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Report Title: How can business respond to the technical, social and commercial uncertainties of nanotechnology?
Report ID: 578
Date: 11/1/2006
Author: Responsible NanoCode Working Group
Report Type: Workshop Report
URL: [Workshop-Report_07112006.pdf]
Country: United Kingdom
Organization: Responsible NanoCode
Summary: In light of the significant uncertainties regarding the safety of nanomaterials, The Royal Society, Insight Investment, and the Nanotechnology Industries Association (NIA) hosted a workshop on November 6, 2006 to explore safety issues with European companies. Seventeen companies attended; this document is the workshop report. Technical uncertainties (issues concerning our understanding of the technology and how it behaves), social uncertainties (perceived benefits and perceived risks), and commercial uncertainties (predicting future legislation) all exist and must be dealt with. In response, a new approach to responding to technical, social and commercial risk is needed, business should be more active in shaping the debates on regulatory systems, standards, and definitions, and coordinated engagement and communication is important. The workshop participants felt that a voluntary code of conduct should be a next step.
Archived Copy: Workshop-Report_07112006-1_578_9199.pdf



Report Title: Nanotechnologies – Good practice guide for specifying manufactured nanomaterials
Report ID: 568
Date: 12/1/2007
Author: British Standards Institution
Report Type: Guidance Document
URL: [PD6699-1.pdf]
Country: United Kingdom
Organization: British Standards Institution (BSI)
Summary: This guidance document seeks to solve the problem of insufficiently descriptive specifications for nanomaterial-containing products. Experience has shown that agreed specifications for nano products often fail to ensure that, on a batch-to-batch basis, the material consistently responds to downstream processing and generates consistent performance in the final product. Therefore, either the specification fails to cover all material characteristics that have an influence on performance, one or more characteristics is being measured by an inappropriate technique, or one or more measurement techniques is being applied in an incorrect manner. This document seeks to rectify such problems and explains various measurement techniques in existence and their characteristics.
Archived Copy: PD6699-1_568_6831.pdf



Report Title: Guidance on the labeling of manufactured nanoparticles and products containing manufactured nanoparticles
Report ID: 567
Date: 12/1/2007
Author: British Standards Institution
Report Type: Guidance Document
URL: [PAS130.pdf]
Country: United Kingdom
Organization: British Standards Institution (BSI)
Summary: This guidance document builds on the suggestion in the Royal Society and Royal Academy of Engineering report (see report ID 446) that there should be guidance for suppliers and users of products containing manufactured nanoparticles. As a publically available standard, this document is intended to quickly provide relevant advice before the possible development of a British Standard in the subject area. Currently there is no generic labeling requirement for manufactured nanoparticles. Consumer labeling is necessary to inform consumers and businesses must be able to read product specifications and to select or avoid ingredients based upon nanotechnology. This document defines nano terms and describes how this labeling should be designed to convey relevant information throughout the lifecycle of a nano product, from upstream suppliers to consumers after purchase.
Archived Copy: PAS130_567_5096.pdf



Report Title: Code of Practice - Nanoparticles
Report ID: 561
Date: 4/1/2007
Author: University of Surrey Advanced Technology Institute
Report Type: Code of Conduct
URL: [nanoparticles%20code%20of%20practice.doc]
Country: United Kingdom
Organization: University of Surrey Advanced Technology Institute
Summary: The Advanced Technology Institute at the University of Surrey created this Code of Practice for how it works with nanomaterials. The Code defines a standard operating procedure for activities involving nanoparticles, which includes being aware of factors affecting exposure, such as liquid media during pouring operations, gas phase nanoparticles, and handling of nanoparticle powders. Procedures for limiting this exposure include engineering controls (e.g. ventilation), work practices (e.g. vacuuming), and personal protective equipment. For spills, while no specific guidance is presently available, it is suggested that current good practice be used. “Cradle to grave” analysis must also be performed for all nano-products. The Code also describes the various nanotechnology processes in use at the ATI.
Archived Copy: nanoparticles code of practice_561_6281.doc



Report Title: An uncertain business: the technical, social and commercial challenges posed by nanotechnology
Report ID: 537
Date: 10/1/2006
Author: Hilary Sutcliffe and Simon Hodgson
Report Type: Briefing Sheet
URL: [Acona-Paper_07112006.pdf]
Country: United Kingdom
Organization: Responsible NanoCode
Summary: On November 7, 2006, Responsible NanoCode held a workshop to explore the scientific, social, and commercial issues of nanotechnology. This briefing paper was published a month prior to stimulate the workshop, and discusses three areas of uncertainty regarding nanomaterials: Technical uncertainties, which include uncertain size definitions, possible explosive effects, unknown lifecycle, and risks in general; social uncertainties, which include public perception of risks, public acceptance, benefit and harm to developing economies, and controversial innovations; and commercial uncertainties, including a lack of consensus as to regulations, uncertain consumer acceptance, proprietary research, and litigation fears.
Archived Copy: Acona-Paper_07112006_537_2442.pdf



Report Title: Nanotechnologies: Influence and Inform the UK Strategy, Summary of Evidence
Report ID: 526
Date: 1/1/2010
Report Type: Government Report
URL: [NanoEvidenceSummary.pdf]
Country: United Kingdom
Organization: Department for Business, Innovation and Skills (UK Government)
Summary: After the UK Government announced its intention to develop a new strategy for nanotechnology in June 2009, it launched a website ("Nanotechnologies: Influence and Inform the UK Strategy") inviting stakeholders from academia, industry, government, and any other interested organizations to respond to questions regarding nanotechnology. Themes addressed in the questionnaire were anticipating opportunities and concerns, managing risks and uncertainties, innovation and business climate, public and stakeholder dialogue, and measurement and standards. Forty-one respondents submitted answers by October 31, 2009, and this document contains their responses. Widely held respondents' themes include concern over the level of government funding into research of environmental, health, and safety concerns, as well as the need for better coordination of research activities and of commercialization.
Archived Copy: NanoEvidenceSummary_526_5193.pdf



Report Title: Nanosciences and Nanotechnologies: A Review of Government's Progress on its Policy Commitments
Report ID: 499
Date: 3/1/2007
Author: Council for Science and Technology (UK)
Report Type: Government Report
URL: [nano_review.pdf]
Country: United Kingdom
Organization: Council for Science and Technology (UK)
Summary: After the Royal Society and the Royal Academy of Engineering's 2004 report "Nanoscience and nanotechnologies: opportunities and uncertainties" (see report ID 446), the UK Government published its response (see report ID 188) which addressed concerns and laid out planned government activities. This report is the Council for Science and Technology (CST)'s two year review of progress on actions outlined in the Government's response. The government has made progress on its commitments for the development of standards, for work on workplace exposure, and for the Defra Voluntary Reporting Scheme. However, the government has not made sufficient progress on its research commitments. The report concludes that although the government committed to an immediate research program and expected "substantial progress" in two years, only 10 million pounds were spent on nanotechnology, 3 million of which went to toxicology and health/environmental impacts. CST suggests that the government invest at least 5 to 6 million pounds per year to research the toxicology and health/environmental impacts of nanotechnology. Other recommendations are to improve the visibility of the Nanotechnology Research Coordination Group and to urgently formulate short-term toxicity protocols.
Archived Copy: nano_review_499_9053.pdf



Report Title: Characterising the Potential Risks posed by Engineered Nanoparticles: A Second UK Government Research Report
Report ID: 473
Date: 12/1/2007
Report Type: Research Report
URL: [nanoparticles-riskreport07.pdf]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: In October 2005, the UK Government published the first research report in this two-part series, which described 19 environmental, health, and safety research objectives for the Nanotechnology Research Co-ordination Group (NRCG) to carry forward with. Following in October 2006 was a progress report; this report builds on the 2006 report to provide an update on the NRCG's objectives and progress on the nanotech action plans. The NRCG set up five task forces for driving nanotechnology research: Metrology, Characterization, Standardization, and Reference Materials; Exposures: Sources, Pathways, and Technologies; Human Health Hazard and Risk Assessment; Environmental Hazard and Risk Assessment; and Social and Economic Dimensions of Nanotechnologies. While significant progress has been made in all areas, research programs are in their infancy. The UK Government has been encouraging the UK research community to participate in the EU's 7th Framework Programme. The report recommends that joint work and international collaboration be continued, and that completed research studies should be more closely reviewed to ascertain what level of risk nanomaterials pose.
Archived Copy: nanoparticles-riskreport07_473_7336.pdf



Report Title: Characterising the Potential Risks Posed by Engineered Nanoparticles
Report ID: 472
Date: 10/1/2006
Report Type: Research Report
URL: [nanoparticles-progressreport.pdf]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: This progress report analyzes the Nanotechnology Research Co-ordination Group (NRCG)'s progress on the 19 research objectives enumerated in the NRCG's first research report (published in November 2005). The objectives have been categorized into five Task Forces: Metrology, Characterization, Standardization, and Reference Materials; Exposures: Sources, Pathways, and Technologies; Human Health Hazard and Risk Assessment; Environmental Hazard and Risk Assessment; and Social and Economic Dimensions of Nanotechnologies. This report lists the progress in each area, along with the status of the study and its budget. For metrology and standardization, progress is being made but there are still no good methods for detecting, characterizing, and quantifying carbon nanotubes except for slow and expensive electron microscopy. While studies are ongoing in the area of human health hazard, there is still large uncertainty regarding the sources of engineered nanoscale materials and potential releases during the product life-cycle. It is expected that in vivo toxicology on animals will yield reliable results in showing the acute and chronic effects of short term and long term exposure to nanoparticles. The report also makes scientific recommendations for areas where additional study is needed.
Archived Copy: nanoparticles-progressreport_472_2398.pdf



Report Title: A Scoping Study Into the Manufacture and Use of Nanomaterials in the Uk
Report ID: 471
Date: 7/1/2005
Report Type: Study
URL: [nano-manufacture.pdf]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: This scoping study was carried out in accordance to the UK Government's response (see report ID 188) to the Royal Society and Royal Academy of Engineering’s review (see report ID 446) of nanotechnology. Currently (as of 2005), there is no UK regulatory framework that specifically addresses the production and application of nanomaterials. As a result, companies involving in nanomaterial production and use are not required to share information, including the presence of nanomaterials in their products. The study strongly recommends that a nanomaterial register be created either through a voluntary industry initiative or through the government. Such a register would enable access to up-to-date data on new materials until sufficient safety information has been developed. UK nanomaterial production also does not match global manufacturing. While globally there is an emphasis on nanotubes and fibers, the UK manufactures mostly nano-metals and metal oxides. The data from this study has been placed in a database and is publicly accessible.
Archived Copy: nano-manufacture_471_2823.pdf



Report Title: Small World: Environmental Nanoscience Initiative
Report ID: 470
Date: 1/1/2006
Author: Natural Environmental Research Council
Report Type: Brochure
URL: [nano-brochure090519.pdf]
Country: United Kingdom
Organization: Natural Environment Research Council
Summary: The UK Environmental Nanoscience Initiative (ENI) was launched in 2006 to address key questions regarding the environmental behavior and fate of manufactured nanomaterials. The first phase held two research calls asking applicants to propose models for environmental effects of nanomaterials and research to validate and refine the proposed models. The second phase will focus on international collaboration and developing validated models of fate, behavior, and bioavailability of nanomaterials in the environment. In April 2009, the UK and US jointly funded a research call. This brochure provides an overview of the initiative and lists projects which have received funding through the ENI.
Archived Copy: nano-brochure090519_470_5059.pdf



Report Title: Government Response to the Lord’s Science & Technology Select Committee Report into Nanotechnologies and Food
Report ID: 469
Date: 3/1/2010
Report Type: Government Response
URL: [govresponsenandf.pdf]
Country: United Kingdom
Organization: HM Government (UK)
Summary: After the House of Lords Science and Technology Committee published its report on Nanotechnologies and Food in January 2010, the UK Government released this response, which addresses all thirty-two of the Committee's suggestions. Many suggestions were accepted and for some, the Government clarified that it was already taking steps in that direction. Regarding the Committee's call for more proactive funding by the Research Councils, the Government pointed out that the Councils are currently evaluating their "nanoscience portfolio" and a report will be published in early 2010. The Government is also addressing the knowledge gaps through the recent commissioning of two projects, both started in early 2010, which will investigate oral nanoparticle toxicology. However, the Government claims that a mandatory database for nanomaterial research would be difficult to enforce and could deter research in the UK. The Government does support a public register of foods containing materials.
Archived Copy: govresponsenandf_469_4041.pdf



Report Title: A Scoping Study to Identify Gaps in Environmental Regulation for the Products and Applications of Nanotechnologies
Report ID: 467
Date: 3/1/2006
Author: Central Science Laboratory
Report Type: Study
URL: [Document.aspx]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: This study examined whether existing regulatory frameworks are suitable for managing nanotechnology-related processes. The research team identified and assessed legislation relevant to nanotechnology, as well as applications for nanomaterials. A number of regulatory gaps were found, including in definitions which called nanotechnologies a "new manufacturing process for producing materials used in existing products and applications." The usage of the words "new" and "existing" may create a regulatory gap. The study also found that most legislation addressed consumer safety rather than environmental safety, and certain nanomaterials were likely to fall below minimum reporting requirements (such as the tonnage requirements of the EU's REACH legislation). Fixing these regulatory gaps will require a substantial body of work, and a scientific consensus must be reached on categorizing nanomaterials into new versus existing substance definitions. The study also recommends that its findings be reviewed and updated as additional information about nanomaterials becomes known.
Archived Copy: CB01075_3484_FRP_467_3356.doc



Report Title: EMERGNANO: a Review of Completed and Near Completed Environment, Health and Safety Research on Nanomaterials and Nanotechnology
Report ID: 466
Date: 3/1/2009
Author: RJ Aitken, SM Hankin, B Ross, et al
Report Type: Research Report
URL: [Document.aspx]
Country: United Kingdom
Organization: Institute for Occupational Medicine (IOM)
Summary: After the Royal Society and Royal Academy of Engineering's 2004 report (see report ID 446) on opportunities and uncertainties in nanotechnology, the UK set up the Nanotechnology Research Coordination Group to coordinate publicly funded research into the risks of nanotechnology. Under the guidance of Defra, this report was commissioned to review and analyze the state of research in 18 research objectives set out in Defra's 2006 first research progress report. This report also assesses the possibility of a qualitative risk assessment and makes recommendations for new research to fill gaps. Research studies were categorized by their relation to one or more of the research objectives. The study finds that there is a widespread imbalance in the work carried out between the research objectives. While 44 studies were relevant to RO14 (Research Objective 14 – research to establish a clear understanding of the deposition, distribution, toxicity, pathogenicity, and translocation potential and pathways for nanoparticles in the airways and lung and their potential impacts on the cardiovascular system and brain), only one study was relevant to RO9 (optimization, development, and application of technologies that enable the measurement of exposure to nanoparticles in soil and water). Many of the studies, although publicly funded, had not released any information into the public domain. A total of 260 relevant studies worldwide were identified in this report, and analysis so far shows that three nanomaterials are cause for concern: carbon nanotubes, silver nanoparticles, and titanium dioxide nanoparticles.
Archived Copy: CB0409_7911_FRP_466_1948.pdf



Report Title: Nanotechnologies and Food (Volume 2: Evidence)
Report ID: 464
Date: 1/8/2010
Author: House of Lords (UK)
Report Type: Government Report
URL: [22ii.pdf]
Country: United Kingdom
Organization: House of Lords (UK)
Summary: The House of Lords Science and Technology Committee, concerned about the use of nanomaterials in food productions, launched this investigation to ensure that adequate regulatory frameworks were in place to protect consumers from any potential risks. This document is Volume 2 of the two-volume report and contains the evidence on which the Committee based its report. The Committee found that there was a lack of transparency in the food industry in reporting its research, and suggested that greater communication be fostered to prevent a negative public reaction. Most significantly, the Committee calls for a publicly available register listing all food and food packaging containing nanomaterials. With regard to health effects, there are many knowledge gaps remaining. The UK Research Councils should establish more proactive forms of funding for basic scientific research in risk assessment. The Committee also suggests that the Food Standards Agency develop a database of nanomaterials so that research can be tracked and prioritized. Industry participation in the database should be mandatory and not voluntary as some earlier schemes have been. Any nanomaterials used in food products should be subjected to a formal risk assessment process through the European Food Safety Authority. The Committee is concerned about the illegal importation of nanomaterial-containing food, particularly through direct Internet ordering, and suggests that tests be developed for enforcement authorities to use on imported food.
Archived Copy: 22ii_464_3325.pdf



Report Title: Nanotechnologies and Food (Volume 1: Report)
Report ID: 463
Date: 1/8/2010
Author: House of Lords (UK)
Report Type: Government Report
URL: [22i.pdf]
Country: United Kingdom
Organization: House of Lords (UK)
Summary: The House of Lords Science and Technology Committee, concerned about the use of nanomaterials in food productions, launched this investigation to ensure that adequate regulatory frameworks were in place to protect consumers from any potential risks. This document is Volume 1 of the two-volume report and contains the report itself including its 32 recommendations. The Committee found that there was a lack of transparency in the food industry in reporting its research, and suggested that greater communication be fostered to prevent a negative public reaction. Most significantly, the Committee calls for a publicly available register listing all food and food packaging containing nanomaterials. With regard to health effects, there are many knowledge gaps remaining. The UK Research Councils should establish more proactive forms of funding for basic scientific research in risk assessment. The Committee also suggests that the Food Standards Agency develop a database of nanomaterials so that research can be tracked and prioritized. Industry participation in the database should be mandatory and not voluntary as some earlier schemes have been. Any nanomaterials used in food products should be subjected to a formal risk assessment process through the European Food Safety Authority. The Committee is concerned about the illegal importation of nanomaterial-containing food, particularly through direct Internet ordering, and suggests that tests be developed for enforcement authorities to use on imported food.
Archived Copy: 22i_463_1192.pdf



Report Title: Nanoparticles: An occupational hygiene review
Report ID: 450
Date: 1/1/2004
Author: RJ Aitken, KS Creely, CL Tran, Institute of Occupational Medicine
Report Type: Research Report
Publication: http://www.hse.gov.uk/research/rrpdf/rr274.pdf
Country: United Kingdom
Organization: Health and Safety Executive (UK Government)
Summary: This review of occupational exposure to nanoparticles is part of the Health and Safety Executive (HSE)'s Research Report Series. This report analyzes nanoparticle production processes in four ways: A conventional scientific review, a web-based review, discussion with key individuals prominent in nanoparticle development or health assessment, and the experience and interpretation of the project team. The team’s review included potential routes for human exposure, level of exposure, means of control measures, trends, and the impact of research use transforming into industrial use. While all four main groups of nanoparticle production processes (gas-phase, vapor deposition, colloidal, and attrition) may potentially cause exposure by inhalation, dermal, or ingestion routes when nanoparticles are agglomerated, only gas-phase processes can cause exposure to primary nanoparticles by inhalation during the synthesis stage. The most appropriate metric for inhalation exposure is particle surface area, but there are no currently available effective methods for workplace assessments of particle surface area. Approximately 2000 people in the UK may be exposed to nanoparticles in some form at present, and this number may double in five years. Key knowledge gaps that must be filled include the lack of a well-defined nomenclature, the lack of convenient methods for measuring workplace exposure, insufficient knowledge regarding exposure, how to evaluate control approaches, and insufficient knowledge to conduct risk assessment.
Archived Copy: rr274_450_9944.pdf



Report Title: Nanoscience and nanotechnologies: opportunities and uncertainties
Report ID: 446
Date: 7/29/2004
Report Type: Advisory Report
URL: [finalReport.htm]
Country: United Kingdom
Organization: The Royal Society and the Royal Academy of Engineering
Summary: In June 2003, the UK Government commissioned the Royal Society and the Royal Academy of Engineering to carry out an independent study into nanotechnology. This study was directed to summarize the current state of scientific knowledge in nanotechnology; identify new applications for its use; identify health, safety, environmental, ethical, and societal implications or uncertainties from the use of nanotechnology; and identify areas requiring additional regulation. This document contains the study report. Current and potential uses of nanotechnology include material coatings, electronics, and biotechnology. While nanoparticles are more toxic per unit of mass than are larger particles, it is expected that nanoparticles will not be introduced into humans in doses large enough to cause adverse health effects. Current exposures are largely limited to workplaces and a few cosmetic uses, but until further studies are done, exposure should be restricted. Regulations must differentiate between new nanomaterials and their existing larger-scale counterparts, and while a moratorium on nanomaterial development is unneeded, an independent group should be convened to assess these issues at both two-year and five-year timelines. Additionally, nanomaterials may pose ethical and social issues if they can be used for radical human enhancement or human/product monitoring.
Archived Copy: Nano report 2004 fin_446_6666.pdf



Report Title: Nanotechnology Research Coordination Group (NRCG) Note of the 17th Meeting
Report ID: 442
Date: 1/12/2009
Report Type: Meeting Notes
URL: [nrcg-meeting17-090112.pdf]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: The Nanotechnology Research Coordination Group (NRCG), chaired by the Department of Environment, Food and Rural Affairs (Defra), coordinates research into the potential risks of nanotechnology. In its 17th meeting of January 12, 2009, representatives from government departments, regulatory agencies, and research councils met to receive updates on Task Force Action Plans and from the councils. Research calls are planned for developing conceptual models and predictive tools of environmental exposure, as well as adaptation or development of risk assessment methodologies for nanoparticle exposure. In the area of food safety, a project is underway to examine the application of nanomaterials as food ingredients and to consider gaps in knowledge and regulations. An overview of the Institute of Medicine's EMERGNANO project was presented; the project aims to present a picture of completed and near completed work looking at the environmental health and safety concerns that nanomaterials pose. Task Force Leaders generally agreed with the project's report, and that the report should be used to review the NRCG's objectives and structure.
Archived Copy: nrcg-meeting17-090112_442_2361.pdf



Report Title: Advisory Committee on Hazardous Substances Report on Nanosilver
Report ID: 405
Date: 10/26/2009
Author: Advisory Committee on Hazardous Substances
Report Type: Advisory Report
URL: [achs-report-nanosilver.pdf]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: At its 32nd meeting in March 2009 Defra requested guidance on nanosilver from the Advisory Committee on Hazardous Substances. Specifically, they wanted information regarding the environmental exposure and effects of nanoparticulate silver, known or predicted environmental exposure levels and their corresponding risks, the nature of appropriate measures to minimize risks, and what action should be taken to further develop understanding in this area. However, the disparate nature of data regarding the (eco)toxicology of nanosilver made investigation of the third criteria impossible. Furthermore, exposure levels in the environment are not known since modeled concentrations vary widely. The Committee concludes that further research is needed and should culminate in a workshop with relevant stakeholders to develop a coherent and integrated research strategy and medium term horizon scanning. As a long term goal, the Committee recommends that relevant government departments work with other funders to address several specific areas outlined in the report. For now, the immediate research objective should be identification and inventory of uses and products containing nanosilver, amounts within products, and their likely release rates.
Archived Copy: uk achs-report-nanosilver_405_8498.pdf



Report Title: Defra Consultation on a Voluntary Reporting Scheme for Engineered Nanoscale Materials
Report ID: 231
Date: 9/1/2006
Author: David Lovell
Report Type: General Report
URL: [defra_nanotechvrs-consultfindings_en.pdf]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: On the 31 March 2006, the Department for Environment, Food and Rural Affairs (Defra) published a consultation seeking views on a proposal for a “Voluntary Reporting Scheme” for engineered nanoscale materials. The purpose of the Voluntary Reporting Scheme, alongside a Government program of scientific research, is to develop a better understanding of the properties and characteristics of different engineered nanoscale materials, so enabling potential hazard, exposure and risk to be considered. The building of an evidence base in this way will allow for a more informed debate about the nature of appropriate controls. This paper summarizes and responds to the findings of this consultation.

Archived Copy: defra_nanotechvrs-consultfindings_en_231_5452.pdf



Report Title: UK Government Response to the Royal Commission on Environmental Pollution (RCEP) Report "Novel Materials in the Environment: The Case Of Nanotechnology"
Report ID: 200
Date: 6/1/2009
Author: HM Government (UK)
Report Type: Government Response
URL: [7620.pdf]
Country: United Kingdom
Organization: HM Government (UK)
Summary: This document contains the UK government's response to the Royal Commission on Environmental Pollutions report, "Novel Materials in the Environment: The Case Of Nanotechnology." The government is in agreement with the Commission that more effort is required to ensure responsible nanotechnology development, and intends to develop a UK strategy to build on existing activities and set a strategic direction. This response is organized into five themes, which reflect the government's priorities: Government coordination on nanotechnology, protecting human health and the environment, building the evidence base, delivering more effective regulation, and widening public engagement and capturing the benefits. While the government largely agrees with the Commission's recommendations in these areas, there are points of disagreement. The Commission's report suggested that companies should be obligated to report reasonable suspicions of risky nanomaterials at the earliest opportunity, and be conferred immunity from criminal liability for doing so. However, the government believes that prosecutorial decisions should be left to the enforcing authorities, as is presently done under existing UK laws, which do not confer immunity but only allow for "due diligence" as a potential defense.
Archived Copy: 7620_200_5556.pdf



Report Title: Environment Agency Interim Advice on Wastes Containing Unbound Carbon Nanotubes
Report ID: 199
Date: 5/19/2008
Author: Natural Environment Research Council
Report Type: Briefing Sheet
URL: [nano-waste.pdf]
Country: United Kingdom
Organization: Natural Environment Research Council
Summary: This document deals with the classification and handling of waste containing unbound carbon nanotubes (CNT). It includes two sections: Key Issues and Disposal Options. Under Key Issues, the document distinguishes the two appropriate List of Wastes classifications for CNT, one a hazardous entry and the other non-hazardous. The document advises that, as a precaution, with CN waste where the CN is unbound, the waste be classified as 16 03 03 a hazardous entry. Under Disposal Options, two methods of safely disposing of such CN waste are listed incineration at 850 degrees Celsius for at 2+ seconds, or chemical treatment to destroy the nanodimensional structure with the agency recommending the incineration method as the preferred method.
Archived Copy: nano-waste_199_5154.pdf



Report Title: An Assessment of Regulatory Testing Strategies and Methods for Characterising the Ecotoxicological Hazards of Nanomaterials CBO1097
Report ID: 198
Date: 10/30/2007
Author: Department for Environment, Food and Rural Affairs (UK Government)
Report Type: Research Project Description
URL: [Default.aspx]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: This document is a description of a completed (12/2006 - 7/2007) DEFRA research project. The objectives of the project include a) a description of the current test strategies and methods for chemical regulatory ecohazard assessment; b) a critical review of studies which have characterized nanomaterial hazards; c) an identification of elements of test strategies and methods that are not fit for purpose; d) a proposal for pragmatic variants on current tests; and e) a proposal for an experimental approach to empirically test proposed variants on the hypothesis that they may be fit for purpose. The project is intended to lay groundwork for a successive phase of work. The document includes descriptions of tasks detailing how the researcher can successfully complete the objectives. Links to the final report and a final expanded report are included, as are the cost of the project, the funded organization/contractor, keywords, associated fields of study, and a contact email address.
Archived Copy: defra an assessment of regulatory testing._198_6023.pdf



Report Title: Impact Assessment of EU Proposal for a Regulation on Novel Foods
Report ID: 197
Date: 4/23/2008
Report Type: Impact Assessment
URL: [novelfoodconsult2008.pdf]
Country: United Kingdom
Organization: Food Standards Agency
Summary: This document is the Food Standards Agencys consultation on the European Commissions proposed changes to regulation of novel foods (current regulation 258/97). The document contains a cost/benefit analysis to businesses and enforcement agencies, finding the overall benefit greater than the cost. The document outlines the benefits to be gained from the legislation: a) streamlined procedures for assessing and authorizing novel foods; b) simplified safety assessment for non-EU countries marketing traditional food with an established safety record; c) clarification of the definition of novel foods and the scope of the regulation; and d) 5-year data protection for original applicants who have made substantial investment in procuring safety data for their product. Foods and processes developed with nanotechnology will be added to the definition of novel foods so as to be included within the scope of the regulation. The document includes an EU annex providing background information on the regulation, criteria for safety assessment, and number of applications since its adoption. The document also includes the following short annexes on specific impacts: competition assessment, small firms test, sustainable development, and race/gender/disability equality issues. The document includes a list of interest parties. A summary of responses to this consult document is available on the FSA website: http://www.food.gov.uk/consultations/consulteng/2008/novelec08eng.
Archived Copy: novelfoodconsult2008_197_6199.pdf



Report Title: Response to the Royal Society and Royal Academy of Engineering Report: Nanoscience and nanotechnologies: opportunities and uncertainties
Report ID: 188
Date: 2/1/2005
Report Type: Government Communication
URL: [file14873.pdf]
Country: United Kingdom
Organization: UK Ministry for Science and Innovation
Summary: The UK government commissioned the Royal Society and Royal Academy of Engineering to conduct an independent joint study. The study examined ethical, social, health, safety, and environmental issues stemming from nanotechnology. This document contains the UK governments response to the general and specific recommendations in the Royal Society and Royal Academys report. The Nanotechnology Issues Dialog Group (NIDG), chaired by the Office of Science and Technology (OST) will coordinate the governments activities described in this response. The NIDG will conduct reviews of such activities after two and five years. One element of the governments response to the report is the chairing of a Research Co-ordination Group by the Department of Environment, Food and Rural Affairs (Defra). Containing representatives from various research councils and government agencies, this group will establish an international dialogue for the exchange of nanotechnology information.
Archived Copy: Michael Vincent UK (2005), Response to the Royal Society Report_188_1081.pdf



Report Title: Summary of Evidence from Civil Society Groups at a Meeting With the Nanotechnology Working Group on 30 October 2003
Report ID: 186
Date: 10/30/2003
Author: The Royal Society and the Royal Academy of Engineering
Report Type: Meeting Notes
URL: [CivilSocietyGroups.pdf]
Country: United Kingdom
Organization: The Royal Society and the Royal Academy of Engineering
Summary: In June 2003, the UK government commissioned the Royal Society and the Royal Academy of Engineering to study health and safety, environmental, social, and ethical issues raised by nanotechnology development. A working group with representatives of six organizations was held to further this study. This document contains a summary of points discussed at the meeting on October 30, 2003. Some representatives believed that science was isolated from mechanisms of democracy, causing low public participation and public control. The imposition of technology upon the public also was discussed as causing problems of acceptance, as it has with genetically modified foods. Two workshops and a web forum were planned for engaging the public in a discussion on nanotechnology, with the web forum to occur in early 2004.
Archived Copy: Michael Vincent RS (2003), Summary of evidence_186_7298.pdf



Report Title: Environmental Applications and Impacts of Nanotechnology: Summary of Evidence Presented to Nanotechnology Working Group
Report ID: 185
Date: 12/8/2003
Author: The Royal Society and the Royal Academy of Engineering
Report Type: Meeting Notes
URL: [environmentForWeb.pdf]
Country: United Kingdom
Organization: The Royal Society and the Royal Academy of Engineering
Summary: In June 2003, the UK government commissioned the Royal Society and the Royal Academy of Engineering to study health and safety, environmental, social, and ethical issues raised by nanotechnology development. Several working groups were held to further this study. This document contains a summary of points discussed at the meeting on December 8, 2003. The meeting began with a presentation of potential industrial applications for nanotechnology, such as paints capable of reacting to the environment, water filtration, bioremediation, catalysis, energy generation, and pollution removal. The following discussion centered on the timeframe for achieving these proposed applications and the environmental issues that accompanied them.
Archived Copy: Michael Vincent RS (2003), Environmental applications and impacts_185_9360.pdf



Report Title: How We Regulate Nanotechnology
Report ID: 183
Date: 2/7/2008
Author: Medicines and Healthcare Products Regulatory Agency
Report Type: Webpage
URL: [index.htm]
Country: United Kingdom
Organization: Medicines and Healthcare products Regulatory Agency (MHRA)
Summary: This brief webpage summarizes the UK governments efforts to regulate nanotechnology in the medical sector and provides links to relevant reports, papers, and efforts. The Nanoscience and nanotechnologies: opportunities and uncertainties report called for the Department of Health to review its regulations to ensure that particle size is used as a factor in determining medicine safety. While at present there are no regulations specifically targeting nanotechnology in medical devices or medicines, existing regulations are being examined. The European Medicines Agency (EMEA) examined this issue in a paper, and a European Medical Devices Expert Working Group is currently assessing the existing regulatory framework. Currently the MHRA believes that existing regulations for medical devices and medicines are sufficient for adequately regulating the use of nanotechnology in those products.
Archived Copy: Michael Vincent MHRA (2008), How we regulate nanotechnology_183_4942.pdf



Report Title: An Outline Scoping Study to Determine Whether High Aspect Ratio Nanoparticles (harn) Should Raise the Same Concerns as Do Asbestos Fibres
Report ID: 182
Date: 8/13/2008
Author: CL Tran, SM Hankin, B Ross, RJ Aitken, AD Jones,
Report Type: Research Report
URL: [Document.aspx]
Country: United Kingdom
Organization: Institute for Occupational Medicine (IOM)
Summary: The similar size and shape of certain nanoparticles, particularly carbon nanotubes, to asbestos fibers has created significant concern because of the well-publicized risks of asbestos towards human health. This study seeks to review existing literature on whether high aspect ratio nanoparticles (HARN) should generate the same concerns as do asbestos fibers. It also establishes a research strategy for the determination of specific health risks posed by HARN. Three fiber characteristics are likely to cause asbestos-like injuries: diameter, length, and biopersistence. The review concludes that HARN are similar enough in these characteristics as to pose similar health risks. The proposed strategy for examining these risks is composed of stages of hazard identification, dose-response assessment, exposure assessment, and risk assessment. The report makes a list of prioritized recommendations for further studies, both in vivo and in vitro, of these areas.
Archived Copy: Michael Vincent IOM (2008), An outline scoping study_182_2184.pdf



Report Title: New Dimensions for Manufacturing: A UK Strategy for Nanotechnology
Report ID: 178
Date: 6/1/2002
Author: UK Advisory Group on Nanotechnology Applications
Report Type: Government Report
URL: [taylor%20report.pdf]
Country: United Kingdom
Organization: UK Advisory Group on Nanotechnology Applications
Summary: This 2002 report, completed by the UK Advisory Group on Nanotechnology Applications, analyzes the current state of nanotechnology research in the UK and identifies a strategy for ensuring the UKs competitiveness in the field. Key obstacles to that competitiveness listed in this report include the lack of a coordinated nanotechnology strategy, fragmentation of research and development, and lack of public support. The report suggests the development a coherent and coordinated strategy which includes the establishment of publicly-funded nanofabrication facilities comparable to those of other countries. Proposed are two National Nanotechnology Fabrication Centres (NNFCs) which should be specialized in an area of nanotechnology and capable of prototyping and fabrication of educational and commercial nanoproducts. The Advisory Group has developed a business plan for these NNFCs and suggests that funding for their construction begin by 2003.
Archived Copy: Michael Vincent DTI (2002), A UK Strategy for Nanotechnology_178_9597.pdf



Report Title: Novel Materials in the Environment: The Case of Nanotechnology
Report ID: 169
Date: 11/1/2008
Author: UK Royal Commission on Environmental Pollution
Report Type: Committee Report
URL: [7468.pdf]
Country: United Kingdom
Organization: Royal Commission on Environmental Pollution
Summary: The UK Royal Commission on Environmental Pollution, recognizing the importance of novel materials such as nanoparticles in consumer and industrial products, undertook an investigation of their properties, environmental and health impacts, and governance frameworks. This document contains the Commissions report, which focused on three priorities: functionality (focusing on specific nanomaterials rather than generalizing), information (the need for new research programs), and adaptive management (recognizing uncertainty regarding novel materials). The Commission recommends a large, coordinated research effort for environmental and health effects of nanomaterials, with emphasis on the use of in vivo models and greater interdisciplinary cooperation in toxicological research. In terms of governance, the Commission recommends that the UK government require companies to report any reasonable suspicion that a material poses a health or environmental risk. Such compliance should grant a degree of immunity from criminal liability from any subsequent problems developing from the nanomaterial. The report additionally suggests that REACH be adapted and amended as appropriate. Specifically, it calls for mandatory reporting at lower weight thresholds (in accordance with the precautionary principle) and a focus upon the properties of nanomaterials rather than size.
Archived Copy: Michael Vincent Royal Commission on Enviro Pollution (2008), Novel Ma_169_2476.pdf



Report Title: Nanotechnologies Part 2: Guide to safe handling and disposal of manufactured nanomaterials
Report ID: 130
Date: 12/1/2007
Report Type: Guidance Document
URL: [Default.htm]
Country: United Kingdom
Organization: British Standards Institution (BSI)
Summary: The UK Department for Innovation, Universities, and Skills (DIUS) commissioned this document to provide guidance for assessing and identifying risks in the production and use of nanomaterials. It describes classifications of nanomaterials and applies an eight-step framework for assessing and managing risks: identifying hazards, identifying precautions, controlling exposure, ensuring that control methods are used, monitoring exposure, health surveillance, contingency planning, and employee training. Each step is described and current safety recommendations are listed. This document also provides guidance on developing a strategy to manage these risks.



Report Title: Risk management of carbon nanotubes
Report ID: 98
Date: 3/1/2009
Report Type: Information Sheet
URL: [web38.pdf]
Country: United Kingdom
Organization: Health and Safety Executive (UK Government)
Summary: This information sheet, prepared by the UK government, presents a five-page guidance for proper handling procedures for carbon nanotubes. Because some nanotubes are similar in shape to asbestos fibers, questions remain regarding safety. Long, thin nanotubes have been shown to create inflammation in animal studies. It is recommended that carbon nanotubes are marked “Caution: substance not yet fully tested” and labeled with relevant quantities and concentrations. The UK Control of Substances Hazardous to Health Regulations 2002 should be followed for these materials. The document also provides guidances on work procedures and equipment (such as recommending ducted fume cupboards) to maximize safety when working with nanotubes.



Report Title: UK Voluntary Reporting Scheme for engineered nanoscale materials
Report ID: 97
Date: 2/1/2008
Report Type: Guidance Document
URL: [url]
Country: United Kingdom
Organization: Department for Environment, Food and Rural Affairs (UK Government)
Summary: The UK's Voluntary Reporting Scheme operated from September 2006 to September 2008 and collected information from any entity involved in the manufacture or use of engineered nanoscale materials. This voluntary government scheme sought to assist the UK government in developing new nanotechnology controls that will prevent risks to human health and the environment. This document describes the operation of the scheme, its administration, and the types of data to be collected. It explains how collected data will be used and how elements of the scheme will be reviewed as necessary in order to meet government objectives.



Report Title: Recommendations for a Municipal Health & Safety Policy for Nanomaterials, a Report to the Cambridge City Manager
Report ID: 87
Date: 7/1/2008
Report Type: Government Report
URL: [July_17_08_Nano_Recommendations.pdf]
Country: United Kingdom
Organization: Cambridge Nanomaterials Advisory Committee (UK)
Summary: After the passage of a nanotechnology ordinance for Berkeley, California, the Cambridge Public Health Department reviewed at the City Manager's request the possibility of a similar ordinance in the city of Cambridge, Massachusetts. A Cambridge Nanomaterials Advisory Committee was convened. This report contains the recommendations of the Committee. Because of the limited health data and standards currently available for nanomaterials, the Committee recommended against the enacting of a city ordinance. However, its recommendations included the creation of an inventory for nanomaterial facilities, the sponsoring of public outreach events, and biannual reporting to the City Council as regulations and data develop.



Report Title: A Brief Review of Nanotechnolgy Related Activities in Italy
Report ID: 79
Date: 9/1/2008
Author: Luca Escoffier; Ph.D. student at Queen Mary Intellectual Property Research Institute in London
Report Type: General Report
Publication: Nanotechnology Law & Business, vol. 4, No. 3, p 385-392
Country: United Kingdom
Summary: Here, Mr. Ecoffier gives an overview and general outlook of the Italian government's investment to foster nanotechnology. He reports that Italy is currently one of the most dedicated nations in the world toward the advancement and research of nanotechnology. Ecoffier reports that although Italy is not able to garner the same public investments as the United States and Japan, its National Program for Research (PNR) had nanotechnology as one its priorities from 2005-2007. Italy received approximately €100 million in national and E.U. funding during 2005. It is projected that Italy is in the best position to receive significant portions of the E.U.'s €3.5 billion budget for nanotechnology research and development. Furthermore, Ecoffier reports that Italy's public research entities and universities are more advanced than the private sector in nanotechnology research and development. However, it is important note that even though there are more public entities involved in nanotechnology, the private sector employs more individuals than the public sector.



 
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