Washington, DC–(ENEWSPF)–April 27, 2012. After years of no federal regulatory oversight, the U.S. Food and Drug Administration (FDA) last week issued two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries. The documents “encourage” safety assessments for cosmetic products containing nanomaterials, including the need for modification or development of new methods for standardized safety tests. The new guidelines for the first time show the FDA believes nanomaterials deserve greater scrutiny.
Federal Oversight to Increase for Nanomaterials
Nanomaterials have been formulated in consumer products for years without any regulatory oversight. Hundreds of products have been identified as containing nanomaterials, including toys, sunscreens, food packaging, and clothing. 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. Now FDA is recommending that industry consult with the agency on the safety of their products before marketing. The two draft guidance documents, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives” and “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” state that such consultations can help agency experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status.
FDA advised companies that use nanomaterials in food additives or food packaging to consult with the agency and show that changes in manufacturing are safe before selling their products. Usually, manufacturers of most U.S. food additives and ingredients tell the FDA that their ingredients are “generally recognized as safe” in order to legally sell them. FDA now believes nanotechnology does not automatically fall into this category, meaning companies would have to provide additional safety data before approval. For cosmetics, companies should do additional testing of products that use nanotechnology to enhance their products.
“The consequences (to consumers and to the food industry) of broadly distributing a food substance that is later recognized to present a safety concern have the potential to be significant,” the draft guide says. However, these guidelines are just voluntary and may not go far enough in assessing and regulating nanomaterials in consumer products. Currently, cosmetics are not strongly regulated by FDA and cosmetic companies are not required to submit safety data before selling their products. Conversely, the European Union requires companies to prove a product with nanomaterial is safe before it can be sold to consumers. But according to the agency, it is investing in an FDA-wide nanotechnology regulatory science program to further enhance FDA’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products.
“Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices,” said FDA Commissioner Margaret A. Hamburg, M.D. She continued, “We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”
Nanotechnology, the science involving manipulation of materials on an atomic or molecular scale, is an emerging technology with a broad range of potential applications, such as increasing bioavailability of a drug, improving food packaging, and in cosmetics. There are hundreds of products currently on the market that contain nanomaterials of various types and functions, the most popular application being the use of nanosilver as an antibacterial substance in many consumer products. Given this, the federal government at this point is playing a game of ‘catch-up.’ The National Research Council (NRC) released a report earlier this year finding that insufficient understanding remains about the environmental, health, and safety aspects of nanomaterials.
Nanomaterials Affect Plant Growth and DNA
Studies have found that nanomaterials pass easily into cells and affect cellular function, depending on their shape and size. A recent study from the National Institute of Standards and Technology (NIST) and the University of Massachusetts Amherst (UMass) have provided the first evidence that engineered nanoparticles are able to accumulate within plants and damage their DNA. The NIST/UMass researchers first exposed radishes and the two ryegrasses to cupric oxide nanoparticles. Twice as many lesions were induced in plants exposed to nanoparticles as were in those exposed to larger particles. Additionally, the cellular uptake of copper from the nanoparticles was significantly greater than the uptake of copper from the larger particles. The DNA damage profiles for the ryegrasses differed from the radish profiles, indicating that nanoparticle-induced DNA damage is dependent on the plant species and on the nanoparticle concentration. The researchers showed that cupric oxide nanoparticles had a significant effect on growth, stunting the development of both roots and shoots in all three plant species tested. “To our knowledge, this is first evidence that there could be a ‘nano-based effect’ for cupric oxide in the environment where size plays a role in the increased generation and accumulation of numerous mutagenic DNA lesions in plants,” say researchers leading this team. The study, “Copper oxide nanoparticle mediated DNA damage in terrestrial plant models,” was published in Environmental Science and Technology.
Preliminary research with laboratory rats has found that nanoparticles can traverse into the brain, and can induce neuronal degeneration and necrosis (death of cells or tissue) by accumulating in the brain over a long period of time. A study conducted in 2008 and confirmed by another study in 2009 shows that washing nano-silver textiles releases substantial amounts of the nanosilver into the laundry discharge water, which will ultimately reach natural waterways and potentially poison fish and other aquatic organisms. A study found nanosilver to cause malformations and to be lethal to small fish at various stages of development since they are able to cross the egg membranes and move into the fish embryos.
In December 2011, a coalition of six consumer safety groups filed suit against FDA, citing the agency’s chronic failure to regulate nanomaterials used in sunscreens, cosmetics and drugs. The lawsuit demands that FDA respond to a May 2006 petition that the coalition filed in which it calls for regulatory action, including nano-specific product labeling, health and safety testing, and an analysis of the environmental impacts of nanomaterials in products regulated by FDA. FDA rejected this petition.
Last year, EPA announced its intentions to obtain information on nanomaterials in pesticide products to determine whether the registration of a pesticide may cause unreasonable adverse effects on the environment and human health. The agency also proposed a new approach for the agency to consider a nanoscale ingredient as a “new” active or inert ingredient for purposes of scientific evaluation under the pesticide laws. Additionally, the National Organic Standards Board (NOSB) passed a recommendation directing the USDA National Organic Program (NOP) to prohibit engineered nanomaterials from certified organic products as expeditiously as possible. While there is overwhelming agreement to prohibit nanotechnology in organics generally, there is still confusion over the definition of what exactly should be prohibited and how to prohibit nanotech products in the organic industry. The recommendation deals specifically with engineered nanomaterials and purposefully omits those that are naturally occurring. Further it would block petitions seeking an exemption and keep nanomaterials out of food packaging and contact surfaces.
For more information on nanotechnology, visit Beyond Pesticides’ program page.
Sources: Reuters, FDA News Release, and NIST Tech Beat, http://www.beyondpesticides.org
All unattributed positions and opinions in this piece are those of Beyond Pesticides.