FDA Voice: Thank you for taking time to discuss the exciting field of Nanotechnology with us. We’ve heard so much about Nanotechnology – what is it exactly and why has it been tagged as the second industrial revolution?
Dr. Howard: Thank you for the opportunity. It’s been tagged as the “second industrial revolution,” because of its ability and promise to create new materials with new properties. Decreasing larger-size materials down to sizes in the nano domain may change the properties of these materials. This could have enormous benefits in many arenas. That’s why there is considerable worldwide investment and research for product performance improvement, usefulness, and marketability using nanotechnology.
Nanotechnology is the science of manipulating materials on a scale so small that they can’t be seen with a regular microscope. The technology could have a broad range of applications, such as increasing the effectiveness of a particular drug, improving the packaging of food, or altering the look and feel of a cosmetic.
Nanotechnology could also be used in medicines designed for the detection, treatment, and prevention of disease; food production and preservation; water decontamination and purification; environmental remediation; lighter and stronger materials for construction and transportation; and energy resources such as solar cells and fuel-efficiency additives, just to name a few.
FDA Voice: Is Nanotechnology considered a new field?
Dr. Howard: Nanomaterials are not new. They have been around as a result of natural and man-made processes for a long time; however, the ability to see and the ability to manipulate matter at the nanoscale are relatively new.
Nanotechnology draws from several science fields like physics, material science, supra-molecular and polymer chemistry, interface and colloidal science, as well as from the chemical, mechanical, biological, and electrical engineering fields.
FDA Voice: If nanotechnology-sized particles are so tiny, how can you actually see them?
Dr. Howard: The best light microscopes you can look through with the human eye get close to seeing materials on the nano scale. However, to best view nanomaterials, electron microscopes are needed.
Typically, “transmission” electron microscopes – either like an X-ray, where the electrons go through the material – or “scanning” electron microscopes – which bounce electrons off the surface of the object to give stunning three-dimensional images, are used.
Another type of microscope is the atomic force microscope. Fundamentally, it is a bit like an old phonograph, with an arm with a tiny tip on the end (stylus) and it “feels” along the surface. When it encounters a nanomaterial, or larger, it deflects, giving a measure of its height.
At the National Center for Toxicological Research (NCTR) and the adjacent FDA Office of Regulatory Affairs laboratory, we use all three types of microscopes to image the smallest nanomaterials.
FDA Voice: How does nanotechnology impact FDA research?
Dr. Howard: Nanotechnology can be used in FDA-regulated products and we are aware that materials that exist in the nanoscale may have unique properties, and thus may warrant examination.
FDA participates in research programs with collaborating federal agencies to understand the behavior of nanomaterials in biological systems, especially any risk of short- or long-term toxicity. FDA also collaborates with the National Nanotechnology Initiative (NNI), which serves as the central point of communication, cooperation, and collaboration for all Federal agencies engaged in nanotechnology research.
FDA Voice: Finally, please tell us about the Nanotechnology Core Facility at FDA’s National Center for Toxicological Research.
Dr. Howard: FDA is investing in an FDA-wide nanotechnology regulatory science program that further enhances FDA’s scientific capabilities, including Laboratory Core Facilities, to support regulatory science.
FDA’s Nanocore facilities are located in Maryland and at FDA’s Jefferson Laboratories just south of Little Rock, Arkansas. The Arkansas Nanocore facility is a joint effort between FDA’s NCTR and Office of Regulatory Affairs’ Arkansas Regional Laboratory. Both facilities are co-located on the Jefferson Laboratories campus.
Nanocore has been designed to support research scientists by providing the equipment and knowledge to characterize nanomaterials. Nanocore also anticipates the needs of scientists by being involved in developing methods to detect nanomaterials in biological samples following the use of nanomaterials in biology experiments.
Characterization is very important in any science endeavor, especially research where you are trying to understand the relationship between an object and its good or bad properties when it is in a biological system.
For example, characterization for nanomaterials includes the average size, the aggregation (where they stick together to form a larger mass), shape, chemical composition and purity, surface area, chemistry properties on the surface, chemical/electrical charge on the surface, and stability. A good description of these is at Characterization Matters, Nanocore experts work with scientists who need to understand nanomaterial behavior or toxicity and support the work of other scientists who investigate the safety of nanomaterials that may be used in FDA-regulated products. We also characterize the nanomaterials before, during, and after biology or toxicology experiments. Since the equipment and expertise are centralized into this core facility, FDA Nanocore operations also serve as a training resource for FDA regulatory scientists in nanomaterial characterization and detection methods.
Paul C. Howard, Ph.D., is the Director of the Office of Scientific Coordination and Director of the Nanotechnology Core Facility at FDA’s National Center for Toxicological Research near Jefferson, Arkansas.