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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

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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

DuPont Environment and Sustainable Growth Center


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Nanomaterials Product Stewardship: Key Commitments

June 14, 2005 Wall Street Journal article co-authored by Chad Holliday and Environmental Defense president Fred Krupp.

“Let’s Get Nanotech Right”


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National Nanotechnology Initiative (NNI) Definition

“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”


Nanoscale science engineering l.jpg

DNA

Human

Gnat

Cell Nucleus

~2 meters

~2 millimeters

~2 micrometers

~2.5 nanometers wide

Nanoscale Science & Engineering

“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”


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EPA Definition

  • “ Nanotechnology is defined as research and technology development at the atomic, molecular or macromolecular level using a length scale of approximately 1 – 100 nanometers in any dimension: the creation and use of structures, devices and systems that have novel properties and functions because of their small size: and the ability to control or manipulate matter on an atomic scale.”

  • The definition of nanotechnology does not include unintentionally produced nanomaterials, nano-sized particles or materials that occur naturally in the environment, such as viruses or volcanic ash and nanoparticle byproducts of human activity, such as diesel exhaust particulates or other friction or airborne combustion byproducts.

    EPA Nanotechnology White Paper 12-1-05


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FDA definition

  • The FDA has not established its own formal definition, though the agency participated in the development of the NNI definition of “nanotechnology.” Using that definition, nanotechnology relevant to the FDA might include research and technology development that both satisfies the NNI definition and relates to a product regulated by FDA.

  • Some of the products regulated by FDA through its Centers include; biological products; cosmetics; devices; foods- human and animal feeds; food additives – color and food containers; dietary supplements; drugs and combination products.

    FDA and Nanotechnology Products FAQ’s 6/13/2006


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FDA Calls it Nanotechnology if it involves all the following

  • Research and technology development at the atomic, molecular or macromolecular levels,in the length scale of approximately 1 – 100 nanometer range.

  • Creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate size.

  • Ability to control or manipulate on the atomic scale.

    FDA and Nanotechnology Products FAQ’s 6/13/2006


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FDA Mission

  • The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and food more effective, safer, and more affordable; and helping the public get accurate, science-based information they need to use medicines and foods to improve their health.

    Dr. Nakissa Sadrieh, FDA Nanobusiness Conference May 2005


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FDA- Risk Management Approach

  • FDA regulates products on a product-by-product basis

    - Pre-market approval

    - Pre-market “acceptance”

    - Post-market

  • FDA does not regulate “technologies”

  • Product Review process is not static- as we learn more,we evolve the process

  • Assistance to the industry we regulate

    Dr. Norris Alderson, FDA March 30, 2004


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What are the food related applications of nanomaterials that are in or nearing commercialization?

  • Food packaging

  • Pathogen and contaminant sensors

  • Taste and texture

  • Functional foods

  • Seed production

  • Pesticides


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Bio-based packaging adhesives are in or nearing commercialization?

EcoSynthetix’s product, Ecosphere cardboard adhesive

is based on nanoparticles of starch


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FDA Forms Internal Nanotechnology Task Force are in or nearing commercialization?

  • On August 9, 2006 Acting FDA Commissioner Andrew C. von Eschenbach, M.D. announced the formation of an internal FDA Nanotechnology Task Force . “ Through this Task Force we are leveraging our expertise and resources to guide the science and technology in the development of nanotechnology-based applications”

  • The Task Force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.

  • The Task Force will identify and recommend ways to address any knowledge or policy gaps that exists so as to better enable the agency to evaluate possible adverse health effects from FDA-regulated products that use nanotechnology materials.

  • FDA will continue to address product-specific nanotechnology-related issues on an ongoing basis.

    FDA NEWS 8/9/2006


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FDA Announces Plans for Nanotechnology Public Meeting are in or nearing commercialization?

  • October 10.2006 public meeting on FDA-regulated products containing nanotechnology materials.

  • The purpose of the meeting is to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products

  • FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), foods and color additives, animals feeds, cosmetics, drugs and biologics, and medical devices

  • Whether there are new or emerging scientific issues about which the regulated industry, academia, and the interested public may wish to inform FDA concerning the use of nanotechnology materials in FDA-regulated products.


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What are the potential regulatory/safety issues that these products pose?

  • “Due to their small size and extremely high ratio of surface area to volume, nanotechnology materials often have chemical or physical properties that are different from those of their larger counterparts.”

  • “Because of some of their special properties, they may pose different safety issues than their larger counterparts.”

  • “ FDA is interested in learning if there are opportunities for it to help overcome scientific hurdles that may be inhibiting the use of nanotechnology in medical product development.”

    FDA Notice of Public Meeting Docket No. 2006N-0106 8/6/06


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Key Challenge products pose?

“ 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.


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How is the DuPont stewardship team addressing those Issues? products pose?

Product Stewardship for Engineered Nanoscale Materials

Continuing

Commitment

Active

Involvement

Collaboration

and Engagement


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Product Stewardship products pose?

The responsible and ethical management of the health, safety, and environmental aspects of a product throughout its total life cycle.

  • Prudent Practices - Companies are developing, where needed, additional

    procedures for nanotechnology products to supplement current product

    stewardship practices.

  • Understanding Current Practices – Utilization of surveys to collect

    information on current practices. http://icon.rice.edu/


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The Nanotechnology Occupational Safety & Health Consortium products pose? (NOSH)

  • In October 2005, industry, academic and government organizations formed a group to sponsor research that will further our understanding of factors relevant to the assessment and control of occupational exposures to engineered nanoparticles.

  • Three Consortium Deliverables:

    • Generate a well-characterized aerosol, evaluate instrumentation to measure aerosol nanoparticles, and characterize aerosol behavior as a function of time.

    • Develop a portable air sampling method for daily monitoring of R&D and manufacturing settings.

    • Measure filtration and barrier efficiency of filter media to specific engineered nanoparticles.


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DuPont and Environmental Defense Partnership products pose?

  • Partnership agreement signed September 1, 2005.

  • Agreement to collaborate on a framework for the responsible development,

    production, use and disposal of nanoscale materials.

  • Seeks to define a process to identify, manage and reduce potential health,

    safety and environmental risks of across all lifecycle stages.

  • Will be demonstrated on specific nanoscale materials or applications of

    commercial interest to DuPont.

  • Create a tool that can be widely adopted by industry, public interest groups,

    academia and government.

  • Engage a wide range of stakeholders and incorporate work being done by

    others.


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Environmental Defense and DuPont products pose?Framework for Responsible Nanotechnology

  • Describe material and use

  • Profile life cycle (material, hazard, exposure)

  • Evaluate risks

  • Assess risk management

  • Decide, document, and act

  • Review and adapt

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.

www.environmentaldefense.org


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(ACC) CHEMSTAR Nanotechnology Panel products pose?

VISION 

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.

MISSION

The Nanotechnology Panel’s mission embodies:

  • Coordinating and advocating information needed to assess and manage the health and environmental risks

    associated with nanoscale materials.

  • Advocating for research on nanomaterials/products that facilitates understanding of the Health, Environmental,

    and Safety (HES) aspects of nanomaterials.

  • Promoting the development of nanotechnology products in conjunction with Global Product Stewardship and

    Sustainable Development principles.

  • Advocating the use of existing regulatory framework for the responsible development and management of

    nanoscale materials.

  • Supporting the development of appropriate, science-based regulations and harmonized international standards

    for nanotechnology.   

  • Engaging and collaborating with other stakeholders to develop and maintain public awareness and acceptance

    of nanotechnology.

  • The Panel will conduct activities in a transparent manner and maintain open dialogue with stakeholders to

    achieve its mission.


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ACC CHEMSTAR Nanotechnology Panel products pose?

  • In order to fulfill the Nanotechnology Panel’s mission, task groups (TGs) have been convened within the Panel to prioritize, focus, and work on specific categories of nanotechnology issues.

  • The Task Groups coordinate the following initiatives related to nanotechnology development.

    • Technical Development

    • Policy/Advisory

    • Product Stewardship

    • Communications/Public Outreach


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ACC CHEMSTAR Nanotechnology Panel – Key Activities products pose?

  • Providing industry comments on key proposals (EPA white paper, EPA voluntary program, Science Advisory Board)

  • Tiered testing under EPA voluntary program

  • Matrix of materials for potential testing

  • Research funding priorities

  • Congressional outreach

  • Industry Best Practices Survey

  • Joint Principles with Environmental Defense and continuing collaboration.

  • Development of outreach communication package

  • International Engagement (ICCA, OECD)

www.chemstar.org


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Other U.S. Group Activities products pose?

  • Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies

  • United States Council for International Business (USCIB)

  • American Chamber of Commerce

  • Crop Life America

  • Nanobusiness Alliance

  • Synthetic Organic Chemical Manufacturers Association (SOCMA)

International Activities

  • Organization for Economic Co-operation and Development (OECD)

  • Business Industry Advisory Committee to the OECD (BIAC)

  • International Council of Chemical Associations (ICCA)

  • European Chemical Industry Council (CEFIC)

  • International Council on Nanotechnology (ICON)


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Woodrow Wilson Project on Emerging Nanotechnologies products pose?

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.

  • “Nanotechnology in Agriculture and Food Production: Anticipated Applications”– Jennifer Kuzma and Peter VerHage- Sept. 7, 2006.

  • “Nanotechnology: A Research Strategy for Addressing Risk” – Dr. Andrew Maynard - July 19, 2006.

  • “First Nanotechnology Consumer Products Inventory Available to Public”

    March 10, 2006 Webcast Event

  • “Nanotechnology & NIOSH: Perspectives from Director John Howard – Feb. 23, 2006

  • “Green Nanotechnology” – Dr. Barbara Karn – Feb. 16, 2006

  • “Managing the Effects of Nanotechnology” – J. Clarence (Terry) Davies – Jan. 11, 2006

  • “ Comprehensive Overview of Nanotechnology’s Potential Workplace Health Impacts” Dr. Andrew D. Maynard and Dr. Eileen Kuempel – Dec. 20, 2005

  • Launch of EHS Inventory Database

Project on Emerging Nanotechnologies Activities

www.wilsoncenter.org/index.cfm?fuseaction=topics.home&topic_id=166192


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United States Council for International Business (USCIB) products pose?

  • Mission: The United States Council for International Business advances the global interests of American

  • business both at home and abroad.  It is the American affiliate of the International Chamber of Commerce (ICC),

  • the Business and Industry Advisory Committee (BIAC) to the OECD, and the International Organization of

  • Employers (IOE).  As such, it officially represents U.S. business positions both in the main intergovernmental

  • bodies and vis-à-vis foreign business communities and their governments.

Business Industry Advisory Committee to the OECD (BIAC)

  • BIAC is the voice of business at the OECD. BIAC’s members are the major industrial and employers’

  • organizations in the 30 OECD member countries.

  • Mission:

    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)

  • The OECD groups 30 member countries sharing a commitment to democratic government and the market

  • economy. With active relationships with some 70 other countries, NGOs and civil society, it has a global reach.

  • Best known for its publications and its statistics, its work covers economic and social issues from

  • macroeconomics, to trade, education, development and science and innovation.

http://www.uscib.org

http://www.biac.org

http://www.oecd.org


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USCIB/BIAC/OECD Nanotechnology Activities products pose?

  • Oct 26-27, 2006 – Committee on Science & Technology Policy Meeting in South Korea

  • Oct 26-27, 2006 – Chemical Committee on Manufactured Nanomaterials meeting in London

  • July 2006 – Committee on Science & Technology Policy Meeting in Zurich

  • March 2006: OECD Committee on Science & Technology Policy 87th Session to review a

    proposal to establish a Working Party on Nanotechnology and Innovation.

  • February 2006: OECD 39th Joint Meeting of the Chemicals Committee and the Working Party

    on Chemicals, Pesticides and Biotechnology recommended a proposal to establish a Working

    Party on Health and Environmental Safety Implications of Manufactured Nanomaterials.

  • December 2005: OECD Workshop on the Safety of Manufactured Nanomaterials hosted by

    the USA.

  • October 2005: ICC Environment Commission, Emerging Issues Contact Group Nanotechnology

    briefing call. (USCIB ONLY)

  • September 2005: OECD Survey/Questionnaire on the Potential Implications of Manufactured

    Nanomaterials for Human Health and Environmental Safety.

  • June 2005: OECD Chemicals Committee Special Session: “Potential Implications of

    Manufactured Nanomaterials for Human Health and Environmental Safety”


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International Council of Chemical Associations - ICCA products pose?

  • ICCA is a world-wide voice of the chemical industry, representing producers that manufacture more than

    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

    and LRI.

  • Mission: To help the global chemical industry improve financial performance and reputation by tackling global

  • issues, and by helping the industry to improve continuously its performance through Responsible Care and

  • other programs.

  • ICCA Nanomaterials Task Force

  • Final membership agreed and co-chairs established

  • March 2006 in Geneva, 1st face-to-face meeting

  • Goals:

    • Serve as a clearing house to support international coordination and information of chemical industry

      activities

    • Act as the global industry monitor on international developments

    • Promote the stewardship of the products of nanotechnology through company or association activity

    • Leverage existing industry programmes

    • Support a transparent communication and advocacy process by developing positions and presentations

    • Facilitate the involvement of other industry that may produce or use nanomaterials

http://www.icca-chem.org


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European Chemical Industry Council (CEFIC) products pose?

  • CEFIC is both the forum and the voice of the European chemical industry. It represents, directly or indirectly,

  • about 27,000 large, medium and small chemical companies which employ about 1.3 million people and

  • account for nearly a third of world chemical production.

  • Mission: To maintain and develop a prosperous chemical industry in Europe by promoting the best possible

  • Economic, social and environmental conditions to bring benefits to society with a commitment to the

  • continuous improvement of all its activities including the safety, health and environmental performance.

  • CEFIC Nanotechnology Center of Excellence

  • Formed in 2005 – Quarterly meetings

  • Mission is to reflect and integrate the different dimensions/facets of nanotechnology and develop a

    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.

  • Participants are from companies (DSM, BASF, Bayer, Dow, DuPont), national chemical federations and

    downstream industries (automobile, food, electronics).

http://www.cefic.org


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International Council on Nanotechnology (ICON) products pose?

  • The International Council on Nanotechnology (ICON) is an organization whose activities are broadly

  • supported by industry, non-profit foundations, and governments. Based at Rice University, the ICON is a

  • currently an affiliates program of the United States National Science Foundation’s Center for Biological and

  • Environmental Nanotechnology; however, its membership extends beyond CBEN to include other national

  • and international centers with an interest in its mission. ICON permits a diverse array of nanotechnology

  • stakeholders to share resources and information with the aim of ensuring a sustainable nanotechnology

  • industry.

  • Mission: To assess, communicate and reduce the environmental and health risks of nanotechnology while maximizing its societal value.

  • Multi-stakeholder, International, Neutral, and Technically based.

  • Current areas of activity.

    • EHS Priority Research Workshops – Nov and Dec 2006

    • Asia Workshop – Dec 2006 – Japan

    • European Workshop – Jan 2006 - Ireland

    • Forums and events to explore EHS issues in nanotechnology.

    • An electronic knowledge base for accessing peer-reviewed publications in nanotechnology.

    • High-quality technical information relevant to decision makers.

    • Proactive communications platform that translates complex scientific data into material easily understood by many stakeholders.

http://icon.rice.edu


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Nomenclature/Definition Activity products pose?

  • American National Standards Institute (ANSI)

    • U.S. Technical Advisory Group to ISO TC 229 Nanotechnologies

    • ISO Technical Committee 229 (3 working groups)

      • WG1 Terminology and Nomenclature

      • WG 2 Measurement and Characterization

      • WG 3 Health, Safety, and Environmental Aspects of Nanotechnologies

  • ASTM International

    • E56.01 Terminology and Nomenclature

    • E56.06 Risk Management and Product Stewardship


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Addressing Nanotech EHS Risks - Real vs Perceptual Risk products pose?

  • Real Risk:

    • Identifying hazard

    • Characterizing hazard

    • Assessing exposure

    • Characterizing risk

  • Perceptual Risk:

    • Emphasize nanotech benefits

    • Communicate toxicology efforts

    • Engage all stakeholders from the outset

    • Avoid self-destructing mudslinging

Source: A Prudent Approach to Nanotech Environmental, Health and Safety Risks

Matthew M. Nordan, Lux Research Inc. 2005


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Summary products pose?

Active Involvement

Continued Commitment

NOSH

Policy

Associations

International Forums

Product Stewardship

Prudent Practices

Multi stakeholder

Transparent and inclusive processes

Collaboration and Engagement


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