One Nanoregulation

... at least for combating and preventing nanopollution and nanotoxicity.

Preface

Advancing along the series of articles I have made ​​dedicated to "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:
• "Why Nanoregulation Must be a Top Priority on Political Agendas";
• "Nanoregulation For The Future";
• and this current article;
• Nanoeducation. The article dedicated to nanoeducation is:
• "Nanoeducation 3.0";
• Ethics (no articles published in NanoMedRev Blog yet);
• Media Professionals (no articles published in NanoMedRev Blog yet).

This one more article I wrote about nanoregulation and the way I envision it must reposition to meet the challenges of the future. Again, my goal in this article is to contribute to make nanoregulation a real legal instrument to be used to its full potential by ALL Countries, thereby contributing to a better world for ourselves and our descendants.


Introduction

I advocate that nanoregulation must be unique.

Put this way, this point of view seems silly and sounds like an unreasonable thing. Therefore, I have to explain and develop my idea.

I recognize that recommending that nanoregulation must be unique in the entire world is at least controversial.

There is a whole diversity of Countries, each with their own features that give them their own identity and differentiate them from all others. This is about culture, nationality, independence, sovereignty, nation, people, identity, national pride, and many other values ​​that any Country hardly (or, better saying, never) abdicates. Therefore any unification of regulation (even in the nanoscience and nanotechnology field) is and will always be controversial.

But its implementation is not impossible. Better saying, its implementation is possible.

The Engagement of ALL Countries

I advocate that ALL Countries must urgently include nanoregulation in their political agendas.

When I explained "Why Nanoregulation Must be a Top Priority on Political Agendas", this was the idea that I advocated.

My goal is that every Country in the world must be, over time, developing (at a first stage) and implementing (at a later stage) nanoregulation.

Nanoregulation covers numerous and diverse areas of intervention. Follow just a few, among many examples:

• Nanopollution ("Fighting & Preventing Nanopollution");
• Nanotoxicity ("A World Without Nanotoxicity");
• Nanobiopharmaceuticals ("Why Nanoregulation Must be a Top Priority on Political Agendas");
• "Nanoengineered Nanoparticles in Consumer Goods".

Fields of Nanoregulation Common to ALL Countries

Moreover, the world is facing problems and threats that are common to ALL Countries. Following the alignment of the thematic scope of this article, I refer to:

• Combating and preventing nanopollution;
• Combating and preventing nanotoxicity.

On the other hand, I recognize that unifying these regulations in all their diverse fields are beyond controversial, a highly complex task (e.g. nanobiopharmaceuticals and nanoengineered nanoparticles in consumer goods).

Thus, what do I propose after all?

I propose that nanoregulation must be unique for ALL Countries at least in these two fields:

• Combating and preventing nanopollution;
• Combating and preventing nanotoxicity.

What Does Unique Mean in This Thematic Context?

In other words, what do I mean by unique?

There must be a worldwide organization with global legitimacy and mandate to exercise global uniformity or standardization of the various nanoregulations developed by ALL the different Countries, prior to its domestic implementation. This global uniformity or standardization of the various nanoregulations developed by ALL the different Countries, must cover, at least, the following fields: (a) combating and preventing nanopollution; (b) combating and preventing nanotoxicity.



Luís Bastos

Nanoregulation For The Future

Fully innovative, collaborative and proactive

Preface

I've been writing a series of articles, all having something in common: "The Roots of Nano-Fear Decoded". I have addressed briefly some of the main roots of nano-fear:

• 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. The articles dedicated to nanotoxicity are:
• "Why Nanoregulation Must be a Top Priority on Political Agendas";
• This current article;
• Nanoeducation. The article dedicated to nanoeducation is:
• "Nanoeducation 3.0";
• Ethics (no articles published in NanoMedRev Blog yet);
• Media Professionals (no articles published in NanoMedRev Blog yet).

Again, like the previous one, this article is dedicated to nanoregulation. I point strategic advice for the future of nanoregulation. Once again, 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. As always, I'll try to do my best.


Introduction

Nanoregulation, to be prepared to meet the challenges of the future, must have certain characteristics:

• Nanoregulation must be fully innovative and collaborative;
• Nanoregulation must be proactive.

Nanoregulation Must be Fully Innovative And Collaborative

Nanoregulation must be fully innovative. Well, some already are by now. In my personal opinion, FDA already is fully innovative. However, this concept must spread to all countries and country regions. Gone are the days when the regulation concerning the scientific and technological aspects and its relationship with society had chances to progress without considering innovation a priority.

Not anymore.

We live in times of reinvention. Any project that is born must have a component of innovation. This rule becomes more rigid for large scale projects. This is the case with nanoregulation, the way as I address it in my articles.

Innovation involves doing something really new, something that has never been done before and proven better. To innovate implies an entire change of mindsets, attitudes, behaviours and processes.

Are these requirements that I just described sufficient?

No.

Nowadays any major project goes far way only doing something really new, that has never been done before, demonstrably better, as a result of a total change of mindsets, attitudes, behaviours and processes.

What is missing then that is so vital to enabling innovation and let it go far away, fly high and bring forth good fruit? Collaboration.

Collaboration is the key. Collaboration is the name of the game. In the times we live in, there is no innovation without collaboration. It's as simple as that: collaborative innovation.

Therefore, back to the approach to nanoregulation, nanoregulation needs to be really innovative in a way that has never been done before and demonstrably better for building a better world for US ALL. An innovative nanoregulation must involve a profound change of mentalities, attitudes, behaviours and processes. But, above all, innovative nanoregulation must be based on the concept of collaborative innovation.


Nanoregulation Must be Proactive


Nanoregulation must be proactive. Nanoregulation must not adopt a passive attitude: waiting for the emerging of issues and problems and then solve them. In other words, nanoregulatory entities reacting to face new situations that had just earned critical mass is not enough.

On the contrary, nanoregulation must anticipate emerging situations. To implement this concept, nanoregulatory authorities must develop mechanisms of permanent monitoring of what is being done, what is happening, reporting emergent situations when these have not yet gained critical mass or expression. Nanoregulators must be open to sharing experiences and opinions of various professionals from various sectors of industry, consumers, users, patients and organizations related to ethics.

Acting this way, when some of these emerging situations gain critical mass, the nanoregulation organizations have already developed work, including debate, opinion listening, sharing professional experiences, all in the context of collaborative innovation such as described above. In other words: when some of these emerging situations gain critical mass, the nanoregulation organizations are already prepared to face them. This way, the solution comes faster and better.

To suggest and give strategic advice is very interesting, but if one does not reach more detailed explanations, the value fades out

Therefore, due to this reason, I will point as examples two specific situations: combat and prevention of nanopollution and nanotoxicity.Regarding the combat and prevention of nanopollution, on my article "Fighting & Preventing Nanopollution", I proposed the creation of a network of nanopollution observatories: observatories operated by highly qualified professionals, equipped with sophisticated computer technology, databases, GPS technology and operating with the aid of satellites. These observatories must be linked to external probes and sensors placed at critical locations, providing these observatories with real-time data. Therefore, these nanopollution observatories will operate with real-time risk monitoring, risk detection and risk assessment. This modus operandi will allow the ability to send automatic warnings (or alerts) to the operating teams. The automatic warnings (or alerts) may be scaled in warning (or alert) levels, linked to pre-established protocols of measures to be triggered accordingly - all these observatories linked on a whole network.

Regarding the combat and prevention of nanotoxicity, on my article "A World Without Nanotoxicity", I proposed the creation of a network of screening centres. These screening centres must operate at full sync and collaboration among themselves and with the nanopollution observatories. These screening centres must be operated by highly qualified professionals, equipped with sophisticated computer technology and databases, receiving constantly reported data from R&D facilities (academic and industry) as new discovered, engineered or already known nanosized molecular structures are nanofabricated, engineered or employed. This modus operandi, as I described, will allow the ability to send automatic warnings (or alerts) to the operating teams. The automatic warnings (or alerts) may be scaled in warning (or alert) levels, linked to pre-established protocols of measures to be triggered accordingly.

Thus, both nanopollution observatories and screening centres, operating in full articulation and collaboration among them and with nanoregulatory organizations will provide a precious help nanoregulation to be proactive.

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.

A World Without Nanotoxicity

Proposal of solutions and directions to combat and prevention of nanotoxicity and nanopollution.

Preface

Following my article "The Roots of Nano-Fear Decoded", I have addressed briefly some aspects of nanotoxicity and nanotoxicology in four articles:

• "Nanotoxicity in Humans";
• "Indicators of Nanotoxicity";
• "Some of The Main Types of Nanoengineered Nanoparticles Reported as Nanotoxic";
• "Nanoengineered Nanoparticles in Consumer Goods".

I start here an attempt to point out ways and propose solutions which I believe will help to combat and prevent effectively nanotoxicity (and nanopollution).

Introduction

From the strategy perspective, I identify three major groups of actions to combat and prevent effectively nanotoxicity:

1. Strategic planning of actions to be implemented immediately or ASAP; 
2. Preventive actions against the increase in nantoxicity; 
3. Actions to combat the already existing nanotoxicity or to minimize the current levels of nanotoxicity down to levels without risk. 

This approach through three points is somehow similar to the three points approach I presented in my article "Fighting & Preventing Nanopollution". Obviously, the details differ.

Concerning to point one, it is far too obvious: if simple actions often require strategic planning, when we have to face highly complex actions such as fighting and preventing nanotoxicity and nanopollution, strategic planning becomes vital and indispensable.

With respect to points two and three, I should add that it is (at least to me), difficult to handle them separately: fighting and prevention. There is an extremely complex chain of actions that must be implemented (after being the subject of an effective strategic planning, of course). The need for effective actions is so huge that in practice most of actions can be implemented for preventive purposes and at the same time taken (and adapted) to combat nanotoxicity that already exists (or to minimize the current levels nanotoxicity down to levels without a significant risk).

I also believe that it is simply impossible to implement points two and three in a sequence. It simply makes no sense and would be disastrous. Thus, these two points must be applied simultaneously in a coordinated, interconnected, integrated, without losing sight of combating and preventing nanopollution.

Strategic Planning of Actions to be Implemented Immediately or ASAP

A strategic planning of actions to be implemented immediately or ASAP requires, at least, the following issues (not necessarily by this order):

• Integration with nanopollution. To be more precise, integration with the fight against nanopollution and its prevention. These two issues are so inextricably interconnected that an effective combat and prevention presupposes necessarily take into account these two aspects - nanotoxicity and nanopollution;
• An urgent debate, serious, extensive, intensive, constructive, optimistic (and integrated with nanopollution). This debate must be conducted under the auspices of the collaboration with the aim of building a better world for us All. We live in times of reinventing everything. Moreover, the issue of nanotoxicity is relatively emerging in time. On the other side yet, our society has been conditioned by a formatted thinking. This formatted thinking has conditioned and atrophied the development of new ideas. The highly qualified specialists have to develop this debate with their spirit free of limiting concepts and wide open to new ideas and innovation in its purest essence. Therefore, the approach to combat the toxicity will require new ideas, new concepts, new practices, new perspectives and ways of seeing things from the scientific, technological and social perspectives. A debate with the participation of actors from different fields of knowledge, under the auspices of a constructive atmosphere, may have the potential to generate an effective strategic planning;
• Prioritizing: Establishing levels of priorities. More specifically, the establishment of priorities in the context of a complex chain of processes and actions to be implemented in steps. Although much valuable work has been done, much more needs to be done. This applies not only to combat but also to prevention. An intelligent scheduling of priorities is essential. If the scheduling of priorities fails, the combat and prevention will not progress and chaos will dominate the situation. The scheduling of priorities also involves the definition of population groups at high risk, medium risk and low risk.
• Regulation. As far as I know, regulation regarding nanotoxicology and nanopollution is already underway. It is, however, absolutely necessary to proceed with this work. Regulation is, among other things, a legal instrument. It is necessary to strengthen regulation, speed it up, and get an international engagement and consensus.

Preventive Actions Against The Increase in Nanotoxicity And Actions to Combat The Nanotoxicity That Already Exists or to Minimize The Current Levels of Nanotoxicity Down to Levels Without Significant Risk


Preventive measures and actions to combat nanotoxicity require, at least, the following issues (not necessarily by this order):

• The creation and dissemination of appropriate awareness and an entire culture and mindset of best practices, always under the auspices of absolute transparency, the highest sense of responsibility and aiming to build a better world for us ALL. All people (actors and civil society) must be clearly informed, using an accessible language, through positive, constructive, informative, transparent and optimistic campaigns. Media campaigns should be carefully planned and created, targeting different audiences, using different languages​​, always appropriate for the target audiences;
• Practices related to risk. Similarly to combat and prevent pollution, practices related to risk necessarily involve the following three aspects (among many others): risk monitoring, risk detection and risk assessment. My proposal goes to the creation of a network of screening centres - operating at full sync and collaboration among themselves and with the nanopollution observatories (as I proposed on my article “Fighting & Preventing Nanopollution”). Again, I do not mean "a network watchdogs". Rather, I refer to screening centres operated by highly qualified professionals, equipped with sophisticated computer technology, databases. I mean screening centres receiving constantly reported data from R&D facilities (academic and industry) as new discovered, engineered or already known nanosized molecular structures are nanofabricated, engineered or employed. These screening centres will not operate in real-time. However, if the operations are well planned and implemented, the delay between the input of data and the event time will be short. In other words, these screening centres will not operate in real-time; however, will operate in a quasi-real-time mode. This modus operandi, as I describe here, will allow the ability to send automatic warnings (or alerts) to the operating teams. The automatic warnings (or alerts) may be scaled in warning (or alert) levels, linked to pre-established protocols of measures to be triggered accordingly. Still with respect to the practices related to risk, I propose the following:
• Standardization of a list of consensual known indicators of nanotoxicity in order to allow routine practices of research, monitoring, risk assessment, risk evaluation;
• Establishment of a system of databases comprising the following information:
• Nanosized molecular structures reported as nanotoxic;
• The respective several levels (or degrees) of nanotoxicity for specific conditions;
• All known data regarding characterization of these nanosized molecular structures;
• Known routes of entrance into the body;
• Known effects caused in the body;
• Known measures to minimize those nanotoxic effects;
• Known possible cumulative effects and how, where, when, how long, etc.;
• Known forms of excretion by the body to the outside;
• Known possible consequences at the level of nanopollution;
• Known possible consumer goods containing at least one of these nanosized molecular structures;
• All known bibliographic references of published material regarding each item described above and free access permission granted to highly qualified and duly authorized staff;
• Permanent update with new reported information.
• R&D. Once again, as I stated in my article “Fighting & Preventing Nanopollution”, since nanotoxicology is closely related to nanopollution, will be very useful that R&D covers the two aspects. Follow some aspects I consider important, among many others:
• Intensive studies on computational simulation and behaviour prediction. Every time a nanosized molecular structure is planned to be produced, nanofabricated, nanoengineered or somehow modified in a facility (academia or industry), prior exhaustive studies on computational simulation and behaviour prediction must be carried out. The reports of the studies must be evaluated by a screening centre having into account the eventual potential risks in terms of nanotoxicity and nanopollution. Depending on the results reported, only then the process of production, nanofabrication, nanoengineering or other modification can be carried out. The screening centres must have legitimate authority (under international consensus) to approve or disapprove the continuation of processes (the passage to the processes of production, nanofabrication, nanoengineering or other modification). We have excellent qualified bioinformaticians, cheminformaticians and computer biologists all over the world. There are excellent industries dedicated to the industry of bioinformatics, cheminformatics and computer biology. These industries must be encouraged and supported to develop intensive R&D in order to release software tools oriented to these purposes;
• Intensive studies on nanocharacterization, nanotoxicology and nanopollution. Every time a nanosized molecular structure is produced, nanofabricated, nanoengineered or somehow modified, exhaustive studies on nanocharacterization, nanotoxicology and nanopollution must be carried out;
• Verification of traceability. Much R&D is required as well as a whole platform of collaborative organizations and individuals in order to implement an effective verification of traceability of the nanosized molecular structures which are reported as nanotoxic and nanopollutant. This means two aspects:
• Verification of traceability (inside the body) of the nanosized molecular structures which are reported as nanotoxic (carried out by the screening centres I proposed);
• Verification of traceability (into the environment) of the nanosized molecular structures which are reported as nanopollutant (carried out by the nanopollution observatories I proposed);
• R&D of key-technologies to fight effectively, in a clean and safe way the nanotoxicity.
• Regulation. Again, I believe that regulation has a role here which is crucial, fundamental and decisive: without regulation is simply not possible to carry out the prevention or combating nanotoxicity. The rules must be very clearly defined, with no gaps and no room for bad and/or ineffective practices. Unfortunately, regulation does not fall from the sky. The regulation is built in stages, gradually. As the information arrives, is analyzed and conclusions are taken, matured and consolidated. Then, decisions are taken and regulation is released. New unexpected situations emerge: the cycle repeats itself and regulation is updated and/or upgrated. Regulation must take into account all matters discussed above and many emerging and unexpected others. Since nanotoxicity affects the entire biosphere and the entire environment on a planetary scale, regulation must also require the participation and consensus of all countries. Regulations to combat and prevent nanotoxicity must involve experts and players from various sectors around the world, working in a collaborative context with the aim of building a better world for us ALL. All countries must provide timely data to a multinational organization (provided with multinational approved authority) to monitor compliance or infringement of the rules established. Measures must be studied to be applied in case of any country violating these regulations. Sanctions must be applied to infringing countries. The screening centres I proposed above must report directly to this multinational organization. Through this way, screening centres will also have authority and legitimate mandates to carry out effectively their mission.
• Change of mindset, attitudes and practices. Education of professionals in the academia and in the industry in changing processes and practices that facilitate the fight against nanotoxicity and nanopollution and their prevention. Again, a whole wide culture of best practices needs to be strengthened, intensified, generalized and adopted as the only option possible.

The Great Lessons That Nature Has to Teach us

It is very common for Humans pass through Life without taking even one single lesson that nature has to teach us. And nature has so many lessons to teach us.

I could start here a never-ending list of examples. I selected two only (not necessarily the most appropriate ones). Those two examples will help me to explain how I perceive a world without nanotoxicity and how it is possible to achieve this status. Nevertheless, dear reader, remember: metaphors and analogies are a good way to explain ideas. However, they are not perfect. Follow the two examples I selected:

• Mutations tend to occur frequently in the cells. However, cells have mechanisms of self-correction which are in a state of alert to prevent the occurrence of such mutations. Through this natural mechanism, most of mutations do not progress and, instead, are naturally corrected and return to normal.
• Tumours tend to form more often than they actually are formed. The immune system has defence mechanisms which prevent early that the vast majority of these tumours have a chance to develop and proliferate. Again, the body has mechanisms of self-protection which are in a state of alert to prevent that these malignancies. Again, through this natural mechanism, the majority of tumours does not grow and, instead, are naturally killed.

These two examples will help me to explain what I call "a concept based on a dynamic and preventive balance".


A World Without Nanotoxicity: a Concept Based on a Dynamic And Preventive Balance

A world without nanotoxicity.

Written this way, even sounds like a fairy tale. Not exactly. At this point, it is appropriate to explain how I perceive and what I mean by "a world without nanotoxicity".

Therefore, in my modest opinion, a world without nanotoxicity is a world in which the existing nanotoxicity does not present significant levels of risk, and these are monitored, evaluated and controlled by a vast, diverse and complex apparatus of highly competent experts and organizations working together in a coordinated and complex network and in continuous mode, combating and preventing nanotoxicity and nanopollution through a process similar to natural defence mechanisms.

I sincerely and strongly believe that the Human species has all the skills and resources to achieve this level in our civilization.


The Great Spiral of Sustainability Applied to Combat And Prevent Nanotoxicity and Nanopollution

Some very important and decisive steps have been taken, with regard to combating and preventing nanotoxicity and nanopollution. There is still much hard work to be done. This is an irrefutable fact. There is no question about it. However, the combat and prevention of nanotoxicity and nanopollution is not exactly in phase zero. Much valuable work has already been developed in various fields.

There is a whole vast and diversified chain of actors, individuals and organizations related to nanoscience, nanotechnology, nanomedicine, life science, physics, chemistry - just to name a few - and science in general. I do not just mean the academia, the industry and the scientific community only.

It was (somewhere in this chain) triggered the implementation of a culture of best practices. I have already observed this. It is extremely important that this culture (which is still in its infancy) is strategically maintained and enhanced to have a strong social impact. If this culture of best practices gains social impact, it will generate a kind of chain reaction along the whole chain of chain actors, individuals and related organizations. This process will generate a highly positive effect that will gradually increase the awareness in all individuals and actors in this chain.

At one point in the future (and may be a near future), we will see actors competing among themselves to see who implements the "best of best practices". This dynamic competition will be highly beneficial to strengthen and implement a vast combat and prevention of nanotoxicity and nanopollution. The world, the biosphere, the human species and the environment will benefit greatly from this great spiral of sustainability.

Nanoengineered Nanoparticles in Consumer Goods

Through regulation, all players win and nobody loses.

Preface

Proceeding with the approach initiated in my article "The Roots of Nano-Fear Decoded", I will address in this article other nanotoxicology topic: consumer goods containing nanoengineered nanoparticles. Later on, I will attempt to point out ways and propose solutions in order fight and prevent nanotoxicity.


Introduction

This theme is vast.

It has been developed numerous, responsible and meritorious studies in the field of scientific research in nanotoxicology. However, the need for knowledge in this field is enormous. What has been done is too little when compared with what is still needed.

Since there is a large gap in scientific knowledge concerning nanotoxicology and nanotoxicity, the emergence of new nanoengineered nanoparticles introduced many and new questions and challenges regarding the risks and benefits:

• To the living organisms (including Humans);
• And to the environment.

The nanoscale size of those nanoparticles, associated with their highly increased surface area available for reactions allows them to penetrate the biological structures, enventually interfering with their normal function. Of course, this interference, when occurs may be nanotoxic or beneficial. 

Scientifically evidence-based proofs are the only way to demonstrate the nanotoxicological or benefical effets of each specific nanoengineered nanoparticle, for each specific set of physiological conditions.

Nanoengineered Nanoparticles in Consumer Goods

There are consumer goods being sold as commercial products containing nanoengineered nanoparticles in their composition.

Regarding the possible toxic, harmless or beneficial effect of these nanoparticles to users, the information available to the general public is, in some cases absent or poor and vague.

These consumer products fall into several categories, regarding the use by consumers and the intended purposes.

However, there is a group of consumer goods already introduced into the commercial channels that 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;
• After-shave lotions.

At this point, I want to express my personal opinion on this subject (and I want to make my position clear): the presence of nanoengineered nanoparticles in consumer goods is not necessarily harmful, as has been published in a sensationalist way in non-specialized press (especially in a minority of non-specialized press).

I even admit that a significant percentage (or even the most) of these manufacturers have conducted tests in their laboratories in order to ascertain the nanotoxicity or the beneficial effects of these nanoengineered nanoparticles and the results have confirmed its safety. it is common to hear in television ads a phrase like "after tests conducted in our laboratories ...".

I even admit that a significant percentage (or even the most) of these manufacturers has contracted independent external laboratories to carry out tests in order to determine the nanotoxicity or the beneficial effects of these nanoengineered nanoparticles and the results have confirmed its safety. It is also common to hear in television ads a phrase like "after tests conducted by independent laboratories highly accredited ...".

However, given the poor and vague (or totally nonexistent) information provided to consumers about the safety of these nanoengineered nanoparticles in some products and given the noise made by some non-specialized media, the climate of suspicion and fear was installed in a few layers of populations.

Therefore, two questions arise:

• How can consumers rely on the laboratory test results?
• How can consumers rely on the quality of these products?

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

These products will inevitably need to be tested in the laboratory, being these tests closely monitored by regulatory authorities.

If the different tests are supervised by regulators and the results are approved, then consumers can use these products safely and confidently.

If the different tests - monitored by regulators - are disapproved, then the products must be removed immediately from the market. These manufacturers must reformulate their not approved consumer goods, in order to improve them to the point of being beneficial for consumers. Again, new tests, once approved, will give credibility and confidence to their use by consumers.

Thereby, through regulation, ends the climate of suspicion and fear regarding the introduction of nanotoxic nanoengineered nanoparticles into the skin of consumers and into the environment.

Regulation will put an end to all doubts that perhaps exist: everything will be crystal clear and transparent with regard to this subject. Through regulation, all players win and nobody loses. I highlight here some of the many advantages:

• Citizens are reassured and start to consume these products with confidence;
• This sector is no longer subject to debate and its credibility rises to an even higher level;
• Regulatory authorities demonstrate once again that they are actively monitoring the toxicity risks of society and respond positively and in accordance;
• The nano-fear decreases significantly, walking this way to fade (if additional measures are taken in other fields).

Personally, I admit that these nanoengineered nanoparticles are quite beneficial. But there is nothing like demonstrating this fact to consumers around the world, with the guarantee of the accuracy of regulatory authorities.


"The Wonders and Worries of NANOTECHNOLOGY" Video

On February 7, 2012 was published on YouTube a video titled "The Wonders and Worries of NANOTECHNOLOGY". This great video was directed and produced jointly by:

• Nanoscale Informal Science Education Network (NISE Net); 
• National Science Foundation (NSF);
• www.whatisnano.org.

This video is simply a "must". "The Wonders and Worries of NANOTECHNOLOGY" is a short video (4 min. and 33 sec.) which aims (according to its co-directors and co-producers - and I agree) to aid in the discussion of the societal and ethical implications of nanotechnology.

In my opinion is well worth watching this video several times, due to the extremely important message that transmits. In order to present a practical example of real life, face creams and skin care products as a whole are referred. The video also focuses on promoting debate of the societal and ethical implication of nanotechnology. As the narrator states, "whenever a new technology emerges, it is necessary to evaluate the risks against the benefits".