Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

On January 8, 2010, the United Kingdom (UK) House of Lords Science and Technology Committee announced the availability of its report entitled Nanotechnologies and Food, which criticizes the food industry for failing to be transparent about its research into the uses of nanotechnologies and nanomaterials. In its report, the Committee urges the Government and Research Councils to fund research into potential health and safety risks arising from the use of nanomaterials in the food sector. The Committee recommends that the Food Standards Agency maintain a publicly available register of food and food packaging containing nanomaterials, and suggests that the register be made available online. The Committee calls for nanomaterials to be defined clearly in food legislation to ensure that all uses of nanomaterials in food are subject to appropriate risk assessment procedures. According to the Committee, regulatory definitions should use a change in functionality, i.e. how a substance interacts with the body, as the criterion that distinguishes a nanomaterial from its larger form, to ensure that any nano-sized materials with novel properties are included. The Committee also recommends that the UK work with other European Union (EU) nations to clarify what is meant by the phrase “properties that are characteristic to the nanoscale” in the draft definition proposed for the revised Novel Foods Regulation, by the inclusion in legislation of a more detailed list of what these properties comprise. The Committee also raises concerns about the potential for the illegal importation of food products containing nanomaterials not approved for use in food in the EU.

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In an October 9, 2009, speech at the stakeholder conference concerning nanomaterials on the market, Stavros Dimas, European Commissioner for the Environment, stated that the European Commission (EC) “will review all relevant legislation within two years to ensure safety for all applications of nanomaterials in products with potential health, environmental, or safety impacts over their life cycle.” The EC’s review is in response to an April 24, 2009, resolution adopted by the European Parliament that questions whether current legislation covers the relevant risks relating to nanomaterials and asks the EC to consider whether revisions are necessary to address nanomaterials.  Dimas stated that the EC “has not made up its mind on how precisely to get the information needed.” The EC intends to look at measures taken by member states and non-European Union (EU) countries, including voluntary reporting programs.

Dimas examined whether the existing regulatory framework of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program is sufficient to ensure “a high level of protection of health, safety and the environment” from nanotechnology products. Dimas stated that nanomaterials are covered by REACH under the definition of a chemical substance, and the general obligations therefore apply as for any other substance. According to Dimas, the “important” question to ask is whether the one tonne threshold used by REACH is appropriate for nanomaterials. Dimas stated:

Once we have a better idea of the scope and nature of nanomaterials on the European market we can then take a step back and go through the rules.  We will need to consider whether registration of the majority of nanomaterials will take place in 2010 or only at the end of the registration timetable in 2018 and if there are some nanomaterials that will not be registered under REACH.  We will also need to look at other key provisions in REACH to see if they are adequate for nanomaterials.

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The London School of Economics (LSE), Chatham House, the Environmental Law Institute (ELI), and the Project on Emerging Nanotechnologies (PEN) at the Woodrow Wilson International Center for Scholars held a conference on September 10-11, 2009, on “Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies,” in London. LSE, Chatham House, ELI, and PEN are participating in an international collaborative project, Regulating Nanotechnologies in the EU and U.S., which is funded by a grant from the European Commission. Their research findings on issues of transatlantic regulatory cooperation were published in a report during the conference. The conference was intended to bring together regulatory experts from the United States (U.S.) and European Union (EU) to discuss recommendations from this research effort and to generate and examine new ideas that would enable greater transatlantic cooperation and convergence on nanotechnology oversight today and in the future. The materials released at the conference include a briefing paper entitled Regulating Nanomaterials:  A Transatlantic Agenda, and the report entitled Securing the Promise of Nanotechnologies:  Towards Transatlantic Regulatory Cooperation.

Lynn L. Bergeson moderated a panel concerning chemicals regulation and nanomaterials, and Steve Owens, Assistant Administrator for Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency (EPA), was one of the panelists. According to Owens, EPA is considering proposing new reporting requirements for manufacturers of nanomaterials. Owens described the Nanoscale Materials Stewardship Program, which EPA intended to encourage submission and development of information, including risk management practices for nanoscale materials, “less than a resounding success.” The reporting requirements would help EPA collect more environmental, health, and safety data regarding nanomaterials.

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The European Agency for Safety and Health at Work (EU-OSHA) announced June 19, 2009, the publication of the Literature Review -- Workplace Exposure to Nanoparticles, which reviews the most recent publications on nanoparticles and focuses on the possible adverse health effects of workplace exposure. The report focuses on the possible adverse health effects of workplace exposure to engineered nanomaterials and possible subsequent activities taken to manage the risk. The report does not include nanomaterials originating from natural sources, as well as non-intended nanoscale by-products, such as diesel engine exhaust, and welding fumes. To provide a broad overview, EU-OSHA collected information from different sources, such as scientific literature, policy documents, legislation, and work programs. EU-OSHA gave priority to documents from the European Union (EU), although national and international activities are also described. The report considers studies published up to November 2008. The report identifies the following topics as priorities for future actions and activities:

• Identification of nanomaterials and description of exposure;
• Measurement of exposures to nanomaterials and efficacy of protective measures;
• Risk assessment of nanomaterials in line with the current statutory framework;
• In vivo studies for assessment of the health effects of nanomaterials;
• Validation of the in vitro methods and methods of physico-chemical properties as methods to determine health effects; and
• Training of workers and practical handling guidelines for activities involving nanomaterials in the workplace.

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On May 28, 2009, during the Helsinki Chemicals Forum organized by the European Commission (EC) and European Chemicals Agency (ECHA), governmental spokespersons said that the way the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program applies to nanoscale substances is being reconsidered. ECHA Executive Director Geert Dancet stated that specific regulation of nanomaterials could be considered when the EC reviews REACH, which it is required to do by June 1, 2012. According to Dancet, the review could cover both the scope and implementation of REACH. Dancet stated that “nanomaterials will be covered in a more systematic way” following the review. European Union (EU) Environment Commissioner Stavros Dimas stated that “further work needs to be done to consider if further legislation is needed” to regulate nanomaterials. After the Forum, Dimas stated that separate legislation could be necessary to ensure to protect the environment and human health. According to Dimas, ECHA could manage nanomaterials, or EU legislation concerning fine particles could be used to regulate nanomaterials. The fine particle legislation concerns particles in air rather than in products, however, and a spokesperson for Dimas stated that the EC is “looking at all sorts of possibilities” and that specific approaches are “unexplored as yet.”

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During the June 29-July 1, 2009, meeting of the United Nations (UN) Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labeling of Substances (GHS), the Committee will discuss a paper entitled “Ongoing Work on the Safety of Nanomaterials.” The paper provides a summary of current activities by the European Union (EU), including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, International Organization for Standardization (ISO), and the Organization for Economic Cooperation and Development (OECD). The paper includes the following questions:

• Can it be considered, for the same chemical (same [Chemical Abstracts Service (CAS) Number] and purity) that nanomaterials with new properties have the same hazards as conventional form?
• Is it possible to distinguish for a same chemical, the properties of its different nanoforms?
• How can this be done? Should new endpoints be determined?
• To which extent information about nanomaterials need be provided?
• What kind of information is needed?
• What kind of communication tool is needed for this purpose?
• What kind of collaboration can be suggested in order to contribute to clarification of nanomaterials hazard classification and indeed to heath safety and environmental issues of nanomaterials?

 

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The European Commission (EC) will hold a scientific hearing on nanotechnology on September 10, 2009. The hearing will focus on the scientific aspects of the issues covered in the nanotechnology opinions issued by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Consumer Products (SCCP) (which is now replaced by the Scientific Committee on Consumer Safety (SCCS)). To prepare for the hearing, the EC is launching a public consultation relating to the three main objectives to be addressed:

• Identification of any possible topics which have not been covered in the opinions from the relevant European Union (EU) risk assessment committees and bodies;
• Identification of what are -- according to current scientific knowledge -- the main potential risks that could emerge from the use of nanomaterials in the future; and
• Identification of the issues to be discussed at the hearing, including provision of background information and comments on those issues.

The outcome of the consultation will be presented at the scientific hearing.  Comments are due June 19, 2009.

 

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On March 24, 2009, the European Parliament (EP) approved an update of European Union (EU) legislation on cosmetics. The new regulation is intended to remove legal uncertainties and inconsistencies, while increasing the safety of cosmetics. The regulation would replace 27 different regulations. The new regulation addresses nanomaterials used as cosmetics ingredients. As requested by the EP, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health. The EP also succeeded in requiring that any nanomaterials present in cosmetics be mentioned in the list of ingredients on the packaging. The new regulation also includes a definition of nanomaterials, which must be adapted by the European Commission (EC) in line with scientific and technological advances. Under the new regulation, nanomaterial would be defined as “an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

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On October 8, 2008, the European Commission (EC) published a regulation amending the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Annex IV to remove carbon and graphite. Although the substances were originally listed in Annex IV, meaning they were exempt from REACH requirements because they were considered to be of minimum risk because of their intrinsic properties, a European Union (EU) expert committee delisted the substances in June 2008. According to the regulation, there is insufficient information for carbon and graphite to be listed in Annex IV, “in particular due to the fact that the concerned EINECS and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.”

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On June 17, 2008, the European Commission (EC) issued a press release entitled “Commission starts public dialogue on nanotechnologies -- tapping economic and environmental potential through safe products.” According to the EC, while current European Union (EU) legislation “covers in principle” the environment, health, and safety issues concerning nanomaterials, “there is further need for research and international cooperation.” EC will begin a consultation with stakeholders and member states that it intends “to increase knowledge and awareness about the potential of nanotechnologies and to continue to ensure an adequate protection of nature, environment and health.” Under “Next Steps,” the EC states:

Knowledge about the characterisation of nanomaterials, hazard and exposure needs to be improved. The Commission is therefore backing targeted actions in a number of areas and at different levels, particularly in the field of research and development under the Research Framework Programmes FP6 and FP7 and the Commission’s Joint Research Centre.) Such activities are coordinated and discussed with stakeholders and in the framework of the [Organization for Economic Cooperation and Development (OECD)] and the International Standardisation Organisation (ISO) and through international cooperation.

The Commission will also engage in an open dialogue with citizens and stakeholders at large to accompany the correct application of existing legislation to the new products arriving on the market.

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In a January 28, 2008, report entitled EU Nanotechnology R&D in the Field of Health and Environmental Impact of Nanoparticles, the European Commission (EC) provides an overview of past and ongoing research projects funded by the Framework Programmes (FP), EU member states, candidate countries, and countries associated to FP6 or FP7 in the area of possible impacts in health, environment, and safety of nanoparticles. The report has information on 106 projects, 14 of which are from the FPs, which provide around 32 million € in grants. The other 92 projects are from the EU members states, which spent around 47 million € in grants. The EC states that the “information may well be incomplete” and asks all interested parties to send additional information on research projects funded through national funding schemes. The EC intends to update the information regularly.

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According to a report recently released by the Danish Ministry of Health and Prevention, nanotechnology research, development, and applications are covered by existing legislation. The report, which includes an English summary, reviews existing national and international legislation in the areas of foods, medicines, the environment, chemicals, and the working environment in relation to current knowledge of nanotechnological products and processes.  The report also includes a chapter on national and international research policy activities, and describes the initiatives, working groups, and network groups the relevant government departments are taking part in, both nationally and internationally. The working group that prepared the report included representatives from the Ministry of the Interior and Health, the Danish Board of Health, the Danish Environmental Protection Agency, the Danish Medicines Agency, the Danish Veterinary and Food Administration, the National Food Institute at the Technical University of Denmark, the Danish Agency for Science, Technology, and Innovation, the Danish Working Environment Authority, and Danish Standards.

The General Summary states:

It is the opinion of the working group that research, development and application of nanotechnology are covered by existing legislation.  In view of this, the working party does not consider there to be a need for special nano-legislation.

However, the working group also considers that there will continue to be a need, determined by future development, to assess and if necessary adapt rules and executive orders etc. within the framework of existing legislation. Work is in progress in a number of national and international forums to create the necessary conditions for such adaptation, in part by establishing standards and limit values.

The [European Union (EU)] and the [Organization for Economic Cooperation and Development (OECD)] are playing a key role in connection with risk assessment of nanotechnology, in part through the EU’s [Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and Scientific Committee on Consumer Products (SCCP)].  It is therefore important to keep an eye out for recommendations and assessments issued by the EU and the OECD, as it will be possible to use these actively in connection with the adjustment of Danish rules and executive orders.

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On 3 January 2008, Lloyd’s released a report entitled Nanotechnology: Recent Developments, Risks and Opportunities, which examines the potential risks and opportunities in the emerging field of nanotechnology. Lloyd’s states that nanotechnology “promises to improve many industries including medicine, food technology, textiles, materials, cosmetics, defence and more, but the risks are still not fully understood.”

The potential risks and opportunities, according to Lloyd’s, include:

1. A Potentially Large Market: One estimate by the Lux Research says that 15% (by value) of all products will contain nanotechnology by 2014. Currently most nanotechnology products are found in the sports, household and food industry, though others are using them to a growing extent. This is a rapidly growing and potentially large future market.
2. Nanoparticles, Different Material Properties: Nanoparticles can be much more reactive than larger volumes of the same substance. Such particles often have unknown toxicity which can be difficult to quantify. They can disperse easily in air or water. Researchers believe this form of nanotechnology is the most risky at present and the insurance industry should monitor developments in this field closely.
3. Unknown Impacts on Health: It is unclear whether nanoparticles can cause chronic health effects. Studies are still speculative, but insurers would be prudent to consider adverse scenarios when agreeing to terms and conditions, and when determining pricing and capital. In particular, whether a claims made trigger as opposed to an occurrence trigger is appropriate, and whether limits should have an aggregate limitation.
4. Unknown Impacts on the Environment: There is still too little research into the potential negative impacts of this technology on the environment. Given the large pollution losses faced by the insurance industry in the past, this is cause for concern although there are now many exclusions in place to limit such losses. As for health impacts, where there is cover, insurers may want to consider the terms and conditions carefully and whether to exclude losses due to the reduction of property values.
5. Many Positive Effects: Nanotechnology could also bring direct benefits to risk mitigation in the form of new materials that are stronger or more adaptive than before. Cars could be made to absorb more of the impact during a crash; building materials could be made stronger and more flexible to resist damage from earthquakes, fire, flood, and corrosion. Environmental clean-up operations could be made easier and cheaper with the use of specialised nanoparticles. Medicine could be transformed by nanotechnology, allowing cheaper and more sensitive diagnostic tools for diseases, giving insurance professionals better statistics to determine pricing. Because the benefits are so “seductive,” however, society may rush to capitalise on them before adequately assessing safety. The insurance industry must ensure that its own financial health is not compromised by systemic aggregations of loss from these technologies.
6. Lack of Regulation: Currently almost all regulation of nanotechnology is done using existing mechanisms. The “wait and see” approach is increasingly becoming a dangerous way to determine the risks. There is progress in this area, and the Organization for Economic Cooperation and Development (OECD) has released a “Nano Risk Framework,” which provides a framework for risk managers to address this. The precautionary principle is now accepted to apply to the degradation of human health as well as the environment, and suggests the use of this technology should be risk assessed appropriately before consumption by the public. This approach is being recommended within the European Union (EU), though the U.S. and Japan “prefer a lighter regulatory touch.” In the past, a vacuum of regulation has proved unhelpful to insurers. The insurance industry should lobby for clarity in this area.

 

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The Swedish Chemicals Agency (KemI) recently released a report entitled Nanotechnology -- Large Risks with Tiny Particles? Although the report is in Swedish, it includes a summary in English. According to the report, the rapid development of new fields of application and a lack of knowledge call for caution. The report states that companies are responsible for ensuring that human health and the environment are not damaged and that legislation needs to be extended to cover nanomaterials.

The report includes the following recommendations for government regulators:

• The Swedish Governmental Agency for Innovation Systems (VINNOVA) should draw up a strategy for nanotechnology research and development, which includes knowledge about risks to human health and the environment;
• Special research funds should be allocated for the Swedish Research Council for Environment, Agricultural Sciences, and Spatial Planning (Formas) for research about the health and environmental risks of nanomaterials;
• KemI should follow developments in the area and propose measures whenever it is justified, and participate actively in the development of new or modified testing methods within the Organization for Economic Cooperation and Development (OECD) cooperative framework;
• KemI should produce a deeper analysis of the use of nanomaterials in chemical products and articles, after consultation with the trade organizations concerned;
• Instruct the governmental agencies concerned to review the need for complementing existing legislation; and
• Arrange, in the context of Sweden’s European Union (EU) presidency in 2009, a workshop on how the health and environmental risks of nanotechnology should be addressed by legislation.

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On August 30, 2007, Greenpeace International (Greenpeace) issued a report entitled Navigating REACH: An Activists’ Guide To Using and Improving the New EU Chemicals Legislation (Guide), which is intended to explain how the European Union’s (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation will work, what main issues are at stake, and how the law will be implemented. The Guide highlights provisions that non-governmental organizations (NGO) and citizens can use to promote safer chemicals and lead ultimately to better protection of human health and the environment from the adverse impact of hazardous chemicals. The Guide includes nanomaterials among the issues for NGOs:

• Adding nanomaterials to the scope of the legislation: The NGOs will keep working to highlight the need to improve current legislation to control the risks and manage this rapidly expanding industrial sector. According to the Guide, one of the windows of opportunity is the review of the scope of the legislation, as well as the review of information requirements for substances between one and ten tonnes (both in 2012). The Guide states that “this may be too late to start gathering data and limiting exposure to the rapidly increasing quantities of manufactured nanomaterials,” however.

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On August 8, 2007, the European Commission (EC) released the scientific opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the appropriateness of the risk assessment methodology in accordance with the European Union’s (EU) technical guidance documents for new and existing substances for assessing the risks of nanomaterials. SCENIHR concluded that modifications to the existing technical guidance documents are necessary because special characterization of nanomaterial properties, which potentially differ considerably from conventional chemicals, is needed. Furthermore, the toxicological behavior and effects on health and the environment need to be assessed properly.  The opinion states that, due to the lack of common rules for the toxicology of nanomaterials, the risk assessment of nanomaterials should be done on a case-by-case basis. SCENIHR identified issues requiring improvements in the technical guidance and methodologies, and proposed a staged strategy for the risk assessment of nanomaterials. Special consideration is required for the assessment of the potential translocation of nanoparticles in humans and other species, and potential adverse effects, for example, within the cardiovascular system or following passage across the blood-brain barrier.

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On May 10, 2007, the European Commission (EC) announced the availability of the results of its April 16, 2007, workshop on intellectual property rights (IPR) in nanotechnology. The objective of the workshop was to identify specific IPR issues for nanotechnology and to discuss possible consequences for patent offices, policy makers, patent consultants, and the research community.  Ongoing academic and political discussions have identified many aspects, such as the costs of patenting and the accessibility of patents for small- and medium-sized enterprises (SME) or developing countries; the need for a transparent and clearly defined scope of patent protection; the implications of “nanopatent land grab” and “patent thickets”; “nanotech patent battles”; and “second nature” and “monopoly patent.”  The discussions were aiming at possible actions specific for nanotechnology, i.e., the need for a better patent monitoring system of nanotechnology for patent application and examining, technology analysis, and policy advice purposes, the possible need for harmonization between the European Union (EU), the U.S., and Japan, the need for a new nanotechnology patent regime, the development of guidelines for the protection of IPR and models for consortium and licensing agreements, lessons for collaborative research projects, and other research collaborations.

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On March 20, 2007, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) released a report entitled Nanotechnology and Life Cycle Assessment: A Systems Approach to Nanotechnology and the Environment, which summarizes the results of the October 2-3, 2006, workshop organized by PEN and the European Commission on life cycle assessment (LCA). LCA is a cradle-to-grave analysis of how a material affects ecosystems and human health. According to the report, the purpose of the October 2-3, 2006, workshop was to determine whether existing LCA tools and methods are adequate to use on a new technology. The report provides an overview of LCA and nanotechnology, discusses the current state of the art, identifies current knowledge gaps that may prevent the proper application of LCA in this field, and offers recommendations on the application of LCA for assessing the potential environmental impacts of nanotechnology, nanomaterials, and nanoproducts.

The report offers the following main conclusions identified by the workshop participants:

• There is no generic LCA of nanomaterials, just as there is no generic LCA of chemicals.
• The International Organization for Standardization (ISO) framework for LCA (ISO 14040:2006) is fully suitable to nanomaterials and nanoproducts, even if data regarding the elementary flows and impacts might be uncertain and scarce. Since environmental impacts of nanoproducts can occur in any life cycle stage, all stages of the life cycle of nanoproducts should be assessed in an LCA study.
• While the ISO 14040 framework is appropriate, a number of operational issues need to be addressed in more detail in the case of nanomaterials and nanoproducts. The main problem with LCA of nanomaterials and nanoproducts is the lack of data and understanding in certain areas.
• While LCA brings major benefits and useful information, there are certain limits to its application and use, in particular with respect to the assessment of toxicity impacts and of large-scale impacts.
• Within future research, major efforts are needed to assess fully potential risks and environmental impacts of nanoproducts and materials (not just those related to LCA).
• There is a need for protocols and practical methodologies for toxicology studies, fate and transport studies, and scaling approaches.
• International cooperation between Europe and the U.S., together with other partners, is needed to address these concerns.
• Further research is needed to gather missing relevant data and to develop user-friendly eco-design screening tools, especially ones suitable for use by small and medium sized enterprises.

The report also offers specific recommendations in the following areas:

• Case-studies/prioritizing efforts: With limited resources, a case-study research approach could be adopted to enhance significantly knowledge on environmental impacts of nanomaterials and nanoproducts.
• LCA studies and presentations of results: Any LCA study on nanoproducts and nanomaterials most likely suffers from high uncertainty issues.
• Approaches.
• Actions from stakeholders: Different stakeholders/authorities can potentially support the application and use of LCA for nanoproducts and nanomaterials through a large set of actions.

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