Nanomaterials: From Science to Regulation...10% TiO2 90% Fe2O3 100% SiO2 80 nm 3% TiO2 97% Fe2O3 100% SiO2 NM 1 NM 2. Tobias Walser for PEA Lecture | May 9, 2017 | 11 Robust Study

| |

Change picture: Select picture – right click – change picture

Prospective Environmental Assessment / May 9, 2017

Nanomaterials: From Science to Regulation

Tobias Walser, PhD

| |

Describing Physical Chemical Properties and Applications

Understanding Regulatory Challenges

Critically evaluating RA and LCA

May 9, 2017 Tobias Walser for PEA Lecture 2

Learning Goals

NANOMATERIALS

| |

- At least one dimension <100 nm

Virus: 100 nm

Width of DNA: 2.5 nm

Aspirin molecule: 1 nm

- Changing properties in comparison with bulk material

- Commercialized and regulated

Tobias Walser for PEA Lecture 3

Physical Chemical Properties of Nanomaterials

Walser et al., Nature Nanotechnology, 2012

May 9, 2017

| |

- At least one dimension <100 nm

Virus: 100 nm

Width of DNA: 2.5 nm

Aspirin molecule: 1 nm

- Changing properties in comparison with bulk material

- Commercialized and regulated

Tobias Walser for PEA Lecture 4

Physical Chemical Properties of Nanomaterials

May 9, 2017

| |

Nano – Surface Principle

Ø [μm] A [μm²] V [μm³] Number [N]* A [μm²]*

1 3.1425000 0,523625000 1 3.143

0.1 0.0314250 0,000523625 1,000 31.425

0.01 0.0003143 0,000000524 1,000,000 314.250

* Based on the same mass

Tobias Walser for PEA Lecture 5 May 9, 2017

| |

Nano – Transport Principle

Passive (e.g. diffusion)

Geiser et al.; Env. H. Persp. 2005: 13 (11 )

1 µm 200 nm 78 nm

Active (e.g. caveoli)


| |

Nano – Material Principle

Xia et al. (2009) Annu. Rev. Public Health 30: 137-150


| | May 9, 2017 Tobias Walser for PEA Lecture 8

Different Nanoforms: Morphology

US EPA 2013


Different Nanoforms: Chemistry

• Uncoated nanomaterials

consisting of different

substances

• Coated nanomaterials with

sealed or permeable

surface

• Aggregates or

agglomerates of different

nanomaterials


Different Nanoforms: Proposal für Regulation

Fiber Paradigm for 1 dimension

> 5 µm

Chemical composition Size distribution Shape

Coating or

Functionalization

n

Core Material

2.5 < C ≤ 10%

10 < C ≤ 25%

25 < C ≤ 100%

C ≤ 2.5%

2.5 < C ≤ 10%

10 < C ≤ 25%

25 < C ≤ 100% Sphere

Tube Rod

Plate

Wide or narrow

21 < S ≤ 500 nm

1 < S ≤ 20 nm

C ≤ 2.5%

* Walser and Studer (2015): Sameness: The regulatory crux with nanomaterial identity

and grouping schemes for hazard assessment. Reg.Tox.Pharm (72): 569–571

65

nm

10% TiO290% Fe2O3

100% SiO2

80

nm

3% TiO297% Fe2O3

100% SiO2

NM 1 NM 2


Robust Study Summaries: Requested Parameters

Chemical

composition (incl.

crystalline structure)

Impurities

Surface chemistry

Size

Shape

Surface area

Solubility (rate)

Dispersibility

Dustiness

Biological reactivity

(e.g. ROS formation)

Photoreactivity

Stability in storage

Rigidity for fibers


Take a stakeholder perspective!

Département fédéral de l’Intérieur DFI

Office fédéral de la santé publique OFSP

Domaine de direction Protection des consommateurs

Case: A new nanoenabled

product that measures body

parameters continuously. Ready

for market entrance.

Authority Producer/Importer Consumer

LCA Expert

Prerequisites

for product

acceptance?

Motivation to

put product on

the market?

Criteria for

buying the

product?

What do I need to

know in order to

complete my LCA?

| |

Nanomaterials and their applications should be safe for human health and the

environment

Regulation need to be adequate and up to date

Avoid market distortions

In contrast to the the clearly defined molecular structure of chemicals, additional

material properties influence the hazard profile of nanomaterials

Similar nanomaterials could be grouped together

…


Nanomaterials in Products: Regulators View

| |

High performance products

First mover effect

Making money

Generating value for customer

Minimizing liability, complying with regulation with low costs and clear rules

Nanomaterials are chemicals and should be assessed as such

…


Nanomaterials in Products: Industry View

| |

Nanoeffect is perceived positively, product performance is ok

The nanoenabled product is of high quality and long durability

The product should not harm the environment and human health

The product is affordable

…


Nanomaterials in Products: Society View

| |

What is the emission rate of nanomaterials from consumer products

Which properties influence the environmental fate and hazard of nanomaterials?

How many (and which cohort) people are exposed?

What are the modes of toxic action at the target organism (ecosphere,

anthroposphere)?

What is the environmental / human health performance in comparison to similar

products (full life cycle inventory)

…


Nanomaterials in Products: Scientific View (LCA perspective)


Considerations for LCA and RA of Nanomaterials

Emitted

amount?

Fate, aging? Bioavailability, mode of toxic

action?

Acute, chronic toxicity

Environmental and human

exposure

Nanomaterials in

products

| | 18

In contrast to LCA, Risk Assessment is used for Regulatory

Assessments of Chemicals

Appendix 4: Recommendations for nanomaterials applicable to the Guidance on Registration, Draft Public Version, May 2016

Appendix R.6-1: Recommendations for nanomaterials applicable to the Guidance on QSARs and Grouping, Draft Public Version, May

2016

A variety of tools are available to guide industry through the registration process (Europe: European Chemicals Agency ECHA)

Data provider is industry (Safety Dossier). At the same time they are responsible for classification, labelling and packaging (CLP) of the chemical.

Nanomaterials:The same aspects as conventional chemicals plus nanospecific

Exposure pathways

Altered behaviour in the environment and the human body

Higher surface activity

Mode of actions

Tobias Walser for PEA Lecture May 9, 2017


Combined use of LCA and RA for Nanomaterials

adapted from Walser et al. 2017 (Environmental Impact Assessment Review Volume 65, July 2017, Pages 156–163)


Comparison of RA and LCA: possible solution

Time

span

Geographic

specificity

Population

or individual

impact?

Data

demand

Granularity

of data

Informative value

for regulators

Regulatory use

LCA Integrated Rather

generic

(sub-)

population

impact

Low to

high, LCA

practitioner

decides

coarse Rather low, expert

knowledge needed

Low, but slowly

developing

RA Specific

point in

time

Rather

specific

Individual

health risk

Rather

high,

tonnage

and hazard

triggered

fine Rather high, fixed

trigger points Fully implemented


Using the Strenghts of LCA and RA for Chemical Assessment

3 products, each releasing nanomaterials. Industry perspective vs. perspective of regulators

How to estimate the «true exposure»?




3 products, each releasing nanomaterials. Industry perspective vs. perspective of regulators

Lowering the impact of all products equally? Or focusing on the «worst»?






Anticipating the Future with a present model fed with old data

2017 2027

Inventory data

Fate models

?

Toxicity data

• Be transparent, report assumptions and uncertainties

• Be agile, and adapt to changes and new knowledge

| |

[email protected]

Documents

Nanomaterials: From Science to Regulation...10% TiO2 90% Fe2O3 100% SiO2 80 nm 3% TiO2 97% Fe2O3 100% SiO2 NM 1 NM 2. Tobias Walser for PEA Lecture | May 9, 2017 | 11 Robust Study