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Tell FDA to regulate unlabeled and untested engineered nanomaterials in food!
Just in time for Halloween, the Food and Drug Administration is discussing its regulation of nanotechnology, a powerful new technology for taking apart and reconstructing nature at the atomic and molecular level. While FDA recently held its first meeting on nanotechnology, the agency is behind the curve: Many products are already on market shelves that contain unlabeled nanomaterials, including food and food packaging products. Thus far, nanotechnology-laced products are treated by FDA like any other products or product ingredients; yet scientists agree that nanoparticles are fundamentally different substances that create new and unique risks to human health and the environment and need new forms of safety testing.
A public comment period is open now through November 10th - Take action now!
**Please note that due to the difficulties many of you have had posting public comments to the regulations.gov site, and the FDA's decision to only allow electronic comments through that site, we will be collecting your comments to deliver to FDA at the close of the comment period (November 10th).
| Sample Letter for Campaign |
Subject: Re: Docket No. 2006N-0107
Dear [ Decision Maker ] ,
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Comments on Docket No. 2006N-0107
(FDA regulation of nanotechnology materials)
I write to express my serious concerns about the FDA's regulatory oversight of nanomaterials in consumer products. Many consumer products containing engineered nanomaterials are already available on U.S. market shelves, including food and food packaging products.
Millions of dollars are being spent by government and industry to apply nanotechnology in areas of food processing, food packaging, and agricultural production. Current nano-food products on the market include a canola oil, a chocolate "slim" shake, a nano-bread, and several nano-food additives and supplements used in soft drinks, lemonades, fruit juices, and margarines. Many food packaging products use nano-composites, nano-clays, and nano-coatings. In addition, if industry observers are correct, hundreds of more new food and agriculture products are under development and many could be on the market in as few as two years. By 2010 the nano-food market will be $20 billion. Many of the world's leading food companies - including H.J. Heinz, Nestle, Hershey, Unilever, and Kraft - are investing heavily in nanotechnology applications.
Scientists have found that the fundamental properties of matter can change at the nano-scale, creating physical and chemical properties distinct from those of the same material in bulk form. We know that the new properties of nanomaterials create new risks, like enhanced toxicity. Studies have raised numerous red flags, and many types of nanoparticles have proven to be toxic to human tissue and cells.
Nanoparticles can gain assess to the blood stream following ingestion. Once inside the body, the super-tiny size of these materials gives them unprecedented mobility and access to the human body; they can access cells, tissues, and organs that larger particles cannot. The length of time that nanoparticles remain in organs and what dose may cause harmful effects remains unknown.
It does not appear that FDA is ready for this wave of nano-food products. I am very concerned about the rapid introduction of these potentially hazardous nanomaterials into our bodies and into our environment without adequate scientific study to ensure that we understand their risks and can prevent harm occurring to people and the environment. The FDA's failure to undertake or review new testing of these nanomaterials despite these known and foreseeable dangers suggests the agency's review process is not acting to ensure consumer health and safety.
For these reasons, I strongly request that FDA use its new Nanotechnology Task Force to discuss the human health and environmental risks presented by nanomaterials in consumer products, including food and food packaging products. FDA should act quickly to shore up its regulation of these substances to account for their fundamentally different properties and their associated dangers, including require new nano-specific testing and the labeling of all nanomaterial products, including nano-food products.
Currently, FDA's reliance on manufacturers' assurances of safety make me and my family into guinea pigs. FDA must instead independently review all testing and assess the safety of these products as well as force manufacturers to label their nanomaterial products. Only with labeling can I make educated decisions about what I buy and put in and on my body. Until such actions are taken, I fully support a moratorium on the manufacture of nanomaterial consumer products and the recall of products currently on the market.
Sincerely,
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Campaign Launched:
September 18, 2006
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For more information on nanotechnology, see the following resources:
Visit our sister organization the International Center for Technology Assessment
For nano food-related research report http://www.nanotechproject.org/50
For general sources of information of the human health and environmental dangers, see the recent Friends of the Earth report Nanomaterials, Sunscreens and Cosmetics: Small Ingredients, Big Risks
Visit the Friends of the Earth Introduction to Nanotechnology
The Woodrow Wilson Center’s Project on Emerging Nanotechnologies has created the first ever searchable publically available nanotechnology consumer product database
Further Resources on Nanotechnology:
Center on Nanotechnology and Society
Nanotechnology has been heralded as the key technological development of the 21st century. Yet, there has been little discussion on the present and future social significance of this nascent technology. To that end, Illinois Institute of Technology's (IIT's) Center on Nanotechnology and Society, an affiliate of the Institute on Biotechnology and the Human Future (IBHF), at Chicago-Kent College of Law, has been created to catalyze informed interdisciplinary research, education and dialogue on the ethical, legal, policy, business, and broader societal implications of nanoscale science and technology - all with a special focus on the human condition.
To achieve these goals, the Center on Nanotechnology and Society brings the foremost scholars and researchers in law, ethics, technical areas, and the social sciences together with leaders in business and industry. http://www.nano-and-society.org/
ETC Group
The ETC Group was one of the first non-governmental organizations working on nanotechnology issues. In 2003 it called for a moratorium on all nanoproducts. This website contains many materials on nanotechnology including the very useful pamphlets- A Tiny Primer on Nano-scale Technologies ...and The Little BANG Theory and a Backgrounder: Open Letter on Synthetic Biology. http://www.etcgroup.org/article.asp?newsid=563
European Commission-Nanotechnology Homepage
This web page provides an overview of nanotechnology related activities at the European Commission. The information provided on this portal website does not replace or supersede similar information in other CORDIS or EUROPA websites. Rather, it highlights elements specifically relevant to nanotechnology in Europe such as the European strategy and the Action Plan, projects and funding opportunities in the Framework Programmes and related publications and events. http://cordis.europa.eu/nanotechnology/
International Center for Technology Assessment (ICTA)
ICTA seeks to halt the commercialization of nanotechnology until products containing nanoparticles have been proven safe. CTA also seeks to force federal regulatory agencies to adopt an accurate and standardized definition of nanotechnology and to regulate emerging nanotechnologies as they would other materials whose safety has not been determined. The ICTA website contains information on legal challenges to nanotechnology, public policy, publications and other resources. http://www.icta.org/nanotech/index.cfm
International Council on Nanotechnology (ICON)
Based at Rice University, ICON is a technically driven organization whose activities are broadly supported by industry, non-profit foundations, and governments. Its multi-stakeholder partnerships and governance, with members that span the globe, make it uniquely positioned to ensure global coordination and cooperation in nanotechnology risk management. ICON has grown from an affiliates program of the Center for Biological and Environmental Nanotechnology, based at Rice University, which has been designated by the U.S. National Science Foundation as a nanotechnology center of excellence.
The ICON Environmental, Health and Safety (EHS) database contains summaries (abstracts) and citations for research papers related to the EHS implications of nanoscale materials. This database was developed initially by Dr. Tim Borges and Ms. LeeAnn Wilson at Oak Ridge National Laboratory. http://icon.rice.edu/about.cfm?doc_id=4380
National Nanotechnology Initiative
The U.S. government's official nanotechnology coordinating office. The National Nanotechnology Initiative (NNI) is a federal R&D program established to coordinate the multiagency efforts in nanoscale science, engineering, and technology. The goals of the NNI are to: Maintain a world-class research and development program aimed at realizing the full potential of nanotechnology; Facilitate transfer of new technologies into products for economic growth, jobs, and other public benefit; Develop educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology; and, Support responsible development of nanotechnology. http://www.nano.gov
The Project on Emerging Nanotechnologies
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.
The Project on Emerging Nanotechnologies collaborates with researchers, government, industry, NGOs, policymakers, and others to look long term, to identify gaps in knowledge and regulatory processes, and to develop strategies for closing them. The Project will provide independent, objective knowledge and analysis that can inform critical decisions affecting the development and commercialization of nanotechnologies. http://www.nanotechproject.org/index.php?id=44
The Royal Society--Royal Academy of Engineering-Nanoscience and nanotechnologies report
This UK government report on nanotechnologies - ‘Nanoscience and nanotechnologies: opportunities and uncertainties’ - was published on 29 July 2004. The report illustrates the fact that nanotechnologies offer many benefits both now and in the future but that public debate is needed about their development. It also highlights the immediate need for research to address uncertainties about the health and environmental effects of nanoparticles – one small area of nanotechnologies. It also makes recommendations about regulation to control exposure to nanoparticles. http://www.nanotec.org.uk/finalReport.htm
