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Challenges in Global Product Safety and Stewardship

Compliance

Alex Ortiz and Julia Tsvetkova

March 17th, 2015


• The Complexity and Challenges of Regulatory Compliance

• Benefits and Best Practices for:

1. Substance-Level Data Management (Regulatory & Scientific)

• Reference Content

• Integrated into your EHS Compliance System

2. Product-Level Data Management

• Integrated into your EHS Compliance System

3. Rules, Phrases & Templates

4. Regulatory Updates

Agenda


The Complexity – A Regulatory Perspective

• Companies struggle under the burden of spiraling global EH&S regulations – Ever more demanding regulators and clients

Restricted Substances

• RoHS

• Phthalates

• BPA

• Drug precursors

• Conflict Minerals

• US CA Prop 65

Authorization/

Registration

• EU REACH SVHCs

• Japan CSCL (PAC)

• Korea “REACH”

Classification

Labeling

• GHS/CLP

• Classification

• Labeling

• Packaging

Environment

• Emissions

• GHGs

• Waste – ELV, WEEE


The Complexity – A Company Perspective

• Product Stewardship teams are under pressure to produce accurate and extensive SDS documentation with: – Fewer resources

– Outsourced IT departments

– Methodologies to collect critical product compliance data within the organization are often inefficient and error prone

– Difficulties getting product data from numerous suppliers

– Consumer green buying patterns and sustainability

– Transparency and corporate responsibility


3. Dynamic and Global Rules, SDS Templates and Multilingual Phrases

Country Specific Industry Requirements

2. Accurate, up-to-date product data

SDS Compliance Documents

1. Accurate, up-to-date substance data

Regulatory Scientific

Regulatory Content – The Pieces


1. Accurate Up-to-date Substance Data

• Substance Data – Regulatory

– Scientific

• Best Practices – Proactive alerts

– Global monitoring and compliance with numerous regulatory topics

– Business impact analysis and risk mitigation


Expert International Staff

• Regulatory attorneys and researchers

• PhDs, chemists, toxicologists, industrial hygienists and chemical engineers

• Software systems and data experts

• Business and strategy consulting professionals

• SDS Authors

• 25+ languages spoken

• Fully dedicated employees


• Subscription based online reference tool with easy-to-use, intuitive interface with robust search, query, reporting and analysis features

• Search through regulations issued by 90+ countries around the globe

• Instantly access close to 1,500 regulatory lists containing thousands of data elements

• Access to Full Text, “Generics” data, GHS classification tools, multilingual phrases and more

• Continuously Changing and Expanding data set

Ariel WebInsight (WI)


WebInsight – New & Amended Lists

95 269

112

607

712 911

0

200

400

600

800

1000

1200

2012 2013 2014


4 Topics of Interest Recently Expanded

• Chemical Weapons Convention (CWC)

• Controlled Drugs and Precursors

• Dual Use Lists and Explosives lists

• PIC lists


Regions Covered

• North America – Canada, US Federal, and some US states

• Latin America – Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, and Venezuela

• Asian Pacific – Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Philippines,

Singapore, Taiwan, Thailand, and Vietnam

• Middle East / Africa – Algeria, Bahrain, South Africa, and Dubai

• International – UN Convention for Narcotics and Psychotropics – Chemical Weapons Convention – Wassenaar Agreement – Rotterdam Convention – Nuclear Suppliers Group

• Western Europe – EU, Norway, Portugal, Switzerland, Germany

• Eastern Europe – Kazakhstan, Russian Federation, Georgia


Generic Analysis

• We have 196 lists total in the following topics Chemical Weapons Convention (CWC) - 26 lists Controlled Drugs and Precursors – 124 lists Dual Use Lists and Explosives lists – 36 lists PIC lists – 10 lists

• In these 196 lists, we have 8,843 entries Only 2,939 entries have CAS# listed Many of these CAS# are assigned by 3E i.e., the regulation does not

assign the CAS

The remaining entries either lack a CAS number or are groupings of chemicals

3E chemists have added total of 15,719 generic children to these regulations. i.e., exploded the specificity of these lists > 5x


Generic Analysis Example

Hong Kong. Narcotics and Psychotropic Substances

• Entry names are typically general descriptions – Any compound (not being methoxyphenamine or a compound for the time being

specified in subparagraph (a)) structurally derived from phenethylamine, an N-alkylphenethylamine, alpha-methylphenethylamine, an N-alkyl-α-methylphenethylamine, α-ethylphenethylamine, or an N-alkyl-α-ethylphenethylamine by substitution in the ring to any extent with alkyl, alkoxy, alkyl-enedioxy or halide substituents, whether or not further substituted in the ring by one or more other univalent substituents

• After structural analysis, we found a total of 210 children • For example: MMDA hydrochloride, Levmetamfetamine,

Etilamfetamine, etc.


Physical Chemical, Toxicological and

Eco-Toxicological data

PCTEC Plus for Scientific Data


PCTEC Plus Scientific Data

200,000+ CAS RN 120+ Sources (DB + FT) 1M+ Records

PC

TEC

Structured Data

NLM, ECHA, EPA, HSDB… P

CTE

C P

lus Full Text

Documents

NTP, NIOSH, ATSDR … P

CTE

C P

lus Full Text

Web resources

IRIS, ITER, TOXLINE, PubMed …


PCTEC Plus Database Scope

60+ Physical-Chemical End Points

• Acid Dissociation Constant

• Boiling Point

• Characteristic Odor

• Color

• Density

• Flammable Limit, Lower and Upper

• Octanol-water partition coefficient

• pH

• Solubility, Water

• Surface Tension

• … and many more

45+ Toxicity End Points

• Acute toxicity

• Carcinogenicity

• Chronic/ Repeated dose toxicity

• Genetic Toxicity: In Vitro / In Vivo

• Eye Irritation

• Skin Irritation

• Skin sensitization

• Neurotoxicity

• Reproductive tox

• Developmental tox

• DNELs


15+ Eco-Toxicity End Points

• Bioaccumulation

• Biodegradation

• Fish, Acute toxicity

• Fish, Chronic toxicity

• Invertebrates (Aquatic) toxicity

• Invertebrates (Aquatic) toxicity, Short term

• PNECs



Applicability

• SDS Creation

• Hazard Classification (GHS, CLP, etc.)

• Hazard Risk Assessments

• Anticipate Regulatory trends – a lot of PCTEC is ahead of regulatory activity

• R&D formulation screening


How WI and PCTEC Works?

• Single click search of both regulatory and chemical hazard, toxicity and eco-toxicity data

• Search over 120 end points in database mode

– Combine your search with full text resources from over 100 sources

• Extensive collection of original study reports as well as integration of web services from NLM’s ToxNet

• Searchable full text by various criteria, including CAS, chemical name and text pattern/keywords


PCTEC Plus – Additional Uses

Evaluate toxicological and physicochemical properties of alternatives – 3E ‘CAAS’

– Green chemistry

– Sustainable alternatives

– Improved compliance


Chemical Alternatives Assessment

CHEMICAL ALTERNATIVES

– Regulatory pressure (e.g. ECHA)

– Manufacturers want “greener” products

SCREENING: 3E GREEN CAS SCORE services

FULL ASSESSMENT:

3E Chemical Alternatives Assessment System


3E Chemical Alternatives Assessment System

Chemical Alternatives Assessment System • Comprehensive method of comparing toxicological and eco-

toxicological effects (and more) of alternative chemicals/mixtures

• Simplified numerical scoring/screening system to compare chemical alternatives

• Scores based on actual toxicology data values -- not imputed from prejudged criteria (e.g. lists or GHS scores) i.e. continuous scale data analytics

• Avoids pitfallof categorical systems: discontinuity

• QSAR/ Read-across available

• Service: expert judgment included


Demonstration


Ariel WebInsight Mobile

• Perform a chemical or database search from your tablet or smart phone

• http://mobile.arielresearch.com


1. Accurate Up-to-date Substance Data

• Best Practices – Proactive alerts

– Global monitoring and compliance with numerous regulatory topics

– Business impact analysis and risk mitigation


Proactive Alerts

• Understand how up and coming regulations impact your substances and products

• Get proactive alerts when: – New chemicals are added on a banned or an SVHC list

– New reporting requirements

Enable Proactive Compliance


Global Monitoring and Compliance

• Make sure SDSs and labels are compliant for the markets in which the products are sold

• Make sure products are compliant for the markets in which products are sold

• Complete incoming customer inquiries, regulatory disclosures

• Quickly identify: – chemical release and spill reporting regulations

– export/import notification and reporting compliance requirements

• Read thousands of regulations and regulatory overviews in English

Enable Global Compliance


Business Impact Analysis

• New Product/New Market Introduction:

– What country specific regulatory requirements are applicable?

• Supplier Selection:

– Do my suppliers use substances that are compliant, properly labeled and classified?

– Do my suppliers use substances that might need registration or are on a list of concern?

• Supplier Responsiveness:

– Respond to supplier compliance questionnaires

• New Manufacturing Facility Selection:

– What are the exposure limits for workers?

Eliminate Risk in the Supply Chain


Accurate Up-to-date ‘Integrated’ Substance Data

• Substance Data – Regulatory

– Scientific

• Best Practices – SDS System Compliance Integration

a. Understand and load data applicable to your business

b. Run Impact Analysis to find impacted substances and products

c. Automated Update process


Understanding Your Data

Regulatory Data

• Classifications

• Health Data

• Restricted Substances

PCTEC

• Physical & Chemical

• Toxicity

• Eco-Tox

Dangerous Goods

• International Data

• Country Specific Lists

Supplier Data

• VSDS

• Manual Entry


The Data Load Process

EHS Compliance System


ADM EHSAP Impact Analysis

• Analyze

• Select

• “Generics”

Decision Support

• Real_Sub impact report

• List_Sub impact report

Impact Analysis • Configure

• Map

• Save

• Schedule

Load

Detailed RegImpact Reports + Usability and Technical Enhancements



Country Specific Industry Requirements


SDS Documents Other Certificates and Rules






• Product Data – Supplier SDS Documents

– Other Certificates and Rules

• Best Practices – ADM VSDS – Collect supplier compliance documentation

– Apply changes regularly

– Make supplier data available for use in downstream compliance processes:

• Classification

• Substance Volume Tracking (SVT) for REACH and other compliance activities

• Regulatory Reporting


Material Inventory

SAP EHSM ADM-

VMSDS Application

Internet Web Service 3E Catalog

SAP Material Master

SAP SD

(Document Distribution)

ADM-Supplier Process

Available Data for Integration

• Material/Product Name

• Manufacturer Name

• Revision Date

• Flash Point, Boiling Point

• Density, pH

• Composition

• Classification - GHS, EU R&S and CLP, NFPA, HMIS, SARA

• VOC

Request a list of products in SAP EHSM

Response with MSDSs and metadata for storage in SAP

Request a list of impacted products

Response with MSDS and metadata for storage in SAP

Initial Load

Data Updates

3E Central Repository

• Real Sub/MM ID

• MSDS/Supplier Cert

• Language


• Automating certain rules outside your company perimeter with VSDS data

– Supplier GHS Classifications and compositions but also:

• Seveso classifications

• Green score analytics

• Other reporting requirements

3E’s Cloud – New Rules

Product Level Data

ADM MM

ADM VSDS

ADM EHSAP


Demonstration



Global Scope Country Specific Requirements


SDS Other Certificates and Rules





3. Up-to-date Expert Rules/Templates/Phrases

• Dynamic SDS Content – Expert Rules

– Document Templates

– Multilingual Phrases

• Best Practices – Rules and Templates – Global scope with country specific variations

– Flexible and proactive application of changes

– User friendly tool to add/change rules

– Easy out-of-the box customizing options/settings

– Update Process


Global Scope

Americas

• US Federal and State

• Canada

• Mexico

• Brazil

• Uruguay

EU

• CLP

• DPD

• DPD to CLP Conversion

• Country specific

Asia Pacific

• Australia

• China

• Japan

• Korea

• Malaysia

• Singapore

• Taiwan

• Thailand

• New Zealand

Non-regional

• Inventory Status

• Formulation

• HNOC

• Global Conventions

• Generic GHS

Transport

• Classes 2, 3, 4, 5, 6.1, 8 and 9


Expert Rule Types

Classifications

Label elements

Hazardous ingredients

Reportable composition

Occupational Exposure limits

Country specific local regulations/Inventories

Ariel Rules Builder

Section 2

Section 3

Section 8

Section 15

Soft Sec. (4. 5, 6, 7, 8, 9, 10, 11)


Rules Builder: A User Friendly Tool to Author/Create Rules

Property Tree

Phrases

Rules Generat

or

.mdb files

.rul files

EHS Expert

SAP EHSM

-Value Assignments

-Inheritance Phrase

Assignment Content

Rules Generator

Rules Builder GUI

Benefits

• Easy to use interface

• Prepackaged content

• Allows extended automation


‘Out of the Box’ Customizing Options

• Rules:

– Ability to apply a regulatory classification for compliance with multiple countries’ GHS requirements

– Specify a threshold or disclosure limit where regulations are grey

– Take advantage of supplier classifications

– Add your own “soft section” content with the Ariel Rules Builder

• Templates:

– Apply logos and customer specific addresses


Ariel Multilingual Phrases

Thousands of distinct regulatory phrases as well as phrases used for the creation of (M)SDSs, including:

– Header and sub-header phrases

– Phrases for specific (M) SDS sections, e.g. First Aid

– GHS phrases (i.e. H and P statements, hazard classes and categories)

– Risk and safety phrases

– Titles of regulations

– Exposure Scenario (ES) phrases

The library has been used and tested by Ariel’s own in-house authoring experts and is provided in:

- 40+ languages and more than 10,000 phrases


SDS Multilingual Phrases

Arabic AR French FR Norwegian NO

Brazi l Portuguese 1P German DE Pol ish PL

Bulgarian BG Greek EL Portuguese PT

Canadian French 3F Hebrew HE Romanian RO

Chinese ZH Hungarian HU Russ ian RU

Chinese trad. ZF Icelandic IS Serbian SR

Croatian HR Indones ian ID Slovakian SK

Czech CS Ita l ian IT Slovenian SL

Danish DA Japanese JA Spanish ES

Dutch NL Korean KO Swedish SV

Engl ish EN Latvian LV Thai TH

Engl ish UK 6N Lithuanian LT Turkish TR

Estonian ET Malays ian MS Ukrainian UK

Finnish FI Mexican Spanish 1X Vietnamese VI

Hindi HI


Ariel SDS Templates

Regulatory Rules, Phrases and Templates


Current Templates Offering

Americas

• Canada

• Mexico

• Brazil

• Uruguay

• OSHA

EU

• CLP

Asia Pacific

• Australia

• China

• Japan

• Korea

• Malaysia

• Singapore

• Taiwan

• Thailand

• New Zealand

Generic GHS

• Arabic

• Non Arabic


Americas

• Mexico

– Norma Mexicana NMX-R-019-SCFI-2011 SISTEMA ARMONIZADO DE CLASIFICACION DE PELIGROS DE LOS PRODUCTOS QUIMICOS - GLOBALLY HARMONIZED SYSTEM (GHS)

• Canada

– Workplace Hazardous Materials Information System (WHMIS)

– Optional: OSHA HCS with Canadian additions (OEL, WHMIS, etc)

• Brazil

– ABNT NBR 147325-4: Chemicals - Information about safety, health and environment

• Uruguay

– Decree No. 307/009

– Decree No. 346/011

• OSHA

– OSHA Hazard Communication Standard Final Rule - 29 CFR 1910.1200


EU and Generic GHS

• CLP

– Annexes I and II to Regulation 453/2010/EU amending Regulation 1907/2006/EC (REACH)

• Generic GHS – UN (4th Revised Edition)


Asia Pacific

• New Zealand

– Code of Practice for the Preparation of Safety Data Sheets (HSNO CoP 8-1 09-06)

– Hazardous Substances (Classification) Regulations 2001

• Malaysia

– Notice of Industry Code of Practice on Chemical Classification and Hazard Communication (ICOP CHC) 2014 GAZETTE [P.U.(B) 128]

– Industry Code of Practice on Chemical Classification and Hazard Communication 2013 (ICOP)

• Australia

– Australia – Preparation of Safety Data Sheets for Hazardous Chemicals section 274 of Work Health and Safety Act (August 10, 2011)

• China

– GB 30000-2013 for Classification of Chemicals (replacing GB 20576 - GB 20602-2006)

• Korea

– MoEL amendment 2013-37 to the Standards for Classification and Labeling of Chemical Substances and Safety Data Sheets


Asia Pacific Continued

• Singapore – SS 586: 2008, as amended by 2014 Amendment No. 1, SS586: Part 3: 2008

• Taiwan

– MoL No. 10302007861 ; EPA No. 0980078120

• Japan – JIS Z 7253:2012

• Thailand – Ministry of Industry Notification Re: the Hazard Classification and Communication

System for Hazardous Substances (B.E. 2555)


Demonstration


3E Releases Quarterly

update notifications

Attend Quarterly

Update webinar and Review

Release Notes

Install Technical Update

Data Sync via ADM

Test Technical Update

Perform Impact Analysis in ADM

&

Load Data

Run Rules and Generate templates

Update Process for your System’s Content


Summary

• Regulatory requirements are constantly changing

• Product Stewardship teams are under pressure to produce accurate and extensive SDS documentation

• Applying best practices for:

- Regulatory and Scientific Data, Expert Rules, SDS Templates and Multilingual Phrase Management can help you stay on top of regulatory changes and ever increasing pressure to produce accurate SDSs


Thank you!