1. www.khlaw.com Washington, DC ● Brussels ● San Francisco ● Shanghai Martha E. Marrapese, Partner Keller and Heckman LLP 1001 G Street NW Suite 500 West Washington, DC 20001 +1 202.434.4123 marrapese@khlaw.com HCS 2012 and Ultraviolet/Electron Beam Technology February 25, 2015

2. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 2Copyright © 2015  A Preliminary Word This presentation provides information about the law. Legal information is not the same as legal advice, which involves the application of law to an individual’s specific circumstances. The interpretation and application of the law to an individual’s specific circumstance depend on many factors. This presentation is not intended to provide legal advice. The information provided in this presentation is drawn entirely from public information. The views expressed in this presentation are the author’s alone.

3. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 3Copyright © 2015 SNAPSHOT OF CHANGES

4. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 4Copyright © 2015  Snapshot of HCS 2012 Changes - Elements Old HCS Purpose Scope and application Definitions Hazard determination Written hazard communication program Labels and other forms of warning Material safety data sheets Employee information and training Trade secrets Effective dates HCS 2012 Purpose (rev) Scope and application (rev) Definitions (rev) Hazard classification (rev) Written hazard communication program (rev) Labels and other forms of warning (rev) Safety data sheets (rev) Employee information and training (rev) Trade secrets (rev) Effective dates (rev)

5. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 5Copyright © 2015 Snapshot of HCS 2012 Changes Old HCS A.Health hazard definitions (M) B.Hazard determination (M) C.Reserved D.Definition of Trade Secret (M) E.Guidelines for Employer Compliance (A)  Old E re-issued as a guidance document HCS 2012 A.Health Hazard Criteria (M) B.Physical Hazard Criteria (M) C.Allocation of Label Elements (M) D.Safety Data Sheets (M) E.Definition of "Trade Secret" (M) F.Guidance for Hazard Classification re: Carcinogenicity (NM)

6. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 6Copyright © 2015  Snapshot of HCS 2012 Changes Old HCS Mixture cut-offs – Health hazards: 1.0% Carcinogens: 0.1% HCS 2012 Hazard Class Label SDS Respiratory / skin sensitization > 0.1% > Germ cell mutagenicity (Cat. 1) > 0.1% > Germ cell mutagenicity (Cat. 2) > 1.0% > Carcinogenicity > 0.1% > Reproductive toxicity > 0.1% > STOT (single exposure) > 1.0% > STOT (repeated exposure) > 1.0% > STOT (Cat. 3)>20%>

7. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 7Copyright © 2015  Snapshot of HCS 2012 Changes – Inner label Old HCS Label elements  Identity of the hazardous chemical(s)  Appropriate hazard warnings  Name and address of the chemical manufacturer, importer or other responsible party Label Phrasing/Language  Developed by the manufacturer, importer or other responsible party  ANSI standard commonly used, other industry guidance. HCS 2012 Label elements  Product identifier  Signal word  Hazard statement(s)  Pictogram(s)  Precautionary statement(s)  Name, address, and telephone number of the chemical manufacturer, importer or other responsible party Label Phrasing/Language  Mandatory language from GHS is provided in Appendix C, Allocation of Label Elements Label border  Must be red, no empty red blocks

8. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 8Copyright © 2015  Workplace Labels Old HCS Label, tag or mark with:  Identity of the hazardous chemical(s)  Appropriate hazard warnings or words, pictures, symbols or a combination thereof which provide at least general information regarding the hazards HCS 2012 Label, tag or mark with : Option A: Elements required for shipped containers – Product identifier – Signal word – Hazard statement(s) – Pictogram(s) – Precautionary statement(s) Option B – Product identifier, and – Words, pictures, symbols, or a combination thereof which provide at least general information regarding the hazards

9. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 9Copyright © 2015

10. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 10Copyright © 2015  Material Safety Data Sheets (MSDS) v. SDS Old HCS No required format Performance-based description of minimum required information HCS 2012 16 section format required Appendix D specifies information required under each heading Sections 12-15 will not be enforced  32 │ www.khlaw.com │ K ELLER AND H ECKMAN LLP Copyright © 2012

11. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 11Copyright © 2015 SDS Elements  Section 1, Identification  Section 2, Hazard(s) identification  Section 3, Composition -- information on ingredients  Section 4, First-aid measures  Section 5, Fire-fighting measures  Section 6, Accidental release measures  Section 7, Handling and storage  Section 8, Exposure controls/personal protection  Section 9, Physical and chemical properties;  Section 10, Stability and reactivity;  Section 11, Toxicological information.  Section 12, Ecological information;  Section 13, Disposal considerations;  Section 14, Transport information; and  Section 15, Regulatory information.  Section 16, Other information, including date of preparation or last revision

12. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 12Copyright © 2015  Reliance on Supplier SDS Old HCS Chemical manufacturers, importers and users may rely on the information provided on current MSDS of the individual ingredients Formulators of physical mixtures could prepare an MSDS by attaching individual ingredient MSDS to cover sheet (no “intermediate” exception?) HCS 2012 Chemical manufacturers, importers and users may rely on the information provided on SDS for the individual ingredients, except – Where the manufacturer, importer or user knows, or in the exercise of reasonable diligence should know, that the SDS misstates or omits required information Need to provide SDS for mixture as a whole based on bridging principles; cover sheet approach not permitted

13. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 13Copyright © 2015  Trade Secrets P rocess remains unchanged For asserting trade secret For responding to requests for trade secret information based on medical need Revised labeling requirement: changed from listing chemical identity to product identifier, which facilitates “missing” protection Concentration of substance in mixture is a potential trade secret Single number % concentration – yes Numerical range % concentration – no (there is no guidance as to what range would be permissible, but presumably couldn’t misrepresent actual nature of hazard). Existing protection against disclosure of “other specific identification of a hazardous chemical” would logically include a unique set of PELs and/or PEL and TLV combination where the properties and effects of the chemical are disclosed.

14. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 14Copyright © 2015 Additional training: whenever a new person or a new physical or health hazard is introduced, not just a new chemical. For example, a new solvent with similar hazards to existing chemicals = no new training is required. Technically, under the HCS, the employer need only make employees aware of the hazards to which they will be exposed and how to identify them. If PPE is required, then a hazard assessment and training would be specific to the hazardous chemicals requiring PPE. –The data sheet for each hazardous chemical must be readily available, and the product must be properly labeled. If a newly introduced chemical presents a new hazard not covered in prior training, the employer must provide new training to exposed employees. In the real world, periodic refresher training is generally necessary. Training

15. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 15Copyright © 2015 SCOPE, EXEMPTIONS, DEADLINES

16. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 16Copyright © 2015  Manufacturers and Importers: Assess inherent hazards (generally not risk) and classify chemical; create SDS (generally inherent hazards) & labels (consider risk)  All Employers: Communicate info to their employees and contractor employers about hazardous chemicals they may be exposed to in normal operations or foreseeable emergencies  Distributors: Transmit required info to downstream employers Also responsible for proper label Scope of Coverage

17. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 17Copyright © 2015  Complete Exemption from HCS Food, drugs or cosmetics for employee consumption/use Food sold, used or prepared in retail store or restaurant (scope of “used” is unclear) OTC drugs and cosmetics packaged for retail sale Drugs in tablet or pill form Consumer product when “consumer” exposure –Greater exposure from foreseeable emergency (leak)? Hazardous waste regulated by EPA Tobacco products Wood products not to be further processed (e.g., saw) Exemptions

18. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 18Copyright © 2015 Phasing in HCS 2012  December 1, 2013 – initial training Label and SDS format and pictograms  June 1, 2015: General compliance deadline Exception: until 12/1/2015, distributors may ship products that were labeled and shipped by manufacturers under the old system prior to 6/1/2015.  June 1, 2016: Update alternative workplace labeling and hazard communication programs as necessary, and provide additional employee training for newly identified (due to HCS-2012) physical or health hazards

19. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 19Copyright © 2015 Supply chain of manufacturers  Same deadline Basic chemicals Formulated products  Commercial products Additives to enhance processing and use Purity varies depending on commercial requirements Supply chain depth varies Problems with Existing Deadlines

20. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 20Copyright © 2015 Sources of the problem Complex supply chains Lengthy supply chains Manufacturers of scores or even hundreds or thousands of chemicals o Coatings/inks with millions of colors Distributors that mix generic chemicals from different sources May easily lead to: Almost daily compliance issues and constant need to update information Problems with Deadlines

21. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 21Copyright © 2015 IMPLEMENTATION

22. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 22Copyright © 2015 Process  Identify substance or mixture Internal knowledge, industry knowledge, public knowledge (the internet?) (info in foreign languages?)  Assess inherent hazards (generally not risk) Internal knowledge, industry knowledge, public knowledge  Classify chemical Appendix A for health hazards Appendix B for physical hazards  Determine appropriate (HCS + tort) label content Appendix C  Determine appropriate (HCS + tort) SDS content Appendix D

23. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 23Copyright © 2015  Substance v. Mixture Substance –Weight of evidence (WOE) to available data Mixture –WOE to adequate test data on mixture –WOE to adequate data on ingredients and substantially similar mixture –Bridging principles –Threshold cutoff levels for each hazard Health Hazard Classification

24. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 24Copyright © 2015 Label Elements

25. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 25Copyright © 2015 Supply chain consists of –  Resin and additive manufacturers  Formulators  End Users Complex formulations –  E.g., Adhesive Resin Diluent Solvent Surfactant Preservative Photoinitiator (optional) UV/EB

26. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 26Copyright © 2015 Acrylate Chemistry  In general, UV/EB curing acrylates have low systemic toxicity, but they can cause skin and eye irritation or burns.  Some individuals may also become sensitized to these chemicals as a result of contact.  Most acrylate oligomers and monomers have a low vapor pressure, and inhalation of vapors is unlikely to occur at room temperatures. Some of these products may form stable aerosols which can be inhaled and may also cause skin and eye irritation.  Low molecular weight acrylate monomers represent the most physiologically active materials in this class, due to the high level of acrylate functionality.  The substantially higher molecular weight and lower net acrylate functionality of acrylate oligomers result in a lower level of physiological activity than the acrylate monomers. Skin and eye irritation due to oligomer exposure normally are minimal to mild, and the oligomers exhibitvery low acute toxicity.

27. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 27Copyright © 2015 Hazard classification considerations  Skin sensitization 1A or 1B? –Cut off amounts of 0.1% and 1.0%, respectively, for having to label –Most SDSs do not classify as HCS 2012 1A or 1B –Difference is the % of animals and the concentration at which effects are seen. –Examples - 2-butanone oxime and cobalt compounds versus maleic anhydride

28. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 28Copyright © 2015 Skin sensitizer determinations – Animal testing 1A - AssayCriteria Local lymph node assay EC3 value ≤ 2% Guinea pig maximization test ≥ 30% responding at ≤ 0.1% intradermal induction dose or ≥ 60% responding at > 0.1% to ≤ 1% intradermal induction dose Buehler assay≥ 15% responding at ≤ 0.2% topical induction dose or ≥ 60% responding at > 0.2% to ≤ 20% topical induction dose 1B - AssayCriteria Local lymph node assay EC3 value > 2% Guinea pig maximization test ≥ 30% to 0.1% to ≤ 1% intradermal induction dose or ≥ 30% responding at > 1% intradermal induction dose Buehler assay≥ 15% to 0.2% to ≤ 20% topical induction dose or ≥ 15% responding at > 20% topical induction dose

29. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 29Copyright © 2015 Other considerations for UV/EB  How to address aquatic toxicity? Required for EU CLP Not required for OSHA compliance  Presence of photoinitiators, inks, may drive classification of mixtures  Amount of information on reproductive toxicity of acrylates is limited  “Family” approach to classifying acrylates in light of TMPTA NTP study?  Radtech resources may be consulted

30. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 30Copyright © 2015 ENFORCEMENT

31. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 31Copyright © 2015  Commonly issued HCS citations were: Missing or inadequate written program Failure to provide training Failure to maintain SDS or chemical inventory or mismatches b/n the two Failure to label in-plant containers  Few citations for inadequate MSDS or label  PPE Failure to use recommended PPE or failure to keep it readily available Historically...

32. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 32Copyright © 2015  Even with a complete set of SDSs, employers have been cited for: An outdated list A list that identified a chemical with a different name than the one appearing on the SDS  Ongoing updating requirement Enforcement – List of chemicals

33. │ www.khlaw.com │ K ELLER AND H ECKMAN LLP 33Copyright © 2015  Increased emphasis on chemical safety  OSHA will continue to make HCS one of its most frequently cited standards  Some greater attention to adequacy of classification, SDS and labeling is likely  OSHA will exercise enforcement discretion for downstream compliance In the Future...

34. www.khlaw.com Washington, DC ● Brussels ● San Francisco ● Shanghai Martha E. Marrapese Partner Keller and Heckman LLP 1001 G Street NW Suite 500 West Washington, DC 20001 +1 202.434.4123 marrapese@khlaw.com Thank you