Controlling Atomic and Molecular Matter - Standards in Nanotech

Regulating nanotechnology remains a challenge because of the diversity of nanomaterials and their applications, the lack of characterisation data and a lack of standardisation in nomenclature and statutory authority.

The multidisciplinary nature of nanotechnology endeavours makes them difficult to communicate. Also, the information needed to adequately regulate nanotechnologies may be proprietary, and there are limited resources devoted to the task.

Nanotechnology and Its Definitions

Nanotechnology is an important and rapidly growing field of scientific and practical innovation that will fundamentally transform our understanding of how materials and devices interact with human and natural environments. These transformations may offer great benefits to society such as improvements in medical diagnostics and treatments, water and air pollution monitoring, solar photovoltaic energy, water and waste treatment systems, and many others. 

Nanotechnology refers to the development and application of materials, devices and systems with fundamentally new properties and functions that derive from their small size structure (in the range of about 1 to 100 nanometers) and from the recent ability to work with and manipulate materials at this scale.

“Lack of common terminology and the difficulty relating it to regulators and decision-makers in companies makes it a challenge to grasp.”

At the nanoscale, the physical, chemical, and biological properties of materials differ in fundamental and valuable ways from the properties of individual atoms and molecules or bulk matter. Downsized material structures of the same chemical elements change their mechanical, optical, magnetic and electronic properties, as well as their chemical reactivity, leading to novel applications for industry, healthcare and consumer goods.

Defining nanomaterials for regulatory purposes is a significant hurdle that has yet to be overcome. Some have defined the upper limit of nanomaterials as being those that measure 1000 nanometers, which covers many nano-size products already on the market. In contrast, the National Nanotechnology Initiative (NNI) and the FDA define that upper limit as being 100 nm. 

Lack of common terminology and the difficulty relating it to regulators and decision-makers in companies makes it a challenge to grasp. How nanotechnology is defined, certainly affects how they are regulated. 

Nanotechnology is used in the medical field as it is able to cross the blood-brain barrier to administer targeted medication.

The Good and the Bad

It is beyond doubt that Nanotechnology has the potential to deliver important health, safety and environment benefits such as curing, managing or preventing diseases; offering new safety enhancing materials that are stronger, self-repairing, and able to adapt to provide protection; efficiently reduce energy consumption; reduce the impact of pollution and assist in clean-up efforts; reduce greenhouse gas emission and remediating environment damage. 

Its uses in the medical field is not short of groundbreaking – Nanoscale silver, which is a highly effective antibacterial agent, can be used in wound dressings to expedite recovering and keep the wound clean. However, there are always two sides to the coin. Experts have expressed concerns that widespread dispersion of nanoscale silver in the environment could kill microbes that are vital to wastewater treatment plants and to ecosystems. Some beneficial bacteria, for example, break down organic matter, remove nitrogen from water, aid in animal digestion, protect against fungal infestations and even aid some animals in defence against predators.

Another benefit is that nanoscale particles – being minuscule – are said to be able to cross the blood-brain barrier. This allows the administration of targeted medication to treat brain tumours. While the potential for this is favourable, one must remember that the effects of nanoscale particles on humans have yet to be thoroughly studied. 

“Nanotechnology has the potential to deliver important health, safety and environment benefits such as curing, managing or preventing diseases; offering new safety enhancing materials that are stronger, self-repairing, and able to adapt to provide protection”

Aside from that, nanotechnology can be applied to E&E and the manufacturing sector. Memory devices, electronics, conductors, sensors and batteries are among the few components that can benefit from this technology. 

To leverage on its benefits and address its challenges, the Malaysian government has established well-equipped Nanoscience research centres such as Institute of Microengineering and nanotechnology (IMEN), Universiti Kebangsaan Malaysia; Advanced Materials Research Centre (AMREC) of SIRIM Bhd; and the Combinatorial Technology and Catalysis Research Centre (COMBICAT), Universiti Malaya.

As one of the priority areas in STEM education, there is an ever-increasing number of postgraduates in nanoscience/advanced materials. The government has introduced the National Science Fellowship (NSF) scheme, which is open to post-graduate studies in nanoscience and technology.

Nanotechnology is used in electronics to enable enhanced performance and even more data storage.

Calls for Standardisation

There are several calls for standardisation in terminology and metrics as having an appropriately descriptive term in the label insert of nanomedicine is vital for clinicians to make informed decisions. 

Definition of nanotechnology needs to be flexible. There may be therapeutic benefits found in products much smaller than their traditional form but fall short of the 100nm size-range limit of technology. Can this then be classified as nanomaterials? Hence, size should not be an issue. This also means that new tests will be required to assess the risks derived from new materials or new conformations of existing materials. 

Conflicting terminologies and lack standardisation makes regulating nanotechnology a challenge. 

Nanomaterial Standards

The Council for the Advancement of Standards (CAS) has made a significant stride in developing nanotechnology standards. So far, 21 standards have been published for nanoscience and nanotechnology in China, three of which were adopted by the International Standards Organisation (ISO). 

The ISO has defined and created standards for different nanotechnologies, but these will not be broadly applicable to all areas. Once again, experts have stressed the need to limit definitions for nanotech in sectors that apply. Any materials or consumer products that require a specific definition for regulation, should be conceived within the sector and not spill over to other sectors. 

However, it is noted that there is a lack of standards for what types of tests needed for nanomedicines. Procedurally, the tests are put together to build an understanding of the product in a bid to assure the regulatory agencies of why these tests are needed. On the other hand, for nanomedicines that are injected, the regulatory framework is well-established. 

There need to be incentives to produce and communicate risk data in a “regulator-ready” form so it not only reaches the government officials who need to consume the information, but it is written such that they can understand it and can incorporate it into their decision making.