“Nanotechnology is defined as the manipulation of matter at the scale of 1 to 100 nanometers to create new products and processes with novel properties” (Kuzma 243). After reading Nanotechnology: Piecing Together the Puzzle of Risk by Jennifer Kuzma I was interested in the governmental regulations on nanotechnology specifically in dietary supplements. Some of the initial questions I had were: Are there any regulations on the manufacturing and sale of products that utilize nanotechnology in dietary supplements? How are policy makers dealing with the new nanotechnology industry? Are similar regulations used worldwide or are they country specific?
Starting with these initial questions my search began. I found ‘The Project on Emerging Nanotechnologies’ whose aim is “ helping to 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.” (Project on Emerging Nanotechnologies 2011) As with any new website I was skeptical of its credibility. Therefore I looked into the two groups that fund this website, The Woodrow Wilson International Center for Scholars and The Pew Charitable Trusts. The Woodrow Wilson International Center for Scholars is a highly trustworthy organization whose aim is to build “a bridge between the worlds of academia and public policy, to inform both to develop solutions to the nation’s problems and challenges. Through public meetings and events, broadcast media and social media, publications in print and online, and a wide range of outreach activities, the Wilson Center is engaged in the global dialogue of ideas. More importantly, the Center provides you with the tools and opportunities to join the national conversation.” (Research, Reason, Relevance 2011) I found their outlook to be very interesting and to fall into two of our course concepts, bidirectional communication and science as a social enterprise. By allowing not only for research and scientific studies to be conducted but also for public meetings and outreach activities, the Wilson Center allows for bidirectional communication. Strong communication between academia and the public is extremely important to the advancement of science. The Wilson Center’s outlook also falls into the science as a social enterprise category. They clearly understand that society affects the way science evolves and have allowed for some public input and critique of their findings.
While searching for relevant articles on nanotechnology I found this video entitled ‘Nanotechnologies Roundtable with Dr. Andrew Maynard’ produced by the Wisconsin Department of Natural Resources in 2009. The video was quite lengthy so I only watched the first half hour. Dr Andrew Maynard is the Chief Science Advisor to the Project on Emerging Nanotechnologies, and Science Advisor to the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars. (Maynard 2008) Dr Maynard was one of the first scientists to focus his research specifically on nanoparticles in the eighties and has his PhD in occupational health. In the video Dr Maynard specifically discussed the different Mindsets on nanotechnology that policy makers and the public have in Europe and the US. In the US under the Bush administration the secret to success was innovation. US policy makers tended to downplay regulations in order to promote innovation and growth in the nanotechnology industry. It was generally understood that organizations such as the EPA and FDA should not mess with business and be extremely careful if they were planning on putting regulations on nanotechnology. In contrast the European mindset was one of social benefits. European policymakers wanted to do whatever was in their power to ensure people have the best ‘quality of life’ and to have effective business practices. A new European chemical regulation system (REACH) was put into place in 2007 (European Commission Environment 2011). This new chemical regulation system aims to “place greater responsibility on industry to manage the risks from chemicals and to provide safety information on the substances,” though how this will effect nanotechnologies is presently unknown. By having different mindsets Europe and the US have gone in different directions with the development of nanotechnology and their policies towards the extent of its use. The US has more of an open mindset with little restriction placed on the development of new technologies while Europe has stricter policies and regulations. Currently it is unclear whether one mindset is more effect than the other and what the long term consequences will be.
On the Project on Emerging Nanotechnologies website I found a study published by William B. Schultz and Lisa Barclaythat discusses the challenges the FDA faces with new dietary supplements that utilize nanotechnology. According to the study Schultz and Barclaythat conducted, three main problems need to be addressed:
1. "FDA does not have the capacity to identify nano-based dietary supplements that are being developed and marketed, unless manufacturers submit to the pre-market notification process for new dietary ingredients.
2. To the extent that FDA is aware of nano-based dietary supplements, it has little regulatory authority over them.
3. Even if it were granted increased regulatory authority, FDA lacks the scientific expertise and resources to effectively regulate nanomaterials in supplements" (Schultz and Barclaythat 30).
These three points show that the FDA and governmental organizations face a huge barrier when it comes to the regulation and development of nanotechnology products. Also there currently exists a cycle of mistrust between the government/FDA and the nanotechnology manufacturing companies. For years the FDA has been unsuccessfully trying to get manufacturing companies to document the type and quantity of nanoparticles that they produce. In the video I watched by Dr Maynard he estimated that only 20 percent of the companies that produce large quantities of nanoparticles have voluntarily documented their production rates for the FDA. With only 1/5th of the nanotechnology industry complying with FDA studies, this makes any progress on the FDA’s part nearly impossible. It should be noted that the pre-market notification process is currently voluntary. It would be highly beneficial for companies to report their production but the FDA currently has no governmental authority to force companies to comply. On the other hand though, nanoparticles manufacturing companies fear that strict FDA regulations on their product would severely impact their production, expansion, and sales. In order to move forward in the right direction the manufacturing companies and the FDA need to find some way to break this cycle of mistrust. Also the government must take a stronger stance on their nanotechnology policies and regulations, giving more power to organizations such as the FDA. With nanotechnology being the next chapter in science we must find a way to safely and effectively use and regulate this technology.
Overall I found that the emerging nanotechnology industry lacks any clear regulation or unity. The European and American mindsets differ significantly on how best to create policies that will both aid society and allow this industry to flourish. There is very limited knowledge as how best to manage the research and development of new dietary supplements utilizing nanotechnology. In order for nanotechnology to move forward in a productive manner the government, governmental agencies such as the FDA and EPA, and nanotechnology manufacturing companies must work together. The current cycle of mistrust between these parties must be broken. Not only is it the government and industries responsibility to make nanotechnology safe and effective for everyone, but it is our responsibility as an individual to stay up to date on advances in nanotechnology. In order for this industry to move forward bidirectional communication between the public and the scientific community is paramount. The Project on Emerging Nanotechnologies and the Woodrow Wilson International Center for Scholars do a wonderful job of organizing events and forums where the public can learn more on nanotechnology and recent advances in this field. These scientific organizations clearly understand that science is a social enterprise and that the public affects how science evolves.
After researching this topic I would like to keep track of any advances in the regulation of nanotechnologies. Specifically will the FDA's attempts to track and regulate nanotechnologies in dietary supplements prove successful? Will the US govenment continue to hold such loose standards over the nanotechnology industry in the future? Also I would like to research specific types of nanotechnology used in dietary supplements and their health benefits/risks. I didnt have enough time to look into this specifically but if given more time would be very interested in researching this in more detail. Nanotechnology in dietary supplements is an important advance in science and modern medicine. It would most likely be in societys best interst to encourage it's safe advancement and expansion through through carefully constructed government regulations and standards.
After researching this topic I would like to keep track of any advances in the regulation of nanotechnologies. Specifically will the FDA's attempts to track and regulate nanotechnologies in dietary supplements prove successful? Will the US govenment continue to hold such loose standards over the nanotechnology industry in the future? Also I would like to research specific types of nanotechnology used in dietary supplements and their health benefits/risks. I didnt have enough time to look into this specifically but if given more time would be very interested in researching this in more detail. Nanotechnology in dietary supplements is an important advance in science and modern medicine. It would most likely be in societys best interst to encourage it's safe advancement and expansion through through carefully constructed government regulations and standards.
Sources Used:
European Commission Environment. "REACH." September 7, 2011. <http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm>.
Kuzma, Jennifer. "Nanotechnology: Piecing Together the Puzzle of Risk." Controversies in Science and Technology: From Evolution to Energy. Kleinman, Lee Daniel, ed. Vol 3. Mary Ann Leibert Inc Publishers: 2010. 243.
Maynard, Andrew. "Andrew Maynard." 2020 Science: A Clear Perspective on Emerging Science and Technology. September 19, 2008. September 7, 2011. <http://2020science.org/andrew-maynard/>.
Nanotechnologies Roundtable with Andrew Maynard. Dr. Andrew Maynard. Wisconson Department of Natural Resources. 2009. September 7, 2011. <http://dnrmedia.wi.gov/main/Viewer/?peid=64d05f50-f81b-4029-9da3-7f5505dddd3d>.
Schultz, B. William and Barclay, Lisa. PEN 17- A Hard Pill to Swallow: Barriers to Effective FDA Regulation of Nanotechnology- Based Dietary Supplements. The Woodrow Wilson International Center for Scholars: January 14, 2009. 6-30.
"Research. Reason. Relevance." Woodrow Wilson Center International Center for Scholars. 2011. September 7, 2011. <http://www.wilsoncenter.org/research-reason-relevance>.
The Project on Emerging Nanotechnologies. 2011. Pew Charitable Trusts and The Woodrow Wilson Internation Center for Scholars. September 7, 2011 <http://www.nanotechproject.org/>.
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