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27
Jan

Report Calls for Greater Review of Nanomaterials While Suit Seeks to Block Nanosilver Approval

(Beyond Pesticides, January 27, 2012) The National Research Council (NRC) released a report on Wednesday, finding that, despite extensive investment in nanotechnology and increasing commercialization over the last decade, insufficient understanding remains about the environmental, health, and safety aspects of nanomaterials. Just one day later, a lawsuit was filed in court by the Natural Resources Defense Council challenging approval by the U.S. Environmental Protection Agency (EPA) of a particular nanomaterial, nanosilver, citing the lack of scientific grounding. The suit, filed in the 9th U.S. Circuit Court of Appeals in San Francisco, seeks to block EPA from allowing nanosilver on the market without legally-required data about its suspected harmful effects on humans and wildlife. Starting in December 2011, EPA allowed the company HeiQ Materials to sell nanosilver used in fabrics for the next four years as the company generates the required data on toxicity to human health and aquatic organisms.

According to the NRC report, without a coordinated research plan to help guide efforts to manage and avoid potential risks, the future of safe and sustainable nanotechnology is uncertain. The report presents a strategic approach for developing research and a scientific infrastructure needed to address potential health and environmental risks of nanomaterials. Its effective implementation would require sufficient management and budgetary authority to direct research across federal agencies.

Nanoscale engineering manipulates materials at the molecular level to create structures with unique and useful properties -materials that are both very strong and very light, for example. 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.

Nanotechnology is a powerful new platform 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. Scientists and researchers are becoming increasingly concerned with the potential impacts of these particles on public health and the environment. A 2010 study by scientists from Oregon State University and the European Union highlights the major regulatory and educational issues that they believe should be considered before nanoparticles are used in pesticides.

The NRC committee that wrote the report found that over the last seven years there has been considerable effort internationally to identify research needs for the development and safe use of nanotechnology, including those of the National Nanotechnology Initiative (NNI), which coordinates U.S. federal investments in nanoscale research and development. However, there has not been sufficient linkage between research and research findings and the creation of strategies to prevent and manage any risks. For instance, little progress has been made on the effects of ingested nanomaterials on human health and other potential health and environmental effects of complex nanomaterials that are expected to enter the market over the next decade. Therefore, there is the need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges, the committee said.

Implementation of the committee’s recommended research strategy should also include the integration of domestic and international participants involved in nanotechnology-related research, including the NNI, federal agencies, the private sector, non-governmental organizations, and the academic community. The committee said that the current structure of the NNI -which has only coordinating functions across federal agencies and no top-down budgetary or management authority to direct nanotechnology-related environmental, health, and safety research- hinders its accountability for effective implementation. In addition, there is concern that dual and potentially conflicting roles of the NNI, such as developing and promoting nanotechnology while identifying and mitigating risks that arise from its use, impede application and evaluation of health and environmental risk research. To carry out the research strategy effectively, a clear separation of management and budgetary authority and accountability between promoting nanotechnology and assessing potential environmental and safety risks is essential.

In May 2008, the International Center for Technology Assessment (ICTA) and a coalition of consumer, health, and environmental groups, including Beyond Pesticides, filed a legal petition with EPA, demanding the agency use its pesticide regulation authority to stop the sale of 250+ consumer products now using nanosized versions of silver. As a result of this petition, EPA announced plans to obtain information on nanoscale materials in pesticide products.

Additionally, in December 2011, a coalition of six consumer safety groups filed suit against the U.S. Food and Drug Administration (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 the coalition filed calling for regulatory actions, including nano-specific product labeling, health and safety testing, and an analysis of the environmental impacts of nanomaterials in products regulated by FDA. The lawsuit cites numerous studies and reports published since 2006 that establish significant data gaps concerning nanomaterials’ potential effects on human health and the environment. Led by ICTA, the coalition calls for FDA to take immediate action to assess the actual risks from nanomaterials and implement appropriate protective measures for consumers. FDA recently released draft guidelines to industries about when the use of nanomaterials might trigger regulatory interest.

In October 2010, the National Organic Standards Board passed a recommendation directing the USDA National Organic Program 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.

In the meantime, consumer products that contain nanosilver and other nanomaterials continue to grow with little to no regulatory oversight. So far, there are hundreds of products with nanosilver from toys to band-aids. For more information on nanosilver, visit Beyond Pesticides’ antibacterials page.

Source: The National Academies

All unattributed positions and opinions in this piece are those Beyond Pesticides.

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