Why Nanoregulation Must be a Top Priority on Political Agendas

... of ALL COUNTRIES

Preface

Following the alignment of my article "The Roots of Nano-Fear Decoded", I have pointed briefly which are the main roots of nano-fear (or at least some of them). Some of them have already been addressed in subsequent articles published by me in NanoMedRev Blog:

• Nanopollution. The articles dedicated to nanopollution are:
• "Nanopollution Revised";
• "Fighting & Preventing Nanopollution";
• Nanotoxicity. The articles dedicated to nanotoxicity are
• "Nanotoxicity in Humans";
• "Indicators of Nanotoxicity";
• "Some of The Main Types of Nanoengineered Nanoparticles Reported as Nanotoxic";
• "Nanoengineered Nanoparticles in Consumer Goods";
• "A World Without Nanotoxicity";
• Nanoregulation (addressed in this current article);
• Nanoeducation. The article dedicated to nanoeducation is:
• "Nanoeducation 3.0";
• Ethics (no article published in NanoMedRev Blog yet);
• Media Professionals (no article published in NanoMedRev Blog yet).

This article is dedicated to nanoregulation. I'll try to do my best to point and suggest paths for the future, with regard to nanoregulation. My goal in this article is to contribute to the nanoregulation to become a real legal instrument to be used to its full potential by ALL COUNTRIES, thereby contributing to a better world for ourselves, our children, our grandchildren and so on.


Introduction

Nanoregulation is already underway. Obviously those differences at the level of attitudes are abyssal, when making a comparison between different Countries:

• A minority of  pioneer Countries are already working at full speed;
• The majority of Countries is divided into two groups:
• The Countries that are waiting for the pioneering Countries in pursuing nanoregulation, so that they may decide to imitate them or affirm themselves by the difference;
• The Countries that are fully asleep, regarding nanoregulation; never heard of such a thing or if heard, it is a low-priority issue on their political agendas.

What Nanoregulation has to do With Priority on The Political Agendas of All Countries?

An interesting question. Though this question sounds simple, an appropriate and quite enlightening response is complex. I'll try to do my best to be clear and at the same time correct and synthetic.

There are several reasons. I'm going to address the ones I consider more critical.


01. Nanopollution

Problem: Humans and the environment spread nanoparticles to the entire Biosphere.

As I explained in my article "Nanopollution Revised", nanoparticles are present:

• In the air (atmosphere);
• In water (hydrosphere)
• In the soil (lithosphere).

They are thus gathered all the requirements necessary for the entire biosphere being contaminated with presence of nanoparticles. It can therefore be said that the nanoparticles tend to be ubiquitous.
Just as an example, nanoparticles that are present in the air (atmosphere):

• Mix well with the humidity in the air. As a consequence, when precipitation occurs (e.g. rain, sleet and snow) this gets contaminated with nanoparticles. The precipitation reaches the soil and open water (e.g. oceans, seas, rivers, lakes);
• Contaminate drinking water exposed to air;
• Contaminate open water (e.g. oceans, rivers, streams, lakes);
• Contaminate the surface of the soils;
• Contaminate the groundwater through infiltration;
• Contaminate the inner part of soils (trough groundwater);
• Enter into the plants through their aerial components (involved in the process of photosynthesis, respiration and transpiration);
• Enter into the animals through respiration, eyes, skin, etc.;
• Contaminate foods exposed to air.

Again, just as an example, nanoparticles that are present in the water (hydrosphere):

• Return to the air (atmosphere), ascending together with the water vapour during the evaporation process of water;
• Are absorbed by the roots of aquatic plants, entering this way into these;
• Enter into the aquatic, underwater, marine animals as well as amphibians;
• Contaminate food during washing with water (supposedly drinking water);
• Contaminate food during the cooking process, when water is used (presumably drinking water).

Once again, and just as a third example, nanoparticles present in soils:

• Return to the air (atmosphere), ascending together with the water vapour during the evaporation process of water;
• Are absorbed by the roots of terrestrial plants, entering this way into these;
• Enter into the underground and terrestrial animals; 
• Contaminate groundwater.

On the other hand, nanoparticles present into plants and animals traverse the entire food chain until reach Humans.

Fact: Countries in general occupy the entire (or almost all) of the surface of the lithosphere (nanopolluted) of the planet Earth. Due to reasons of sovereignty, most countries hold territorial waters (hydrosphere, nanopolluted, by the way) and airspace (atmosphere, also nanopolluted, by the way).

Therefore, it starts to become quite clear that nanopollution affects ALL Countries of planet Earth.

By consequence, it is also clearly explained why the regulation has to do (a lot) with the priorities defined in the policy agendas of all countries.

The pollution itself is a reason more than enough to justify the engagement of ALL countries in the nanoregulation

02. Nanotoxicity

Therefore, since nanoparticles are present into the entire environment (which includes ALL COUNTRIES) these easily enter into the Human body of ALL POPULATIONS OF ALL COUNTRIES.

Nanotoxicity and nanotoxicology are highly complex subjects. It falls out of my objective a full coverage of this topic on this article. I will address two only:

• Routes for entry of nanotoxic nanoengineered nanoparticles into the Human body;
• Destinations of nanotoxic nanoengineered nanoparticles, after entering the Human body.

Regarding the routes for entry of nanotoxic nanoengineered nanoparticles into the Human body, as I explained in my article "Nanotoxicity in Humans", in general terms, nanotoxic nanoengineered nanoparticles may enter into the human body via different routes. This entry of nanotoxic nanoengineered nanoparticles into the Hyman body happens through episodes usually incidental and/or involuntary. For example, Humans may:

• Inspire accidentally and/or involuntarily air (previously contaminated with nanotoxic nanoengineered nanoparticles);
• Absorb casually and/or involuntarily through their skin (through the skin breathing process) air (previously contaminated with nanotoxic nanoengineered nanoparticles);
• Absorb accidentally and/or involuntarily, through the eyes, air, raindrops
  dew droplets, droplets humidity or water vapour or other impurities (previously contaminated with nanotoxic nanoengineered nanoparticles);
• Accidentally and/or involuntarily eat food (previously contaminated with toxic nanoengineered particles);
• Drinking accidentally and/or involuntarily, water (supposedly drinking water) and consumption beverages (previously contaminated with nanotoxic nanoengineered nanoparticles).

These incidental and/or involuntary episodes are associated with a lack of knowledge, information, awareness and nanoeducation by populations of ALL COUNTRIES. Therefore, through episodes of incidental and/or involuntary nature, the nanoparticles can enter the Human body via (not necessarily by this order):

• Inhalation;
• Cutaneous and eyes;
• Ingestion;
• Other.

Regarding the destinations of nanotoxic nanoengineered nanoparticles, after entering the Human body, these can undergo different fates:

• Can be totally or partially excreted;
• Can be totally or partially metabolized;
• Can be totally or partially cumulated into cells, tissues and organs.

Regarding excretion, follow some different examples of excretion of nanoengineered nanoparticles:

• Through the kidneys, during the blood filtration in which the nanotoxic nanoengineered nanoparticles are to be a product of excretion (a constituent of the urine);
• Through the intestines, during the formation of faeces and excreted through the anus;
• Through the sweat glands in order to be excreted in sweat during perspiration;
• Through the lungs (after venous blood having executed gas exchanges with the lung alveoli) being released into the environment during the exhalation.

In what concerns to metabolism, follow two examples of where nanotoxic nanoengineered nanoparticles can be metabolized:

• In the liver; 
• In the spleen.

Regarding total or partial bioaccumulation into cells, tissues and organs, nanotoxic nanoengineered nanoparticles which are insoluble or poorly soluble in biological fluids are of great concern in terms of public health:

1. Some nanotoxic nanoengineered nano particles which are insoluble or of low solubility can pass through the various defence mechanisms of the body. Thus, these nanotoxic nanoengineered nanoparticles which are insoluble or low solubility can be transported along the human body in an insoluble form: passing into the blood stream (blood and/or lymphatic vessels) after passing through the respiratory membranes (lung alveoli via gas exchanges) and/or gastrointestinal membranes. These nanotoxic nanoengineered nanoparticles which are insoluble or low solubility are then distributed to the various organs and eventually may accumulate at specific sites.
2. Other nanotoxic nanoengineered nanoparticles which are insoluble or poorly soluble can still find a direct link to the brain: after they are inhaled, they can travel through the olfactory nerves and penetrate directly into brain neurons.

As a consequence of what I explained above, it is easy to conclude that nanotoxicity is or should be a concern of ALL COUNTRIES.


03. Nanobiopharmaceuticals

Pharmaceuticals, biopharmaceuticals and nanobiopharmaceuticals are allowed to enter into the commercial channels after approval by regulatory authorities.

As a rule base, it can be stated that the regulatory authorities have as jurisdiction territory the Country where they belong. In other words, regulatory authorities operate in their own country and only in their own country.

As far as I know, there may be regional agreements in Organizations of Countries regarding some aspects of regulation.

If a pharmaceutical, for example, is approved in one country A, this fact does not necessarily imply that other country B adopts the introduction into their commercial channels, just because it was approved in the country A.

This general concept, described to pharmaceuticals, also applies to biopharmaceuticals and nanobiopharmaceuticals.

Since the nanomedicine is relatively new, these nanobiopharmaceuticals are also relatively new. They present a whole series of challenges in terms of legislation and regulation to the diverse regulatory authorities of ALL COUNTRIES around the globe. Most of these Countries are not yet ready to face these challenges, but one day will be.

This is therefore a reason per se more than sufficient to justify that ALL COUNTRIES include the nanoregulation subject as a top priority in their political agendas.


04. Nanoengineered Nanoparticles Present in Consumer Goods

As I explained in my article "Nanoengineered Nanoparticles in Consumer Goods", there are consumer goods being sold as commercial products containing nanoengineered nanoparticles in their composition.

As we can naturally imagine, the trade relations between countries are highly dynamic:

• New business relationships are always flourishing among the most diverse and distant countries;
• Import and export flows are developed or are changed;
• New distribution networks and channels are constantly created, so that a good produced in a country can be sold in other countries across the globe.

I want to emphasize that this dynamics also covers consumer goods being sold as commercial products containing nanoengineered nanoparticles in their composition.

These consumer goods are divided into several categories, regarding the use that consumers give them and the intended purpose. Nevertheless, there is a group of consumer goods already released into the commercial channels, which has been a particular target of debate: cosmetics, sunscreens and personal care products. Follow some examples: deodorants, soaps, toothpastes, shampoos, hair conditioners, sunscreens, anti-wrinkle creams, lipsticks, blushes, eye shadows, nail polishes, perfumes and after-shave lotions (just to mention a few).

Regarding the possible beneficial, harmless or nanotoxic effects of these nanoparticles to consumers, the information available to consumers is, in some cases, none, a bit vague or enlightening.

Personally, I am convinced of the presence of nanoengineered particles in consumer goods is not necessarily harmful, as was published in the sensationalist and non-specialized press.

I even admit that:

• A significant percentage of (or even most) of these manufacturers have performed quality and safety tests into their laboratories, in order to determine the beneficial, harmless or nanotoxic effects of these nanoengineered nanoparticles and the results have confirmed that they were safe;
• A significant percentage (or even most) of these manufacturers have hired independent external laboratories (outsourcing) to perform laboratory tests in order to  determine the beneficial, harmless or nanotoxic effects of these nanoengineered nanoparticles and the results have confirmed that they were safe.

However, given (a) the enlightening information (or absent) provided to consumers about the nanosafety of these nanoengineered particles in some consumer goods and given (b) the background noise made ​​by some sensationalist and not specialized media, the atmosphere of suspicion and fear was gradually settling into a few layers of populations.

Therefore, how consumers can rely on the results of laboratory tests? How can consumers trust the quality of these products?

In my personal opinion, there is only one answer: nanoregulation.

As we can naturally imagine, the trade relations between countries are highly dynamic:

• New business relationships are always flourishing among the most diverse and distant countries;
• Import and export flows are developed or are changed;
• New distribution networks and channels are constantly created, so that a good produced in a country can be sold in other countries across the globe.

Is therefore once again demonstrated ALL COUNTRIES must include nanoregulation as a top priority on their political agendas, with the objective of putting some order regarding this subject of the presence of nanoparticles into consumer goods.

Again, The Great Spiral of Sustainability (Now With ALL COUNTRIES Involved)

As I described in several pprevious articles, there is a phenomenon that has already been triggered - it's what I call "the great spiral of sustainability". Entities, organizations and players (in the world of nanotechnology, science, science-related, academia, industries) already started to compete with each other to see which is the one that applies and implements the best of the practices. Now, whith the advice I presented in this article - nanoregulation must be a top Priority on political agendas of ALL COUNTRIES - Countries will start to compete with each other to see which is going to develop the best nanoregulation.

In fact, this competition already started. In other words, some Countries have already joined (even without taking aware of it) to the big spiral of sustainability.

Again, this whole competition of best practices is highly positive and beneficial to the entire world.

Conclusion

I could have presented a lot more reasons for ALL COUNTRIES include nanoregulation as a top priority on their political agendas. However, I am absolutely sure that the four topics I presented above fully justify it.

The Countries that are waiting for the pioneer Countries in nanoregulation to proceed further (in order that they can then decide to imitate them or affirm themselves by the difference) don't need to do it. They can change of attitude and be proactive - by starting their own home work.

The Countries that are fully asleep in what regards nanoregulation can also change their attitude. They can start to be proactive - by starting their own home work.

Besides, there is a world trend to let it happen.