NRC Publishes A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials

Posted on January 25, 2012 by Lynn L. Bergeson

On January 25, 2012, the National Research Council (NRC) posted the pre-publication version of its report entitled A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials. The U.S. Environmental Protection Agency (EPA) asked NRC to perform an independent study to develop and monitor the implementation of an integrated research strategy to address the environmental, health, and safety (EHS) aspects of engineered nanomaterials (ENM). NRC convened the Committee to Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, which concluded that there is need for a research strategy that is independent of any one stakeholder group, has human and environmental health as its primary focus, builds on past efforts, and is flexible in anticipating and adjusting to emerging challenges.

To help guide research, the Committee noted the following four research categories, which it states should be addressed within five years:

  • Identify and quantify the nanomaterials being released and the populations and environments being exposed;
  • Understand processes that affect both potential hazards and exposure;
  • Examine nanomaterial interactions in complex systems ranging from subcellular to ecosystems; and
  • Support an adaptive research and knowledge infrastructure for accelerating progress and providing rapid feedback to advance research.

The Committee acknowledged a gap between funding and the level of activity required to support its strategy. The Committee concluded that any reduction in the current funding level of approximately $120 million per year over the next five years for health and environmental risk research by federal agencies would be a setback to nanomaterials risk research. Moreover, according to the Committee, additional “modest resources” from public, private, and international initiatives are needed in critical areas -- informatics, nanomaterial characterization, benchmarking nanomaterials, characterization of sources, and development of networks for supporting collaborative research -- to derive maximum strategic value from the research investments.

The Committee states that implementation of the strategy should also include the integration of domestic and international participants involved in nanotechnology-related research, including the National Nanotechnology Initiative (NNI), federal agencies, the private sector, non-governmental organizations, and the academic community. The Committee noted that the current structure of the NNI, which has no top-down budgetary or management authority to direct nanotechnology-related EHS research, hinders its accountability for effective implementation. In addition, according to the Committee, there is concern that dual and potentially conflicting roles of the NNI, such as developing and promoting nanotechnology while identifying and mitigating risks that arise from its use, impede application and evaluation of health and environmental risk research. The Committee concluded that, to carry out the research strategy effectively, a clear separation of management and budgetary authority and accountability between promoting nanotechnology and assessing potential environmental and safety risks is essential.

 
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EFSA Publishes Guidance for Assessing Engineered Nanomaterial Applications in Food and Feed

Posted on May 11, 2011 by Lynn L. Bergeson

On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. According to EFSA, the guidance “is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.” The guidance covers risk assessments for food and feed applications, including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides. EFSA’s Scientific Committee prepared the guidance in response to a request from the European Commission (EC). EFSA states that the guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorization in food and feed. The guidance stipulates the additional data needed for the physical and chemical characterization of ENMs in comparison with conventional applications, and outlines different toxicity testing approaches to be followed by applicants. The guidance presents six scenarios outlining different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required. EFSA states: “Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.”

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EFSA Begins Public Consultation on Draft Guidance on Risk Assessment for Nanoscience and Nanotechnologies

Posted on January 14, 2011 by Lynn L. Bergeson

On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides). The draft guidance states that the general risk assessment paradigm is applicable for these applications, and consequently appropriate data and information for the various steps should be made available to the risk assessor to carry out a risk assessment. Adequate characterization of engineered nanomaterials (ENM) is essential for establishing its identity and physico-chemical forms in food/feed products. In cases in which transformation of the ENM into a non-nanoform in the food/feed matrix or in gastrointestinal fluids is judged to be complete, then EFSA guidance for non-nanoforms for the specific intended use should apply. The ENM covered by the draft guidance fall into two categories: (1) when a nanoform of an already approved non-nanoform with the same intended use in food/feed is produced; and (2) when a new ENM without a corresponding approved non-nanoform is produced. In the situation where there is an approved non-nanoform of a substance with the same intended use in food/feed, the aim of the draft guidance is to indicate the supplementary and specific data required on the potential additional hazards and risks that may arise from the nanoform. In the situation where the ENM persists in the food/feed matrix and in gastrointestinal fluids and has no approved non-nanoform application, toxicity tests on the ENM should follow the relevant EFSA guidance for its intended use, with some modifications in the testing due to the nanoproperties. Comments are due February 25, 2011.

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NIEHS Begins Intramural NanoHealth Signature Program

Posted on August 3, 2010 by Lynn L. Bergeson

 

The August 2010 issue of the National Institute of Environmental Health Sciences (NIEHS) Environmental Factor includes an article regarding the Intramural NanoHealth Signature Program, which is intended to investigate the health effects of engineered nanomaterials (ENM) in susceptible populations. According to the article, ENMs are increasingly found in medications, cosmetics, electronics, and other consumer products, creating environmental as well as occupational exposures. Over the next three years, researchers in the Clinical Research Unit (CRU) will engage in bidirectional collaborations with the National Toxicology Program (NTP), labs in the NIEHS intramural program, and the U.S. Environmental Protection Agency (EPA) as they explore the effects of exposure among healthy and susceptible populations to ENMs that are already present in the atmosphere.  The team will study the effects in cells tissue, animals, and human subjects. The research team will test the hypothesis that selected engineered nanomaterials induce pulmonary inflammation and that asthmatic individuals are particularly susceptible to ENM effects, in a translational exposure model with three aims:

  • Exposing human bronchial epithelia and alveolar macrophages -- native lungs cells donated by healthy volunteers -- to ENMs ex vivo to evaluate inflammation and cell toxicity;
  • Comparing the ex vivo response to ENMs of human bronchial epithelia and alveolar macrophages between healthy and asthmatic individuals to understand whether pre-existing disease alters the effect of ENMs on human cells; and
  • Performing controlled chamber exposures of human volunteers to select ENMs of interest to assess the potential for effects on lung function and inflammation.

 

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