- What are nanomaterials?
- Why are nanomaterials in food important to investors?
- Are nanomaterials regulated?
- What are the effects of ingesting nanomaterials?
- Where can I learn more?
What are nanomaterials?
Nanotechnology is the science of manipulating matter at the molecular scale to build structures, tools, or products. A nanomaterial is generally defined as any material that consists of nano-sized (extremely small) particles. To understand the size of a nanoparticle, consider that one nanometer is one-millionth the length of a grain of sand.
This emerging science offers many new opportunities for food industry applications, such as nutritional additives, stronger flavorings and colorings, or antibacterial ingredients for food packaging. Nanomaterials may be more effective than their larger counterparts as dispersants or pigments, or provide a range of other utilities.
However, at such a small scale, nanoparticles are more likely to pass through biological membranes, circulate through the body, and enter cells, potentially causing harm. They can have physical, chemical, and biological properties that differ from larger particles of the same molecules.
Why are nanomaterials in food important to investors?
When technology is used before ensuring that it is safe for humans and the environment, and before regulatory standards exist, companies can be exposed to significant financial, legal, and reputational risk. The limited studies that exist on nanomaterials, including nanoscale titanium dioxide*, have indicated that ingestion of these particles may pose health hazards.
The inaction of regulators does not protect companies, especially when the regulators themselves warn of the dangers of nanoparticles’ largely unknown risks. Draft guidance issued by the U.S. Food and Drug Administration raises questions about the safety of nanoparticles and demonstrates the general lack of knowledge about the technology and its effects. (1)
Asbestos litigation is a good example of the risks that can arise from using an emerging technology before it is proven safe. Use of asbestos (a nanomaterial) has created the longest, most expensive mass tort in national history with total U.S. costs now standing at over $250 billion. (2) If companies been asked to investigate and minimize or avoid risks prior to adopting asbestos technology, a sad and expensive chapter in worker harm could have been avoided.
* Titanium dioxide is a common pigment and FDA-approved food additive. It is used as a whitener, a dispersant, and a thickener.
Are nanomaterials regulated?
The U.S. Food and Drug Administration has yet to enact any nanomaterial-specific regulation. It has released draft guidance for industry that warns of potential danger, noting that:
- Nanoparticles can have chemical, physical, and biological properties that differ from those of their larger counterparts; (3)
- “[w]hen a food substance is manufactured to include a particle size distribution shifted more fully into the nanometer range, safety assessments should be based on data relevant to the nanometer version of the food substance;” (4)
- “FDA has not to date established regulatory definitions of ‘nanotechnology,’ ‘nanoscale’ or related terms;” (5)
- At this time, when considering whether an FDA-regulated product contains nanoparticles or otherwise involves the application of nanotechnology, FDA will ask:
- Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
- Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer;” (6)
Regulatory bodies, insurance corporations, and scientific advisors have criticized the FDA’s inaction and warned of the potential harms of nanotechnology.
- 2008: The insurance giant Swiss Re noted that “what makes nanotechnology completely new from the point of view of insuring against risk is the unforeseeable nature of the risks it entails and the recurrent and cumulative losses it could lead to, given the new properties â€“ hence different behavior — of nanotechnologically manufactured products.”
- 2009: The European Union’s Scientific Committee on Emerging and Newly Identified Health Risks concluded that “health and environmental hazards have been demonstrated for a variety of manufactured nanoparticles,” that “nanoparticles are similar to normal chemicals/substances in that some may be toxic and some may not”, and that “a case-by-case approach for the risk assessment of nanoparticles is still warranted.”
- 2010: A report from the U.S. Government Accountability Office states “the FDA’s approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS [generally recognized as safe] substances without FDA’s knowledge… Because GRAS notification is voluntary and companies are not required to identify nanomaterials in their GRAS substances, FDA has no way of knowing the full extent to which engineered nanomaterials have entered the U.S. food supply as part of GRAS substances. In contrast to FDA’s approach, all food ingredients that incorporate engineered nanomaterials must be submitted to regulators in Canada and the European Union before they can be marketed.”
- 2011: Gen Re noted that “[t]here are, at this time, dozens of studies associating exposure to various nanoparticles with adverse health effects.”
2012: The National Research Council conducted an EPA-requested study of nanotechnology research and found that “despite increasing budgets for nanotechnology-EHS research and a growing number of publications, regulators, decision-makers, and consumers still lack the information needed to make informed public health and environmental policy and regulatory decisions.”
- 2013: The President’s Council of Advisors on Science and Technology, in its assessment of the National Nanotechnology Initiative (NNI), expressed concerns about “a lack of integration between nanotechnology-related [environmental health and safety] research funded through the NNI and the kind of information policymakers need to effectively manage potential risks from nanoparticles.”
What are the effects of ingesting nanomaterials?
Recent research on the ingestion of nanoparticles has raised concerns regarding their toxicity to humans and the environment. (8) Research suggests that nanoparticles of many materials are more biologically active than their normal size counterparts because they have significantly greater surface area per mass. (9) A sample of peer-reviewed studies from the field of nanotoxicology shows that:
- Nanoparticles less than 300 nm are able to pass through cell membranes in organisms, and their interactions with biological systems are relatively unknown. (10)
- Silver nanoparticles have a toxic effect on human and mice testicular cells, suppressing cellular growth and multiplication and causing cell death. (11)
- Mice fed certain kinds of titanium dioxide nanoparticles with their drinking water for 5 days exhibited DNA and chromosomal damage and inflammation. (12)
- Male offspring of pregnant mice injected with certain titanium dioxide nanoparticles experienced genital malformations and neurologic damage (13) as well as changes in gene expression in the brain. (14)
- In vitro studies have suggested that some types of both titanium dioxide and zinc oxide nanoparticles are toxic to human brain and lung cells. (15) (16)
Where can I learn more?
Last year, As You Sow released an issue brief, Slipping Through the Cracks: An Issue Brief on Nanomaterials in Foods. Previously, we released a first-of-its-kind framework is designed to help food companies make informed decisions regarding sourcing products containing nanomaterials.
(1) Food & Drug Administration, 2011, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm
(2) The Economist, Jan. 26 2005, The War on Tort, http://www.economist.com/node/3598225
(3) Food and Drug Administration, Nanotechnology, http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm
(5) Food & Drug Administration, 2011, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm
(6) Considering whether…
(7) Food and Drug Administration, 2012, Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes,” Paragraph III Section E, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm300661.htm
(8) See, e.g., James Yeagle, “Nanotechnology and the FDA,” Virginia Journal of Law & Technology, Summer 2007, Vol. 12, No. 6, http://www.vjolt.net/vol12/issue3/v12i3_a2-Yeagle.pdf.
(9) Oberdorster, G., et al, 2005, Nanotoxicology: An Emerging Discipline Evolving From Studies of Ultraï¬ne Particles (Environmental Health Perspectives), http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1257642/.
(10) Garnett, M.C. and P. Kallinteri, 2006, Nanomedicines and Nanotoxicology: Some Physiological Principles (Occupational Medicine), http://occmed.oxfordjournals.org/content/56/5/307.short.
(11) Asare, N. et al, 2012, Cytotoxic and genotoxic effects of silver nanoparticles in testicular cells (Toxicology), http://www.sciencedirect.com/science/article/pii/S0300483X11004616.
(12) Trouiller, B., et al, 2009, Titanium dioxide nanoparticles induce DNA damage and genetic instability in vivo in mice (Cancer Research), http://jsanderslaw.com/blog/wp-content/uploads/2010/04/nanotechnology-titanium-dioxide-health-issues.pdf.
(13) Takeda, K., et al, 2009, Nanoparticles transferred from pregnant mice to their offspring can damage the genital and cranial nerve systems (Journal of Health Science), http://www.researchgate.net/publication/228666236_Nanoparticles_transferred_from_pregnant_mice_to_their_offspring_can_damage_the_genital_and_cranial_nerve_systems.
(14) Shimizu, M., et al, 2009, Maternal exposure to nanoparticulate titanium dioxide during the prenatal period alters gene expression related to brain development in the mouse (PubMed), http://www.particleandfibretoxicology.com/content/6/1/20.
(15) Lai, J.C., et al, 2008, Exposure to titanium dioxide and other metallic oxide nanoparticles induces cytotoxicity on human neural cells and fibroblasts (International Journal of Nanomedicine), http://www.ncbi.nlm.nih.gov/pubmed/19337421.
(16) Gurr, J.R., et al, 2005, Ultrafine titanium dioxide particles in the absence of photoactivation can induce oxidative damage to human bronchial epithelial cells (Toxicology), http://www.ncbi.nlm.nih.gov/pubmed/15970370.