DEBATE: Can product stewardship replace regulation? Case nanomaterials Presentation: David Warheit, Technical Fellow − Toxicology and Risk Assessment, The Chemours Company, US

1. Helsinki Chemicals Forum Debate:
Can product stewardship replace regulations?
Case nanomaterials
David B. Warheit, Ph.D.
Chemours Company
Wilmington, Delaware, USA
Helsinki Chemicals Forum
June 15, 2018

2. Product Stewardship – Responsible Care®
• Product stewardship provides the platform for companies to identify
risks at an early stage and manage those risks along the value chain,
thereby enabling adequate protection of human health and the
environment.
• Product stewardship is an important pillar of Responsible Care®

3. Product Stewardship – Responsible Care®
• Responsible Care®–covers all products including nanomaterials
• Responsible Care is self administered – and many companies do third-
party audits to evaluate compliance
• Many nanoscale materials have been in commerce for decades and
have a huge database behind them (fumed silica, carbon black, etc.)

4. Evaluate
Risks
Profile
Lifecycle(s)
Exposure
Hazards
Properties
Assess
Risk Mgmt
Decide,
Document
&
Act
Describe
Material
&
Application
Review
&
Adapt
Iterate
Assess, prioritize & generate data
PS –DuPont/EDF Nano Risk Framework (2007)
ISO/TC 229 TR 13121:2011

5. Hazard Base Set – Guidelines and Methods
• Pulmonary Bioassay + full histopathology + NM Characterization –
BALF + BrdU + histopath
• Skin Irritation Test – OECD 404
• Skin Sensitization – LLNA- OECD 429
• Acute Oral Toxicity Test – OECD 425
• Eye Irritation Test – OECD 405
• Genotoxicity Tests (2) - Ames – OECD 471 Chromosomal Ab Study –
OECD 473
• Aquatic Battery (3) - Rainbow Trout – OECD 203; Daphnid –OECD 202;
Green Algae – OECD 201

6. Physicochemical Characterization of Ultrafine TiO2 Particles
Sample
Crystalline
phase
Median size and
width distribution
(nm)
Surface
area
(m2/g)
pH
Chemical
reactivity
in water* in PBS
deionized
water
in
PBS
delta b*
F-1 rutile
382.0
± 36%
2667.2
± 35%
5.8 7.49 6.75 0.4
uf-1 rutile
136.0
± 35%
2144.3
± 45%
18.2 5.64 6.78 10.1
uf-2 rutile
149.4
± 50%
2890.7
± 31%
35.7 7.14 6.78 1.2
uf-3
80/20
anatase/
rutile
129.4
± 44%
2691.7
± 31%
53.0 3.28 6.70 23.8

7. OECD Working Party on Manufactured Nanomaterials
(WPMN) Sub-groups
• SG-Risk Assessment and Regulatory Programmes
• SG-Testing and Assessment
• SG-Exposure Measurements and Mitigation
• SG-Environmental Sustainable Use

8. 8
Nanotechnology: Delivering on the Promise
It is a SHARED Responsibility
Working Together
Company
Strategy and
Commitment
Effective
Collaborations
Proportional
Regulatory
Actions