Green - Global Product Stewardship

Global Product Stewardship Environmental Initiative Business & Environment Series Product Stewardship October 25, 2011

Objective and Overview
Objective Today:
Product Stewardship Fundamentals
Business Impacts/Applicability
Regulatory Drivers
Approaches and Actions

What is Product Stewardship?
Product Safety Support
Is the product safe and sustainable as used for humans and the environment at all stages of product lifecycle from raw material sourcing, manufacturing, to marketing/use and disposal/recycle?
Toxicology, ecotoxicology, physical/chemical property assessment to identify hazards (ex. PBT), fate & transport and impact assessment, and assistance in selection of “Greener Alternatives”
This is quantitatively managed via Risk Assessment and Life Cycle Assessment tailored to the appropriate audience whether workers, customers, regulators, the public, or NGOs.
Chemical Product Hazard Classification, MSDSs, and Labeling is a key issue that impacts global business (i.e., GHS/CLP).

What is Product Stewardship?
2. Global Product Regulatory Compliance
Strategic and technical support to meet current and emerging regulatory compliance requirements
New and existing chemical product registration at federal, state, and international levels:
Chemicals, Pesticides, Drugs, Feed Additives, Consumer Products and durable goods across US, Canada, EU, China, South Korea, Japan
Improved speed to market via ability to replicate regulators decision making schemes to gain government approvals of new products ASAP
EU REACH legislation is a gigantic product re-registration issue with global business impacts and it is expanding globally
Hazard classification, labeling, MSDS, product defense, Nanotechnologies, customs certification and supply chain issues like Walmart/Kmart registration

The squeeze Operations Your Customers Their Customers (Consumers) Sources & Suppliers End of Life Products& Services Supplier Resistance Market and Regulatory Expectations

Three business questions
What is in your products?
What is the chemical composition?
If you have these data, are they in a smart-searchable and automatable database system?
What matters?
What product performance claims are you making?
What obligations or restrictions do you need to be concerned about in the markets where you ship them?
What can you do about it?
Can you comply, substitute, or reduce?
Can you educate regulators or customers?
Are there other business options to consider?

Three business approaches
Put technical issues into business terms
Understand business impacts
Use business language
Look for both risk and opportunities
Risks of product deselection and operating disruption are real
Dealing with risks faster and better than the competition creates opportunities
Build collaborative solutions
Inside your company- probably not your traditional network
Beyond your company, starting with business partners up- and down-stream

Value Chain in the Product Development Lifecycle Product Stewardship Services
Current / Pending International Regulatory Understanding and Compliance
Global Regulatory Inventory Status
Sustainability Assessment
Risk Screening, Ranking and Prioritization Tools
Designing Waste/Risk out from Processes
Litigation
HPV / VCCEP / ICCA
Monitoring and Compliance Reporting to Government Agencies
Regulatory Influencing
Trade Association Task Force Management
Public Relations Issue Management
REACH and REACH-Like Regs
Safety Reassurance
Literature Searching
QSAR Application
GLP Product Testing
Phys/Chem
Environmental
Human Health
Efficacy
Global Hazard Classification and Labeling
Customized for Regulator or Client Needs
Use of Regulator ’s computer models/tools for exposure & risk assessment
Site Specific
Nationally Marketed
Product Life Cycle and Risk/Benefit Assessment
Assembly of Dossier for regulatory submission
Managing interface with regulators
Poison Control Center Registration
Technical Claim Support
Public Relations Risk Management
Crisis
Proactive
Industrial Hygiene
Training
Occupational Exposure Guidelines
Plant and Field Auditing and Monitoring and Permitting
Waste Characterization and Management
Post-Market Product Support Manufacturing Optimization Registration Dossier Prep. Risk Assessment Product Testing Technology / Product Optimization

Emerging strategic product issues
Proliferating regulations in developed and emerging markets
Innovation, global competition and “speed to market”
Nanotechnology
Energy consumption and related products
Supply chain “Greening”
Step changes in analytical measurement and hazard assessment methodology
Personal Care/Pharmaceuticals in Environment
Endocrine Disruption
Cumulative and aggregate risk assessment

DSL HPV/IUR/ TSCA/FQPAFDA/CPSC HPV/VCCEP EPR and Reverse Logistics REACH ELV WEEE/ROHS New Laws and Amendments in Emerging Markets METI POPs/PBTs/CMRs Global Climate Change Sustainability Transparency NICNAS Globally Harmonized System & MSDSs Green House Gases TCCL Product Global Regulatory Compliance Challenges

Product Global Regulatory Compliance Challenges
The global proliferation of chemical control and downstream product regulations and restrictions is a major challenge facing Multi-National Corporations (MNCs)
In business terms this represents a strategic barrier to innovation and a major source of enterprise risk that MNCs are not all suitably positioned to control
As these regulations have evolved…….
No two are alike
They tend to have global supply chain impacts beyond the specific national jurisdiction
Net, the cost of international business is increasing, and product & supply chain compliance and stewardship is becoming a critical business function
A significant burden, but also a potential source of opportunity and competitive advantage

Key Points:
Nearly 10-fold increase in number of emerging environmental regulations globally within the last 8-yrs!
Focus on substance related regulations in the coming years (REACH, GHS/CLP, TSCA, Safe Chemicals Act etc)

Key Point:
General increasing trend of the number of environmental regulations on a global-scale
Dynamic switch in recent year from EU & AP to US and Canada
Technical progress and milestones for implementation of regulations entered into force in previous years are becoming increasingly important to follow.

GE notes critical nature of product stewardship
GE Citizenship – 2009 Global Focus on Regulations
Released July 20, 2010 “ Examples include the release of a Product Stewardship toolkit as an interactive, user-friendly and relevant framework in support of R&D, Product Design/Re-design and launch to market.”

Enterprise Risk? SOME EXAMPLES
Global Product Stewardship/Compliance KEY in supporting ability to sustain:
global product development;
global market access;
global company reputation
Product Global Regulatory Compliance Challenges Strategic
Risk that can affect Brand and demand for your products
Risks that can impact Speed to Market and Intellectual Property
Change in Customer Critical Requirements (Black List Effects)
Operational
Disruption of supply chain or site operations
(i.e. materials stuck in Customs or no longer available)
Risks that can damage your credibility in the marketplace
(i.e. – Producer Responsibility / Product Take back)
Financial
Risk to shareholder and marketplace acceptance
Risks to Raw Material pricing and availability
(i.e. chemicals under pressure in the market place)
Legal & Compliance
Risk of action by regulatory agencies, courts, individuals, customers, suppliers/partners, supply chain

Product Global Regulatory Compliance Challenges How Did We get Here?
North American and EU Chemical and Product Safety Reassurance and “Right to Know” initiatives been the foundational driver for these regulations
>50,000 chemicals in commerce pre-1970 ’s were “Grandfathered” and accepted as already on the markets without government review and transparent safety reassurance
Hazard versus Risk based approaches had been a key variable
Early regulations sought to control chemical products with an eye towards:
Worker/Public/Consumer Safety, and eventually Worker, Community, & Public Right to Know (i.e. Transparency)
Latest trends have focused on Sustainability and Transparency with a “Reversal of the Burden of Proof of Safety” from Government to Industry
Importantly, EU regulators have been leading the way in evolving and globally exporting their regulatory initiatives for the past 20 years
The Globally Harmonized system for Hazard Classification & Labeling (GHS), REACH, and Extended Producer Responsibility initiatives are key examples
These are spreading around the world and no two are identical!

GHS (Globally Harmonized System for Classification and Labeling of Chemical Substances) What is GHS? Why is there a GHS?
Classification and Labeling globally inconsistent:
Disparate “Hazard Communication”
Dissimilar Labeling
Compromised SDS content
Enhance safety to human health & environment, including the workplace
Global Market: “Level the Field”
Help standardize existing national regulatory regimes (mature countries)
Simplify development and deployment of new chemical regulatory regimes (developing countries)
Standardizes and classifies chemical substances by “hazard”
Provides comprehensive communication criteria for packaging (labels) and SDS ’s
Non-regulatory as such, but countries encouraged to adopt in to their own
Regulatory programs
by 2008. Adoption is
ramping up now
across the globe
(e.g. REACH/CLP, China)
The so-called “Purple Book” Third Revised Version Global Implementation is NOT harmonized!

EU Harmful (St. Andrew ’ s Cross) US Toxic CAN Toxic Australia Harmful India Non-toxic Japan Toxic Malaysia Harmful Thailand Harmful New Zealand Hazardous China Not Dangerous Korea Toxic Historically, there has been global disharmony in chemical Classification and Labeling. ex. Different risk phrases were used for a substance with an Acute Oral Toxicity LD 50 ~257 mg/kg/day. Illustration of why is GHS necessary? GHS Toxic (Danger + Skull & Cross Bones)

GHS Pictograms Physical-Chemical Hazards Explosives Self-Reactive Substances and Mixtures Organic Peroxides Oxidizing Gases Oxidizing Liquids Oxidizing Solids Gases under pressure Refrigerated Liquefied gas Corrosive to Metals Flammable Gases Flammable Aerosols Flammable Liquids Flammable Solids Organic Peroxides Self-Reactive Substances and Mixtures Pyrophoric Solids Self-Heating Substances and Mixtures Contact with Water, Emit Flammable Gas

GHS Pictograms Human Health and Environmental Hazards Acute Toxicity: Danger Acute Toxicity: Warning Skin Corrosion/Irritation: Warning (irritation) Eye Damage/Irritation: Warning (irritation) Skin Sensitization: Warning STOT* Single: Warning (Category 3) * Specific Target Organ Toxicity Skin Corrosion/Irritation: Danger (Corrosion) Eye Damage/Irritation: Danger (Corrosion) Germ Cell Mutagenicity: Danger, Warning Respiratory Sensitization: Danger Germ Cell Mutagenicity: Danger, Warning Carcinogenicity: Danger, Warning Toxic to Reproduction: Danger, Warning STOT Single : Danger (Cat 1), Warning (Cat 2) STOT Repeated: Danger, Warning Aspiration Toxicity: Danger, Warning Hazardous to the Aquatic Environment, Warning

Alignment of the OSHA Hazard Communication Standard to the GHS
Final Rule pending
Expected in August, 2011, then September, 2011 – still waiting…..
Phase-in period of 2-3 years anticipated once final
Major proposed changes to the HCS
Hazard classification (substances and mixtures)
Labels (includes harmonized signal word, pictogram and hazard statement + precautionary statements)
Safety Data Sheets (specified 16-section format)
Information and training (require workers are trained within 2 years of the publication of final rule)
Over 40 million workers and 5 million workplaces will be impacted
Significant costs associated with classifying chemicals and revising SDSs and labels (OSHA estimates $11 MM/year for ~90,000 establishments)
OSHA estimates worker training costs of ~44 MM/year for affected workplaces

REACH R egistration E valuation A uthorization/Restriction ……………….of Ch emical Substances In some respects true, but it really means……. new European Union Chemicals Legislation Implemented from 2007 through 2018, but this regulatory framework and approach to chemical control is now “spreading” globally!

R eally E liminate A ll Ch emicals REACH =

REACH Covers:
Chemical substances – as such
Preparations – Mixtures of Chemical Substances
- Including Alloys
Articles
Articles designed to release
An ink cartridge is an article that contains a substance/preparation (ink)
REACH IS NOT a PRODUCT REGULATION [like WEEE (waste electrical and electronic equipment) and RoHS (restriction of the use of certain hazardous substances in electrical and electronic equipment)]. IT IS A CHEMICAL SUBSTANCE REGULATION with direct impact on Products and Global Supply Chains. SiO 2 Powders Organic Polymer + Pigments Metal Alloy formed to give it a functional part Article with embedded Perfume designed to release

II. No Data/No Info….. No Market in the EU
Manufactures, Importers and downstream users all have obligations
Management of Change systems needed to stay in compliance
Principle REACH Concepts:
“ Safe Use” of Chemicals Across Supply Chains + Elimination of the “Hazardous” Ones
Global Supply Chain Impacts
Requires Industry Collaboration and Alignment
Introduces “Substances of Very High Concern” (SVHCs) which also impact articles (e.g., automobiles, furniture, packaging, etc.)

New CLP (including GHS Classification & Labeling System) Substances & Mixtures Transition (3 yrs) Current EU System (DSD/DPD): Obligatory CLP/GHS System for substances and mixtures: Voluntary *Deadline for reclassification of substances according to CLP (GHS) — 12/01/10 *Obligation to confirm supply chain alignment with Art. 36 record keeping EU CLP IMPLEMENTATION MILESTONES Mixtures Transition (+ 4.5 yrs) DPD System mixtures: Obligatory CLP/GHS System Obligatory (substances); Voluntary (mixtures) *Deadline for reclassification of Mixtures according to CLP (GHS) — 06/01/15 Current EU Directives 67/48/EEC & 1999/45/EC repealed 06/01/15 GHS System: Obligatory CLP Regulation (EC) 1272/2008 EIF 1/20/2009 GHS Proposal adopted by EU Commission 06/27/07
In 2009 Companies Implement CLP
Check and Align on Annex VI for Classifications made by EU Authorities, 30 th & 31 st ATP
Align and Classify according to the EU CLP criteria and SIEFs where self-classification is necessary
Understand the implication of new CLP classifications to REACH substance registration timing and possible Candidate Listing
Pre-CLP EU classification & labeling System (DSD/DPD) SDS format under REACH Mixture Deadline 06/01/15 Substances Deadline 12/01/10 AND C&L Notification Deadline 1/3/11 KEY: ECHA = EU Chemical Agency; CLP = Classification and Labeling and Packaging Regulation; EIF = Enters in Force; GHS = Globally Harmonized System of Classification and Labeling; DSD/DPD = Dangerous Substances and Preparations Directives and 67/48/EEC & 1994/45/EC; SVHC = Substance of Very High Concern EU REACH and CLP Implementation Timelines 2007 2008 2009 2010 2013 // 2018
Companies Prepare for REACH in 2009
Update Chemical Substances Inventories
Define legal entity structure in EU
Register phase-in substances
Track REACH strategy, by substance:
What is the Registration deadline?
Is there an Authorization risk?
Suppliers registrations?
Locate (internal) data, ID data gaps
Participate in SIEFs
ECHA Operational REACH EIF 06/01/07 Pre-Registration 06/01/08 - 12/01/08 Phase-In Registration > 1000 tpa; CMR 1&2 > 1 tpa; R50-53 > 100 tpa Deadline 11/30/10 Phase-In Registration > 1 tpa; Deadline 05/31/18 Registration of New Substances with Chemicals Agency Phase-In Registration > 100 tpa; Deadline 05/31/13 Pre-Registration SIEFs Operational until 1 June 2018 Pre-SIEF Discussions > 1000 tpa/ CMR/R50/R53 Phase-In 11/30/10 > 100 tpa Phase-In 05/31/13 > 1 tpa Phase-In 05/31/18 Rec. Authorization List Annex XIV 06/01/09 Initial Candidate List Release 10/9/08 First 7 substances prioritized for Annex XIV 1/14/09 Second Group for Candidate List Proposed 9/1/09; Added to CL 1/13/10 EU REACH IMPLEMENTATION MILESTONES 8/3/2010 Public Consultation on 8 new Potential Candidate List Substances; 30/3/10 Acrylamide added to the CLS

GHS and “REACH-Like” Chemical Control Programs are Spreading Globally, but No Two are Alike! General Chemical Control Laws (Registrations, Inventories, GHS/SDS/Label Restrictions, Notifications, Bans, Lists, etc.) Countries Comment Comment China (REACH Like amendments ) Effective Date 10/15/2010 GHS 2/2/2009, Classification, Labeling Hazard Communication of Chemicals 5/1/2010 (one year transition period for labels of substances and mixtures). India 2000 Amended HCR (List based - 685), no Inventory. GHS compatible CLP Q2-2011 Korea TCCA Amended 10/2009 (blend of TSCA & REACH) New REACH like amendments announced week January 24, 2011 Final classifications est. 12/17/2010 - mandatory C&L substances 7/ 2011 / for mixtures July 2013. GHS implemented July 1, 2011-substances / July 1, 2013-mixtures. Manufacturers/importers to supply GHS compliant SDSs by July 2011. Malaysia Notification and registration scheme (Volume based / REACH-like) expected mandatory in 2011. Final GHS requirements expected late 2010 or in 2011, implementation is expected between 2010-2012 timeframe Taiwan Inventory built by Ind Noms thru 12/2010. NSN scheme expected 7/2011. Existing chemicals nominations required 12/30/2010. Publication of Existing Substances Inventory 6/30/2011. List based since 2006, 6/30/2010, 12/31/2014 Singapore Restrictions / Licenses required 11/08-12/10 | 11/09-12/12 Japan First phase in 2010 - harmonize with international practice. Second phase in 2011 - achieve the WSSD 2020 goal efficiency. Chemicals will be designated by end of FY2010, exempted for certain chemicals. List based since 2006. All mixtures/subs by 12/2010. Indonesia TBD GHS MSDS and labels mandatory - single substances and voluntary for mixtures (Q2)-2010. Russia TBD Chemical product safety passport, labeling 1/1/2009. Test methods-planned effective date: end of 2010 to end of 2011. Classification of mixtures of environmental hazards-planned effective date end of 2012. Philippines A pre-manufacturing & pre-import notification required for chemicals placed on the market >1000 kg/yr. I mplemented 6/2009 (1-2 yr implementation) Adoption of GHS elements for labels and MSDSs (2007)-3 year window). Thailand 1600 substances on Hazardous List Registration required; Permit required. 7/2008 / 7/2012 Vietnam New CL 2008 (new Agency 1/2009) - Registration New Chemical Law as of 7/2008. Effective now - was adopted as part of new C&L by 2011.

Chemicals Regulation & GHS Components
General Chemical Control Laws
MAJOR Regulatory Amendment 1/2010 (REACH Like)
Six Supplementary Documents 9/2010
Guidance for New Chemical Substance Notification and Registration
Codes for Supervision, Management and Check on new Chemical Substances
General Notification Form for New Chemical Substance and Instructions
Simple Notification Form for New Chemical Substance and Instructions
Scientific Research Filing Table for New Chemical Substance and Instructions
First Activity Reporting Form and Instructions
Effective Date 10/15/2010
GHS/SDS/Label
Incorporates (as provisions) 28 existing standards covering Material Safety Data Sheets, 26 GHS endpoints, GLP and the International Program on Chemical Safety/Environmental Health Criteria No. 225
Mandatory GHS Implementation 5/1/2010, one year transition period for substances and mixtures
China

Brazil Product & Chemical Programs Topic Legislation Effective Date Effect Status WEEE type Article 33 of Law # 12.305 (Brazil New Waste Law) 08/02/2010 Supersedes all existing federal level waste laws Mandatory RoHS type ABNT NBR IECQ 080000-2010 01/01/2011 Aligns with EU RoHS Directive Non-mandatory (for now) DfE / Eco Design type ABNT NBR IECQ 62430-2010 02/01/2011 Aligns with EU EuP / ErP Directives Non-mandatory (for now) Chemical Control Laws No Federal level Inventory program. All sectoral specific Legacy Driven in sectoral and state level programs Mandatory / Non-mandatory …No view toward a REACH-like program (yet) GHS NBR 14725 : 2009 02/27/2011 Substances 06/01/2011 Mixtures Authoring and Receiving SDS ’s from Suppliers Mandatory NOW for substances

GHS in Brazil
There currently is no banned/controlled substances lists or chemical inventory or registration scheme
But, GHS has been implemented in Brazil (NBR 14725:2009)
currently based on UN GHS Rev. 1 (with only 2 very minor differences)
Brazil currently working toward alignment with UN GHS Rev. 3
The NBR implements GHS in 4 Sections:
14725:2009-1 Terminology
14725:2009-2 Classification
14275:2009-3 Labeling
14275:2009-4 SDS
includes unique CBI clause option (to mask identity so long as hazards presented)
requires in Section 15 reference to any applicable Brazil legislations (I.e. Mercosul Agreement on bilateral trade) / International Conventions (I.e. Montreal Protocol)
Mandatory Implementation
for substances as of February 27, 2011
for mixtures as of June 1, 2015 (can use NBR 2005 or NBR 14725:2009 until mandatory deadline)
Everything in Portuguese
When “receiving” (including Imports) or placing on Brazil Market
When exporting to other country, destination country language typically required

Brazil National Waste Law (12.305/2010) and Implementing Regulation (Decree 7.404/2010)
Solid / Hazardous Waste Provisions
Reverse Logistics on certain waste “products” and their “packagings”
Consumer Merchants/ Distributors (M/D) Manufacturer / Importer (M/I) Adequate Environmental Treatment by M/I Adequate Environmental Disposal (refuse) by M/I No Reporting (yet) -------------------- General Recordkeeping Expectation on M/D ’s AND M/I’s to demonstrate compliance upon inspection $ $ $
Product Categories cited in Scope:
Agrochemicals (includes pesticides & their packagings)
Batteries
Tires
Oil lubricants & their packagings
Fluorescent lamps, sodium & mercury vapor lamps
and mixed lamps
Electro-electronic products and their components
Implementation details / other definitions remain unclear Potential impact on MNCs is large Reverse Logistics Concept (applicable product and/or packaging) Law contains 57 legislative “Articles” Article 33 is that of the “Reverse Logistics” program Full scope of products/product types in this category remains unclear

Global Product Regulations Across Chemical Supply Chains & Market Sectors
Petroleum and Coal Derived materials
Mined Ores
Plant and Animal Derived Products and Feedstocks
Specialty Organic and Inorganic Chemicals
Polymers
Industrial Products
Pesticides/Agricultural Chemicals
Parts/Articles
Building Materials
Perfumes/Dyes
Packaged Consumer Goods
Pesticidal, Anti-Microbial
Food Contact/Additives
OTC Healthcare/Medical Devices
Cosmetics, Personal Care
Pharmaceuticals
OEMs:
Transportation (Auto, Rail, Aerospace, Defense)
Electronics, Batteries
Public Sector
Nanotechnology
Global/Local Regulatory Tracking
REACH, GHS, RoHS Cut Across These Sectors Globally
MNCs need a global supply chain approach to addressing their specific obligations
Downstream product regulations become increasingly specialized and MNCs need to invest in mastery of these regulations to be in these markets
Finished Products Intermediate Products Primary Chemicals

ERM Perspective: The global proliferation of chemical control and downstream product regulations and restrictions is a major challenge facing MNCs
What it takes to Comply
MNCs need to operationalize for product compliance and stewardship
Proactive internal and external program elements
Internal – To your Business and Supply Chain
Cross Functional Business Engagement:
Management, EHS, Product Quality/Technology, Legal, IT, Purchasing/Sourcing
Appropriate use of outside resources for expertise and capacity
Know your products, supply chains, and obligations:
Develop Inventory of Chemical Substances, Direct and Indirect, how much do you use and what used for? Which ones are “Critical” or “At Risk”
Understand your suppliers and customers, what are they doing with your products and are they supporting your uses?
Be prepared to demonstrate safe and sustainable use … ”Take the Scientific High Ground” and consider providing proactive leadership and transparency

ERM Perspective:
What it takes to Comply Continued……
External – To your Business and Supply Chain
Understand and Influence the Regulations
Mastery in regulatory requirements, especially how new products are reviewed and assessed by authorities, can be a source of competitive advantage
(i.e. Speed to Market!)
Opportunity to influence new regulations and restrictions if you engage early enough
Know your Industry Peers and Industry Associations
Benchmark to identify common shared interests and best practices
Industry voice more impactful than single company voice
Protect Intellectual Property & Confidential Business Information (CBI)
Steward Critical to Business Technologies
Know the current and emerging scientific trends
Consider proactive presentations and peer review publications, blue ribbon panels and scientific advisory groups as appropriate

THANK YOU!
Dianne Green
Senior Project Manager - ERM
9987 Carver Road - Suite 240
Cincinnati, OH 45242
513-830-9035 (Office)
513-830-9031 (Fax)
513-739-7111 (Mobile)

One Planet. One Company. ERM.

Green - Global Product Stewardship

by Environmental Initiative on Oct 26, 2011

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Green - Global Product Stewardship — Presentation Transcript