NANO TECHNOLOGY
What Is Nanotechnology?
Nanotechnology is science, engineering, and technology conducted at the nanoscale, which is about 1 to 100 nanometers. Physicist Richard Feynman, is the father of nanotechnology.
Nanoscience and nanotechnology are the study and application of extremely small things and can be used across all the other science fields, such as chemistry, biology, physics, materials science, and engineering.
Nanotechnology is the manipulation of matter on a near-atomic scale to produce new structures, materials and devices. The technology promises scientific advancement in many sectors such as medicine, consumer products, energy, materials and manufacturing. Nanotechnology refers to engineered structures, devices, and systems.
Nanotechnology is the understanding and control of matter at the nanoscale, at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. Matter can exhibit unusual physical, chemical, and biological properties at the nanoscale, differing in important ways from the properties of bulk materials, single atoms, and molecules.
Some nanostructured materials are stronger or have different magnetic properties compared to other forms or sizes of the same material. Others are better at conducting heat or electricity. They may become more chemically reactive, reflect light better, or change color as their size or structure is altered.
Although modern nanoscience and nanotechnology are relatively new, nanoscale materials have been used for centuries. Gold and silver nanoparticles created colors in the stained-glass windows of medieval churches hundreds of years ago. The artists back then just didn’t know that they were using nanotechnology to create these beautiful works of art! Nanotechnology encompasses nanoscale science, engineering, and technology in fields such as chemistry, biology, physics, materials science, and engineering. Nanotechnology research and development involves imaging, measuring, modeling, and manipulating matter between approximately 1–100 nanometers.
FDA’s Action on Nanotechnology
FDA’s Approach to Regulation of Nanotechnology Products
Fundamental Concepts in Nanoscience and Nanotechnology
Nanotechnology Overview
Nanotechnology is an emerging technology that has the potential for use in a broad array of FDA-regulated products, including medical products, foods and cosmetics. Nanomaterials, developed using nanotechnology, are measured in nanometers — equal to about one-billionth of a meter — so small that they cannot be seen with a regular microscope. These nanomaterials can have different chemical, physical, or biological properties than their conventionally-scaled counterpart materials used in many products regulated by FDA.
FDA has long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies. 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. Understanding nanotechnology remains a top FDA priority. FDA is monitoring the evolving science and has a robust research agenda to help assess the safety and effectiveness of products using nanotechnology.
FDA is investing in a 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. In general, the agency considers the current framework for safety assessments sufficiently robust and flexible to be appropriate for a variety of materials, including nanomaterials.
FDA is maintaining a product-focused and science-based regulatory policy to appropriately regulate products using this emerging technology. Legal standards vary among various product-categories that FDA regulates. FDA 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 is 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.
FDA’s Action on Nanotechnology
In 2006, the acting Commissioner of Food and Drugs charged FDA's Nanotechnology Task Force with issuing a report to determine regulatory approaches that would enable the continued development of innovative, safe, and effective FDA-regulated products that use nanoscale materials. The Nanotechnology Task Force was asked to identify and recommend ways to address any knowledge or policy gaps that exist to better enable the agency to evaluate safety aspects of FDA-regulated products that contain nanoscale materials. The Nanotechnology Task Force published the report in July 2007 and, among other things, the report presented recommendations to the Commissioner for actions the agency can take in furtherance of its mission to protect and promote the public health. Please click here to view the full report.
Since this report published, FDA issued several guidance documents on topics relating to application of nanotechnology in FDA-regulated products. While guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public, they do represent FDA's current thinking on a topic. Click here for more information about FDA's nanotechnology guidance documents.
FDA’s Approach to Regulation of Nanotechnology Products
FDA will continue to regulate nanotechnology products under its existing statutory and regulatory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. FDA intends to ensure transparent and predictable regulatory pathways grounded in the best available science.
- FDA does not make a categorical judgment that nanotechnology is inherently safe or harmful. We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nano materials in the particular biological context of each product and its intended use.
- Particular approaches for each product area will vary according to the statutory authorities. The scope and issues covered in the product-specific guidance documents reflect this approach.
- FDA’s nanotechnology regulatory science research portfolio focuses on understanding interactions of nano materials with biological systems; and on the adequacy of testing approaches for assessing safety, effectiveness, and quality of products containing nano materials.
- FDA’s regulatory policy approach is consistent with relevant overarching U.S. government policy principles, and supports innovation under appropriate oversight.
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. FDA encourages industry to consult with the Agency early in the product development process 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. Early consultations with FDA facilitate a mutual understanding of the specific scientific and regulatory issues for nanotechnology products. Click here for more information on FDA's approach to regulation of nanotechnology products.
FDA Nanotechnology-programs fact-sheet
Nanotechnology involves the understanding and control of matter at the nanometer-scale. The so-called nanoscale deals with dimensions between approximately 1 and 100 nanometers.
A nanometer is an extremely small unit of length—a billionth (10-9) of a meter. Just how small is a nanometer (nm)? A single human hair is about 80,000 to 100,000 nm wide.
On the nanometer-scale, materials may exhibit unusual properties. When you change the size of a particle, it can change color, for example. That’s because in nanometer-scale particles, the arrangement of atoms reflects light differently. Gold can appear dark red or purple, while silver can appear yellowish or amber-colored.
Nanotechnology can increase the surface area of a material. This allows more atoms to interact with other materials. An increased surface area is one of the chief reasons nanometer-scale materials can be stronger, more durable, and more conductive than their larger-scale (called bulk) counterparts.
Nanotechnology is not microscopy. "Nanotechnology is not simply working at ever smaller dimensions," the National Nanotechnology Initiative says. "Rather, working at the nanoscale enables scientists to utilize the unique physical, chemical, mechanical, and optical properties of materials that naturally occur at that scale."
Scientists study these properties for a range of uses, from altering consumer products such as clothes to revolutionizing medicine and tackling environmental issues.
Classifying Nanomaterials
There are different types of nanomaterials, and different ways to classify them.
Natural nanomaterials,
as the name suggests, are those that occur naturally in the world. These include particles that make up volcanic ash, smoke, and even some molecules in our bodies, such as the hemoglobin in our blood. The brilliant colors of a peacock’s feathers are the result of spacing between nanometer-scale structures on their surface.
Artificial nanomaterials
are those that occur from objects or processes created by people. Examples include exhaust from fossil fuel burning engines and some forms of pollution. But while some of these just happen to be nanomaterials—vehicle exhaust, for instance, was not developed as one—scientists and engineers are working to create them for use in industries from manufacturing to medicine. These are called intentionally produced nanomaterials.
National Nanotechnology Initiative National Geographic Nanotechnology
Fundamental Concepts in Nanoscience and Nanotechnology
It’s hard to imagine just how small nanotechnology is. One nanometer is a billionth of a meter, or 10-9 of a meter. Here are a few illustrative examples:
- There are 25,400,000 nanometers in an inch
- A sheet of newspaper is about 100,000 nanometers thick
- On a comparative scale, if a marble were a nanometer, then one meter would be the size of the Earth
Nanoscience and nanotechnology involve the ability to see and to control individual atoms and molecules. Everything on Earth is made up of atoms—the food we eat, the clothes we wear, the buildings and houses we live in, and our own bodies.
But something as small as an atom is impossible to see with the naked eye. In fact, it’s impossible to see with the microscopes typically used in a high school science classes. The microscopes needed to see things at the nanoscale were invented in the early 1980s.
Once scientists had the right tools, such as the Scanning tunneling microscope (STM) and the atomic force microscope (AFM), the age of nanotechnology was born.
Although modern nanoscience and nanotechnology are quite new, nanoscale materials were used for centuries. Alternate-sized gold and silver particles created colors in the stained glass windows of medieval churches hundreds of years ago. The artists back then just didn’t know that the process they used to create these beautiful works of art actually led to changes in the composition of the materials they were working with.
Today's scientists and engineers are finding a wide variety of ways to deliberately make materials at the nanoscale to take advantage of their enhanced properties such as higher strength, lighter weight, increased control of light spectrum, and greater chemical reactivity than their larger-scale counterparts.
Worker Risks
Workers within nanotechnology-related industries may experience exposure to uniquely engineered materials. This includes novel sizes, shapes, and physical and chemical properties. Occupational health risks associated with manufacturing and using nanomaterials are not yet clearly understood. Minimal information is currently available on dominant exposure routes, potential exposure levels, and material toxicity of nanomaterials.
Current Research
Studies have indicated that low solubility nanoparticles are more toxic than larger particles on a mass for mass basis. Particle surface area and surface chemistry are strong indicators for observed responses in cell cultures and animals. Studies suggests that some nanoparticles can move from the respiratory system to other organs. Research is continuing to understand how these unique properties may lead to specific health effects.
The NIOSH Effort
NIOSH leads the federal government health and safety initiative for nanotechnology. The NIOSH Nanotechnology Research Center (NTRC), established in 2004, coordinates research and activities.
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