GHS: what's new in the Americas? Webinar, 30 April 2013, 2pm BST

Transcription

1 GHS: what's new in the Americas? Webinar, 30 April 2013, 2pm BST

2 Today s webinar aims (1/2) Provide delegates with a round-up of changes to OSHA and implementation; Provide an overview of activities in Canada, setting out the implications for Canadian industry, next steps and suggestions for pre-implementation preparations; Consider WHMIS, highlighting anticipated changes;

3 Today s webinar aims (2/2) Provide a regional update, with a specific focus on Latin America. Look at Argentina's new Labelling and Safety Data Sheet standards aligning with GHS (4th edition) as well as recent Brazil GHS versions. Detail central American countries adopting GHS and the wider acceptance of GHS.

4 Q&A session If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.

5 Speakers Deana Holmes, Health Scientist, OSHA Directorate of Standards and Guidance; Leticia Cuevas, Latin America Regulatory Analyst, 3E Company; Ginette Bouchard, Environmental Affairs Specialist, Bayer Inc.; Chair: Oliver Curl, Reporter, Chemical Watch

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7 Hazard Communication and the Globally Harmonized System (GHS) Deana Holmes OSHA, Directorate of Standards & Guidance April 30, 2013

8 Overview Major changes to the Hazard Communication Standard Hazard Communication Guidance and Outreach

9 Development of Final Rule ANPR modifying the existing HCS to align it with the GHS was published on September 12, 2006 NPRM Published in the Federal Register on September 30, 2009 (74 FR ) Public hearings in 2010 Final rule published in the Federal Register on March 26, 2012 and became effective on May 25, 2012

10 MODIFIED HAZARD COMMUNICATION STANDARD

11 How Hazard Communication Works

12 Organization of the Final Rule (a) Purpose (b) Scope and Application (c) Definitions (d) Hazard Classification (e) Written Hazard Communication Program (f) Labels and Other Forms of Warning (g) Safety Data Sheets (h) Employee Information and Training (i) (j) Trade Secrets Effective Dates Appendices A-F

13 Appendices Appendix A, Health Hazard Criteria (Mandatory) (NEW) Appendix B, Physical Hazard Criteria (Mandatory) (NEW) Appendix C, Allocation of Label Elements (Mandatory) (NEW) Appendix D, Safety Data Sheets (Mandatory) (NEW) Appendix E, Definition of Trade Secret (Mandatory) Appendix F, Guidance for Hazard Classifications re: Carcinogenicity (Non-Mandatory) (NEW)

14 d) Hazard Classification HazCom 1994 Performance-oriented Definitions in paragraph (c), Appendices A and B Appendix B parameters for evaluating data Floor of chemicals considered hazardous One study rule Standardized mixture cut-off rules HazCom 2012 Specific and detailed Concept of classification vs. determination in current rule Each hazard class has detailed criteria to apply to data on the chemical No floor; based on weight of evidence Mixture rules are specific to each hazard class

15 Hazard Classification Manufacturers are still responsible for determining the hazards of the chemicals they produce or import Classification (similar to hazard determination) is based on the full range of available information The procedures for determining if the manufacturer has properly performed the hazard classification are provided in Appendix A (health) and Appendix B (physical)

16 Health Hazards Hazard Class Hazard Category Acute Toxicity Skin Corrosion/Irritation 1A 1B 1C 2 Serious Eye Damage/ Eye Irritation 1 2A 2B Respiratory or Skin Sensitization 1 Germ Cell Mutagenicity 1A 1B 2 Carcinogenicity 1A 1B 2 Reproductive Toxicity 1A 1B 2 Lactation STOT Single Exposure STOT Repeated Exposure 1 2 Aspiration 1 Simple Asphyxiants Single Category 11

17 Hazard Class Explosives Unstable Explosives Flammable Gases 1 2 Flammable Aerosols 1 2 Oxidizing Gases 1 Gases under Pressure Compressed Gases Liquefied Gases Refrigerated Liquefied Gases Dissolved Gases 1 Hazard Category Div 1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6 Flammable Liquids Flammable Solids 1 2 Self-Reactive Chemicals Type A Type B Type C Type D Type E Type F Type G Pyrophoric Liquids 1 Pyrophoric Solid 1 Pyrophoric Gases Single category Self-heating Chemicals 1 2 Chemicals, which in contact with water, emit flammable gases Oxidizing Liquids Oxidizing Solids Organic Peroxides Type A Type B Type C Type D Type E Type F Type G Corrosive to Metals 1 Combustible Dusts Physical Hazards Single Category

18 Hazards not Otherwise Classified This definition was added to ensure that hazards currently covered by HazCom continue to be covered Information will be required on the safety data sheets in Section 2 Hazard information on the label, is not mandatory, but can be provided under supplementary information Such hazards must also be addressed in worker training

19 f) Labels and Other Forms of Warning HazCom 1994 Shipped containers to be labeled with identity, appropriate hazard warnings, and responsible party Performance-oriented, specifics left to discretion of chemical manufacturer or importer HazCom 2012 Shipped containers to be labeled with product identifier; signal word; hazard statement(s); pictograms; precautionary statements; and responsible party Specifies information by hazard class and category

20 Approach to Labels The final rule like the GHS is a specification approach to labels. In Appendix C, OSHA has indicated by hazard class and hazard category the label elements that must be on the label Appendix C provides guidance on the application of label elements once classification of the hazards is completed, Appendix C is to be consulted to determine how to convey the required information

21 Label Requirements Shipped Containers Product identifier Signal word Hazard statement(s) Pictogram(s) Precautionary statement(s) Name, address, and phone number of the responsible party

22 Pictograms and Hazards

23 Red vs. Black Borders OSHA is requiring red borders regardless of the shipment s destination. The red borders increase comprehensibility. Blank red diamonds are not permitted on a label.

24 g) Safety Data Sheets HazCom 1994 Specifies what information is required, but chemical manufacturer or importer can use whatever format or order of information they want HazCom 2012 Mandates 16-section SDS headings, order of information, and what information is to be provided under the headings Will not enforce sections that require information outside OSHA s jurisdiction

25 16-Section Safety Data Sheet 1. Identification of the substance or mixture and of the supplier 2. Hazards identification 3. Composition/information on ingredients Substance/Mixture 4. First aid measures 5. Firefighting measures 6. Accidental release measures 7. Handling and storage 8. Exposure controls/personal protection. 9. Physical and chemical properties 10. Stability and reactivity 11. Toxicological 12. Ecological information (non mandatory) 13. Disposal considerations (non mandatory) 14. Transport information (non mandatory) 15. Regulatory information (non mandatory) 16. Other information including information on preparation and revision of the SDS

26 h) Employee Information and Training HazCom 1994 Requires employee information and training before a worker is exposed to the hazardous chemicals in the workplace, and whenever the hazard changes HazCom 2012 Clarifies that the labels on shipped containers and workplace labels must be explained, as well as SDS format Workers will have to be trained on the new label and SDS formats before all the provisions of the rule are effective

27 Employee Information and Training Employers shall train employees regarding the new label elements and safety data sheet format by December 1, Label elements: Train employees on the type of information that the employee would expect to see on the new labels. How they might use that information Product identifier, Signal word, Hazard statement(s), Pictogram(s), Precautionary statement(s), and Name, address and phone number of the responsible party General understanding how the elements interact. For example, explain the two signal words: Danger means a more severe hazard within a hazard class. Warning is for the less severe hazard. Safety Data Sheet Format Train the employees on the standardized 16-section format and the type of information they would find in the various sections.

28 j) Effective Dates HazCom 2012 Effective Completion Date Requirement(s) Who December 1, 2013 June 1, 2015* December 1, 2015 Train employees on the new label elements and SDS format. Comply with all modified provisions of this final rule, except: Distributors may ship products labeled by manufacturers under the old system until December 1, June 1, 2016 Update alternative workplace labeling and hazard communication program as necessary, and provide additional employee training for newly identified physical or health hazards. Transition Period Comply with either 29 CFR (this final standard), or the current standard, or both. Employers Chemical manufacturers, importers, distributors and employers Employers All chemical manufacturers, importers, distributors and employers *This date coincides with the European Union implementation date for classification of mixtures.

29 GUIDANCE & OUTREACH

30 Updated HazCom Webpage

31 Guidance & Outreach OSHA is developing an array of guidance materials Initial Materials Quick cards, fact sheets, OSHA briefs, small entity compliance guides, frequently asked questions Technical Materials Model Training Materials, Safety Data Sheet Preparation Guidance, Hazard Classification Guidance Web Applications SDS Electronic Form; Acute Toxicity Calculator; Label Elements Application

32 Updated Webpages HazCom 2012 Webpage UN GHS Sub-Committee Home Page s_welcome_e.html

33 Deana Holmes Contact information

34 2013 GHS Developments in Latin America Leticia Cuevas Regulatory Analyst 2013, 3E Company, All Rights Reserved

35 First North American Country to adopt GHS Mexico When? Adopted UN GHS 3 rd edition June 4, 2011 Why? To assist the chemical industry already burdened with dual labeling and safety data sheet requirements. Before GHS adoption, NOM-018-STPS-2000 mandatory for chemical industry After GHS, chemical industry has option of using GHS (voluntary), or using NOM-018-STPS-2000 (still in force) 2013, 3E Company, All Rights Reserved

36 First North American Country to adopt GHS Highlights: Mexico GHS contains 5 Annexes that mirror the UN Purple Book 3rd Edition (2009) Annex 1 describes the allocation of labeling elements Annex 4 fully explains the 16-Section format and content of the Safety Data Sheet. It is a voluntary standard, therefore there are no transitional periods When using GHS, all communication must be written in Spanish (as is required by NOM-018-STPS-2000) 2013, 3E Company, All Rights Reserved

37 Central American Countries soon to adopt GHS Guatemala GHS Pending Implementation Highlights Under second revision by the Ministry of Environment and Natural Resources GHS Regulations targeted for 2013 for Chemicals and Transport Include Classification, Labeling and Safety Data Sheet requirements Currently, because there is no current regulation in place, Guatemala accepts UN Purple Book 2013, 3E Company, All Rights Reserved

38 Central American Countries soon to adopt GHS El Salvador GHS Pending Implementation Highlights El Salvador has been working toward: Approved tariff codes related to pesticides and ozone-depleting substances. On transport of dangerous goods. El Salvador accepts the codes set forth in the framework of the U.N. On special substance matter: waste and hazardous waste regulation issued through (Decree No. 41, June 2000). Articles 52 to 69 establish the kinds of identification of dangerous materials and the type of labeling (which correspond to those that are accepted internationally for the transport of dangerous goods of the UN (Orange Book) and the emergency response Guidebook). 2013, 3E Company, All Rights Reserved

39 Central American Countries soon to adopt GHS Honduras GHS Pending Implementation Highlights The Ministry of the Environment and Natural Resources published: Environmentally Rational Management of Hazardous Chemicals, which is the draft of the GHS regulation. Classification, Labeling and Safety Data Sheet requirements for hazardous chemicals Waiting to be signed by President of Honduras Like Guatemala, Honduras accepts UN Purple Book 2013, 3E Company, All Rights Reserved

40 South American GHS Countries Brazil ABNT NBR 14725: Chemicals -Information about safety, health and environment (2009) Part 1: Terminology Part 2: Hazard Classification Part 3: Labeling Part 4: Safety data sheet for chemicals (SDS) With the exception of Part 2, currently in review, the transitional periods have changed since 2009: 2013, 3E Company, All Rights Reserved

41 South American GHS Countries Brazil (continued) ABNT NBR Revisions Part 1: Terminology, Chemicals Information about safety, health and environment- Corrected version: 2010 (in force) Part 2: Hazard Classification (ABNT 14725:2009) -Corrected version 2010 (in force) -Under revision (update expected mid-2013) Part 3: Labeling (ABNT 14725:2012) -June 14, Corrected version: Aug. 16, 2012 Part 4: Safety data sheet for chemicals (SDS) (ABNT 14725:2012) -Aug. 3, , 3E Company, All Rights Reserved

42 South American GHS Countries Brazil (continued) ABNT NBR Transitional Periods While Part 2: Classification, is still being revised and, according to ABNT, should be ready sometime in 2013, the transitional periods under this regulation: February 26, 2011 for Substances already expired June 1, 2015 for Mixtures Part 3: Labeling of June 14, 2012 transitional period for Substances, has expired. December 10, 2012 However, for Mixtures, using this standard is optional until: May 31, 2015, BUT as of June 1, 2015, chemical products MUST BE LABELED in accordance to ABNT : , 3E Company, All Rights Reserved

43 South American GHS Countries Brazil (continued) ABNT NBR Transitional Periods Basis for ABNT was based on Ordinance SIT No. 229 (NR26) of May 24, 2011, issued by the Ministry of Labor and Employment Part 4: Safety Data Sheet of August 3, 2012 transitional period for Substances, has expired: February 3, 2013 But the transitional period for Mixtures is: June 1, 2015 ABNT :2012 is a 16-Section Format based on UN Purple Book 3 rd Edition Language Requirement: the Safety Data Sheet must be prepared in Brazilian Portuguese 2013, 3E Company, All Rights Reserved

44 South American GHS Countries Uruguay GHS implemented through Presidential Decree 307/009 of July 3, 2009 Entry into force originally 120 days after publication in Official Gazette Transition period for labeling of chemicals was one year after its publication in Official Gazette. Annex 1 - Labels Annex 2 - Safety Data Sheets (SDS) adopt the guidelines of the GHS 2013, 3E Company, All Rights Reserved

45 South American GHS Countries Uruguay (Continued) But Decree 346/011 of September 28, 2011, published on Oct. 13, 2011: To extend the transitional period to give companies sufficient time to comply with the labeling requirements To require min. labeling information (Annex I) Substances (Dec. 31, 2012 expired) Mixtures (Dec. 31, 2017) To require min. information on SDS (Annex II) SafetyData Sheet requirements mirror UN Purple Book -16 Sections, etc. Language Requirement: The SDS must be in Spanish language no matter where the chemical productwas manufactured. 2013, 3E Company, All Rights Reserved

46 GHS Status of South American Countries Safety Data Sheet Argentina IRAM Standards and GHS Alignment IRAM standard No /2006 of October 02 is an identical adoption of ISO (1: ) chemical safety data sheet with 16 sections. According to IRAM, the standard is being revised for alignment with the GHS 4 th edition. (It was scheduled for late 2012 release, but now it needs to be updated with observations ; therefore, a future release date is unknown.) Labeling IRAM on labeling of chemicals is also being revised. When published, it will also be aligned with GHS 4th Edition and will repeal IRAM 3797, currently in force. At this time, the standard is up for public comments. 2013, 3E Company, All Rights Reserved

47 GHS Status of South American Countries Ecuador INEN Standards and GHS Classification, Labeling and Packaging of Hazardous Chemicals Ecuador s GHS version was published in the Official Gazette No. 881 on January 29, Currently, the standard is voluntary, but once Technical Regulation No. 078 is published, which could be in late 2013, INEN 2266:2013 will become mandatory. When this happens, both the standard and the Technical Regulation will be required. The purpose of INEN 2266:2013: It establishes the requirements that must be met for the transport, storage and handling of hazardous materials. Its Scope: It applies to activities in production, marketing, transport, storage and handling of hazardous materials. 2013, 3E Company, All Rights Reserved

48 GHS Status of South American Countries Ecuador (Continued) INEN Standards and GHS The Safety Data Sheet (SDS) is found in Annex B, which has 16 Sections and requires the SDS to be written in Spanish. The standard also specifies that the labeling of containers and packaging must also be in Spanish. NTE INEN 2266: 2013 combines the UN Purple and Orange Books: Annexes A through D are the Purple Book Component. Annexes F through L belong to the Transport Component (Orange Book). Labeling INEN 2288: 2000 This labeling standard for hazardous industrial chemicals is still in force and it is mandatory. The standard contains label precautions and specifications. 2013, 3E Company, All Rights Reserved

49 GHS Status of South American Countries GHS Status Peru Peru does not have a regulatory framework for labeling of chemicals and for Safety Data Sheets; however, it is working on ways to implement the GHS within its regulatory framework. Labeling and Safety Data Sheets Peru accepts labeling and Safety Data Sheets created under the UN GHS System Purple Book 2013, 3E Company, All Rights Reserved

50 Regional GHS Developments Mercosur-GHS There is a current initiative in cooperation with the EC to implement GHS into Mercosur. Why? Total Harmonization According to some experts, currently there is no total harmonization, at least in Latin American countries: In Mexico there are a set of standard rules that implement the GHS regarding the classification, labeling and chemical safety data sheets. However, they are voluntary. In Brazil there is a similar situation to the one in Mexico, we have a series of standards concurring with GHS, but some are believed to be voluntary. Argentina has a voluntary standard concurrent also with GHS, but its Safety Data Sheet standard is voluntary. Ecuador s GHS standard is quite unusual with two Books in one, and until the Technical Regulation is published, it is just a voluntary standard. Uruguay decree, which was modified to extend the deadline for implementation of substances and mixtures, requires the application of the GHS. 2013, 3E Company, All Rights Reserved

51 GHS Standards Voluntary or Mandatory? Japan Russia Japan s GHS concurring standards have obligated companies to use best efforts to comply. However, on 27 March, Japan published a new GHS-based standard, JIS Z 7253, combining two current standards. Under the new standard, the Japanese Ministry of Health, Labor and Welfare obligates companies to comply with the standard at the latest by 31 December 2016, when the transitional period ends and use of the two current standards is no longer allowed. Implementation of the standard, is 1 April To determine whether Russia s GHS standards (GOSTs and GOST R) are voluntary or mandatory: Law on Technical Regulation, N 184-ФЗ (as amended through March 3, 2012) specifies: Art. 2 -GOSTs and GOST R are voluntary Art GOSTs and GOST R are mandatory if: 1. related to environment or health, and 2. no specific technical regulation pertaining to the subject is adopted Because Russia has no technical regulations on this subject matter classification, labeling and SDS, the GOST and GOST R are to be followed -mandatory) 2013, 3E Company, All Rights Reserved

52 Global GHS Developments Croatia Now, Countries such as Croatia are just concluding the preparation and capacity-building activities for EC CLP and GHS. Highlights: Croatia is to become the newest member of EU on July 1, Published on February 15 in the Official Gazette: Decision on the Proclamation of the Chemicals Act (18/2013). -establishes the legal framework for implementing in Croatia the REACH, CLP, and Prior Informed Consent (PIC) Regulations (i.e., 1907/2006/EC, 1272/2008/EC, and 689/2008/EC), among others. Approved two amendments on February 6, 2013 to its current laws: implementing the European Union s REACH and CLP Regulations, respectively. 2013, 3E Company, All Rights Reserved

53 Global GHS Developments Croatia (continued) Published, on February 15, 2013, amendments (that enter into force July 1, 2013 on the day Croatia officially joins the European Union): To expand the Ministry of Health s executive powers with regard to the laws, sanctioning it to issue regulations for REACH s and CLP s implementation in Croatia, and To authorize other government agencies to act in its stead to do the same. - Most provisions of the act refer directly to EU legislation, applying community requirements for chemicals classification, SDS compilation, import and export, and marketing and use. - The act preserves some provisions specific to Croatia, including the obligation to electronically notify the Croatian Institute for Toxicology and Antidoping (CITA; before chemicals are placed on the domestic market. 2013, 3E Company, All Rights Reserved

54 Global GHS Developments India has a draft concurrent with GHS, titled, Hazardous Substances Rules, Published by Ministry of Environment and Forests on July 8, 2011 on: Classification, Packaging and Labeling It covers 685 chemicals and classifies 9 classes of physical hazards The Labeling component is Harmonized with the transport of dangerous goods (UN Orange Book) The Safety Data Sheet (SDS) has 16 sections in a GHS format After publication in the Official Gazette, the regulation will become effective 360 days after publication. 2013, 3E Company, All Rights Reserved

55 2013 GHS Developments in Latin America Thank you. 2013, 3E Company, All Rights Reserved

56 GHS -A Canadian Industry Perspective Ginette Bouchard Bayer Inc. (Toronto) Canada April 30, 2013

57 Agenda Implications for industry in Canada WHMIS: what will change?/what will stay the same? GHS activities in Canada How industry can prepare for implementation Bayer Inc.

58 Implications for Industry in Canada GHS affects the following key Canadian sectors: Health Canada Workplace Chemicals (WHMIS) Pest Control Products Consumer Chemical Products Transport Canada Transportation of Dangerous Goods (TDG) Pharmaceuticals, food additives, cosmetics and pesticide residues in food will be captured where workers may be exposed and in transport. Bayer Inc.

59 WHMIS: What Will Change? New classification criteria New hazard classes Material Safety Data Sheets (MSDS) will be known as Safety Data Sheets (SDS) - 16 sections, in a specified order (accepted for use now) New requirements for labels New hazard symbols (pictograms) Bayer Inc.

60 WHMIS: What Will Stay the Same? WHMIS will not be replaced by the GHS Roles and responsibilities for suppliers, employers and workers still remain Suppliers: classify hazardous products prepare labels and SDSs and provide to customers Employers: educate and train employees ensure the controlled products have WHMIS labels ensure SDSs on file are current and are accessible Workers: participate in the training provided Bayer Inc.

61 GHS Activities in Canada December the prime minister of Canada and the U.S. president announce the Joint Action Plan for the Canada-U.S. Regulatory Cooperation Council Health Canada s focus has always been to align as much as possible with the U.S., while making sure the level of protection is not reduced Legislative and regulatory changes will be required at both the federal and provincial/territorial levels Amendments to the Hazardous Products Act (HPA) are expected to be tabled by this Spring (2013) Required changes to the Controlled Products Regulations (CPR) are also expected to be ready for publication and consultation around the same time Target implementation date is June 1, 2015 in sync with the U.S. Bayer Inc.

62 Preparing for Change Familiarize yourself with the Purple Book Stay informed/participate in consultations Have ongoing discussions with your IT personnel, health & safety personnel, WHMIS trainers, etc. to identify and implement the changes that will be required to your existing programs and systems Assemble a change team Look at the possible implementation costs for your organization, and establish a plan/budget Bayer Inc.

63 Thank you! Ginette Bouchard Bayer Inc. (Toronto) Canada April 30, 2013

64 Q&A session If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.

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