Por: André Luiz Aguiar*
Nanoalimentos: para quem chegará essas "maravilhas" tecnológicas?
Vale lembrar que a organização FAO tem 191 países membros na sua composição atual, além da Comunidade Europeia. E a OMS tem 194 estados-membros. Então, dá para se ter uma ideia da abrangência que haverá com este documento.
Ele ainda não está findado, pois, como eu disse, está em fase de revisão pública até dia 30 de novembro de 2012. Quem estiver disposto e interessado é só se engajar e participar.
"FAO/WHO has developed a technical paper entitled “State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors" and it is currently under public review. Anyone who is interested in reviewing the paper, downlaod the paper and send us comments by no later than 30 November2012. Comments should be sent to Masami Takeuchi (Masami.Takeuchi@fao.org) with a copy to Mina Kojima (kojimam@who.int)."
E sobre este documento/rascunho, faço aqui uma abordagem de alguns pontos e levanto algumas questões sobre o que ele traz em seu conteúdo.
Começando pela metodologia (Methodology) usada pela FAO. Segundo consta no documento, das linhas 08 até 25:
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"This report was commissioned by FAO and WHO with the objective of summarizing and analysing the information that has become available since the 2009 expert meeting and determining possible courses of action to be followed by FAO and WHO in this matter.
Following up on one of the recommendations of the 2009 FAO/WHO expert meeting, the present report reviews national and international activities on the risk analysis of nanomaterials in the food and agriculture sectors that have been carried out since the meeting. It presents national and international risk assessment and risk management approaches that identify and implement strategies to address potential hazards associated with the use of nanotechnology-related products or techniques.
Information on relevant regulations and risk assessment activities was gathered from the web sites of national and international institutions, organizations and governments. Specific reference to these web sites is given in the respective sections of this report. It should be noted that terms used in this report reflect the definitions applied within the various sources of information; no attempt was made to align the terminology with definitions agreed to by the 2009 expert meeting or other definitions applied internationally—for example, by the Codex Alimentarius Commission.
Information on actual and planned uses of nanomaterials resulting in human exposure through food or food packaging/contact materials since 2009 was collected from a variety of sources, including the scientific literature, web sites, patent databases, market analysis reports and material presented at conferences, workshops and symposia."
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Esta metodologia pautou-se em outro documento que a FAO e OMS veicularam há dois anos atrás, intitulado: "Application of nanotechnologies in the food and agriculture sectors: potential food safety implications". Dessa maneira, eles dão continuidade ao investigado, esquadrinhando as atividades de certas nações sobre a análise e gestão dos riscos nos setores de alimentos e agricultura cujas questões e indagações foram levantadas pelos peritos das organizações (FAO/OMS) no documento de 2010 (obs: a reunião que deu ensejo a este referido documento ocorreu em junho de 2009).
Assim, num futuro próximo, o que é conhecido é só o que está informado na rede ou por liberalidade dos organismos e estados, uma vez que não há sanção por não informar. Aqui entra as questões de "segurança nacional", propriedade intelectual, direitos e etc. Portanto, nem tudo o que está disponível na rede pode ser o verdadeiro cognoscível, mas sim o que se quer dar a conhecer. Isso é temerário para se guiar a feição de um documento que terá a abrangência que se espera.
Em seguida, no resumo (Summary) referente à reunião de peritos da FAO / OMS ocorrida em 2009 consta que; linhas 26 a 67:
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"Summary of the FAO/WHO expert meeting in 2009
Use of nanotechnology
The expert meeting agreed that nanotechnology offers considerable opportunities for the development of innovative products and applications for agriculture, water treatment and food production, processing, preservation and packaging, and its use may benefit farmers, the food industry and consumers alike.
It was noted that nanotechnology-derived food products will be increasingly available to consumers worldwide. It was recognized that there was a need for clear and internationally recognized definitions and that gaps in definitions in the food area could be addressed by the Codex Alimentarius Commission.
Assessment of human health risks
Materials that are produced intentionally with structural features at a nanoscale range (between 1 and 100 nm) may have properties that are different from those of their conventional counterparts. Such differences may have an impact on human health following consumer exposure to nanomaterials.
Current risk assessment approaches used by FAO, WHO and the Codex Alimentarius Commission were considered to be suitable for engineered nanomaterials used in food and agriculture. Additional safety concerns may arise owing to the characteristic properties of nanomaterials that make them different from their microscale/macroscale counterparts. For example, the very high surface area of engineered nanomaterials has consequences that need to be considered in their risk assessment.
Nanoparticles may interact with other substances present in the food matrix, and such effects and interactions of engineered nanomaterials need to be characterized. Understanding their fate in the environment is also important, as it may result in indirect human exposure.The experts agreed that risk assessment strategies might benefit from the use of a tiered approach for prioritization of the types or classes of material for which additional data are likely to be necessary to reduce uncertainties in the risk assessment. Further research could lead to novel risk assessment strategies; the development of validated testing methods and guidance would help to address specific data gaps.
Stakeholder confidence and dialogue
Engagement of stakeholders was acknowledged as imperative for any emerging or controversial issue in the area of food safety. Critical to the success of a research strategy for nanomaterials would be addressing the key interests, priorities and concerns of stakeholders and ensuring that all potential pathways and risks are addressed.
Consumer attitudes towards the application of nanotechnology in food and agriculture were seen as complex; consumer understanding of the potential risks and clear, tangible benefits of nanotechnology was key. It was noted that advocacy groups had expressed the desire for industry and governments to implement measures to protect consumers from the consequences of the unregulated release of commercial nanoproducts.
Greater access of scientists to the public debate was needed. A forum for continued international dialogue to develop strategies to address stakeholder issues was proposed, and it was noted that the public should be engaged at the national level. Also, the existing FAO/WHO food safety risk analysis framework might be reviewed in particular with regard to engaging stakeholders.
Mechanisms should be identified to support the need for transparency and traceability of nano-enabled products or engineered nanomaterials in food and agriculture and their associated risks."
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Vimos que a FAO e a OMS reconhecem que a nanotecnologia está no mercado de consumo e com uma tendência de crescimento exponencial. E no setor de alimentos e agricultura não é diferente.
Suscitam que a Comissão do Codex Alimetarius poderia ser o local para dirimir os entraves possíveis quanto às definições do que seja nanoalimentos e derivados, bem como local para suprimir disputas sobre segurança alimentar e proteção dos utentes.
Suscitam que a Comissão do Codex Alimetarius poderia ser o local para dirimir os entraves possíveis quanto às definições do que seja nanoalimentos e derivados, bem como local para suprimir disputas sobre segurança alimentar e proteção dos utentes.
Reconhecem que quando se labuta com nanotecnologia existirá os fenômenos emergentes, onde um material na escala menor não se comporta igual ao da escala maior (v.g.: maior área de contato) e que isso pode ocasionar riscos à saúde dos consumidores.
Ademais, inferem que é necessário uma maior abrangência na avaliação dos possíveis riscos e mais pesquisas para auxiliar na estratégia de gestão dos riscos.
Foi, também, ressaltado a importância do engajamento dos setores da sociedade, órgãos públicos, e empresas para o bem da informação dos consumidores e um verdadeiro diálogo das partes para desenhar uma construção da Era Nano mais consolidada.
Em relação às atividades avaliadas pela FAO/OMS desde 2009 quanto aos países ou regiões, o Brasil (Brazil) também aparece como perscrutador de nanotecnologia em alimentos e agricultura -- a partir da linha 145 até 150.
Nesse análise, a FAO e a OMS dão ênfase para a definição que os estados membros fazem quanto ao termo "nanotecnologia". Deixa-se claro que a FAO/OMS não perquirem se há uma regulação específica do país quanto às nanotecnologias, pois para elas, as regulações existentes que dizem respeito aos alimentos são abrangentes a ponto de incluir os alimentos e derivados produzidos com nanotecnologia.
No que pertine ao Brasil afirma-se:
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"On 9 August 2011, experts from the Brazilian Competitiveness Forum on Nanotechnology met in São Paulo to address the issue of regulating nanotechnology for the industrial sector (NIA, 2011). The meeting was attended by representatives of the working groups of the forum, who discussed a study funded by the Brazilian Agency for Industrial Development on the development of possible standards, laws and guidelines for nanotechnology regulation in Brazil (ABDI, 2010)."
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Como vocês puderam ler, o texto acima não disse nada em relação ao Brasil e às Nanotecnologias em alimentos e agricultura. Apenas comentou um fórum que ocorrera no ano passado em cooperação com a ABDI, sem acrescentar nada.
Isso significa que o Brasil não fez nada na área da Nanotecnologia aplicada à Agricultura nesses últimos anos -- desvalorizando, assim, o trabalho da Embrapa e demais órgãos governamentais espalhados pelo país, que é reconhecidamente uma potência em produção de grãos -- ou o pessoal da FAO / OMS não pesquisou muito a fundo. Fico com a segunda opção.
Para findar, o documento/rascunho da FAO / OMS traz as seguintes conclusões e recomendações (Conclusions and recommendations):
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"Conclusions and recommendations
The review of national and international scientific (i.e. risk assessment related) and regulatory (i.e. risk management) activities on applications of nanotechnology in food and agriculture that have been undertaken since 2009 demonstrates that progress has been made in all three major areas addressed by the joint FAO/WHO expert meeting in 2009.
a. Use of nanotechnology
The concepts of potential use of nanomaterials in food and the implied benefits for stakeholders including consumers have not changed significantly. The main areas, as summarized in Appendix 4 of the FAO/WHO (2010) report, remain valid. New products are being developed and probably enter the market, but the available data from published sources do not allow an assessment of whether product ideas are just concepts or are already resulting in exposure of consumers to food being produced with nanotechnology/nanomaterials at any significant rate.
Whether a product would be considered to be a nanomaterial or representing an application of nanotechnology also depends on available definitions applied by regulators. Several regulatory bodies have meanwhile introduced or proposed definitions of nanomaterials for regulatory purposes that reflect one of the two main issues of the discussion: whether the dimension of materials of nanometer scale or the change of the properties of materials due to smaller particle size is more relevant. One definition extends the possible range of materials of concern to dimensions that are 10 times higher than the nanoscale range of 1–100 nm that was defined by the 2009 expert meeting.
There is a trend to apply in the definitions two criteria, an altered or new dimension at nanoscale and a concurrent change of properties due to the change of dimension. A true nanomaterial that requires the attention of regulators and a specific risk assessment would need to meet both criteria. This was not fully clarified by the definitions as discussed and proposed by the 2009 expert meeting, but the discussion did address this issue, which was reflected in the proposal of a tiered approach for classifying nanomaterials for risk analysis purposes. Such a tiered approach would apply several criteria, of which dimension and change of properties expected to result in a modified hazard identification and characterization would be two important ones.
b. Assessment of human health risks
The statement by the 2009 joint FAO/WHO expert meeting (FAO/WHO, 2010) that current risk assessment approaches were suitable to assess nanomaterials and nanotechnologies used in food is supported by those agencies/institutions that have investigated this issue in more detail. National and regional food safety agencies increased their focus during the past few years on investigating the implications of nanomaterials added to or used with food. Policies and guidance documents have been published that allow a better understanding of how risk assessment of nanomaterials will be performed in the future.
Significant progress was made by OECD, which provides the globally accepted testing guidelines for hazard identification and characterization of food chemicals, such as additives, pesticides and veterinary drugs, and other substances resulting in human exposure, such as cosmetic ingredients.OECD reviewed these guidelines and found them to be generally applicable for the testing of nanomaterials. Other research-oriented projects initiated by OECD will provide valuable insights into aspects of risk assessment specific to engineered nanomaterials.
The approach to be published by ILSI for nanomaterials to be used in food is interesting, as it tries to systematically review the information already available for conventional material and discusses what properties would allow extrapolation from conventional to novel nanomaterials. Further development and implementation of this concept may lead to reduced animal testing.
Whether the paradigm of testing materials in animals at a toxic dose, determining a no-effect level and applying an uncertainty factor to establish a safe intake for humans is applicable to all nanomaterials continues to be challenged. The tiered approaches that are discussed may allow in vivo testing for specific groups such as nano-salts of micronutrients to be waived.
The number of published risk assessments of products that are nanomaterials or contain particles that fall within applicable definitions is growing slowly. As agencies apply different strategies with respect to communication, it is difficult to develop a clear picture of the true number of substances assessed and the issues discussed that are specific for nanomaterials. Particle risk assessment is a new field; risk assessment has always been done with defined chemicals, with no attention paid to particle size. There is not enough known about nanomaterial toxicity to be able to group the particles into low-toxicity or high-toxicity groups.
Therefore, nanomaterial risk assessment currently needs to be done on a case-by-case basis, as size, shape, chemical composition, surface area and surface charge influence the toxicity of nanomaterials (Park et al., 2010). With respect to the three different exposure routes, more risk assessment has been done for inhalation and dermal exposure and less for ingestion exposure, because there are more nanomaterial products on the market in textiles, cosmetics and sprays than in food and food contact materials.
The main areas of chemical risk assessment at the international level address food additives, pesticide residues, veterinary drug residues, some processing aids, such as enzymes, and occasionally micro-nutrients. Nanomaterials would be within the scope of such activities; for example, a nanoscale food additive could be addressed by the Joint FAO/WHO Expert Committee on Food Additives, and residues from a nanoscale pesticide could be addressed by the Joint FAO/WHO Meeting on Pesticide Residues.
There are, however, some areas of food chemicals, such as materials in contact with foods (e.g. food packaging), that occasionally are addressed by FAO/WHO expert bodies, but for which no comprehensive and systematic programme is in place; for a “nano-plastic material” to be used in food packaging, there is no risk analysis framework at the international level currently in place.
c. Stakeholder confidence and dialogue
A key finding of the 2009 FAO/WHO expert meeting was that public confidence in engineered nanomaterials can be supported through institutional efforts to provide an overview of applications of nanotechnology in food and packaging that are transparent and allow public involvement (FAO/WHO, 2010). However, for this report, it was difficult to assess the extent to which engineered nanomaterials are already being used in the food and agriculture sectors. Inventories that register nanotechnology in consumer products are scarce; only one database is publicly available.
Besides inventories, mandatory labelling would lead to greater transparency for the consumer and enable consumer freedom of choice. However, mandatory labelling could also lead to the avoidance of the use of nanotechnologies in consumer products, including those that are beneficial (Gruère,2011). So far, apart from the European Union, no country has set a regulatory framework for the mandatory labelling of nanomaterials in food (EU, 2011).
The mandatory labelling of materials that meet a definition that reflects only dimension (i.e. is not risk based) provides a new element in the discussion that might be of interest to the Codex Alimentarius Commission, as it could result in technical barriers to trade of foods to which nanomaterials have been added.
In a report on the European Commission’s public online consultation among key stakeholders about nanomaterials, the majority of the 716 respondents regarded applications in agriculture and food with more scepticism than applications in other areas (EC, 2010). The major concern was the possible toxicity of poorly understood nanomaterials.
In accordance with the recommendations of the Science and Technology Committee of the United Kingdom Parliament, it may be valuable to develop a database of information on nanomaterials in development, in collaboration with the food industry, to anticipate future safety assessment needs and to aid in the prioritization of research (United Kingdom Parliament, 2010).
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Percebe-se que há uma preocupação (ou ao menos a citação de que estão atentos), por parte da FAO e pela OMS, quanto ao uso das Nanotecnologias em Alimentos. E que uma maior avaliação se faz premente.
Na realidade, o que se tem é uma verdadeira indefinição. Cada vez mais vamos caminhando para o desconhecido. Deixando para o mercado regular a nossa segurança. Sempre se justifica "a não regulação" das novas tecnologias, com a afirmação de que regular ou se precaver quanto ao uso delas é temerário para o desenvolvimento da sociedade, do mercado e do suprimento humano. E assim se deu com a energia atômica, fomos deixando, fomos deixando até que....a História nos faz relembrar bem!
Este texto-rascunho da FAO e da OMS está para revisão pública para daqui seis meses, mas sou cético em vislumbrar uma mudança nos parâmetros dela. E mais descrente ainda, sobretudo em acreditar que esse pesquisar e esse cuidado da FAO e da OMS quanto às Nanotecnologias redundará em diminuição da miséria no mundo.
| Mais de 1 bilhão de pessoas no mundo passam fome |
A cada dia vemos mais e mais seres humanos morrendo de fome. E mesmo com tantas tecnologias "disponíveis" desde a Revolução Industrial não se findou com míngua alimentar.
Agora, com a Revolução Nanotecnológica, imagino que não verterá em diminuição da miséria e da escassez de comida no mundo -- até que me provem o contrário.
Eu costumava dizer que a Nanotecnologia poderia ser a primeira tecnologia gestada no âmbito capitalista que poderia se voltar à sociedade, à redução da miséria, ao acesso de todos ao verdadeiro desenvolvimento humano, todavia o locupletamento é tão voraz que o que está ocorrendo é mais do mesmo: lucro, em cima de lucro, e mais um pouco de lucro.
Precisamos estar atentos e engajados pois além da fome, outros problemas sociais ainda perduram, em detrimento das "maravilhas tecnológicas" que estão nas prateleiras, à mão de "todos". Porém, não à mão daqueles que precisam realmente: pobres, famintos, doentes, abandonados, esquecidos, refugiados, sem-teto, favelados, enfim.
Precaução na Era Nano, pois o estômago de muitos ainda continua a roncar de fome!
* André Luiz Aguiar é advogado formado pela
Pontifícia Universidade Católica do
Paraná (PUC-PR), pesquisador e consultor
em Nanotecnologias e regulamentação.
Vejam:
d) Países membros da FAO concluem acordo mínimo sobre biocarburantes e subsídioss
e) UN, WHO consult on nanotechnology in food
f) FAO and WHO publish report from nano in food and agriculture meetinge) UN, WHO consult on nanotechnology in food
