GHS Implementation: The First Wave after the Tsunami The Work is Just Beginning

Transcription

1 GHS Implementation: The First Wave after the Tsunami The Work is Just Beginning Denese Deeds, CIH, Senior Consultant Industrial Health & Safety Consultants, Inc. Jonathan Hellerstein, CIH, CSP Senior Lead Global Product Stewardship, MeadWestvaco Bernie Lindquist, PhD, DABT Principal, Lindquist Consulting, LLC. Tuesday June 2 10:00 AM - 12:30 PM

2 Program Description This interactive session will allow participants to discuss challenges ahead for the continued transition to the GHS. Prior to this conference, attendees will be surveyed on SDS management development and communication issues. Based on these results, presenters will introduce topics including customer and management communication, restricted and controlled chemicals, international differences in classification, data gaps and classification impacts, perception of changes in risks and hazards of products and practical labeling and SDS revision challenges. Attendees will discuss and identify key issues, gaps, solutions and future resource needs that can be addressed by the Product Stewardship Society.

3 Agenda - Overview of GHS Implementation Challenges and Opportunities Introduction & Overviews (~ 45 minutes) 1. Hazard Classification SDS Author / Practitioner Perspective 2. Workplace Perspective 3. Product and Business Downstream Impacts & Opportunities 4. GHS Survey Results Workshop (~ 100 minutes) Breakouts / Discussions Participant - Report Outs Issue Summary & Conclusions (5 minutes)

4 Learning Objectives Identify specific challenges that companies will face in the coming year related to GHS implementation. Prioritize action plans for managing impacts on customers, products and workers to achieve the objectives of the GHS. Establish net-working relationships with fellow Society members to share best practices, identify common problems and solutions.

5 GHS Implementation: The First Wave after the Tsunami The Work is Just Beginning Deep Dive Session Hazard Classification and SDS/Label Authoring under GHS The Challenges

6 The Challenges - Basic Seek Learn Apply Learn/understand the GHS system New substance/mixture criteria New mixture rules Seek/Find data and Apply the criteria Find pertinent and reliable data Interpret the data Classify substance/mixture Document/store the data/ classifications/decisions Develop SDS and labels

7 The Challenges - Basic Seek Learn Apply Learn/apply a new software system (or new rules in an existing system)? How do rules work? What data is read? How does data have to be entered? Product vs. component data Implement new SDS and label templates What goes where, i.e. how does your template function? What can you / what should you customize?

8 The Challenges Classification Conflicts The same chemical may be classified differently by country what harmony? Differences in GHS regulations (competent authority options) Endpoints/categories adopted Mixture rules Different thresholds Conflicting supplier information

9 The Challenges Classification Conflicts Conflicting classifications Impacts of other regulations Mandatory classifications E.g. EU CLP, Korea Ministry of the Environment REACH Registration dossiers how to approach Pesticide regulations Do you need to agree with a specific registration?

10 The Challenges Knowing WHAT you are classifying! Raw Material 45% Trade Secret 20% Alcohol Ethoxylate 10% Aromatic hydrocarbon 25% Unknown Degree of ethoxylation? Benzene content?

11 The Challenges Output Documents Label and SDS considerations Content/design requirements Variations in P phrase inclusion on labels Color pictogram requirement Country variations Is a global SDS a dream?

12 Other Challenges Managing the volume of data/classification information Storing data/classifications/decisions Keeping up with new information and managing updates Understanding the regulations Waiting for guidance from OSHA Overwhelming amount of guidance from ECHA

13 Other Challenges Pace of global regulatory change Training/retaining personnel with sufficient experience/expertise in GHS Considering all of these challenges, how do we consistently turn out high quality SDS and labels?

14 GHS Implementation: The First Wave after the Tsunami The Work is Just Beginning Deep Dive Session Safety, Hygiene, Environment perspectives on GHS Impacts Workplace Issues

15 Conflicting Classifications SDS for the same product from different vendors have different classifications Company A classified an oil as Carcinogenic other vendor does not SDS have confusing classifications Both Eye 2A and 2B Inhalation toxicity for both gas and dust Section 2 shows classification but data in Section 11 does not support it

16 SDS is Non-Compliant Name changed from MSDS to SDS but No Classification in Section 2 No labeling in Section 2 Pictograms do not match classification Hazard Statements not from Appendix C Section 2 has components OSHA format not followed

17 Proprietary Information OSHA limits what can be claimed as proprietary Supplier SDS lists hazards but does not identify ingredients How can you verify what you do not know? What information is required from the supplier What are your rights?

18 What About Risk New GHS SDS are scary Hazard Communication deals with intrinsic hazards Ricks adds the exposure component Workers really care about risk How can we explain risk to workers and put the hazard into context

19 Practicalities How will I respond to the new classifications? How can I easily manage all these new SDS and hazard information? Do I need to keep all the old ones? What about secondary container labeling? Will I keep using HMIS/NFPA?

20 GHS Implementation: The First Wave after the Tsunami The Work is Just Beginning Deep Dive Session Product Stewardship Perspective Product and Business Downstream Impacts & Opportunities

21 Customer and Management Communications Who should be informed, educated and/or trained? Internal Stakeholders / Management / Process Leaders External Distributors, Customers and Downstream Users What are key messages / content to communicate about new classifications, SDS and Product Labels? How to deliver the information on a need to know basis? What are the desired and expected outcomes? How to avoid Customers Reacting Negatively to new SDS and Hazard Classifications?

22 Managing Manufacturer /Supplier Relationships to Favor GHS Implementation Success What can you do if Manufacturer's / Suppliers are not providing GHS Compliant SDS? Who can you engage to get information needed? (internally and externally) What leverage do you have to get information needed or to resolve issues with SDS / labeling?

23 Impacts Along the Supply Chain What are Added Costs? What is driving increased costs? Describe Increased Sales and Marketing Opportunities that GHS May Create? Who is impacted? What are the impacted products or services? What to expect and what to do about differences in your and your competitor SDS s or labels? How can you engage suppliers, trade organizations etc., to promote consistent conformance and application of GHS?

24 Business Opportunities How to capitalize on the Opportunities GHS Creates for Competitive Advantage for products or services that your company manufactures, distributes or services it provides? What can / should be communicated about the potential to Increase Global Product Marketing (because GHS removes barriers for trade)? What are the productivity gains? Examples of increased productivity for H&S managers and/or logistics personnel? How to realize and measure gains? What are important considerations for more effective and efficient use of Consultants for GHS related projects? What can be done to enable more effective and efficient completion of classifying raw materials / product formulations or author SDS & labels?

25 SDS Distribution to Customers What systems can be used to distribute SDS to customers? What should be included in the communications for distribution of GHS compliant SDS? How to utilize the internet to provide customers access to SDS? Considerations and best practices for SDS web page designs?

26 Combustible Dust SDS & Label Communications What new challenges are anticipated or encountered under OSHA s regulation of combustible dust under GHS? How to determine if product is an article or no longer an article under OSHA s GHS combustible dust requirements? Approaches to label products with combustible dust hazards? How to communicate and explain SDS for Products formerly considered to be exempted under HazCom? What are key messages and methods to communicate with customers, sales/marketing, technical support, R&D, engineering, workers, maintenance, regulators, property loss insurance carriers and others?

27 R&D and New Product Development How does GHS affect new product development? How should R&D consider and know about GHS? Will GHS drive reformulation of products and how to make informed decisions about reformulation? How to address GHS in stage gate?

28 GHS Implementation: 2015 Survey Results Product and Business Downstream Impacts & Opportunities

29 Survey Participants Professional Association Membership 19 % Product Stewardship Society 68% AIHA 23% ACGIH Conference Attendance 55% AIHce % Stewardship 2015

30 Survey Participants - Best describes your company, business or employer and products as may relate to GHS implementation: Manufacturers 38% Chemical Manufacturer 17% Raw Material Manufacturer 13% Consumer Product Manufacturer 8% Equipment Manufacturer or Supplier 8% Retail Products / Brand Owner of Commercial Products Distribution 8% Distributor /Warehousing/Transportation Packaging 2% Packaging Manufacturer or Printer Converter 4% Packer of Product / Fulfillment Non Manufacturing 11% Government / Regulatory Agency 13% Consultant 4% Academia 15% Other Comments: Additional / Description Crude Oil Refinery Healthcare Returns Electronic Parts Manufacturer healthcare provider Research Laboratories Customer / End User Pharmaceutical Industry Clinical Laboratory Molecular medical diagnostics Industrial NGO representing a business sector in Europe User/formulator of intermediates Pharmaceutical manufacturer

31 Extent your (your company's) understanding of new OSHA 2012 GHS requirements or magnitude of impacts.

32 Extent your (your company's) understanding of new OSHA 2012 GHS requirements or magnitude of impacts.

33 Extent your (your company's) understanding of new OSHA 2012 GHS requirements or magnitude of impacts.

34 Extent your (your company's) understanding of new OSHA 2012 GHS requirements or magnitude of impacts.

35 Extent your (your company's) understanding of new OSHA 2012 GHS requirements or magnitude of impacts.

36 Comments Just noting the difference in GHS implementation for consumer and commercial/industrial products. We are aware of the regulations of updating our SDS and getting them out to our customers as well as receiving SDS from vendor or suppliers. Research Laboratories and Secondary Container Labeling...There has been very little to NO information on this and the OSHA lab standard hasn t updated with the GHS standard creating confusion and some anxiety As a consultant, I advise companies impacted by GHS, but it does not directly impact my company. Pharma sometimes will manufacture their own drugs (intermediates) and in other cases (well known or established drugs) will be manufacture by contracted third parties. We are going through a change in our authoring system (yes in the middle of OSHA GHS), therefore, we are not saving any money at this time, as we work out the bugs and establish our classifications for our substances I suspect the savings will occur. My "company" manages the rules themselves and helps employers understand and come into compliance. This was a poorly worded survey question. As you asked for both "understanding" and "magnitude of impacts" i.e. for each item I may fully understand OSHA GHS and it may have "no" impact. So not sure which way to answer these. Responses checked not applicable are because the information is not currently available to provide an answer.

37 SDS Authoring Roles & Experience Role in Authoring SDS / Labels 45% Author SDS or Labels 35% Manage group or department that authors SDS and Labels 12% Develop or implement software to author SDS and Labels 41% No Direct Role in Authoring SDS or Labels Experience in Authoring SDS / Labels Comments Provide information of products to authors for SDS Manage our GHS/SDS program. Work with third party authoring firm. Review relevant changes Responsible for toxicology sections and related health classifications and general guidance on SDS (includes sections 2,4,8, 9 and 11, sometimes 6 and 7. Comments Contract out development to a third party provider for both SDS and Labels. manage authoring contractors No longer author SDS, but steward their completion Related to development of labels, not SDSs SME for certain sections of an SDS

38 Roles in HazCom Training or Education

39 Are these in the Top 10? 83% Suppliers/Manufacturer's Not Providing GHS Compliant SDS (e.g., impacts on workplace training; authoring finished product SDS based on raw material SDS) 81% Training of Workers on GHS SDS and Labels 75% Accessible and Reliable Data to Classify Raw Materials / Ingredients 73% Compliance Time Line 71% Quality Control for Classification and SDS / Labels 65% Labeling System Conflicts (HMIS/NFPA & GHS) 1-4 / 4-1 Dual Labeling Systems 65% Communicating with Customer(s) about how GHS classifications changed product labels / pictograms 63% Impacts of GHS Reclassification on other HS&E Regulatory Compliance Programs 62% Inbound SDS (Document) Management 62% Re-labeling tanks, containers and revising batch sheets, internal documents

40 Are these in the Top 10? 59% Software for SDS Authoring and Data Management 55% Education of Management 50% Insufficient Pool of Qualified SDS Authors 49% Maintaining Multiple Formats for SDS 47% Customers Reacting Negatively to new SDS and Hazard Classifications 28% Inconsistencies between pesticide labels and consumer labels in North America 25% Other Issue: (describe below):

41 Ranking Importance of Top 10 Issues Accessible & Reliable Data to Classify Raw Materials / Ingredients Compliance Time Line Other Issue: (describe below): Training of Workers on GHS SDS and Labels Suppliers/Manufacturer's Not Providing GHS Compliant SDS QC for Classification & SDS / Labels Labeling System Conflicts (HMIS/NFPA & GHS) Customers Reacting Negatively to new SDS & Hazard Classifications Insufficient Pool of Qualified SDS Authors

42 Ranking Importance of Top 10 Issues Communicating with Customer(s) about GHS classifications & product labels /pictograms Inconsistencies between pesticide labels and consumer labels in North America Education of Management Maintaining Multiple Formats for SDS Inbound SDS (Document) Management Software for SDS Authoring and Data Management Re-labeling tanks, containers and revising batch sheets, internal documents Impacts of GHS Reclassification on other HS&E Regulatory Compliance Programs

43 Top 10 - Other Comments No harmonization between Countries presents difficulties with labelling as not standardized. Need to re-label for shipping into regions that are not harmonized. 1) Classification inconsistencies between manufacturers of the same products in the US; and 2) classification inconsistencies between different regional units within the same company due to each region or country's interpretation of the UN GHS standard. Note: Our customers are mostly internal. Although we have done GHS training and have been impacted by CLP for years now, our internal US customer (employees) seem to be having trouble with the GHS. NFPA/HMIS is more of a site specific preference, however, it impacts us (as a central SDS function only because our current Authoring system is ultra-conservative). Multiple formats is ultimately why we had to change to a new Authoring system after had started a new one prior to CLP changes in Finding data for raw materials isn't so difficult, however, trying to get our vendor to understand our point of view has been challenging. Insufficient qualified SDS authors for multiple formats is another reason for switching to a new authoring system. Also, the software maintenance was another aspect for our switch. However, with the added benefits of multiple formats and software help, we lost a lot of control. Other: High impact on us is the fact that our SDS vendor template does not include section 12 data or the ecotox classifications (as optional information) on our US GHS template because OSHA didn't make it mandatory. This causes lots of issues with consistency between information for multiple countries and also causes issues with accurate Dangerous goods information.

44 Top 10 - Other Comments (cont) Onerous label requirements for small vials/containers versus all other countries conflicts with REACH 5 - getting compositional information on raw materials from small chemical suppliers. They're afraid to give out there "secret sauce" as they only have 1-5 products in portfolio. Inability to recognize that amount of material in container impact the value/validity of hazard warnings and precaution statements. (i.e. inability to reasonably apply risk assessment to the process). For example, a 2 ml container of methy ethyl flammable stuff does not require the same precautions as a 10,000 gallon tank of the same material. Other Issue - Individuals/companies who use this change as an opportunity to self promote their services even when the information they are disseminating is contrary to OSHA I hear not all datasheets have to comply with the new SDS format. How would you determine this if this is the case? You are making a mountain out of a small hill!

45 Top 10 Issues Practical Solutions / Comments Accessible and Reliable Data to Classify Raw Materials / Ingredients Use GHS classification data from other zones Extensive data cleanup and individual ingredient classification program. Use ECHA website for GHS classification and toxicology info Communicating with Customer(s) - - e.g., about how GHS classifications have changed product labels / pictograms Develop customer talk sheets explaining the different sections of the SDS and what they mean. Additional opportunity to talk with customers and use the OSHA website to help guide them about the new system Compliance Time Line Partnered with a reputable SDS authoring entity for product SDSs and labeling solutions Time management; use of consultants Hired 3rd party to write SDS Compliance with other EHS Programs Change the other Programs or state the Hazcom standard is newer and therefore everything stated in this pertains to the other standards Inbound SDS (Document) Management Linked with 3E online to track and verify SDS for incoming products and/or substances Inconsistencies between pesticide labels and consumer labels in North America Identify inconsistencies in note on SDS.

46 Top 10 Issues Practical Solutions / Comments Insufficient Pool of Qualified SDS Authors Automate SDS of similar content We outsourced this service. However, GHS conversion of SDS and reclassification of materials has created a bottleneck in workflow learned to author them myself Going to a cloud-based system has eliminated the need for staff, however, the downside is the learning curve in understanding the vendor's system and the amount of information they chose to pass along to the client. Quality Control for Classification and SDS / Labels Establish a regulatory oversight body of OSHA or EPA to audit chemical manufacturers SDS content The system hinges on accurate and consistent information. Adding the SDS to annual product Quality review Hired 3rd party to write SDS No in-house expertise on format - outsource auditing of documents A standardized solution does help make the SDSs less complex (haven't had a chance to deal with the constraints for such a simplified SDS format compared to the paragraphs written in the past). This also help make the process also move faster. Software for SDS Data Management Gensuite Maintaining Multiple Formats for SDS Using most detailed/complicated format for all markets/jurisdictions

47 Top 10 Issues Practical Solutions / Comments Non compliant SDSs OSHA should provide a customer hotline to report non-compliant SDSs, with follow up to inspect noncompliant manufacturers, suppliers and importers Document failure of supplier The shorter the transition to the new format, the greater the benefit to employers. Use their GHS SDSs from other countries/zones Re-labeling tanks, containers and revising batch sheets, internal documents purchase standard labels or wrote own labels Convert label to placard with appropriate font size Training of Workers on GHS SDS and Labels Software for SDS Authoring and Data Management Training needs to be ongoing with updates as frequent as receipt of new SDSs and labels development of training materials and use of elearning OSHA could provide more training materials, perhaps tailored to various industries (using the Alliance program?) Other Comments No substitute for planning Hire someone outside organization to provide appropriate education Still figuring out a new system. New system, new problems over previous system. Point: No matter which system solution you go with, you will have years of work ahead.

48 Characterize of Impacts of OSHA HazCom 2012 Regulation of Combustible Dust

49 Comments on Combustible Dust We do not use or generate combustible dusts. Still trying to get our hands around what we use to communicate to our customers and how it should be communicated now under the combustible dust warning. We use to have Kst values and MIE values- no place on our new vendor template. Defaulted to adding it for us until we have a better handle on it. Government enforcement role. Confusion about what must be treated as a combustible dust when in relatively limited quantities in containers intended to control release.

50 Impacts of GHS requirements on your products and related business or services Survey Respondents Opinions on Impacts No significant impacts 15% Creates Opportunities for Competitive Advantage for products that my company manufactures or services provided Increases Global Product Marketing Opportunities (removes barriers for trade) Productivity Gains - Increases productivity for H&S managers and/or logistics personnel Greater use of Consultants to classify raw materials / product formulations or author SDS & labels Customer Communications - Increased need to communicate about changes to your product labels (e.g., GHS warnings and pictograms) with customers Product Reformulation - Drives reformulation of existing products or affects new product development to use "less hazardous" materials/ingredients Updating Product Labels on formerly "non-hazardous" products now classified as "hazardous" under GHS 13% 11% 6% 35% 35% 22% 41%

51 Impacts of GHS requirements on your products and related business or services Impacts Re-Authoring Review SDS with supplier provided classifications may trigger re-authoring SDS and labels or identify discrepancies requiring resolution Training - Will acquire or have acquired (or developed) new or updated training programs or computer based training (CBT) to deliver required GHS training to company workers Training - Increased Resources and Time to schedule, deliver and track completion GHS related training H&S Professional Development - Company H&S managers will need to complete professional development courses on GHS regulatory requirements Label Printing Hardware - Upgraded computer hardware / equipment to print and apply GHS compliant Labels SDS Label Authoring Software - Will acquire or have acquired new or updated software to author GHS compliant SDS / labels SDS Storage Software - Will acquire or have acquired new or updated software to store / maintain inbound GHS compliant SDS SDS Distribution Software - Will acquire or have acquired new or updated software to distribute GHS compliant SDS 41% 46% 37% 28% 44% 35% 28% 19%

52 What is Done when a Sub-standard" SDS is Received?

53 How would I know if the SDS is sub-standard? (General Comments) If the SDS has not been updated yet or does not list the precautionary statements. Not much can be done at the moment... this takes a lot of oversight and resources that many companies do not have. By comparing hazard classification given against technical criteria of the definition. If mfg or supplier is non-responsive to a written communication regarding a sub-standard SDS, I would report them to OSHA. As noted above, I would like an easy way to make this complaint to OSHA. Lack of data in section 9 and 11 and 12 (wish the US had EPA's permission to include Ecotox or highly encouraged the addition of section 12). Overclassification or unclassification for obvious ingredients. Had various luck with contacting the vendor. We find that our internal folks usually have Quality Assurance (QA) data that is helpful. Less than 16 sections Absence of signal word, pictogram(s), hazard statement(s), precautionary statement(s), and supplier information Improper classification, insufficient data