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Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: KBBE.2010.2.3-02 | Award Amount: 12.29M | Year: 2011

The present proposal sees the development of business and value creation models as central to the development of personalised nutrition and thus it is intended to engage in a series of interviews with key stakeholders, which will generate a number of scenarios to be considered by these stakeholders. Parallel to that we will run some focus groups with consumers and develop a tool to ascertain consumer attitudes to personalised nutrition in 8 EU countries (1,000 per country) representing a breadth of gastronomic traditions. Within these 8 countries, we will recruit 1,280 subjects and offer 3 levels of personalised nutrition: 1 Personalised dietary advice alone; 2: personalised dietary advice based on biochemical phenotypic data; 3: the latter to include genomic data. These will be compared with a control group, which will be offered non-personalised dietary advice. All of the data on dietary intake and all of the advice will be Internet delivered and will last 6 months. Within each of the 3 levels of personalised nutrition groups, half will receive their feedback at months 0, 3 and 6 while the other half will have continuous feedback on demand with intensive coaching. The overall outcome measurement will be changes in a healthy eating index. The data gathered in this study will feed into the development of algorithms to provide automated feedback for future services delivering personalised advice on food choice. We will bring together an international group of experts to develop best practice in the application of all aspects of nutrigenomic research to personalised nutrition. We will also scope out existing and future technologies, particularly those involving biofeedback, which will help the development of personalised nutrition. Finally we develop position papers on the ethical and legal aspects of personalised nutrition. Permeating all of this work will be a wide-ranging communications programme aimed at all stakeholders of relevance to personalised nutrition.


Ahlgren J.,Lund University | Nordgren A.,Linköping University | Perrudin M.,Keller and Heckman LLP | Ronteltap A.,Wageningen University | And 5 more authors.
Genes and Nutrition | Year: 2013

Consumers often have a positive attitude to the option of receiving personalized nutrition advice based upon genetic testing, since the prospect of enhancing or maintaining one's health can be perceived as empowering. Current direct-to-consumer services over the Internet, however, suffer from a questionable level of truthfulness and consumer protection, in addition to an imbalance between far-reaching promises and contrasting disclaimers. Psychological and behavioral studies indicate that consumer acceptance of a new technology is primarily explained by the end user's rational and emotional interpretation as well as moral beliefs. Results from such studies indicate that personalized nutrition must create true value for the consumer. Also, the freedom to choose is crucial for consumer acceptance. From an ethical point of view, consumer protection is crucial, and caution must be exercised when putting nutrigenomic-based tests and advice services on the market. Current Internet offerings appear to reveal a need to further guaranty legal certainty by ensuring privacy, consumer protection and safety. Personalized nutrition services are on the borderline between nutrition and medicine. Current regulation of this area is incomplete and undergoing development. This situation entails the necessity for carefully assessing and developing existing rules that safeguard fundamental rights and data protection while taking into account the sensitivity of data, the risks posed by each step in their processing, and sufficient guarantees for consumers against potential misuse. © 2013 Springer-Verlag Berlin Heidelberg.


Swick D.,American Petroleum Institute | Jaques A.,RegNet | Walker J.C.,Keller and Heckman LLP | Estreicher H.,Keller and Heckman LLP
Regulatory Toxicology and Pharmacology | Year: 2014

Significant efforts have been made to characterize the toxicological properties of gasoline. There have been both mandatory and voluntary toxicology testing programs to generate hazard characterization data for gasoline, the refinery process streams used to blend gasoline, and individual chemical constituents found in gasoline. The Clean Air Act (CAA) (Clean Air Act, 2012: § 7401, et seq.) is the primary tool for the U.S. Environmental Protection Agency (EPA) to regulate gasoline and this supplement presents the results of the Section 211(b) Alternative Tier 2 studies required for CAA Fuel and Fuel Additive registration. Gasoline blending streams have also been evaluated by EPA under the voluntary High Production Volume (HPV) Challenge Program through which the petroleum industry provide data on over 80 refinery streams used in gasoline. Product stewardship efforts by companies and associations such as the American Petroleum Institute (API), Conservation of Clean Air and Water Europe (CONCAWE), and the Petroleum Product Stewardship Council (PPSC) have contributed a significant amount of hazard characterization data on gasoline and related substances. The hazard of gasoline and anticipated exposure to gasoline vapor has been well characterized for risk assessment purposes. © 2014 The Authors.


Swick D.,American Petroleum Institute | Jaques A.,RegNet | Walker J.C.,Keller and Heckman LLP | Estreicher H.,Keller and Heckman LLP
Regulatory Toxicology and Pharmacology | Year: 2014

•The US government has authority to regulate worker and consumer exposures to gasoline.•Industry has implemented broad measures to minimize the risks from gasoline use.•Extensive risk management measures exist at all stages of the gasoline life cycle.•Highlighted are current regulatory controls and industry standards and practices.•These measures mitigate potential environmental and human health risks from gasoline. This paper is part of a special series of publications regarding gasoline toxicology testing and gasoline risk management; this article covers regulations, standards, and industry practices concerning gasoline risk management. Gasoline is one of the highest volume liquid fuel products produced globally. In the U.S., gasoline production in 2013 was the highest on record (API, 2013). Regulations such as those pursuant to the Clean Air Act (CAA) (Clean Air Act, 2012: § 7401, et seq.) and many others provide the U.S. federal government with extensive authority to regulate gasoline composition, manufacture, storage, transportation and distribution practices, worker and consumer exposure, product labeling, and emissions from engines and other sources designed to operate on this fuel. The entire gasoline lifecycle-from manufacture, through distribution, to end-use-is subject to detailed, complex, and overlapping regulatory schemes intended to protect human health, welfare, and the environment. In addition to these legal requirements, industry has implemented a broad array of voluntary standards and best management practices to ensure that risks from gasoline manufacturing, distribution, and use are minimized. © 2014 The Authors.


PubMed | RegNet, American Petroleum Institute and Keller and Heckman LLP
Type: Journal Article | Journal: Regulatory toxicology and pharmacology : RTP | Year: 2014

Significant efforts have been made to characterize the toxicological properties of gasoline. There have been both mandatory and voluntary toxicology testing programs to generate hazard characterization data for gasoline, the refinery process streams used to blend gasoline, and individual chemical constituents found in gasoline. The Clean Air Act (CAA) (Clean Air Act, 2012: 7401, et seq.) is the primary tool for the U.S. Environmental Protection Agency (EPA) to regulate gasoline and this supplement presents the results of the Section 211(b) Alternative Tier 2 studies required for CAA Fuel and Fuel Additive registration. Gasoline blending streams have also been evaluated by EPA under the voluntary High Production Volume (HPV) Challenge Program through which the petroleum industry provide data on over 80 refinery streams used in gasoline. Product stewardship efforts by companies and associations such as the American Petroleum Institute (API), Conservation of Clean Air and Water Europe (CONCAWE), and the Petroleum Product Stewardship Council (PPSC) have contributed a significant amount of hazard characterization data on gasoline and related substances. The hazard of gasoline and anticipated exposure to gasoline vapor has been well characterized for risk assessment purposes.


Stearns F.A.,Keller and Heckman LLP
Plastics Engineering | Year: 2014

The medical device industry represents a potential market that biomaterials suppliers should not dismiss out-of-hand. There are a number of tools available to potential suppliers to help mitigate their risk. Suppliers should consider these options to ensure that they make a fully-informed decision about whether to supply raw materials or component parts to medical device manufacturers.


Walker J.-C.,Keller and Heckman LLP
SMT Surface Mount Technology Magazine | Year: 2011

Importers and manufacturers in the U.S. are increasingly being asked by downstream customers to provide products, including component parts that are safe, "environmentally-friendly" and free of a host of substances that may or may not be regulated. This article presents a top-level summary of those requirements.


Scheuplein R.J.,Keller and Heckman LLP
Skin Pharmacology and Physiology | Year: 2013

I want to thank Mike Roberts for arranging this issue of the journal and Annette Bunge and Richard Guy for reviewing this paper. This is, first, a history of my introduction to the field of skin permeability, and then an attempt to recall (with the inaccuracies that implies) the highlights of my research (1960-1975) on skin permeation, and finally a reflection by an old-timer on more recent concepts. © 2013 S. Karger AG, Basel.


Walker J.-C.,Keller and Heckman LLP
SMT Surface Mount Technology Magazine | Year: 2011

The FTC is still in the process of reviewing public comments for its "Green Guides," and likely will issue a final guidance later this year. In the interim, industry members should begin reviewing the environmental claims now, as we would expect to see some enforcement activity once the revised "Green Guides" are finalized.


Norton C.L.,Keller and Heckman LLP
SMT Surface Mount Technology Magazine | Year: 2013

With changes coming to restrictions on exports in the industry, Corey Norton, an international trade attorney, outlines updates to ITAR , EAR, the U.S. Munitions List, and more. The goal of these revisions is to create a control list of specific items with real inherent military significance.

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