The Need for Stronger Nanotechnology Regulation

By Adam Soliman | October 16, 2012 Opinion Nanotechnology is an innovative science involving the design and application of small-sized particles measuring one hundred nanometers or less. (An average human hair measures 80.000 nanometers in diameter) (1). Most nanomaterials are derived from conventional chemicals. Their miniscule size and large surface area help to enhance their mechanical, electrical, optical and catalytic features. Thus, nanotechnology is incorporated into a large variety of consumer and health goods, such as food, food packaging, sunblock, chemical fertilizers and animal feed. However, little is currently known about the possible effects of nanotechnology on human, animal or environmental health. What we do know is that nanoparticles have a tremendous ability to penetrate cells and DNA structures. With increased use of nanoparticles, concerns are growing around the possible harm they may have on humans and other living organisms. Lately there has been a growing international call for stronger legislation on nanotechnology because current laws monitoring its safety and risks are highly insufficient. Concerns Surrounding Nanotechnology Studies show that nanoparticles can easily penetrate DNA and the cells of the lungs, skin and digestive system, thereby causing harm to living organisms (2). One example of a commonly used but potentially harmful nanoparticle can be found in the beverage industry. Beverage companies have been using plastic bottles made with nano-composites, which minimize the leakage of carbon dioxide out of the bottle. This increases the shelf life of carbonated beverages without using heavy glass bottles or more expensive aluminum cans. Think of the numbrt of people who are unknowingly being exposed to untested nanocomposites. Nanoparticles are also now being engineered to be more resilient, thereby increasing the risk of causing irreversible damage to living organisms. We simply do not have sufficient data or risk assessment laws in place to analyse whether nanoparticles are safe for consumption. International Regulations Legislation governing the use of nanoparticles is limited around the world, particularly in the U.S. In 2007, a report released by the U.S. Food and Drug Administration's Nanotechnology Task Force 33 stated that despite the 'special properties' of nanomaterials, no further regulation is needed (3). This report was opposed by environmental group Friends of the Earth and the International Center for Technology Assessment. The organizations filed a petition with FDA urging it to take action to highlight the risks associated with nanotechnology (4). As a result, the federal Nanotechnology Research and Development Act was passed in 2003. The Toxic Substances Control Act (TSCA) was also developed to assess the risk posed by substances, and to provide authority to the Environmental Protection Agency (EPA) in regulating them (5). The TSCA set out provisions to protect living systems against unknown risks of new or engineered substances by regulating and testing new and existing chemicals. However, the EPA does not hold much sway in the American political sphere. In fact, the U.S. legislature does not even require pre-market approval of consumer goods; the FDA relies solely on manufacturers to ensure product safety (6). Moreover, only evidence of a very specific harm associated with a product can elicit legal restrictions, and nanoparticles have not yet been tested for such specific risks. The EU organization Strategy for Nanotechnology asserts that nanotechnology has the potential to enhance quality of life and industrial competitiveness, and therefore lobbies aggressively for minimal legislation on nanotechnology. Current laws state that anyone producing or importing nanomaterials into Europe is required to provide written notification to public authorities; this notification requires the manufacturer to conduct research illustrating the properties and dangers of the product (7). However, this research is not monitored, making the data difficult to validate and allowing manufacturers to exaggerate, forge or omit crucial information. In Hong Kong, the Centre for Food Safety has referred to the World Health Organization's (WHO) requirement for risk assessment on nano-scale materials for assessing nanoparticles before they can be used in food (8). Additionally, the Public Health and Municipal Services Ordinance requires all food sold in Hong Kong to be fit for human consumption. But consumer goods lack specific legislation monitoring nanotechnology's expanding applications. Furthermore, no comprehensive and compulsory danger assessment scheme has been introduced to manage the potential risks posed by nanoparticles to public and environmental health. Demand for Legislation Internationally, there is a shortage of regulations on nanotechnology due to a lack of accumulated research on the science. As a result, untested nanoparticles seem to slip through the cracks of existing legislation into widely used consumer products. Since the long-term impact of nanomaterials on the natural environment and human health is unknown, it is difficult to comprehensively regulate this technology in a single piece of legislation that would capture its risks. Rather, nanotechnology should be regulated by a series of laws which govern the exposure of nanotechnology on specific areas: food, environment, medicine and agriculture. Recommendations for Nanotechnology Given the increasing use of nanomaterials, comprehensive legislation must soon be developed (9). Our current juncture offers good opportunities for relevant authorities to make greater efforts in guiding the development of nanoproduction. Existing laws are scattered across new/toxic substances, public health and food regulations, in which areas action is only demanded once a clear risk is proven. But such proof is not yet available for this technology. Manufacturers should legally be required to research nanoproduction and its risks. In addition, a mandatory safety reporting scheme should be introduced to monitor the risks of nanomaterials present in imported and sold products. This reporting scheme should be required for distribution of nanoparticles in any amount to ensure that manufacturers are accountable for all of their products. These safety regulations would hopefully provide protection for consumers until sufficient research can prove that the benefits outweigh the risks of utilizing engineered nanoparticles. Governing bodies can also be responsible for collecting relevant data and establishing a centralized research authority that monitors nanoparticles' long term effects. This would create awareness and offer the consumer a choice between products that include nanoparticles and the ones that don't. Conclusion Nanotechnology is a new science that lacks clear definition and regulations for managing these particles. Untested nanomaterials are already widely engineered into food, medical and agricultural products. The lack of research and management in place for the vast application of nanoparticles make legislation challenging. Meanwhile, various interest groups lobby strongly for limited legislation on nanotechnology in efforts to allow this science to come to full fruition. The long-term effects of nanoparticle use may be positive, but they may also have a negative impact on health. Thus, jurisdictions should continue to broaden legislation monitoring the development of nanotechnology. — (1) BJ Koops, 'On small particles and old articles – An Exploration of Legal and Regulatory Issues of Nanotechnologies', TILT Law & Technology Working Paper Series, Working Paper No 009/2008. (2) G Oberdörster et al, 'Nanotoxicology: An emerging discipline evolving from studies of ultrafine particles, Environmental Health Perspect 2005, 113, 823-839. (3) FDA Nanotechnology Task Force, Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology Task Force 33 (2007). (4) See <action.foe.org/pressRelease.jsp?press_release_KEY=249>. (5) A. Soliman and H. Yip 'Nantotechnology and Animal Welfare: A legal comparative study from Hong Kong'. (6) MN Duvall, FDA Regulation of Nanotechnology, February 2012, available at <www.shb.com/newsevents/2012/FDARegulationofNanotechnology.pdf>. (7) A. Soliman and H. Yip 'Nantotechnology and Animal Welfare: A legal comparative study from Hong Kong' (8) See 'Nanotechnology and food safety', Food Safety Focus (54th Issue, January 2011) – Food Safety Platform, reported by Ms. Shuk-man CHOW, Scientific Officer, Risk Assessment Section, Centre for Food Safety at http://www.cfs.gov.hk/english/multimedia/multimedia_pub/multimedia_pub_fsf_54_02.html. (9) A. Soliman and H. Yip 'Nantotechnology and Animal Welfare: A legal comparative study from Hong Kong' © Food Safety News More Headlines from Opinion & Contributed Articles » Tags: EPA, FDA, nanomaterials, nanoparticles, nanotechnology