September 7, The business of sustainability

Transcription

1 Managing Business Risks with Effective Product Stewardship September 7, 2017 Copyright 2017 by ERM Worldwide Limited and/or its affiliates ( ERM ). All Rights Reserved. No part of this work may be reproduced or transmitted in any form or by any means, without prior written permission of ERM.

2 Health & Safety Moment 2

3 Today s Presenters Kate Sellers kate.sellers@erm.com Boston, MA +1 (617) Kerrie Canavan kerrie.canvan@erm.com New York, NY +1 (212) Jo Lloyd, Ph.D. jo.lloyd@erm.com London, UK +44 (0) Moderator Sarah Medearis sarah.medearis@erm.com Washington, DC +1 (202)

4 Public Outrage and Legislative Action Managing the Business Risks

5 Public Outrage and Legislative Action Media Public outcry Market Deselection / Regulation Fringe concern Academic study Interest groups 5

6 DDT, in 20:20 Hindsight 1948 Nobel Prize in Physiology or Medicine awarded to Paul Müller "for his discovery of the high efficiency of DDT as a contact poison against several arthropods" AMA: The development and use of new pesticides and herbicides have created public health hazards Rachel Carson: How could intelligent beings seek to control a few unwanted species by a method that contaminated the entire environment and brought the threat of disease and death even to their own kind? 1972 US EPA: The general use of the pesticide DDT will no longer be legal in the United States after today, ending nearly three decades of application US DDT Production (tons/yr) Thousands

7 Public Outrage Contributing Factors Choice Delayed Effect Familiarity vs. Habituation Elimination vs. Reduction Controllability Natural vs. Manmade Risk-Benefit Distribution Among People Managing Factors Maintain compliance Monitor with persistent effort Set aside biases and technical lenses Consider early action 7

8 Anticipate Issues and Formulate Response 8

9 Which Regulation Fits Where? Managing the Business Risks

10 Case Study SCENARIO Manufacture a unique polymer that biodegraded into inert substances Register in nine jurisdictions CHALLENGES Polymer definitions and uses Country differences (EU vs. Japan vs. Canada) SOLUTIONS Understand cultural differences (i.e. testing waiver) Utilize local and subject matter experts Engage with the authorities LESSONS Understand product composition and inventory Seize opportunities to submit similar notifications 10

11 Challenges Legislative demands Language barriers Local/global inconsistencies Supply chain communication Regulatory nuances Classifications and interpretations Data requirements and quality standards English as a main vs. second language Availability and liability of translated documents Framework to identify data gaps Use of languages, databases, and pictograms to unify Disconnect between business units Lack of compliance or understanding holds up supply chain Variations vs Commonalities Manage based on differences 11

12 Organizational Strategies Inventory Awareness Open Communication Jurisdictional Understanding Obtain substance details at the granular level Monitor volumes and potential for phase-outs Connect business units Obtain product information from relevant entities Identify the most demanding legislation and needs of each location Understand the necessity for the product Prioritization Create awareness for emerging markets and changing regulations Gain business insights to drive compliance strategies IT Systems Staffing Track products using a central repository Be aware of databases that track regulations to stay informed Engage local experts and staff to assist with compliance Outline translation and interpretation tasks 12

13 What s the Silver Bullet? Simplicity = Complexity Revenue generation Data standards Compliance down the supply chain becomes increasingly difficult Jurisdictional demands 13

14 Next Steps Manage differences Create adaptable IT systems Promote data sharing REACH Centrum Make rules and regulations understandable Form taskforces, create user-friendly tools, promote soft skills Support government collaboration Change the reputation of chemical legislation Moving Towards Global Integration! 14

15 Create and Follow a Logical Process Scoping Business Case Development Testing and Validation Launch Products Countries Inventory status Regulatory review Define regulatory requirements Develop regulatory strategy Connect with local experts Train key personnel Volume tracking systems Data gap analysis Testing Classification, SDS, labels Technical dossiers Build relationships across business units Look toward other jurisdictions Track product safety, potential hazards, and uses Record keeping Annual reporting Maintain IT systems 15

16 Keeping up With Global Chemical Regulatory Changes An EU Perspective

17 EU Chemical Management Framework Started in 1967 with adoption harmonized rules for classification, packaging, and labelling of chemical substances across the EU In 2002 EU made commitment at the world summit on sustainable development that by 2020, chemicals are produced and used in ways that minimise significant adverse impacts on human health and the environment In 2006 REACH came into force in the EU Reversal of burden on proof Works in collaboration with product specific legislation 17

18 REACHing Forward Final 31st May 2018 registration deadline fast approaching Many businesses now well-practiced and efficient in preparing REACH registration dossiers Many though resource constrained seeking outside help Large number of 1 to 100 ton range substances which are more exotic But also many smaller non-traditional chemical importers in the EU having first exposure to REACH Today some 9,700 unique substances been registered Number expected to double by end of Tier 3 deadline 18

19 Beyond Registration The EA(R) part of REACH is now also starting to bite bringing an increasing and less predictive workload: Addressing dossier Evaluation questions; Keeping up to date with SVHC (Substance of Very High Concern) communication obligations as more substances are added to the REACH Candidate List for Authorization; Managing the implications of increasing number of entries in Annex XVII Restricting the uses of certain substances of concern. Navigating through the Authorization process as authorities agree that an increasing number of SVHC s require an Authorisation; And classification requirements continue to grow Chemicals Identified to be of very high concern under REACH 117 Chemicals to be evaluated before 2019 by European member states 320 Harmonized hazardous classifications proposed during the past 8 years

20 The Elements of Authorization Definition of Substance Use (BIU) Chemical Safety Report (CSR) Analysis of Alternatives (AoA) Socio- Economic Analysis (SEA) What are the precise technical and process functions of the substance in this specific use? What combination of technical and process criteria are critical for this specific use? What are the exposure scenarios? Which risk management measures are employed? What monitoring is available to assess exposure? What are the risks to human health and the environment? Are there any other substances of lower toxicity profile that can fulfill the defined technical criteria? Are there other processes or technology that can be used to generate the same end result? How robust is this analysis? What is the impact on human health and/or the environment if Authorization is granted? What is the impact on society and the economy if the substance is no longer used from the sunset date? 20 Typically costs K 2 year process No guarantee time limited authorization will be granted

21 Another REACH Review Improve the quality of registration dossiers Level the playing field on SVHCs in imported articles Do more to identify SVHCs Bring in additional requirements for Nanomaterials, Endocrine Disrupting Chemicals and Combination effects Do more to encourage substitution and benign design of new chemicals 862 Chemicals that NGO s would like to be regulated 189 Chemicals identified Internationally as possibly carcinogenic to humans Potential endocrine disrupters currently being scrutinized in different regions 21

22 The Next EU Chemicals Strategy Regulation of nanomaterials, endocrine disrupters and hazardous polymers not only within REACH, but more widely within product laws such as pesticides, cosmetics, biocides and more will follow suit A new Circular Economy Action Plan is assessing the interaction between waste, products, and chemicals legislations in order to facilitate the traceability of chemicals in the recycling process Task of creating an EU strategy for a non-toxic environment is due next year and will set of the direction of travel to

23 Keeping up With Global Chemical Regulatory Changes An Asia Perspective

24 Major Regulations China Japan Korea Taiwan New Chemical Registration Measures on the Environmental Management of New Chemical Substances (MEP Order No.7) Chemical Substances Control Law (CSCL) Industrial Safety and Health Law (ISHL) Act on Chemical Registration and Evaluation of Chemicals (K-REACH) Occupational Safety and Health Act (OSHA) Toxic Chemical Substances Control Act (TCSCA) Occupational Safety and Health Act (OSHA) Existing Chemical Registration Regulation on the Safe Management of Hazardous Chemicals (Decree 591): ~3,000 ECs K-REACH: ~2,000 ECs TCSCA: total ~500 ECs Chemical Handling Implementation Rules Poisonous and Deterious Substances Control Law (PDSCL) Chemical Control Act (CCA) OSHA OSHA Note Regulations are stable and industry act proactively before regulations are established Major amendments on K- REACH (~7,000 ECs expected) and new enactment of Biocide Act (K-BPR) are coming. First batch of existing chemicals required for registration is to be published in a few months. 24

25 Case Study SCENARIO Manufacture a new nanomaterial Register globally, including USA and APAC CHALLENGES Nanomaterial definitions and CAS# R&D and commercial uses SOLUTIONS Phased approach to registration using local experts throughout the process LESSONS Understand product definition and uses Communicate with the authorities 25

26 General Requirements Understand definitions Calculate annual volume Determine use Identify importers or legal entities 26

27 Japan CSCL Main regulation for chemical management Addresses new chemical notification, annual reporting, and prohibition/restriction Exemptions available Small Volume Exemption Low Volume Exemption ISHL Main regulation for occupational health including exposure to hazardous chemical Addresses new chemical notification, prohibition/restriction, risk assessment, and GHS Allows for Small Volume Exemption of 100 kg/y 27

28 China China Chemical Control Chemical Type New Chemical Substances Hazardous Chemicals List/Catalogue for Control Inventory of Existing Chemical Substances in China (IECSC) (45,612 substances) Catalogue of Hazardous Chemicals (3,777 substances) and those classified in certain categories under GHS Required Actions New Chemical Substance Notification (MEP Order 7) Hazardous Chemicals Registration (Decree 591) Governing Authority Ministry of Environmental Protection (MEP) State Administration of Work Safety (SAWS) 28

29 Taiwan Authority Substance Registration Requirements Who When TCSCA (Registration target: new & existing chemicals) OSHA (Registration target: new chemicals) New Chemical Existing Chemical New Chemical Existing Chemical Standard registration Simplified registration Small-quantity registration (depending on chemical type, tonnage and uses) Phase I registration: all existing substances(>=0.1t/y); Phase II Standard registration: designated existing substances announced by EPA Standard registration Simplified registration Small-quantity registration (depending on chemical type, volume and uses) Reporting: priority management chemicals Apply permit: controlled chemicals Importer/ manufacturer in Taiwan Importer/ manufacturer in Taiwan Importer/ manufacturer in Taiwan Importer/ manufacturer/ supplier/ employer in Taiwan 90 days prior to import/manufacture Phase I: 2015/09/ /03/31 Late Phase I (after 2016/04/01): 90 days after 1 st manufactured/ Imported volume reaches 0.1 t/yr Phase II: to be announced by EPA Before import/manufacture Reporting: annually Permit: before handling 29

30 Korea Updated Timeline Enforce K-BPR Re-Notification of TCCA exempted substances Pre-Registration for all existing substances over 1 ton (~7,000) Registration (~1,170) 1000< & CMR Registration for 100~1000 tons (~ 1,096 substances) Registration for 10~100 tons (~ 2,075 substances) Registration for 1~10 tons (~ 2,642 substances) 2 nd half Jan nd half

31 Emerging Markets Thailand Notification on the List of Hazardous Substances (No. 2) B.E (2015) addressed 10 hazard properties and tonnage requiring notification Currently collecting hazardous chemical information to establish a national inventory The schedule and requirements for registration are not yet outlined Vietnam Article 44 regulation establishes registration requirements, however a national inventory is required Disclosed a draft national inventory in 2016 Registration requirements will be provided in an official publication Indonesia Chemical management regulation No. 74/2001is currently under revision Revised requirements have not yet been disclosed 31

32 Wrap-Up

33 ERM Product Stewardship Insight Series Managing Business Risks with Effective Product Stewardship Integrating Product Stewardship Into Business Practices The Business Value of Product Stewardship 33

34 Contacts Kate Sellers Technical Director Boston, MA T +1 (617) E kate.sellers@erm.com Jo Lloyd, Ph.D. Partner London, UK T +44 (0) E jo.lloyd@erm.com Kerrie Canavan Project Manager New York, NY T +1 (212) E kerrie.canavan@erm.com Sarah Medearis Partner Washington, DC T +1 (202) E sarah.medearis@erm.com 34

35 ERM Sustainability Report 2017 Sustainability means business. ERM is shaping a sustainable future by working with leading organizations around the world and delivering sustainable business results for our clients and for ourselves. Click here to view our online Sustainability Report 2017 Megatrends ERM is helping organizations address the most pressing sustainability issues. Four megatrends with a significant impact on our clients businesses and our services include: Click image to learn more. Climate change Digital transformation Our world is changing and fast. And business has an important role to play KERYN JAMES CHIEF EXECUTIVE OFFICER Population growth Emerging middle classes 35

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