Product Stewardship

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

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

Shift from Product Safety Toward Sustainability

Hazard
Characterization

Communicate
Hazard

Customer
Safe Handling

Design Safer,
Environmentally
Preferable Products
Reduce
Environmental
Footprint

Product Safety Group

Product Safety

Proactive

Reactive

PS + BU + Customers
Product Stewardship

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

Sustainability

Pull

Push
The evolution from product safety to sustainability

Shift requires PSRA employees with sound product, organizational,

business and regulatory knowledge and excellent communication skills

Global Increase in Chemical Regulations

ACC, 2012

Proliferation of chemical regulations barrier to global market entry

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
Obtain
global regulatory
approvals and
registrations
for products
in support of
BU initiatives

Hazard
Communication
Develop and evaluate
hazard data needed
to protect human
health and
the environment.
Communicate
information
through MSDS
in a timely manner

Toxicology
Conduct safety
evaluations
of products to
support product
registrations
and hazard
assessment

Stewardship/
Sustainability
Proactively work
with R&D and
key stakeholders
to promote product
stewardship
and sustainable
development
throughout the
product lifecycle

Advocacy
Determine
the impact
of developing
regulations and
proactively work
to positively influence
regulatory outcomes

Cross Functional Effectiveness with Stakeholders is Essential

Product Stewardship Vocabulary

SDS

REACH

GHS
TSCA

DSL

EPA

Physical Hazard
Green chemistry
6

Product Stewardship

Customer
Inquires

Marketing
Claims &
Declarations

Recycling &
Take-back
programs

Global
Chemical &
Product
Safety
Regulations

Adverse Event
Recording
&
Response

Product
Stewardship
Product
Exposure &
Risk
Assessment

Product
Safety
Testing

Safety Data,
Sheets,
Labels, & Safe
Hangling
Instructions
Dangerous
Good
Transportation

Banned/
restricted
Substances
Management
Sustainable
Product
Design/
Development

The cross-functional nature of Product Stewardship requires collaboration between

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

Stewardship Along the Value Chain

Samples to
Customer

Manufacturing / Supply Chain

Commercialization

(incl Tolling / Distribution)

Change effect (Regulatory)

PSCF
AMA

Raw Materials

Product
Quality

Production
New Product
Development

New Process

= Rep Process Gaps

Warehousing &
Distribution

Customer

R&D

Ultimate
Consumer
Product use
Product life
Disposal
Ultimate Fate

Solid waste

TSCA
Inventory

Regulated Shipments

MSDS

Product

Packaging

Label
Hazard Info

& MSDS

Label
We Are All Product Stewards

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

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

Becoming more proactive/Develop creative

solutions

Potential for employee burnout

and/or retention issues

Become more integrated with BUs

Noncompliance/Fines

Leverage our database technology

Increase responsibilities to BU s/R&D/Man.

Inward focus decreases lack of

organizational effectiveness

Develop career paths

Immediate

LI0

MI2

HI7

Longer Term

TIMING

Risk Map

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?
To which function does your product stewardship
Also ~organization
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 FTEs 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 FTEs 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%

Other
1%

R&D
10%

Operations
14%
Legal
10%

24

Randy Deskin, Ph.D., DABT, ERT

Deskin Associates, LLC
Randy@Drdeskin.com
973-980-9332

25