Chemical Industry Perspectives and Activities Food Products Association “Members Only” Workshop Food Nanomaterials: Regulatory and Policy Insights Washington, D.C. September 18, 2006 Terry L Medley, Global Director Corporate Regulatory Affairs
Chemical Industry Perspectives and Activities
Food Products Association “Members Only” Workshop
Food Nanomaterials: Regulatory and Policy Insights
September 18, 2006
Terry L Medley, Global Director
Corporate Regulatory Affairs
DuPont Environment and Sustainable Growth Center
June 14, 2005 Wall Street Journal article co-authored by Chad Holliday and Environmental Defense president Fred Krupp.
“Let’s Get Nanotech Right”
“Nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications. Encompassing nanoscale science, engineering and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale”
~2.5 nanometers wide
“The creation of functional materials, devices, and systems through control of matter on the nanometer (1 to 100+ nm) length scale and the application of novel properties and phenomena developed at that scale.”
From NNI definition:
Properties of nanomaterials “differ in fundamental and valuable ways from the properties of individual atoms and molecules or bulk matter”
EPA Nanotechnology White Paper 12-1-05
FDA and Nanotechnology Products FAQ’s 6/13/2006
FDA and Nanotechnology Products FAQ’s 6/13/2006
Dr. Nakissa Sadrieh, FDA Nanobusiness Conference May 2005
- Pre-market approval
- Pre-market “acceptance”
Dr. Norris Alderson, FDA March 30, 2004
EcoSynthetix’s product, Ecosphere cardboard adhesive
is based on nanoparticles of starch
FDA NEWS 8/9/2006
FDA Notice of Public Meeting Docket No. 2006N-0106 8/6/06
“ Engineered nanomaterials… typically possess nanostructure-dependent properties (e.g., chemical, mechanical, electrical, optical, magnetic, biological), which make them desirable for commercial or medical applications. However, these same properties potentially may lead to nanostructure-dependent biological activity that differs from and is not directly predicted by the bulk properties of the constituent chemicals and compounds.”
"Principles for characterizing the potential human health effects from exposure to nanomaterials:
elements of a screening strategy". Gunter Oberdorster et al, Particle & Fibre Toxicology,
October 6, 2005.
How is the DuPont stewardship team addressing those Issues?
Product Stewardship for Engineered Nanoscale Materials
The responsible and ethical management of the health, safety, and environmental aspects of a product throughout its total life cycle.
procedures for nanotechnology products to supplement current product
information on current practices. http://icon.rice.edu/
production, use and disposal of nanoscale materials.
safety and environmental risks of across all lifecycle stages.
commercial interest to DuPont.
academia and government.
Framework currently organized into 6 steps
Process designed to be iteratively applied, with each of the
steps conducted at each major stage of product development.
The American Chemistry Council (ACC) CHEMSTAR Nanotechnology Panel(Panel) is composed of companies engaged in the production, distribution, and/or use of chemicals with business interests in nanotechnology products and applications. The Panel’s vision is to be recognized as the primary forum for nanotechnology issues in the chemical industry and a leading resource regarding responsible nanotechnology development.
The Nanotechnology Panel’s mission embodies:
associated with nanoscale materials.
and Safety (HES) aspects of nanomaterials.
Sustainable Development principles.
achieve its mission.
Other U.S. Group Activities
The Project on Emerging Nanotechnologies was established in April 2005 as a partnership between the
Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts. The Project is dedicated to
helping ensure that as nanotechnologies advance, possible risks are minimized, public and consumer
engagement remains strong, and the potential benefits of these new technologies are realized.
March 10, 2006 Webcast Event
Project on Emerging Nanotechnologies Activities
Business Industry Advisory Committee to the OECD (BIAC)
Positively influence the direction of OECD policy initiatives.
Ensure business and industry needs are adequately addressed in OECD policy decision instruments.
Provide members with timely information on OECD policies and their implication s for business and industry.
Organization for Economic Co-operation and Development (OECD)
USCIB/BIAC/OECD Nanotechnology Activities
proposal to establish a Working Party on Nanotechnology and Innovation.
on Chemicals, Pesticides and Biotechnology recommended a proposal to establish a Working
Party on Health and Environmental Safety Implications of Manufactured Nanomaterials.
briefing call. (USCIB ONLY)
Nanomaterials for Human Health and Environmental Safety.
Manufactured Nanomaterials for Human Health and Environmental Safety”
75 percent of global chemical production. ICCA promote and co-ordinates Responsible Care ®, Responsible
Care Global Charter, Global Product Strategy and other voluntary chemical industry initiatives such as HPV
European industry position to contribute and influence the policy debate at European and international level.
The center of excellence has links to ICCA and within CEFIC to the Research and Science expertise
through the SUSCHEM group and ECETOC.
downstream industries (automobile, food, electronics).
Source: A Prudent Approach to Nanotech Environmental, Health and Safety Risks
Matthew M. Nordan, Lux Research Inc. 2005
Transparent and inclusive processes
Collaboration and Engagement