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The Need for Stronger Nanotechnology Regulation

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
  • Keene Observer

    Progress in nantechnology research should include all of these concerns. Here is a role for government to guide research. But the opportunity to sow fear of the unknown will be too much for professional alarmists to resist. The “precautionary principle” will be invoked (Luddites always cite it to justify stifling and vandalizing technology) and the war cry will be  “be afraid, be very afraid”! How will bureaucrats pass up another opportunity to seize greater authoritarian control? This will become just one more emerald facet among the precious nanny state jewels. Just one more modern marvel to be dragged down into the foodie anti-intellectual cesspit. Let the bashing begin!

    • Jan

      The opposite of precaution is to shoot first and (maybe) ask (pertinent) questions afterwards.

      So Here we go — again (and again and again…) Let’s turn these WWII nerve agents into — pesticides (on and in our food)! Let’s greenlight these transgenic experiments into our food supply (unlabeled, of course)!! And here’s nanotech — the new industrial profit-generator. 

      Why not do the science first and then MAYBE consumer releases AFTER there’s a clean bill of health?  Nah — modern business-as-usual shoots first then counts the money and squelches any real appraisals…Nanotechnology is a relatively new technology for taking apart and reconstructing nature at the atomic and molecular level. Just as the size and chemical characteristics of manufactured nanoparticles can give them unique properties, those same new properties –tiny size, vastly increased surface area to volume ratio, high reactivity– can also create unique and unpredictable human health and environmental risks. Many of the products containing nanomaterials on the market now are for skin care and cosmetics, but nanomaterials are also increasingly being used in products ranging from medical therapies to food additives to electronics. In 2009, developers generated $1 billion from the sale of nanomaterials, and the market for products that rely on these materials is expected to grow to $3 trillion by 2015. (via Beyond Pesticides)

  • MN

    This is worth quoting: “Internationally, there is a shortage of regulations on nanotechnology…”

    Say what?

    A “shortage of regulations”? Seriously? A shortage! Like a shortage of food or gasoline or toilet paper or blood donations when supplies are depleted and needy people are left wanting. That kind of a shortage.

    To say regulations are too few, indeed that they are in too short supply…well, dang it all, that just about sums up the authoritarian nanny state mindset, doesn’t it? I mean, we know how much regulation is too little without knowing how much is too much. And of course we sidestep any sane consideration of rational purposing of regulation. Just add more…you can never really have too much regulation or too many stifling progress snuffing alarmist enforcers, can you?

  • Lin sasman

    I agree with Jan’s comments and would add  that this opinion statement
     (1)   is so passive that I wonder if Mr. Soliman meant to make a co-oping statement such as would be put out by corporate interests (or paid for by corp interests),  (2) is harmful in not mentioning what there is of  research showing problematic nanotechnology affecting human health and further seems to imply that there is none reported and ongoing,   and (3) puts out bogus arguments for helplessness without naming the real basis and tools available to us for the fight we are engaged in.I would suggest that:1.  We have a major fight just to get labeling so that concerned consumers can choose whether to be part of this giant lab experiment.  I propose that this is the fight we need to concentrate on now. And until its is accomplished, we need to organize private lists to help us — like the clothing mfg who advertizes in my dermatoligist’s office….supermarket and pharmacy products, etc .  We will need to fund a non-profit to do this. Doctors, scientists, and public interest organizations will join as momentum builds.  I haven’t checked  NRDC or other public interest groups that  have started but we need to publicize them and join their efforts by petition and money- even’t $20 from 1000s makes a difference.2.  If we can’t organize ourselves to pressure for labeling, what chance does govt have to follow thru on the authority it has to regulate further (legislatures will defund agencies), let alone get stronger legislation passed.  Let’s priortize intelligently, folks, for this next wave of disastrous mis-use of scientific knowledge. It is not a matter of IF but WHEN we discover massive problems from unregulated thoughtless use and dissemination of nanotechnology. It is such a no-brainer, that we will have massive propaganda from corporate interests once this point takes hold of the public.    We need to be conscious and committed to the long term game plan.  Economic interests are thoroughly aware of the dangers and intend to continue to apply economic and political pressure. Scientists and govt agencies can expect to be pressured and threatened. Citizen action is the important power  at this point.3.  Europe has already reported at least one study on problem health effects from carbon nanotechnology in consumer products. We need to keep a listing service, keep repeating what is found and reasons for continuing, and find funding sources for studies. 4.  This opinion does a dis-service in stating that “no harmful effects are known (not true across the board) so no stronger reaction can be pushed” –  that is the corporate shills’ mantra — don’t buy into it.    We have plenty of toxic and hazardous substances historical examples to use for reasonable jpositions.