Nanotechnology: Too small to be ignored

by Jay Sjerven
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The Food and Drug Administration on April 20 issued a draft guidance advising food manufacturers on what they should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change in food substances.

The draft guidance titled “Assessing the effects of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food contact substances, including food ingredients that are color additives” was distributed for comment purposes only.

Nanotechnology generally is defined as the control and restructuring of matter at the nanoscale, in the size range of approximately 1 to 100 nanometers, in order to create materials, devices and systems with fundamentally new properties and functions due to their small structure. A nanometer is one-billionth of a meter (the thickness of a human hair is about 75,000 nanometers).

The F.D.A. said nanotechnology has the potential to be used in a broad array of F.D.A.-regulated products, including foods. The F.D.A. noted nanomaterials, materials developed from using nanotechnology, may have different chemical, physical, or biological properties than their conventionally-scaled counter-part materials used in many products regulated by the agency. This may “introduce
issues that warrant additional or different evaluation during a safety assessment of a food substance,” the F.D.A. said.

“The F.D.A. has long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies,” the agency said. “Nanotechnology is not unique in this regard. The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting also may merit examination to determine any effects on product safety, effectiveness, or other attributes.”
The F.D.A. said understanding nanotechnology was one of its top priorities. The agency said it is monitoring the evolving science and has a “robust” research agenda it said would help assess the safety and effectiveness of products using nanotechnology.

Efforts are under way to develop a nanotechnology regulatory science program to enhance the F.D.A.’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products. The F.D.A. said that, in general, it considers the current framework for safety assessments sufficiently robust and flexible to be appropriate for a variety of materials, including nanomaterials.

“F.D.A. is maintaining a product-focused and science-based regulatory policy to appropriately regulate products using this emerging technology,” the agency said.  It will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. The agency said it was taking a “prudent scientific approach to assess each product on its own merits, and does not make broad, general assumptions about the safety of nanotechnology products.”

The draft foods guidance alerted manufacturers to the potential impact of any significant manufacturing process change, including those involving nanotechnology, on the safety and regulatory status of food substances. The guidance said manufacturers should consider how the process affects the identity of the food substance, how it affects the safety of the use of the food substance, how it affects the regulatory status of the use of the food substance, and if it warrants a regulatory submission to the F.D.A.

The guidance recommended that manufacturers consult with the F.D.A. regarding any significant change in manufacturing process for a food substance already in the market “irrespective of your conclusion about whether that change affects the safety or regulatory status of the food substance.”

“It is prudent practice for you to do so, particularly when the change in manufacturing process involves emerging technology,” the agency said. “Food substances may be used in a wide array of products manufactured, distributed and sold at retail by a large number of firms. 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 F.D.A. intends to ensure transparent and predictable regulatory pathways grounded in the best available science.

“One size does not fit all,” the F.D.A. said. “We intend our regulatory approach to be adaptive and flexible. It is necessary for technical assessments to be product-specific, taking into account the effects of nanomaterials in the particular biological and mechanical context of each product and its intended use.”
The F.D.A. guidance asserted, “Industry remains responsible for ensuring that its products meet all applicable legal requirements, including standards for safety — regardless of the emerging nature of a technology involved in the manufacturing of a product. F.D.A. encourages industry to consult early with the agency to address any questions related to the safety, effectiveness, or other attributes of products that contain nanomaterials, or about the regulatory status of such products.”

The agency also stated, “We expect that there will be circumstances where a significant change in manufacturing process impacts the safety, regulatory status, or both, of a food substance. In such circumstances, a new regulatory submission may be necessary to clearly establish the conditions under which the food substance, manufactured by a new process, is safe and lawful. In the case of emerging technologies, a manufacturing process may alter the identity or intended use of the food substance and a new authorization may be required.”

The Institute of Food Technologists in a recent background document indicated research into novel food-related nanomaterials was ongoing in a number of areas such as food packaging; food quality, safety and defense; food ingredients and nutrient delivery systems; and food processing. It indicated commercial applications in foods are still limited partly because of incomplete knowledge of the potential safety implications relative to human health and the environment.

The I.F.T. indicated the current regulatory approach worldwide was on a case-by-case basis, which it said make it difficult to predict costs and the timeframe from research to market for nano-based products. It said there was a need for specific guidance for safety testing to aid investment and innovation and to safeguard consumers, communities, workplaces and the environment.

The draft guidance was issued by the F.D.A. in part to begin to address those concerns.

David Acheson of Leavitt Partners, a former top ranking F.D.A. official, said the draft guidance was a signal to the food industry that the F.D.A. considers this an important emerging technology with promise but also risks. Dr. Acheson pointed to the experience with bio-engineering in crops and food, which to this day, despite ample scientific evidence it is benign with regard to food safety and human health when used and regulated properly, still is resisted by many consumers and even national governments. He said, too, the F.D.A. was suggesting that it as well as industry were at the early stages in understanding the implications of the use of nanotechnology in food manufacture, and they were apt to learn together.

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