C L I E N T A LERT. Ha r m o n i z i n g Ha z a rd Co m m u n i c a t i o n : OSHA Pr o p o s e s t o. I. Ba c k g r o u n d

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1 C L I E N T A LERT October 16, 2009 Authors: Mark N. Duvall 1350 I Street, N.W. Suite 700 Washington, DC (202) mduvall@bdlaw.com Jayni Lanham 201 N. Charles Street Suite 2210 Baltimore, MD (410) jlanham@bdlaw.com Ha r m o n i z i n g Ha z a rd Co m m u n i c a t i o n : OSHA Pr o p o s e s t o Implement the Globally Harmonized System The hazard communication standard ( HCS ) is the principal federal requirement governing labels and material safety data sheets for hazardous chemicals used in the workplace. On September 30, 2009, the Occupational Safety and Health Administration ( OSHA ) issued a proposed rule that would substantially modify the HCS to conform with the Globally Harmonized System of Classification and Labeling of Chemicals ( GHS ) of the United Nations ( UN ). 1 OSHA s proposed modifications to the existing HCS include minor changes in terminology and definitions, revised criteria for classification of chemical hazards, revised labeling provisions, a specified format for safety data sheets, and requirements for employee training on labels and safety data sheets. Comments on the proposed rule are due by December 29, OSHA plans to schedule an informal public hearing on the proposed rule. This alert reviews the key aspects of the proposal. I. Ba c k g r o u n d For more information about our firm, please visit If you do not wish to receive future Client Alerts, please send an to: jmilitano@bdlaw.com The HCS 2 is a comprehensive standard that requires chemical manufacturers and importers to evaluate the hazards of the chemicals they produce or import and to provide that information to downstream distributors and employers that use those chemicals. Those employers must in turn provide information to their employees. The HCS was first issued by OSHA in Subsequent amendments in and expanded its coverage and made technical changes. Other countries have developed regulatory systems governing the evaluation of chemical hazards and the dissemination of information about those hazards. However, these regulatory systems vary with regard to the scope of chemicals covered, the definitions of hazards, and the specificity of requirements for labels and safety data sheets. These inconsistent requirements place additional regulatory burdens on companies selling chemicals in multiple countries and have led to inconsistent information being provided. In 1992, after recognizing the problems associated with differing international requirements, the UN Conference on Environment and Development issued a mandate to develop a globally harmonized chemical classification and labeling system. Pursuant to this mandate, a coordinating group comprised of countries, stakeholder representatives, and international organizations developed the GHS. It contains classification criteria for physical hazards, classification criteria for health and environmental hazards, and hazard communication elements, including requirements for labels and safety data sheets. The UN formally adopted the GHS in 2003 and encouraged countries to implement it as soon as possible. The GHS has subsequently

2 been revised, with the third revised edition of the GHS released in Additional information about the GHS is available at attachments/ GHS Update - 3rd Revised Edition of GHS Released.pdf. In 2006, OSHA announced that it planned to modify the HCS so that it conforms with the GHS. 6 On September 30, 2009, OSHA issued the proposed rule in the Federal Register. II. Proposed Modifications While many provisions of the current HCS would be retained, OSHA s proposed rule includes revisions to HCS terminology (e.g., changing from chemical to substance and mixture ) and definitions, criteria for classification of chemical hazards, labeling requirements, safety data sheet requirements, and employee training requirements. It also includes revisions to other OSHA standards, including standards for flammable and combustible liquids, process safety management, and most substance-specific health standards, so that they are consistent with the modified HCS requirements. The most significant modifications from the existing HCS are those to the criteria for classification of chemical hazards, labeling provisions, and safety data sheet provisions. Accordingly, these modifications are discussed in more detail below. A. Criteria for Classification of Chemical Hazards Under the current HCS hazard determination requirements, chemical manufacturers and importers must evaluate available scientific data about the chemicals they produce or import to determine whether the chemicals are hazardous, but they are not required to characterize the degree of hazard (e.g., a carcinogen may simply be indicated as such, without indicating whether it is an animal or human carcinogen). The proposed rule would replace that performance standard with the systematic approach of the GHS for evaluating chemical hazards and classifying the degree of severity of chemical hazards (e.g., designating a carcinogen as Category 1 or 2). The approaches for evaluating and classifying these hazards are set forth in detail in Appendices A and B, which OSHA has proposed to thoroughly revise from their present text. They would address health hazards and physical hazards, respectively. Guidance on carcinogenicity classifications would appear in a new Appendix F. The proposed rule would also depart from the existing HCS by requiring chemical manufacturers and importers to classify chemical mixtures as a whole, under prescribed rules. Under the existing HCS, chemical manufacturers and importers are required to base their hazard determinations on the individual hazardous components present above a 1.0% threshold (0.1% for carcinogens), or lower thresholds in some cases, unless the mixture has been tested as a whole. The proposal would establish detailed rules for how the hazards of a mixture are to be determined, based on the proportions of the components in the mixture (i.e., consideration of dilution) and their hazards. Thus, the HCS rule that a single positive study may be sufficient to determine that a chemical (and a mixture of which it is a part) has a hazard would be dropped. OSHA has not proposed to adopt the GHS classifications wholesale. It has edited them and decided not to include three minor health hazard categories. To address hazards not addressed by the GHS, such as combustible dust, OSHA has proposed an unclassified hazard category. Concerning the current standard, the preamble

3 states that It has been the longstanding position of the Agency that the hazard determination covers dusts known to be subject to deflagration and subsequent explosion, i.e., combustible dusts. This information must be conveyed on the MSDS. For physical hazards, OSHA has used the GHS definitions, which differ in some ways from the OSHA definitions. For example, currently a flammable liquid has a flashpoint below 100 F (37.8 C), and a combustible liquid has a flashpoint at or above 100 F and below 200 F (93.3 C). Under the proposal, a flammable liquid would be one with a flash point of not more than 93 C (199.4 F), and there would be four categories of flammable liquids based on flashpoints and boiling points. The Department of Transportation s Hazardous Materials Regulations have used the GHS criteria for some time, so the proposal would harmonize OSHA and DOT definitions. Because the GHS does not operate off of lists of substances, OSHA has proposed to delete the floor of chemicals deemed to be hazardous, i.e., the list of Threshold Limit Values ( TLVs ) of the American Conference of Governmental Industrial Hygienists ( ACGIH ), and the carcinogen lists of the International Agency for Research on Cancer ( IARC ) and the National Toxicology Program ( NTP ). B. Labeling Requirements Under the existing HCS, chemical importers and manufacturers are required to include labels on shipped containers that include the identity of the chemicals, appropriate hazard warnings, and the name and address of the chemical manufacturer, importer, or other responsible party. While the current rule identifies the basic information requirements for labels, it does not specify a format or particular label elements that are to be used. In contrast, under the proposed rule, chemical importers and manufactures would be required to include more information on chemical labels and to use a specific format. Under this proposal, the labels on all shipped containers would have to include the following information: product identifier, signal word (i.e., warning or danger ), 7 hazard statement(s), pictogram(s), precautionary statement(s) (e.g., wear protective gloves ), and the name, address and telephone number of the chemical manufacturer, importer, or other responsible party. This information would have to be prominently displayed and located together on the label. In addition, the signal word, hazard statement, pictogram, and precautionary statements would have to appear in the format that is required by the GHS and set forth in revised Appendix C. The proposed rule would allow somewhat more flexibility with respect to inplant containers, as they may either use the labels used for shipped containers or an alternative label that meets the general labeling requirements. The proposal would move from a performance requirement for appropriate hazard warnings to the use of harmonized hazard statements. OSHA cites as one reason supporting this change the use of control banding, a guidance approach to recommending control measures for chemical exposures that NIOSH has recently championed. 8 The required text would be the GHS hazard statements in revised Appendix C, where applicable. OSHA would also require the use of the Appendix C precautionary statements, even though in the GHS the precautionary statements are only suggested language. The OSHA interpretation allowing labels not to mention

4 IARC Group 2B carcinogens would be dropped. OSHA has proposed to require that a pictogram appearing on the label be a black symbol on a white background with a red frame. In rejecting suggestions that it allow the frame to be black, OSHA would create the need for all labels to be printed in color. The proposal has a requirement to update labels with significant information within three months of learning of it. Currently, the HCS has a label update requirement of three months, but OSHA stayed that provision years ago due to the practical considerations of updating labels that quickly. Under the proposal, that provision would be enforced. C. Safety Data Sheet Requirements Under today s HCS, chemical manufacturers and importers are required to obtain or develop material safety data sheets ( MSDSs ) for each hazardous chemical that they produce or import. The HCS specifies what information must be included on an MSDS, but does not specify a format for the MSDS or an order for the information to be displayed. Under the proposed rule, the term MSDS would be changed to safety data sheet ( SDS ), so that the HCS would use the same term as the GHS. All SDSs that are prepared under the proposed rule would have to include 12 of the 16 categories of information that are required under the GHS and be presented in a format and order that are consistent with the GHS, as set forth in revised Appendix D. The required categories of information would be: identification, hazard(s) identification, composition/information on ingredients, first-aid measures, fire-fighting measures, accidental release measures, handling and storage, exposure controls/personal protection, physical and chemical properties, stability and reactivity, toxicological information, and other information. OSHA indicated that 4 categories of the SDS required by the GHS (ecological information, disposal considerations, transport information, regulatory information) would not be mandatory because these are outside of OSHA s jurisdiction. To aid regulated parties in being fully GHS compliant, however, the proposed rule advises where these sections should be included on an SDS. Companies already following the format of the ANSI Z400.1 MSDS standard would have the appropriate format, except that GHS and the proposal reverse the order of sections 2 and 3, so that hazard information would appear before chemical identity information, unlike under the ANSI standard. The proposal would alter the list of information which must appear in the SDS from what the current HCS requires (see Appendix D as proposed). For instance, the concentrations of mixture components present above the relevant thresholds and their CAS numbers must be identified (subject to trade secret restrictions). Rather than using the current 1.0% and 0.1% thresholds (in most cases), the proposal would follow complicated GHS rules, set forth in Appendices A and B, to determine whether a chemical component would need to be disclosed due to its contributing to the hazard of the mixture. More than just carcinogens would have a threshold of 0.1%. Odor threshold, vapor density, n-octanol/water partition coefficient, and viscosity, among other properties, would be required where available (although the proposal would not require testing to generate information where

5 not available). While the GHS does not require occupational exposure limits to be included on SDSs, the proposal would continue the present requirement to include OSHA permissible exposure limits and other occupational exposure limits used or recommended by the manufacturer or importer. It would delete the current requirement to include ACGIH TLVs specifically. D. Implementation OSHA plans to complete the rulemaking and issue a final rule within 18 months, i.e., by March Employers would have two years after the effective date in which to train employees on the revised hazard communication system. Manufacturers and importers would have three years in which to update their labels and SDSs. During that three-year transition period, companies could comply either with today s HCS or the amended one. The proposal acknowledges that the GHS is a living document, suggesting that future GHS changes may trigger follow-up revisions to the HCS. The proposal is based on the latest (third revised edition, 2009) version of the GHS, but OSHA is already working on further changes to the GHS, including the addition of provisions directly addressing combustible dust. III. Pu b l i c Participation Comments on the proposed rule must be submitted by December 29, OSHA also plans to hold an informal public hearing on the proposed rule. The location and date of the hearing and procedures for participating in the hearing will be announced in the Federal Register. These proposed changes to the HCS are the most far-reaching since its scope was extended beyond the manufacturing sector. Virtually every product label and MSDS would have to be thoroughly revised if the proposal were adopted. The regulated community will want to review this extensive rulemaking notice carefully and take advantage of the opportunity to comment. Office Locations: Washington, DC Maryland New York Massachusetts New Jersey Texas California This client alert was prepared by Mark Duvall. Jayni Lanham assisted in its preparation Hazard Communication, 72 Fed. Reg (Sept. 30, 2009), available at C.F.R , , , , Hazard Communication, 48 Fed. Reg (Nov. 25, 1983). 4 Hazard Communication, 52 Fed. Reg (Aug. 24, 1987). 5 Hazard Communication, 59 Fed. Reg (Feb. 9, 1994). 6 Hazard Communication, 71 Fed. Reg (Sept. 12, 2006). 7 While the American National Standards Institute ( ANSI ) standard on precautionary labeling, ANSI Z129.1, also has a third signal word, caution, the proposal would only allow use of warning and danger. 8 NIOSH Publication No : Qualitative Risk Characterization and Management of Occupational Hazards: Control Banding (CB) (2009), available at Copyright 2009 Beveridge & Diamond, P.C. All rights reserved This Client Alert is not intended as, nor is it a substitute for, legal advice. You should consult with legal counsel for advice specific to your circumstances. This communication may be considered advertising under applicable laws regarding electronic communications.