Implementation of GHS Amendment to OSHA HCS American Bakers Association Safety Committee Meeting May 8, 2012 Lawrence P. Halprin Partner Keller and Heckman LLP 1001 G Street, N.W. Washington, DC 20001 202-434-4177 halprin@khlaw.com www.khlaw.com
Topics to be Covered Combustible Dust The Baker As A Chemical Manufacturer Ingredients with NTP or IAC Listings, or Positive Cancer Studies Hazards Not Otherwise Classified (HNOC) Continued Use of NFPA and HMIS Hazard Rating Systems Trade Secrets Compliance Deadlines 2
Combustible Dust Now a covered HCS hazard Not defined in HCS, refer to OSHA NEP Employer knowledge Supplier SDS Testing not required by HCS Is testing required under reasonable diligence standard applied to GDC and other OSHA standards? Tort law? Knowledge of composition and particle size Raw, oven and packing line material 3
The Baker as a Chemical Manufacturer Manufacturer "Chemical manufacturer" means an employer with a workplace where chemical(s) are produced for use or distribution. "Produce" means to manufacture, process, formulate, blend, extract, generate, emit, or repackage. Scope: This section applies to any chemical which is known to be present in the workplace in such a manner that employees may be exposed under normal conditions of use or in a foreseeable emergency. 4
The Baker as a Chemical Manufacturer Manufacturer s On-Site Obligations Prepare and provide all personnel at its site with updated SDS for the hazardous chemicals it manufactures. Prepare and provide updated labels for all containers of hazardous chemicals at the site. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical. 5
The Baker as a Chemical Manufacturer Donut Manufacture starts with series of blending steps Micro ingredients Flour Sugar Shortening Flavorings Oil When is mix no longer a combustible dust? SDS for each new temporary mixture? 6
The Baker as a Chemical Manufacturer Current HCS Manufacturers that blend chemicals to create mixtures (with no chemical reaction) may prepare an MSDS by attaching individual ingredient MSDS to cover sheet (hard copy or electronically). GHS Amendment Manufacturers that blend chemicals to create mixtures (with no chemical reaction) must prepare an SDS for the mixture as a whole based on bridging principles; cover sheet approach not permitted 7
Cancer Studies Current (Old) HCS NTP and IARC listings must be on MSDS and are conclusive Single positive cancer study must be referenced on MSDS GHS Amendment NTP and IARC listings must be on SDS (if SDS is required) Single positive cancer study must be referenced on SDS (if SDS is required) if not classified as carc. 8
Cancer Studies Chemicals Titanium dioxide, carbon black, etc. Look to EU classifications Food Exemptions Label when subject to FDA requirements Product sold in retail establishments (including product packaged for sale in retail establishment, but still in chain of distribution) or an article 9
Hazards Not Otherwise Classified (HNOC) An adverse physical or health effect, identified through evaluation of scientific evidence during the classification process, that does not meet the specified classification criteria for the listed physical hazards and health hazards Expands scope of physical hazards Open-ended, brings new uncertainty Identification OSHA announcement or enforcement action Supplier SDS New category added to UN GHS Some articles may become hazardous chemicals 10
Continued Use of HMIS and NFPA Hazard Rating Systems GHS severity categories: severity goes down as numerical rating goes up NFPA and HMIS severity categories: severity goes up as numerical rating goes up OSHA: preamble says can continue to use NFPA and HMIS systems, but 11
HCS-GHS v. HMIS Warnings for Acute Toxicity (Oral) HCS Acute Toxicity (Oral) Warning Statements ATE (mg/kg body weight) Hazard Category Signal word Hazard statement Pictogram 5 1 Danger Fatal if swallowed Skull and crossbones > 5 and 50 2 Danger Fatal if swallowed Skull and crossbones > 50 and 300 3 Danger Toxic if swallowed Skull and crossbones > 300 and 2,000 4 Warning Harmful if swallowed Exclamation point ATE = acute toxicity estimate HMIS Ratings LD 50 Oral (Rat): mg/kg body weight HMIS Number Hazard Rating > 5,000 0 Minimal hazard > 500 but 5,000 1 Slight hazard > 50 but 500 2 Moderate hazard > 1 but 50 3 Serious hazard 1 4 Severe hazard 12
Compliance Deadlines May 25, 2012: Effective Date Begins official transition period May comply with either the amended HCS or the current HCS or both December 1, 2013 Train all exposed employees on the new label elements and SDS format, existing by 12/1/2013 and new before start work (exposure) June 1, 2015 Comply with all amended provisions of the final rule, except, Distributors may ship products labeled by manufacturers under the old system until December 1, 2015 June 1, 2015 is consistent with the EU deadline for classification of mixtures June 1, 2016 Update alternative workplace labeling and hazard communication programs as necessary, and provide additional employee training for newly identified physical or health hazards 13
Compliance Deadlines Training Realities New label and SDS formats: 12/1/2013 New labels and SDSs: 6/1/2015 (for personnel who update labels and SDS) GHS hazards, in-plant label systems and program: 6/1/2016 (for personnel who read labels and SDS) Potential for Confusion 60 days after publication (May 25, 2012), manufacturers and importers may comply with the amended HCS Will be operating under two systems: OSHA: No big difference from current situation??? Significant differences can t be ignored Pictograms: each covers 6 hazards GHS v. HMIS and NFPA ratings 14
Trade Secrets Process 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 Name of substance can be trade secret Concentration of substance in mixture can be a trade secret only if a fixed (single number) percent and not a percent range Consequence: create new products with fixed concentrations to replace range and qualify for trade secret protection 15
Q&A Session I welcome your questions! 16
Thank you Lawrence P. Halprin Partner Keller and Heckman LLP 1001 G Street, N.W. Washington, DC 20001 202-434-4177 halprin@khlaw.com www.khlaw.com Washington, D.C. Brussels San Francisco Shanghai
Lawrence Halprin Partner, Keller and Heckman LLP Lawrence Halprin focuses his practice in the areas of occupational safety and health, and chemical regulation. He is nationally recognized for his work at the federal and state levels in those fields. His occupational safety and health practice covers all aspects of legal advocacy, including: representing clients in OSHA investigations; defending clients in OSHA and MSHA enforcement actions; providing compliance counseling and training; conducting incident investigations, compliance audits and program reviews; participation in OSHA, NIOSH and MSHA rulemakings and informal stakeholders processes; bringing and intervening in preenforcement challenges to final OSHA rules; advising on legislative reform and oversight; and participation in the development of national consensus standards under the ANSI process, and TLVs under the ACGIH process. Mr. Halprin's engineering background and historical knowledge of OSHA rulemakings have greatly enhanced his ability to provide compliance counseling and represent clients in OSHA and MSHA enforcement actions. His engineering and financial background have been particularly useful in evaluating and critiquing OSHA and MSHA rulemaking proposals and suggesting alternative approaches. On behalf of one or more clients, Mr. Halprin has participated in almost every major OSHA rulemaking over the past 25 years as well as numerous Cal-OSHA rulemakings. 18
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 and not those of the author s clients. 19