Nanotechnology

 Every day, nanotechnology, the miniaturization of particles in the industrial and manufacturing process down to a billionth of a meter in size, is changing the way we live and work—starting with the food we consume, the cars we drive and the medicines we are developing.  After many years of basic nanoscience research and focused R&D under the National Nanotechnology Initiative (NNI), nanotechnology aims to revolutionize industries with applications for medicine, vaccines, food safety, environmental science, energy, information technology, homeland security and transportation.  As we look to recover from the first wave of the global pandemic and prepare for a potential second wave, no matter who wins the November elections in the United States, nanotechnology will play an important role.

What Is It?

Nanoscience and nanotechnology are the studies and applications of things as tiny as a billionth of a meter in size, which are then used across the scientific fields of chemistry, biology, physics, materials science, and engineering for industrial purposes.  The quantum mechanical effects across these scientific fields give rise to the “fourth industrial revolution,” the paradigm-shifting movement coined by World Economic Forum founder Klaus Schwab that changes the way we live and work, as the physical, digital and biological spheres of science and engineering converge.

Nanotechnology manipulates the molecular structure of materials to change their intrinsic properties and derive others. This process involves the ability to see and control atoms and molecules. To put things into perspective, everything on Earth is made up of atoms— food, clothes, cars, homes, and even our bodies. However, something as small as an atom is impossible to see. Special microscopes needed to see things at the nanoscale were invented about 30 years ago. Once scientists had the right tools, nanotechnology was born.

Today’s scientists and engineers are finding new ways to make materials at the nanoscale to exploit properties like higher strength, lighter weight, increased control of the light spectrum, and more.

Market Applications for Nanotechnology

To understand how nanotechnology is changing the way we live and work, and bringing about the convergence of physical, digital and biological spheres of science and engineering, consider the market applications for nanotechnology in these areas:

Electronics: Carbon nanotubes are on the brink of replacing silicon and can be used to make faster, smaller, and more efficient microchips and devices, as well as lighter and stronger quantum nanowires. Graphene’s properties make it ideal for developing flexible touchscreens.

Wearables: Carbon nanotubes and dielectric elastomers present in fitness trackers allow us to keep a record of fitness metrics such as pulse rate, blood pressure, and to come up with therapeutic solutions.

Energy: A semiconductor developed by Japan’s Kyoto University makes it possible to manufacture solar panels that double the amount of sunlight converted into electricity. Over time, quantum dot solar cells will further increase the efficiency of solar panels.  Nanoparticles in lubricants reduce friction produced by the spinning of wind-turbine blades, increasing the life span of the device, while nanocomposites lead to stronger and lighter blades. Throughout the entire energy industry, nanotechnology is helping to reduce costs and improve fuel efficiency.

Biomedicine: The properties of nanomaterials make them ideal for improving early diagnosis and treatment of neurodegenerative diseases or cancer. They can attack cancer cells selectively without harming other healthy cells.  Biosensors will detect biomarkers of disease and someday deliver drugs with thin films.

Environment: Wastewater purification with nanobubbles, air purification with ions, or nanofiltration systems for heavy metals are some of its environmentally friendly applications.  As the global population grows, we will increasingly rely on nanofiltration to safely disinfect and clean water for reuse.

Food: Nanobiosensors can detect pathogens or nanocomposites to improve food production by increasing mechanical and thermal resistance and decreasing oxygen in packaged products.

Fuel: Nanotechnology can ameliorate the shortage of fossil fuels by producing fuels from low-grade raw materials more economically as well as by increasing the mileage of engines.

Fabrics: Nanotechnology makes it possible to develop smart fabrics that don’t stain or wrinkle as well as fabrics that are lighter and more durable. Scientists are also finding new ways to use nanoparticles for coating fabrics—with a thin layer of zinc oxide, clothing remains unharmed from UV rays.

Regulatory Landscape

From a regulatory perspective, nanotechnology falls under the FDA because of safety issues surrounding the use of medical and personal consumer products. The FDA has given its support for nanotechnology in innovative new products. However, it also plans to establish regulatory guidelines grounded in existing practices and the available science.

In July 2020, the FDA issued a report on the last decade of nanotechnology’s progress and innovation, with a roadmap for international standardization and regulation to anticipate emerging challenges, build and share regulatory science knowledge, facilitate innovation and coordinate policy.

The FDA’s technical evaluations will be product-specific, considering nanomaterials’ effects from each product and its specific use. Manufacturers may want to seek advice from the agency early in the development phase to expedite a mutual knowledge of their nanotechnology products’ scientific and regulatory issues.

When evaluating food additives, the FDA looks to mitigate any potential risk from the use of nanotechnology products. On the other hand, medications are examined not just based on their risk profile but also with regard to their expected benefit.

Over the past 15 years, the FDA has issued interpretive releases on how to regulate nanotechnology, including:

• Whether a product should be regulated;
• Nanomaterials in cosmetics;
• Manufacturing process changes on the safety of food ingredients and food for animals; and
• Biological products containing nanomaterials

These various legal standards show how multiple contexts could result in various regulatory outcomes, even if products have a similar degree of risk. The FDA said it would continue post-market tracking of nanotechnology products and would take regulatory action as needed. It has also emphasized that industry must take primarily accountability for making sure products meet applicable legal guidelines. Just as with conventional products, manufacturers will need to ensure that their nanotechnology products meet appropriate safety standards and comply with regulations.

The FDA’s future regulatory roadmap includes participating in international standards development and performing prospective regulatory science on emerging technologies.

In the United States, there has been broad bipartisan support of research and development for nanotechnology, which is expected to continue no matter who wins the upcoming elections.

Welcome to the Future

As we look to the future, we see nanotechnology on track for significant global expansion, driven by increased government support, technological advances, private investment, and increased demand for smaller devices. In the midst of a global pandemic, its applications for preventative care and remedial therapies are critical.  Wide-spread adoption is always at risk, however, from any potential environmental, health or safety events.

Nanotechnology is changing the way we live and work, and legal and regulatory regimes will need to adapt to enable new products in new markets.  Lawyers and policy makers should zoom in and examine how to make it happen quickly and safely.