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Princpios para a superviso de nanotecnologias e nanomateriais

NanoAction

Um projeto do International Center for Technology Assessment

Produzido com financiamento da Fundao CS-Fund Traduzido por Rel-UITA Secretara Regional Latinoamericana de la Unin Internacional de Trabajadores de la Alimentacin, Agrcolas, Hoteles, Restaurantes, Tabaco y Afines (UITA)

Princpios para a superviso de nanotecnologias e nanomateriais


NanoAction

Em janeiro de 2007, o International Center for Technology Assessment (Centro Internacional para a Avaliao da Tecnologia) e a organizao Friends of the Earth (Amigos da Terra) organizaram em conjunto a primeira cpula estratgica de ONGs sobre nanotecnologia em Washington, DC, que atraiu o interesse pblico e das organizaes de trabalhadores, de sade da mulher, da sociedade civil, de ambientalistas, e de organizaes de base formadas por cidados da Amrica do Norte para debater e chegar a acordos sobre os princpios fundamentais para a avaliao e superviso da nanotecnologia. Durante os seis meses seguintes, os participantes desenvolveram princpios liderados pelo projeto NanoAction do International Center for Technology Assessment. Este documento o resultado desses seis meses de trabalho. At agora, cerca de 70 grupos procedentes de seis continentes j o aprovaram.

Princpios para a superviso de nanotecnologias e nanomateriais

Princpios para a superviso de nanotecnologias e nanomateriais


Os abaixo-assinados, em uma ampla coalizo de organizaes de trabalhadores, de ambientalistas, de interesse pblico e da sociedade civil, motivados pela preocupao com os diferentes aspectos dos impactos ticos, sociais, ambientais e na sade humana, entre outros, decorrentes das nanotecnologias, apresentam a declarao Princpios para a Superviso de Nanotecnologias e Nanomateriais.

Princpios para a superviso de nanotecnologias e nanomateriais

Introduo
Os governos, universidades e empresas de todo o mundo deram incio a uma corrida pela comercializao de nanotecnologias e nanomateriais. Na verdade, centenas de produtos de consumo contm nanomateriais (produtos qumicos em nanoescala) no produto acabado ou os produtos so fabricados usando nanotecnologia. Entretanto, evidncias indicam que esta nova revoluo dos materiais apresenta riscos signicativos para o meio ambiente, para a sade e para a segurana, bem como profundos desaos sociais, econmicos e ticos. So as empresas, governos e universidades que aceleram a comercializao de nanotecnologias, sem esperarem pelo resultado daspesquisas necessrias para esclarecer e reduzir os riscos, nem pelos necessrios mecanismos de superviso regulatria, legal e tica. Estes mecanismos so fundamentais para evitar a repetio dos fracassos de tecnologias e materiais mgicos do passado. A situao atual no nos d qualquer esperana de que acertaremos com a nanotecnologia. A fabricao e as condies de laboratrio so desenvolvidas sem medidas de proteo nem pautas de segurana adequadas. Os consumidores esto expostos de forma involuntria aos ingredientes de nanomateriais sem haver avisos nos rtulos dos produtos e sem os consumidores serem informados dos possveis riscos. Os nanomateriais so descartados ou liberados no meio ambiente, embora seja desconhecido o impacto que isso ter e a falta de meios adequados para detect-los, para realizar um acompanhamento ou para elimin-los. Os governos e os criadores de nanotecnologias oferecem escassas oportunidades reais para uma participao informada do pblico nos debates e decises sobre a forma ou mesmo se conveniente seguir com a nano-nizao do mundo. Este documento apresenta oito princpios fundamentais que acreditamos devem proporcionar a base para uma avaliao e superviso adequadas e ecazes do campo emergente da nanotecnologia, incluindo aqueles nanomateriais cuja utilizao comercial generalizada. OS PRINCPIOS I. Princpio da precauo II. Princpio sobre a Regulamentao Mandatria Nanoespecca III. Princpio da proteo sade e segurana para o pblico e trabalhadores IV. Princpio da sustentabilidade ambiental V. Princpio da transparncia VI. Princpio da participao do pblico VII. Princpio da incluso de amplos impactos VIII. Princpio da responsabilidade do produtor Uma abordagem de precauo fundamental. A abordagem preventiva exige a presena de mecanismos de superviso nanoespeccos obrigatrios que considerem as caractersticas tpicas dos materiais. Dentro desses mecanismos, a proteo da sade pblica e a segurana dos trabalhadores requerem um enfoque comprometido com a pesquisa de risco crtico e uma ao imediata para mitigar as possveis exposies at que que provada a sua segurana. Deve ser colocada a mesma nfase nas medidas que salvaguardem o meio-ambiente. A superviso deve ser sempre transparente e oferecer acesso pblico informao com respeito tomada de decises, aos testes de segurana e aos produtos. essencial que a participao do pblico seja aberta, signicativa e completa em todos os nveis. Essas discusses e anlises devem considerar os efeitos de amplo alcance da nanotecnologia, incluindo os impactos ticos e sociais. Finalmente, desenvolvedores e produtores devem garantir a segurana e a eccia dos seus processos e produtos, assim como assumir a responsabilidade por quaisquer consequncias negativas da decorretes. Os rgos governamentais, as organizaes e participantes relevantes devero implementar amplos mecanismos de superviso que promovam, incorporem e interiorizem estes princpios bsicos o mais rpido possvel.1

Uma abordagem de precauo exige a existncia de mecanismos de superviso nanoespeccos obrigatrios que considerem as caractersticas tpicas dos materiais.

Princpios para a superviso de nanotecnologias e nanomateriais

I. Princpio da precauo
O princpio da precauo deve ser aplicado s nanotecnologias porque a pesquisa cientca atual sugere que a exposio a alguns nanomateriais, nano-aparelhos ou produtos derivados da nanobiotecnologia, pode causar srios danos sade ou ao meio ambiente.
O princpio da precauo,2 integrado em vrias convenes internacionais,3 foi descrito da seguinte maneira: Quando alguma atividade ameaa a sade humana ou o meio ambiente, medidas de precauo devem ser tomadas, inclusive quando as relaes de causa e efeito no so totalmente estabelecidas de maneira cientca.4 Com as nanotecnologias existe um elemento importante de ameaa, que requer aes preventivas ou de precauo, atribuindo uma carga de responsabilidade queles que realizam atividades com as nanotecnologias que possam gerar danos, que considerem alternativas para os seus novos processos e atividades, e que promovam a participao pblica nos processos de deciso de suas aplicaes. Isto tambm deveria incluir a proibio da comercializao e uso de nanomateriais no provados, assim como requerer dos fabricantes e distribuidores a garantia de que estes produtos sejam de baixo risco. Em outras palavras, sem informao sobre sade e risco, no h mercado. Um ciclo adequado de avaliao dos nanomateriais deve de ser denido e conduzido muito antes de sua comercializao. Adicionalmente, recursos adequados devem ser destinados para pesquisar os processos, produtos e uso de materiais que impliquem em menor risco. O princpio da precauo deve ser aplicado s nanotecnologias porque a pesquisa cientca atual sugere que a exposio a alguns nanomateriais, nano-aparelhos ou produtos derivados da nanobiotecnologia, pode causar srios danos sade ou ao meio ambiente. O tamanho diminuto dos nanomateriais engenheirados pode dot-los de propriedades fsicas, qumicas e biolgicas inovadoras e teis; entretanto, a alta reatividade, mobilidade e outras propriedades, que acompanham a matria em nvel molecular, podem gerar de maneira paralela nveis de toxicidade desconhecidos.5 Pesquisas e estudos recentes, sobre os impactos dos nanomateriais na sade humana e no meio ambiente, levantaram o alarme que legitima aes precautrias e a execuo de mais estudos em profundidade.6 As regulamentaes devem ser rigorosas, precisas, compreensveis e implementadas antes da comercializao; assim como devem ser consideradas as propriedades exclusivas dos nanomateriais em sua avaliao sobre os riscos.6 Sendo assim, o potencial de toxicidade dos materiais na nano-escala no pode ser estudado e prognosticado com relao ao perl de massa total (bulk) dos compostos, isto , sem estar em nano-forma. As regulamentaes baseadas no princpio da precauo so crticas para os novos desenvolvimentos tecnolgicos, onde os impactos na sade e no meio ambiente so desconhecidos a longo prazo, estudados de maneira inadequada e/ou imprevisveis.7 A falta de dados ou de evidncia sobre riscos ou danos especcos, no pode ser motivo para se menosprezar o princpio da precauo

Princpios para a superviso de nanotecnologias e nanomateriais

II. Comeando sobre os regulamentos e obrigaes especcas para os nanomateriais


A legislao atual prev uma regulamentao inadequada para os nanomateriais. Um regime regulatrio especco, modicado ou sui generis, para o caso dos nanomateriais, deve ser parte integral no desenvolvimento das nanotecnologias. Considerando o j avanado desenvolvimento e a contnua comercializao de nanomateriais, urgente e necessrio criar mecanismos de avaliao e regulamentao governamental, levando em conta as propriedades exibidas pelos nanomateriais. Mesmo quando existe uma autoridade legal, provavelmente so necessrias mudanas regulatrias substanciais nas legislaes atuais, a m de se adequar e efetivamente regulamentar o uso das diferentes propriedades dos nanomateriais e os novos desaos que os nanomateriais apresentam.8 As legislaes atuais no esto equipadas para supervisionar os produtos e processos atualmente em desenvolvimento, como os nanossistemas ativos e as nanoestruturas.9 As agncias governamentais falharam at agora no uso da sua qualidade de autoridade reguladora da matria.10 Os atuais sistemas reguladores devem ser adaptados e aplicados como uma resposta temporria aos nanomateriais, at a gerao de mecanismos que possam ser aplicados de acordo com as especicidades dos nanomateriais.11 Finalmente, aes reguladoras retroativas devem abranger todos os produtos de nanomateriais que existem atualmente no mercado. Os efeitos adversos dos nanomateriais no podem ser previstos com conana a partir da conhecida toxicidade do material em massa (bulk).12 Alguns especialistas recomendam que, acima de dezesseis parmetros fsico-qumicos, devem ser avaliados muito longe dos dois ou trs parmetros geralmente medidos em materiais em massa.13 Devido s suas novas propriedades e riscos associados, os nanomateriais devem As iniciativas voluntrias so ser classicados como novas substncias para sua avaliao 14 completamente insucientes e para qualquer propsito regulatrio. As iniciativas voluntrias so completamente insucipara supervisionar a entespara supervisionar a nanotecnologia. Os programas nanotecnologia. voluntrios no tm incentivos de participao para os atores ruim ou aqueles que fabricam produtos com risco, deixando de fora os compostos que requerem regulamentao exaustiva.15 Alm disso, no mbito das iniciativas voluntrias, as companhias carecem de motivao para avaliar em longo prazo os efeitos crnicos sobre a sade e o meio ambiente.16 Finalmente, as iniciativas voluntrias muitas vezes atrasam e enfraquecem as regulamentaes adequadas, limitam a participao do pblico e restringem o acesso a informaes vitais sobre o meio ambiente ou a sade. Por estas razes, o pblico prefere as regulamentaes emitidas pelo governo ao invs de iniciativas voluntrias.17

A legislao atual prev uma regulamentao inadequada para os nanomateriais. Um regime regulatrio especco, modicado ou sui generis, para o caso dos nanomateriais, deve ser parte integral no desenvolvimento das nanotecnologias.

Devido s suas novas propriedades e riscos associados, os nanomateriais devem ser classicados como novas substncias para sua avaliao e para qualquer propsito regulatrio.

Princpios para a superviso de nanotecnologias e nanomateriais

III. Princpio de proteo e sade do pblico e dos trabalhadores


A regulamentao adequada e ecaz dos nanomateriais requer uma nfase imediata na preveno da exposio conhecida ou potencial dos nanomateriais perigosos ou daqueles que no foram comprovados como seguros. Isto essencial para o pblico e os trabalhadores da indstria, porque alguns nanomateriais representam ameaas potenciais e muitos outros no esto sendo estudados. As nanopartculas livres (nanomateriais que esto no ar) merecem especial preocupao, pois provvel que possam entrar no corpo, reagir com as clulas, e causar danos aos tecidos.18 As nanopartculas integradas ou encapsuladas em massa tambm so uma preocupao. Os trabalhadores podem estar expostos a esse tipo de partculas ou materiais durante o processo de produo, enquanto o pblico e o meio ambiente podem car expostos aos resduos destinados ao descarte ou reciclagem. Por causa de seu tamanho, as nanopartculas podem atravessar as membranas biolgicas, clulas, tecidos e rgos mais facilmente do que as partculas maiores.19 Quando essas partculas so inaladas podem, por exemplo, passar dos pulmes para o sistema sanguneo.20 Alm disso, h crescentes evidncias sobre a forma como alguns nanomateriais podem penetrar a pele,21 especialmente na presena de tensoativos22, e assim ter acesso ao sistema circulatrio.24 Quando ingeridos, estes nanomateriais podem atravessar as paredes gastrointestinais e chegar ao sistema circulatrio, sem problemas.25 Uma vez que as nanopartculas cheguem ao sistema circulatrio, elas podem aderir e se inltrar em vrios rgos e tecidos, incluindo o crebro, o fgado, o corao, os rins, o bao, a medula ssea e o sistema nervoso.26 E uma vez dentro das clulas, as nanopartculas podem interferir no funcionamento celular normal, causar oxidao e, eventualmente a morte celular.27 O nanciamento inadequado e a falta de nfase governamental na pesquisa sobre os riscos para a sade tm sido os fatores que permitiram a atual situao em que algumas pessoas esto expostas diariamente aos nanomateriais, apesar da variada informao sobre os riscos crnicos e a longo prazo decorrentes da exposio a esses materiais.28 As pessoas que pesquisam, desenvolvem, fabricam, embalam, manuseiam, transportam, usam e descartam nanomateriais sero os mais expostos e, consequentemente, os mais propensos a Por esta razo, a proteo sofrer os danos potenciais sua sade. Por esta razo, a proteo do trabalhador deve ser um componente essencial previsto do trabalhador deve ser em qualquer regime regulatrio. A Fundao Nacional para a um componente essencial Cincia dos Estados Unidos estima que, para 2015, a indstria da nanotecnologia empregar dois milhes de trabalhadoprevisto em qualquer res em todo o mundo.29 Alm disso, muitos pesquisadores regime regulatrio. e estudantes trabalham com nanomateriais em laboratrios acadmicos. Apesar do crescimento da nano-mo-de-obra, no existe regulamentao, nem nenhum padro de sade, que observe os riscos associados com as nanotecnologias e os nanomateriais, e ainda no h mtodos aceitveis para medir a exposio aos nanomateriais no ambiente de trabalho. Qualquer regime destinado a proteger os trabalhadores contra os riscos de sade associados aos nanomateriais exige estatutos que, com clareza, protejam a sade e a segurana do local de trabalho onde existam nanomateriais. Os empregadores devem utilizar o princpio da precauo como base para a aplicao de medidas cautelares para garantir a sade e o bem-estar dos trabalhadores.A hierarquizao dos controles de exposio - eliminao, substituio, engenharia de controle, os aspectos do trabalho e/ou administrativos, e equipamento de proteo individual - deve ser implementada. Da mesma forma, a monitorizao da exposio, a vigilncia mdica e o treinamento dos trabalhadores so essenciais para garantir que os trabalhadores recebam as ltimas informaes sobre nanomateriais. Tanto os trabalhadores como os seus representantes devem estar envolvidos em todos os aspectos relacionados com o ambiente de trabalho seguro, com relao s nanotecnologias, sem medo de represlias ou discriminao. Finalmente, os procedimentos e os padres de proteo e sade atuais devem ser objeto de pesquisa para a sua adequao no que diz respeito aos nanomateriais.30

A regulamentao adequada e ecaz dos nanomateriais requer uma nfase imediata na preveno da exposio conhecida ou potencial dos nanomateriais perigosos ou daqueles que no foram comprovados como seguros.

Tanto os trabalhadores como os seus representantes devem estar envolvidos em todos os aspectos relacionados com o ambiente de trabalho seguro, com relao s nanotecnologias, sem medo de represlias ou discriminao.

Princpios para a superviso de nanotecnologias e nanomateriais

IV. Princpio da sustentabilidade ambiental


Para a avaliao do ciclo31 de um nanomaterial incluindo fabricao, transporte, uso do produto, reciclagem e eliminao dos resduos necessrio entender quando se aplicam os estatutos do sistema e onde existem lacunas regulatrias.32 Os efeitos do ciclo completo sobre o meio ambiente, a sade e a segurana devem ser avaliados antes da comercializao. Uma vez dissolvidos na natureza, os produtos fabricados com nanomateriais representam uma classe sem precedentes de contaminantes fabricados. Novos impactos e danos ambientais podem ser esperados a partir da natureza inovadora dos produtos fabricados com nanomateriais, incluindo a mobilidade e a persistncia no solo, gua e ar, bioacumulao e interaes antecipadas com materiais qumicos e biolgicos.33 O nmero limitado de estudos existentes tm levantado algumas luzes vermelhas, como a alta exposio de alumnio a nvel de nanoescala aderidos ao crescimento de cinco tipos de gros,34 por produtos associados com a fabricao de ligas simples de nanotubos de carbono, causando um aumento na mortalidade e no desenvolvimento tardio de estuarine crustacean de pequeno porte,35 e danos aos microorganismos bencos por parte das nanopartculas de prata.36 A Real Sociedade do Reino Unido recomendou que a liberao de nanopartculas e nanotubos no meio ambiente deve ser evitada sempre que possvel e que as empresas e laboratrios de pesquisa devem tratar as nanopartculas e os nanotubos fabricados como perigosos, e tambm devem procurar reduzir o seu uso ou elimin-los dos sistemas de resduos.37 Os riscos potenciais para o meio ambiente no foram identicados por no ter sido dada prioridade pesquisa dos impactos sobre o meio ambiente, bem como, ao dcit nos recursos designados para a pesquisa dos riscos relevantes.38 Os fundos governamentais para estudos ambientais, de sade e segurana devem ser aumentados dramaticamente e deve ser delineado um plano estratgico sobre os riscos.39 Os nanomateriais criam imensas diculdades na aplicao dos sistemas de proteo ambiental.40 As agncias carecem de ferramentas e mecanismos adequados para detectar, monitorar, medir e controlar a produo de nanomateriais, e muito menos os meios para remov-los do meio ambiente. As empresas, usando o argumento do segredo industrial e da condencialidade da informao empresarial, no fornecem os dados necessrios ao governo e ao pblico em geral. A avaliao dos riscos, a negligncia, os parmetros da toxidez e os limites mnimos de regulao utilizados pelas leis ambientais em muitos pases, incluindo os Estados Unidos, a Unio Europeia e o Brasil, so projetados com base nos parmetros de toxidez de material em massa (Bulk). As medidas utilizadas na legislao vigente, tais como a relao entre massa e exposio, so insucientes para os nanomateriais. As leis existentes no dispem de uma anlise do ciclo e no conseguem identicar e regular as lacunas legais. A gesto da sustentabilidade ambiental dos nanomateriais envolve a direo e a correo destas falhas.

Os efeitos do ciclo completo sobre o meio ambiente, a sade e a segurana devem ser avaliados antes da comercializao.

Os fundos governamentais para estudos ambientais, de sade e segurana devem ser aumentados dramaticamente e deve ser delineado um plano estratgico sobre os riscos.

Princpios para a superviso de nanotecnologias e nanomateriais

V. Princpio da transparncia
A avaliao e regulao dos nanomateriais exigem mecanismos que assegurem a transparncia, o que inclui adequada rotulagem dos produtos que contenham nanomateriais, o reconhecimento do direito, especialmente no local de trabalho, do conhecimento das leis e das medidas de proteo e acesso pblico a um inventrio de informaes sobre sade e segurana. O direito pblico ao saber inclui o direito de estar bem informado para tomar decises bem informadas. Pesquisas mostram que a maioria das pessoas carece das mais simples informaes sobre a nanotecnologia ou sobre a presena de nanomateriais em produtos de consumo.41 Em muitos casos, os produtores no informaram ao pblico sobre os riscos e testes de toxicidade de seus artigos, bem como, ainda no rotularam seus produtos avisando quando estes contm nanomateriais.42 Como resultado, o pblico no pode tomar decises informadas sobre os produtos com nanomateriais.43 O direito do pblico de saber o que consome requer adequada rotulagem que informe os consumidores sobre aqueles produtos que contm nanoingredientes. As Informaes sobre os testes de segurana e riscos devem ser colocadas disposio para o escrutnio pblico. Os escassos antecedentes em relao ao papel da indstria e seus esforos para prevenir exposies no local de trabalho e a eliminao de substncias qumicas daninhas no meio ambiente, do espao para se fazer um by pass sobre a condencialidade da utilizao secreta de nanomateriais. As orientaes e as previses de diversas convenes internacionais sobre o acesso pblico informao devem ser respeitadas.44

O pblico no pode tomar decises informadas sobre os produtos com nanomateriais.

Princpios para a superviso de nanotecnologias e nanomateriais

VI. Princpio da participao do pblico


O potencial de transformao que as nanotecnologias oferecem a nvel global em termos sociais, econmicos e polticos faz com que a participao do pblico se torne um elemento essencial no seu processo de desenvolvimento.45 A participao do pblico deve ser aberta, facilitando a contribuio dos diferentes atores e interessados. As parcerias entre o governo e as corporaes (as PPP, Parcerias Pblico-Privadas) ignoram os princpios democrticos quando deixam de ser transparentes ou deixam de ser responsveis e prestar contas sociedade. O pblico em geral de todas as naes, bem como as futuras geraes, devem ser considerados como agentes ou interessados nestas questes. A participao do pblico deve ser signicativa, ou seja, deve contribuir na formao da poltica e na tomada de decises, ao invs de simplesmente ser um agente de eventos ex post ou de dilogos unilaterais em que a indstria ou o governo educam o pblico para reduzir ao mnimo o debate, ou para assegurar a aceitao pblica do assunto em questo. A participao signicativa da opinio pblica requer, da mesma forma, um compromisso srio por parte dos governos e sucientes recursos para a sua considerao. Finalmente, a participao pblica exige procedimentos democrticos, a serem considerados em todos os processos em que as nanotecnologias so desenvolvidas e utilizadas; e necessrio que, em cada fase do desenvolvimento, as preocupaes do pblico e seus valores informem e terminem guiando a regulamentao da nanotecnologia. E, em vez de partir da falsa alegao de que as mudanas tecnolgicas so inevitveis e / ou sempre bencas, o processo de desenvolvimento das nanotecnologias, seus produtos e sistemas devero submeter-se s necessidades sociais que devem ser identicadas a partir do debate e dos processos de deciso abertos, nos quais o pblico interessado participe. Os esforos devem ser feitos especialmente para incluir as pessoas que vivem em comunidades pobres, que sofreram o impacto desproporcional do desenvolvimento de novas tecnologias no passado.

O potencial de transformao que as nanotecnologias oferecem a nvel global em termos sociais, econmicos e polticos faz com que a participao do pblico se torne um elemento essencial no seu processo de desenvolvimento.

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Princpios para a superviso de nanotecnologias e nanomateriais

VII. Princpio sobre a considerao de outros impactos


Alm de representar riscos potenciais para a sade, segurana e meio ambiente, os nanomateriais geram preocupaes scioeconmicas.
importante considerar o amplo espectro de efeitos associados com o surgimento da nanotecnologia, tais como impactos ticos e sociais. essencial para a correcta avaliao tanto das importaes quanto das exportaes que contm nanomateriais. Alm de representar riscos potenciais para a sade, segurana e meio ambiente, os nanomateriais geram preocupaes scio-econmicas. Por exemplo, quando difundida a utilizao de um novo nanomaterial, este altera o mercado dos produtos existentes, com consequncias potencialmente devastadoras para as economias dependentes de bens primrios ou os pases subdesenvolvidos.46 Os impactos adversos do patenteamento de materiais fundamentais podem causar a privatizao da essncia da natureza. Alm disso, as prximas geraes de nanotecnologias, incluindo a produo de nanoequipamentos mais sosticados para a indstria manufatureira, para a polcia ou em usos mdicos incluindo a modicao do desempenho humano podem chegar a representar riscos complexos assim como desaos ticos e sociais. Alguns laboratrios criaram vrus, agentes e bactrias para fazer nanomateriais. O debate pblico sobre esses pontos ser crucial. Como acontece com qualquer nova tecnologia, a alocao de fundos para a pesquisa determinar a trajetria percorrida no desenvolvimento das nanotecnologias. A anlise das cincias sociais sobre as implicaes da nanotecnologia ser realizada em paralelo com os estudos das cincias da sade e do meio ambiente. Impactos sociais, avaliaes ticas, equidade, justia e preferncias individuais da comunidade devero orientar a distribuio de fundos pblicos para a pesquisa. Uma proporo signicativa desta pesquisa dever estar baseada na comunidade e pensada para motivar o pblico a participar.47 So inaceitveis os fundos excessivos na pesquisa militar e os escassos fundos para a pesquisa sobre os desaos sociais da nanotecnologia, assim como tambm so inaceitveis os possveis riscos para a sade pblica, os trabalhadores e o meio ambiente.48 essencial desenvolver mais pesquisas de impactos sobre o meio ambiente, sade, segurana e aspectos econmicos das nanotecnologias. Isto dever incluir a pesquisa de ao comunitria para ajudar os cidados a entender os potenciais benefcios e prejuzos dos projetos das nanotecnologias. Esta pesquisa dever ser nanciada e conduzida pelas agncias governamentais com mandatos claros sobre a ateno e a pesquisa dos impactos ambientais, da sade, da segurana e dos aspectos scioeconmicos. Todos os resultados devem estar disponveis para o pblico.

Impactos sociais, avaliaes ticas, equidade, justia e preferncias individuais da comunidade devero orientar a distribuio de fundos pblicos para a pesquisa.

Basel Action Network 2006.

Princpios para a superviso de nanotecnologias e nanomateriais

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VIII. Princpio da responsabilidade do produtor


Os nanomateriais explodiram no mercado, so vendidos como substncias milagrosas de caractersticas peculiares, o que faz dessas substncias objetos de desejo em todos os setores da economia. Como no caso do amianto, quando foi introduzido no mercado, os impactos sobre a sade e o meio ambiente destes produtos foram pouco estudados. Hoje em dia, as caractersticas que os nanomateriais possuem superam aquelas do amianto (em forma, tamanho e reao qumica) o que faz com que sejam potencialmente perigosos. Os nanomateriais esto sendo vendidos maciamente ao pblico e esto presentes nos produtos de consumo corrente, sem qualquer advertncia ou informao sobre seus riscos. Alm disso, como na indstria do tabaco, a nanoindstria parece satisfeita por estar comercializando os seus produtos sem um profundo conhecimento dos riscos e sem informar ao pblico sobre os mesmos. Qualquer pessoa que comercializa nanoprodutos, incluindo as pessoas que desenvolvem nanomateriais, as que os operam, os seus fabricantes e as pessoas envolvidas em sua venda devem ser responsabilizadas por quaisquer danos causados pelos seus produtos. Embora a responsabilidade por danos causados pelos produtos da indstria da nanotecnologia seja a mais provvel de sofrer mecanismos legais de responsabilisao, outras formas de responsabilidade, como a negligncia, danos causados a terceiros, danos em primeiro grau e fraudes tambm so relevantes. Alm disso, os regimes regulatrios dos nanomateriais devem incluir mecanismos de nanciamento, nanciados pelos fabricantes e distribuidores, que garantam e permitam o acesso a compensaes e / ou apoio para resolver quaisquer problemas de sade ou do meio ambiente causados por estes produtos. Os grupos potencialmente sujeitos a este tipo de risco incluem indivduos do pblico em geral, as classes de indivduos que experimentam danos semelhantes como, por exemplo, trabalhadores ou consumidores, governos locais, estaduais ou federais, as naes estrangeiras, investidores, seguradoras e sindicatos. Por conseguinte, ambos os atores, os que nanciam a comercializao e os ativamente envolvidos em nanotecnologia e seus setores devem ser responsveis pela segurana de seus produtos e por quaisquer danos decorrentes da ausncia de medidas de precauo para proteger o pblico ou o meio ambiente.

Concluso
Proponentes da revoluo nanotecnolgica prevem que ele ir causar mudanas dramticas e radicais em todos os aspectos da vida humana. Acreditamos que ao no campo da precauo necessria a m de: a) salvaguardar a sade e a segurana do pblico e dos trabalhadores; b) conservar nosso meio ambiente natural; c) assegurar a participao pblica e o alcance de metas decididas democraticamente; d) restaurar a conana pblica e apoio a governo e a pesquisa acadmica ; e) permitir a viabilidade comercial de longo prazo. Apelamos a todas as instituies e atores a tomar medidas para implementar, incorporar e internalizar imediatamente os princpios acima referidos para a superviso das nanotecnologias e nano-material.

Qualquer pessoa que comercializa nanoprodutos, incluindo as pessoas que desenvolvem nanomateriais, as que os operam, os seus fabricantes e as pessoas envolvidas em sua venda devem ser responsabilizadas por quaisquer danos causados pelos seus produtos.

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Princpios para a superviso de nanotecnologias e nanomateriais

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1 This declaration in no manner limits or binds the signatories from any other relevant actions or statements, This declaration in no manner limits binds the signatories including other relevant actions or statements, from any unilateral or joint superseding statements on nanotechnology policy. Each organization continues to fulfill their respective mission statements in accordance with their own fundamental guiding principles. including unilateral or joint superseding statements on nanotechnology policy. Each organization continues This their respective mission statements in accordance with their own fundamental declaration is not to fulll joint declaration supplements our organizations work in this and related areas. This guiding principles. Thisintended to be a comprehensive statement of all possible oversight and related areas. This declaration is not joint declaration supplements our organizations work in this principles or to encompass all subsequent steps to be a comprehensive statement of all is a starting point intended needed for their implementation; rather, itpossible oversight from which future implementations of oversight policy encompass principles or to can build. all subsequent 2 Veja em ingls, generally Perspectives on the Precautionary Principle (Ronnie Harding & Elizabeth steps needed for their implementation; rather, it is a starting point from which future implementations of Fisher, eds., 1999). oversight policy can build. 3 Veja em ingls, e.g., Declaration on Environment and Development, Junho 14, 1992, 31 I.L.M. 874, 879 2 See generally PERSPECTIVES ON THE PRECAUTIONARY PRINCIPLE (Ronnie Harding & Elizabeth Fisher, eds., 1999). 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Sass, Natural Resources Defense EUROPEAN COMMISSIONS SCIENTIFIC C Threat, (2007); Friends of Earth, Nanomaterials, Sunscreens and Cosmetics: Small THE APPROPRIATENESS Risks (2006). NEWLY IDENTIFIED HEALTH RISKS (SCENIHR), OPINION ON Ingredients, Big OF EXISTING METHODOLOGIES TO ASSESS THE 7 POTENTIAL RISKS ASSOCIATED WITH pela ComissoADVENTITIOUS que pretende aplicar o princpio de precauo a Maynard, Veja o que foi estabelecido ENGINEERED AND Europeia, PRODUCTS OF NANOTECHNOLOGIES 6 (2005); Andrew tudo o que gerar efeitos potencialmente nocivos ao meio Ado about Nothing?, 51 ANNALS OF e vegetal. European Nanotechnology: The Next Big Thing, or Much ambiente, ou sade humana, animalOCCUPATIONAL HYGIENE Commission, Communication from the Commission OUNCIL,Precautionary Principle (2000). , (2007); 1, 4-7 (2006); J. SASS, NATURAL RESOURCES DEFENSE C on the NANOTECHNOLOGYS INVISIBLE THREAT 8 FRIENDS OF THE EJ. CLARENCE DAVIES, SUNSCREENS AND COSMETICS: SMALL INGREDIENTS, BIG RFOR(2006). Veja em ingls, ARTH, NANOMATERIALS, WOODROW WILSON INTERNATIONAL CENTER ISKS SCHOLARS, PROJECT ON EMERGING NANOTECHNOLOGIES, MANAGING THE EFFECTS that may have 7 The European Union plans to apply the precautionary principle to issues OF NANOTECHNOLOGY (2006); J. CLARENCE DAVIES, WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS, PROJECT

Princpios para a superviso de Princpios para a superviso de nanotecnologias e nanomateriais nanotecnologias e nanomateriais

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potentially dangerous effects on the environment, human, animal or OVERSIGHT EUROPEAN ON EMERGING NANOTECHNOLOGIES, EPA AND NANOTECHNOLOGY: plant health. COMMISSION, COMMUNICATION FROM THE COMMISSION ON THE PRECAUTIONARY PRINCIPLE (2000). FOR THE 21ST CENTURY, (2007); MICHAEL TAYLOR, WOODROW WILSON INTERNATIONAL CENTER. FOR SCHOLARS, WOODROW W EMERGING NANOTECHNOLOGIES, REGULATING EMERGING J. CLARENCE DAVIES,PROJECT ON ILSON INTERNATIONAL CENTER FOR SCHOLARS, PROJECT ON THE PRODUCTS OF NANOTECHNOLOGY: DOES THE HAVE OF NANOTECHNOLOGY (2006); J. CLARENCE NANOTECHNOLOGIES, MANAGING FDAEFFECTSTHE TOOLS IT NEEDS? (2006); American DAVIES, WOODROW WILSON IBar Association,ENTER FORofCHOLARS, PROJECT ON EMERGING NANOTECHNOLOGIES, EPA AND NANOTECHNOLOGY: NTERNATIONAL C Section S Environment, Energy, and Resources, Nanotechnology Project, at http://www.abanet.org/environ/nanotech/; George Kimbrell, The Environmental Hazards of OVERSIGHT FOR THE 21ST CENTURY, (2007); MICHAEL TAYLOR, WOODROW WILSON INTERNATIONAL CENTER. Nanotechnology and the Applicability of Existing Law, in NANOSCALE: ISSUES AND PERSPECTIVES FOR SCHOLARS, PROJECT ON EMERGING NANOTECHNOLOGIES, REGULATING THE PRODUCTS OF NANOTECHNOLOGY: FOR THE FDA H CENTURY, (Nigel Cameron, ed. 2007); George Kimbrell, Nanomaterial Consumer Products DOES NANO AVE THE TOOLS IT NEEDS? (2006); American Bar Association, Section of Environment, and FDA Regulation: Regulatory Challenges and Necessary Amendments, 3 NANO L. & BUS. 329 (2006); Energy, and Resources, Nanotechnology Project, at http://www.abanet.org/environ/nanotech/; Steffen Kimbrell, The Environmental Hazards incremental approach the the European of Existing George Hansen et al., Limits and prospects of theof Nanotechnology and and Applicability legislation on the in NANOSCALE: SSUES AND PERSPECTIVES FOR THE N 48 CENTURY, (Nigel Cameron, AND PHARMACOLOGY Law,management of Irisks relating to nanomaterials, ANOREGULATORY TOXICOLOGY ed. 2007); 171-83 (2007). George Kimbrell, Nanomaterial Consumer Products and FDA Regulation: Regulatory Challenges Veja de maneira geral em ingls, Mihail C. Roco, and Necessary Amendments, 3 NANO L. & BUS. National Science Foundation and al., Limits and 329 (2006); Steffen Hansen et National Nanotechnology Initiative, Presentation at Science and Technology for Human Future, April 28, 2006; M. C. Roco, prospects of the incremental approach and the European legislation on the management of Nanotechnologys Future, SCIENTIFIC AMERICAN Aug. 2006. risks relating to nanomaterials, 48 REGULATORY TOXICOLOGY AND PHARMACOLOGY 171-83 (2007). Veja em ingls, J. CLARENCE DAVIES, WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS, See generally EMERGING NANOTECHNOLOGIES, EPA AND NANOTECHNOLOGY: OVERSIGHT FOR THE Mihail C. Roco, National Science Foundation and National Nanotechnology PROJECT ON Initiative, Presentation at Science and Technology for this section is theApril 28, 21ST CENTURY 32 (2007) (What I have described in Human Future, entire experience that EPA has 2006; M.to date with regulating nano. OneCIENTIFIC not guess,Aug. 2006. experience, that nano is a major reported C. Roco, Nanotechnologys Future, S would AMERICAN based on this J. CLARENCE DAVIESbeing commercialized at a very rapid pace. SRather, itPROJECT ON EMERGING widening gap new technology , WOODROW WILSON INTERNATIONAL CENTER FOR CHOLARS, refl ects the rapidly NANOTECHNOLOGIES, EPAof theNANOTECHNOLOGY: OVERSIGHT FOR THE 21ST CENTURY 32 (2007) (What to between the adoption AND technology in the private sector and the governments lagging attempts Iunderstand nano in this ensure thatthedoes notexperience thatand the environment.); George Kimbrell, have described and to section is it entire harm humans EPA has reported to date with regulating nano. One would not and FDA Regulation: Regulatory Challenges andaNecessary Amendments, 3 Nanomaterial Consumer Products guess, based on this experience, that nano is major new technology BUS. 329 (2006). NANO L. & being commercialized at a very rapid pace. Rather, it reects the rapidly widening gap between anterior. Veja a nota 8 the adoption of the technology in the private sector and the governments lagging attempts toALLIANZ GROUP AND THE ORGANISATION FOR ECONOMIC CO-OPERATION AND Veja em ingls, THE understand nano and to ensure that it does not harm humans and the environment.);SMALL SIZES THAT Nanomaterial Consumer Products and FDA Regulation: DEVELOPMENT, George Kimbrell, MATTER: OPPORTUNITIES AND RISKS OF NANOTECHNOLOGIES, 6.4 (2005) (Experts are overwhelmingly of the opinion that the adverse effects of nanoparticles cannot be Regulatory Challenges and Necessary Amendments, 3 NANO L. & BUS. 329 (2006). reliably predicted See note 8 supra. or derived from the known toxicity of the bulk material.); EUROPEAN COMMISSIONS SCIENTIFIC COMMITTEE ORGANISATION FOR ECONOMIC CO-OPERATION HEALTH RISKS (SCENIHR), THAT THE ALLIANZ GROUP AND THEON EMERGING AND NEWLY IDENTIFIED AND DEVELOPMENT, SMALL SIZES OPINION ON THE APPROPRIATENESS OF EXISTING METHODOLOGIES TO ASSESS THE POTENTIAL RISKS ASSOCIATED MATTER: OPPORTUNITIES AND RISKS OF NANOTECHNOLOGIES, 6.4 (2005) (Experts are overwhelmingly of WITH ENGINEERED adverse effects of nanoparticles OF NANOTECHNOLOGIES, 6 (2005) (Experts the opinion that the AND ADVENTITIOUS PRODUCTS cannot be reliably predicted or derived from are of known toxicity of the bulk material.); EUROPEAN COMMISSION S SCIENTIFIC COMMITTEE ON EMERGING AND thethe unanimous opinion that the adverse effects of nanoparticles cannot be predicted (or derived) from the known toxicity of material of macroscopic size, which obey the laws of classical physics.); Royal Society NEWLY IDENTIFIED HEALTH RISKS (SCENIHR), OPINION ON THE APPROPRIATENESS OF EXISTING METHODOLOGIES TO ASSESS THE Report, RISKS ASSOCIATED WITH (Free particles in the nanometre NANOTECHNOLOGIES, 6 (2005) (Experts are of POTENTIAL supra note 6 at 49 ENGINEERED AND ADVENTITIOUS PRODUCTS OFsize range do raise health, environmental, and safety concerns opinion toxicology cannot be inferred from that of particles of the same chemical at a the unanimous and their that the adverse effects of nanoparticles cannot be predicted (or derived) larger size.); TRAN ET AL., A SCOPING STUDY TO IDENTIFY HAZARD DATA laws of classical physics.); from the known toxicity of material of macroscopic size, which obey the NEEDS FOR DRESSING THE RISKS PRESENTED BY Royal Society Report,NANOPARTICLES49 (Free particles in the nanometre size range do raise health, supra note 6 at AND NANOTUBES, INSTITUTE OF OCCUPATIONAL MEDICINE 34 (2005), at 34 (Because of their size and the ways they are used, [engineered nanomaterials] have specific environmental, and safety concerns and their toxicology cannot be inferred from that of particles of the physical-chemical properties and therefore may behave differently from their parent materials when released same chemical at a larger size.); TRAN ET AL., A SCOPING STUDY TO IDENTIFY HAZARD DATA NEEDS FOR ADDRESSING and interact differently with living systems. It is accepted, therefore, that it is not possible to infer the safety of THE RISKS PRESENTED BY NANOPARTICLES derived from theINSTITUTE OF OCCUPATIONAL MEDICINE 34 (2005), at AND NANOTUBES, nanomaterials by using information bulk parent material.). 34 (Because of their size and the ways they areThe Next Big Thing, or Much Ado about Nothing?,c51 Veja em ingls, Andrew Maynard, Nanotechnology: used, [engineered nanomaterials] have speci physical-chemical propertiesHYGIENE 1, 7 (2006); Nel etdifferently from Oberdrster et al., Principles ANNALS OF OCCUPATIONAL and therefore may behave al., supra note 6; their parent materials when released and interact Potential Human Health Effects Fromis accepted, therefore, that it is not possible for Characterizing the differently with living systems. It Exposure to Nanomaterials: Elements of a to infer the safety 2 PARTICLE AND FIBRE TOXICOLOGY 8, 1.0 (2005). Additional tests should include Screening Strategy, of nanomaterials by using information derived from the bulk parent material.). Andrew Maynard, Nanotechnology: The Next Big Thing, or metabolism,about Nothing?, 51 ANNALS testing for pharmacological properties; absorption, distribution, Much Ado excretion studies; genotoxicity; OF OCCUPATIONAL HYGIENE 1,of embryonic and fetal organisms, immunotoxicity, and carcinogenicity. Physicoeffects on the development 7 (2006); Nel et al., supra note 6; Oberdrster et al., Principles for Characterizing the Potential Humanincluding shape,From Exposure to Nanomaterials: Elements of a chemical properties additional to size, Health Effects surface structure, polarity etc, infl uence the toxicity Screening Strategy, 2therefore AND Falso TOXICOLOGY 8, 1.0 (2005). Additional tests should include testing of nanomaterials and PARTICLE must IBRE be assessed. Exposure metrics must include surface area, number and for pharmacological properties; mass. Jaydee Hanson, Nano metabolism, excretionand Safetygenotoxicity; concentration of particles not just absorption, distribution, Matters: Environmental studies; Concerns, effects on Nanotechnology and Biotechnology in Society Conference, (Mar. 29, 2006).and carcinogenicity. Speech to the development of embryonic and fetal organisms, immunotoxicity, Physico-chemical properties additional to size, including shape, surface structure, polarity etc, infl uence the toxicity of Physico-chemical properties additional to size, including shape, surface structure, polarity etc, nanomaterials and therefore must also be and therefore must also must include surface area, number and inuence the toxicity of nanomaterials assessed. Exposure metrics be assessed. Exposure metrics must concentration of particles not just mass. include surface area, number and concentration of particles not just mass. Jaydee Hanson, Nano Veja o exemplo em ingls, THE ROYAL SOCIETY AND THE ROYAL ACADEMY OF Biotechnology Matters: Environmental and Safety Concerns, Speech to Nanotechnology and ENGINEERING, in Society NANOSCIENCE AND NANOTECHNOLOGIES: OPPORTUNITIES AND UNCERTAINTIES 6, 43, 73, Conference, (Mar. 29, 2006). Physico-chemical properties additional to size, including shape, surface 83 (2004); NRDC etc, Comments to EPA, Re: EPA Proposal to regulate nanomaterials through a structure, polarity et al.,inuence the toxicity of nanomaterials and therefore must also be assessed. voluntary pilot program, Docket surface area, number and concentration of particles to Exposure metrics must include ID: OPPT-2004-0122, July 5, 2005; ICTA et al., Petitionnot just mass. FDA on Regulation SOCIETY AND THE Products, FDA Docket 2006P- 0210/CP1, AND NANOTECHNOLOGIES: See, e.g., THE ROYAL of NanomaterialROYAL ACADEMY OF ENGINEERING, NANOSCIENCEMay 2006, at http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf OPPORTUNITIES AND UNCERTAINTIES 6, 43, 73, 83 (2004); NRDC et al., Comments to EPA, Re: EPA Proposal to regulate nanomaterials through a voluntary pilot program, Docket ID: OPPT-2004-0122, July

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15 5, 2005; ICTA et al., Petition to FDA on Regulation of Nanomaterial Products, FDA Docket 2006PVeja o exemplo em ingls, British Department for Environment, Food, and Rural Affairs, www.defra.gov.uk/environmental/nanotech (voluntary program launched in September 2006, 0210/CP1, May 2006, at http://www.icta.org/doc/Nano%20FDA%20petition%20nal.pdf and e.g., British Department for only six submissions) 15 See, as of April 2007, has received Environment, Food, and Rural Affairs, www.defra. 16 gov.uk/environmental/nanotech (voluntary program launched in September Veja em ingls, J. CLARENCE DAVIES, WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS, PROJECT ON of April 2007, has received only six submissions). 2006, and as EMERGING NANOTECHNOLOGIES, EPA AND NANOTECHNOLOGY: OVERSIGHT FOR THE 16 21ST CENTURY. 18 (2007) (ItILSON INTERNATIONAL CENTER FOR SCHOLARS, PROJECT ON carry out chronic and J. CLARENCE DAVIES, WOODROW W is hard to see what will motivate manufacturers to environmental testing if regulation does not require it.). EMERGING NANOTECHNOLOGIES, EPA AND NANOTECHNOLOGY: OVERSIGHT FOR THE 21ST CENTURY 17 Veja(2007) (ItJANE MACOUBRIE, WOODROW WILSON INTERNATIONAL CENTER FOR 18 em ingls, is hard to see what will motivate manufacturers to carry out SCHOLARS, PROJECT ON EMERGING NANOTECHNOLOGIES, INFORMED PUBLIC PERCEPTIONS OF chronic and environmental testing if regulation does not require it.). 17 NANOTECHNOLOGY ANDWILSON INTERNATIONAL CENTER FOR SCHOLARS, PROJECT ON EMERGING JANE MACOUBRIE, WOODROW TRUST IN GOVERNMENT 14 (2005). 18 Veja em ingls por ex., The Royal Society and the Royal Academy of Engineering, Nanoscience and NANOTECHNOLOGIES, INFORMED PUBLIC PERCEPTIONS OF NANOTECHNOLOGY AND TRUST IN GOVERNMENT 14 (2005). nanotechnologies: Opportunities and uncertainties 36, 79-80 (2004); Oberdrster et al., Principles for 18 See, e.g., THE ROYAL SOCIETY AND THE ROYAL ACADEMY OF ENGINEERING, NANOSCIENCE AND NANOTECHNOLOGIES: Characterizing the Potential Human Health Effects From Exposure to Nanomaterials: Elements of a Screening OPPORTUNITIES AND UNCERTAINTIES 36, 79-80 (2004); Oberdrster et al., Principles for Strategy, 2 Particle and Fibre Toxicology 8, 29 (2005). Characterizing the Potential Human Health Effects From Exposure to Nanomaterials: 19 Veja em ingls, Holsapple et al., Research Strategies for Safety Evaluation of Nanomaterials, Part II: Elements of Screening Strategy, of ARTICLE AND FIBRE TOXICOLOGY 8, 29 and Data Toxicologicalaand Safety Evaluation 2 PNanomaterials, Current Challenges (2005). Needs, 88 Toxicological 19 See, e.g.,12 (2005) et al., Research Strategies for Safety Evaluation of Sciences Holsapple 20 Nanomaterials, Part II: Toxicological and Safety Evaluation of Nanomaterials, I d. at 829, 837. 21 Current ingls, Monteiro-Riviere N. et al., TOXICOLOGICAL SIntact Skin by Quantum Dots with Diverse Veja em Challenges and Data Needs, 88 Penetration of CIENCES 12 (2005). 20 Id. at 829, 837. Properties, 91 Toxicological Sciences 159 (2006); Rouse J et al., Effects of Mechanical Physicochemical 21 Monteiro-Riviere N. et al., Penetration of Intact Skin by Quantum Dots with Diverse Flexion on the Penetration of Fullerene Amino Acid-Derivatized Peptide Nanoparticles through Skin, 7(1) Physicochemical (2007). Nano Letters 155 Properties, 91 TOXICOLOGICAL SCIENCES 159 (2006); Rouse J et al., 22 Effects of Mechanical Flexion on the al., Skin Penetration of Fullerene Substituted Amino Acids and their Veja em ingls, Monteiro-Riviere N. et Penetration of Fullerene Amino Acid-Derivatized Peptide Nanoparticles through Skin, 7(1) NANO LETTERS 155 (2007). 168 (2006). Interactions with Human Epidermal Keratinocytes, 827 The Toxicologist 22 Monteiro-Riviere N. et et al., Effects of Mechanical Flexion Substituted Aminoof Fullerenetheir Acid23 Veja em ingls, Rouse J. al., Skin Penetration of Fullerene on the Penetration Acids and Amino Derivatized with Nanoparticles through Skin, 7(1) 827 Letters 155 (2007). InteractionsPeptideHuman Epidermal Keratinocytes,NaNoTHE TOXICOLOGIST 168 (2006). 24 Veja em et al., Effects of Mechanical Flexion of the Penetration of Fullerene Amino Terminal Hair 23 Rouse J.ingls, Toll R. et al., Penetration Profile onMicrospheres in Follicular Targeting ofAcidFollicles, 123 The Journal of Investigative Dermatology, 168 (2004). Derivatized Peptide Nanoparticles through Skin, 7(1) NANO LETTERS 155 (2007). 25 Veja em ingls, Florence A. et al., of Microspheres in Follicular Targeting of Delivery 24 Toll R. et al., Penetration ProleTranscytosis of Nanoparticle and DendrimersTerminal Systems: Evolving Vistas, 50 Adv 123 Deliv Rev S69 INVESTIGATIVE DERMATOLOGY, 168 Advances Hair Follicles,Drug THE JOURNAL OF(2001); Hussain N. et al., Recent(2004). in the Understanding of Uptake of Microparticulates Across the of Nanoparticle and Dendrimers Drug Deliv Rev 107 (2001); Hillyer 25 Florence A. et al., Transcytosis Gastrointestinal Lymphatics, 50 AdvDelivery Systems: Evolving Vistas, J. F. et ADV DRUG DELIV R persorption and tissue distribution of differently sized colloidal gold nanoparticles, 90 J 50al., GastrointestinalEV S69 (2001); Hussain N. et al., Recent Advances in the Understanding Pharm Sci of Microparticulates of Uptake 1927-1936 (2001). Across the Gastrointestinal Lymphatics, 50 ADV DRUG DELIV 26 Veja 107ingls, Oberdrster F. et al., Gastrointestinal persorption and tissue distribution of REV em (2001); Hillyer J. et al., Nanotoxicology: An Emerging Discipline From Studies of Ultrafine Particles, 113 Environmental Health Perspectives 823-83990 J PHARM SCI 1927-1936 (2001). differently sized colloidal gold nanoparticles, (2005). 27 Veja em ingls, Borm PJ, Kreyling, W, Toxicological hazards of inhaled nanoparticles--potential implications for 26 See, e.g., Oberdrster et al., Nanotoxicology: An Emerging Discipline From Studies drug delivery, 4 J Nanosci Nanotechnol 521-531 (2004). of Ultrane Particles, 113 ENVIRONMENTAL HEALTH PERSPECTIVES 823-839 (2005). 28 Veja em ingls, Rick Weiss, Nanotechnology Risks Unknown; Insufficient Attention Paid to Potential Dangers, 27 Borm PJ, Kreyling, W, Toxicological hazards of inhaled nanoparticles--potential Report Says, Wash. Post, Sept. 26, 2006, at A12. implications for drug delivery, 4 J NANOSCI NANOTECHNOL 521-531 (2004). 29 Veja em ingls, Mihail C. Roco, Nanotechnologys Future, Scientific American, Aug. 2006. 28 Veja e.g., Rick Occupational Safety and Risks Act (OSHA) standards (29 CFR). Paid 30 See, em ingls,Weiss, Nanotechnology HealthUnknown; Insufcient AttentionSpecific attention should to PotentialHazard Communication WASH. POST, Sept. 26, 2006, at A12. (1910.134), Personal Protective be given to Dangers, Report Says, (1910.1200), Respiratory Protection 29 See, e.g., Mihail C. Roco, Nanotechnologys Future, SCIENTIFIC AMERICAN, Aug. 2006. Equipment (1910.132), Access to Medical And Exposure Records (1910.1020), Hazardous Chemicals in 30 See Occupational Safety and Health Act (OSHA)standards where CFR). Specic attention should be given Laboratories (1910.1450), and Chemical-specific standards (29 applicable (1910, Subpart Z). 31 to Hazard Communication (1910.1200),systematic analysis of the resources usages (e.g.,Protective Veja em ingls, A lifecycle assessment is the Respiratory Protection (1910.134), Personal energy, water, Equipment (1910.132), Access over the complete supply chain from the cradle of primary resources to raw materials) and the emissions to Medical And Exposure Records (1910.1020), Hazardous Chemicals in Laboratories (1910.1450), and Chemical-specic standards where applicable (1910, Subpart Z). the grave of recycling or disposal. THE ROYAL SOCIETY AND THE ROYAL ACADEMY OF ENGINEERING, 31 A lifecycle assessment is the systematic analysis of the resources usages (e.g., energy, water, NANOSCIENCE AND NANOTECHNOLOGIES: OPPORTUNITIES AND UNCERTAINTIES 32 (2004). 32 raw materials) em ingls, THE ROYAL SOCIETY AND THE ROYAL ACADEMY OFcradle of primary Veja o exemplo and the emissions over the complete supply chain from the ENGINEERING, resources to the grave of recycling or disposal. THE ROYAL SOCIETY AND THE ROYAL ACADEMY OF (Any NANOSCIENCE AND NANOTECHNOLOGIES: OPPORTUNITIES AND UNCERTAINTIES 46 (2004) widespread NANOSCIENCE AND NANOTECHNOLOGIES: as medicines (if UNCERTAINTIES 32 (2004). ENGINEERING,use of nanoparticles in products suchOPPORTUNITIES ANDthe particles are excreted from the body rather than biodegraded) and cosmetics (that are washed off) will NANOSCIENCE AND NANOTECHNOLOGIES: 32 See, e.g., THE ROYAL SOCIETY AND THE ROYAL ACADEMY OF ENGINEERING, present a diffuse source of nanoparticles toPPORTUNITIES AND UNCERTAINTIES 46 (2004) (Any widespread use ofthis presents a riskproducts such as O the environment, for example through the sewage system. Whether nanoparticles in to the environment will depend on the toxicity are excreted from the body about which almost nothing is known, and medicines (if the particles of nanoparticles to organisms,rather than biodegraded) and cosmetics (that the washed off) will discharged.) (emphasis of nanoparticles to the environment, for example and are quantities that are present a diffuse source added); see, also Wardak et al., The Product Life Cycle through Challenges system. Whether Regulation, risk to the environment will depend 507 (2006). Scientifi the sewageto Nanotechnologythis presents3aNANOTECHNOLOGY LAW & BUSINESSon the toxicity of c experts estimated that it might take until 2012 to have the ability to quantities impact discharged.) nanoparticles to organisms, about which almost nothing is known, and the evaluate thethat are of engineered nanomaterials from see, also grave. et al., The Product Life Cycle Nanotechnology, Vol 444 NATURE 267(emphasis added); cradle to WardakMaynard et al., Safe Handling ofand Challenges to Nanotechnology 69 (November 16, 2006). Regulation, 3 NANOTECHNOLOGY LAW & BUSINESS 507 (2006). Scientic experts estimated that it might 33 take o exemplo em ingls, U.S.ability to evaluate the impact of engineered nanomaterials from cradle Veja until 2012 to have the ENVIRONMENTAL PROTECTION AGENCY, NANOTECHNOLOGY WHITE PAPER 11 (2006). to grave. Maynard et al., Safe Handling of Nanotechnology, Vol 444 NATURE 267-69 (November 16, 2006). 34 Veja em ingls,Yang L. et al., Particle surface characteristics may play an important role in phytotoxicity of 33 See, e.g., U.S. ENVIRONMENTAL PROTECTION AGENCY, NANOTECHNOLOGY WHITE PAPER 11 (2006). alumina nanoparticles, 158(2) TOXICOL LETT. 122-32 (2005).

Princpios para a superviso de nanotecnologias e nanomateriais

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35 Veja L. ingls,Templeton R. et al., Life-cycle Effects of Single-Walled Carbon Nanotubes (SWNTs) on an 34 Yangem et al., Particle surface characteristics may play an important role in Estuarine Meiobenthic Copepod, 40 ENVIRONMENTAL SCIENCE AND TECHNOLOGY 7387-7393.(2006). phytotoxicity of alumina nanoparticles, 158(2) TOXICOL LETT. 122-32 (2005). 36 R. SENJEN, R. et al., OF THE EARTH AUSTRALIA, NANOSILVER Nanotubes (SWNTs) on an 35 Templeton FRIENDS Life-cycle Effects of Single-Walled Carbon A THREAT TO SOIL, WATER AND HUMAN HEALTH?, (2007) available at http://nano.foe.org.au/; J. SASS, NATURAL RESOURCES DEFENSE COUNCIL, Estuarine Meiobenthic Copepod, 40 ENVIRONMENTAL SCIENCE AND TECHNOLOGY 7387-7393.(2006). NANOTECHNOLOGYS EARTH AUSTRALIA, N (2007). 36 R. SENJEN, FRIENDS OF THE INVISIBLE THREATANOSILVER A THREAT TO SOIL, WATER AND 37 HUMANexemplo em ingls, THE ROYAL SOCIETY AND THE ROYAL ACADEMY OF ENGINEERING, Veja o HEALTH?, (2007) available at http://nano.foe.org.au/; J. SASS, NATURAL NANOSCIENCE AND NANOTECHNOLOGIES: INVISIBLE THREAT (2007). RESOURCES DEFENSE COUNCIL, NANOTECHNOLOGYS OPPORTUNITIES AND UNCERTAINTIES 46 (2004). 38 Veja o exemplo em SOCIETY AND THE ROYAL ACADEMY OF E Risks Unknown; Insuffi 37 See, e.g., THE ROYAL ingls, Rick Weiss, NanotechnologyNGINEERING, NANOSCIENCE cient Attention Paid to Potential Dangers, Report Says, WASH. POST, Sept. 26, 2006, at A12. AND NANOTECHNOLOGIES: OPPORTUNITIES AND UNCERTAINTIES 46 (2004). 39 Veja em geral, ANDREW MAYNARD, WOODROW WILSON INTERNATIONAL CENTER. FOR SCHOLARS, 38 See, e.g., Rick Weiss, Nanotechnology Risks Unknown; Insufcient Attention Paid PROJECT ON EMERGING NANOTECHNOLOGIES, NANOTECHNOLOGY: A RESEARCH STRATEGY FOR to Potential Dangers, Report Says, WASH. POST, Sept. 26, 2006, at A12. ADDRESSING RISK (2006). 39 See generally ANDREW MAYNARD, WOODROW WILSON INTERNATIONAL CENTER. FOR SCHOLARS, PROJECT ON 40 Veja em ingls,George Kimbrell, The Environmental Hazards of Nanotechnology and the Applicability of EMERGINGLaw, in NANOSCALE: ISSUES AND PERSPECTIVES FOR THEFOR ADDRESSING RISK (Nigel Cameron, ed. NANOTECHNOLOGIES, NANOTECHNOLOGY: A RESEARCH STRATEGY NANO CENTURY, (2006). Existing 40 George J. CLARENCE DAVIES, WOODROW WILSONNanotechnology and the Applicability of PROJECT ON Kimbrell, The Environmental Hazards of INTERNATIONAL CENTER FOR SCHOLARS, 2007); Existing Law, in NANOSCALE: ISSUES AND PERSPECTIVES FOR THE NANO CENTURY, (Nigel Cameron,21ST CENTURY EMERGING NANOTECHNOLOGIES, EPA AND NANOTECHNOLOGY: OVERSIGHT FOR THE ed. 2007); J. CLARENCE Association, Section of Environment, Energy, and Resources, , PROJECT (2007); American Bar DAVIES, WOODROW WILSON INTERNATIONAL CENTER FOR SCHOLARS Nanotechnology Project, ON EMERGING NANOTECHNOLOGIES, EPA AND NANOTECHNOLOGY: OVERSIGHT FOR THE 21ST CENTURY (2006), at http://www.abanet.org/environ/nanotech/; 41 (2007); ingls, DAN KAHAN et aL., WOODROWEnvironment, Energy, and Resources, SCHOLARS, Veja em American Bar Association, Section of WILSON INTERNATIONAL CENTER FOR Nanotechnology Project,NANOTECHNOLOGIES, NANOTECHNOLOGY RISK PERCEPTIONS 2 (2006) PROJECT ON EMERGING (2006), at http://www.abanet.org/environ/nanotech/; 41 DAN KAHAN ETwith WOODROW W(PeterINTERNATIONAL CENTER FOR SCHOLARS, Pthe resultsEsuggested that Americans (Consistent AL., past surveys ILSON D. Hart Research Associates, 2006), ROJECT ON MERGING NANOTECHNOLOGIES, NANOTECHNOLOGY RISK PERCEPTIONS of (2006) (Consistent with past surveys (Peterat all are largely uninformed about nanotechnology: 81% 2 subjects reported having heard either nothing D. Hart Research Associates, 2006), the results suggested that Americans are largely uninformed about (53%) or just a little (28%) about nanotechnology prior to being surveyed, and only 5% reported having nanotechnology: 81% of subjects reported having heard either nothing at all (53%) or just a little heard a lot.). 42 (28%) about nanotechnology prior to being surveyed, andUNKNOWN PROMISE, UNKNOWN RISK 40 Veja em ingls, CONSUMER REPORTS, NANOTECHNOLOGY: only 5% reported having heard a lot.). (2007) (Consumer Reports asked N outside lab to test for nanoparticles of zinc oxide 40 42 See. e.g., CONSUMER REPORTS, anANOTECHNOLOGY: UNKNOWN PROMISE, UNKNOWN RISK and titanium dioxide in eight sunscreens that listed either compound on their test for eight contained zinc oxide and (2007) (Consumer Reports asked an outside lab to label. Allnanoparticles ofthe nanoparticles, yet only one disclosed that use in eight sunscreens titanium dioxide of nanotechnology). that listed either compound on their label. All eight 43 contained the nanoparticles, yet of Agriculture, 118 Cal. App. 2d 348, 353-54 (1953) (holding that the Veja em ingls, Paraco Inc v. Dept only one disclosed that use of nanotechnology). public have a right v. Dept what they are buying); App. 2d 348, 353-54 (1953) (holding 43 See, e.g., Paraco Inc to know of Agriculture, 118 Cal. Fredrick H. Degnan, The Food Label and the Rightto-Know, 52 Food & Drug L.J. 49, 50 (1997) (Pursuant to the consumers H. Degnan, The that the public have a right to know what they are buying); Fredrick right to know, the public has a basic Label and the Right-to-Know, 52 Food about food or a commodity before being forced Food right to know any fact it deems important& Drug L.J. 49, 50 (1997) (Pursuant to the to make a purchasing decision.). consumers right to know, the public has a basic right to know any fact it deems important 44 about food or aEconomic Commission for Europe (UNECE),aAARHUS CONVENTION, CONVENTION ON United Nations commodity before being forced to make purchasing decision.). ACCES TO INFORMATION, PUBLIC PARTICIPATION IN DECISION-MAKING AND ACCES TO JUSTICE IN 44 United Nations Economic Commission for Europe (UNECE), AARHUS CONVENTION, ENVIRONMENTAL MATTERS, adopted June 25, 1998. CONVENTION ON ACCESS TO INFORMATION, PUBLIC PARTICIPATION IN DECISION-MAKING AND 45 Veja em ingls, National Science and Technology Council, National Nanotechnology Initiative, ACCESS TO JUSTICE IN ENVIRONMENTAL MATTERS, adopted June 25, 1998. Nanotechnology: Shaping the World Atom by Atom 4 (1999) (proclaiming nanotechnology as a likely 45 See, e.g., NATIONAL SCIENCE AND TECHNOLOGY COUNCIL, NATIONAL NANOTECHNOLOGY INITIATIVE, NANOTECHNOLOGY: launch pad to a new technological era because it focuses on perhaps the final engineering scales people SHAPING THE master.);TOM at 8 TOM present trends in nanoscience and nanotechnology continue, most aspects have yet to WORLD A id. BY A(If 4 (1999) (proclaiming nanotechnology as a likely launch pad to a new technological era because it focuses ontotal societal impact of nanotechnologypeople have to of everyday life are subject to change.); id. (The perhaps the nal engineering scales is expected yet much greater than that(Ifthe silicon integrated circuit because it is applicable in many moremost than be to master.); id. at 8 of present trends in nanoscience and nanotechnology continue, fields aspects of everyday life 1 (stating the nanotechnology(The totalwill result in unprecedented control just electronics.); id. at are subject to change.); id. revolution societal impact of nanotechnology is expected to beworld.); see also Asia-Pacific Economic integrated circuit because it isand Technology over the material much greater than that of the silicon Cooperation Industrial Science applicable in many more elds than just electronics.); id. at 1 (stating the nanotechnology Full Report 24 (2002), Working Group, Nanotechnology: The technology for the 21st Century. Vol II: The revolution will result in unprecedented control overrevolutionize manufacturing,also ASIA-PACIFIC ECONOMIC COOPERATION (If nanotechnology is going to the material world.); see health care, energy supply, communications INDUSTRIAL SCIENCE AND TECHNOLOGY transformGROUP, NANOTECHNOLOGY: THE medical system, THE 21ST CENTURY. and probably defense, then it will WORKING labor and the workplace, the TECHNOLOGY FOR the transportation VOL II: THE FULL REPORT 24and the military. None of these latter will be changed without significant social and power infrastructures (2002), (If nanotechnology is going to revolutionize manufacturing, health care, energy supply, communications and probably defense, then it will transform labor disruption.). 46 and the workplace, the medical system, the transportation and power infrastructures and the ON Veja o exemplo em ingls, THE SOUTH CENTRE, THE POTENTIAL IMPACT OF NANOTECHNOLOGIES COMMODITY MARKETS: latter will be changed COMMODITY DEPENDENT DEVELOPING military. None of these THE IMPLICATIONS FORwithout signicant social disruption.).COUNTRIES (2005). 46 See, e.g., THE SOUTH CENTRE, THE POTENTIAL IMPACT OF NANOTECHNOLOGIES ON COMMODITY 47 MARKETS:ingls, Richard E.FOR COMMODITY DEPENDENT DEVELOPING COUNTRIES (2005).States: An Introductory Veja em THE IMPLICATIONS Sclove et al., Community-Based Research in the United Reconnaisance (1998). 47 Richard E. Sclove et al., Community-Based Research in the United 48 States: An Introductory Reconnaisance (1998). Veja em ingls, In 2006, the United States government allocated 33% of the US$1.3 billion National Nanotechnology Initiative budget to military applications. However the billion National Center estimated 48 In 2006, the United States government allocated 33% of the US$1.3 Woodrow Wilson Nanotechnology that only budget to military applications. However the Woodrow Wilson Center estimated that Initiative US$11 million (0.85% of the 2006 NNI budget) was dedicated to highly relevant research into health $11 million (0.85% At a nanotechnology workshop held in 2005 by the relevant research only USand environment risks.of the 2006 NNI budget) was dedicated to highly United Kingdoms Royal Society and the environment risks. At a representatives from the United States National Science Foundation into health andScience Council of Japan, nanotechnology workshop held in 2005 by the United indicated that they would Kingdoms Royal Society spend only US$7.5 million (0.58% of the 2006 NNIfrom theon research into and the Science Council of Japan, representatives budget) United States nanotechnologys ethical, legal and social issues National Science Foundation indicated that they would spend only US$7.5 million (0.58% of 49 See note 45 supra. the 2006 NNI budget) on research into nanotechnologys ethical, legal and social issues.

16

Princpios para a superviso de nanotecnologias e nanomateriais

Original Signatories Accin Ecolgica (Ecuador) African Centre for Biosafety American Federation of Labor and Congress of Industrial Organizations (U.S.) Bakery, Confectionery, Tobacco Workers and Grain Millers International Union Beyond Pesticides (U.S.) Biological Farmers of Australia Canadian Environmental Law Association Center for Biological Diversity (U.S.) Center for Community Action and Environmental Justice (U.S.) Center for Food Safety (U.S.) Center for Environmental Health (U.S.) Center for Genetics and Society (U.S.) Center for the Study of Responsive Law (U.S.) Clean Production Action (Canada) Ecological Club Eremurus (Russia) EcoNexus (United Kingdom) Edmonds Institute (U.S.) Environmental Research Foundation (U.S.) Essential Action (U.S.) ETC Group (Canada) Forum for Biotechnology and Food Security (India) Friends of the Earth Australia Friends of the Earth Europe Friends of the Earth United States GeneEthics (Australia) Greenpeace (U.S.) Health and Environment Alliance (Belgium) India Institute for Critical Action-Centre in Movement Institute for Agriculture and Trade Policy (U.S.) Institute for Sustainable Development (Ethiopia) International Center for Technology Assessment (U.S.) International Society of Doctors for the Environment (Austria) International Trade Union Confederation International Union of Food, Agricultural, Hotel, Restaurant, Catering, Tobacco and Allied Workers Associations Loka Institute (U.S.) National Toxics Network (Australia) Public Employees for Environmental Responsibility (U.S.) Science and Environmental Health Network (U.S.) Silicon Valley Toxics Coalition (U.S.) Tebtebba Foundation - Indigenous Peoples International Centre for Policy Research and Education (Philippines)

The Soils Association (United Kingdom) Third World Network (China) United Steelworkers (U.S.) Vivagora (France)

Post-release Signatories (as of October 8, 2008) Institute for Inquiry (U.S.) Mother Earth Foundation - Philippines International Science Oversight Board (U.S.) International Environmental Intelligence Agency (U.S.) Physicians and Scientists for Responsible Genetics (New Zealand) Center for Encounter and active Non-Violence (Austria) Observatori del Deute en la Globalitzaci (Spain) Centro de Informacin y Servicios de Asesoria en Salud (Nicaragua) Comit Regional de Promocin de Salud Comunitaria, Centroamrica Movimiento de MOMS - Making Our Milk Safe (U.S.) Salud de los Pueblos (Latin America) Partners for the Land and Agricultural Needs of Traditional Peoples (U.S.) Sustainlabour - International Labour Foundation for Sustainable Development (Spain) Agricultural Missions (U.S.) Greenpeace International The Latin American Nanotechnology & Society Network (ReLANS - Red Latinoamericana de Nanotecnologa y Sociedad) Citizens Against Chemicals Pollution (Japan) Citizens Coalition on Nanotechnology (U.S.) Australian Council of Trade Unions Saskatchewan Network for Alternatives to Pesticides (Canada) Foundation Sciences Citoyennes (France) South African Council of Churches Bund fr Umwelt und Naturschutz Deutschland (BUND) Bundesverband Brgerinitiativen Umweltschutz (BBU) Canadian Institute for Environmental Law and Policy (CIELAP) Public Interest Lawyers (UK) European Environmental Bureau (EEB) Organic Consumers Association (U.S.) Food and Water Watch (U.S.) Rede Brasileira de Pesquisas em Nanotecnologia, Sociedade e Meio Ambiente (Brasil)

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