Session No.

608-b

International Nanotechnology Law Governing Workplace

Exposures
Ilise L Feitshans, JD and ScM
Visiting Scientist
Institute for Work and Health
University of Lausanne
Lausanne, Switzerland

I. Nanotechnology: Redefining Workplace Safety

Nanotechnology s revolution for the global economy can also revolutionize public health,
especially occupational health, return-to-work rehabilitation, and the delivery of workplace
health services.
Sound occupational health programs that implement best strategies are the grease for
the machinery of powerful economic engines. Information provided through occupational
health programs helps employers survive because accidents and disease are not simply
expensive but wasteful. No one can afford waste in this economy. The fat to be trimmed,
however is not the same as the grease for the wheels and machinery that makes smooth
commerce. Using well- honed tools for in-house occupational health and safety compliance
systems therefore can save the life of marginal employers despite a difficult economy.
Since 2008, an increasing body of international expertise has agreed that
nanotechnology holds both great promise and unquantified, unknown major risks to workplace
health. In 2012, several international organizations began the first steps towards making a
harmonized system of nanotechnology regulation. This presentation outlines those basic steps.
Scientists and governments agree that the application of nanotechnology to commerce poses
important potential risks to human health and the environment, but the risks are unknown.
Examples of high level respected reports that express this concern include: the Swiss
Federation (Precautionary Matrix 2008),1 the Royal Commission on Environmental Pollution
(UK 2008),2 German Governmental science commission,3 Public testimony sought by USA
National Institute for Occupational Safety and Health (NIOSH, Feb 2011),4 the OECD
working group (since 2007) the World Health Organization,5 and several industrial groups, and
various non-governmental organizations. Yet, qualitative data to protect exposed people and
the greater ecological system that surrounds the human environment lags behind industrial use,
research and application of nanotechnology to consumer products.
Nanotechnology is expected to represent about three trillion dollars of USA GDP by

2015.
The sheer economic importance of nanotechnology will change several antiquated
systems regarding industrial processes, scientific understanding and categorization of
chemical informatics, and ultimately, the health care delivery systems that must use or correct
the end products of these changes anyway. Therefore, nanotechnologys arrival in commerce
provides an unprecedented excellent opportunity to change society for the better, especially
benefiting aging and disabled populations.

II. WHO Background paper for Draft Guidelines

WHOs PURPOSE: These Guidelines 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.

Fulfilling WHO's Own Commitment to Achieving UN Millennial Development Goals

Nanotechnology provides the perfect opportunity to correct long standing system problems in
the access, public awareness and delivery of services associated with public health. If applied
with forethought when rethinking these vital social values, two sets of benefits can be realized
by civilization at the same time: not as competing interests, but as one invaluable social
change.
WHO is a signatory to the UNMDGs, http://www.un.org/millenniumgoals. The
MDGs reflect an organization-wide consensus of political will to correct antiquated working
assumptions which in turn created long-standing systemic social problems. The UN itself has
determined that such long-standing embedded problems are rooted in sexism, racism and
economic inequalities. By definition, the UNMDGs embrace the needs of specific populations
whose stakeholder rights were not fairly reflected in the first generation of UN documents in
order to correct embedded systemic harms. Correcting such long established inequalities
requires a deliberate conscious effort by each and every UN agency, every time a new
programmatic effort is established. And, each program must prove it has met this test of
consciously correcting historic inequalities in order to gain approval by the greater UN
community. In this regard, WHO has undertaken to transfer technology not only concerning
basic medical needs, applied research and primary health care, but also advancing transfer of
State of the Art methods for understanding unquantified risk in any new technology, including
nanotechnology.
1. promoting sustainable development among low and medium-income countries;
2. deliberately creating a rightful space for instituting Gender Equity where there has been
none before, and
3. addressing the needs of aging workers, disabled workers and other vulnerable populations
by reducing the impact of health disparities that undermine public health.

Redefining workplace exposure tools and workers health constituents, and removing
embedded gender discrimination which creates health disparities between men and women in
the workplace and in society in general is a key development that will remain after
nanotechnologys tidal wave of economic and social change, and for embedding into
workplace infrastructures the UNMDGs.

UNMDGs: Gender Equality Promoting Reproductive Health

According to UN WOMEN, the agency of the UN Charged with promoting gender

equality, "Raising gender on the global development agenda", Posted on March 28 2012
the established method for achieving integrated implementation of the MDGs requires
application of "Four key principles" across the board in all UN programming and strategic
planning, including the development of Guidelines for risk management of public health: "1.
Equality: the goals need to be framed from an equality perspective and address biases and
discrimination based on gender, class, race, ethnicity, among other factors in order to reach
those that need it the most. 2.
Holistic and integrated: This requires strong multi-sectoral approaches and forms
of collaboration among actors in the social, economic and environment fields. 3.
Participatory and inclusive: the goals need to emerge from strong participation and
ownership at all levels: local, national, regional and global levels. Only when the process is
in the hands of the peopleboth women and menand their decision-makers, will there be
true ownership and accountability for the required progress and results. and 4.
Implementation: aligned with existing declarations and normative frameworks.
A fundamental gravamen of the powers delegated to WHO is the reality that the rights of
sovereigns to engage in international relations reciprocally embraces an obligation for
sovereigns to protect the health and well-being of their people. WHOs background paper
ignores these important conceptual underpinnings of legal protection for worker health, even
though these laws clearly support the rationale for its achieving goals. There is already plenty
of law: a cornucopia of statutes, conventions, treaties, regulations, municipal laws, national
protections written and the WHO Constitution itself support the justification for workplace
health protections. The Guidelines therefore should refer to instruments such as: The ILO
Constitution; ILO Conventions, OECD Good Laboratory Practices ("GLPs") and The
International Covenant on Economic, Social and Cultural Rights (ICESCR) weave an
international legal fabric protecting heal The preamble to the Guidelines and the rationale for
their implementation must clearly and convincingly articulate a profound understanding of the
significance of occupational health as a fundamental concern impacting the survival of all civil
society. Clearer language must be used, as part of a broader effort by WHO to demonstrate the
hands-on applicability of the Guidelines to all workers and all industrial or commercial users of
manufactured nanomaterials, once the Guidelines will have been finished. Achieving these
goals may ultimately determine whether the text of the Final Guidelines will be workable or
mere dreams.

Absence of Clear Justification for Protecting the Human Right to Health at Work

Unfortunately, the WHO Background paper failed to address the role of workplace safety
and health for protecting the health of society. The document also must use clear language to
convince readers of the overarching importance of occupational health for and inform them

about basic industrial hygiene and risk mitigation methods using clear plain text, in order to
justify the time, money and research resources that are dedicated to the implementation of the
Guidelines. This purpose is best achieved by underscoring the inextricable link between
work, health and the economic viability of any employer or corporate entity. The
stakeholder organizations participating in the Comment therefore objected to the narrow
rationale offered in the background paper, which overlooked societys inevitable need to
address occupational health problems in order to survive. Due to an almost myopic,
nineteenth century view of industrial hygiene and occupational health the Background paper
did not persuade readers of the importance of occupational health to the survival of
greater society, nor does it support the valid legal rationale for practical application of the
Committees work. "I. Introduction" to the Background document presents a platitudinal
concern for worker health, without making the case regarding its importance for all
stakeholders in civil society. But, the existing text does not emphasize the successful tools
already available, such as accreditation systems, nanosafety assessment consultants,"
elearning" and interactive video training that is the linchpin for the proper use of any
protection system for manufactured nanomaterials, or the importance of due diligence
documentation and internal audits on a cyclical basis, which are accepted building blocks for
effective risk mitigation.

Failure to Define Risk Mitigation

The term of art 'risk mitigation' is a result-oriented process designed to prevent, detect, report
and correct potentially dangerous conditions that can result in harm to human health or the
global environment. The degree of acceptable risk, the methods of risk assessment and the
measures of effectiveness for the same or similar hazards change in different circumstances.
Key building blocks for risk mitigation infra structures include : (1) Managerial
statements in writing, (2) Documentation of the components of the compliance infrastructure,
using internal audits; (3) in house communication including interactive video training and
web-based elearning; (4) two way communication that enables complaints about problems to
be recorded with response in a timely manner, using hotlines in -house newsletters and
intranet ; (5) Documented ongoing interaction with regulators and stakeholders.
The stakeholders commenting on the Background paper objected to the use of the term
"risk mitigation" without providing a definition at the outset of the section. The absence of a
definition impedes use of the Guidelines by novices, including but not limited to workers,
their families, small enterprises and the general public who may have the desire to
implement the Guidelines but may have no clue about standard industrial hygiene methods
for reducing risk in the workplace or risk assessment. In light of the UMDGs, WHO must
expand the scope of topics covered within the parameters of "Risk Mitigation" thereby
making accessible key facets of corporate compliance successes, using tools including but
not limited to Due Diligence, Commitment from Management, In-house Communication
through newsletters and hotlines, maximizing global access and use of interactive videos and
online "elearning" for worker training, embracing the needs of aging workers, disabled
workers, women and reducing the expensive global disease burden.

III. Council of Europe Steps Towards a Study Commission

In 2012, the Council of Europe (CoE) Parliamentary Assembly began the first steps towards
nanotechnology regulation with a view to respecting the scientific precautionary principles.
The CoE is the health and human rights vanguard for law governing the right to health, public
health and consumer protection throughout Europe, and its human rights court has remained a
leading model for jurisprudence throughout the world. The CoE has 47 (forty seven) Member
nations. Its jurisdiction therefore embraces 800 million people. Switzerland is a member of
the CoE, as is Greece. The human rights voice of the Council of Europe differs in its
emphasis and force from the European Union.
The CoE expert report, Nanotechnology: balancing benefits and risks to public health
and the environment http://www.assembly.coe.int/Communication/Asocdoc27rev_2012.pdf
was enthusiastically accepted at the CoE meeting of the Committee on Social Affairs, Health
and Sustainable Development in Moscow, Russian Federation on November 19, 2012. and
was debated before the entire Council of Europe Parliamentary Assembly in Strasbourg
France, on or before April 26, 2013.
The report is an essential part of understanding the future public discourse concerning
nanosafety for three reasons:
1. First, the report was praised because of its excellent synthesis of leading issues in
nanotechnology regulation confronting all civil society, including but not limited to bioethics
issues, impact on human and non-human health, environmental impact ant the promising
impact of nanomedicine for improving quality of life.
2. Second, the CoE is using the report as one of several resources for determining which path
it will follow regarding possible treaties or international agreements governing the use and
monitoring of nanotechnology, in its view correcting what EU regulations ignore.
3. Third, CoE legal instruments frequently are the basis of juridical determinations in the Court
of Human rights and serve as influential models for the entire world.

IV. Conclusions
The protection and promotion of the health and welfare of its citizens is considered to be one of
the most important functions of the modern state."5 It is not surprising therefore that,
throughout history, precautionary principles of science have been embedded into laws and
public health policies, both within specific nations and across international borders. This
universal responsibility to protect people by applying scientific principles of precaution within
governance explains the birth and global acceptance of WHO itself, and is a guiding star for
the work of the Council of Europe, too.

Endnotes
1. Swiss National Science Foundation, Opportunities and Risks of Nanomaterials
Implementation
2. Plan of the National Research Programme NRP 64 Berne, 6 October 2009, Swiss Federal

Office of Public Health (FOPH) and Federal Office for the Environment (FOEN)
Guidelines on the Precautionary Matrix for Synthetic Nanomaterials Version 1.0 Berne
2008. http://www.bag.admin.ch/themen/chemikalien/00228/00510/05626/index.html?lang=en
suva.ch/webshop/4D/4D212E53C9BB06F0E10080000A630358.pdf Aufgrund der
aktuellen Datenlage knnen folgende Richtwerte formuliert werden:
Kohlenstoffnanorhrchen und -fasern (Lnge ber 5 m, Durchmesser weniger als 3 m,
Lnge - zu Durchmesser - Verhltnis von ber 3:1): 0.01 Fasern/ml; dieser Wert entspricht
dem Grenzwert fr lungengngige Asbestfasern.
3. Chairman: Sir John Lawton CBE, FRS Royal Commission on Environmental Pollution,
Twenty-seventh report: Novel Materials in the Environment: The case of
nanotechnology. Presented to Parliament by Command of Her Majesty November 2008.
4. SRU, German Advisory Council on Environment, Special Report "Precautionary
strategies for managing nanomaterials Sept 2011. The German Advisory Council on the
Environment (SRU) is empowered by the German government to make
"recommendations for a responsible and precautionary development of this new
technology.
5. Legal basis and justification: Niosh recommendations preventing risk from carbon
nanotubes and nanofibers post- hearing comments Niosh current intelligence bulletin:
occupational exposure to carbon nanotubes and nanofibers Docket NO. NIOSH-161
Revised 18 February 2011; Testimony on behalf of ISRA (International Safety Resources
Association) Before NIOSH, USA. Comments prepared by Ilise L Feitshans JD and
ScM, Geneva, Switzerland. Testimony presented by Jay Feitshans, Science Policy
Analyst; ISRA Draft Document for Public Review and Comment NIOSH Current
Intelligence Bulletin: Occupational Exposure to Carbon Nanotubes and
Nanofibers, Docket Number NIOSH-161-A.
6. Ilise L Feitshans, The Work, Health and Survival Project, (WHS) including: International
Safety Resources Association (ISRA), Fullerton California, Earth Focus Foundation,
Geneva Switzerland, Digital 2000 Productions, Stafford Texas USA, Donald H. Ewert, IH,
VP-Field Services nanoTox, Inc. and Director, Field Services Assured Nano Dr Gustav
Grob, and International Sustainable Energy Organization (ISEO) Geneva, Switzerland
Comments on WHO Guidelines on "Protecting Workers from Potential Risks of
Manufactured Nanomaterials" (WHO/NANOH), (Background paper) 2011 Draft,
comments presented March 2012.

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