Global Harmonization System: Impact On OSHA’s Hazard Communication Standard

1. Global Harmonization System:Impact On OSHA’s Hazard Communication Standard Adele L. Abrams, Esq., CMSP Law Office of Adele L. Abrams P.C. www.safety-law.com 301-595-3520

2. Overview • OSHA is at final rule stage to release revision to 29 CFR 1910.1200 (Hazard Communication Standard) • Proposed rule published in 9/30/2009 Fed. Reg. • Goal is to integrate components of the UN project’s Global Harmonization Standard (GHS) into HazCom • Rule cleared OMB/OIRA 3/12 after extended review • Rule would modify MSDS requirements, labeling, classifications, and require retraining of all employees. • Significant opposition to standard from some business groups due to: • Inclusion of “unclassified hazards” • Challenges to economic impact estimates (costs of training, revised labels and MSDSs etc.)

3. Global Harmonization Project Goal of establishing globally harmonized system for hazard communication established in 1992 at “Rio” Earth Summit. Mandate: “A globally harmonized hazard classification and compatible labelling system, including national safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000.”

4. Global Harmonization Project Organization for Economic Cooperation and Development (OECD) coordinated the development of environmental and health hazard classification criteria. UN Committee of Experts on Transport of Dangerous Goods (UN COE) developed criteria for physical hazards (explosives, flammables, reactives). International Labour Organization (ILO) served as Secretariat for overall coordination.

5. Global Harmonization System:Based on Existing Frameworks Requirements of systems in the US for workplace, consumers and pesticides Requirements of Canada for workplace, consumers and pesticides European Union directives for classification and labelling of substances and preparations United Nations Recommendations on Transport of Dangerous Goods

6. Global Harmonization Project Rationale for U.S. adoption of GHS: American companies are major importers of chemicals as well as exporters, and missing or incomplete information on chemicals we import may lead to reduced protections for workers and public. Large number of varying requirements around the world create potential barriers to trade in chemicals, particularly for small businesses. A harmonized and consistent approach has benefits both in terms of protection and trade.

7. GHS General Principles The Globally Harmonized System (GHS) is not in itself a regulation or a model regulation. It is a framework from which competent authorities may select the appropriate harmonized classification & communication elements. Competent authorities will decide how to apply the various elements of the GHS within their systems based on their needs and the target audience. OSHA has to adopt through conventional rulemaking (governed by APA) before it can include components in mandatory HazCom standard Current OSHA agenda now calls for final rule 4/12 MSHA has not yet placed HazCom revision (30 CFR Part 47) on its agenda The GHS includes the following basic elements: harmonized criteria for classifying substances and mixtures according to their health, environmental and physical hazards; and harmonized hazard communication elements, including requirements for labeling and material safety data sheets.

8. OSHA Rulemaking – Current Rule • HazCom has been in effect for over 25 years; founddation for building a chemical health and safety program in workplace • Addresses needs of employers/employees to obtain information about chemicals, and worker “right-to-know” about hazards • Requires chemical manufacturers and importers to evaluate hazards and provide info to customers through labels, data sheets and worker training programs • Also addresses trade secret protection • Requires all chemicals to be evaluated and incorporates wide range of hazardous effects to be addressed. • OSHA claims HazCom has resulted in 40% decrease in injuries/illnesses due to chemical exposures

9. OSHA – Proposed Rule • Current standard is “performance oriented” and does not specify formats for labels or data sheets – GHS would change that by specifying warnings and format • Method of communication and information transmitted now varies – GHS would make more consistent • GHS system is based on international negotiations and OSHA plans to learn from implementation experience of other nations • New rule CANNOT reduce level of protections afforded under current HazCom standard (29 CFR 1910.1200)

10. OSHA – Proposed Rule • GHS/HazCom still covers all chemicals and wide range of hazards, requires downstream flow of information, and communication of information on labels and data sheets, along with worker training • Sections that remain about the same as the current HazCom rule are: scope/application, written program, training requirements, and trade secret protections • Modified parts apply to manufacturers/importers (hazard classification and preparation of labels and SDS); and employers (receiving revised labels and SDSs in new format, integrating into workplace, and training workers on new approach) • Specification oriented nature of GHS requires additional text in warnings • Detailed info on classification criteria, label elements and SDSs are included in mandatory appendices to standard, not in regulatory text itself

11. OSHA – Proposed Rule • OSHA is looking at 3-year implementation schedule from date of final rule • OSHA would remove the “floor” of covering substances based on several cited references, as well as eliminate the “one-study criteria • GHS’ “Building block” approach allows competent authorities to choose from regulatory options in terms of which hazard classes and categories are adopted • OSHA has proposed to adopt the same BB as the EU … EXCEPT it will not address environmental hazards (outside jurisdiction) and it proposes to add one more category of the flammable liquid class than EU did. • OSHA must also adjust substance-specific health standards that include labeling provisions inconsistent with GHS • OSHA claims that the proposal is economically and technically feasible – some commenters disagreed!

12. Sample Comments - Union • AFL-CIO “strongly support” proposal but wanted OSHA to expand exposure limits listed on SDSs to include ACGIH TLVs and NIOSH RELs, because OSHA PELs are outdated • Union also wants substance-specific standards to be included in SDSs (Sec. 15) to alert workers that there is a comprehensive standard on that chemical • Union supports adding a definition of “unclassified hazards” to make sure that emergent hazards can be included within the scope of HazCom and to address combustible dust hazards.

13. Sample Comment - Business • US Chamber of Commerce has had several meeting with OIRA opposing inclusion of “unclassified hazards” in the rule • It has also challenged the purported cost savings as well as the economic impact analysis prepared by OSHA • Urged switching the compliance deadlines (currently 2 years to train, 3 years to prepare new SDSs) so training can be done after SDSs are available. • Another group with significant concerns is the American Chemistry Council, which also met with OIRA

14. Sample Comments – ASSE • ASSE endorsed the rule, but was “disappointed” that control banding was ignored in the development of the rule • Urged OSHA to incorporate elements of control banding into HazCom to avoid need to revisit this later • Challenged cost estimates for training time • Suggested ACGIH TLVs should continue to be listed as well as NIOSH RELs, and suggested additional references to be considered by end users (AIHA also supports retention of TLVs and RELs) • Advocated a quicker effective date for training but not for phsae in for the SDS and labeling requirements, and recommended significant compliance assistance be made available from OSHA

15. What’s the Impact? • Rule will impact nearly 5 million workplaces, and 40 million workers • OSHA claims costs range from $38-$47 per covered entity for one-hour of training • This did not add costs for developing new labels, SDSs etc. • According to OSHA: • Annualized savings for employers of between $585 mil and $798 mil • Most of this through increased productivity for H&S managers and logistics personnel • Savings attributed to uniform SDSs and labels accounts for between $16 mil and $32.2 mil

16. HazCom & GHS Comparison GHS scope is consistent with the HazCom exemptions and labeling exceptions. HazCom includes laboratories, sealed containers and distributors while, as a framework for systems, GHS does not include these specific issues. GHS addresses testing in the scope section, while HazCom addresses testing under hazard determination. Neither GHS and HazCom require testing for health hazards. Physical hazards in the HazCom are not linked to specific test methods (as is the case in the GHS) and testing for physical hazards is not required.

17. HazCom & GHS Comparison HazCom is performance -- oriented; GHS is a specification oriented. OSHA may choose to incorporate only selected building blocks from GHS. HazCom may not implement all GHS hazard classes, e.g., hazardous for the environment. HazCom may not regulate all hazard categories, e.g., acute toxicity. Many hazard classes will require some type of change to the HazCom standards if OSHA/MSHA wish to achieve global consistency. Substantive GHS implementation will require: Changes to required label elements Modification of required MSDS format Criteria changes.

18. HazCom & GHS Comparison A significant difference between HazCom and GHS is the evaluation of mixtures. GHS criteria for mixtures varies by hazard class. HazCom allows test data on mixtures to be used for all hazard classes. GHS allows test data on carcinogens, mutagens & reproductive toxins on a case-by-case basis. GHS expectation of physical test data for mixtures is another difference. HazCom "floor" of hazardous chemicals is a difference and one which is likely helpful to small businesses. OSHA suggests that guidance on how IARC, NTP and OSHA carcinogens fit with the GHS cancer classification scheme could be useful in the future.

19. Sector-Specific Implementation For transport, application of GHS will be similar to application of current transport requirements. US DOT has already adopted. Containers of dangerous goods will be marked with pictograms that address acute toxicity, physical hazards, and environmental hazards. Workers in the transport sector will be trained. In the workplace, it is expected that all GHS elements will be adopted by OSHA, including labels that have the harmonized information, and safety data sheets. This must be supplemented by employee training to ensure effective communication Training constitutes the majority of OSHA’s estimated costs for the rule For the consumer sector, it is expected that labels will be the primary focus of GHS application. These labels will include the core elements of the GHS, subject to some sector-specific considerations in certain systems. CPSC has already adopted GHS.

20. Safety Data Sheet Impact The performance orientation of HazCom’s MSDS will need to be changed. GHS requires a 16 section MSDS format with specified sequence and minimum required contents. There is discretion in the GHS for determining when an MSDS is required: the hazard pictogram/symbol can be graphically reproduced on the MSDS or the name of the symbol may be provided instead. The level of hazardous components can be given as ranges or concentrations - the values for component disclosure in mixtures vary by end point. Therefore, some changes will be needed for component disclosure.

21. Safety Data Sheets Guidance on Preparation of Safety Data Sheet: ILO Recommendation 177 on Safety in the Use of Chemicals at Work ISO Standard 11014 European Union SDS Directive 91/155/EEC ANSI Standard Z400.1

22. Hazard Determination GHS and HCS hazard determination/classification are self-classification processes Classification is more involved in the GHS because GHS uses “weight of evidence” in hazard determination (positive and negative results are considered, although a strong single positive study may be determinative) HazCom uses a “one positive study” threshold, while GHS provides for the one positive study issue within the individual endpoints. In vitro studies are treated differently and substances not bioavailable or inextricably bound are addressed. Professional/expert judgment is included. Human experience is taken into account. GHS addresses the import concept of previously classified substances.

23. Health Hazard Considerations GHS has several health hazard endpoints, e.g., mutagenicity and target organ systemic toxicity, that do not exactly correspond to the HazCom system. Major difference between HazCom and the GHS is untested mixtures. OSHA has a single 1% cut-off value for all health hazards, except carcinogens at 0.1%. These cut-off values require labels, MSDSs, and disclosure of hazardous components. In the GHS, cut-off values for mixtures vary by endpoint. GHS cut-off values for labeling, MSDSs and disclosure can be different. GHS acute toxicity and irritant hazard determinations for mixtures have more steps.

24. Acute Toxicity Five GHS categories have been included in the GHS Acute Toxicity scheme from which the appropriate elements relevant to means of transport, consumer, worker and environment protection can be selected. HazCom has 2 Acute Toxicity hazard categories whose cut-off values do not exactly correspond to the GHS cut-offs. The untested mixture hazard determination is different in HazCom and GHS. The GHS Acute Toxicity hazard determination for mixtures is involved. Acute Toxicity is a common data set in GHS.

25. Acute Toxicity

26. Classification of Carcinogens OSHA HazCom A chemical is considered to be a carcinogen if: It has been evaluated by the International Agency for Research on Cancer (IARC), and found to be a carcinogen or potential carcinogen;or It is listed as a carcinogen or potential carcinogen in the Annual Report on Carcinogens published by the National Toxicology Program (NTP) (latest edition); or It is regulated by OSHA as a carcinogen. GHS Carcinogen means a chemical substance or a mixture of chemical substances which induce cancer or increase its incidence. Substances and mixtures of this hazard class are assigned to one of two hazard categories.

27. GHS Carcinogen Classes GHS Category 1 : Known or Presumed Human Carcinogen Category 1A - Known Human Carcinogen Based on human evidence Category 1B :Presumed Human Carcinogen Strength of evidence with additional considerations Evidence of animal carcinogenicity (presumed human carcinogen). On a case by case basis, limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in animals.Including mixtures containing > 0.1% of such a substance. GHS Category 2: Suspected human carcinogen Evidence from human and/or animal studies, Strength of evidence together with additional considerations. Including mixtures containing more than >0.1 or >1.0 % of such a substance.

28. Physical Hazards In GHS, physical hazards are defined by criteria that specifies a test method. For several physical hazard endpoints, the HazCom criteria is a definition. GHS has multiple subcategories within an endpoint, leading to specific signal words, hazard phrases and pictograms. For substances previously classified under HazCom, existing data should be accepted when the substances are reclassified under GHS. HazCom has only one hazard category for Explosives, while GHS has 6 hazard categories.

29. GHS Labeling Requirements Information Required on GHS Label: Signal Words Hazard Statements Precautionary Statements and Pictograms Product Identifier Supplier Identification Multiple Hazards and precedence of hazard information Arrangements for presenting the GHS label elements Special Labelling Arrangements

30. Comparison of Labeling Requirements HazCom label requirements are totally performance -- oriented. The GHS labeling requirements are specified: signal words, hazard statements, and pictograms. The use of pictograms is a significant change for US labeling. If HazCom retains NTP/OSHA/IARC carcinogen info, guidance on labeling is needed to conform with GHS. USA liability concerns are a label consideration.

31. Sample Pictograms

32. Sample Flammability Pictograms Liquids Solids Gases

33. GHS Sample Label –HAZARDS (Liquid): flammable liquid, flash point = 120°F;  oral LD50 = 275 mg/kg Danger! Toxic if swallowedFlammable liquid and vapor Contains: XYZ Do not taste or swallow.  Get medical attention.  Do not take internally.  Wash thoroughly after handling.  Keep away from heat, sparks and flame.  Keep container closed.  Use only with adequate ventilation. FIRST AIDIf swallowed, induce vomiting immediately, as directed by medical personnel. Never give anything by mouth to an unconscious person.See Material Safety Data Sheet for further details regarding safe use of this product.Company name, Address, Phone number

34. GHS Sample Label – Suspected Carcinogen (inhalation) My Product Warning!Cause Skin And Eye IrritationSuspected of causing cancer by inhalationContains: XYZDo not breathe vapors or mist. Use only with adequate ventilation. Avoid contact with eyes, skin and clothing. Wash thoroughly after handlingFIRST AIDEYES: Immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention.SKIN: In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Wash clothing before reuse. Get medical attention if irritation develops and persists.Company name, Address, Phone number HAZARDS (Liquid): moderate skin and eye irritant, possible cancer hazard by inhalation

35. Global Harmonization System GHS hazard classification criteria were adopted by consensus for physical hazards and key health and environmental classes. Standardized label elements (symbols, signal words, hazard statements) were developed along with standard format for SDS. GHS also addresses product identifiers, confidential business information, and precedence of hazards.

36. Global Harmonization - Training Training users of hazard information is integral part of hazard communication. Systems should identify appropriate education and training for GHS target audiences who must interpret label and/or SDS information and take action in response to chemical hazards. Training should address: workers, emergency responders, and those involved with preparation of labels, SDS and HazCom strategies as part of risk management systems. Systems should also educate consumers in interpreting label information on products they use.

37. Global Harmonization Summary GHS is a VOLUNTARY system – it does NOT impose binding treaty obligations on countries, but where countries adopt GHS into national regulatory requirements, it will be part of mandatory standards. Implementation objective was January 2008 – many countries (but not US) met this deadline. Congress has considered legislation in prior sessions that would force OSHA to adopt a rule, but those lost momentum when the rulemaking proceeded.

38. GHS Summary Level of protection offered to workers, consumers, general public and environment should not be reduced by GHS Involvement of concerned organizations of employers, workers, consumers and other relevant groups is essential Validated data already generated for classification of chemicals under existing systems should be accepted when reclassifying the chemicals under GHS The new harmonized system may require adaptation of existing methods for testing.

39. Conclusion Overall benefits of globally harmonized system: Promotes safer transportation, handling and use of chemicals; Improves understanding of hazards; Increases compliance and reduces costs for companies involved in international activities; Helps protect workers, consumers and potential exposed populations around the globe. Bottom Line: A new OSHA HazCom standard is inevitable . . . Plan ahead!

40. QUESTIONS ? Contact Adele L. Abrams, Esq., CMSP at 301-595-3520 or write to: safetylawyer@aol.com