NANOTECHNOLOGY LAW

FOR COMMERCIALIZATION OF
NANO-ENABLED PRODUCTS
DR. ILISE L FEITSHANS
JD and SCM (PUBLIC HEALTH)and DIR (INTERNATIONAL RELATIONS)
FELLOW IN INTERNATIONAL LAW OF NANOTECHNOLOGY
EUROPEAN SCIENTIFIC INSTITUTE
ARCHAMPS FRANCE
INVITED PROFESSOR ISTERRE UNIVERSITY OF GRENOBLE FRANCE
EXECUTIVE DIRECTOR THE WORK HEALTH AND SURVIVIAL PROJECT
WHS-PROJECT.ORG
AUTHOR GLOBAL HEALTH IMPACTS OF NANOTECHNOLOGY LAW
THE TIME HAS ARRIVED
TO BRIDGE SCIENCE FROM THE LAB &

Alimentation, construction et…

LAW FROM CIVIL SOCIETY
FOR COMMERCIALIZATION OF
******************* NANO-ENABLED PRODUCTS
Working assumpton
Nanotechnology’s
revolution for
commerce will
revolutionize public
health
The DEBATE TEN YEARS AGO WAS….

SHOULD WE REGULATE NANOTECHNOLOGIES?

when decisionmakers who have little time
and know little about the subject include
published research results in their findings to
justify policy decisions?………………………………….
Debate is over…
nanoregulations and
new laws cover our planet
 Objectives
A Where the law is now

➲ B. Where is the law going?

C. New laws that bridge lab to market

Encourage you to have your say!

 Defining the Issue
Nanotechnology and Risk
 Nanotechnology - The Challenge

Does the nature of engineered

nanostructured materials and
devices present new safety and
health risks?
How can the benefits of
nanotechnology be realized while
proactively minimizing the
potential risk?
 WHAT
QUESTIONS?
 1. NANO definitions

 What is nanotechnology?

 What is a nanoparticle?

 (ethically or under law, for the purposes of

applying a community standard fo action or care
 For the purposes of applying that standard in face
of risk
 WHAT
QUESTIONS?
 2. Should there be strict liability for

 using nanomaterials?

 To prevent harm to human health?

 Impact on global burden of disease

 WHAT
QUESTIONS?
 3. Is worker health

 consistent with
 Or
 competing with

 Environmental protection?
 WHAT QUESTIONS?

How
 Does society strike the balance
 Liability or immunity?
 Stakeholders
 Civil society and consumers?
 Emerging Laws
of Nanotechnology

UN General Assembly, New York City, Aug 2006, passing the UN Convention
on the Prevention of Discrimination Against Persons With Disabilities.

What is the future for a UN Convention on nanotechnology?

Dr John Howard, MD JD MPH LLM, Director of NIOSH, the
National Institute for Occupational Safety and Health

“...these laws..

Are here to stay”

  OECD
WHO  WHO
Is doing or influencing nano law?
 ISO… not a government
 European Union
Some
KEY  USA
PLAYERS
 China
 South Africa
 India
 NATO 14

 Think tanks
 IN EUROPE.........
REACH - UNIFIED system for new & existing chemicals
in the EU • Registration of: • substances ≥ 1 tonne/yr (staggered
deadlines) manufactured and/or imported • information/communication
up and down the supply chain • Evaluation - of substances and
individual dossiers • Authorisation – before a substance can be used or
“placed on the market” • Restrictions – banning specific chemicals
• REACH DOES NOT REACH nanomaterials •
 BUT IT WILL IN JANUARY 2020!

Current ECHA Guidance for nanomaterials •

Registrant needs to demonstrate the safe use of
its substance including its (nano)forms
Numerous of potential nanoforms exist
depending on modifications that may influence
hazard properties such as e.g. surface
treatments, shape and size
 IS NANOTECHNOLOGY COVERED UNDER
EUROPEAN FOOD SAFETY LAWS?
European Food Safety Authority
Published May 2018
Guidance on risk assessment of the application of
nanoscience and nanotechnologies in the food and feed
chain: Part 1, human and animal health

The text covers the application areas within EFSA’s

remit, e.g. novel foods, food contact materials,
food/feed additives and pesticides.

Statutory test for whether a material is actually a

nanomaterial: Use of nanosilver in transport along the
food chain has been called into question because the
science of whether it is ingested or otherwise enters
food for humans, livestock or feed for animals has not
yet been clarified
 European Legislation (EU)
27 countries

 Collective will
Political will

Legislature exercises power

Does Europe speak with one voice?

 Yes twice !!
–European Union
–Council of Europe
 Council of Europe (COE)

47 countries

The Council of Ministers

The Parliamentary Assembly
The Congress
The Conference of International NGOs
The European Court of Human Rights
 Stepwise self-enforcing laws
stepwise analysis offers adaptive regulation
where risks remain largely unknown
Flexibility ... requires the endusers
themselves to engage in testing.
Self-examination with candor is the heart of
stepwise analysis, because enforcement
penalties are typically quite high if the
analysis is wrong.
… not so simple!
 REVISION OF THE INFAMOUS TSCA

Everyone was so happy when the USA revised the

Toxic Substances Control Act of 1970 in 2016... it
does not specifically mention nanomaterials.. but
it describes activities that involve manufacturing
nanomaterials

Limbo... what is covered? Is copnsequently

unknown and unclear ... and expensive to find out
in the wake of litigation about nanosilver during
three years .
 Stepwise…step carefully!

one false or incorrect evaluation can ruin all

the subsequent analysis... thus strong
incentive to test accurately
Protects trade secrets
without disclosing their ingredients or process
 Stepwise but step carefully
➲ Problems limiting stepwise analysis

➲ Burden is on the regulated entity

➲ You must get it right but what if you havent
the resources... SME
➲ Or Nanotechnology has too much scientific
uncertainty
➲ No statutory limit on expense of hazardous
waste disposal
➲Example USA RCRA
➲Hazardous waste –generator makes the determination– are your
silver nanowires hazardous even though in a miniscule quantity?
➲Different statutes different steps.. may ask very different
questions and the burden is on the regulated entity to show why
the tests should not be done
➲Expense may not matter to the regulator!

➲Toxic characteristic NOT quantity

CASE EXAMPLE: SILVER

NANOWIRES..ARE THEY
HAZARDOUS WASTE?
 WHO Guidelines
a promise… temporary
to be rewritten in 2022
The big news for people who apply the final Guidelines is one
message: use the Global System for Harmonization of Chemical
Safety (GHS) methods of Classification and Labelling of Chemicals,
and then, using the authorized safety data sheets (SDS) disclose
potential harm from workplace exposure to nanomaterials.
The Guidelines Development Group (GDG) stated that its scope and
purpose included prioritization and classification of hazards posed by
MNMs.“The GDG recommends updating safety data sheets with
MNM-specific hazard information or indicating which toxicological
end-points did not have adequate testing available including
respirable fibres and granular biopersistent particles’ groups”.
WHO Guidelines for “Protecting Workers from Potential Risks
of Manufactured Nanomaterials”

The World Health Assembly identified exposure to nanomaterials

as a priority action for the Global Plan of Action on Workers Health
adopted in 2007, and the World Health Organization (WHO) global
network of collaborating centers in occupational health has
selected this field as one of key focus of its activity: guidelines for
"Protecting Workers from Potential Risks of Manufactured
Nanomaterials."

purpose “ aim to facilitate improvements in occupational health and

safety of workers potentially exposed to nanomaterials in a broad
range of manufacturing and social environments. The guidelines
will incorporate elements of risk assessment and risk management
and contextual issues. They will provide recommendations to
improve occupational safety and protect the health of workers using
nanomaterials in all countries and especially in low and medium-
income countries”
 Pathbreaking precautionary
principles operationalized
Unprecedented
***No specific link between
workplace exposure
And ANY known harm

Pre-emptory strike
Established reasonable safe
procedures
No guarantees
WHO has NO Enforcement
POWER! And no inspectors..
 Emerging Laws
of Nanotechnology

UN General Assembly, New York City, Aug 2006, passing the UN Convention
on the Prevention of Discrimination Against Persons With Disabilities.

What is the future for a UN Convention on nanotechnology?

Nanotechnology’s revolution
for commerce can
revolutionize public health
 THANK YOU!!!
Merci grazie gracias
toda riba spasiba
efkadisto
Dr. Ilise L. Feitshans JD & ScM and DIR
BRINGING HEALTH TO WORK
 DESIGNING AN EFFECTIVE OSHA COMPLIANCE
PROGRAM
GLOBAL HEALTH IMPACTS OF
NANOTECHNOLOGY LAW
ilise.feitshans@gmail.com
Whatsapp 917 239 9960 Swiss 41 79 836 3965