate that asthma is a risk. However, the more technical language meets the requirements of the HCS. Other reports substantiate the belief that many SDS users have difficulty understanding the information on the documents. For example, in a study evaluating the comprehensibility of SDSs at a large research laboratory, 39 percent of the workers found SDSs ``difficult to understand'' (Phillips, 1997). The study also indicated that a third of the information provided on SDSs was not understood. These results were obtained from a study population of literate, trained workers who spoke English as their first language. Smith-Jackson and Wogalter corroborated this finding in a study involving 60 undergraduates and community volunteers (Smith-Jackson and Wogalter, 1998). The subjects were asked to sort SDS data into a logical order. After completing the task, subjects were asked for their opinions on the difficulty of the content. Overall, 43 percent found the information easy to understand, 42 percent said it was not easy, and the remaining 15 percent felt that only scientists, experts, or very experienced workers would be able to understand the information. These studies are consistent in reporting that workers have difficulty understanding a substantial portion of the information presented on SDSs. This finding can be explained at least in part by the fact that not all of the information on SDSs is intended for workers. SDSs are intended to provide detailed technical information on a hazardous chemical. While they serve as a reference source for exposed employees, SDSs are also meant for other audiences as well. SDSs provide information for the benefit of emergency responders, industrial hygienists, safety professionals, and health care providers. Much of this information may be of a technical nature and would not be readily understood by individuals who do not have training or experience in these areas. For example, language that may be readily understood by a population of firefighters may be poorly understood by chemical workers. In addition, Title III of the Superfund Amendments and Reauthorization Act (SARA, also known as the Emergency Response and Community Right-to-Know Act of 1986) mandated that SDSs be made available to State emergency response commissions, local emergency planning committees, and fire departments in order to assist in planning and response to emergencies, as well as to provide members of the general public with information about chemicals used in their communities. It is difficult, if not impossible, for a document to meet the informational needs of all of these audiences while being comprehensible to all as well. Product liability concerns also play a role in the comprehensibility of SDSs. Producers of chemicals may be subject to ``failure to warn'' lawsuits that can have significant financial implications. Attempts to protect themselves against lawsuits can affect the length and complexity of SDSs, as well as the way in which information is presented. In some cases the length and complexity of SDSs reportedly make it difficult to locate desired information on the documents. For example, in testimony before the U.S. Senate Subcommittee on Employment, Safety, and Training, one hospital safety director described a situation in which an employee was unable to find critical information on an SDS in an emergency situation: * * * two gallons of the chemical xylene spilled in the lab of my hospital. By the time an employee had noticed the spill, the ventilation had already sucked most of the vapors into the HVAC. This, in turn, became suspended in the ceiling tile over our radiology department. Twelve employees were sent to the emergency room. To make the matter worse, the lab employee was frantically searching through the MSDS binder in her area for the xylene MSDS. Once she found it, she had difficulty locating the spill response section. After notifying our engineering department, she began to clean up the spill with solid waste rags, known for spontaneous combustion, and placing the rags into a clear plastic bag for disposal. She did not know that xylene has a flash point of 75 degrees Fahrenheit. She then walked the bag down to our incinerator room and left it there, basically creating a live bomb. Twelve people were treated from this exposure. The lab employee was very upset and concerned about the safety of the affected employees and visitors, and hysterically kept stating that she could not find the necessary spill response information (Hanson, 2004). SDSs at this particular hospital were reported to range from one page to 65 pages in length. To accommodate the needs of the diverse groups who rely on SDSs, a standardized format has been viewed as a way to make the information on SDSs easier for users to find, and to segregate technical sections of the document from more basic elements. A standardized format was also thought to facilitate computerized information retrieval systems and to simplify employee training. OSHA established a voluntary format for SDSs in 1985 to assist manufacturers [[Page 50300]] and importers who desired some guidance in organizing SDS information. This 2-page form (OSHA Form 174) includes spaces for each of the items included in the SDS requirements of the standard, to be filled in with the appropriate information as determined by the manufacturer or importer. However, some members of the regulated community desired a more comprehensive, structured approach for developing clear, complete, and consistent SDSs. In order to develop this structure, the Chemical Manufacturers Association (now known as the American Chemistry Council) formed a committee to establish guidelines for the preparation of SDSs. This effort resulted in the development of American National Standards Institute (ANSI) standard Z400.1, a voluntary consensus standard for the preparation of SDSs. Employers, workers, health care professionals, emergency responders, and other SDS users participated in the development process. The standard established a 16-section format for presenting information as well as standardized headings for sections of the SDS. An updated version of the ANSI standard published in 2004 is consistent with the GHS format that is included in the proposed rule. By following the recommended format, the information of greatest concern to employees is featured at the beginning of the document, including information on ingredients and first aid measures. More technical information that addresses topics such as the physical and chemical properties of the material and toxicological data appears later in the document. The ANSI standard also includes guidance on the appearance and reading level of the text in order to provide a document that can be easily understood by readers. OSHA currently allows the ANSI format to be used as long as the SDS includes all of the information required by the HCS. Because it is a voluntary standard, however, the ANSI format has not been adopted by all chemical manufacturers and importers. As a result, different formats are still used on many SDSs. The International Organization for Standardization (ISO) has published its own standard for SDS preparation. This standard, ISO 11014-1, has been revised for consistency with the GHS (new version issued in 2009). The standard includes the same 16 sections as the GHS, as well as similar data requirements in each section. These two consensus standards, ANSI Z400.1-2004 and ISO 11014-1 (2009), have essentially the same provisions and are consistent with GHS. There are minor differences, such as units of measure recommended in the national ANSI standard versus the international ISO standard. Another development has been the creation of International Chemical Safety Cards (ICSCs). The documents, developed by the International Programme on Chemical Safety, summarize essential health and safety information on chemicals for use at the ``shop floor'' level by workers and employers (Niemeier, 1997). ICSCs are intended to present information in a concise and simple manner, and they follow a standardized format that is shorter (one double-sided page) and less complex than the ANSI approach. The ICSCs were field tested in their initial stages of development, and new ICSCs are verified and peer reviewed by internationally recognized experts (Niemeier, 1997). ICSCs have been developed in English for 1,646 chemicals, and are also available in 16 other languages. The ICSCs are being updated to be consistent with the GHS. A study by Phillips compared the effectiveness of different SDS formats as well as ICSCs among workers at a large national laboratory (Phillips, 1997). The employees represented a variety of trades, including painters, carpenters, truck drivers, and general laborers. Each worker was tested for knowledge regarding a hazardous chemical before and after viewing an SDS or ICSC. Three designs were tested: a 9-section OSHA form, the 16-section ANSI Z400.1 format (an earlier and slightly different version of the current ANSI Z400.1 format), and the 9-section ICSC. A subsequent paper described the final results of this study (Phillips, 1999). All three formats led to significant improvements in subjects' knowledge, and there was no statistically significant difference among the three formats in terms of total test score. However, there were a few significant differences in how well readers of each SDS format answered specific types of questions: The ICSC performed better than the OSHA form regarding chronic and immediate health effects. The other two formats performed better than the ANSI format on fire-related questions. The OSHA form performed better than the other two formats on spill response questions. The OSHA form was better than the ANSI format regarding carcinogenic potential. In a separate comparison, Conklin also found similarities in the overall performance of several standard SDS formats (Conklin, 2003). In this study, employees of a multinational petrochemical company were given one of three versions of an SDS for an unfamiliar chemical: a U.S. version (OSHA's required content within an ANSI Z400.1-1998 16- part structure); a Canadian version following the 9-part structure prescribed by Canada's Workplace Hazardous Materials Information System (WHMIS); and a version following the European Union's content and 16- part structure. SDSs were controlled for font, layout, and reading level. Overall, Conklin found no statistically significant difference in mean post-test scores using the three different formats, although there were significant differences on 5 out of 10 questions (no one format was consistently better). Because extensive searching can be a barrier to SDS use, researchers have examined whether there is a preferred order of information that more closely matches users' cognitive expectations. Smith-Jackson and Wogalter asked 60 undergraduates and community volunteers to arrange portions of six SDSs in the order they considered most usable (Smith-Jackson and Wogalter, 1998). The authors found a few consistent results: Information about health hazards, protective equipment, and fire and explosion data tended to be placed toward the beginning. Physical and reactivity data tended to be placed near the end. Spill or leak procedures were placed near the beginning or the middle, depending on the type of chemical. A majority of subjects reported that they had attempted to prioritize the hazard information that needed to be communicated. The participants' suggested order of information generally did not match either the original SDS order or the order listed in the HCS-- particularly the subjects' emphasis on health hazard information near the beginning. In the previously discussed 1991 study that evaluated the comprehensibility of SDSs by a group of 91 unionized workers in manufacturing industries in the State of Maryland, a subset of the group (18 workers) was also tested on an ICSC (Kearney/Centaur 1991). While the results indicated that workers on average understood about two-thirds of the health and safety information on SDSs, ICSCs provided better results. The average ICSC test score ranged from 6% to 23% higher than the average test score on the four SDSs evaluated. This finding was considered by the authors to suggest that an improved format for SDSs may [[Page 50301]] serve to increase user comprehension of the information presented. OSHA believes that a standardized format would improve the effectiveness of SDSs. The primary basis for this belief is very simple: A consistent format would make it easier for users to find information on an SDS. Headings for SDS sections would be standardized, so SDS users would know which section to consult for the information they desire. The sections would be presented in a consistent, logical sequence to further facilitate locating information of interest. Information commonly desired by exposed employees and of greatest interest to emergency responders (e.g., Hazards Identification; First Aid Measures) would be presented in the beginning of the document for easy reference. More technical information (e.g., Stability and Reactivity; Toxicological Information) would be presented later. By segregating more complex information on an SDS from the information that is generally easier to understand, the standardized format included in the proposed rule has the potential to address many of the concerns that have been raised regarding the comprehensibility of information on SDSs. The standardized order of information will allow SDS users who desire only basic information about a hazardous chemical to find that information without having to sift through a great deal of technical information that may have little meaning to them. In emergency situations, rapid access to information such as first-aid measures, fire-fighting measures, and accidental release measures can be critically important. A standardized format does not address all issues affecting SDS comprehensibility. Reading level and some design elements would continue to vary. In many respects, this is inevitable given the different target audiences that SDSs have, and the varying qualifications of those who prepare SDSs. Nevertheless, OSHA believes that the proposed revisions will result in a substantial improvement in the quality and ease of comprehension of information provided on SDSs. In addition to the issues regarding comprehensibility, a number of researchers have raised concerns that some SDSs may be incomplete or contain erroneous information. The magnitude of the problem is unclear, because only very limited numbers of SDSs have been evaluated in these studies and in some cases the investigations were performed so long ago that the results may not reflect current practices. Nevertheless, the evidence appears to indicate that a substantial number of SDSs may not contain complete and correct information. An initial examination of the accuracy of SDSs was commissioned by OSHA shortly after the scope of the rule was expanded to cover all industries in 1987 (Karstadt, 1988). The report, which analyzed the content of 196 SDSs for products used in auto repair and body shops, provided a general indication that the content and presentation of information was inconsistent on the SDSs examined. In 1991, OSHA commissioned an additional study that examined the accuracy of SDSs (Kearnet/Centaur, 1991). The study examined information presented in five areas considered crucial to the health of workers potentially exposed to hazardous substances. These five areas assessed were chemical identification of ingredients; reported health effects of ingredients; recommended first aid procedures; use of personal protective equipment; and exposure level regulations and guidelines. The evaluation indicated that 37% of the SDSs examined accurately identified health effects data, 76% provided complete and correct first aid procedures, 47% accurately identified proper personal protective equipment, and 47% correctly noted all relevant occupational exposure limits. Only 11% of the SDSs were accurate in all four information areas, but more (51%) were judged accurate, or considered to include both accurate and partially accurate information, than were judged inaccurate (10%). The study also concluded that the more recent SDSs examined (those prepared between 1988 and 1990) appeared to be more accurate than those prepared earlier. This belief that some SDSs are not complete and correct was corroborated by an examination of SDSs for lead and ethylene glycol ethers (Paul and Kurtz, 1994). Although these substances are known reproductive and developmental toxicants, researchers found that 421 of 678 SDSs examined (62%) made no mention of effects on the reproductive system. OSHA also commissioned a study, completed in 1999, focusing specifically on the accuracy of first aid information provided on SDSs (Lexington Group, 1999). A total of 56 SDSs for seven chemicals were examined. First aid information on the SDSs was compared with information from established references. The researchers reported that nearly all of the SDSs reviewed had at least minor inaccuracies. A standardized format does not directly address the concerns that have been raised regarding the accuracy of information present on SDSs. However, standardization would improve the accuracy of chemical hazard information indirectly. With consistent presentation of information, the task of reviewing SDSs and labels to assure accuracy would be simplified. Individuals preparing and reviewing these documents should find it easier to identify any missing elements, and compare information presented on an SDS to reference sources and other SDSs. OSHA enforcement personnel would be able to more efficiently examine SDSs when conducting inspections. The detailed entries proposed for the SDS are particularly noteworthy in this regard. The sub-headings would provide an organized and detailed list of pertinent information to be included under the headings on the SDS. For example, while the HCS currently requires physical and chemical characteristics of a hazardous chemical to be included on the SDS, the proposed rule would provide a list of 18 properties for Section 9 of the SDS. The party preparing the SDS would either include the relevant information for these entries, or indicate that the information is not available or not applicable. This approach would provide both a reminder to the party preparing the SDS regarding the information required, and a convenient means of reviewing the section to ensure that relevant information is included and is accurate. OSHA anticipates that the classification criteria included in the proposed rule would also improve the accuracy and precision of information on SDSs. The detailed criteria provided would direct evaluators to the appropriate classification for a chemical. For example, while directing the evaluator to use expert judgment in taking all existing hazard information into account, the criteria for serious eye damage/eye irritation is tied to specific results found in animal testing. In addition, assignment to hazard categories would lead to provision of detailed information that would be specific to the degree of hazard presented by the chemical. Classification of hazards would also play an important role in increasing the usefulness of SDSs under the proposed rule. By including the classification of the substance on the SDS, employers would be in a much better position to compare the hazards of different chemicals. Hazard categories generally give an indication of the severity of the hazard associated with a chemical. For example, all other things being equal, a chemical classified for skin corrosion/ [[Page 50302]] irritation in category 1 as a skin corrosive would be more hazardous than a chemical classified in category 2 as a skin irritant. If chemicals are classified into hazard categories, this information can be used to simplify the process of comparing chemicals. As noted previously, employers use SDSs as a means of comparing chemical hazards to select less hazardous alternatives. Thus it is reasonable to believe that the proposed rule would result in more effective use of the SDS as an instrument for identifying less hazardous substitutes for hazardous chemicals. Support for a standard SDS format has been expressed consistently by a variety of stakeholders for a long period of time. The development of an industry consensus standard for preparation of SDSs, ANSI Z400.1, in itself, shows a desire on the part of many parties for a consistent approach to SDSs. As noted previously, ANSI Z400.1 was updated in 2004 to include the same sections and sequence as the proposed rule. Responses to OSHA's Request for Information in the Federal Register of May 17, 1990 (55 FR 20580) indicated widespread support for a standard SDS format, with many specifically supporting the ANSI format. In its report of its evaluation of the HCS, the GAO included several recommendations. Among these was a recommendation that OSHA clearly specify the language and presentation of information on SDSs (GAO, 1991). In addition, the report of the National Advisory Committee for Occupational Safety and Health Review of Hazard Communication (September 12, 1996) indicated that during the public presentations and workgroup discussions, there was general agreement that a uniform format should be encouraged and most workgroup members agreed that OSHA should endorse use of the ANSI Z400.1 format (NACOSH, 1996). Comments received in response to the ANPR also indicate widespread support for a standard format for SDS (e.g., Document ID s 0054, 0064, 0030, 0124, and 0158). The American Foundry Society, for example, said that consistent SDSs make it easier for users to find information and compare products (Document ID 0158). The Jefferson County Local Emergency Planning Committee maintained that critical information can be missed by first responders due to the current lack of consistency in presentation of information on SDSs, stating: ``It is not overreaching for us to say that lives will be saved through harmonization'' (Document ID 0037). Based on the information in the record, OSHA thus believes not only that the proposed standardized SDS format would improve the quality of information provided on SDSs, but that stakeholders generally prefer a standardized format. Training Along with labels on containers and SDSs, employee training is one of three core components of a comprehensive hazard communication program. Training is needed to explain and reinforce the information presented on labels and SDSs, to ensure that employees understand the chemical hazards in their workplace and are aware of the protective measures to follow. The proposed rule includes a relatively minor revision to the HCS training requirements, intended to ensure that labels and SDSs are adequately explained to employees (see Section XV for a detailed discussion of the proposed requirements). In light of the evidence previously discussed relating to label and SDS comprehension, the importance of training should not be underestimated. Training is necessary to ensure that employees understand the standardized heading and sequence of information on SDSs. Likewise, employees must be able to understand the meaning of the proposed standardized label elements in order for them to be effective. In certain instances, label elements already appear to be fairly well understood. For example, ``Danger'' already appears to be generally recognized to represent a higher degree of hazard than ``Warning''. Other label elements, particularly some pictograms, are less well understood. This finding is not surprising given the limited amount of exposure that most of the population has had to these pictograms. A relatively high level of understanding is generally recommended for pictograms. For example, ANSI Z535.3, the American National Standard that addresses criteria for safety symbols, contains a test method for determining the effectiveness of a pictogram. The criterion for success is 85% correct responses, with no more than 5% critical confusion. (Critical confusion refers to when the message conveyed is the opposite of the intended message.) A score below 85% does not mean the pictogram should not be used, but rather that it should not be used without some additional element, such as written text. The International Standards Organization has similar criteria in ISO 9186, Procedures for the Development and Testing of Public Information Symbols. This standard recommends testing methodologies to evaluate symbols intended to be used internationally. It sets a somewhat lower level of acceptability (66%) than the ANSI standard. While initial understanding of some pictograms may not be satisfactory, research shows that training can improve comprehension. In one study, Wogalter et al. tested how well undergraduate subjects comprehended a set of 40 pharmaceutical and industrial safety pictorials before and after training (Wogalter et al., 1997c). Training led to a significant increase in pictorial comprehension. The improvement was greatest for the most complex symbols. Training was equally effective whether the subject was given a simple printed label (e.g., ``Danger, cancer-causing substance'') or a label with additional explanatory text. Lesch conducted a similar study, testing how well workers recognized a set of 31 chemical and physical safety symbols before and after training (Lesch, 2002; 2003). Training significantly improved comprehension, which remained higher up to 8 weeks later. As in the Wogalter et al. study described above, Lesch found little difference in performance whether training took the form of a written label assigned to each symbol, a label plus explanatory text, or an accident scenario. Training also improved response speed. In a survey of South African workers, London examined the impact of brief training on the meaning of symbols and hazard phrases (London, 2003). Here, the author found no statistical difference in comprehensibility of four familiar hazard symbols, but did find that training improved comprehension of one symbol (the proposed health hazard symbol), and it also reduced the overall incidence of critical confusion. This study also found that workers with previous workplace training were more likely to understand label text and some pictograms, and were better able to identify the active ingredient. A similar result was reported by Banda and Sichilongo in their evaluation of GHS labels in Zambia. The authors found that ``correct responses to label elements were not a result of social class and/or age but appeared to be influenced by extent of duration of exposure either through specialized training or acquaintance'' (Banda and Sichilongo, 2006). Recognizing that symbols are the items most often recalled from a label, London advised a strong emphasis on training for GHS symbols, particularly the ``flame over circle'' and ``flame'' symbols--which were reported to be easily confused--and symbols that may [[Page 50303]] generate critical confusion (London, 2003). These reports serve to reinforce OSHA's longstanding belief that labels, SDSs, and training are complementary parts of a comprehensive hazard communication program--each element reinforces the knowledge necessary for effective protection of employees. The need for training to ensure comprehension of hazard information is widely recognized. Annex A of ANSI Z535.2 (the American National Standard for Environmental and Facility Safety Signs), for example, recommends training on the meaning of standard safety symbols and signal words, and ANSI Z535.4 contains similar guidance. It is a longstanding Agency position that employees have the ``right to know'' and understand the hazards of chemicals they are exposed to in the workplace (FR 53:29826; FR 59:6126). This knowledge is needed in order to take the precautions necessary for safe handling and use, to recognize adverse health effects associated with chemical exposure, and to respond appropriately in emergency situations. Equally important in terms of employee protection is that employers have access to chemical hazard information as well. Chemical information is the foundation of workplace chemical safety programs-- without it, sound management of chemicals cannot occur. By ensuring that emergency responders, physicians, nurses, industrial hygienists, safety engineers and other professionals have the information they need to devise protections, the HCS serves to reduce the likelihood of chemical source illnesses and injuries. Selection of appropriate engineering controls, work practices, and personal protective equipment is predicated knowing the chemicals that are present, the form they are present in, and their hazardous properties. OSHA believes that the proposed requirements would improve the quality and consistency of the chemical hazard information provided to employers and employees. A combination of label elements--signal word, hazard statement(s), pictogram(s), and precautionary statement(s)--is expected to make label warnings more noticeable, easier to understand, and better communicate hazard and precautionary information. Standardized headings and a consistent order of information are anticipated to make it easier for users to find information on SDSs, improve their accuracy, and better enable users to compare the relative hazards of different substances. Along with effective training in the context of a comprehensive chemical hazard communication program, these revisions would serve to more adequately inform employees of chemical hazards, and lead to better protections in the workplace. OSHA's preliminary determination to modify the HCS is based on its assessment of the potential to improve employee safety and health. While enhancing protection of employees is the Agency's objective in this rulemaking, implementation of the GHS is also anticipated to provide other benefits. As indicated in Section IV, modification of the HCS is expected to promote a range of objectives. Many countries do not currently have regulatory requirements addressing chemical hazard communication. Those countries that do not have the resources to develop a regulatory system can use the GHS as a basis for establishing such requirements. Implementation in these countries will thus lead to dissemination of information about chemical hazards and protective measures to individuals who would not otherwise be afforded this benefit. Transmittal of information provides a basis for the sound management of chemicals, which is beneficial not only to the country where it is practiced, but to neighboring countries as well. For example, uncontrolled releases of hazardous chemicals are not confined by national borders. A coordinated and harmonized approach to developing and providing chemical hazard information is beneficial to all. The United Nations Institute for Training and Research (UNITAR) and the International Labor Organization (ILO) have initiated a program to support GHS implementation. The program provides assistance regarding development of national GHS implementation strategies, legislation, and other topics. UNITAR is supporting national GHS implementation and capacity building projects in Cambodia, Indonesia, Laos, Nigeria, Senegal, Slovenia, Thailand, the Gambia, and the Philippines, and has supported meetings, workshops, and regional activities as well. Over 80 countries have requested assistance from UNITAR/ILO, indicating widespread interest in GHS adoption throughout the world. Adoption of the GHS is also expected to reduce the amount of testing performed to identify hazardous properties of chemicals. The HCS does not currently require testing of chemicals, and will not require testing with adoption of the GHS. However, testing is often performed to determine how a chemical will be classified under the various systems currently in place. By harmonizing definitions of hazards, such testing would be minimized, saving unnecessary use of test animals and associated costs. Implementation of the GHS is expected to lessen the regulatory burden associated with classification of chemical hazards and labeling of hazardous chemicals. In the U.S., regulatory authorities with jurisdiction over the workplace, environment, consumer and transport sectors (i.e., OSHA, EPA, CPSC, and DOT) are not currently harmonized with regard to definitions of hazards and other requirements related to classification and labeling of chemicals. Widespread adoption of the GHS among the agencies would simplify the process of classifying chemicals and developing labels. For example, most chemicals are produced in a workplace and shipped elsewhere. As a result, manufacturers must comply with at least two sets of requirements that are currently not harmonized. Adoption of the GHS would simplify this process. Thus every chemical manufacturer would be likely to experience some benefits from harmonization, even if they are not involved in international trade. For those who are involved in international trade in hazardous chemicals, the expected benefits would be even greater. As discussed in Section III, different countries have established requirements for chemical hazard classification, labeling, and SDSs that vary with regard to the scope of chemicals covered, definitions of hazards, the specificity of requirements, and the use of symbols and pictograms. Tracking the requirements of different regulatory authorities and developing different labels and SDSs is a burden for all manufacturers, importers, distributors, and transporters. Chemical manufacturers that do not have the resources to identify and comply with the requirements of regulatory authorities in different countries are precluded from engaging in trade with those countries. Small businesses are particularly affected. Implementation of the GHS would alleviate this burden and simplify the provision of chemical hazard information in international commerce. VI. Pertinent Legal Authority The primary purpose of the Occupational Safety and Health Act (the ``OSH Act'' or ``Act'') (29 U.S.C. 651 et seq.) is to assure, so far as possible, safe and healthful working conditions for every American employee over the period of his or her working lifetime. One means prescribed by the Congress [[Page 50304]] to achieve this goal is the mandate given to, and the authority vested in, the Secretary of Labor to ``promulgate, modify, or revoke'' mandatory occupational safety and health standards. OSH Act Sec. 6(b), 29 U.S.C. 655(b). An occupational safety and health standard is defined under the Act as: [A] standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide a safe or healthful employment and places of employment. OSH Act Sec. 3(8), 29 U.S.C. 652(8). The Supreme Court has interpreted this provision as requiring OSHA to determine, before promulgating a permanent standard under section 6(b) of the Act, that the standard is reasonably necessary and appropriate to remedy a significant risk of material health impairment. Industrial Union Dep't v. American Petroleum Institute, 448 U.S. 607, 642 (1980) (``Benzene''). This ``significant risk'' determination constitutes a finding that, absent the change in practices mandated by the standard, the workplaces in question would be ``unsafe'' in the sense that employees would be threatened with a significant risk of harm. Id. OSHA's Hazard Communication Standard (``HCS'') is a health standard promulgated under the authority of sections 6(b)(5) and 6(b)(7) of the Act. Associated Builders & Contractors, Inc. v. Brock, 862 F.2d 63, 67- 68 (3d Cir. 1988); United Steelworkers of America v. Auchter, 763 F.2d 728, 738 (3d Cir. 1985); United Steelworkers of America v. Auchter, 819 F.2d 1263, 1267 (3d Cir. 1987). Authority for the HCS may also be found in section 8(c) and 8(g) of the Act. Section 8(c)(1) of the Act empowers the Secretary to require employers to make, keep, and preserve records regarding activities related to the Act and to make such records available to the Secretary. 29 U.S.C. 657(c)(1). Section 8(g)(2) of the Act empowers the Secretary to ``prescribe such rules and regulations as (she) may deem necessary to carry out (her) responsibilities under this Act * * *'' 29 U.S.C. 657(g)(2). Section 6(b)(5) provides that: The Secretary, in promulgating standards dealing with toxic materials, or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of standards, and experience gained under this and other health and safety laws. Whenever practicable, the standard promulgated shall be expressed in terms of objective criteria and of the performance desired. 29 U.S.C. 655(b)(5). Thus, once OSHA determines that a significant risk due to a health hazard is present and that such risk can be reduced or eliminated by a proposed standard, section 6(b)(5) requires it to issue the standard, based on the best available evidence, that ``most adequately assures'' employee protection, subject only to feasibility considerations. As the Supreme Court has explained, in passing section 6(b)(5), ``Congress * * * place[d] worker health above all other considerations save those making attainment of this benefit unachievable.'' American Textile Manufacturers Institute, Inc. v. Donovan, 452 U.S. 490, 509 (1981) (``Cotton Dust''). Where, however, OSHA is confronted with two feasible methods of reducing risk to the appropriate level, OSHA must chose the cheaper method. Id. at 513 n.32; International Union, UAW v. OSHA, 37 F.3d 665, 668 (D.C. Cir. 1994). In addition, section 6(b)(7) of the Act provides in part that: Any standard promulgated under this subsection shall prescribe the use of labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and appropriate medical treatment, and proper conditions and precautions of safe use or exposure. 29 U.S.C. 655(b)(7). Section 6(b)(7)'s labeling and employee warning requirements provide basic protections for employees in the absence of specific permissible exposure limits, particularly by providing employers and employees with information necessary to design work processes that protect employees against exposure to hazardous chemicals in the first instance. The Supreme Court has recognized such protective measures may be imposed in workplaces where chemical exposure levels are below that for which OSHA has found a significant risk. Benzene, 448 U.S. at 657-58 & n.66. In Benzene, the Court relied on Sec. 6(b)(7) to uphold the imposition of exposure and medical monitoring requirements at exposures to benzene below the permissible exposure limit. Id. These requirements serve as a ``backstop,'' the Court said, allowing OSHA to check the validity of its assumptions in developing the PEL and employers to remove workers before they suffered any permanent damage. Id. at 657-58. In making the determinations required by the Act, OSHA's conclusions must be ``supported by substantial evidence in the record considered as a whole.'' OSH Act Sec. 6(f), 29 U.S.C. 655(f). OSHA must use the ``best available evidence,'' which includes ``the latest scientific data in the field''; ``research, demonstrations, experiments, and such other information as may be appropriate''; and ``experience gained under this and other health and safety laws.'' OSH Act Sec. 6(b)(5), 29 U.S.C. 655(b)(5). The Supreme Court has held that OSHA is not required to support its finding of significant risk ``with anything approaching scientific certainty,'' and that the determination of whether a particular risk is `` `significant' will be based largely on policy considerations.'' Benzene, 448 U.S. at 655-56 & n.62. The OSH Act allows the Secretary to ``modify'' and ``revoke'' existing occupational safety or health standards. OSH Act Sec. 6(b), 29 U.S.C. 655(b). In passing the Act, Congress recognized that OSHA should revise and replace its standards as ``new knowledge and techniques are developed.'' S. Rep. 91-1282 at 6 (1970). The Supreme Court has observed that administrative agencies ``do not establish rules of conduct to last forever, and * * * must be given ample latitude to adapt their rules and policies to the demands of changing circumstances.'' Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Automobile Ins. Co., 463 U.S. 29, 42 (1983) (internal quotation marks and citations omitted). A. Significant Risk. Most OSHA health standards protect employees by imposing requirements when employees are exposed to a concentration of a hazardous substance that OSHA has found to create a significant risk of material health impairment. Thus, in making the significant risk determination in these cases, OSHA is concerned with measuring the exposure an employee may be expected to incur when dealing with these substances to determine the level at which a significant risk arises. OSHA took a different approach to its significant risk determinations in promulgating the HCS in 1983 and revising it in 1994. Rather than attempting to assess the exposure--and therefore the risk-- associated with the use of each hazardous chemical in each industry to determine if that chemical posed a significant risk in that industry, [[Page 50305]] OSHA took a more general approach. It relied on NIOSH data showing that about 25 million or about 25% of American employees were potentially exposed to one or more of 8,000 NIOSH-identified chemical hazards and that for the years 1977 and 1978, more than 174,000 illnesses were likely caused by exposure to hazardous chemicals. 48 FR 53282. It then noted the consensus evident in the record among labor, industry, health professionals, and government that an ``effective federal standard requiring employers to identify workplace hazards, communicate hazard information to employees, and train employees in recognizing and avoiding those hazards'' was necessary to protect employee health. 48 FR 53283. Thus, OSHA found that because inadequate communication about serious chemical hazards endangers workers and that the practices required by this standard are necessary or appropriate to the elimination or mitigation of these hazards, the Secretary is hereby able to make the threshold ``significant risk'' determination that is an essential attribute of all permanent standards. 48 FR 53321. The U.S. Court of Appeals for the Third Circuit has on several occasions upheld this determination of significant risk as sufficient to justify the HCS under OSH Act Sec. 6(b). See Associated Builders & Contractors, 862 F.2d at 67 (discussing the history of its review of the issue). A characteristic of hazard communication that OSHA confronted in adopting the HCS is that information about the hazards associated with a particular chemical, and the exposures associated with its use, are not uniformly distributed across industry. That is, chemical manufacturers and importers tend to have greater knowledge and scientific expertise with respect to the composition of the chemicals they make or import. See 48 FR 53306, 53322. Therefore, they are usually in the best position to assess the inherent hazards associated with them. Id. However, it is the downstream users and their employees who tend to have the best information about the means and methods of exposure, and are therefore usually in the best position to determine the risk arising from the use of the chemical in their workplaces. See 48 FR 53295-96, 53307; 59 FR 6132. OSHA's approach in promulgating the HCS reflects this reality. It places the duty to ascertain and disclose chemical hazards on manufacturers and importers, so that downstream users can use this information to avoid harmful exposures to chemical hazards. But because manufacturers and importers will often have less information about the particular exposures of downstream users, their hazard assessment and communication obligations are imposed only for all normal conditions of use of their chemicals and foreseeable emergencies associated with those chemicals. 29 CFR 1910.1200(b)(2). In previous rulemakings, OSHA rejected suggestions that these obligations should arise only where the downstream use creates a significant risk because it is difficult, if not impossible, for OSHA or manufacturers and importers to know where these risks might occur before the fact. 49 FR 53295-96; 59 FR 6132. Further, it is only by the provision of hazard information that downstream employers and employees can determine how to use the chemical so that exposure and risk may be minimized. Id. Thus, the HCS protects employees from significant risk by requiring communications about all chemicals that may present a hazard to employees, regardless of the exposure or risk levels any particular downstream user might actually experience. Durez Div. of Occidental Chemical Corp v. OSHA, 906 F.2d 1, 4 (D.C. Cir. 1990); General Carbon Co. v. OSHRC, 860 F.2d 479, 485 (D.C. Cir. 1988). For these reasons, hazard communication--as opposed to risk communication--``most adequately assures'' employee protection from the significant risk of material impairment of health arising from the use of hazardous chemicals in the workplace for purposes of OSHA's authority under section 6(b)(5) of the Act. In addition, HCS is authorized under section 6(b)(7), which requires OSHA to prescribe ``labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and proper conditions and precautions of safe use or exposure.'' As noted above, the Benzene case recognizes that the ``backstop'' provisions of section 6(b)(7) allow OSHA to impose information requirements even before the employee is exposed to the significant risk. In this way, the HCS assures that employers and employees have the information they need to avoid situations of exposure in the work place even before the employee is exposed to a hazardous chemical. The current proposal makes no conceptual or theoretical change in this approach. It still imposes the same general requirements: Hazard identification, labeling, safety data sheets, a written hazard communication program, and employee training. OSHA's determination that inadequate communication about hazardous chemicals constitutes a significant risk supports the incorporation of the GHS into the HCS, just as it supported the promulgation of the original HCS and its subsequent modifications. Further, the data discussed in parts V and VII of this preamble show that the significant risk continues to exist even under the current standard. OSHA estimates that over 40 million employees are potentially exposed to hazardous chemicals. BLS data show that in 2007, there were approximately 54,000 illnesses related to hazardous chemical exposure and 125 chemically-related fatalities. These new statistics probably represent only a small portion of the illnesses experienced by exposed employees because many illnesses are not reported as being related to workplace exposures, due to long latency periods, and other factors. For all the reasons detailed in Section V, the agency believes that adoption of the GHS will improve communication of the hazards associated with the use of chemicals, and reduce significant risk. B. Section 6(b)(7) Authority. With respect to labels and employee warnings, the last sentence of section 6(b)(7) provides that: The Secretary, in consultation with the Secretary of Health and Human Services, may by rule promulgated pursuant to section 553 of title 4, United States Code, make appropriate modifications in the foregoing requirements relating to the use of labels or other forms of warning, monitoring or measuring, and medical examinations as may be warranted by experience, information, or medical or technological developments acquired subsequent to the promulgation of the relevant standard. 29 U.S.C. 655(b)(7). OSHA has used the authority of section 6(b)(7) in the past to revise its standards. See, e.g., Standards Improvement Project--Phase II, 70 FR 1112 (January 5, 2005); Standards Improvement (Miscellaneous Changes) for General Industry and Construction Standards, 63 FR 33450, 33458 (June 18, 1998). For example, it used this authority to revise the inorganic arsenic and coke oven emissions standards to eliminate the requirement of sputum cytology testing and to reduce the required frequency of mandatory chest x-rays from semi-annual to annual. 63 FR 33458. OSHA justified these changes on the grounds that studies reported after the promulgation of the relevant standards showed that sputum-cytology did not improve employee survival rates and the survival rates for semi-annual x-rays were not higher than annual exams. 63 FR 33458-59. In addition, OSHA has [[Page 50306]] used its section 6(b)(7) authority to authorize new respirator fit protocols under its respiratory protection standard. 69 FR 46986 (August 4, 2004); see generally 29 CFR 1910.134 App. A, Pt. II. OSHA's proposal to revise the HCS fits well within the authority granted by the last sentence of Sec. 6(b)(7). Adoption of GHS provisions would constitute a ``modification[]'' of the HCS regarding ``the use of labels or other forms of employee warning.'' For the reasons summarized above and explained more fully elsewhere in this preamble, OSHA believes that the adoption of GHS to be ``appropriate'' based on ``experience, information, or medical or technological developments acquired subsequent to the promulgation of the relevant standard.'' The formulation of GHS may also be considered a ``technological development'' that has occurred since the promulgation of the original standard in 1983. GHS was negotiated and drafted through the involvement of labor, industry, and governmental agencies, and thus represents the collective experience and information on hazard communication gathered by the participants in these sectors over the last several decades. See Part III above and 71 FR 53618-19. Indeed, OSHA noted the possibility of a future internationally harmonized standard in the preamble accompanying the original rule. 48 FR 53287. The last sentence of section 6(b)(7) also requires consultation with the Secretary of Health and Human Services. OSHA briefed NIOSH on this proposal as a part of the October 2008 OSHA-NIOSH Issues Exchange meeting, which was attended by NIOSH's Acting Director, and NIOSH expressed its support. OSHA has also briefed NIOSH on the GHS in previous Issues Exchange meetings. In addition, NIOSH has actively supported the GHS during its development and has been involved in the development of control banding, international chemical safety cards, and employee training for the GHS. NIOSH has submitted a comment supporting OSHA's proposal, (Ex. 2-46-1), and reviewed a draft of both this NPRM and the ANPR before it was published. NIOSH has stated that it supports OSHA in its proposal to update the HCS and to address the changes in hazard criteria, to include all 16 physical hazard criteria, and to adopt the specific labeling requirements and the safety data sheet (SDS) order of information in the Globally Harmonized System of Classification and Labelling of Chemicals. (Document ID 0082) These consultations coupled with OSHA's on-going relationship with NIOSH are more than sufficient to satisfy the requirement. For all the reasons set forth above, revision of the HCS through adoption of the GHS as proposed by OSHA is authorized by section 6(b)(7) of the OSH Act, 29 U.S.C. 655(b)(7). C. Section 6(b)(5) Authority. OSHA also has authority to adopt the proposal under section 6(b)(5) of the Act, 29 U.S.C. Sec. 655(b)(5). As noted above, section 6(b) explicitly allows OSHA to ``modify'' standards, and adoption of the GHS is justified because it ``most adequately assures'' employee protection for purposes of section 6(b)(5) for the reasons detailed in part V of this preamble. Section 6(b)(5) also requires a finding that the proposed standard is feasible, which means ``capable of being done, executed or effected.'' Cotton Dust, 452 U.S. at 508-09. Feasibility has two aspects, economic and technological. United Steelworkers of America v. Marshall, 647 F.2d 1189, 1264 (D.C. Cir. 1981) (``Lead I''). A standard is technologically feasible if the protective measures it requires already exist, can be brought into existence with available technology, or can be created with technology that can reasonably be expected to be developed. See Lead I, 647 F.2d at 1272. A standard is economically feasible if industry can absorb or pass on the cost of compliance without threatening its longer term profitability or competitive structure. See Cotton Dust, 452 U.S. at 530 n.55; Lead I, 647 F.2d at 1265. In addressing feasibility in the 1994 HCS revisions, OSHA found that: The feasibility question raised by the HCS is not difficult to resolve. This standard does not relate to activities on the frontiers of scientific knowledge; the requirements are not the sorts of obligations that approach the limits of feasibility. Associated Builders & Contractors, 862 F.2d at 68. The record on which the original and expanded HCS's were based did not contain credible evidence that the HCS would be technologically or economically infeasible for any industrial sector, id., and there was substantial evidence of feasibility, 52 FR 31855-58. 59 FR 6133. OSHA has repeatedly found that the requirements of the HCS are technologically feasible. See 52 FR 31855-57; 59 FR 6133. While the GHS modifications to HCS impose more specific requirements for hazard classification, labeling, and safety data sheets, employers may use the same methods to meet these requirements as they are already utilizing to comply with the requirements of HCS. The most important resource employers will need to comply with the GHS modifications to HCS is technical expertise in hazard classification and the communication of those hazards. OSHA found that such expertise was already available in promulgating the initial HCS rule in 1983. 48 FR 53296-99. OSHA believes that the availability of professionals with this expertise has only increased in the intervening time. At least one professional organization provides training in hazard communication to professionals and businesses. (Document ID s 0021 and 0145.) Through OSHA's Alliance with the Society for Chemical Hazard Communication, training to small businesses in the requirements of hazard communication and information about the GHS modifications has been made available. See http://www.osha.gov/dcsp/ alliances/schc/schc.html. NIOSH is preparing a program for employers to use in training their employees in the new labeling scheme. (Document ID 0082.) OSHA received numerous comments in response to its September 12, 2006 ANPR discussing the professionals and tools (both manual and electronic) that employers have available to comply with current hazard communication requirements. (See, e.g., Document ID s 0042, 0046, 0050, 0053, 0072, 0077, 0015, 0024, 0026, 0036, 0038, 0107, 0108, 0116, 0123, 0128, 0141, 0144, 0145, 0154, 0155, and 0163.) The Agency has been engaged on several fronts to facilitate the transition from the current standard to the GHS modifications, if ultimately adopted. For instance, the United Nations Institute for Training and Research (UNITAR) is developing basic and more advanced training courses for the GHS, and OSHA has been involved with and committed resources to this effort. NIOSH's comment also discussed the development of the WHO/IPCS International Chemical Safety Cards, which includes the GHS pictograms and signal words. (Document ID 0082.) OSHA believes that adopting the GHS modifications as proposed poses no technological feasibility issues. Likewise, for the reasons more fully discussed in the Preliminary Regulatory Analysis, OSHA believes that there is nothing about the adoption of GHS that will pose economic feasibility issues. Again, OSHA has found that the implementation of HCS in the first instance would have no such effect. See 52 FR 31855-57; 59 FR 6133. Most commenters agreed that, once conversion to the new system is completed, compliance with the GHS-modified HCS will not be more expensive than compliance with the current HCS. (Document ID s 0046, 0047, 0080, 0103, 0104, 0105, 0179, [[Page 50307]] 0119, 0123, 0129, 0135, 0139, 0145, 0147, and 0163.) While industry will incur the cost of converting to the new system, OSHA does not believe that this cost is so substantial as to threaten long term profitability or the competitive structure of any industry. Finally, OSHA is not proposing to ``delegate[e] power to an international body'' through the adoption of the GHS or justifying this proposal as a means to reduce ``potential barriers to international trade,'' as suggested in the comments. (Document ID s 0065 and 0026). OSHA recognizes, however, that there are potential benefits to international trade by adopting the GHS, and these are discussed in section VII of this preamble, OSHA is proposing to comply with the OSH Act's mandate to assure as far as possible safe and healthful working conditions in this country by incorporating the GHS's improved hazard communications requirements into the HCS through the process authorized by section 6 of the OSH Act. Adoption of the GHS modifications into the HCS would not place any new obligations on OSHA to comply with the requirements of any foreign or international body. VII. Preliminary Economic Analysis and Initial Regulatory Flexibility Screening Analysis A. Introduction and Summary Introduction OSHA is required by the Occupational Safety and Health (OSH) Act of 1970 to ensure and demonstrate that standards promulgated under the Act are reasonably necessary and appropriate, as well as technologically and economically feasible. Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act also require OSHA to estimate the costs, assess the benefits, and analyze the impacts of certain rules that the Agency promulgates. Accordingly, OSHA has prepared this Preliminary Economic Analysis (PEA), including an Initial Regulatory Flexibility Screening Analysis (IRFSA), for the proposed modifications to the Hazard Communication Standard (HCS). The OSHA PEA is based largely on research conducted for this purpose by Policy, Planning, and Evaluation, Inc. (PP&E), as presented in their report, ``Data and Analysis in Support of an Economic Analysis of Proposed Changes to the OSHA Hazard Communication Standard,'' prepared under contract to OSHA. The PP&E report is available in the public docket for this rulemaking, OSHA-H022K-2006- 0062, through www.regulations.gov. Need for Regulation Employees in work environments covered by the HCS are exposed to a variety of significant hazards that can and do cause serious injury and death. The HCS serves to assure that both employers and employees are provided needed information about chemical hazards that was not provided by markets in the absence of such a standard. The HCS also facilitates interstate commerce by promoting consistency among Federal and individual State requirements. The proposed changes would create a uniformity standard for the presentation of risk information and, as such, would serve to improve the efficiency and effectiveness of the existing hazard communication system in the U.S., and to reduce unnecessary barriers to trade. Hazard communication is currently addressed by many different international, national, and State authorities. As described in Section V of the preamble, these existing requirements are not always consistent and often contain different definitions of hazards and varying provisions for what information is required on labels and safety data sheets. Complying with these different rules results in increased costs for employers with hazardous chemicals in their workplace and for chemical manufacturers, distributors, and transporters involved in international trade. In addition to these effects on businesses, the different existing requirements result in workplaces receiving chemicals with varying information, with potential adverse impacts on the safety and health of employees. The proposed revisions to the OSHA HCS would standardize the hazard communication requirements for products used in U.S. workplaces, and thus provide employees with uniform and consistent hazard communication information. Secondarily, because these proposed revisions would harmonize the U.S. system with international norms, they would facilitate international trade. Affected Industries The proposal would affect employers and employees in many different industries across the economy. Based on the PP&E report, OSHA estimates in Table VII-2 that the HCS covers over five million workplaces in which employees are potentially exposed to hazardous chemicals. For establishments with employees whose exposures to hazardous chemicals results from their use of the chemical products, the proposed revisions to the HCS would generally involve minor effects, such as familiarization with new warning labels. For establishments producing hazardous chemicals, which are generally part of the chemical manufacturing industry, the revisions to the standard would involve reclassifying chemicals in accordance with the new classification system and revising safety data sheets (SDSs) and labels associated with hazardous chemicals. OSHA has preliminarily judged that SDSs for imported chemicals would normally be produced in the country of origin, and thus would not represent expenses for importers. OSHA welcomes comment on this judgment. Benefits, Net Benefits, and Cost-Effectiveness There is ample evidence of the substantial risks of chemical exposure in the workplace. In 2007, according to the Bureau of Labor Statistics, employees suffered an estimated 55,400 illnesses attributable to chemical exposures (BLS, 2008), and some 17,340 chemical-source injuries and illnesses involved days away from work (BLS, 2009). However, as noted in the preamble to the HCS in 1983, BLS estimates probably only reflect a small percentage of occupational illnesses (48 FR 53284) because most occupational illnesses are not reported. The principal reasons are that they are not recognized as being related to workplace exposures and are subject to long latency periods between exposure and the manifestation of disease. The key study of the issue of the number of fatalities from chronic illnesses, not recorded in any way by BLS, is Leigh et al., 1997. That study found that in 1992, there were from 46,900 to 73,700 fatalities from chronic illnesses related to occupational exposures to chemicals. This critical category dwarfs all acute injuries and illnesses due to chemicals recorded by BLS.\1\ --------------------------------------------------------------------------- \1\ A more recent study prepared by the University of California Centers for Occupational and Environmental Health, and commissioned by the California Environmental Protection Agency, suggests that fatalities from chronic illnesses remain an important problem (University of California COEH, 2008, p. 18). That study estimated that, in 2004, more than 200,000 workers, in California alone, were diagnosed with serious chronic diseases (encompassing cancer, COPD, asthma, pneumoconiosis, chronic renal failure, and Parkinson's disease) attributable to chemical exposures in the workplace, and that an additional 4,400 workers in California died during that year from chemical exposures in the workplace. Underlying studies are to appear in forthcoming publications. --------------------------------------------------------------------------- Section V of the preamble describes some of the incidents that may have been related to the non-standardized approach to SDSs in the current HCS, [[Page 50308]] including xylene exposure at a hospital when an employee was unable to find critical information on an SDS in an emergency spill situation (Hanson, 2004). As a result, twelve employees required emergency room treatment. Another example is the explosion at a manufacturing plant in Corbin, KY, which resulted in the death of 7 workers and injuries to another 37 workers. A Federal investigation into the explosion concluded that the cause was the inability to effectively identify and respond to the inherent explosive hazards of phenolic resin and specifically referenced the MSDS for phenolic resin dust (U.S. Chemical Safety and Hazard Investigation Board, February 2005). Were the information on SDSs more uniformly formatted and comprehensible, as required under the proposed modifications to HCS, incidents such as those described above would be less likely to occur. In general, the proposed modifications to the HCS are expected to result in increased safety and health for the affected employees and to reduce the numbers of accidents, fatalities, injuries, and illnesses associated with exposures to hazardous chemicals. It is difficult to quantify precisely how many injuries, illnesses, and fatalities would be prevented due to the proposed revisions to the HCS. The benefits associated with the existing HCS may indirectly help provide a general sense of the potential magnitude of the benefits of the proposed revisions to the HCS. OSHA preliminarily estimates that if the proposed rule could capture one percent of the benefits estimated for the original 1983 and 1987 HCS rules, the proposed revisions would result in the prevention of 318 non-lost-workday injuries and illnesses, 203 lost-workday injuries and illnesses, 64 chronic illnesses, and 43 fatalities annually. The monetized value of the corresponding reduction in occupational risks among the affected employees is an estimated $266 million on an annualized basis. The harmonization of hazard classifications, safety data sheet formats, and warning labels for affected chemicals and products would also involve substantial savings to businesses. Fewer different SDSs would have to be produced for affected chemicals, and many SDSs would be able to be produced at lower cost due to harmonization and standardization. The benefits represented by these cost reductions would primarily affect businesses involved in chemical manufacturing. In addition, businesses that purchase or use hazardous chemicals can expect reductions in operating costs as a result of the promulgation and implementation of the proposed modifications. PP&E conducted extensive research on the processes that companies use to classify chemical hazards, to develop SDSs and labels, and to handle, store, and use hazardous chemicals. PP&E evaluated how these processes would be affected by the proposed revisions to the HCS and analyzed the potential savings that would be realized as a result of adopting these revisions. Based on PP&E's research, OSHA has concluded that the annual cost savings for these companies would be an estimated $585 million. As an additional benefit, the modification of the HCS by the inclusion of the globally harmonized system (GHS) of classification and labelling of chemicals would be expected to facilitate international trade, increasing competition, increasing export opportunities for U.S. businesses, reducing costs for imported products, and generally expanding the selection of chemicals and products available to U.S. businesses and consumers. As a result of both the direct savings resulting from harmonization and the increased competitiveness, prices for the affected chemicals and products, and the corresponding goods and services using them, would be lowered. The proposed revisions may also result in reductions in the costs associated with providing training for employees as required by the existing OSHA HCS. Finally, the proposed GHS modifications to the OSHA HCS would meet the international goals for adoption and implementation of the GHS that were supported by the U.S. government. Implementing GHS in U.S. Federal laws and policies through appropriate legislative and regulatory action was anticipated by the U.S. support of international mandates regarding the GHS in the Intergovernmental Forum on Chemical Safety, the World Summit on Sustainable Development, and the United Nations. It is also consistent with the established goals of the Strategic Approach to International Chemical Management that the U.S. helped to craft (see http://www.chem.unep.ch/saicm/). Table VII-1 provides a summary of the costs and benefits of the proposed modifications to the OSHA HCS, and it shows the net benefits of the modifications to the standard, which are estimated to be $754 million annually. Because compliance with the proposed standard would result in cost savings that exceed costs, OSHA has not provided estimates of costs per life saved or other metrics of cost- effectiveness. However, it should be noted that the estimated benefits exceed costs by a factor of eight. BILLING CODE 4510-26-P [[Page 50309]] [GRAPHIC] [TIFF OMITTED] TP30SE09.000 BILLING CODE 4510-26-C Compliance Costs The estimated compliance costs for the proposed revisions to the HCS represent the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance that [[Page 50310]] has already been achieved with regard to the new requirements; nor do they include costs necessary to achieve compliance with existing requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements. The costs associated with compliance with the proposed revisions to the HCS would generally be incurred by the affected industries as one- time transition costs over the phase-in period of three years. Aside from the transition costs, the ongoing annual compliance costs associated with the proposed revisions to the HCS generally are expected to be the same or lower than under the existing standard. The compliance costs are expressed as an annualized cost for purposes of assessing the cost-effectiveness of the proposed revisions, in order to be able to compare the economic impact of the rulemaking with other regulatory actions, and to be able to add and track Federal regulatory compliance costs and economic impacts in a consistent manner. Annualized costs also represent a better measure for assessing the longer-term potential impacts of the rulemaking. The annualized cost was calculated by annualizing the one-time costs over a period of 20 years and applying a discount rate of 7 percent, as recommended by the Office of Management and Budget. The total annualized cost of compliance with the proposed standard is estimated to be about $97 million. The major cost elements associated with the revisions to the standard 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 ($11 million); training for employees to become familiar with new warning symbols and the revised safety data sheet format ($44 million); and management familiarization and other management-related costs as may be necessary ($42 million). Economic Impacts To assess the nature and magnitude of the economic impacts associated with compliance with the proposed rule, OSHA developed quantitative estimates of the potential economic impact of the new requirements on entities in each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide an assessment of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts. Only the compliance costs were considered for purposes of assessing the potential economic impacts and economic feasibility of the proposed revisions. As described in section D of this PEA, the overall economic impacts associated with this rulemaking are expected to result in significant net benefits to employers, employees, and the economy generally. As described in greater detail in section G of this PEA, the costs of compliance with the proposed rulemaking are not large in relation to the corresponding annual financial flows associated with each of the affected industry sectors. The estimated costs of compliance represent about 0.0004 percent of revenues and about 0.007 percent of profits, on average, across all entities; compliance costs do not represent more than 0.02 percent of revenues or more than 0.3 percent of profits in any individual affected industry sector. The economic impact of achieving compliance with the proposal, without considering the associated benefits, is most likely to consist of an extremely small increase in prices of about 0.0004 percent, on average, for affected hazardous chemicals. It is highly unlikely that a price increase of this magnitude would significantly alter the types or amounts of goods and services demanded by the public or any other affected customers or intermediaries. If the compliance costs of the proposal can be substantially recouped with a minimal increase in prices, there may be little or no effect on profits. In general, for most establishments, it would be very unlikely that none of the compliance costs could be passed along in the form of increased prices. In the event that a price increase of 0.0004 percent were not possible, profits in the affected industries would be reduced by an average of about 0.007 percent. Given the minimal potential impact on prices or profits in the affected industries, OSHA has preliminarily concluded that compliance with the requirements of the proposed rulemaking would be economically feasible in every affected industry sector. In addition, based on an analysis of the costs and economic impacts associated with this rulemaking, OSHA preliminarily concludes that the effect of the proposed standard on employment, wages, and economic growth for the United States would be negligible. The effect on international trade is likely to be beneficial and similar to the effect of a small reduction in non-tariff trade barriers. Initial Regulatory Flexibility Screening Analysis OSHA has analyzed the potential impact of the proposed rule on small entities, and has prepared an Initial Regulatory Flexibility Screening Analysis (IRFSA) in conjunction with this rulemaking to describe the potential effects on small entities. The IRFSA is included as a part of this PEA in section H. As a result of the analysis of the potential impact on small entities, OSHA concludes and certifies that the rulemaking would not have a significant impact on a substantial number of small entities. Therefore, an Initial Regulatory Flexibility Analysis (IRFA) is not required for this rulemaking. Nevertheless, OSHA has voluntarily provided the elements of the IRFA as part of the IRFSA presented in Section H. In proceeding with this rulemaking, OSHA will fulfill its requirements under the Regulatory Flexibility Act and under the Small Business Regulatory Enforcement Fairness Act, as applicable, to ensure that no unnecessary burdens are imposed on small businesses. The remainder of this PEA includes the following sections: B. Need for Regulation; C. Profile of Affected Industries; D. Benefits, Net Benefits, and Cost-Effectiveness; E. Technological Feasibility; F. Costs of Compliance; G. Economic Feasibility and Impacts; H. Initial Regulatory Flexibility Screening Analysis; I. Environmental Impacts; J. Unfunded Mandates Reform Act Analysis; K. Sensitivity Analysis. B. Market Failure and the Need for Regulation Employees in work environments addressed by the HCS are exposed to a variety of significant hazards associated with chemicals used in the workplace that can and do cause serious injury and death. OSHA's HCS was designed to assure that employers and employees are provided the information they need about the chemical hazards in chemical products both to make informed purchases and to provide for safe use. In the existing HCS, OSHA developed a set of requirements for chemical products, to include mandatory classification, labeling, and detailed information provision (in safety data sheets). OSHA believes that the improvements in the proposed rule would make the hazard communication system more worker-protective and more efficient and effective. In addition, the improvements would have the effect of harmonizing [[Page 50311]] hazard communication to facilitate international trade--replacing a plethora of national rules with a single international system. The proposed standard, through conformance with GHS (as explained in Section IV of the preamble), contains a number of changes to improve the performance of the U.S. hazard communication system: Revised criteria for more consistent classification of chemical hazards; Standardized signal words, pictograms, hazard statements, and precautionary statements on labels; and A standardized format for SDSs. In short, GHS is a ``uniformity standard'' for the presentation of hazard information (Hemenway, 1975, p. 8). And much like other uniformity standards, such as driving on the right side of the road (in the U.S.), screw threads for fire hose connectors, ``handshake'' protocols for communication between computers, and, for that matter, language, GHS would provide significant efficiencies and economies.\2\ In the case of GHS, manufacturers would be able to produce SDSs at lower cost, and users of SDSs would be able to more fully and quickly utilize the information contained in the SDSs, thereby reducing costs and, more importantly, better protect workers against chemical hazards.\3\ --------------------------------------------------------------------------- \2\ In contrast to a uniformity standard, a specification standard, such as an engineering standard, would spell out, in detail, the equipment or technology that must be used to achieve compliance. The usual rationale for a specification standard is that compliance would be difficult to verify under a performance standard; hence, only a specification standard would guarantee that employees are protected against the risk in question. Note that an engineering standard would generally not provide efficiencies or economies to the regulated community. On the contrary, an engineering standard would impose additional costs on some firms, in that they could effectively protect workers using an alternative approach, if it were permitted. It is also worth noting that, for uniformity standards with technological implications, the benefits of reduced information costs, economies of uniformity, and facilitation of exchange may need to be weighed against possible losses of flexibility, experimentation, and innovation. However, because GHS is limited to the presentation of hazard information and does not involve technological or strategic considerations, the possible costs of uniformity here would be non-existent or minuscule. \3\ On the ability of individuals to more fully and effectively utilize knowledge when uniformity requirements are present, see Hemenway, 1975, pp. 34-35. --------------------------------------------------------------------------- Since publication of the existing HCS, there has been some movement by industry toward standardization, consistent with the proposed revisions. However, OSHA does not believe that full and comprehensive standardization, as required under the proposed revisions, or that the goal of harmonizing the U.S. system with the international one could be achieved voluntarily in the absence of regulation. First, in a basic sense, GHS cannot simply be implemented by the market. Some aspects of GHS, such as the reorganization of SDSs, would be allowed under the existing OSHA standard, but other aspects, such as the classifications system, would not be. Use of differing classification criteria would lead to label warnings that are not consistent with current HCS requirements in some situations. Thus, at a minimum, OSHA would need to modify HCS to allow the use of GHS in the U.S. OSHA cannot simply provide a compliance interpretation that labels and safety data sheets prepared in accordance with the GHS meet the HCS requirements because the requirements of a standard cannot be changed through a compliance interpretation. While there is considerable overlap between the HCS and the GHS in terms of coverage, there are differences in the criteria used to classify both substances and mixtures that will result in different hazards being covered in some situations. This is particularly true in the area of acute toxicity, where OSHA is covering more substances under the modified rule than the current HCS, but potentially fewer mixtures.\4\ --------------------------------------------------------------------------- \4\ The coverage of fewer mixtures is due to the bridging principles and formula being applied to their classification, rather than being based strictly on a 1 percent cut-off. --------------------------------------------------------------------------- Second, it is important to understand that while the costs of creating SDSs and labels under GHS are borne directly by the chemical producers, the bulk of the benefits of adopting GHS accrue to the users. The set of all users includes employers who are direct customers of a chemical manufacturer, employees who use or are exposed to workplace chemicals, and emergency responders, who typically have no market relationship with the producers of the chemical. Even if one thought that market forces might assure the socially optimal approach to SDSs between manufacturers of chemicals and their customers, there are limited market forces at work between the chemical manufacturer and these two other sets of users--the employees and the emergency response community. Therefore, the presence of positive GHS externalities would prevent the private market, without regulation, from achieving the socially optimal adoption of GHS. OSHA does anticipate that there will be some increased market pressure to comply with GHS that will affect some firms that may think that they have no need to switch to the GHS system because they do not ship their products internationally. Many small firms do not realize the extent to which they are involved in international trade. There are probably few companies who have products that are never involved in international trade, or who never import chemical products and need hazard communication information for them. Many chemical producers ship their products to distributors and are unaware of where their products are ultimately used. OSHA can envision a likely scenario in which these distributors provide pressure to their suppliers to become GHS- compliant. Further, small companies sell products to larger companies. The larger companies may use those products to prepare goods that are exported. These larger companies might also be expected to pressure their small firm suppliers to be GHS-compliant. Nevertheless, such an approach would surely involve a long transition period, with attendant losses in worker protection and production efficiencies, and it is doubtful that market pressure alone would achieve full compliance. The changes made by GHS will involve costs for all parties. Producers of chemicals will incur substantial costs but will also achieve benefits--in part because they themselves benefit as both producers and users, and in part, as a result of foreign trade benefits that OSHA has not quantified. Some producers will not see these types of trade benefits if they do not engage in exporting chemicals. However, many small companies are currently prevented from engaging in international trade because of the substantial burdens of complying with many different countries' requirements. International harmonization of hazard communication requirements would enable these small companies to become involved in international trade if they so desire. Of more significance to the concerns of the OSH Act, the changes also provide substantial benefits to users, including: Fewer illnesses, injuries, fatalities, and accidents due to a more consistent, comprehensible, and clearer system that does not require English literacy to obtain some minimal hazard information; Greater ease of use of SDSs; and Reduced training requirements for workers due to a clearer and more uniform system. Because many of these benefits require uniformity, and the benefits are dispersed throughout a network of producers and users, only some of [[Page 50312]] which have direct market relationships with each other, OSHA believes that only a single, uniform standard can achieve the full net benefits available to a hazard communications system. C. Profile of Affected Industries The proposed revisions to the HCS would affect establishments in a variety of different industries in which employees are exposed to hazardous chemicals or in which hazardous chemicals are produced. Every workplace in OSHA's jurisdiction in which employees are exposed to hazardous chemicals is covered by the HCS and is required to have a hazard communication program. The proposed revisions to the HCS are not anticipated to either increase or decrease the scope of affected industries or establishments. The proposed revisions define and revise specific classifications and categories of hazards, but the scope of the requirements under which a chemical, substance, or mixture becomes subject to the requirements of the standard are not substantially different from the current HCS. Therefore, the proposed revisions should have little or no effect on whether an entire establishment falls within the scope of the standard. OSHA requests comments from the public regarding this preliminary determination. For establishments with employees exposed to hazardous chemicals, the proposed revisions to the HCS would generally involve management becoming familiar with and employees receiving training on the new warning labels and the new format of the SDSs. For establishments producing or importing hazardous chemicals, generally as part of the chemical manufacturing industry, the revisions to the standard would involve reclassifying chemicals in accordance with the new classification system and revising safety data sheets and labels associated with hazardous chemicals. OSHA's estimates of the number of employees covered by the standard are based on the preliminary determination that all production employees in manufacturing would be covered, and that, in addition, employees in other industries working in any of the occupations specified in the PP&E report would also be exposed to hazardous chemicals. Table VII-2 provides an overview of the industries and estimated numbers of employees potentially affected by the HCS. OSHA welcomes additional information and data that may help improve the accuracy of these estimates. The industries and establishments affected by the proposed revisions can be divided into two categories. The first category contains establishments that are required to produce labels and SDSs; the second category contains establishments that do not produce labels or SDSs but are required to provide employee access to labels and SDSs, supplied by others, for the chemicals to which their employees may be exposed in the workplace. As noted, OSHA has preliminarily judged that SDSs for imported chemicals would normally be produced in the country of origin, and thus would not represent expenses for importers or other US firms. As shown in Table VII-2, approximately 75,000 firms, in over 90,000 establishments, create hazardous chemicals (i.e., products, substances, or mixtures) for which a label and an SDS are required in accordance with the OSHA HCS. Approximately 880,000 SDSs and corresponding container labels would be potentially affected by the proposed revisions to the HCS. OSHA estimates that the adoption of GHS through this proposal would not significantly change the numbers of labels and SDSs produced. OSHA welcomes comment on this issue. In many instances, firms may be already producing several different versions of SDSs and labels for the same product to satisfy different regulatory requirements in different jurisdictions, including SDSs and labels consistent with GHS criteria. For these products, the proposed revisions to the OSHA HCS would be satisfied relatively easily and may result in a reduction in overall compliance costs by reducing the number of different labels and SDSs needed for each affected product. BILLING CODE 4510-26-P [[Page 50313]] [GRAPHIC] [TIFF OMITTED] TP30SE09.001 [[Page 50314]] [GRAPHIC] [TIFF OMITTED] TP30SE09.002 [[Page 50315]] [GRAPHIC] [TIFF OMITTED] TP30SE09.003 [[Page 50316]] [GRAPHIC] [TIFF OMITTED] TP30SE09.004 [[Page 50317]] [GRAPHIC] [TIFF OMITTED] TP30SE09.005 [[Page 50318]] [GRAPHIC] [TIFF OMITTED] TP30SE09.006 [[Page 50319]] [GRAPHIC] [TIFF OMITTED] TP30SE09.007 [[Page 50320]] [GRAPHIC] [TIFF OMITTED] TP30SE09.008 BILLING CODE 4510-26-C OSHA requests comments from the public regarding these preliminary conclusions and requests information on the number and type of labels and [[Page 50321]] SDSs that would be affected or produced as a result of this proposal. The second category of industries and establishments affected by the proposed revisions contains those that do not produce SDSs but are required to provide their employees with access to SDSs supplied by others as part of a hazard communication program covering chemicals to which employees may be exposed in the workplace. The effects on these establishments would generally involve promoting employee awareness of and management familiarization with the revisions to SDSs and labels. As shown in Table VII-2, an estimated 38 million employees are potentially exposed to hazardous chemicals in these workplaces and are covered by the OSHA HCS. Including employees working in establishments that produce SDSs, a total of 41 million employees would potentially need to become familiar with the proposed revisions to SDSs and labels. As also shown in Table VII-2, OSHA estimates that there are over five million workplaces where employees may be potentially exposed to hazardous chemicals. OSHA requests comments and information from the public regarding these estimates. D. Benefits, Net Benefits, and Cost-Effectiveness OSHA estimates that the promulgation of the proposed revisions would result in substantial benefits from a variety of sources. OSHA's estimates of the benefits include improvements in occupational safety and health and a corresponding reduction in the annual number of injuries, illnesses, and fatalities sustained by employees from exposure to hazardous chemicals; reductions in costs for producers of hazardous chemicals; increased efficiencies in the handling and use of hazardous chemicals; and other benefits as described in this section. OSHA requests comments and information from the public regarding the nature and extent of any benefits that may be associated with the proposed revisions. OSHA expects the proposed revisions to the HCS would result in an increased degree of safety and health for the affected employees and to reduce the number of accidents, fatalities, injuries, and illnesses associated with exposure to hazardous chemicals. As explained in detail in Section V of the preamble, the design of GHS was based on years of extensive research that demonstrated the effectiveness of pictograms, specific signal words, and a standardized format. As a result of this research, OSHA is confident that the GHS revisions to the HCS standard for labeling and safety data sheets would enable employees exposed to workplace chemicals to more quickly obtain and more easily understand information about the hazards associated with those chemicals. Warning labels on products covered by the standard, which provide an immediate visual reminder of the chemical hazards involved, would be made more intuitive, self-explanatory, and logical, and the nature and extent of any associated hazards would be more readily understood as a result of the training required under the proposal. Relatedly, the revisions are expected to improve the use of appropriate exposure controls and work practices that can reduce the safety and health risks associated with exposure to hazardous chemicals. In addition, the standardized format of the safety data sheets would enable critical information to be accessed more easily and quickly during emergencies. This can reduce the risk of injury, illness, and death to exposed employees and to rescue personnel and can reduce property damage. It is difficult to quantify precisely how many injuries, illnesses, and fatalities would be prevented due to the proposed revisions to the HCS. The benefits associated with the existing HCS may help provide a general sense of the potential magnitude of the benefits of the proposed revisions to the HCS. A discussion and analysis of the benefits that would result from the implementation of the existing OSHA HCS were included as part of the rulemaking process for the promulgation of the existing standard in the 1980s. The existing HCS was originally promulgated in two parts. First, a final rule covering the manufacturing industry was published in the Federal Register in 1983 (48 FR 53280, November 25, 1983); a second final rule covering other general industries, maritime industries, construction industries, and agricultural industries was published in the Federal Register in 1987 (52 FR 31852, August 24, 1987). For both of these final rules, OSHA conducted research specifically regarding the benefits that could be expected from the promulgation of these standards, as described in the preambles to the final rules. In addition, through the rulemaking process, OSHA evaluated the best available evidence, including the data and comments submitted by the public. The information, data sources, analyses, and findings related to the estimation of the benefits associated with the standards are included in the public records for the rulemakings. The complete rulemaking records for these standards can be found in OSHA public dockets H-022B and H-022D. The estimated benefits associated with the Hazard Communication Standards were published in the Federal Register with the promulgation of the final standards (48 FR 53329, November 25, 1983 and 52 FR 31872, August 24, 1987). OSHA estimated that compliance with the various Hazard Communication Standards would produce annual benefits that would include the prevention of 31,841 non-lost-workday injuries and illnesses, 20,263 lost-workday injuries and illnesses, 6,410 chronic illnesses, and 4,260 fatalities. Using a willingness-to-pay approach for valuing these benefits, OSHA determined that the annual safety and health benefits would be over $18.2 billion annually, expressed in 1985 dollars. According to the inflation calculator provided by the Bureau of Labor Statistics, the buying power of $18.2 billion in 1985 is equivalent to the buying power of about $35.3 billion in 2007 after adjusting for inflation of 94 percent over the period.\5\ --------------------------------------------------------------------------- \5\ http://data.bls.gov/cgi-bin/cpicalc.pl. BLS inflation calculator used on September 23, 2008. --------------------------------------------------------------------------- Based on the material presented in this preamble, OSHA expects that the proposed revisions to the HCS would result in incremental improvements in employee health and safety above that already achieved under the existing HCS. For purposes of this proposal, OSHA has selected an estimate of 1 percent of the health and safety benefits due to the existing HCS as the benefits that could be attributed to compliance with the proposed revisions. It is conceivable that actual benefits might be somewhat lower, but because GHS is expected to result, in some situations, in more timely and appropriate treatment of exposed workers, OSHA believes actual benefits may be larger, perhaps several times larger.\6\ \7\ --------------------------------------------------------------------------- \6\ For example, one commenter on the ANPR, representing an organization whose membership includes first response and emergency management, wrote the following: ``The emergency planning and first responder community depends upon MSDS information for life and safety. The ability to immediately examine an MSDS and glean hazard and response information at the scene of an incident is critically important. The lives of first responders, employees of the facility and the public depend upon the accuracy and ease of use of the MSDS.'' (Document ID 0033.) \7\ OSHA believes that a reasonable range for the magnitude of the health and safety benefits resulting from the proposed revisions would be equal to between 0.5 percent and 5 percent of the benefits associated with the existing HCS. These ranges are considered in the sensitivity analysis presented in Section VII.K. --------------------------------------------------------------------------- [[Page 50322]] If the 1 percent estimate is correct, then once all requirements take effect, they would result in the prevention of 318 non-lost- workday injuries and illnesses, 203 lost-workday injuries and illnesses, 64 chronic illnesses, and 43 fatalities annually. The monetized value of these health and safety benefits is an estimated $353 million annually. In order to obtain a sense of how realistic these estimated safety and health benefits are in light of the current level of occupational injuries, illnesses, and fatalities that are chemically-related, OSHA reviewed relevant BLS data for the periods 1992-2007. OSHA's examination of these data shows a 42 percent decline in chemically- related acute injuries and illnesses over the period, but both remain significant problems--55,400 chemically-related illnesses and 125 chemically related-fatalities in 2007. However these readily measurable reported acute illnesses and fatalities are dwarfed by chronic illnesses and fatalities. For chronic illness fatalities, there is little information available, and certainly no annual time series data. The most recent estimate is that there were 46,900 to 73,700 fatalities due to occupational illnesses in 1992 (Leigh et al., 1997). OSHA believes these more recent data from 1992-2007 show that it is plausible that HCS has had a desirable effect on chemically-related illnesses and injuries, but there remains a very significant role for further and better hazard information, as would be provided by GHS. OSHA requests information and data from the public that could assist the agency in more accurately determining the safety and health benefits associated with the proposed revisions. The annual benefits associated with the proposed revisions to the OSHA HCS would generally begin after full implementation of the changes and associated employee training. The phase-in period is expected to take about three years. Thus, in order to calculate the estimated annualized benefits over a twenty-year period associated with this proposed rule in a manner that would be comparable to the corresponding annualized costs, the delay in the realization of the benefits was incorporated into the calculation. Using a discount rate of 7 percent, the annual benefits beginning three years after the effective date of the revisions were multiplied by 0.7523 to calculate the annualized benefits over a twenty-year period beginning with the effective date of the final rule.\8\ Thus, the annualized monetized benefit associated with the reduction in safety and health risks attributable to the proposed revisions is an estimated $266 million. --------------------------------------------------------------------------- \8\ The formula for annualizing the benefits is equal to: [(1.07)-3] * [ (1-(1.07)-17)/0.07] * [0.07/((1-(1.07)-20)], where the first term in brackets reflects the three year delay until annual benefits are realized; the second term in brackets reflects the present value of seventeen years of annual benefits (from years 4 through 20), and the third term in brackets annualizes the present value of benefits over a 20-year period. --------------------------------------------------------------------------- Other substantial benefits, in addition to the improved occupational safety and health of affected employees, are also expected to result from this rulemaking, as discussed in the following paragraphs. The harmonization of hazard classifications, safety data sheet formats, and warning labels for affected chemicals and products would yield substantial savings to the businesses involved in these activities. Fewer different SDSs would have to be produced for affected chemicals, and many SDSs would be able to be produced at lower cost due to harmonization and standardization. The benefits represented by these cost reductions would primarily affect businesses involved in chemical manufacturing. In addition, reductions in operating costs are also expected as a result of the promulgation of the proposed revisions for many businesses that purchase or use hazardous chemicals. The current non- uniformity of SDSs and labels received by establishments in practically all industries requires employees and managers in numerous positions to spend additional time on a daily basis to ascertain the appropriate way to handle and store the hazardous chemicals in their workplace. Under the revised standard, the presence of uniform and consistent information would help employers and employees to make decisions more efficiently and save substantial time. PP&E conducted extensive research on the processes that companies use to classify chemical hazards, to develop SDSs and labels, and to handle, store, and use hazardous chemicals. PP&E evaluated how these processes would be affected by the proposed revisions to the HCS and analyzed the potential savings that would be realized as a result of adopting these revisions. Based on the PP&E report, OSHA developed estimates of the cost reductions that the affected companies would expect to obtain as a result of the proposed revisions to the OSHA HCS. Among the various benefits expected to be realized as a result of the implementation of the proposed revisions, as described in this section, OSHA quantified two general categories of cost savings. First, OSHA estimated the number of hours that each industry would save by improving the efficiency and productivity of personnel who use SDSs in performing their job functions. OSHA estimated that the amount of time spent during affected activities in the manufacturing sector could be reduced by 3 percent for health and safety supervisors and by 15 percent for logistics personnel specializing in handling hazardous chemicals.\9\ OSHA further estimated that this time reduction, and the associated cost savings, would apply to about 7,000 health and safety supervisors and 52,000 logistics personnel in the manufacturing sector and would yield annualized benefits of approximately $569 million.\10\ Similar potential time and cost savings as a result of the proposed revisions to the OSHA HCS were not quantified for the non-manufacturing sectors. --------------------------------------------------------------------------- \9\ For example, as described by PP&E, the job of a logistics person, depending on the company, consists of the following tasks: (1) Receive hazardous chemicals; (2) gather the associated SDSs-- either those that are attached to the shipment or those that are attached to the invoice; (3) extract the relevant information from the SDSs and enter it in the plant's SDS management system; (4) insert paper copies of the SDSs into the (hard copy) SDS management folder; (5) if the information is not available (particularly in the older 9-section SDSs), then look for 12-section SDSs prepared by some other manufacturer; (6) prepare in-plant labels; (7) determine special storage and use requirements, make appropriate arrangements for short-term and long-term storage, and distribute information to different process lines or field offices; (9) participate in the training of line supervisors and production workers; (10) train new employees; and (11) carry out other logistics duties at the plant. The proposed GHS standard, by making the structure and content of SDS uniform, would help to reduce the time it takes to perform each of the above tasks. \10\ These estimates assume 2,000 hours of work a year for 7,070 health and safety supervisors and 52,280 logistics personnel specializing in handling hazardous chemicals in the manufacturing sector; an hourly wage of $47; and a time savings of 3 percent and 15 percent, respectively, for health and safety supervisors and logistics personnel. The resulting annual savings of $757 million was multiplied by 0.7523 to annualize the savings over a twenty-year period with savings not accruing until three years after the effective date of the revisions. --------------------------------------------------------------------------- Second, OSHA estimated that, for the manufacturing sectors, the costs associated with the creation and revision of SDSs in future years would be reduced by the proposed revisions. The creation and revision of individual SDSs would be less burdensome, and, in addition, fewer different versions of SDSs would need to be produced for affected chemicals and products. OSHA estimated that, depending on firm size, the combination of these two effects [[Page 50323]] would result in annual savings equivalent to between 2.5 and 4 hours of a professional's time per existing SDS and a total annualized savings of $16 million.\11\ --------------------------------------------------------------------------- \11\ These estimates assume \1/3\ of the estimated 880,260 SDSs are reviewed each year; savings per SDS is between 2\1/2\ and 4 hours, depending on firm size (with an average per SDS of about 3.2 hours); personnel reviewing the SDSs receive an hourly wage of $47; and existing compliance rates are between 1 percent and 75 percent, depending on firm size (with an average per SDS of about 53 percent). The resulting annual savings of $21 million was multiplied by 0.7523 to annualize the savings over a twenty-year period with savings not accruing until three years after the effective date of the revisions. --------------------------------------------------------------------------- Combining the improved productivity of personnel who use SDSs and the improved efficiency of those who revise SDSs and labels, OSHA concluded that the annual cost savings for companies in the manufacturing sector would be an estimated $585 million. A secondary benefit of the adoption of GHS is that it would facilitate international trade, increasing competition, increasing export opportunities for U.S. businesses, reducing costs for imported products, and generally expanding the selection of chemicals and products available to U.S. businesses and consumers. As a result of the direct savings resulting from the harmonization and the associated increase in international competition, prices for the affected chemicals and products, and the corresponding goods and services using them, should decline, although perhaps only by a small amount. The proposed revisions may also result in reductions in the costs associated with providing training for employees as required by the existing OSHA HCS. Companies would save considerable time and effort in training new employees in the future. The potential savings would be attributable in part to reducing or eliminating the need to explain the different types of formats used to convey hazard information and the different types of information included in the contents of SDSs and labels. Finally, the proposed GHS modifications to the OSHA HCS would meet the international goals for adoption and implementation of the GHS that were supported by the U.S. government. Implementing GHS in U.S. Federal laws and policies through appropriate legislative and regulatory action was anticipated by the U.S. support of international mandates regarding the GHS in the Intergovernmental Forum on Chemical Safety, the World Summit on Sustainable Development, and the United Nations. It is also consistent with the established goals of the Strategic Approach to International Chemical Management that the U.S. helped to craft. Table VII-1 provides a summary of the costs and benefits of the proposed revisions to the OSHA HCS, and it shows the net benefits and cost-effectiveness of the revisions to the standard. Net monetized benefits are estimated to be $754 million annually. The cost- effectiveness of the standard can be expressed as more than eight dollars of benefits for every dollar of cost. Some qualitative evidence of the cost-effectiveness of the standard was provided by comments submitted in response to the Advance Notice for Proposed Rulemaking (ANPR) published by OSHA in the Federal Register on September 12, 2006 (71 FR 53617). There was widespread (but not unanimous) support among the commenters for the adoption of GHS in the United States. This included commenters who provided some of the largest estimates of the costs of the proposed revisions. (Document IDs 0032 and 0050).\12\ --------------------------------------------------------------------------- \12\ One of these commenters is an international trade association for the institutional and industrial cleaning industry that represents over 4,600 manufacturer, distributor, building service contractor, and in-house service provider members worldwide. The other is a trade association representing some 400 manufacturers of paints, coatings, adhesives, sealants, and caulks, raw materials suppliers to the industry, and product distributors. --------------------------------------------------------------------------- E. Technological Feasibility In accordance with the OSH Act, OSHA is required to demonstrate that occupational safety and health standards promulgated by the Agency are technologically feasible. In fulfillment of this requirement, OSHA has reviewed the requirements that would be imposed by the proposal, and has assessed their technological feasibility. As a result of this review, OSHA has determined that compliance with the requirements of the proposal is technologically feasible for all affected industries. OSHA requests comments and information from the public with regard to this preliminary determination. The proposal would require employers producing chemicals to reclassify chemicals in accordance with the new classification criteria and revise safety data sheets and labels associated with hazardous chemicals. Compliance with these requirements is not expected to involve any technological obstacles. The proposal would also require employers whose workplaces involve potential exposure to hazardous chemicals to train employees on the relevant aspects of the revised approach to hazard communication. Affected employees would need additional training to explain the new labels and safety data sheets. Compliance with these requirements is not expected to involve any technological obstacles. Compliance with all of the proposed requirements can be achieved with readily and widely available technologies. Businesses in the affected industries have long been required to be in compliance with the existing HCS which includes similar requirements. The revised HCS would simply require modifying the labels and SDSs for hazardous chemicals and adding some training to ensure employee familiarization with the changes made. Therefore, there are no new technologies required for compliance with the modifications. In addition, some businesses in the affected industries have already implemented many of the requirements of the proposed standard to varying degrees. OSHA believes that there are no technological constraints associated with compliance with any of the proposed requirements, and welcomes comments regarding this conclusion. F. Costs of Compliance Introduction This section presents the estimated costs of compliance for the proposed revisions to the OSHA HCS. The estimated costs of compliance represent the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance with the new requirements. The compliance costs associated with the proposal generally consist of the one-time transition costs to adopt the modified criteria for classifications and formats as required under the new system. Ongoing annual costs associated with compliance with the existing OSHA HCS are not expected to increase. As discussed in the benefits section, the adoption of the new system is expected to reduce some of the ongoing costs associated with compliance with the HCS after the completion of the transition period. The costs of compliance with the proposed revisions consist of three main categories: the cost of reclassification and revision of SDSs and labels, the cost of training employees, and the cost of management familiarization and other management costs associated with the administration of hazard communication programs. [[Page 50324]] The estimated compliance costs associated with the proposed revisions are based on a preliminary determination that the revisions would not significantly change the number of chemicals or products for which an SDS will be required, which also means that there will be no change in the number of establishments required to implement a hazard communication program. OSHA requests comments and information from the public regarding this preliminary determination. Other than the direct costs of reclassification and relabeling, the estimated compliance costs do not include any further costs or impacts that may result from the reclassification or relabeling of chemicals and products already subject to the HCS, such as possible changes in production or demand for products. Theoretically, such impacts, if any, with regard to possible changes in the uses and applications of affected chemicals, could be positive as well as negative. OSHA has preliminarily determined that such effects, if any, will not be significant, and requests comments and information from the public regarding this determination. In addition to the proposed revisions to the HCS, the proposed rulemaking also includes related proposed revisions to other OSHA standards. The revisions to the other standards generally ensure that all OSHA requirements related to hazard communication remain consistent with each other and become consistent with the GHS. OSHA has preliminarily determined that the proposed revisions to the other standards would not impose significant costs beyond those reflected in the preliminary compliance cost estimates for this rulemaking, and requests comments and information from the public regarding this determination. In order to have compliance costs presented on a consistent and comparable basis across various regulatory activities, the costs of compliance for this proposed rule are expressed in annualized terms. Annualized costs represent the more appropriate measure for assessing the longer-term potential impacts of the rulemaking. The estimated annualized cost of compliance is also provided for purposes of comparing compliance costs and cost-effectiveness across diverse regulations with a consistent metric. In addition, annualized costs are often used for accounting purposes to assess the cumulative costs of regulations on the economy or specific parts of the economy across different regulatory programs or across years. Annualized costs also permit costs and benefits to be presented in a comparable manner. The annualized cost was calculated by annualizing the one-time transition costs over a period of 20 years and applying a discount rate of 7 percent. Table VII-3 shows the estimated annualized compliance cost by cost category and by industry sector. As shown in Table VII-3, the total annualized cost of compliance with the proposed rulemaking is estimated to be about $97 million. Of this amount, the cost of chemical hazard reclassification and revision of SDSs and labels is an estimated $11 million, the cost of training employees is an estimated $44 million, and the cost of management familiarization and other management costs is an estimated $42 million. As shown in Table VII-3, most of the compliance cost associated with chemical hazard reclassification and revision of SDSs and labels would be borne by the chemical manufacturing industry. Table VII-3 also shows that compliance costs are spread across all industries in the U.S. economy subject to OSHA jurisdiction, reflecting the fact that employee exposures to hazardous chemicals occur in almost every industry sector. OSHA expects that the compliance costs would be incurred over a period of three years, as the proposal would incorporate a three-year transition period into the compliance schedule for the standard. Specifically, for purposes of estimating the annualized compliance costs, OSHA assumed that the compliance costs associated with employee training would be incurred in the two-year period following the effective date of the final standard, and that other compliance costs would be incurred in the three-year period following the effective date of the final standard. BILLING CODE 4510-26-P [[Page 50325]] [GRAPHIC] [TIFF OMITTED] TP30SE09.009 [[Page 50326]] [GRAPHIC] [TIFF OMITTED] TP30SE09.010 [[Page 50327]] [GRAPHIC] [TIFF OMITTED] TP30SE09.011 [[Page 50328]] [GRAPHIC] [TIFF OMITTED] TP30SE09.012 [[Continued on page 50329]] From the Federal Register Online via GPO Access [wais.access.gpo.gov] ] [[pp. 50329-50378]] Hazard Communication [[Continued from page 50328]] [[Page 50329]] [GRAPHIC] [TIFF OMITTED] TP30SE09.013 [[Page 50330]] [GRAPHIC] [TIFF OMITTED] TP30SE09.014 [[Page 50331]] [GRAPHIC] [TIFF OMITTED] TP30SE09.015 [[Page 50332]] [GRAPHIC] [TIFF OMITTED] TP30SE09.016 BILLING CODE 4510-26-C In order to make the compliance cost estimates comparable with the corresponding benefits estimates, the expected timing of these costs was taken [[Page 50333]] into account. A seven percent discount rate was applied to costs incurred in future years to calculate the present value of these costs for the base year in which the standard becomes effective, and the same discount rate was then applied to the total present value costs, over a 20-year period, to calculate the $97 million annualized costs. In the appendix to this cost section, Table VII-4 shows, by industry and by cost element, total non-annualized (non-discounted) compliance costs of about $1.1 billion estimated to be incurred during the three-year phase-in of the proposed revisions. Estimation of Compliance Costs The remainder of this section explains how the compliance costs were calculated by describing the data and methodology used to estimate each of the major cost elements. A more complete and detailed description of the estimation of compliance costs can be found in the PP&E report. The major elements of the proposed revisions that involve compliance costs include (1) the classification of chemicals in accordance with the proposed criteria and the revisions to the safety data sheets and labels corresponding to the affected hazardous chemicals; (2) incremental training for employees already trained under the existing OSHA hazard communication programs to ensure their familiarization with the new formats, information, and symbols that would be introduced into the workplace as a result of the proposed revisions; and in addition, (3) even though it is not directly a result of any specific requirement included in the proposed revisions, the cost for managers and administrators of hazard communication programs to become familiar with the revisions to the standard and to manage, update, and revise their programs as may be necessary to ensure compliance with the revised standard. The estimated compliance costs presented in this analysis of the proposed revisions to the HCS are largely based on research conducted by PP&E. PP&E performed this research under contract to the Department of Labor specifically for the purpose of developing estimates of compliance costs for, and assessing the potential impacts that may be associated with, possible revisions that may be made to the OSHA HCS in order to implement the GHS. The estimated costs of compliance with many of the provisions of the proposed standard involve wages paid for the labor hours required to fulfill the requirements. In some cases, compliance could be achieved by purchasing services or products in lieu of paying employees directly. The estimated compliance costs are intended to capture the resources required for compliance, regardless of how individual establishments may choose to achieve compliance. Costs Associated With Chemical Classifications and Revisions to Safety Data Sheets and Labels The proposed revisions to the OSHA HCS would continue to require firms that sell hazardous chemicals to employers to provide information about the associated hazards. Information is required to be presented in a safety data sheet (SDS) in the format specified in the revised standard, and some information is also required to be presented on product labels. The existing OSHA HCS already requires information about hazardous chemicals to be provided in SDSs and on labels. In addition, under the existing standard, SDSs are to be revised after a manufacturer or employer becomes aware of any significant new information about the hazards of a chemical. The proposed revisions to the standard would require chemicals to be classified into the appropriate hazard classes and categories based on the information about the chemicals that the manufacturers currently have. This information would have been assembled for purposes of conducting a hazard determination under the current HCS. In addition, the current HCS requires chemical manufacturers and importers to remain aware of developments regarding the hazards of the chemicals they produce or import in order to update the labels and SDSs for the chemicals in a timely manner. The classification of the chemicals into the hazard classes and categories under the revised provisions would not require any additional testing, studies, or research to be conducted. Manufacturers would be able to rely on the information they already have in determining how to properly classify their chemicals. Generally, chemical manufacturers and importers periodically review, revise, and update SDSs and labels. Changes are made as necessary as information regarding specific hazards develops, new information about protective measures is ascertained, or changes are made to product information and marketing materials. Labels and SDSs must also be produced or modified when products are introduced or changed. Therefore, there is a regular cycle of change for these documents for a variety of reasons. The proposed revisions may require a more extensive change than would normally occur, but the phase-in period is such that the chemical manufacturers and importers can take advantage of the normal cycle of change to phase in the revisions for all their products over a reasonable time period. This should have less impact on normal operations than a short time period that would require all SDSs and labels to be revised at the same time. The transition period that would be allowed by the delayed effective date for the requirement to adopt the new format should help ensure that the transition can be completed in conjunction with revisions and updates that would normally be expected to occur even without the implementation of the proposed revisions. In addition, the format required by the proposed revisions for SDSs is consistent with the format already adopted by the American National Standards Institute (ANSI) and therefore has already been implemented by many of the affected businesses. Based on the PP&E report, OSHA developed estimates of the costs that would be associated with the classification of chemicals in accordance with the proposed criteria and with the revisions to the corresponding SDSs and labels for those chemicals. The estimated compliance costs represent the incremental costs that would need to be incurred to achieve compliance with the proposed revisions; these estimated costs would be in addition to the costs that would already be incurred to continue to remain in compliance with applicable requirements of the existing HCS. The proposed revisions would allow for a transition period of three years following the publication of a final rule. During this period, even in the absence of any pertinent OSHA rulemaking, producers of affected chemicals would presumably be ensuring that the information provided in their SDSs and labels remains accurate and current. Producers of hazardous chemicals are generally expected to regularly review the available information regarding any hazards that may be associated with their products and to revise SDSs and labels accordingly. In addition, for every affected product that is newly created, reformulated, mixed with new ingredients, modified with new or different types of additives, or has any changes made in the proportions of the ingredients used, the chemical producer would be required under existing OSHA and other applicable standards to review the available hazard information, to classify the chemical in accordance with [[Page 50334]] applicable hazard criteria, and to develop corresponding SDSs and labels. The estimated costs of compliance with the proposed revisions do not include the costs associated with activities such as those described in the above paragraphs, but rather reflect only the additional costs that chemical producers would not already be expected to incur. The estimated compliance costs associated with the proposed reclassification of hazards and changes to SDSs and labels are based on the numbers of SDSs affected. Based on the PP&E report, OSHA developed estimates of the number of potentially affected SDSs by industry, for each of the industries producing the corresponding chemicals and products (as shown in Table VII-2). Downstream users, distributors, and wholesalers are expected to continue to rely on SDSs provided by manufacturers to fulfill their obligations under the OSHA standard, as has been the practice for decades. OSHA requests comments and information from the public regarding this aspect of compliance with the standard. The costs of compliance associated with the classification of chemicals in accordance with the proposed criteria and with the revisions to the corresponding SDSs and labels for those chemicals were based on PP&E industry interviews and estimated as follows. Generally, for smaller establishments with relatively few chemicals affected, OSHA estimated the incremental compliance costs to be the equivalent of the cost of seven hours of time of a professional with the requisite expertise for each affected chemical, on average. Based on the PP&E report, OSHA estimated the cost of hourly compensation for a professional for this purpose to be $47. As a result, a small establishment (with fewer than 100 employees) with 20 SDSs for 20 chemicals, for example, would have estimated incremental compliance costs of $6,580 (7 hours times 20 SDSs times $47). In larger establishments with more affected chemicals, the incremental compliance costs were estimated to consist of two parts. First, labor costs were estimated according to the size of the establishment. OSHA, based on PP&E interviews with stakeholders, estimated that entities with 100 to 499 employees would incur, on average, the equivalent of five hours of time of a professional with the requisite expertise for each affected chemical, and that entities with 500 or more employees would incur the equivalent of three hours of professional time per chemical. Based on the PP&E report, OSHA estimated the hourly compensation for a professional for this purpose to be $47. The labor cost per SDS was estimated to be lower for larger companies based on the determination that larger companies produce more SDSs, and would therefore experience efficiencies associated with producing them. These efficiencies include economies of scale, the use of software specifically designed to classify hazards and produce SDSs, and the generally lower cost per SDS associated with many mixtures. Second, many of these larger establishments may incur additional expenditures to purchase or modify software that can be used to classify chemicals and to produce corresponding SDSs and labels. Such software is available from a variety of vendors; the software can be purchased or used on a subscription basis. Publicly available information about the products and services being offered and sold to businesses for purposes of complying with hazard communication requirements indicates that most of the relevant vendors are aware of and prepared for an upcoming transition to the GHS, and that their products and services are or will be adapted to enable compliance with the proposed revisions. In addition, some firms may purchase custom or proprietary software from private vendors to achieve compliance with existing or proposed revisions to hazard communication requirements and for other purposes. Regardless of the particular approach individual companies may choose to most efficiently fulfill their obligations under the existing or proposed HCS, OSHA expects that a part of the costs associated with achieving compliance with the proposed revisions would involve costs attributable to software modifications. Based on industry data obtained by PP&E, OSHA apportioned these costs on a per-SDS basis and estimated the cost per SDS to be $200, on average. Based on the PP&E report, OSHA estimated the numbers of SDSs produced in each industry that would potentially need to be revised under the proposed standard, as shown in Table VII-2. A total of about 880,000 SDSs, one for each type of chemical produced by an individual manufacturer in the United States, were estimated to be in potential need of revision. In developing estimates of the compliance costs associated with the proposed rule, PP&E also considered the extent to which many firms have already performed the necessary reclassifications of chemical hazards and revisions to SDSs. Some chemical hazards have already been reclassified as would be required by the proposed OSHA standard because the U.S. Department of Transportation has required such classifications as part of their regulations for the transportation of hazardous chemicals (49 CFR parts 171-180). The criteria for physical hazard classifications for purposes of transport have been internationally harmonized for some years, and these criteria formed the basis for the physical hazard criteria in the GHS. Therefore, many products intended for transport have already been classified under the new proposed physical hazard criteria as well as the existing criteria in the HCS. Many current SDSs are already produced to varying degrees in accordance with the requirements of the proposed OSHA standard because the widely-followed ANSI industry consensus standard already reflects many of these requirements in its relevant criteria. In addition, many firms have implemented or are beginning to implement hazard reclassifications, SDS revisions, software modifications, and other changes in accordance with the requirements of the proposed OSHA standard, because these provisions are generally anticipated to be adopted as part of the implementation of the GHS in countries and regions around the world. Since some other countries are already implementing the GHS, companies in the U.S. that ship to those countries are already having to comply with the GHS for products being exported. Research conducted by PP&E indicates that all of these factors contribute to a substantial degree of current compliance with the proposed rule, even if the existing OSHA standard remains unchanged.\13\ Based on the PP&E report, OSHA estimates that, on average, about 53 percent of the gross costs that would otherwise be associated with the proposed revisions to the HCS have already been incurred by firms. However, this average is a result of very different levels of current compliance for different sizes of firms. PP&E estimated that the percentage of firms in current compliance with the proposed revisions--with the exception of employee training--is 75 percent for firms with over 500 employees; 25 percent for firms with 100 to 500 employees; 5 percent for firms with 20 [[Page 50335]] to 99 employees; and 1 percent for firms with fewer than 20 employees. OSHA used these percentages to reduce the number of firms reported in Table VII-2 for purposes of estimating the costs for affected firms to comply with the proposed revisions (again, with the exception of employee training). --------------------------------------------------------------------------- \13\ By current compliance, OSHA means firms that have already reclassified chemicals and prepared SDSs and labels in accordance with proposed GHS requirements and would therefore be ready to introduce these modifications at negligible additional cost when GHS becomes effective. --------------------------------------------------------------------------- Based on the preceding analysis, OSHA estimates an annualized cost of approximately $11 million for the classification of chemicals in accordance with the proposed criteria and for revisions to the corresponding SDSs and labels for those chemicals.\14\ --------------------------------------------------------------------------- \14\ This annualized estimate of $11 million reflects software costs of $32 million and labor costs of $100 million multiplied by 0.082573 to annualize these costs (incurred over the first three years) over a 20-year period. The $32 million in software costs is the result of about 160,000 modified SDSs [(574,000 SDSs for large establishments x 25% not in existing compliance x 95% requiring modification) + (128,000 SDSs for establishments with 100-500 employees x 75% not in existing compliance x 25% requiring modification)] at a cost of $200 per SDS. The $100 million in labor cost is the result of about 413,000 affected SDSs multiplied by an average of 5.14 hours per SDS (from 3 to 7 hours per SDS) multiplied by $47 per hour. The annualization factor, 0.082573, is equal to: [(\1/3\] * [ (1--(1.07)-3)/0.07] * [0.07/((1-- (1.07)-20)], where the first term in brackets reflects the fact that these costs are assumed to be spread equally over the first three years; the second term in brackets calculates the present value of the costs, and the third term in brackets annualizes the present value of the costs over a 20-year period. --------------------------------------------------------------------------- OSHA requests data and information from the public that would assist the Agency in ensuring that any costs associated with the proposed revisions are accurately estimated. For example, OSHA would appreciate data from individual companies on the number of actively distributed SDSs; the number that would be affected by the GHS proposal; the time required to revise SDSs; the occupation and hourly cost of the individuals working on the revisions; and whether software would need to be modified or purchased and the costs of the modification or purchase. As discussed below, OSHA received some comments from the public regarding the estimated costs associated with chemical classifications and revisions to safety data sheets in response to the Advance Notice for Proposed Rulemaking (ANPR) published by OSHA in the Federal Register on September 12, 2006 (71 FR 53617). The comments received are publicly available as part of the rulemaking record, accessible through regulations.gov, in docket OSHA-H022K-2006-0062. Relevant information submitted by the public was incorporated into the development of the methodology and estimates presented in this preliminary economic analysis. Some commenters provided examples of cost estimates that generally support the estimates of the preliminary economic analysis. Information from other commenters provided a wide range of cost estimates. The figures presented in some comments appeared to correspond to gross costs of creating SDSs, and in other cases it was not clear whether gross or incremental costs were being presented. In general, commenters did not provide the rationale underlying their cost estimates. OSHA requests that, in submitting any data or information on compliance costs, commenters distinguish between the costs attributable to compliance with existing requirements, costs already incurred voluntarily or in compliance with another standard, and the incremental costs attributable to the new requirements associated with this rulemaking. The rationale or basis for assigning these compliance costs would also assist OSHA in developing accurate cost estimates. One commenter, the Fragrance Materials Association of the United States, stated that its best assessment is that it would take anywhere from two to eight hours to review information and prepare new labels and safety data sheets for each hazardous chemical. (Document ID 0061). Another commenter, the Flavor and Extract Manufacturers Association of the United States, also reported that it would take from two to eight hours to review the necessary information and produce new labels and safety data sheets for each hazardous chemical. (Document ID 0062). One company that produces and distributes about 4,000 different hazardous chemicals estimated that it will take four to six hours per product to prepare a GHS SDS. (Document ID 0026). The National Paint and Coatings Association stated that it would take approximately five hours to research the information for a product SDS/label at a small company, at a cost of about $300 per product; it also estimated that, at a medium-sized company, this same task would take from 3-5 days to 3 weeks at a cost of approximately $1,000 to $1,800, and that at a larger company, the task would be even more expensive. (Document ID 0050). The National Association of Chemical Distributors estimated that converting an existing SDS to the new GHS format would require about 150 hours as compared to about 100 hours currently to revise an MSDS. (Document ID 0060). Another commenter, Merck, which produces, imports, or distributes about 500 hazardous chemicals annually, estimated that, on average, it takes approximately 3 weeks to generate a single safety data sheet at an average cost of $1,500. Merck also stated that with a sufficient transition period of three to six years, the costs of moving to GHS would be minimal. Merck noted that the time and cost for additional changes to the GHS format should be minimal because it had already converted its SDSs to the 16-section ANSI/GHS format several years ago. (Document ID 0072). One trade association estimated that the costs associated with revising SDSs and labels for the 1,600 firms in the cleaning product formulator industry would total $575 million, not including the time needed to review changes to hazard classifications. The total numbers of SDSs per establishment are generally higher for the establishments represented by the trade association than the OSHA estimates for the industry category as a whole. (Document ID 0032). This trade association also provided some of the details underlying its cost estimates for individual companies. Cost estimates provided by the trade association for individual companies included costs per SDS as low as $30 and $80, and as high as $600 or more. One company (identified as Company 11) estimated the cost to revise the label and SDS would be $120 per product; another company (Company 2) estimated that this cost would be $2,600 per product. Some of the higher compliance cost estimates appear to be unrealistically high; for example, the estimated costs associated only with revising labels for company 3 appear to represent about 3 percent of total annual sales. While acknowledging that some firms may incur higher costs than others to revise SDSs and labels, these data generally appear to support that, at least for several firms in the industry, the costs minimally necessary to achieve compliance would be close to or less than the costs estimated by OSHA. Several other commenters provided cost estimates related to the adoption of GHS requirements for chemical classifications and revisions to safety data sheets and labels. See, for example, Document ID s 0015, 0018, 0024, 0036, 0079, 0105, 0107, 0116, 0128, 0141, and 0145, among others. Many estimates are broadly consistent with OSHA's estimates; in addition, some estimates appear to be similar to, but may actually be substantially lower than, OSHA's estimates to the extent they include costs attributable to the existing [[Page 50336]] standard rather than just the incremental costs associated with the proposed modifications. Other estimates are substantially higher, but many of these also appear to represent gross costs associated with fulfilling hazard communication requirements without consideration of the incremental nature of the compliance costs for the proposed revisions, as discussed above. OSHA requests additional comments and information from affected establishments and from the public regarding the nature of the incremental costs of classifying chemicals and modifying SDSs and labels associated with the proposed revisions. Comments would be most helpful to the Agency if they included the underlying data and methodology used to develop the cost estimates. Management Familiarization and Other Management-Related Costs The implementation of GHS as part of the OSHA HCS would require that employees currently covered by the standard become familiar with the new system. The nature and extent of the familiarization required would vary depending on an employee's job and business. OSHA considered separately various training needs that may be imposed by the proposed revisions. Although it would not be explicitly required by the proposed revisions, some establishments may choose to provide training to managers and other employees that are not directly covered by the training requirements of the HCS. Other management-related costs may include revisions, if necessary, to existing hazard communication programs; promoting awareness of and providing information about the revisions to hazard communication programs; coordinating and integrating changes to hazard communication programs with other programs, processes, and functions; serving as an in-house resource for supporting the general adoption of GHS; creating supplemental capacity for providing training and assistance to affected employees; and other ancillary costs for company-specific changes and general hazard communication program administration that may be incurred at some establishments. These costs could be considered discretionary in that they would not be explicitly required by the proposed regulatory provisions; however, OSHA recognizes that these costs may be incurred in practice due to the manner in which some companies have implemented and integrated hazard communication programs in their facilities. The particular circumstances that would cause these costs to be incurred partly reflect the fact that hazard communications programs often are not implemented solely for purposes of complying with the OSHA standard, but may serve a variety of other purposes that are part of and that benefit the overall production process. In some cases, health and safety supervisors, logistics personnel, and other personnel involved in administering, implementing, and ensuring compliance with the requirements of the HCS in affected establishments would be expected by company managers to become familiar with the proposed revisions. The responsibilities of these employees may include modifying written hazard communication programs as necessary, reviewing and preparing training materials, and training new and existing employees regarding the changes. An estimated 8 hours of time, or an equivalent cost, would be associated with the necessary familiarization and implementation of revisions to hazard communication programs in affected establishments in the manufacturing sector. In many potentially affected establishments that do not produce SDSs, and that have few affected chemicals or few affected employees, a very basic hazard communication program may achieve compliance with the OSHA standard. For these establishments, outside of the manufacturing sector, that have a health and safety supervisor, the incremental management and administrative costs associated with the proposed revisions to the OSHA standard were estimated to be 2 hours per establishment. For establishments outside of the manufacturing sector that do not have a health and safety supervisor, OSHA estimated that these costs would be negligible. Based on the preceding analysis, OSHA estimates an annualized cost of approximately $42 million for management familiarization and other related management activities in response to GHS.\15\ --------------------------------------------------------------------------- \15\ This annualized estimate of $42 million reflects total costs of $490 million multiplied by 0.085332 to annualize these costs (incurred over the first two years) over a 20-year period. The $490 million is equal to $5.9 million for health and safety managers (5,900 affected managers x $1000 per manager) plus $16.4 million for logistics personnel in manufacturing (43,600 affected logistics persons x 8 hours x $47 per hour) plus $116 million for health and safety supervisors in manufacturing (309,000 affected health and safety supervisors in manufacturing x 8 hours x $47 per hour) plus $351.7 million for health and safety supervisors in non- manufacturing (3,740,000 affected H&S supervisors in non- manufacturing x 2 hours x $47 per hour). The annualization factor, 0.085332, is equal to: [(\1/2\] * [ (1-(1.07)-\2\)/0.07] * [0.07/((1- (1.07)-\20\)], where the first term in brackets reflects the fact that these costs are assumed to be spread equally over the first two years; the second term in brackets calculates the present value of the costs, and the third term in brackets annualizes the present value of the costs over a 20-year period. --------------------------------------------------------------------------- OSHA requests additional comments and information from affected establishments and from the public regarding the nature of the incremental management familiarization costs associated with the proposed revisions. Costs Associated With Training Employees Production employees who are currently covered by and trained under the provisions of the existing HCS would need to receive some additional training to become familiar with the proposed changes to SDSs and labels. In many potentially affected establishments that do not produce SDSs, and that have few affected chemicals or few affected employees, a very basic hazard communication program may achieve compliance with the OSHA standard. In these establishments, the incremental employee training costs associated with the proposed revisions to the OSHA standard may be relatively small. In other cases, employers may be able to integrate the necessary training into existing training programs and other methods of distributing safety and health information to employees, and thus may not incur much additional cost. Nevertheless, in order to adequately reflect the opportunity costs of devoting time and resources to the necessary training, and in order to ensure that the estimated compliance costs reflect an adequate emphasis on the familiarization with the proposed new hazard communication system, a more substantial training cost was estimated. An estimated 30 minutes of training, in addition to training that would otherwise be received, would provide adequate time for employees to become familiar with the new system. For some occupations for which the use of hazardous chemicals is minimal and the number of hazards for which training is needed is small, OSHA estimated that 15 minutes of training would be sufficient. For some occupations in the transportation sector, where GHS pictograms are already in use, OSHA estimated that only 5 minutes of training would be needed. A complete occupation-by-occupation review of OSHA's estimates is provided in the PP&E report. [[Page 50337]] The training costs associated with the proposed revisions are expected to be incurred during the transition to the new hazard communication system. Compliance with the proposed revisions is not expected to involve any additional training costs after the transition period. Based on the preceding analysis, OSHA estimates that the annualized cost of training employees in response to GHS would be approximately $44 million.\16\ --------------------------------------------------------------------------- \16\ This annualized estimate of $44 million reflects total costs of $519 million multiplied by 0.085332 to annualize these costs (incurred over the first two years) over a 20-year period. The $519 million is equal to $444 million in employee hours to receive training (40.6 million affected employees x 0.42 hours x $26 per hour) plus $75 million in management hours to provide the training (3.8 million managers x 0.42 hours x $47 per hour). The 0.42 hours is the average estimated training time for all affected employees, with most receiving 30 minutes of training, some receiving 15 minutes of training, and a very few receiving 5 minutes of training. The total number of managers providing training (3.8 million) would, on average, be equal to approximately 9.4 percent of the number of employees receiving training in response to GHS. --------------------------------------------------------------------------- The proposed revisions may result in reductions in the costs associated with providing training for employees as required by the existing OSHA HCS. Affected companies could save considerable time and effort in training new employees in the future. The savings may be attributable in part to reducing or eliminating the need to explain the different types of formats used to convey hazard information and the different types of information included in the contents of SDSs and labels. OSHA did not quantify these potential savings in training costs associated with the proposed revisions. OSHA requests additional comments and information from affected establishments and from the public regarding the nature of the incremental training costs associated with the proposed revisions. Summary of Unit Cost Estimates The following list provides a summary of the input estimates underlying the calculation of the compliance costs. It should be noted that these costs are intended to reflect only the incremental costs that would be incurred in addition to the associated costs that would be incurred in the absence of the proposed revisions to the standard. Except for employee training, these costs would apply only to those businesses not already in compliance with the proposed revisions. OSHA requests comments and information from the public regarding these estimates. Reclassifying chemicals and modifying SDSs and labels: Large establishments (over 500 employees): An average of 3 hours per SDS; in addition, for 95 percent of establishments, an average of $200 per SDS for software modifications. Medium establishments (100-499 employees): An average of 5 hours per SDS; in addition, for 25 percent of establishments, an average of $200 per SDS for software modifications. Small establishments (1-99 employees): An average of 7 hours per SDS. Management familiarization and other costs: Eight hours for health and safety managers and logistics personnel in the manufacturing sector. Two hours for each hazard communication program manager not in the manufacturing sector. Employee training: 30 minutes per production employee in most industries; 15 minutes in occupations exposed to few hazardous chemicals and types of hazards; 5 minutes per employee in some occupations where GHS-type pictograms are already in use. Appendix to Section F: Total Non-annualized Costs of Compliance Table VII-4 shows the total non-annualized (non-discounted) compliance costs by industry and by cost element that are estimated to be incurred during the three-year phase-in of the proposed revisions. Except for employee training, these estimates include no costs for businesses already in compliance with the proposed revisions. As shown in Table VII-4, the total cost of compliance with the proposed rulemaking over the course of the transition period of three years is estimated to be about $1.14 billion. This amount also represents the total non-annualized cost of compliance for the proposed rule. Of this amount, the cost of chemical hazard reclassification and revision of SDSs and labels is an estimated $132 million, the cost of training employees is an estimated $519 million, and the cost of management familiarization and other costs such as updates to hazard communication programs is an estimated $490 million. BILLING CODE 4510-26-P [[Page 50338]] [GRAPHIC] [TIFF OMITTED] TP30SE09.017 [[Page 50339]] [GRAPHIC] [TIFF OMITTED] TP30SE09.018 [[Page 50340]] [GRAPHIC] [TIFF OMITTED] TP30SE09.019 [[Page 50341]] [GRAPHIC] [TIFF OMITTED] TP30SE09.020 [[Page 50342]] [GRAPHIC] [TIFF OMITTED] TP30SE09.021 [[Page 50343]] [GRAPHIC] [TIFF OMITTED] TP30SE09.022 [[Page 50344]] [GRAPHIC] [TIFF OMITTED] TP30SE09.023 [[Page 50345]] [GRAPHIC] [TIFF OMITTED] TP30SE09.024 [[Page 50346]] BILLING CODE 4510-26-C G. Economic Feasibility and Impacts This section presents OSHA's analysis of the potential economic impacts of the proposal and an assessment of economic feasibility. A separate analysis of the potential economic impacts on small entities (as defined in accordance with the criteria established by the Small Business Administration) and on very small entities (those with fewer than 20 employees) is presented in the following section as part of the Initial Regulatory Flexibility Screening Analysis, conducted in accordance with the criteria laid out in the Regulatory Flexibility Act. In order to assess the nature and magnitude of the economic impacts associated with compliance with the proposal, OSHA developed quantitative estimates of the potential economic impact of the requirements on each of the affected industry sectors. The estimated costs of compliance presented in Section F of this economic analysis were compared with industry revenues and profits to provide a measure of potential economic impacts. Table VII-5 presents data on revenues and profits for each affected industry sector, along with the corresponding estimated annualized costs of compliance in each sector. Potential impacts in the table are represented by the ratios of compliance costs to revenues and compliance costs to profits. As is evident from the data and estimates presented in Table VII-5, the costs of compliance for the proposal are not large in relation to the corresponding revenues and profits in each of the industry sectors. The estimated costs of compliance represent about 0.0004 percent of revenues and about 0.00712 percent of profits on average across all entities; compliance costs do not represent more than 0.02 percent of revenues or more than 0.3 percent of profits in any individual industry sector. The Agency preliminarily concludes that the proposal is economically feasible for the affected industries. In general, the courts have held that a standard is economically feasible if there is a reasonable likelihood that the estimated costs of compliance ``will not threaten the existence or competitive structure of an industry, even if it does portend disaster for some marginal firms'' (United Steelworkers of America v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980)). The potential impacts of employer costs associated with achieving compliance with the proposal fall well within the bounds of economic feasibility in each industry sector. OSHA does not expect compliance with the requirements of the proposal to threaten the viability of employers or the competitive structure of any of the affected industry sectors. The economic impact of the proposal is most likely to consist of a very small increase in prices for affected hazardous chemicals, of about 0.0004 percent on average. Chemical manufacturing companies, all of whom must incur the costs of compliance unless they are already doing so, should be able to pass through costs to customers. The additional costs of a one-time change to revised SDS and labeling criteria are extremely small in relation to the value of the corresponding products, and there are generally no economic substitutes, or alternatives, that would not be subject to the same requirements. It is unlikely that a price increase of this magnitude would significantly alter the types or amounts of goods and services demanded by the public or any other affected customers or intermediaries. If the compliance costs of the proposal can be substantially recouped with a minimal increase in prices, there would be little or no effect on profits. BILLING CODE 4510-26-P [[Page 50347]] [GRAPHIC] [TIFF OMITTED] TP30SE09.025 [[Page 50348]] [GRAPHIC] [TIFF OMITTED] TP30SE09.026 [[Page 50349]] [GRAPHIC] [TIFF OMITTED] TP30SE09.027 [[Page 50350]] [GRAPHIC] [TIFF OMITTED] TP30SE09.028 [[Page 50351]] [GRAPHIC] [TIFF OMITTED] TP30SE09.029 [[Page 50352]] [GRAPHIC] [TIFF OMITTED] TP30SE09.030 [[Page 50353]] [GRAPHIC] [TIFF OMITTED] TP30SE09.031 [[Page 50354]] [GRAPHIC] [TIFF OMITTED] TP30SE09.032 BILLING CODE 4510-26-C In profit-earning entities, compliance costs can generally be expected to be absorbed through a combination of increases in prices or reduction in [[Page 50355]] profits. The extent to which the impacts of cost increases affect prices or profits depends on the price elasticity of demand for the products or services produced and sold by the entity. The price elasticity of demand refers to the relationship between changes in the price charged for a product and the resulting changes in the demand for that product. A greater degree of elasticity of demand implies that an entity or industry is less able to pass increases in costs through to its customers in the form of a price increase and must absorb more of the cost increase through a reduction in profits. In the case of cost increases that may be incurred due to the requirements of the proposal, all businesses within each of the covered industry sectors would be subject to the same requirements. Thus, to the extent potential price increases correspond to costs associated with achieving compliance with the standards, the elasticity of demand for each entity will approach that faced by the industry as a whole. Given the small incremental increases in prices potentially resulting from compliance with the proposed standards and the lack of readily available substitutes for the products and services provided by the covered industry sectors, demand is expected to be sufficiently inelastic in each affected industry to enable entities to substantially offset compliance costs through minor price increases without experiencing any significant reduction in revenues or profits. OSHA expects the economic impact of the proposed rulemaking to be both an increase in the efficiency of production of goods and services and an improvement in the welfare of society. First, as demonstrated by the analysis of costs and benefits associated with compliance with the requirements of the proposal, OSHA expects that societal welfare will increase as a result of these standards, as the benefits exceed the necessary compliance costs. The proposal is estimated to yield net benefits of over $500 million annually that would be achieved in a cost-effective manner. Second, until now, many of the costs associated with the injuries, illnesses, and fatalities resulting from the risks addressed by the proposal have been externalized. For example, the costs incurred by society to supply certain products and services that are accompanied by injuries, illnesses, or fatalities from employee exposure to hazardous chemicals have not been fully reflected in the prices of those products and services. To the extent that fewer of these costs are externalized because of improved employer and employee information about hazardous chemicals in the workplace, the price mechanism will enable the market to produce a more efficient allocation of resources. However, reductions in externalities by themselves do not necessarily increase efficiency or social welfare unless the costs of achieving the reductions (including indirect and unintended consequences of regulatory approaches) are outweighed by the associated benefits, as they are in this instance. In addition, based on an analysis of the costs and economic impacts associated with this rulemaking, OSHA preliminarily concludes that the effects of the proposal on employment, wages, and economic growth for the United States would be negligible. The effects on international trade are expected to be small but not negligible, because of the increased import and export opportunities with U.S. trading partners arising from harmonization of the U.S. system with GHS. Hence, the primary effect on international trade is likely to be beneficial. OSHA requests comments from the public regarding these preliminary conclusions and requests information on whether and how much this proposal would affect international trade. Statement of Energy Effects As required by Executive Order 13211, and in accordance with the guidance for implementing Executive Order 13211 and with the definitions provided therein as prescribed by the Office of Management and Budget (OMB), OSHA has analyzed the proposed standard with regard to its potential to have a significant adverse effect on the supply, distribution, or use of energy. As a result of this analysis, OSHA has determined that this action is not a significant energy action as defined by the relevant OMB guidance. H. Initial Regulatory Flexibility Screening Analysis The Regulatory Flexibility Act, as amended in 1996, requires the preparation of an Initial Regulatory Flexibility Analysis (IRFA) for proposed rules where there would be a significant economic impact on a substantial number of small firms. (5 U.S.C. 601-612). Under the provisions of the law, each such analysis shall contain: 1. A description of the impact of the proposed rule on small entities; 2. A description of the reasons why action by the agency is being considered; 3. A succinct statement of the objectives of, and legal basis for, the proposed rule; 4. A description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply; 5. A description of the projected reporting, recordkeeping and other compliance requirements of the proposed rule, including an estimate of the classes of small entities which will be subject to the requirements and the type of professional skills necessary for preparation of the report or record; 6. An identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap or conflict with the proposed rule; and 7. A description and discussion of any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities, such as (a) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (b) The clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (c) The use of performance rather than design standards; and (d) An exemption from coverage of the rule, or any part thereof, for such small entities. The Regulatory Flexibility Act further states that the required elements of the IRFA may be performed in conjunction with or as part of any other agenda or analysis required by any other law if such other analysis satisfies the relevant provisions. While a full understanding of OSHA's analysis and conclusions with respect to costs and economic impacts on small businesses requires a reading of the complete PEA and its supporting materials, this IRFA will summarize the key aspects of OSHA's analysis as they affect small businesses. 1. A Description of the Impact of the Proposed Rule on Small Entities. The proposed regulation would require classification of chemicals, especially chemical mixtures, somewhat different from current hazard determination methods; a standardized format for the organization of MSDSs (now called SDSs); standardized labels and standardized pictograms; and training for affected employees on these changes. (Some commenters argued that GHS would also impose more stringent testing requirements, but as explained in Section V of the preamble, the HCS [[Page 50356]] does not currently require testing of chemicals, and will not require testing with adoption of the GHS.) For the purpose of its cost analysis, OSHA estimated three types of cost: (1) Costs to chemical producers of classifying chemicals, reformatting SDSs, and developing new labels; (2) Costs for safety and health managers and logistics personnel to familiarize themselves with the standard (although not required by the regulation, this is a necessary step in its implementation); and (3) Costs of training affected employees on how to find the information they need on SDSs and to comprehend pictograms and standard labels. OSHA believes that each of these is a one-time cost that would be incurred during the three-year transition period after the final rule is published. OSHA anticipates that, once the final rule is implemented, the costs under GHS will be equivalent to the costs under the existing HCS system. In other words, once chemical producers and distributors set up for and shift to the GHS system, OSHA expects there will be no additional costs arising from the proposed rule for classification, SDSs, and labeling. OSHA also anticipates that, after the three-year transition period, the familiarization costs for health and safety managers, logistics personnel, and emergency response planners and the training costs for affected employees will be lower under the uniform GHS system than under the existing HCS system. (However, in its estimates of economic impacts, OSHA has not included any cost savings for the expected lower training costs.) OSHA welcomes comments on these points, which are critical to OSHA's economic analysis of costs, benefits, and economic impacts. OSHA's criteria for determining whether there are significant economic impacts on a substantial number of small firms are that, for any given industry, the annualized costs as a percentage of revenues do not exceed 1 percent and that the annualized costs as a percentage of profits do not exceed 5 percent. All of OSHA's calculations of the economic impacts on small firms totally ignore any offsetting benefits of any kind, even though OSHA estimates that, for most small firms, the benefits of this rule will actually exceed the costs. OSHA's industry-by-industry analysis, both for small firms as defined by SBA and for very small firms with fewer than 20 employees, shows that in no industry size class do the annualized costs exceed 0.013 percent of revenues or 0.4 percent of profits. For affected small firms as defined by SBA, the average annualized cost per firm of the proposed rule would be $16 per year. In terms of chemical producing industries only, the average annualized cost per small firm as defined by SBA would be $452 per year. For affected firms with fewer than 20 employees, the average annualized cost per firm of the proposed rule would be $12 per year, and the average annualized cost per firm that produces chemicals would be $167 per year. Given these results, OSHA concludes that the proposed rule will not have a significant economic impact on a substantial number of small firms. Thus, an IRFA is not required for this rulemaking. However, recognizing the possible value that such an analysis may provide, OSHA has voluntarily included the elements of the IRFA as part of this Initial Regulatory Flexibility Screening Analysis (IRFSA) and has analyzed the potential impact of the proposed revisions on small entities. As described in Section D of this economic analysis, the proposed revisions to HCS, on the whole, are expected to result in significant net benefits to employers, as the associated cost savings outweigh the corresponding compliance costs. The underlying analysis included the effects on small entities, and this conclusion generally applies to the small entities affected by the proposed rule. In order to ensure that any potential significant adverse impact on a substantial number of small entities would be appropriately considered, OSHA also specifically evaluated the impact on small entities of the costs of compliance alone, without regard to the associated savings. The total annualized cost of compliance with the proposal for small entities is estimated to be approximately $63 million, as shown by industry in Table VII-6. To assess the potential economic impact of the proposal on small entities, OSHA calculated the ratios of compliance costs to profits and to revenues. These ratios are presented for each affected industry in Table VII-6. OSHA expects that among small entities potentially affected by the proposal, the average increase in prices necessary to completely offset the compliance costs would be 0.0009 percent. The average price increase necessary to completely offset compliance costs would not exceed 0.02 percent among small entities in any single affected industry sector. In the event that no costs could be passed through, the compliance costs could be completely absorbed through an average reduction in profits of less than 0.02 percent. In most affected industries the compliance costs could be completely absorbed through an average reduction in profits of less than 0.05 percent; the reduction would be no more than 0.4 percent in any of the affected industries. To further evaluate the potential for any adverse effects on small entities resulting from the proposal, OSHA assessed the short-term impacts that may be associated with the compliance costs during the transition period. BILLING CODE 4510-26-P [[Page 50357]] [GRAPHIC] [TIFF OMITTED] TP30SE09.033 [[Page 50358]] [GRAPHIC] [TIFF OMITTED] TP30SE09.034 [[Page 50359]] [GRAPHIC] [TIFF OMITTED] TP30SE09.035 [[Page 50360]] [GRAPHIC] [TIFF OMITTED] TP30SE09.036 [[Page 50361]] [GRAPHIC] [TIFF OMITTED] TP30SE09.037 [[Page 50362]] [GRAPHIC] [TIFF OMITTED] TP30SE09.038 BILLING CODE 4510-26-C The total non-annualized compliance costs for small entities during the three-year transition period are estimated to be $740 million, or about $247 million [[Page 50363]] per year for three years. Thus, the potential temporary impact would be about 0.003 percent of revenues or about 0.1 percent of profits, on average, per year for three years. In order to further ensure that potential impacts on small entities were fully analyzed and considered, OSHA also separately examined the potential impacts of the proposed standard on very small entities, defined as those with fewer than 20 employees. As shown in Table VII-7, the total annualized costs for entities in this size class would be an estimated $40 million. The annualized costs represent about 0.001 percent of revenues and less than 0.03 percent of profits. The total non-annualized compliance costs for very small entities during the three-year transition period are estimated to be $463 million, or about $154 million per year for three years. Thus, the potential temporary impact would be less than 0.005 percent of revenues or 0.15 percent of profits, on average, per year for three years. In order to more carefully focus on the industry sectors most likely to have significant economic impacts, OSHA carefully examined those industries in the chemical manufacturing and petroleum and coal products manufacturing sectors (``chemical and petroleum producers'') that produce chemicals and SDSs. OSHA examined the extent to which these firms might have significant economic impacts if they produced an unusually high number of chemical products requiring SDSs. To examine this issue, OSHA examined all small chemical and petroleum producers with respect to their costs as a percentage of revenues and profits. Using the same cost estimation methods as the base analysis, OSHA estimated how many separate chemical products a small firm would have to produce for its annualized costs of compliance with the proposed rule to exceed 5 percent of profits. OSHA found that the firm would have to produce 3,385 distinct chemical products, each requiring its own SDS. OSHA thinks it very unlikely that there are substantial numbers of small firms (with an average of 27 employees) that produce 3,385 or more distinct chemical products. Swedish data show that less than 0.1 percent of all firms (including large firms) in Sweden produce more than 500 distinct chemical products. (Swedish Chemical Agency, http://www.kemi.se/templates/Page____4268.aspx, 2007 data.) OSHA conducted a similar analysis for very small firms with fewer than twenty employees. This analysis found that such firms, with an average of 4.7 employees, would need to produce more than 140 distinct chemical products for costs to exceed 5 percent of profits. OSHA estimates that this would be a very rare situation. Further, even if small firms could be found that produce more than 3,385 chemical products and very small firms that produce more than 140 chemical products, the costs would probably be much lower than OSHA estimates. First, firms producing this many distinct products probably would not produce SDSs and labels by hand, as OSHA assumes most small firms do, but would instead invest in appropriate software to lower their costs, as most larger firms do. Second, firms producing large numbers of chemical products commonly do so because they sell a variety of different mixtures. Once appropriate data for the ingredients of these mixtures had been developed, using the bridging principles outlined in Appendix A of the preamble, small firms developing SDSs and labels for each mixture would take far less than the 7 hours per chemical product that OSHA has estimated for small firms to convert to the GHS system. BILLING CODE 4510-26-P [[Page 50364]] [GRAPHIC] [TIFF OMITTED] TP30SE09.039 [[Page 50365]] [GRAPHIC] [TIFF OMITTED] TP30SE09.040 [[Page 50366]] [GRAPHIC] [TIFF OMITTED] TP30SE09.041 [[Page 50367]] [GRAPHIC] [TIFF OMITTED] TP30SE09.042 [[Page 50368]] [GRAPHIC] [TIFF OMITTED] TP30SE09.043 [[Page 50369]] [GRAPHIC] [TIFF OMITTED] TP30SE09.044 BILLING CODE 4510-26-C OSHA therefore concludes that there are not a substantial number of firms that would incur significant economic [[Page 50370]] impacts as a result of producing a very large number of chemical products. OSHA remains concerned with the possible problems of small and very small firms that might produce very large numbers of distinct chemical products. OSHA welcomes comments on the issue of whether there are small and very small firms that produce a very large number of products, what industries they are in, and their anticipated costs to convert to the GHS system. 2. A description of the reasons why action by the agency is being considered. OSHA's HCS was first adopted in 1983 for manufacturing (48 FR 53280). Later the Agency expanded the scope of coverage to include all industries where employees are potentially exposed to hazardous chemicals (52 FR 31852). The HCS requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import. The rule provides definitions of health and physical hazards to use as the criteria for determining hazards in the evaluation process. The information about the hazards and protective measures is then required to be conveyed to downstream employers and employees by putting labels on containers and preparing and distributing safety data sheets. 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. Ensuring that this information is available in workplaces helps employers design and implement appropriate controls for chemical exposures, and gives employees the right-to-know and the knowledge of the hazards and identities of the chemicals, as well as allowing them to participate actively in the successful control of exposures. Together, these actions of employers and employees reduce the potential for adverse effects to occur. The information transmitted under the HCS requirements provides the foundation upon which a chemical safety and health program is built in the workplace. Without this information, appropriate controls could not be identified and implemented. OSHA's HCS is designed to disseminate information on chemicals to precipitate changes in handling methods and thus protect those exposed to the chemical from experiencing adverse effects. To protect employees and members of the public who are potentially exposed to 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. These laws vary with regard to 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 between the various laws are substantial enough that different labels and safety data sheets must often be used for the same product when it is marketed in different nations. For example, Canada has established requirements for labels under its Workplace Hazardous Materials Information System (WHMIS). WHMIS requires that labels include specified symbols within a defined circle. U.S. chemical manufacturers must label their chemicals accordingly for marketing in Canada. Development of multiple sets of labels and safety data sheets for each product when shipped to different countries is a major compliance burden for chemical manufacturers, distributors, and transporters involved in international trade. Small businesses may have particular difficulty in coping with the complexities and costs involved, and it has been argued that these differing requirements may be a technical (non-tariff) barrier to trade. These concerns led, in June 1992, to a mandate from the United Nations Conference on Environment and Development (UNCED) (Chapter 19 of Agenda 21), supported by the U.S., calling for development of a globally harmonized chemical classification and labeling system. The negotiations were extensive and spanned a number of years. The product resulting from this effort, the Globally Harmonized System of Classification and Labeling of Chemicals, 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 Labeling of Chemicals in December 2002. The proposed modifications to the HCS incorporate the GHS's requirements. They would require chemical manufacturers to apply new hazard classification criteria to their chemicals and to prepare and distribute new labels and safety data sheets. Further, these SDSs and labels would be standardized in a way that they are not under the existing hazard communication standard. OSHA's current performance- based approach to SDSs and labeling can create confusion among those who seek to use hazard information effectively. For example, labels and safety data sheets may include symbols and hazard statements that are unfamiliar to readers or not well understood. This lack of standardization and the absence of pictograms are particularly a problem for U.S. workers not literate in English. Containers may be labeled with such a large volume of information that important statements are not easily recognized. OSHA believes that adoption of these new requirements would benefit employers and enhance employee safety. Employers who use chemicals, and exposed employees, would benefit from receiving the revised labels and safety data sheets prepared in a consistent format. The information should be easier to comprehend and access in the new approach, allowing it to be used more effectively for the protection of employees. The primary effect in workplaces where chemicals are used but not produced would be to integrate the new approach into the workplace hazard communication program, including assuring that both employers and employees understand the pictograms and other information provided on the chemicals. OSHA believes that adoption of the GHS would improve labels and SDS comprehensibility through implementation of a standardized approach. The current regulatory system includes a performance-oriented approach to labels and SDSs, allowing the producers to use whatever language or format they choose to provide the necessary information. This results in a lack of consistency that makes it difficult for users of chemicals to properly identify their hazards and protective measures, particularly when purchasing the same product from multiple suppliers. Having the information provided in the same words and pictograms on labels, as well as having a standardized order of information on SDSs, would help all users, including employers, employees, and safety and health responders, more easily identify the critical information necessary to protect employees. In addition, American employees and employers should receive benefits from the international adoption of GHS. Development of the GHS system required extensive work by a great number of people, and resources from many countries and organizations. The reason it received such support is that there is a belief that there are significant benefits associated with implementation of a globally harmonized approach to hazard communication. Countries, international organizations, chemical producers, and users of chemicals would all benefit. There are at least four [[Page 50371]] reasons to expect that GHS will be adopted globally. First and foremost, implementation of the GHS would enhance protection of humans and the environment. Occupationally related injuries, illnesses, and fatalities remain a serious problem in the U.S. For example, although likely to contain very significant underreporting, data from the Bureau of Labor Statistics indicate that, in 2007, employees suffered an estimated 55,400 illnesses attributable to chemical exposures (BLS, 2008), and that some 17,340 chemical-source injuries and illnesses involved days away from work (BLS, 2009). As shown in the preliminary economic analysis, the adoption of the proposed revisions is expected to result in a significant reduction in injuries, illnesses, and fatalities among U.S. employees exposed to hazardous chemicals. In addition, while some countries, such as ours, already have the benefits of protection under existing systems, the majority of countries do not have such comprehensive approaches. Thus, implementation of the GHS would provide these countries with the important protections that result from dissemination of information about chemical hazards and protective measures. In our country, we expect to improve and build on protections we already have. Second, implementation of such an approach would facilitate international trade in chemicals. It would reduce the burdens caused by having to comply with differing requirements for the same product, and allow companies who do not have the resources to deal with those burdens to be involved in international trade. Third, one of the initial reasons this system was pursued internationally involved concerns about animal welfare and the proliferation of requirements for animal testing and evaluation. Existing systems with different definitions of hazards often result in duplicative testing to produce data related to the varying cut-offs in the different systems. Having one agreed definition would reduce this duplicative testing. It should be noted, however, that OSHA has never had testing requirements. The HCS is based on collecting and evaluating the best available existing evidence on the hazards of each chemical. Fourth, information transmittal systems provide the underlying infrastructure for the sound management of chemicals in a country. Those countries that do not have the resources to develop and maintain such a system can use the GHS to build their chemical safety and health programs. Since it has been developed, and will be maintained, through an international approach, national resources to accomplish chemical safety and health can be streamlined. Unlike some other issues, a country's approach to the sound management of chemicals definitely affects others countries. In some cases, bordering countries may experience pollution and other effects of uncontrolled chemical exposures. In all countries, there is a need to acquire sufficient information to properly handle the chemical when it is imported from other countries. Thus having a coordinated and harmonized approach to the development and dissemination of information about chemicals would be mutually beneficial to importing and exporting countries. In the U.S., there are four primary regulatory agencies that exercise jurisdiction over chemical hazard communication: OSHA; the Department of Transportation, which regulates chemicals in transport; the Consumer Product Safety Commission, which regulates consumer products; and the Environmental Protection Agency, which regulates pesticides and has other labeling authority under the Toxic Substances Control Act. These agencies are not domestically harmonized in terms of definitions of hazards and other requirements. If all four agencies adopt the GHS, the U.S. would have the additional benefit of harmonizing the overall U.S. approach to classification and labeling. Since most chemicals are produced in a workplace and shipped elsewhere, nearly every employer deals with at least two sets of Federal requirements. Thus every producer would be likely to experience some benefits from domestic harmonization. OSHA has made a preliminary determination that the proposed revisions would improve the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. The Agency anticipates this improved information would enhance the effectiveness of the HCS in ensuring that employees are apprised of the chemical hazards to which they are exposed, and in reducing the incidence of chemical-related occupational illnesses and injuries. OSHA preliminarily estimates that (1) savings in benefits from improved employee health and safety exceed the costs of the proposed rule, and (2) cost savings to chemical users exceed the costs of the proposed rule. An additional and more complete discussion of the reasons why this standard is being proposed by the Agency is provided in other parts of the preamble section of this Notice of Proposed Rulemaking (NPRM). 3. Statement of the objectives of, and legal basis for, the proposed rule. The primary objective of the proposed revisions to the OSHA HCS is to achieve the potential benefits of the OSHA HCS in a more comprehensive, efficient, and effective manner. The revisions are expected to provide an increased degree of occupational safety and health for employees exposed to hazardous chemicals in the workplace. Another objective of the proposed revisions is to provide updated, clear, and comprehensive standards regarding the classification of chemical hazards and the manner in which relevant information about chemical hazards is disseminated to affected employees. The intent of the HCS is to ensure that the hazards of all chemicals are evaluated and that information concerning chemical hazards and associated protective measures is transmitted to employers and employees. The standard achieves this goal by requiring chemical manufacturers and importers to review available scientific evidence concerning the physical and health effects 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 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. The three information components in this system--labels, SDSs, and employee training--are all essential to the effective functioning of the program. Labels provide a brief, 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. [[Page 50372]] Information provided in accordance with the HCS serves to reduce the incidence of chemical-related illnesses and injuries in the workplace. This is accomplished by modifying the behavior of both employers and employees. Providing information to employers enables them to implement protective measures in the workplace. Less hazardous alternatives may be chosen, or appropriate engineering controls, work practices, and personal protective equipment can be selected. 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 in their workplace 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. OSHA believes that the comprehensive approach adopted in the HCS, which includes requiring evaluation of chemicals and the transmittal of information through labels, SDSs, and training, is sound. This proposed rule does not alter that approach. Rather, the proposed rule is intended to improve the effectiveness of the HCS by enhancing the quality and consistency of the information provided to employers and employees. OSHA believes this can be accomplished by revising the requirements of the standard to conform to the more specific and detailed provisions of the GHS for classification, labeling, and SDSs. The legal basis for the rule is the responsibility given the Department of Labor through the Occupational Safety and Health (OSH) Act of 1970. The OSH Act authorizes and obligates the Secretary of Labor to promulgate mandatory occupational safety and health standards as necessary ``to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources.'' 29 U.S.C. 651(b). The OSH Act gives the Agency authority to issue and revise standards and regulations to further this goal. A thorough discussion of the legal basis can be found in the preamble to the proposed standard in Section VI--Pertinent Legal Authority. 4. Description of and estimate of the number of small entities to which the proposed rule will apply. OSHA has completed a preliminary analysis of the impacts associated with this proposal, including an analysis of the type and number of small entities to which the proposed rule would apply, as described above. In order to determine the number of small entities potentially affected by this rulemaking, OSHA used the definitions of small entities developed by the Small Business Administration (SBA) for each industry. The proposed standard would impact firms that are the primary producers or distributors of hazardous chemicals, and firms whose employees are exposed to hazardous chemicals. Based on the definitions of small entities developed by SBA for each industry, the proposal is estimated to potentially affect a total of 4,215,404 small entities, as shown in Table VII-6. The rule would have its greatest impacts on the 72,000 small firms that produce chemicals that require SDSs and labels. 5. Description of the projected reporting, recordkeeping and other compliance requirements of the proposed rule. The proposed standard includes revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, and hazard statements; a specified format for safety data sheets; and related revisions to definitions of terms used in the standard, employee information and training requirements, and other sections of HCS. The preamble to the proposed standard provides a comprehensive description of, and further detail regarding, the compliance requirements of the proposed rulemaking. A description of the types of entities which would be subject to the new and revised requirements, and the types of professional skills necessary for compliance with the requirements, is presented in the relevant sections of this economic analysis and the corresponding supporting research, and is summarized below with a summary of unit costs. Except for employee training, these costs would apply only to those businesses not already in compliance with the proposed revisions. OSHA requests comments and information from the public regarding these estimates: Reclassifying chemicals and modifying SDSs and labels: Medium establishments (100-499 employees): an average of 5 hours per SDS; in addition, for 25 percent of establishments, an average of $200 per SDS for software modifications. Small establishments (1-99 employees): an average of 7 hours per SDS. Management familiarization and other costs: Eight hours for health and safety managers and logistics personnel in the manufacturing sector. Two hours for each hazard communication program manager not in the manufacturing sector. Employee training: 30 minutes per production employee in most industries; 15 minutes in occupations exposed to few hazardous chemicals and types of hazards; 5 minutes per employee in some occupations where GHS-type pictograms are already in use. 6. Federal rules which may duplicate, overlap or conflict with the proposed rule. OSHA has not identified any other Federal rules which may duplicate, overlap, or conflict with the proposal, and requests comments from the public regarding this issue. 7. Alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities. As discussed in Section IV, this rulemaking is unique for OSHA in that it seeks to improve employee protections by adopting an internationally harmonized approach to hazard communication issues. While the current HCS has provided protections for exposed workers by disseminating information about chemicals in their workplaces for many years now, the approach taken in the GHS strengthens and refines the system, and gives OSHA the opportunity to improve hazard communication by adopting it. The GHS has the same general concept of an integrated, comprehensive process of identifying and communicating hazards, but provides more extensive criteria to define the hazards in a consistent manner, as well as standardizes label elements and SDS formats to help to ensure that the information is conveyed consistently. OSHA has preliminarily concluded that required adoption of GHS is the [[Page 50373]] best approach to modifying the HCS to achieve the goals of global harmonization, ease of use, and improved health and safety. As addressed in Section XV of the preamble, many commenters supported the concept of OSHA moving forward to adopt the GHS. Several objected to adoption, and OSHA has identified and responded to their concerns in Section XV of the preamble as well. In addition, there were several commenters who noted that small chemical manufacturers that are not engaged in international trade of chemicals would have a large burden associated with adopting the GHS, and questionable benefits due to their lack of involvement in international trade. The Small Business Administration (SBA) suggested that OSHA ``consider `grandfathering' or exempting small businesses that do not export regulated chemicals.'' (Document ID 0022) Others simply noted that they believed there would be high costs and limited benefits for such employers, or that it would be costly and difficult to adopt (Document ID s 0015, 0026, 0178, and 0144). There was no discussion in any of these comments about how this might work in the revised standard. None of these commenters suggested a detailed approach to exactly how such a grandfathering or exemptions might work. OSHA welcomes comments on how such approaches might work. A somewhat different alternative that might achieve the goals of those employers who anticipate high costs for little benefit to themselves would be for OSHA to consider simply facilitating the voluntary adoption of GHS. With some very minor exceptions that could easily be changed by rule, the existing HCS performance-based approach to MSDS would permit chemical producers and importers to use the proposed GHS SDS format and approach. They could not however, adopt the GHS classifications without a change to the rule allowing the use of GHS classifications where they differed from those in HCS. The use of labels adopting GHS signal words, precautionary statements, formats, and pictograms could be possible under the HCS performance-based approach to labels. However, it should be carefully noted that, although the resulting label might appear GHS compliant, it need not actually be GHS-compliant, and in some case would not be based on the GHS classifications. Further, individual firms could produce labels using GHS formats, etc., with meanings quite different from those in GHS. The advantages of a system that simply facilitated voluntary adoption of GHS are that (1) those engaged in international trade, whether as exporters or importers, could obtain the full benefits of international harmonization; (2) those producers of chemicals who saw no market advantage to changing systems would not need to incur the costs associated with changing their hazard classification, MSDSs, and labels and (3) it is possible that employee training under a performance-based system for MSDSs and labels would not need to be required or changed. OSHA sees a number of disadvantages to a rule that simply facilitates the voluntary adoption of GHS. First consider the issues of a common MSDS/SDS format versus MSDS/SDS formats that can vary in any way whatsoever while meeting a standard of what an MSDS must contain. Such an approach would eliminate a proportion of the possible benefits from knowing where to look in an SDS for the information one wants or needs, since many SDSs will still not be standardized. From OSHA's perspective, a key issue of concern in such an approach is that the classification criteria in the GHS are different from the hazard definitions in the current HCS. In general, as discussed in Section XV of the preamble, they cover the same scope of hazard, so these differences do not result in significant differences in the chemicals covered. But the GHS criteria divide most of the hazard classes into hazard categories that convey the severity of the effect, while few of the hazard definitions in the current HCS take this approach. The standardized label elements are associated with these specific hazard categories, i.e., the harmonized pictograms, signal words, and hazard statements are assigned by hazard category and reflect the degree of hazard it presents to those exposed. Likewise, the precautionary statements assigned are also reflective of the degree of hazard, with responses related to these presumed hazard levels. Third, consider the possible disadvantages of not having a common, well-understood labeling system with signal words, pictograms, precautionary statements and common formatting. In the absence of such a system it would be extremely difficult to teach persons not literate in English how to understand labels, and even those literate in English may have difficulty with major differences in the symbols and language used for the same substance or hazard. It should also be noted that allowing the voluntary use of GHS might not be considered GHS-compliant as the phrase is used in GHS publications. It is difficult to quantify the benefits and costs of the alternative of simply facilitating adoption of GHS. Part of the problem is that it is difficult to forecast the extent to which persons would voluntarily adopt GHS. OSHA therefore considered two scenarios. In the first scenario, there is no extensive adoption of GHS and GHS becomes simply a minor sub-class of the performance-oriented options already available. This scenario has the effect of minimizing the costs associated with the facilitation of voluntary adoption of GHS, but at the expense of minimizing the benefits of this alternative. In the second scenario, GHS would be adopted widely enough to become the norm for hazard communication, but some would continue their existing HCS approaches unchanged. Under this scenario, most firms would insist that their health and safety managers and logistics personnel be thoroughly familiar with GHS, and that employees be trained on GHS. This scenario minimizes the loss in benefits associated with the first scenario, but involves much greater costs than scenario 1 and may involve significantly increased costs over the option of full compliance with GHS. OSHA believes that the actual results will fall between these two scenarios and is seeking comment on the relative likelihood of these or other scenarios. OSHA suspects that second scenario might be the more likely possibility. For example, the standardized MSDS system adopted by GHS is widely used in the U.S., particularly by large firms and firms with many MSDSs, though many have not adopted this system. Domestic and international producers, and large and small producers are not mutually exclusive--a large business engaged in international trade can not simply implement the GHS regardless of its suppliers. Small businesses sell to large businesses. If small businesses do not adopt the GHS, then the large businesses would have to generate GHS classifications for chemicals they buy from them in order to follow the GHS. It would be difficult for them to do this, particularly for mixtures, since they are not the producer of the chemicals. This concept was addressed in comments regarding the effective dates for the rule, when many suggested it was not appropriate to differentiate dates based on the size of the business. For example, ORC Worldwide, Inc. stated (Document ID 0123): OSHA should consider a company's place in the manufacturing supply chain, not size, in determining how the phase-in is implemented. It would be sensible to start with producers of raw materials and basic chemicals. The technical information, [[Page 50374]] classification and categorization they perform will be useful downstream for the intermediate chemical producers and specialty chemical manufacturers. Lastly, the end user will benefit from the influx of information developed by the upstream professionals. Just as the size of the company may not be an appropriate criterion to determine when that company should be in compliance, it also does not appear to be a useful way to determine whether the GHS provisions should be adopted by them. It is difficult to determine how a voluntary system, or a system based on business size, would be successfully implemented and enforced given the structure of the supply system. Because of these factors, OSHA anticipates that many smaller firms who may think they do not need GHS may be forced through the market to adopt the system to satisfy the needs of customers who do engage in international trade. Under the first scenario, with no extensive voluntary adoption of GHS, the annualized costs $11 million per year for reclassification of chemicals and the $44 million in annualized costs for one-time retraining of workers would be largely eliminated. OSHA estimates that the $45 million in annualized costs for health and safety managers and logistics personnel to familiarize themselves with the GHS system would still be incurred. This alternative might add a continuing cost not present under either system of the need for new health and safety managers and logistics personnel to be familiar with both systems. Assuming a 5 percent annual turnover among such professional, assuring continuing knowledge of both systems would add costs of $25 million per year. This alternative under Scenario 1 would thus reduce the costs from $97 million per year to between $42 million per year and $77 million per year depending on whether it is assumed that new health and safety managers and logistics personnel would need to be familiar with both systems. In return for this reduction in costs, under Scenario 1, because of the assumption of no significant adoption of GHS, the benefits of $851 million per year are also lost. Furthermore, this analysis ignores non-quantified benefits of full adoption of GHS, such as decreases in training costs associated a full GHS system. In choosing the voluntary adoption of GHS alternative, OSHA would be ignoring the potentially substantial health and safety benefits arising from the economically feasible (and, for most businesses, the economically desirable) option of full compliance with GHS and instead adopting a system with no such health and safety benefits for the sole reason of possibly saving a small minority of all affected businesses some costs. Under Scenario 2, with widespread voluntary adoption of GHS, more benefits would be achieved than under Scenario 1, but all the benefits available under the proposed rule would not be achieved, and OSHA believes there would be greater costs than under the option of requiring full compliance with GHS. However, if widespread adoption of GHS is to result in substantially higher benefits than under Scenario 1, then health and safety managers and logistic personnel would have to be fully familiar with both systems, and employees would also need to be trained on GHS as the primary system and not just as one of many performance-oriented options. Thus, Scenario 2 would save some portion of the $11 million in annualized costs per year spent by chemical producers for reclassification and modifying SDSs and labels. However, the full costs of management familiarization and one-time employee training would still need to be incurred. In addition continuing costs would have to be incurred for new health and safety managers and logistic personnel to familiarize themselves with two systems and for new employees to be trained on both systems. Assuming turnover of 5 percent for manager and 20 percent for employees, the associated annual costs would be $150 million per year. Under Scenario 2, the alternative of facilitating voluntary adoption would achieve some portion of the benefits of GHS but with significantly greater costs--an additional $150 million per year for continuing GHS training of new employees and GHS familiarization for new health and safety managers and logistics personnel, offset by a very modest reduction in costs to chemical producers. In terms of benefits, both OSHA's proposed full GHS compliant approach and that of a dual system would retain possible benefits to chemical producers and to international trade. However, OSHA is concerned that the confusions arising might negate some of the benefits associated with reduced injuries, illnesses and fatalities. While there would still be some situations where use of GHS would prevent injuries, there would also be situations where confusion and misunderstanding would lead to injuries, illnesses, and fatalities that might not otherwise be incurred. For example, employees used to seeing pictograms might easily make the false assumption that chemicals without a pictogram are safe. This has the potential to eliminate a significant portion of the annual health and safety benefits. Other benefits would also need to be reduced, though it is not clear by how much. In addition to the chosen alternative of full compliance with GHS, OSHA also considered options requiring full compliance with some but not all portions of GHS. One such option would be to adopt the provisions of the GHS that are presumed to provide the greatest benefits at the least cost. For example, OSHA could adopt the standardized label provisions without the associated hazard classification criteria. Employers would be free to continue to use the existing hazard determination scheme, but present the label information in the standardized form anticipated under the GHS. Since the standardized labels appear to be relatively inexpensive to implement, while reviewing classifications is more costly, this has the potential to reduce the overall cost of implementation of the revised rule. This option--adopting the label provisions but not the classification criteria--presents many of the same concerns. First, the reason the label provisions are relatively cost-efficient to adopt is that the GHS assigns the various required elements by hazard class and category. It is basically a cookbook approach. Once the classification or re-classification has been accomplished, the GHS provides the specific information for the label. Requiring this standardized approach to labeling without the infrastructure of the criteria would be more burdensome for the chemical manufacturer to accomplish, though OSHA could consider whether it would be appropriate to provide criteria for HCS classification under this alternative that would reduce burden. However, OSHA is also concerned that this alternative would result in labels that may look the same but which actually do not have consistent warnings based on the precise hazardous effect. Without the GHS criteria that breaks hazard classes into multiple categories for most effects, it would be difficult to relate the label elements to the hazard determinations under the current HCS. For example, the current standard treats all carcinogens the same way, rather than differentiating them into several categories. OSHA would either have to provide some type of decision logic to employers in order to have a consistent approach or allow the responsible party to determine the appropriate labeling elements that should be included on the label. The most protective approach would be to treat all carcinogens or other effects as [[Page 50375]] being in the most hazardous category of each class so there will be no choice of label elements that would cause differences among employers. Regardless, chemical producers will have to undergo an assessment of their current determinations and attempt to relate them to the established hazard categories. This will be difficult, particularly for small producers. Alternatively, OSHA could create a regulatory system assigning HCS categories to each GHS label, but this would be totally contrary to the performance-orientation of the current HCS system, as well as having undetermined costs. It is thus unlikely that this would provide significant savings relative to simply reviewing classifications for purposes of putting the chemicals into GHS classes and categories. However, apart from this burden, the benefits of standardized labeling would be reduced by not having common criteria upon which they are based. Chemical producers following this approach would likely not be able to use their labels in other countries where the GHS has been adopted. Hence, there would be costs of adoption without commensurate benefits in either comprehensibility or facilitation of trade. Another type of dual approach would have OSHA adopt some, but not all, of the label elements. In particular, the Agency might not adopt the exact language of the precautionary statements since this language has been codified but are not yet considered to be ``harmonized'' under the GHS--they are provided for guidance and reference, but competent authorities may choose to implement other statements. The exact language for precautionary statements could be adopted later when they are harmonized under the GHS. Alternatively, OSHA could either allow label preparers to use whatever precautionary statements they deem appropriate or develop its own set of statements to require. The precautionary statements, however, are the part of the GHS label that provides the measures to follow to ameliorate the possible hazardous effects of exposure. Delaying adoption of the precautionary statements would likely reduce the effectiveness of the labels significantly, and reduce the appropriate information on the SDSs as well. Labels that lack a precautionary statement would not be fully harmonized. The second alternative, to simply require precautionary statements, but not to specify what they are, would provide some protection but would not correct the current situation of inconsistent precautions due to the performance-oriented approach that allows the label preparer to determine what they are or if they are included. One communication advantage of providing the information in the same language from label-to-label is that workers and other users can be assured that the same action is required. If you take a simple preventive measure such as ``wash your hands,'' but convey it in several different ways, the reader of the label could think you mean something different. This is one of the advantages of providing the text for these statements in the revised HCS. It should be noted that it appears that all of the commenters favoring an alternative of less than full compliance with GHS saw the primary benefits of adopting the GHS would be in facilitating international trade. As has been addressed throughout the PEA, however, OSHA has based the benefits of this action on improved communication to workers and to health and safety managers and logistics personnel resulting in improved safe handling of hazardous chemicals, not on the trade benefits which, while recognized, have not been quantified. Therefore, OSHA believes that any grandfathering or exemption related to this rule would result in some of these parties not obtaining the same level of benefits of increased comprehensibility as workers in other types and sizes of workplaces. OSHA welcomes comments on these issues, but in the absence of a clear case for one of the alternatives presented, OSHA will continue to consider the alternative proposed, full compliance with GHS by all U.S. firms, the best alternative. OSHA considered one other set of alternatives to the proposed rule: changing the proposed three-year duration of the phase-in. A shorter phase-in period was criticized by all commenters both because of feasibility issues and for radically increasing compliance costs. OSHA did examine the costs and benefits of a longer phase-in, over a five- year period, and found that the longer phase-in would lower annualized costs from $97 million to $88 million per year, but would also lower the annualize benefits from $851 million per year to $693 million per year, with the ultimate effect of lowering net benefits. Even the lowering of costs may be somewhat illusory because these estimates do not take account of the additional confusion caused by having two different systems in place for an additional two years. I. Environmental Impacts The provisions of this proposal have been reviewed in accordance with the requirements of the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321, et seq.), the Council on Environmental Quality (CEQ) NEPA regulations (40 CFR parts 1500-1508), and the DOL NEPA Procedures (29 CFR part 11). As a result of this review, OSHA has determined that the proposed standards would have no significant adverse effect on air, water, or soil quality, plant or animal life, use of land, or other aspects of the environment. OSHA anticipates that the more complete and easier-to-understand SDSs resulting from this proposal would, in addition to increasing employee health and safety, have positive effects on the environment. J. Unfunded Mandates Reform Act Analysis Section 3 of the Occupational Safety and Health Act makes clear that OSHA cannot enforce compliance with its regulations or standards on the U.S. government ``or any State or political subdivision of a State.'' Under voluntary agreement with OSHA, some States enforce compliance with their State standards on public sector entities, and these agreements specify that these State standards must be equivalent to OSHA standards. Thus, although OSHA may include compliance costs for affected public sector entities in its analysis of the expected impacts associated with a proposal, the proposal would not involve any unfunded mandates being imposed on any State or local government entity. Based on the analysis presented in this preliminary economic analysis, OSHA concludes that the proposal would impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year. Accordingly, this preliminary economic analysis of the proposed revisions to the HCS constitutes the written statement containing a qualitative and quantitative assessment of the anticipated costs and benefits of the Federal mandate, as required under Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532(a)). K. Sensitivity Analysis The methodology and calculations underlying the estimation of the compliance costs, benefits, and economic impacts associated with this rulemaking are generally linear and additive in nature. Thus, the sensitivity of the results and conclusions of the analysis will generally be proportional [[Page 50376]] to variations in the relevant input parameters. For example, if the estimated time that companies need to reclassify chemical hazards and revise SDSs and labels were doubled, the corresponding labor costs (but not software costs) of reclassification and revision of SDSs and labels would double as well. OSHA evaluated a series of such changes in input parameters to test whether and to what extent the general conclusions of the economic analysis held up. On the whole, OSHA found that the conclusions of the analysis are reasonably robust, as changes in any of the input parameters tend not to produce disproportionately large changes in the results. The results also show significant net benefits for the proposed rule regardless of the individual revisions to costs, benefits, or discount rate. The results of the individual sensitivity tests are summarized in Table VII-8 and are described in more detail below. In the sensitivity test where OSHA doubled the estimated time that companies need to reclassify chemical hazards and revise SDSs and labels, and estimates of other input parameters remained unchanged, as shown in Table VII-8, the estimated total costs of compliance would increase by $8 million annually, or by about 8 percent, while net benefits would also decline by $8 million, from $754 million to $746 million annually. BILLING CODE 4510-26-P [[Page 50377]] [GRAPHIC] [TIFF OMITTED] TP30SE09.045 BILLING CODE 4510-26-C In a second sensitivity test, when OSHA increased the estimated total number of affected SDSs addressed by this rulemaking by 50 percent, the [[Page 50378]] corresponding estimated total cost of reclassification and revision of SDSs and labels increased by 50 percent as well. As shown in Table VII- 8, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $5.5 million annually, or by about 6 percent, while net benefits would also decline by $5.5 million annually, from $754 million to $748 million annually.\17\ --------------------------------------------------------------------------- \17\ For this sensitivity analysis, OSHA calculated only the impact on costs of an increase in the number of SDSs. However, in principle, each additional SDS would yield future benefits due to improved efficiencies in creating and revising SDSs under GHS. Although not shown in Table VII-8, this effect would increase benefits by $8 million annually, more than offsetting the $5.5 million annual cost increase. --------------------------------------------------------------------------- In a third sensitivity test, when OSHA increased by 50 percent the estimated number of employees required to be covered by hazard communication programs and to be trained on GHS, the corresponding estimate of the total costs associated with training employees increased by 50 percent. As shown in Table VII-8, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $22 million annually, or by about 23 percent, while net benefits would also decline by $22 million annually, from $754 million to $732 million annually. In a fourth sensitivity test, when OSHA doubled the estimated incremental amount of time necessary for training employees on GHS, the corresponding estimate of the total costs associated with training employees also doubled. As shown in Table VII-8, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $44 million annually, or by about 45 percent, while net benefits would also decline by $44 million annually, from $754 million to $710 million annually. OSHA also performed sensitivity tests on several input parameters used to estimate the benefits of the proposed rule. In one sensitivity test on benefits, OSHA reduced its estimate of health and safety benefits of the proposed rule from 1 percent to 0.5 percent of the benefits estimated for the existing HCS. As shown in Table VII-8, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the proposed rule would decline by $133 million annually, or by about 16 percent, while net benefits would also decline by $133 million annually, from $754 million to $610 million annually. In a second, parallel sensitivity test on benefits, OSHA increased its estimate of health and safety benefits of the proposed rule from 1 percent to 5 percent of the benefits estimated for the existing HCS. As shown in Table VII-8, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the proposed rule would increase by $1,064 million annually, or by about 125 percent, while net benefits would also increase by $1,064 million annually, from $754 million to $1,818 million annually. In a third sensitivity test on benefits, OSHA reduced its estimate of savings due to the improved efficiency in creating and revising SDSs under GHS by 50 percent. As shown in Table VII-8, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the proposed rule would decline by $8 million annually, or by about 1 percent, while net benefits would also decrease by $8 million annually, from $754 million to $746 million annually. In a fourth sensitivity test on benefits, OSHA reduced its estimate of savings due to the improved efficiency of safety and health managers and logistics personnel by 67 percent. As shown in Table VII-8, if OSHA's estimates of other input parameters remained unchanged, the total estimated benefits of the proposed rule would decline by $313 million annually, or by about 37 percent, while net benefits would also decrease by $313 million annually, from $754 million to $441 million annually. OSHA also examined the effect of a change in the discount rate on the annualized costs and benefits. Changing the discount rate from 7 percent, used in the base case, to 3 percent would have the effect of lowering the costs to $73 million per year and increasing the benefits to $916 million per year. The result, as shown in Table VII-8, would be to increase net benefits by $89 million per year, from $754 million to $843 million per year. OSHA also considered the sensitivity of its findings that the proposed rule is economically feasible and does not have a significant economic impact on a substantial number of small entities. Since the estimated potential negative impacts of the rulemaking are relatively small, these impacts would remain small even with relatively large changes in the input parameters. For example, even if the total estimated costs of compliance were increased by a factor of five, these costs would still represent less than 0.002 percent of revenues, and no industry or size class would have costs in excess of 5 percent of profits or 1 percent of revenues. In conclusion, the sensitivity analysis demonstrates that even with relatively large variations in the input parameters, there would not be any disproportionately large changes in the estimates of compliance cost or benefits. Further, even if there were relatively large uncertainties in the estimates of compliance costs and benefits, there would still be a relatively high confidence in OSHA's finding concerning economic feasibility, the certification that the standard will not have significant economic impacts on a substantial number of small firms, and the conclusion that the benefits exceed the costs. OSHA welcomes input from the public regarding all aspects of this sensitivity analysis, including any data or information regarding the accuracy of the preliminary estimates of compliance costs and benefit and how the estimates of costs, benefits, and economic impacts may be affected by varying assumptions and methodological approaches. VIII. OMB Review Under the Paperwork Reduction Act of 1995 The proposed modifications to the Hazard Communication Standard would revise existing Hazard Communication collection of information (paperwork) requirements that are currently approved by the Office of Management and Budget (``OMB'') under the Paperwork Reduction Act of 1995 (``PRA-95''), 44 U.S.C. 3501 et seq., and OMB's regulations at 5 CFR part 1320. The Paperwork Reduction Act defines ``collection of information'' as ``the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public of facts or opinions by or for an agency regardless of form or format.'' (44 U.S.C. 3502(3)(A).) OSHA has submitted the proposed revised Hazard Communication collection of information requirements identified in this NPRM to the OMB for review in accordance with 44 U.S.C. 3507(d). As part of its continuing effort to reduce paperwork and respondent burden, the Department of Labor conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the PRA-95 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collections instruments are clearly understood, and OSHA's estimate of burden is accurate. The Department notes that a Federal agency cannot conduct or sponsor a [[Continued on page 50379]] From the Federal Register Online via GPO Access [wais.access.gpo.gov] ] [[pp. 50379-50428]] Hazard Communication [[Continued from page 50378]] [[Page 50379]] collection of information unless it is approved by OMB under the PRA, and displays a currently valid OMB control number, and the public is not required to respond to a collection of information unless it displays a currently valid OMB control number. Also, notwithstanding any other provisions of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number. OSHA will publish a notice of OMB's action at the final rule stage. OSHA solicits comments on the modified collection of information requirements and the estimated burden hours associated with these collections, including comments on the following: [cir] Whether the proposed collection of information requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful; [cir] The accuracy of OSHA's estimate of the burden (time and cost) of the information collection requirements, including the validity of the methodology and assumptions used; [cir] The quality, utility, and clarity of the information collected; and [cir] Ways to minimize the burden on employers who must comply, for example, by using automated or other technological techniques for collecting and transmitting information. The title, description of the need for and proposed use of the information, description of the respondents, and frequency of response of the information collections are described below, along with an estimate of the annual reporting burden and cost as required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2). Title: Proposed Changes to the Hazard Communications Standard (Globally Harmonized System of Classification and Labeling of Chemicals (GHS)). Description and Proposed Use of the Collections of Information: The proposed Standard would modify existing information collection requirements that are currently approved under OMB Control Number 1218- 0072 (Expiration Date: October 2009). OSHA has submitted the proposed modification of the Hazard Communication Standard to OMB and has requested a new OMB control number addressing the proposed modification. OSHA will maintain OMB approval of the existing collections of information contained in the Hazard Communication Standard, under OMB Control Number 1218-0072. The proposed revisions to the OSHA Hazard Communication Standard would standardize the hazard communication requirements for products used in U.S. workplaces, and thus provide employees with consistent hazard communication information. Hazard communication is currently addressed by many different international, national, and State authorities. These existing requirements are not always consistent and often contain different definitions of hazards and varying provisions for what information is required on labels and safety data sheets. The proposed revisions would harmonize the U.S. system with international norms and therefore would facilitate international trade. The proposed modifications to the Standard's collection of information requirements include: (1) Revised criteria for classification of chemical hazards; (2) revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; (3) a specified format for safety data sheets; and (4) related revisions to definitions of terms used in the Standard and to requirements for employee training on labels and safety data sheets. Paragraph (d), ``hazard classification,'' requires chemical manufacturers and importers to evaluate chemicals produced in their workplaces or imported by them to classify their health and physical hazards in accordance with the Standard. For each chemical, the chemical manufacturer or importer must determine the hazard classes, and the category of each class, that apply to the chemical being classified. Employers are not required to classify chemicals unless they choose not to rely on the classification performed by the chemical manufacturer or importer for the chemical. Chemical manufacturers, importers or employers classifying chemicals must identify and consider the full range of available scientific literature and other evidence concerning the potential hazards. There is no requirement to test the chemical to determine how to classify its hazards. Mandatory Appendix A to Sec. 1910.1200 shall be consulted for classification of health hazards, and Mandatory Appendix B to Sec. 1910.1200 shall be consulted for the classification of physical hazards. For mixtures, chemical manufacturers, importers, or employers evaluating chemicals must follow the procedures described in Appendixes A and B to Sec. 1910.1200 to classify the hazards of the chemicals, including determinations regarding when mixtures of the classified chemicals are covered by the Standard. A chemical manufacturer or importer of a mixture is responsible for the accuracy of the classification of the mixture even when relying on the classifications for individual ingredients received from the ingredient manufacturers or importers on the safety data sheets. Paragraph (f) modifies existing label requirements by requiring more specific information. Paragraph (f)(1) requires chemical manufacturers, importers, or distributors to ensure that each shipped container of classified hazardous chemicals leaving the workplace is labeled, tagged, or marked with the following information: (i) Product identifier; (ii) Signal word; (iii) Hazard statement(s); (iv) Pictogram(s); (v) Precautionary statement(s); (vi) Name, address, and telephone number of the chemical manufacturer, importer, or other responsible party; and (vii) Supplemental information as appropriate. Information provided under (i) through (v) above must be in accordance with mandatory Appendix C, Allocation of Label Elements, for each hazard class and associated hazard category for the hazardous chemical; prominently displayed; and in English (other languages may also be included if appropriate). In addition, the information in (ii) through (iv) must be located together on the label, tag, or mark. For containers of hazardous chemicals that do not fall into one of the new hazard classes, (f)(2) requires that the label include the name of the chemical, the name, address, and telephone number of the manufacturer, importer, or other responsible party, and, as supplementary information, a description of the unclassified hazards and appropriate precautionary measures to ensure the safe handling and use of the chemical. For labels in the workplace, except as provided in paragraphs (f)(8) and (f)(9) of the Standard, employers must ensure that each container of hazardous chemicals in the workplace is labeled, tagged, or marked with either (i) the information specified under (f)(1)(i) through (v) for labels on shipped containers: or, (ii) product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals, and which, in conjunction with the other information immediately available to employees under the hazard communication program, will provide employees with the specific information regarding the physical and health hazards of the hazardous chemical. [[Page 50380]] OSHA is also proposing to update the language for workplace signs and labels to incorporate the GHS hazard statement and the applicable precautionary statement(s), where required. Most OSHA substance- specific health standards require hazard warning signs, usually for regulated areas, and the language required on the signs varies. With the GHS revision, these standards retain the requirements for specific warning language for specific signs; however, OSHA is proposing to modify the language to be compatible with GHS and consistent throughout the OSHA standards. The GHS classification process for a specific substance as proposed in this revision of the HCS will dictate the hazard warnings and the precautionary statements that will be required on the new GHS-compliant labels. OSHA believes that having signs and labels in the same formats and containing identical warnings for the same health effects will make it far easier for employers and employees to quickly recognize the hazard and the degree of danger of a hazard, thus enhancing communication. The proposal modifies the requirements for signs and labels found in the Agency's health standards listed below. Since OSHA is providing specific language for signs and for labels on containers of contaminated clothing, waste and debris, the Agency is exempted from taking burden hours and costs for these provisions. (See 5 CFR 1320.2(c)(2) (``Controlling paperwork burden on the public'')). The Agency is taking burden hours and costs for employers to label, tag, or mark each container of hazardous chemicals with either (i) the information specified under (f)(1)(i) through (v) for labels on shipped containers: or, (ii) product identifier and words, pictures, symbols, or combination thereof, which provide at least general information regarding the hazards of the chemicals. General Industry ------------------------------------------------------------------------ ------------------------------------------------------------------------ Asbestos 1910.1001......................................... 1218-0133 13 Carcinogens 1910.1003................................... 1218-0085 Vinyl Chloride 1910.1017................................... 1218-0010 Inorganic Arsenic 1910.1018................................ 1218-0104 Lead 1910.1025............................................. 1218-0092 Chromium (VI) 1910.1026.................................... 1218-0252 Cadmium 1910.1027.......................................... 1218-0185 Benzene 1910.1028.......................................... 1218-0129 Coke Oven Emissions 1910.1029.............................. 1218-0128 Cotton Dust 1910.1043...................................... 1218-0061 1,2-dibromo-3-chloropropane 1910.1044...................... 1218-0101 Acrylonitrile 1910.1045.................................... 1218-0126 Ethylene Oxide 1910.1047................................... 1218-0108 Formaldehyde 1910.1048..................................... 1218-0145 Methylenedianiline 1910.1050............................... 1218-0184 1,3-Butadiene 1910.1051.................................... 1218-0170 Methylene Chloride 1910.1052............................... 1218-0179 Hazard Communication 1910.1200............................. 1218-0072 ------------------------------------------------------------------------ Construction Industry................................................... ------------------------------------------------------------------------ Methylenedianiline 1926.60................................. 1218-0183 Lead 1926.62............................................... 1218-0189 Asbestos 1926.1101......................................... 1218-0134 Chromium 1926.1126......................................... 1218-0252 Cadmiun 1926.1127.......................................... 1218-0186 ------------------------------------------------------------------------ Paragraph (g)(2) requires the chemical manufacturer or importer preparing the safety data sheet (SDS) to ensure that it is in English (although the employer may maintain copies in other languages as well), and include the following section numbers and headings, and associated information under each heading, in the order listed (see Appendix D to Sec. 1910.1200--Safety Data Sheets, for the specific content of each section of the safety data sheet). (i) Section 1, Identification; (ii) Section 2, Hazard(s) identification; (iii) Section 3, Composition/information on ingredients; (iv) Section 4, First-aid measures; (v) Section 5, Fire-fighting measures; (vi) Section 6, Accidental release measures; (vii) Section 7, Handling and storage; (viii) Section 8, Exposure controls/personal protection; (ix) Section 9, Physical and chemical properties; (x) Section 10, Stability and reactivity; (xi) Section 11, Toxicological information. Note 1 to paragraph (g)(2): To be consistent with the GHS, an SDS must also include the following headings in this order: Section 12, Ecological information; Section 13, Disposal considerations; Section 14, Transport information; and Section 15, Regulatory information. Note 2 to paragraph (g)(2): OSHA will not be enforcing information requirements in sections 12 through 15, as these areas are not under its jurisdiction. (xii) Section 16, Other information, including date of preparation or last revision. Paragraph (g)(5) requires the chemical manufacturer, importer or employer preparing the safety data sheet to ensure that the information provided accurately reflects the scientific evidence used in making the hazard classification. If the chemical manufacturer, importer or employer preparing the safety data sheet becomes newly aware of any significant information regarding the hazards of a chemical, or ways to protect against the hazards, this new information must be added to the safety data sheet within three months. If the chemical is not currently being produced or imported, the chemical manufacturer or importer must add the information to the safety data sheet before the chemical is introduced into the workplace again. Paragraph (g)(11) requires that employers ensure the safety data sheets are readily available, upon request, to designated representatives, the Assistant Secretary, and the Director, in accordance with the requirements of 29 CFR 1910.1020(e). Affected Public: Business or other for-profit. Number of Respondents: 90,801 firms producing Safety Data Sheets and labels. Frequency: One time. Average Time per Response: Time to convert Safety Data Sheets and labels to the new system ranges from 7 hours for establishments having between 1 to 19 employees; to 3 hours for establishments having greater than 500 employees. Estimated Total Burden Hours: 2,125,414. Estimated Costs (Operation and Maintenance): $32,055,258. Submitting comments. Members of the public who wish to comment on the paperwork requirements in this proposal should send their written comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503; Attn: OSHA Desk Officer (RIN 1218-AC20). The Agency encourages commenters also to submit their comments on these paperwork requirements to the rulemaking docket, along with their comments on other parts of the proposed rule. Comments may be submitted by using the Federal eRulemaking portal at http://www.regulations.gov. Comments and submissions are posted without change; therefore OSHA cautions commenters about submitting personal information such as social security numbers and date of birth. Information on using the http://www.regulations.gov Web site to submit comments and access the docket is available at the Web site's ``User Tips'' link. For instructions on submitting these comments to the rulemaking docket, see the sections of this Federal Register notice titled DATES and ADDRESSES. Docket and inquiries. To access the docket in order to read or download comments and other materials related to this paperwork determination, including the complete Information Collection Request (ICR) (containing the Supporting Statement (describing the paperwork determinations in detail) and [[Page 50381]] attachments), use the procedures described under the section of this notice titled ADDRESSES. To make inquiries, or to request other information, contact Mr. Todd Owen, Directorate of Standards and Guidance, OSHA, Room N-3609, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-2222. IX. Federalism The Agency reviewed the proposed Hazard Communication Standard according to the Executive Order on Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999). This Executive Order requires that Federal agencies, to the extent possible, refrain from limiting State policy options, consult with States before taking actions that restrict their policy options, and take such actions only where there is constitutional and statutory authority to do so and the problem is of national significance. The Executive Order generally allows Federal agencies to preempt State law only where there is clear evidence of Congressional intent to allow it, or where the exercise of State authority would conflict with the exercise of Federal authority under a statute; in such cases, Federal agencies must limit preemption of State law to the extent possible. Section 18 of the Occupational Safety and Health Act (the ``Act'' or ``OSH Act''), 29 U.S.C. 667, expresses Congress' clear intent to preempt State laws with respect to issues for which OSHA has promulgated an occupational safety and health standard under section 6 of the Act. Under section 18 of the Act, a State may avoid preemption only if it submits and obtains OSHA approval of an occupational safety and health plan. See Gade v. National Solid Wastes Management Association, 112 S. Ct. 2374 (1992). With respect to States that do not have OSHA-approved plans, the Agency concludes that this proposal falls under the preemption provisions of the Act. Additionally, section 18 of the Act prohibits States without approved plans from issuing citations for violations of OSHA standards; the Agency finds that this proposed rulemaking does not expand this limitation. OSHA has authority under Executive Order 13132 to propose a Hazard Communication Standard because the problems addressed by these requirements are national in scope. Section 18(c)(2) of the Act permits State-plan states to develop their own requirements to deal with any special workplace problems or conditions, provided, inter alia, these requirements are at least as effective as the Federal standards promulgated under section 6 of the Act. Although a State standard becomes effective in accordance with State promulgation provisions, and is enforceable upon promulgation, OSHA must also review and approve the standard to assure that it is ``at least as effective'' as the Federal standard. OSHA intends to closely scrutinize State hazard communication standards submitted under current or future State plans to assure equal or greater effectiveness, including assurance that any additional requirements do not conflict with, or adversely affect, the effectiveness of the national application of OSHA's standard. OSHA must determine in its review whether any State plan standard provisions that differ from the Federal provisions, when applicable to products distributed or used in interstate commerce, are ``required by compelling local conditions and do not unduly burden interstate commerce.'' OSH Act section 18(c), 29 U.S.C. 667(c). X. State Plans The 26 States and territories with their own OSHA-approved occupational safety and health plans must adopt comparable provisions within six months after the Agency publishes a final standard. These States and territories are: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, and Wyoming. Connecticut, New Jersey and New York have OSHA approved State Plans that apply to State and local government employees only. Each state- plan State's existing requirements will continue to be in effect until it adopts the required revisions. XI. Unfunded Mandates Under Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, an agency must prepare a written ``qualitative and quantitative assessment'' of any regulation creating a mandate that ``may result in the expenditure by the State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more'' in any one year before issuing a notice of proposed rulemaking. OSHA's proposal does not place a mandate on State or local governments, for purposes of the UMRA, because OSHA cannot enforce its regulations or standards on State or local governments. (See 29 U.S.C. 652(5).) Under voluntary agreement with OSHA, some States enforce compliance with their State standards on public sector entities, and these agreements specify that these State standards must be equivalent to OSHA standards. The OSH Act also does not cover tribal governments in the performance of traditional governmental functions, though it does when tribal governments engage in commercial activity. However, the proposal would not require tribal governments to expend, in the aggregate, $100,000,000 or more in any one year for their commercial activities. Thus, although OSHA may include compliance costs for affected governmental entities in its analysis of the expected impacts associated with a proposal, the proposal does not trigger the requirements of UMRA based on its impact on State, local, or tribal governments. Based on the analysis presented in the Preliminary Economic Analysis (section VII above), OSHA concludes that the proposal would impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year. The Preliminary Economic Analysis constitutes the written statement containing a qualitative and quantitative assessment of the anticipated costs and benefits required under Section 202(a) of UMRA (2 U.S.C. 1532). XII. Protecting Children From Environmental Health and Safety Risks Executive Order 13045 requires that Federal agencies submitting covered regulatory actions to OMB's Office of Information and Regulatory Affairs (OIRA) for review pursuant to Executive Order 12866 must provide OIRA with (1) an evaluation of the environmental health or safety effects that the planned regulation may have on children, and (2) an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. Executive Order 13045 defines ``covered regulatory actions'' as rules that may (1) be economically significant under Executive Order 12866 (i.e., a rulemaking that has an annual effect on the economy of $100 million or more, or would adversely effect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities), and (2) concern an environmental health risk or safety risk that an agency has reason to believe may disproportionately affect children. In this context, the term ``environmental health risks and safety risks'' means risks to health or safety that are attributable to products or substances [[Page 50382]] that children are likely to come in contact with or ingest (e.g., through air, food, water, soil, product use). The proposed HCS is economically significant under Executive Order 12866 (see section VII of this preamble). However, after reviewing the proposed HCS, OSHA has preliminarily determined that the standard would not impose environmental health or safety risks to children as set forth in Executive Order 13045. XIII. Environmental Impacts The Agency reviewed the proposed Hazard Communication Standard according to the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), the regulations of the Council on Environmental Quality (40 CFR part 1500), and the Department of Labor's NEPA procedures (29 CFR part 11). As a result of this review, OSHA has made a preliminary determination that the proposed HCS will have no impact on air, water, or soil quality; plant or animal life; or the use of land or aspects of the external environment. Therefore, OSHA concludes that the proposed HCS would have no significant environmental impacts. XIV. Public Participation OSHA encourages members of the public to participate in this rulemaking by submitting comments on the proposal. Written Comments. OSHA invites interested persons to submit written data, views, and arguments concerning this proposal. In particular, OSHA encourages interested persons to comment on the issues raised in section II of this preamble. When submitting comments, persons must follow the procedures specified above in the sections titled DATES and ADDRESSES. The comments must clearly identify the provision of the proposal you are addressing, the position taken with respect to each issue, and the basis for that position. Comments, along with supporting data and references, received by the end of the specified comment period will become part of the record, and will be available for public inspection and copying at the OSHA Docket Office as well as online at www.regulations.gov (Docket Number H022K-2006-0062). Informal Public Hearing. Pursuant to section 6(b)(3) of the Act, members of the public will have an opportunity to provide oral testimony concerning the issues raised in this proposal at informal public hearings. The hearings will be announced in the Federal Register. XV. Summary and Explanation of the Proposed Standard The advance notice of proposed rulemaking (ANPR) published by OSHA on September 12, 2006 (71 FR 53617) included a series of questions to solicit information on a number of specific topics. The responses from more than 100 commenters have been used by the Agency to help prepare the required analyses for this rulemaking, as well as to make determinations regarding the proposed text. The discussion below on each paragraph of the proposed standard addresses the comments that were related to those subjects, and the discussion on the regulatory impact analysis in Section VII of this preamble refers to responses related to that topic. In addition to the responses to specific questions in the ANPR, OSHA has also received general comments covering topics such as statements of support for the rulemaking, approaches or principles to follow in the rule, suggestions for outreach and compliance assistance, and other subjects of concern. Before addressing the specific paragraphs of the proposed rule, we would like to discuss these general comments. Support for the rulemaking. Many of those who responded to the ANPR expressed their support for adoption and implementation of the GHS. The supporters far out numbered those who opposed or questioned adoption (see, e.g., Document ID s 0003, 0007, 0047, 0050, 0052, 0062, 0106, 0011, 0033, 0038, 0123, 0130, 0151, 0163, and 0171). The reasons presented for this support varied, but included the belief that adoption of the GHS will bring consistency and clarity to hazard communication (e.g., Document ID s 0046, 0059, 0081, and 0038); will help to ensure that employees have reliable, consistent, comprehensive and comprehensible information (e.g., Document ID s 0054, 0030, 0037, and 0124); will help to enhance human health and the environment (improved worker safety) (e.g., Document ID s 0064, 0081, 0032, and 0128); and will reduce burdens associated with preparing multiple classifications and labels for the same product (e.g., Document ID s 0048, 0080, 0030, and 0123). Support for implementation of the GHS by OSHA was expressed by both users and producers of chemicals. For example, the Aerospace Industries of America, Inc., representing companies that are generally large users of chemicals, identified many of these benefits in its statement of support (Document ID 0054): AIA supports OSHA's current efforts to adopt the GHS and its past participation in the development of the UN's GHS for classification and communication of chemical hazards. We believe that the GHS adoption will help bring consistency and clarity to national and international regulation of hazardous chemicals and will help ensure that employers and employees have reliable, consistent, and comprehensive information on hazardous chemicals in the workplace. With the great diversity in the current systems of hazard communications globally, where MSDSs and chemical labels and classification systems vary in content details and length, type of information, format, and depth of hazard warnings and procedures, there is often inconsistency, redundancy, and incompatibility in labels developed by manufacturers and distributors. This often results in confusion for workers who try to interpret the MSDSs and labels, particularly across differing industry sectors and geographic areas where language, culture, and levels of experience and training may vary. OSHA's proposal to adopt applicable provisions of the GHS into the U.S. workplace is a positive step in working toward developing standardized, uniform, classification, labeling, and related procedures for worker hazard communications systems. The United Parcel Service, Inc., also a user of chemicals as well as a transporter, supported implementation of the GHS too (Document ID 0064): UPS is pleased to support OSHA's adoption of the GHS and applauds the publication of the ANPRM as an important step toward implementation. We believe that the implementation of the GHS has the potential to (1) contribute to the safety of workers through standardized and more easily understood Safety Data Sheets (``SDSs''); (2) streamline domestic hazard classification and labeling across all pertinent U.S. agencies (OSHA, EPA, DOT, CPSC); and (3) facilitate international trade in chemical-based products by harmonizing hazard communication requirements across national borders. UPS also recognizes that the current HAZCOM standard, while not perfect, has helped promote the safety and health of American workers. We believe that OSHA can reap the benefits of the GHS without compromising the substantial benefits of the existing HAZCOM regime. The American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), representing employees exposed to chemicals in the workplace, also recognized the value of revising the HCS to adopt the GHS provisions (Document ID 0124): [T]he GHS offers a standardized and specific approach to the creation of labels and Safety Data Sheets (SDS), with a set format, content and order. Additionally, the GHS has an established set of hazard criteria and employs the use of standardized pictograms. We believe these elements of the GHS, when incorporated into the HCS, will assist greatly in generating labels and SDS's [[Page 50383]] that are vastly more consistent and comprehensible in comparison to the current MSDS's and labels. The improved consistency will also increase the ability to communicate the hazard information to workers. The AFL-CIO fully supports the efforts of OSHA to modify the HCS so that these objectives are realized. Similarly, DuPont, a major chemical manufacturer, also expressed its support for pursuing harmonization through adoption of the GHS (Document ID 0038): DuPont supports OSHA adoption of the GHS and the publication of this ANPRM as a concrete step towards implementation of the GHS in the United States. DuPont urges OSHA to use the information received in response to this ANPRM and move quickly and judiciously to the next step towards a globally harmonized system--publication of a proposed rule. DuPont believes that implementation of the GHS will mean that workers who must handle hazardous chemicals will find hazard information presented in a standardized and more comprehensible manner. DuPont also believes that implementation of the GHS will ultimately reduce the costs to businesses of classifying chemicals as to their hazards and creating warning labels and safety data sheets. While support for implementation of the GHS was widespread in the comments, these supporters also recognized the challenges associated with implementation. For example, it was noted by a number of commenters that there will be short-term costs associated with implementation, and they urged OSHA to take steps to minimize them by providing a reasonable time period for phase-in, coordinating with other agencies, and providing extensive outreach (see, e.g., Document ID s 0032, 0111, 0155, 0157, and 0162). As will be addressed in other parts of this preamble, OSHA also recognizes the costs associated with implementation of the changes necessitated by adoption of the GHS, and has taken a number of steps to address them, including those recommended by these and other commenters. Others were concerned that the GHS is not completely harmonized because it allows countries and agencies within countries, to select from among a collection of building blocks when determining the scope of their requirements (e.g. Document ID 0076). The GHS was designed in this manner because the existing systems all had scope accommodations for different sectors. For example, the most notable difference among sectors involves transport of dangerous goods and the workplace. In the transport sector, only those hazards which involve the types of exposures expected to be encountered in transport are covered. In the area of health effects, this has been defined as acute health effects, and the transport sector does not include any chronic health hazards in its coverage. Representatives of transport authorities involved in the negotiations indicated that this coverage was considered appropriate, and the building block concept that allowed them to continue to have that scope was necessary to include transport within the GHS. On the other hand, workplace authorities are concerned about chronic health hazards occurring as a result of workplace exposures, and expected the GHS to include those types of effects. Thus the GHS does not specify that all provisions should be applied to all sectors. However, as will be addressed below in specific paragraphs where this may be a concern, OSHA does not presently preclude employers from including additional information on labels and safety data sheets to address areas that are not covered by OSHA, and would not do so when implementing the proposed revisions. For example, where employers are preparing labels and SDSs for products that will be marketed in both the consumer and the workplace sector, additional information on acute toxicity at lower levels of concern may be included for the consumer sector without violating any current or proposed OSHA requirements. Similarly, information regarding transportation and environmental concerns may be included on SDSs required by OSHA. However, the Agency only enforces the standard with regard to the information required under its own provisions. The same situation would apply in implementation of the proposed revisions. In addition to those who supported implementation, but raised areas of concern regarding the way in which it is pursued, there were others who did not support implementation (Document ID s 0004, 0065, 0068, and 0108). These commenters argued that it would be too financially burdensome (Document ID 0004); delegates power to an international body which can only be accomplished through a treaty, if at all (Document ID 0065); would change the current hazard communication scheme and thus potentially impair safety (Document ID 0065); and should not be applied to pesticides because they are already heavily regulated (Document ID 0108). With regard to the costs and economic impacts, OSHA has prepared extensive analyses of the costs, benefits, and economic impacts of the rules, which are summarized in Section VII of this preamble. The Agency has preliminarily concluded that the draft proposed standard is an economically significant rule under E.O. 12866 in that the costs exceed $100 million in each of the first three years. However, OSHA will certify that a regulatory flexibility analysis is not necessary under the Regulatory Flexibility Act (RFA), because although the proposed standard will affect a substantial number of small firms, the impacts do not rise to the level of significance that would require a regulatory flexibility analysis under the RFA. Section VI of the preamble addresses the legal authority of the Agency to pursue this rulemaking. OSHA believes that adoption of the GHS through rulemaking is the appropriate mechanism to achieve this increased protection for exposed employees as well as global harmonization, and that a treaty is not the only means to accomplish this goal. More importantly, however, adoption of the GHS through rulemaking does not delegate ``power to an international body'' as argued by the National Association of Home Builders (Document ID 0065). NAHB also argues that the proposal would allow hazard determinations ``to be based on something other than fact and scientific evidence.'' This rulemaking process is the legal means to modify the current HCS requirements to make them consistent with GHS. Promulgation of the GHS modifications and implementation of the revised HCS will be by OSHA under the Agency's authority in the OSH Act. No international body will dictate the terms of the adoption. Moreover, there will be no international body with any authority in American workplaces with regard to hazard communication. Furthermore, the hazard determination process under the HCS is currently based on an evaluation of scientific facts and evidence, and would continue to be so under the revised HCS as proposed. The proposed revisions simply provide more extensive guidance on the scientific approach to hazard classification to help ensure a consistent evaluation process by multiple chemical manufacturers. As will be discussed in other parts of this preamble, OSHA believes that adoption of the GHS would lead to increased accuracy and reliability in evaluations of scientific evidence, and thus better information for employers and employees to use to protect them in the workplace. OSHA believes that arguments presented in this preamble, and the accompanying analyses, indicate that pursuing modifications to the HCS will [[Page 50384]] enhance employee protection, as well as ultimately facilitate compliance for all companies including those in the construction industry that use hazardous chemicals. Therefore, while OSHA did not include questions regarding the support of stakeholders for adoption of the GHS, it is clear that a majority of those responding to the ANPR support moving forward with the rulemaking. The arguments presented by those few who actively objected to adoption have been addressed in this preamble and the analyses for the rule, and have not been found persuasive. Other issues raised by supporters as concerns or suggestions for addressing concerns, have also been addressed in the proposed rule. While OSHA has addressed many of the identified issues in the proposal, the Agency recognizes that stakeholder input is needed to resolve some of the concerns, and these have been described in Section II. Other general issues. Commenters also raised a number of other issues related to the rulemaking that were not directed to specific paragraphs of the HCS. Some respondents indicated that OSHA should limit changes to the HCS to those required to align with the GHS, thus keeping the framework of the existing HCS (see, e.g., Document ID s 0047, 0080, 0104, 0123, 0145, 0163, 0167, and 0170). For example, ORC Worldwide (Document ID 0123) stated: * * *[O]SHA can help minimize the cost to businesses by only modifying those sections of the OSHA Hazard Communication Standard (HCS) that must be changed to be consistent with GHS. Therefore, we strongly support OSHA's stated intent to maintain the current scope, application, and interpretations of the HCS, and only modify those sections of the standard necessary for consistency with the GHS. Not only will this help minimize the implementation burden on industry, it should also serve to minimize confusion among employers and employees during the implementation period. As will be described in greater detail below with regard to specific provisions, OSHA has made every effort to maintain the framework of the current HCS in the proposed revisions. The modifications proposed are believed by OSHA to be those that are required to align the current HCS with the GHS, but do not address provisions of the current standard that are not addressed in the GHS. Thus, for example, the scope and application paragraph remains largely unchanged, as does the paragraph addressing trade secret protection. The primary modifications proposed in these paragraphs are changes in terminology required to ensure consistency. Many commenters also suggested that OSHA should coordinate implementation of the GHS with other Federal agencies. These included primarily EPA, DOT, and CPSC (see, e.g. Document ID s 0048, 0050, 0053, 0076, 0104, 0111, 0123, 0134, 0154, 0162, and 0170). Others mentioned the Mine Safety and Health Administration (MSHA) (Document ID s 0049, 0101, and 0111). For example, the Soap and Detergent Association (Document ID 0170) stated: SDA urges OSHA to coordinate implementation of revisions to the HCS related to the GHS with the Environmental Protection Agency (EPA), Department of Transportation (DOT), and the Consumer Product Safety Commission (CPSC), which all have announced their intentions to implement GHS provisions in their regulations. Workplace hazard communication occurs in a stage of the overall life cycle of chemicals and finished products. Coordination and synchronization of implementation timing could greatly improve the efficiency of implementation of the GHS by industry. OSHA agrees with these commenters that the U.S. government agencies should continue to coordinate their activities with regard to implementation of the GHS. In terms of adopting the GHS provisions, DOT has substantially aligned the criteria for physical hazards in their regulations with those of the GHS under the HM-215I rulemaking (71 FR 78595). EPA and CPSC have not initiated rulemaking on the GHS. Thus at this point, there is little to coordinate in terms of timelines. As rulemaking develops in these Agencies, discussions will continue to take place in the interagency committee on this subject. With regard to MSHA, Department of Labor rulemaking activities are coordinated through Department officials, and MSHA has been apprised of OSHA's activities in order to determine what action may be appropriate for them to pursue in this area. A number of commenters also argued that OSHA should coordinate implementation with major U.S. trading partners (see, e.g., Document ID s 0042, 0048, 0101, 0116, 0128, 0141, 0155, and 0170). Similarly, several argued that countries should limit modifications to the GHS that are country-specific, and that the UN process should be used to control such changes (Document ID s 0042, 0018, 0134, 0154, 0163, 0164, and 0171). For example, the American Petroleum Institute (API) addressed these issues as follows (Document ID 0171): API strongly recommends that OSHA ensure that timing and coordination of GHS implementation schedules are in line with those of other countries, allowing sufficient time for companies to organize and accomplish necessary work. In order to achieve international harmonization of hazard communication materials and to avoid undue burden on companies, OSHA must stay engaged with all other actors to encourage even and consistent implementation of GHS by individual countries. Further, API recommends that OSHA work closely with other government agencies and countries to ensure alignment to the UN endorsed version of the GHS. As the implementation of the GHS by countries deviates from the UN version of GHS, the perceived benefits of harmonization substantially decrease. OSHA agrees with these commenters that coordination among trading partners would enhance harmonization and facilitate implementation. The Agency remains active in the UN process, participating in the Subcommittee of Experts on the GHS, as well as the UNITAR Programme Advisory Group. There is increased emphasis in the Subcommittee on implementation issues as well as coordination. OSHA led a correspondence group that reviewed implementation of the mixture classification provisions, and modifications to address concerns raised were incorporated into Revision 3 of the GHS to help ensure consistency in approach. OSHA will continue to lead a correspondence group on practical classification and hazard communication issues. In addition, the Subcommittee has established a correspondence group to address broader implementation issues, and OSHA is participating in those deliberations as well. The Agency has also had bilateral discussions in the past with Canada, as well as the European Union (EU), on issues related to implementation. These are two of the key trading partners for the U.S. The EU has recently revised its overall approach to the regulation of chemicals in a new European Community Regulation (EC 1907/2006) referred to as REACH: Registration, Evaluation, Authorization and Restriction of Chemical substances. The new law entered into force on June 1, 2007, and the provisions will be phased in over 11 years. REACH addresses chemical hazards over the life cycle of a chemical, and gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on substances. Manufacturers and importers will be required to gather information on the properties of their chemical substances, [[Page 50385]] which will allow their safe handling, and to register the information in a central database run by the new European Chemicals Agency (ECHA). The Agency will act as the central point in the REACH system: it will manage the databases necessary to operate the system, coordinate the in-depth evaluation of suspicious chemicals, and run a public database in which consumers and professionals can find hazard information. On September 3, 2008, the EU Parliament completed revisions to its longstanding chemical classification and labeling approach to align with the GHS (referred to now as the European Regulation on the Classification, Labelling, and Packaging of Substances and Mixtures). It applies to substances as of December 1, 2010, and mixtures as of June 1, 2015. The final version was published in the EU Official Journal on December 31, 2008. In terms of these proposed provisions, OSHA examined the European Commission's regulation to coordinate where possible on approaches to implementation. However, the primary principles followed by OSHA in developing this proposal were to ensure that the modifications maintain or enhance the protections of the current standard, and that the modifications are consistent with the negotiated provisions of the GHS. One of the issues of concern regarding implementation by some other countries has been deviation from the GHS itself. Because GHS is intended to be globally implemented, efforts by countries to deviate in a collective manner from the GHS, rather than maintaining consistency, defeats the purpose, and consequently, lessens the benefits of the GHS. OSHA will continue to seek opportunities to ensure coordination of implementation and promote harmonization, both internationally and bilaterally. It should also be noted that the GHS is a living document, and the UN actively reviews it and considers possible changes based on implementation experiences and other information. These changes are made on a two-year cycle, referred to as a biennium. The OSHA proposal is based on Revision 3 of the GHS. Revision 3 was adopted by the UN Subcommittee of Experts on the GHS (UNSCEGHS) in December 2008. A compilation of the approved changes is available on the UN Web site (ST/SG/AC.10/36/Add. 3), and the full text of Revision 3 will be accessible later this year. There are a number of clarifications and small modifications in Revision 3 that address inconsistencies or discrepancies in the previous text of the GHS, and these have been incorporated into this proposal. It is expected that as the UNSCEGHS fulfills its mandate to ensure that the GHS is up-to-date and relevant, further changes will be adopted on a biennium basis. If the change(s) is substantive and controversial, OSHA will have to engage in notice and comment rulemaking in order to amend the HCS. However, for non-substantive or clarification changes, OSHA has rulemaking options available that can be utilized to implement the changes and can be done more quickly than the full notice and comment rulemaking process. Two possible means are the Standards' Improvement Process (SIPs) or a Direct Final Rule (DFR). Each of these options also gives the public notice and opportunity to comment, but has the advantage of a faster process. Either method could be used to ensure that the HCS remains current with the GHS. Outreach/Compliance Assistance. The ANPR included a series of questions to solicit input from the public on what outreach or compliance assistance materials would be appropriate and useful. OSHA received many comments in response to these questions, with a number of creative and interesting suggestions for outreach products. The Agency will use this input to develop an outreach plan and prepare materials for distribution when the rulemaking is completed. In addition, and as suggested by a number of commenters (see, e.g., Document ID s 0047, 0065, 0081, 0104, 0018, 0025, and 0154), OSHA will continue working with its partners, alliances and other interested parties to examine projects that could be completed by them, or in coordination with them, that could be targeted to specific industries or interest groups. With regard to the questions on the media through which to distribute materials, all of the methods mentioned in the ANPR received considerable support. In addition, a number of commenters indicated that all types of distribution systems should be used to reach the widest audience, including the Web site, electronic tools, PowerPoint presentations, flash videos, a dedicated web page, mail, train-the- trainer sessions, regional workshops, etc. All of the possible subjects suggested by OSHA (e.g., hazard classification, labels, and safety data sheets) were also endorsed as being of interest. Many commenters agreed with OSHA that training on understanding pictograms and symbols, as well as hazard statements, signal words, labels, and SDSs, would be useful for both small businesses and employees (see, e.g., Document ID s 0044, 0061, 0072, 0028, 0034, 0107, 0139, 0163, and 0170). There were also several recommendations that OSHA prepare a poster with the pictograms that can be displayed in workplaces (Document ID s 0046, 0047, 0064, 0028, 0123, and 0171). In addition, it was suggested that training on classification procedures, particularly for mixtures, would be useful, as would software that could complete mixture calculations (see, e.g., Document ID s 0046, 0054, 0032, 0038, 0128, 0140, and 0154). And a number of respondents believe that OSHA should develop a series of training modules on different aspects of the revised HCS (Document ID s 0047, 0051, 0080, 0025, and 0135), and provide training online (Document ID s 0059, 0032, 0125, 0129, 0155, and 0157). Commenters also suggested that OSHA prepare a comprehensive comparison of the current standard to the revised HCS when completed (Document ID s 0054, 0135, and 0145), as well as a reference table with different requirements around the world (Document ID s 0047, 0080, 0123, and 0171). It was also noted that materials should be available in multiple languages (Document ID s 0046 and 0080). Other ideas presented included electronic seminars (Document ID 0064); model programs (Document ID s 0064, 0076, 0080, 0029, and 0124); toolbox talks (Document ID 0065); Quick Cards (Document ID 0065); online inventory lists (Document ID s 0076 and 0178); Q and A document (Document ID s 0072 and 0160); hotline (Document ID s 0077, 0104, 0179, 0140, and 0163); GHS resource CD (Document ID s 0021 and 0155); SDS template (Document ID s 0144 and 0145); timely compliance directive (Document ID 0124); and approximate conversion table for classifications (Document ID s 0145 and 0163). The proposed standard. The following is a description of the provisions of the proposed standard. Comments received that were related to the proposed provisions are also addressed. (a) Purpose. The HCS includes a paragraph that states the purpose of the rule. This stated purpose is two-fold. First, the paragraph indicates that the standard addresses assessment of the hazards of workplace chemicals, and the transmittal of that information to employers and employees. It also describes the contents of a comprehensive hazard communication [[Page 50386]] program as being container labeling and other forms of warning, material safety data sheets, and employee training. The second part of the paragraph addresses the preemption of State or local laws by this Federal standard. It indicates that OSHA is addressing comprehensively the issues described, and thus the standard preempts States, and political subdivisions of States, from addressing these issues except under the authority of a Federally-approved State plan under Section 18 of the OSH Act. While Section 18 applies to every occupational safety and health standard that OSHA promulgates, the HCS raises particular issues because of the nature of the provisions. It requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import, and to prepare labels and material safety data sheets based on those evaluations to transmit hazard information and appropriate precautionary advice to users downstream. This is a unique, but highly appropriate approach for an OSHA standard, as it recognizes that chemical manufacturers and importers are in the best position to assess the hazards of their products and develop appropriate information for labels and SDSs. There is a national, indeed international, marketplace for industrial chemicals, and thus chemical manufacturers and importers affect commerce within the meaning of the OSH Act and therefore fall under OSHA's jurisdiction. If a State or a political subdivision of a State, were to establish different requirements for labels and safety data sheets, such requirements would have an impact on chemical manufacturers and importers that are not located in that State. This is a burden that the HCS eliminates by establishing national requirements. The proposed revision to HCS has essentially the same purposes, and OSHA is proposing only minor modifications to this paragraph. Paragraph (a)(1)would change the language regarding the assessment of hazards to indicate that the hazards will be ``classified'' rather than simply assessed or evaluated. This is consistent with the approach in the GHS. In addition, OSHA is proposing to modify this paragraph to clearly indicate that the standard is intended to be consistent with the GHS, Revision 3. That change is a reflection of the purpose of this rulemaking to harmonize the existing requirements with the provisions of the GHS, which is the international instrument that includes globally harmonized provisions on hazard communication. In addition, in this paragraph and succeeding paragraphs of the revised rule, the term ``material safety data sheet'' has been modified to ``safety data sheet'' to reflect the terminology of the GHS. The only modifications proposed to paragraph (a)(2) also address terminology, using ``classifying'' instead of ``evaluating'', and ``safety data sheet'' instead of ``material safety data sheet''. There were no specific comments received in response to the ANPR regarding the Purpose paragraph of the HCS. One comment suggested that the standard should be limited to a purpose of international communication so as not to trigger hazard assessments under other OSHA standards that address respiratory protection, personal protective equipment, or process safety management (Document ID 0049). There were several other comments that indicated that new assessments would have to be done for these standards (Document ID s 0178, 0111, 0134, and 0164). Arguments were made that this would lead to extensive additional costs for new engineering controls, respirators, or other personal protective equipment. As discussed above, there is no identified link to these other standards in the stated purpose of the HCS either currently or with the proposed modifications. While the HCS itself requires the provision of information on recommended control measures, including respiratory protection, personal protective equipment, and engineering controls, there is no requirement for employers to implement the recommended controls. All information available to an employer when designing an appropriate protective program must be used, but a recommendation on a safety data sheet by itself would not trigger the need to implement new controls. Furthermore, these comments seem to imply that there will be major changes in the hazards of chemicals based on implementation of the GHS provisions. Both the HCS and the GHS are based on identifying and communicating the inherent hazards of chemicals. Thus the biggest change for most chemicals under the proposal will be in categorizing the chemical's hazards. Under the current standard, for example, a chemical either is, or is not, a carcinogen. Under the revised HCS, if a chemical is a carcinogen, it would be categorized as a Category 1 or a Category 2 carcinogen. Such a change would not generally result in a need to change engineering controls or respiratory protection. It is possible that a chemical may be classified under the proposal as having a hazard it did not have before, but OSHA believes that this is not likely to happen frequently given the broad coverage of the current rule. Furthermore, the physical and chemical characteristics of the chemical--which affect the types of protection required--would not be changed as a result of this proposal. OSHA believes that these revisions would result in few, if any, changes in protective measures required under other OSHA standards. Several commenters noted what they believed to be the continued need to address the preemption of State standards (see, e.g., Document ID s 0048, 0056, 0080, 0178, 0036, 0123, and 0135). In addition, commenters also noted that the impact of GHS adoption on State and local laws should be considered in the process (for example, California Proposition 65), and that differences between such laws and the revised HCS should be discouraged (Document ID s 0042, 0072, 0015, and 0038). It was also indicated that changes in State laws should be coordinated with the Federal changes to facilitate implementation (Document ID 0146). See Section IX and X of this preamble for a comprehensive discussion regarding Federalism and State plans. (b) Scope and Application. The HCS is a generic standard that has very broad provisions in terms of chemicals addressed and workplaces covered. It also interfaces with a number of requirements of other Federal agencies that address labeling of chemical hazards. Paragraph (b) thus includes all of the practical modifications the Agency has developed to ensure that employers and employees understand how the standard is to be applied, and to accommodate various circumstances that potentially affect the application of the standard. The provisions of paragraph (b)(2) in the HCS address the overall scope of the standard as applying to ``any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency.'' This provision addresses many questions that are raised about the application of the standard. There was one comment received regarding this paragraph which indicated that hazard classification and labeling of steel for chronic health effects should not result from welding being considered a normal condition of use (Document ID 0160). OSHA has made it clear in past interpretations of the rule that where such products are intended to be welded, this information must be provided for hazard communication purposes. That [[Page 50387]] interpretation does not change as a result of the proposed provisions in the revised rule. In general, OSHA does not expect significant changes in the chemicals covered by the HCS under the proposed revisions as compared to the current standard. The scope of hazards covered by the GHS is very similar to what is covered by the current HCS. Additional chemicals may be considered to be acutely toxic due to the proposed adoption of Category 4 in acute toxicity which would expand the criteria for inclusion from the current definition (see the discussion under ``Hazard classification''). However, these chemicals are already covered under the voluntary national industry consensus standard on precautionary labeling of industrial chemicals (ANSI Z129) that many manufacturers follow in their labeling programs, as well as being covered in the requirements that apply to chemicals shipped to the EU. Thus many manufacturers are already classifying and labeling these chemicals as acute toxins. The proposal is also likely to cover fewer mixtures as acute toxins than the current rule given the hazard classification approach in the GHS that uses a calculation based on proportionality to determine whether a mixture is covered, rather than a strict percentage cut-off of 1%. Other definitions of health hazards would maintain the current broad HCS scope. In addition to the overall scope statement, the HCS provides for limited coverage in workplace situations that have special circumstances, including laboratories and work operations where employees only handle chemicals in closed containers. OSHA also addresses the interface with other Federal agency requirements by either exempting the products covered from additional OSHA labeling (such as pesticides required to be labeled by the EPA), or completely exempting the product (such as hazardous waste regulated by EPA). These accommodations help to ensure that Federal requirements do not conflict or duplicate each other. Under the GHS, such provisions are left under the purview of the ``competent authority''. In developing the GHS, it was recognized that countries' regulatory authorities would need to have the discretion to address such national circumstances in ways that are suited to the regulatory perspective of the country. Thus authorities such as OSHA are free to make determinations about scope and application issues while still being harmonized with the primary provisions of the GHS. OSHA has reviewed the current provisions of paragraph (b), and has determined that no significant changes are required to be consistent with the GHS. Several minor changes to revise terminology are proposed (involving the terms ``classifying'' and ``safety data sheets''), but OSHA is not proposing to modify any of the remaining provisions of paragraph (b). The Agency is also deleting Appendix E of the current HCS, which was guidance for application of the standard, and thus is deleting the reference to it in paragraph (b)(1). As is discussed elsewhere in this preamble, new outreach and compliance assistance materials are being prepared to replace this appendix and other existing outreach materials. Several commenters indicated that OSHA should adopt exemptions included by the European Union in its requirements. Specifically, these exemptions address non-isolated intermediates, chemicals involved in research and development, and waste (Document ID s 0049, 0134, and 0164). All of these situations are already addressed in paragraph (b), and OSHA does not believe it is necessary to change them. In terms of non-isolated intermediates, the overall scope provision in paragraph (b)(2) adequately addresses this situation. This was specifically addressed in the preamble to the 1983 final rule (48 FR 53335): That is, the term ``known'' means the employer need not analyze intermediate process streams, for example, to determine the presence or quantity of trace contaminants. However, where the employer knows of such contaminants, and they are hazardous, then they fall under the provisions of the standard. With regard to chemicals involved in research and development, paragraph (b)(3) limits coverage in laboratories, and partially addresses this situation. Where there is no knowledge of the hazards of such chemicals, the HCS does not apply at all since there is no requirement to generate new hazard information. Where information is available, it must be provided to exposed employees, consistent with paragraph (b)(3) when it is in a laboratory situation. Therefore, it appears to OSHA that this situation is also adequately addressed under the current provisions. Hazardous waste as regulated by EPA is already exempted under paragraphs (b)(6)(i) and (ii). There were commenters who suggested that OSHA maintain current exemptions or limitations in the revised GHS, including the consumer product exemption (Document ID 0064), guidance on byproducts (Document ID 0064), the relative roles of manufacturers and employers (Document ID 0064), and the article exemption (Document ID 0160). OSHA agrees and all of these accommodations remain the same in the proposed revised rule. As indicated in the ANPR, the Agency does not intend to change those parts of the HCS that are not affected by the GHS. One commenter indicated that the revised HCS should indicate that it does not apply fully to State prison inmates because the GHS information would give them data that could be used illegally, and perhaps lead to harm (Document ID 0069). Generally speaking, State prison inmates are not directly subject to Federal requirements under OSHA, although such requirements may be applied to them under State laws or the provisions of another Federal agency. This comment regarding limitations needed for inmates should be addressed in those jurisdictions, but nothing in these revisions would substantially change the application of the HCS to them. There were also a few comments regarding the scope of the revised rule in terms of provisions of the GHS that affect the environment or transportation (see, e.g., Document ID s 0072 and 0179). As OSHA indicated in the ANPR, it does not have the authority to require information in these areas since they are not directed to the protection of employees under its jurisdiction. However, OSHA does not prohibit this type of information on labels or safety data sheets, and is aware that it is often included on labels and safety data sheets currently developed to comply with the HCS. OSHA expects that chemical manufacturers will, in fact, continue to voluntarily include such data on their labels and safety data sheets to meet the requests of their domestic and international customers. (c) Definitions. This paragraph in the HCS includes the terminology used with the corresponding definitions. Comprehension of the appropriate definitions is critical to understanding the provisions of the standard. In some cases, terms are defined somewhat differently than when used in other contexts, so familiarity with the standard's definitions is important. In the proposed revisions, OSHA has retained as many definitions as possible from the current HCS. Changes are proposed only when there is a new term used that needs to be defined, or there is a different definition in the GHS, and consistency with the international definition is needed for harmonization purposes. As with the preceding paragraphs, minor modifications have [[Page 50388]] been proposed to ensure terminology is appropriate--primarily the use of terms related to classification and safety data sheets. One important difference between the HCS and GHS in terminology involves the use of the term ``chemical.'' The HCS has used this term since it was originally promulgated, and defines it to include elements, chemical compounds, and mixtures of elements and/or compounds. It has been a convenient way to describe the coverage of the rule. The GHS, like some other international standards, uses the terms ``substance'' and ``mixture''. OSHA has decided to maintain a definition of ``chemical'' in the revised standard, which minimizes the number of terminology changes that have to be made to the regulatory text, as well as providing a shorthand way to define the scope to include both individual substances and mixtures of substances. This term is used in the body of the proposed regulatory text, similar to the use of it in the current HCS. However, the proposed modifications also include definitions for ``substance'' as well as ``mixture'' to align with the GHS, and both of these terms are used as well. In particular, in the appendixes that are adopting GHS language, the separate terms ``substance'' and ``mixture'' are used consistent with the GHS. ``Substance'' means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurities deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. A ``mixture'' is defined as a ``combination or a solution composed of two or more substances in which they do not react.'' This is consistent with the GHS definition--and while slightly different than the definition in the current HCS, means the same thing. OSHA is also proposing to maintain the term ``hazardous chemical'' as used in the current standard (a chemical which is a physical or health hazard), except to add the term ``classified'' to indicate how it is determined that it is a physical or health hazard, and to add the coverage of unclassified hazards as those terms are defined in a new definition explained below. This term will be used throughout the standard to indicate that the classification process is completed, and the chemical manufacturer has determined that the chemical poses a hazard--either by meeting the requirements for a physical or health hazard or by virtue of being considered an unclassified hazard under this section. Most of the substantive requirements of the rule apply to hazardous chemicals. Another proposed modification to the definitions paragraph is to move the physical hazard definitions to an appendix. In the current HCS, health hazard definitions are addressed specifically in Appendix A to the rule, but the physical hazard definitions were included in paragraph (c). In the proposed revisions, health hazard definitions will continue to be addressed in Appendix A, but a new Appendix B will address physical hazards. Both of these appendixes will be discussed below under the summary and explanation of ``Hazard Classification.'' As noted in Section III above, the physical hazard definitions in the GHS are drawn from the United Nations' Recommendations on the Transport of Dangerous Goods. Since DOT has adopted this international approach, the GHS definitions are substantially harmonized with the U.S. requirements for labeling of dangerous goods in transport. All chemicals that are shipped in the U.S. have already been classified according to DOT's physical hazard definitions. This will reduce the burdens associated with classifying physical hazards under the revised HCS. The primary differences involve exceptions that make the definitions more applicable to workplace situations (for example, coverage of flammable liquids that are currently defined as combustible under the HCS). Modifying the HCS to align with the GHS thus serves the purpose of harmonizing many of these definitions domestically, and results in shippers only having to classify their chemicals once for most physical hazards. OSHA is proposing to add a definition for the term ``classification'' in order to ensure that the meaning of this term is clear. Consistent with the definition of classification in the GHS, the proposed definition of ``classification'' is ``to identify the relevant data regarding the hazards of a chemical; review those data to ascertain the hazards associated with the chemical, and decide whether the chemical will be classified as hazardous, and the degree of hazard where appropriate, by comparing the data with the criteria for health and physical hazards.'' This definition is very similar to the process of hazard determination that is currently in the HCS, with the exception of determining the degree of hazard where appropriate. This reflects the GHS approach of having categories for each class of hazard. Under the current HCS, there are some definitions that have categories in a hazard class (e.g., acute toxicity, flammability), but other definitions are simply one category (e.g., carcinogenicity). The additional breakdown in the GHS of classes into categories that reflect different severities or levels of effect will provide both employers and employees with more precise information to understand the hazards, to consider when evaluating workplace conditions to determine the risks in the workplace, and to respond to exposure incidents. In addition to the definition of classification, OSHA has proposed a definition for ``hazard class'' and ``hazard category'' to further explain the approach of breaking down the hazardous effects into levels of severity. A ``hazard class'' is defined as ``the nature of the physical or health hazards, e.g., flammable solid, carcinogen, acute oral toxicity.'' The definition of ``hazard category'' is ``the division of criteria within each hazard class, e.g., oral acute toxicity and flammable liquids include four hazard categories. These categories compare hazard severity within a hazard class and should not be taken as a comparison of hazard categories generally.'' These definitions are also taken from the GHS. OSHA is proposing to modify the term ``health hazard'' to reflect the specific hazards defined in the GHS. While the overall scope of what is covered is expected to be essentially the same as th