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U.S. national organic program approves ban on engineered nanomaterials from organic products

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Courtesy of Bergeson & Campbell, P.C.

On December 17, 2010, the US National Organic Program (NOP) voted to accept the recommendation of the US National Organic Standards Board (NOSB) to prohibit engineered nanomaterials from the production, processing, and packaging of certified organic products. The decision was made with little fanfare, but has big implications.

Background

The NOP is a federal program managed under the U.S. Department of Agriculture (USDA). Farmers and others wishing to use the coveted term 'organic' on their products must be 'certified' organic. The NOP develops, implements, and administers national production, handling, and labeling organic standards.

According to the NOSB's October 28, 2010, statement summarizing its recommendations, there is 'overwhelming agreement' within the organic industry to 'prohibit nanotechnology in organic production and processing at this time.' The concern chiefly expressed is the ability of the NOP to 'control two of the major sources of contamination in final organic food products: food contact surfaces and primary packaging. This subject is further complicated since nanotechnology is a new and developing technology.'

A 'technical review' initiated earlier to assist in framing the NOSB's discussion was requested to address key technical issues. The review was prompted in part by questions the NOSB's Materials Committee had asked, as well as public comment that had been received on the topic previously.

The technical review identified three sources of nanosized materials pertinent to the food industry: natural, incidental, and engineered. According to the technical review report, natural nanosized products such as corrosion particles and sea spray are not practical to prohibit. Incidentally produced nanosized particles, including those created in traditional production methods (grain milling and milk homogenization) similarly have been present in materials utilized within the crops, livestock, and food industries for many years and are 'not the areas of concern.' As for the third category, engineered nanosized materials, the technical report referred to the Materials Committee proposed definition for engineered nanomaterials, which was as follows:

substances deliberately designed, engineered and produced by human activity to be in the nanoscale range (approx 1-300 nm) because of very specific properties or compositions (eg. shape, surface properties, or chemistry) that result only in that nanoscale. Incidental particles in the nanoscale range created during traditional food processing such as homogenization, milling, churning, and freezing, and naturally occurring particle in the nanoscale range are not intended to be included in this definition. All nanomaterials (without exception) containing capping reagents or other synthetic components are intended to be included in this definition.

Based on the technical report, the Materials Committee of the NOSB formally proposed to the NOP last October that it would do the following: accept the proposed definition of engineered nanomaterials stated above; disallow the engineered nanomaterials form of substances currently on the National List of Allowed Prohibited Substances (NL) since, according to the Committee, this form of listed materials has not been reviewed; accept materials that meet the working definition of engineered nanomaterials as synthetic substances even when those same materials in bulk form are non-synthetic; accept that engineered nanomaterials 'may have unique properties that distinguish them from all listings of these substances in a bulk form, and that they are not allowed by a listing of the bulk form of the substance on the NL, pending a further recommendation from the NOSB'; work with the NOSB to determine whether enforcement of restrictions in primary packaging and food contact surfaces is possible, practical, and legal; and work with the NOSB to schedule a symposium on the topic of engineered nanomaterials to aid in evaluating all of these issues.

NOP Response to NOSB Recommendations

On December 17, 2010, the NOP voted to accept the recommendations of the NOSB. According to the NOP, 'the lack of a legal definition is one of the biggest obstacles to regulating nanomaterials' and, due to the absence of 'legal agreement' on a definition of nanomaterials, 'it would be difficult for organic producers and handlers, certifying agents, and the NOP to identify the presence of nanomaterials and verify their absence in organic products.' The NOP also stated that it 'intends to gather additional information about how nanomaterials are regulated and used in agricultural production and handling.' Instead of convening a symposium, however, the NOP expressed its preference for 'gather[ing] information from other agencies that are reviewing their regulatory oversight of nanomaterials and report back to the NOSB.'

For nano stakeholders, none of this is especially welcome news. Any wholesale ban on 'engineered nanoscale materials' reflects adversely on the technology and products of the technology that are purely size-driven. Importantly also, it is regrettable that the NOP opted to reject convening a public symposium that could attract a diverse community of stakeholders committed to discuss key issues in an open forum instead of a less transparent NOP information collection exercise. Many believe an open forum would yield a better understanding of how applications of nanotechnology are used in the food production and processing industry.

The process going forward is unclear. The prohibition has been formally accepted by the NOP and this development alone is stigmatizing to nanoscale materials generally. Whether and how the NOP is gathering information in a way that informs its judgment on implementing the recommendation is equally unclear.

Regardless of the merits of the NOP's' decision to adopt the prohibition, nano stakeholders may wish to urge the NOP to reconsider its decision to defer a symposium and urge it to convene a public symposium as soon as possible to ensure that all views are fairly and openly considered.

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