HCS 2012 and the June 2015 Deadline

Transcription

1 A Practical Primer on Pesticides Seminar Washington, DC HCS 2012 and the June 2015 Deadline April 24, 2015 David G. Sarvadi Partner Keller and Heckman LLP 1001 G Street NW, Suite 500 West Washington, DC sarvadi@khlaw.com

2 Objectives History of the GHS. Brief overview of US implementation. OSHA s HazCom Discuss pesticide product coverage Discuss briefly differences 2 Copyright 2015

3 Scope of Coverage 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 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 3 Copyright 2015

4 Intent of the GHS Harmonizes classification and labeling of chemicals including pesticide chemicals. Not a prescriptive model regulation Classification criteria Language for warnings and precautions. Building-block approach. Competent authority Not a mandated system 4 Copyright 2015

5 OSHA s HazCom 2012 Rule Overview March 26, 2012: Final Rule for OSHA s HazCom 2012 regulations published in the Federal Register. The Final Rule was effective on May 25, Sections of 29 CFR substantively impacted: (c): Definitions (d): Hazard Classification (f): Labels and Other Forms of Warning (g): Safety Data Sheets (SDSs) (h): Employee Information and Training (j): Effective Dates Appendices A-F (more info. on the next slide) 5 Copyright 2015

6 OSHA s HazCom 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) 6 Copyright 2015

7 OSHA s HazCom Pesticides Covered by the standard SDSs required Pesticide with approved labels. This section does not require labeling [to] [a]ny pesticide as defined in FIFRA, when subject to the labeling requirements of [FIFRA] and labeling regulations issued under [FIFRA] by the [EPA]; FIFRA Labeling vs GHS Different cutoffs =>Signal words, warnings, and precautions GHS reduced categories from 4 to 3 Chronic effects PR Notice Copyright 2015

8 OSHA HazCom 2012 Resources OSHA s Hazard Communication 2012 Webpage: HCS/HazCom Final Rule Regulatory text Appendices HCS Comparison: HazCom 1994 vs. HazCom 2012 Side-by-side Red-line strike-out of the regulatory text HazCom 1994 Guidance documents: OSHA Briefs, Fact Sheets, Quick Cards Other items: Downloadable Pictograms, SCHC Webinars, PowerPoint Presentations, Questions of the Month 8 Copyright 2015

9 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. December 1, 2015: Distributor shipments with HCS-2012 labels 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 9 Copyright 2015

10 Problem with the Existing Deadline Formulators vs manufacturers Common deadline for all in supply chain. Formulated products depend on classifications of basic chemicals Formulated products contain formulated products Supply chain depth and complexity varies Serial receipt of updated information => continuous revisions 10 Copyright 2015

11 Is This a Solution? February 9, 2015 Enforcement Memorandum to Regional Administrators. Exercise enforcement discretion for product formulators... Demonstrate reasonable diligence and good faith efforts to comply with the June 1, 2015 deadline... Need additional time What are good faith efforts? 11 Copyright 2015

12 Enforcement Discretion Manufacturers need to document efforts Request classification information and SDSs from upstream suppliers? Find hazard information from alternative sources (e.g., chemical registries)? Classify the data themselves? Does not take into account GHS complexity Classifications in US and EU differ Data not always categorical Toxicological judgment required 12 Copyright 2015

13 Reasonable Diligence Process to get classification information from suppliers Status Find hazard information from alternative sources Chemical registries NIOSH Medline Written record of continued dialogue with Dated copies of relevant written communication?? Clear timeline for compliance Communication with distributors 13 Copyright 2015

14 OSHA s Enforcement Discretion Extends the deadline to revise SDSs based on revised supplier SDS to 6 months Deadline under (g)(5) = 3 months Deadline under (f)(11) for labels is 6 months (no change) Shipments after 6 months = new label Case-by-case determination Policy expires December 1, Copyright 2015

15 Distributors Does not address sell through or stream of commerce issues Chemical manufacturers, importers, distributors, or employers... shall revise the labels... within six months of... and shall ensure that labels on containers of hazardous chemicals shipped after that time contain the new information. Who is a distributor? Warehouse on site Warehouse remote? More than one manufacturer? 15 Copyright 2015

16 Distributors In the limited situation described in this memorandum Distributors ship until December 1, HCS 1994-compliant labels NOT a solution Existing inventory with shelf life over 2 years? Products manufactured less than annually? Inventory in distributors hands 16 Copyright 2015

17 UN Still At It United Nations Economic Commission for Europe GHS Subcommittee Current version Purple Book 5 th Ed. GHS Rev.6 (2015) in process includes, inter alia, new hazard class: desensitized explosives new hazard category: pyrophoric gases miscellaneous provisions to clarify some hazard classes explosives, specific target organ toxicity single exposure aspiration hazard hazardous to the aquatic environment) additional information SDS section 9 Revised and further rationalized precautionary statements New example Annex 7 labelling of small packagings How will OSHA incorporate? 17 Copyright 2015

18 International GHS Resources UN ECE Website: GHS Purple Book Rev. 5 (2013): ml Rev. 6 is expected to be published in History: 18 Copyright 2015

19 Thank You! David. G. Sarvadi Partner Keller and Heckman LLP 1001 G Street NW, Suite 500 W Washington, DC sarvadi@khlaw.com