While new technologies may offer society numerous benefits, they always raise some concern about potential harm to human health or the environment. This holds true for nanotechnology as well. In early December 2016, Brazilian researchers helped put the final touches on NANoREG, a European Union initiative launched in 2014 to compile information and present government regulatory agencies and industry with a set of risk assessment proposals that address facets of nanotechnology safety. At the conference, a group of 180 experts from around the world discussed the relevance of regulatory measures and the applicability of what science has learned over the past ten years about the use of nanomaterials and their relation to the environment, health, and safety.
“We’re toppling a number of myths through NANoREG,” says pathologist Wagner Fávaro, professor at the Institute of Biology of the University of Campinas (Unicamp). Fávaro represented the Unicamp Laboratory of Nanostructure Synthesis and Interactions with Biosystems (NanoBioss) at the final edition of the NANoREG conference, held in Paris by the Organization for Economic Co-operation and Development (OECD). “Through a broad network of research institutions, which included those from Europe as well as researchers invited from the Food and Drug Administration and elsewhere in the United States, Brazil, and South Korea, we were able to reach major scientific findings, for example, knowing what type of nanotube crosses biological barriers or manages to collect inside a cell,” says Fávaro. “The papers presented at the conference made it evident that many scientific methods and approaches have been validated and can reliably be applied to regulations in the short term. This has been an enormous endeavor because every test must be thought out in terms of every type of material. Many had to be redesigned according to predetermined standards to avoid discrepant results, which was common not long ago.”
Brazil was represented at NANoREG by seven groups from research institutes, coordinated by the National Institute of Metrology, Quality, and Technology (Inmetro). Conference results will be published in book form in mid-2017 and will offer recommendations pertinent to future regulations on the testing and evaluation of the effects and risks of each type of nanomaterial.
Alongside Fávaro, the group from Unicamp is also led by Oswaldo Alves and Nelson Durán, both from the university’s Chemistry Institute (IQ-Unicamp). Working in collaboration with Danish researchers, the team presented a paper at the NANoREG conference on the histopathological and toxicological evaluation of tissue samples from the kidneys of mice that had received different types and concentrations of nanotubes through their trachea. Findings showed that the material collected in the lungs, then moved into the bloodstream, and finally accumulated in the kidneys, where it caused inflammation and was not eliminated naturally.
In Brazil, a pioneer study in this field was conducted in 2008 by a joint team from IQ-Unicamp and the Fisheries Institute, Cananéia, São Paulo, led by Oswaldo Alves. “We successfully demonstrated that when carbon nanotubes come in contact with the pesticides used on agricultural crops, it substantially increases their toxicity for fish (see Pesquisa FAPESP Issue nº 226).” The team performed a laboratory simulation where discarded nanotubes met with pesticides in an aquatic environment. “We discovered that nanotubes are excellent concentrators of pesticides, which get trapped in the gills and contaminate the fish,” explains Alves. “Nanotubes are very good for use in sensors and chips, for example, but you have to be careful when disposing of them,” Alone, the material showed no sign of acute toxicity when found in concentrations of up to 3 milligrams per liter, but it apparently reduced the animal’s oxygen consumption and its elimination of ammonia.
“In laboratories and during basic and applied research, it’s easy to control and destroy these materials because there are such very small amounts of them, but when you move up the scale to an industrial system, the situation is different,” warns Fernando Galembeck, professor at IQ-Unicamp and former director of the National Nanotechnology Laboratory (LNNano). “The guideline that I enforced at LNNano was that no nanoproduct technology should be developed without assessing toxicological and environment risks, starting as early as possible. We need to know the risks right from the earliest stages of research, because technological development involves big spending. Any business person, faced with some new discovery, worries about potential environmental and toxicological risks,” he says.
In 2015, Galembeck traveled to Brasilia as head of LNNano to present his position to the lower house. Speaking before the Joint Committee on the Environment and Sustainable Development and on Science and Technology, Communication, and Information, he addressed two bills sponsored by Representative José Sarney Filho (PV-MA): House Bill 5133/2013, which calls for the labeling of products that use nanotechnology, and House Bill 6741/2013, which deals with National Nanotechnology Policy as it relates to research, production, waste disposal, and the use of nanotechnology in Brazil.
“In a literal reading of the draft law on labeling, I listed different kinds of well-known, familiar products that would be subjected to labeling, like butter, margarine, milk, cosmetics, hand soap, tires, and paint. These products have always contained particles and other nanometric structures in their composition. For example, the calcium phosphate in milk is in the form of nanoparticles,” he explains. “As to the other bill, I showed how its wording jeopardizes all nanotechnology research and development projects in Brazil because it would make us register what we were going to do with a government agency before starting a project. This is impossible and incompatible with the very nature of research, which is a leap into the unknown.” Both bills are currently before the Committee on Economic Development, Industry, Commerce, and Services.
“Anyone who has worked in the field of chemistry over the last 40 years knows that a new product can involve risks. It has to go through environmental and health safety assessments, and industry has to have very high safety standards,” says Galembeck. “In nanotechnology, we can regulate what is known to carry significant risk and we should research what isn’t known, in order to enhance public safety and the safety of the developer. However, scientific research, businesses, and national development have been seriously harmed by Brazil’s regulatory practices. Regulatory abuse is an important part of what makes the environment for innovation unhealthy in Brazil.”
For some years, Brazil has been debating the problems that nanotechnology might cause. “We started discussing the topic around 2002, surveying risks. In the beginning, my fellow researchers in the field accused me of ‘friendly fire’,” Alves recalls. In 2013, he co-authored one of the first books on the topic in Brazil: Nanotoxicology: Materials, Methodologies and Assessments. The title was published by Springer, which has a series on the topic, edited by Professor Valtencir Zucolotto of the São Carlos Institute of Physics, at the University of São Paulo (IFSC-USP).
In the industrial arena, a book with new information for those working directly with nanotechnology in the production sector came out in 2015: Nanossegurança: Guia de boas práticas em nanotecnologia para fabricação e laboratórios (Nanosecurity: Guide to good practices in nanotechnology for manufacturers and laboratories). It was co-written by Luismar Marques Porto, engineer with a PhD in chemical engineering and professor at the Federal University of Santa Catarina (UFSC), and Leandro Antunes Berti, PhD in nanotechnology and executive secretary of API.nano, a network of companies and institutions working in the sustainable industrial development of nanotechnology in Brazil and headquartered at the Certi Foundation in Florianópolis, Santa Catarina. Funded by the Santa Catarina Research Foundation (Fapesc), the book is a practical guide written in plain language that offers straightforward explanations of nanotechnology, its applications, and its role in everyday life. It is the product of a meticulous survey of agencies like the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and other international and foreign institutions.
“We tried to highlight the safety-by-design paradigm as well as the best paths for developing and producing nanomaterials, with a focus on the concept of nanosafety,” says Berti. “We presented recognized practical techniques and the most modern methods for producing and characterizing nanomaterials.”
Another new title is Engineered Nanomaterials: Nanotoxicology Issues, Nanosafety and Regulatory Affairs, released in 2016 by Editora Cultura Acadêmica, the Unesp press. The book was written by researchers from São Paulo State University (Unesp) and edited by materials engineer Antônio Carlos Guastaldi, from the Chemistry Institute at Unesp’s Araraquara campus. Contributing authors included pharmacist Carla dos Santos Riccardi, from the Unesp School of Agricultural Sciences in Botucatu, and chemist Márcio Luiz dos Santos, from the Federal University of the ABC (UFABC). Guastaldi took an interest in the topic while doing research, focused especially on dentistry, with the Biomaterials Group at Unesp, which he heads. “We decided to do a review of the topic and survey world knowledge on the matter,” says Guastaldi. They identified 187,000 studies conducted from 1990 to 2014 that contained the word “nanoparticle” and 6,900 scientific papers with the words “nanoparticle” and “toxicity.” A survey of an international patent database found that only 795 of the 20,216 patents related to nanotechnology through 2014 mentioned “nanotoxicity.”