Product Stewardship

Management
Systems
Randy Deskin, Ph.D., DABT, ERT
Deskin Associates, LLC

1
Product Safety to Stewardship - Evolution

Scope and complexity of Global Regulations Exploding

Transition from Product Safety to Product Stewardship greatly broadened the

scope of knowledge required

Cross Functional Effectiveness – complexity increased greatly

This evolution has created the need for a highly skilled PSRA organization

Governance- greater need for transparency

Greater involvement of value stream- up and down

Heightened public awareness of chemicals by public

Greater pressure to regulate and ban chemicals

2
Shift from Product Safety Toward Sustainability
Design Safer,
Environmentally
Hazard Communicate Customer Preferable Products
Characterization Hazard Safe Handling
Reduce
Environmental
Footprint
Product Safety Group
Product Safety

PS + BU + Customers
Reactive

Proactive
Product Stewardship

PS + BU + R&D +MFG + Customers + Stakeholders

Sustainability

Push Pull
The evolution from product safety to sustainability

Shift requires PSRA employees with sound product, organizational,

business and regulatory knowledge and excellent communication skills

3
Global Increase in Chemical Regulations

ACC, 2012

Proliferation of chemical regulations – barrier to global market entry

4
 Product Stewardship

To promote the protection of human health and

the environment and to ensure global product
regulatory compliance and safe handling of
products in a cost effective manner.
We all need to be “Product Stewards”

Regulatory Hazard Toxicology Stewardship/ Advocacy

Obtain Communication Conduct safety Sustainability Determine
global regulatory Develop and evaluate evaluations Proactively work the impact
approvals and hazard data needed of products to with R&D and of developing
registrations to protect human support product key stakeholders regulations and
for products health and registrations to promote product proactively work
in support of the environment. and hazard stewardship to positively influence
BU initiatives Communicate assessment and sustainable regulatory outcomes
information development
through MSDS throughout the
in a timely manner product lifecycle

Cross Functional Effectiveness with Stakeholders is Essential

5
 Product Stewardship Vocabulary
REACH
GHS DSL
SDS

EPA
TSCA
Physical Hazard
Green chemistry
6
Product Stewardship
Global Adverse Event
Chemical & Recording
Product &
Safety Safety Data,
Response Sheets,
Regulations
Customer Labels, & Safe
Inquires Hangling
Instructions

Marketing Dangerous
Claims & Product Good
Transportation
Declarations
Stewardship
Banned/
Recycling &
restricted
Take-back
Substances
programs
Product Sustainable Management
Exposure & Product
Risk Product Design/
Assessment Safety Development
Testing

The cross-functional nature of Product Stewardship requires collaboration between

all functional groups within an organization (Product Stewardship Society, 2014)

7
 Stewardship Along the Value Chain
Manufacturing / Supply Chain
R&D (incl Tolling / Distribution)
Commercialization
Samples to Change effect (Regulatory)
Customer

Customer
Ultimate
PSCF Product Consumer
Raw Materials
AMA Quality Product use
Production Product life
Disposal
Ultimate Fate
New Product
Development

New Process
Warehousing &
Distribution ø Solid waste
TSCA

Inventory Regulated Shipments Label

ø= Rep Process Gaps ø MSDS Product Packaging

Hazard Info
& MSDS

Label
We Are All Product Stewards

8
SWOT Analysis Organization
Strengths (Competencies)
Knowledge of regulations & company
products
Experience & institutional knowledge
Efficient work processes (e.g., global issues
handled in one place; centralized)
Proficient problem solving
Strong network of outside resources
Core group of dedicated, hardworking
professionals
Opportunities
Becoming more proactive/Develop creative
solutions
Become more integrated with BUs
Leverage our database technology
Increase responsibilities to BU s/R&D/Man.
Develop career paths
Weaknesses
Lack of resources, bench strength
& capacity; little redundancy
Lack of employee career path
and growth opportunities, Lack of
succession planning
Trend towards being reactive
Inward focus, lack of continuous
communication with BU s/R&D/Man.
Lack of integration with BU X
Threats
Potential for employee burnout
and/or retention issues
Noncompliance/Fines
Inward focus decreases lack of
organizational effectiveness
9
Risk Map

Immediate

LI0 MI2 HI7

TIMING

Longer Term

LL8 ML3 HL0

LOW MEDIUM HIGH

PRIORITY

10
Representative RACI(X)

11
12
Product Stewardship Core Competencies
by Function

13
Questionnaire

1. Company

Total annual sales (USD)

Geographic breakdown of sales by region or country (percent)
Number of manufacturing facilities and their geographic distribution by
region or country
Number of major R&D centers and their geographic distribution by region
or country
Approximate number of active products irrespective of grade
or packaging

14
Questionnaire EACH and GHS Biggest issues
2. PS Organizational Model

What are the biggest challenges you are facing in the product stewardship
area?
What are the total number of FTE's engaged in Product Stewardship in
your company?
Also ~organization
To which function does your product stewardship 4 FTE/ Breport?
$ 1 Sales
Do you use a centralized or decentralized model? Please describe
Do you use a regional or a global organization model? Please describe
Do you hire PS professionals from within and train or do you hire
externally?
On average, how long does it take to hire product stewardship talent?
What are the key Core Competencies you seek in new talent?

15
Questionnaire

3. Product Regulatory Compliance (focuses on the control

of chemical substance manufacturing, importing and sales
excluding REACH and Hazard Communication)
How many full-time equivalent (FTE) product regulatory compliance specialists
do you employ internally ?
What is the geographic distribution of your product regulatory compliance
specialists and how is their work or areas of specialization allocated?
What are the educational backgrounds of your product regulatory compliance
specialists? Do they have any certifications?
Do your specialists receive on-going regulatory training or participate in trade
associates to stay current?
Global organizational models
with centralized PSRA

16
Questionnaire

3. Product Regulatory Compliance (focuses on the control

of chemical substance manufacturing, importing and sales
excluding REACH and Hazard Communication)
What is their range of years’ experience in product regulatory compliance?
Range of years’ tenure with your company?
Do you outsource any of your product regulatory compliance work?
If so, what type of work and at what approximate annual spend?
What specific types of registrations are your product regulatory compliance
special responsible for? Approximately how many do they obtain per year
on average? How many are they currently working on?
Do your product regulatory compliance specialists routinely response to
customer or business unit requests for regulatory information? If so,
approximately how many information requests do they respond to per year?

2 to 30 years of experience

17
Questionnaire Majority of REACH specialists
located in the EU
4. Reach
How many full-time equivalent (FTE) REACH specialists do you employ
internally?
Where are your REACH specialists physically located?
What are the educational backgrounds of your REACH specialists?
Do they have any certifications?
Do your REACH specialists receive on-going regulatory training or participate
in trade associates to stay current?
What is their range of years’ experience in REACH? Range of years’ tenure
with your company?
Do you outsource any of your REACH work? If so, what type of work and
at what approximate annual spend?
What is your approximate number of Tier 4 chemical substances
(2018 registrations)?

18
Questionnaire

5. Hazard Communication (Safety Data Sheets (SDS) and Labeling)

How many full-time equivalent (FTE) hazard communication specialists
do you employ internally to author SDS?

What is the geographic distribution of your hazard communication specialists

and how is their work allocated? Is their SDS authoring work is done on
a regional or global basis, i.e., do author based in the US only author
US format SDS or do they author for all formats?

What are the educational backgrounds of your hazard communication

specialists? Do they have any certifications?

Do your specialists receive on-going regulatory training or participate in

trade associates to stay current?

On the job training/experience

to B.S. degree

19
Questionnaire 1 to 35 years of experience;
median 5 to 10 years
5. Hazard Communication (Safety Data Sheets (SDS) and Labeling)
What is their range of years’ experience in hazard communication?
Range of years’ tenure with your company?

To what degree in FTE’s are they supported by specialists from outside

the hazard communication group, e.g., toxicology, industrial hygiene,
environmental, chemical control, etc.?

How many FTEs of non-professional level support are within the hazard
communication group?

How many FTEs of technical IT type support from outside the hazard
communication group do you rely on to use and maintain your hazard
communication database system

Do you outsource any of your SDS preparation? If so, approximately how

many SDS per year and at what cost?

20
Questionnaire Most companies ~ 30 formats
and 20- 30 languages
5. Hazard Communication (Safety Data Sheets (SDS) and Labeling)
How many different format SDS do you maintain? How many languages?

How many active SDS do you have (counting all formats and language
variations)?

Approximately how many SDS do you publish per year?

What is your average turnaround time to author a single format/language

SDS for a new formulation? For an urgent “rush” request?

Of your active formulations, what is the approximate ratio of substances

versus mixtures?

What database system or other methods do you use to prepare and maintain
SDS and labels?

21
Questionnaire

6. Toxicology

How many full-time equivalent (FTE) toxicologists do you employ internally?

Where are your toxicologists physically located?
What are the educational backgrounds of your toxicologists? Do they have
any certifications?
Do your toxicologist receive on-going training or participate in trade
associations to stay current?
What is their range of years’ experience in industry? Range of years’ tenure
with your company?
Do you outsource any of your toxicology work? If so, what type of work and
at what approximate annual spend?
How many REACH registrations are your toxicologists currently working on?

10 to 30 years experience

22
Product Stewardship Organization Questionnaire
Benchmarking Major Takeaways

All have multi-national businesses and thousands of products

REACH and GHS appear to be a common major challenge for most
respondents
Total number of FTE’s appear somewhat comparable commensurate
with company size- 20 FTE/ B $5 Sales
Most respondents have some degree of a global organizational
model with centralized common work processes
Various core competencies sought by the respondents but almost all
included technical skills.
All respondents except one mostly allocated resources into
the discrete functional areas of Product Regulatory Compliance,
Hazard Communication, Toxicology and REACH with minimal overlap.
Respondents seemed to favor hiring from within.
Experience ranges varied widely across the respondents but almost
all included highly experienced staff in each functional area.

23
Reporting Structure of PSRA Organizations

EH&S
60%

Operations
R&D 14%
Other 10% Legal
1% 10%

24
Randy Deskin, Ph.D., DABT, ERT
Deskin Associates, LLC
Randy@Drdeskin.com
973-980-9332

25