The next plenary meeting of IVTIP will be held on:
April 22-23, in Amboise, France
The meeting will be hosted by IVTIP member company Pfizer. The programme features in vitro alternatives in the cosmetics field, in vitro neurotoxicology and Immunotoxicology/pulmonary models. If you have not registered yet: there are still some places available!
The Commission's plan to register, evaluate and authorize chemicals is under fire from a swathe of countries, most notably the US. But the Commission remains unfazed.
The REACH proposal, jointly drawn up by the ECs Environment and Enterprise Directorates, came under heavy fire from both governments and industry when it was unveiled last October 2003. Via last minute modifications (aimed at reducing costs and complexity) the proposal was watered down sufficiently to make it palatable to most EU member states (i.e. the Nordic States, the Netherlands and the UK), although heavy opposition from i.e. the German chemical industry and the EUs employers association Unice remain. Another strong adversary is the US Bush administration.
In March, the American diplomats in the EU member and accession states received a confidential cable from US Secretary of State Colin Powell, directing them to lobby governments against the REACH proposal. Arguments: the REACH proposal will create a costly, disproportionably burdensome and complex regulatory system, which could prove difficult if not unworkable in its implementation. US exports in most industrial sectors, totaling tens of billions of dollars, would be severely affected. In addition to Powell's letter, the US has spearheaded an attack within the Asia-Pacific Economic Cooperation (APEC) coalition of countries. In March key players from APEC, including the US, Canada, Mexico, Australia, Japan, China, Indonesia, Malaysia and others, sent a joint statement to the Commission expressing their ëserious concern'. APEC warns that the greatest negative impact would be on developing economies and SMEs, as well as on economies and trade.
The APEC statement was dismissed by a spokesperson from Environment Commission Margot Wallstrom as just ëone of many' that pour in daily. The spokesperson said there is not a single proposal in the Commission this well prepared, and there is now a fair compromise following months of consultation with hundreds of stakeholders. The Commission still has a lot of confidence in it and dismisses the recent attacks of APEC as ëhighly US and politically motivated'. Moreover, Canadian and US officials and researchers have expressed a positive interest in the proposal. However, the Bush administration is preparing a new statement by June 1, so the issue is not likely to go away. The US Council for International Business is urging the Bush administration to take a tough stance; meanwhile, San Francisco has formally adopted a resolution in favor of the draft EU chemicals policy.
Source: European Voice, April 14, 2004
The European Commission has outlined its plans for the Interim Strategy on REACH. The plans were unveiled at a multi-stakeholder workshop, organised by DG (Directorate General) JRC (Joint Reseearch Centre) in Ispra on 11-14 February 2004.
In the workshop, the work plan to be carried out during the Interim period was discussed and priorities set. The work plan focuses on the development of tools, methodologies and guidance under the REACH Implementation Projects (RIPs). The general structure for the work plan and projects were agreed, and sub-projects discussed in greater detail. The participants also debated Strategic Partnerships.
The Interim Period started officially on 29 October with the adoption of the Commission's proposal for REACH, and will continue until the Regulation enters into force.
The Interim Strategy aims at preparing all parties, the Commission, Member States (including accession countries) and industry for the practical application of REACH. Work will be carried out in five main areas, including methodologies, guidance and tools for industry and authorities.
Cefic will actively participate and contribute to the Interim Strategy. It is vital that the industry takes the opportunity to promote the most efficient and cost-effective way to carry out the practical work under REACH.
In the workshop, Cefic presented its proposal for a comprehensive pilot trial to the Commission and the Member States to:
A comprehensive trial would not only deliver results on the above but would also be a test on whether - if at all - REACH meets its overall objectives and regulatory purpose. Such a trial would need sufficient time for completion. Cefic believes that a target date of mid-2005 would be realistic for a final report.
The Commission will further refine the work plan in the coming weeks.
More information: CEFIC, aoj@cefic.be" Annemaria Ojanperü ; +32 2 676 73 78
Source: CEFIC News, issue 20, march 2004
Though improvements have been achieved in REACH's scope and requirements, it is still considered too bureaucratic and disproportionate with regard to its objectives. Cefic will be contributing to the cost of pilot studies to test its requirements in practice and to analyse their consequences for our industry and for the chemicals supply chain.
CEFIC members attending the annual business assembly were urged to involve themselves more in the preparation of the implementation of REACH, in order to have it as workable as possible. They were invited to pass on their ideas for improving the system via Cefic's working groups with the European Commission.
The Assembly was also briefed on the ìTechnology Platform on Chemicalsî under Cefic's research agreement with the European Commission ABM Members were asked to input their priorities and to propose projects in this innovation programme that will establish the framework for setting industry priorities in the European research funding rounds. The next is the Framework 7 programme.
More information:
jcl@cefic.be
Jean-Claude Lahaut ; Office of the Director General; +32 2
676 72 03
Source: CEFIC News, issue 21, April 2004
The European Commission has responded to a European Life Scientist Organization (ELSO) petition calling for a 'new and ambitious European science policy' and the restructuring of the EUs research funding programme. A spokesperson told CORDIS News that while some criticisms are valid, many of the initiatives called for by ELSO have already been launched.
The ELSO petition, which will be presented to the European institutions in the autumn of 2004 is intended to influence the next Framework Programme, due to begin in 2007. The organization believes that there are three fundamental flaws with the way the European research is funded, namely excessive bureaucracy, inadequate emphasis on 'basic research' and a lack of funding.
The Commission spokesperson replied that:
* the Commission agrees that it is necessary to simplify the procedure. However, strict procedures are also necessary as taxpayers' money is involved.'
* some of the issues raised by ELSO have already been discussed. Indeed, a new European arrangement characterized by minimum bureaucracy and closely involving the scientific and engineering communities has been declared a priority last February
* the European Commission has proposed to raise the budget for research by 60 per cent by 2013, and talks are currently underway on a European Research Council for basic research. 'The plan is to model it on the American National Institute for Health (NIH) and National Science Foundation (NSF). There would be grants instead of consortia, while the Framework Programme would continue as it is as we believe it is possible to have both models.'
To read and sign the ELSO petition, please visit: http://ultr23.vub.ac.be/petition/
Source: CORDIS News, March 2, 2004
Recently, Dr. Hans-Jˆrg Bullinger, President of the Fraunhofer Gesellschaft and member of the high level panel charged with carrying out a mid-term evaluation on the new instruments in FP6 presented some preliminary findings.
While the high number of proposals received is to be welcomed, along with the general acceptance of the new instruments and their integrating objectives, there are issues of clarity, project management and transparency for further analysis.'
The number of submitted proposals shows the attractiveness of the programme, particularly IST [information society technologies], but for those that were refused funding, was is said precisely enough what the EU wanted?
Many groups face difficulties with respect to management costs (7% of the budget) and management capacity (not enough)
A main comprehension problem relates to the Network of Excellence concept. It remains unclear whether such a network should be constructed according to political criteria, ensuring coverage of the whole of Europe, or whether the concept means that only those organizations that genuinely demonstrate excellence should be included. 'Excellence is being impaired by thoughts on cohesion. If a Network of Excellence is really a Network of Excellence, it should be based on excellence,' he said.
While welcoming the new instruments as tools which really do encourage integration and collaboration, it is questioned whether such large consortia really fulfill the aims of increasing flexibility and reducing bureaucracy. With so many partners involved in each project, the amount of EU funding received by each partner is often low.
For the remainder of FP6, it is proposed that the Commission provides more specific information on what is required in project proposals, and retains the traditional funding instruments alongside the new ones, as 'Networks of Excellence and Integrated Projects are not suitable for all priority areas.'
It is also proposed that more money should be allocated to project management, and that the cut to the requested budget upon selection of a project should be less dramatic.
As for FP7, the Commission is called to retain the Framework Programmes as the key instrument for supporting European research, but requested higher funding for core areas. There is also a need for preserving continuity and diversity with regard to the funding instruments.
Professor Bullinger was skeptical of calls for a new funding initiative for basic research, and called on the Commission not to make a division between basic and applied science. 'There is no difference, it is simply a question of a perspective of time,' he said. 'There is research that will give results in 20 years and research that will give results in five years. There is also research for which one cannot say now when the results will be available.
For further information on the mid-term review, please visit: http://www.cordis.lu/fp6/instruments_review
Source: CORDIS News, February 18, 2004
New figures show that many promising female scientists in Eastern Europe and the Baltic states are squeezed out of well-funded research opportunities to the benefit of their male colleagues. "A waste of talent" complains the Commission.
A new report by the Commission paints a dire picture of the situation of women researchers in Central and Eastern European countries and the Baltic states. Although more than one third of scientists in these countries are female (compared to only 27.2 per cent in the EU-15), the report shows that a large proportion of women researchers are employed in areas where R&D expenditure is poor. As a result, women are squeezed out of competitive, high-expenditure R&D systems and the progress of a whole generation of promising scientists is hampered.
The younger generation of scientists faces the same dilemma as in many other European countries. In spite of their potential for a scientific career, social and economic factors and structural conditions of the research systems make it difficult for them to pursue their career while having children.
According to the findings, men are three times more likely to reach senior academic positions than women. While women represent the majority of teaching staff in universities, their careers tend to stop in lower academic positions.
As for EU research programmes, the report shows that a high percentage of female researchers from Eastern Europe participate in the framework programmes. Research Commissioner Philippe Busquin welcomed this fact as one of the objectives of EU programmes is to boost the participation of women in research.
Source: Euractiv, February 2, 2004
On February 10, 2004, the Commission adopted a Communication outlining its proposals for the EUs budget plan for the period 2007-2013 ( financial perspective). The financial perspective defines the EUs revenue and expenditure ceilings over a multi-annual period.
In its \t "OTHR" Communication on the financial perspective , the Commission states that in order to "become a beacon of excellence attracting researchers and investments", Member States must continue their efforts to create a genuine 'European Research Area' (ERA). They must also follow up their words with some deeds by to increasing research investment to 3 per cent of GDP by 2010.
However, more direct financial research support at EU level is also necessary. The Commission proposes to significantly increase EU research funding, which is currently at 0.04 per cent of GDP. According to the Communication, Community action should focus on five main areas:
1. Providing grants to research teams, which will be selected on a competitive basis at European level; although this is not explicitly stated, this indicates a renewed Commission effort to create a 'European Research Council' along the lines of the US National Science Foundation.
2. Strengthening research infrastructure, education and training and promoting researchers' transnational mobility.
3. Setting up public-private partnerships at EU level in key research areas such as hydrogen & fuel cells, nanotechnology, mobile telecommunication, solar energy etc.
4. Stimulating networking and collaboration at laboratory level to develop 'poles of excellence' through the new instruments of the 6th Framework Programme.
5. Coordinating national and regional research programmes and policies to improve efficiency and avoid duplication of research efforts.
The Commission's proposal also emphasizes the need for increased investment in the space and security policy, in which science and technology play a key role.
Council and Parliament will have to adopt the proposal before the end of 2005.
Source: Euractiv, February 19, 2004
According to the current Irish presidency, two areas in research need improvements: making Europe more attractive for researchers and making investment in research more efficient. Of great concern is that 400,000 of Europe's best researchers are currently based in the US and a large majority of them do not want to return to Europe. To tackle the brain drain phenomena, the Irish research minister pointed to the advances made in Ireland in the last decade. He said that Ireland's progress in the field of research was built on financing decisions based solely on scientific excellence and competitiveness which in turn had forced research institutions and universities to focus on the same principles.
In July 2003, the Commission adopted a package of measures to stop the brain drain to the US. Steps proposed include the development of a code of conduct for the recruitment of researchers, a common way of evaluating and recording researchers' skills, qualifications and achievements, advanced training tools, access to adequate funding and providing minimum social security benefits for PhD students (seehttp://www.euractiv.com/cgi-bin/cgint.exe/891666-805?714&1015=7&1014=p22073g EurActiv, 22 July 2003 ).
Member State Finland is the only one that is meeting and actually surpassing the Barcelona target of investing 3 percent of GDP in research by 2010. According to a Finnish minister this came about by a determined investment in education and research, establishing regional universities and the two funding agencies Tekes and Academy of Finland as well as creation of the Science and Technology Policy Council."
Source: Euractiv, April 8, 2004
The EUs Heads of State and Government agreed on 26 March that a focus on just four priorities is necessary in order to enhance European competitiveness - completing the internal market, better regulation, higher rates of research and development (R&D) and effective institutional arrangements. The most important priority is increasing R&D, particularly that relating to life sciences.
The Council conclusions include a call on the Member States to improve the general conditions for R&D investment and to consider targeted support and incentives to encourage greater investment by business.
The Commission's Framework Programmes for research must be simplified, agreed the Council, in order to make it more user friendly, particularly for small and medium sized enterprises and start-ups. Leaders pledged to examine the case for increased funding for basic research, and narrowed down the priorities for the Framework Programmes to promoting cooperation between business and research, boosting future technologies, and supporting basic and applied research.
To see the European Council conclusions, please consult the following web address: http://ue.eu.int/pressData/en/ec/79696.pdf
Source: CORDIS News, March 29
On November 18, 2003, the European Parliament adopted a paper on ëinvestment in research'. The report, by rapporteur Linkohr, claims that the 'trauma of Europe' is that 'we decide, we are courageous on paper, but then nothing happens.'
Most likely this is due to a lack of lobbying by the research community: 'Those that have a job don't protest, and those that don't aren't accustomed to protesting. The research community is too polite and simply goes abroad,' Mr. Linkohr said, contrasting the research community with the agriculture community.
Mr Linkohr also warned of a 'deadly mood' in Europe. 'Europe consumes and does not invest in the future,' he said. Other MEPs stated that the research system is far more isolated in Europe than in the US, and that more links are needed with society, as well as the private sector.
There will be two principal implications to come out of the Parliament's adoption of his report. The first is that, having called for an increase in budget to 30 billion euro for the Seventh Framework Programme (FP7), MEPs should be firm in policy towards the Council,' and truly fight for this increase.
The second consequence relates to the creation of a European Research Council (ERC). 'This only makes sense if it is well funded,' i.e. by making available five billion euro over a four year period. Mr Linkohr has asked the Commission to prepare a proposal on how to link an ERC with the Framework Programmes. However, an ERC should remain independent and much more flexible than the Framework Programmes, enabling very small amounts of money to be distributed as and when necessary.
Source: Euractiv, November 19, 2004
The European Research Advisory Board (EURAB) has issued a set of recommendations on European Technology Platforms and suggests the principles that should guide their establishment and operations.
Essentially, the report sees such platforms as innovation initiatives that draw together all relevant international stakeholders to tackle a major European challenge or need. In the first phase of such an initiative, the members of the platform must develop a vision that leads to the creation of an action plan, or road map. During the second phase, which could last a decade or more, the platform will then oversee and coordinate the implementation of that road map.
EURAB sets out five guiding principles for the establishment of European Technology Platforms:
The challenge to be addressed must be major, and the response long term in nature. Technology platforms 'are not short term, problem solving devices,' argues the report;
A second and related principle states that platforms should only be established when there is a well defined European strategic need for such an instrument.
To affect change across national, industrial and technological boundaries, platforms must create strong political support and be highly visible at a European, [and even] a global level,
platforms should be driven by actors from the application or 'problem' end of the innovation process, rather than by policy makers.
There must be a road map with a longer term vision, a sound strategy for achieving this vision and a detailed action plan for carrying out the necessary activities.
EURAB warns that technology platforms must not be considered the answer to everything, concluding that 'If they become simply the fashion of the year, they will lose their value and industry will refuse to participate.'
To read the recommendations, please consult the following web address: http://europa.eu.int/comm/research/eurab/index_en.html
Source: CORDIS, February 24, 2004
CORDIS, the European Community's Research and Development Information Service, has developed a new service to follow discussions on the Seventh Framework Programme (FP7)
The debate on FP7 started in September 2003 when the Competitiveness Council invited the Commission and Member States to make more effective use of financing instruments, including the EUs Structural Funds, for research and development (R&D).
Since then, several stakeholders have contributed to the debate. The most important contributions are available from the FP7 related news section of the new service.
The CORDIS FP7 service aims to keep users informed of important developments related to the FP7 debate - where appropriate, links are also given to other related web sites. The service will provide a comprehensive information platform on this issue.
Source: CORDIS News, March 11, 2004
The dedicated website is located at: www.cordis.lu/fp7
The Treaty establishing the European Community (part 3, title XVIII, art. 166, pag.114) provides for the creation of multi-annual RTD programmes. The Seventh framework programme (FP7) will probably span the period 2006-2010 and will be an important instrument to implement the "European Research Area ".
On 22 September 2003 the Brussels Competitiveness Council invited the Commission and Member States to make more effective use of financing instruments, including the EUs structural funds, for research and development (R&D).
The European Parliament unanimously adopted a http://www2.europarl.eu.int/omk/sipade2?L=EN&OBJID=31218&LEVEL=4&MODE=SIP&NAV=X&LSTDOC=N report on 18 November 2003 by German MEP Rolf Linkohr calling for the budget of the Seventh Framework Programme (FP7) to be raised to 30 billion euro for the four year period.
The proposal on the Commission's future budget between 2007 and 2013 (ftp://ftp.cordis.lu/pub/era/docs/com2004_0101_en.pdf COM(2004) 101 final ), unveiled on 10 February 2004 amongst much controversy, made a claim for higher contributions from the EUs Member States for research and innovation initiatives at EU level (see article above).
Europe does not need more research, but more efficient and effective research, if an innovation-based economy is to develop, Academic Director of the animal hygiene department at Munich's Technical University, Walter Grünzer, has told CORDIS News.
'As a first step we do not need additional committees and commissions, but a wide ranging re-engineering of publicly financed research,' said Dr Grünzer.
Only through such restructuring will Europe embrace an innovation-based economy and turn around its growth performance, claims Dr Grünzer. He emphasizes that this was also the conclusion drawn in 'An agenda for a growing Europe', the study requested by Commission President Romano Prodi on growth in Europe. 'The Group views Europe's unsatisfactory growth performance during the last decades as a symptom of its failure to transform into an innovation-based economy,' wrote the high level study group.
Dr Grünzer claims that this streamlining of European research necessitates 'engineers, machinists, physicists, biologists, physicians, chemists and computer scientists,' and compares their task to that of a car manufacturer. 'They must be able to build and sustain automated research assembly lines. The most important lever for the economic growth in Europe is optimization of the efficiency and effectiveness of research by means of advanced automation in research processes,' he says.
Dr Grünzer believes that there is, essentially, no difference between the production of cars and the production of scientific information. He gives the following example: 'The preparation of a defined molecule out of natural material requires many extensive trials numerously repeated with different process parameters in order to find out the correct concentration of a precipitation medium for the protein chemistry. Then we need additional extensive trials in order to verify or to deny the once detected result.'
Anticipating criticisms to this approach, Dr Grünzer argues that the flexibility essential for research 'assembly lines' can continue in such a system: 'Each car to be built on the assembly lines is different from the others, it is even possible to build two different models on one assembly line.'
Dr Grünzer believes the lack of automation, particularly where publicly funded research is concerned, is responsible for an absence of efficiency and effectiveness. 'Automation', he argues is 'the most urgent task for FP7.
Source: CORDIS News, October 30, 2004
The Europe's Innovation Scoreboard 2003 is an annual benchmarking aimed at Europe's innovation potential. The EIS 2003 confirms that &endash; on almost all measures for which comparable data is available &endash; the EUs innovation performance remains significantly weaker that that of the United States. The Scoreboard is based on 12 indicators, including the number of high tech patents, early-stage venture capital, population with a tertiary education, high-tech manufacturing value-added, business R&D expenditures, ICT expenditures, Public R&D expenditures, EPO patents and Science & Engineering graduates. Only on the latter indicator is Europe outperforming the US, with the greatest gap on number of high tech patents and availability of early-stage venture capital. Sobering, at the present rate of improvement, this gap on 10 of the 12 indicators will remain until at least 2010. However, positive developments are Europe's improved performance with respect to the number of science and technology graduates, value-added by high tech manufacturing (still 40% lower than in the US but catching up), and EU spending on information technologies (only 15% below US spending).
The EIS 2003 confirms that all new member states are catching up with average EU Innovation performance &endash; in some cases, very rapidly. Four of the Union's new member states (the Czech Republic, Estonia, Hungary and Slovenia) are already outperforming a number of EU-15 countries. All have improved their innovation performance more rapidly than the EU-15 average. Countries such as France, the Netherlands, Ireland, Germany and Belgium are on the EU average, while the UK, Finland, Denmark and Switzerland are slightly losing momentum (as are Japan and the US!). Falling further behind are Italy and Bulgaria.
Regularly updated information on the Innovation Scoreboard is available at http://trendchart.cordis.lu
The Innovation Regions in Europe (IRE) network is part of the Research and Innovation activities within FP6. It aims to facilitate the exchange between regions developing regional innovation policies, strategies and schemes, and to improve their access to good practice. Over 100 European regions are already members. The network is currently being enlarged to include both new thematic networks and regions in Central and Eastern Europe, which will develop their own regional innovation strategies.
For more information: www.innovating-regions.org
Source: 'European Innovation Scoreboard'; Innovation & Technology Transfer, no. 1/04
The full report can be ordered from:
http://europa.eu.int/comm/enterprise/informa/index.cfm
or
ftp://ftp.cordis.lu/pub/focus/docs/innovation_scoreboard_2003_en.pdf
ECVAM organized in February the following Task Force meetings:
chronic toxicity (1st meeting, chair Prof Walter Pfaller, Dr. Pilar Prieto)
alternatives to animal experiments in the biological testing of medical devices (2nd meeting, chair Prof James Kirkpatrick)
immunotoxicity (1st meeting, Dr. Laura Gribaldo)
in January: workshop on: metabolism, a bottle-neck in in vitro toxicological test development
Skin Irritation Validation Study The contract for carrying out the Skin Irritation Validation Study was awarded to ZEBET at the Federal Institute for Risk Assessment (Berlin, D) and the management team met at ECVAM.
Source: ECVAM News, January and February 2004
The "ICCVAM Biennial Progress Report - December 2003", providing a description of the activities carried out during the past two years by ICCVAM and NICEATM, is available at:
http://iccvam.niehs.nih.gov/docs/FR/6907777.pdf in PDF or
http://iccvam.niehs.nih.gov/docs/FR/6907777.htm in HTML.
You can also access this report from the ICCVAM home page at
http://iccvam.niehs.nih.gov through the links in the "Announcements" box.
The posters presented on March 22 during the NICEATM meeting are now available on the ICCVAM web site at
http://iccvam.niehs.nih.gov/meetings/SOT04/sotablst.htm and linked from the
ICCVAM home page (http://iccvam.niehs.nih.gov).
The posters deal with ICCVAM Regulatory and Policy Development Processes (Minimum Performance Standards,Nomination and Submission Guidelines), Dermal Corrosion and Irritation, and the In Vitro Cytotoxicity Validation Study.
NICEATM requests public comments on the nomination for ocular toxicity test methods and related activities and requests data on chemicals evaluated by in vitro or in vivo ocular irritancy test methods. The request is available at: http://iccvam.niehs.nih.gov/docs/FR/6913859.pdf in PDF or
http://iccvam.niehs.nih.gov/docs/FR/6913859.htm in HTML.
NICEATM requests submission of:
(1) public comment on four test methods for ocular toxicity and related activities nominated to the ICCVAM by the U.S. EPA,
(2) public comment on ICCVAM's recommended actions for the nomination, and
(3) data from completed studies on chemicals and products tested for ocular irritancy using in vitro and/or in vivo test methods.
It concerns the BCOP, HET_CAM, ICE and IRE tests.
Data and other information
received by May 24, 2004, will be forwarded to the ICCVAM
and the ICCVAM Ocular Toxicity Working Group (OTWG) for
their consideration.
Data and information received after this date will be
periodically compiled and added to the database maintained
by NICEATM.
Please submit comments by email to
iccvam@niehs.nih.gov,
or fax to 919-541-0947
The National Library of Medicine's Division of Specialized Information Services (SIS) has introduced the "Review of PDA Applications in Toxicology and Environmental Health,"
(http://sis.nlm.nih.gov/Tox/PDAReview/PDAHomePage.htm) an ongoing
descriptive review of selected PDA applications in the fields of toxicology and environmental health.
Individual reports in the review series are based on downloadable demo versions of selected PDA applications. Each review typically covers: General Information, Intended Users, Authorship/Data Source, Contents, Navigation, Requirements, Application Type/Price, Availability, Useful Web Links, and Updates when applicable.
SIS staff welcomes any comments on completed reviews or suggestions for additional reviews of other such applications not currently included (tehip@teh.nlm.nih.gov).
Agency responses to ICCVAM test recommendations for:
1) the revised Up-and-Down Procedure (UDP) for determining acute oral
toxicity and
2) in vitro methods for assessing acute systemic toxicity
Were announced in the Federal Register. A copy can be viewed at: http://iccvam.niehs.nih.gov/docs/FR/6911448.pdf in PDF or
http://iccvam.niehs.nih.gov/docs/FR/6911448.htm in HTML.
The recommendations are listed and
linked on the test method pages at
iccvam.niehs.nih.gov/methods/udp.htm
for the UDP and
http://iccvam.niehs.nih.gov/methods/invitro.htm
for the in vitro methods for assessing acute systemic
toxicity.
In 1997, a project was granted by the Institute Center for Alternatives to Animal Testing (CAD of the RIVM), aimed to evaluate the risk assessment process for sensitizing potency of contact allergens in a more reliable manner, and to investigate the possibility of developing alternative approaches to in vivo testing. Dr François van Och, who worked on this project as PhD student, received his PhD in november 2002. Here we give a short description of the study outline and the conclusions.
The prevalence of contact hypersensitivity (CHS) tends to grow proportionally to the increasing exposure to an expanding variety of chemicals. Predictive animal tests to identify sensitizing properties of chemicals are therefore carried out at a large scale. For a better risk assessment, a more quantitative assessment of the sensitizing potency of chemicals is needed. These two current developments result in an increasing number of animals used. The scope of this thesis was therefore to evaluate the process of risk assessment for sensitizing potency of low molecular weight chemicals, pertaining to both in vivo and alternative approaches.
In vivo: The murine local lymph node assay (LLNA) has recently been accepted as a stand-alone test and evaluates the sensitization potential by measuring cell proliferation in the lymph node (LN), which drains the site of application, being the ear. The sensitizing potential of ten model allergens was evaluated using a dose-response analysis on data obtained using the LLNA. In addition, information on the reliability of the data was obtained using a bootstrap approach.
In vitro: the relative potency of known allergens on cytokine dose-response relationships was investigated using a murine and a human keratinocyte (KC) cell line. The cytokine dose-response data were evaluated and EC3 values calculated. The EC3 values obtained in the murine KC cell line were used to rank these chemicals and to compare it with the ranking obtained from the LLNA (in vivo). Second, the EC3 values obtained in the human KC cell line were compared to the EC3 values obtained in the murine KC cell line. The ranking of the allergens based on the EC3 values derived from the IL-1a and IL-18 dose-response relationships using the murine KC cell line corresponded to the in vivo classification data based on the LLNA. Therefore, IL-1a and IL-18 production by KC may be seen as a possible tool for the prediction of sensitizing strength of a particular chemical.
In silico: Another approach for the identification of potential sensitizing capacity that would not rely on in vivo animal or in vitro testing is directed towards the construction of in silico models. Multiple regression analysis of the EC3 with different properties resulted in different equations from which predicted sensitizing values could be calculated. Potency evaluation resulted in a classification of the different chemicals in which the weak allergens could be distinguished from the strong allergens, solely based on their physio-chemical properties.
In conclusion, with the methodology described in the thesis, it is now possible to assess the potency of sensitizing chemicals in the LLNA in a more accurate way. This results in a better estimation of the minimal number of test animals needed, which inevitably leads to a decrease in animal use. The in silico and in vitro approaches used in this study may be seen as possible tools for the prediction of sensitizing potency of a particular chemical, and may ultimately lead to a reduction in the use of experimental animals. In addition, the in vitro approach provided more insight in the differences in sensitivity between murines and humans. With such findings it may be possible to interpolate LLNA dose response data towards an estimation of risk in man.
For more information: François M.M. van Och; N.V. Organon, The Netherlands
E-mail: francois.vanoch@organon.com
Source: NCA Newsletter 16, March 2003
The Foundation, a leader in the funding and promotion of alternatives to the use of laboratory animals in research, testing, and education, announces that it is currently soliciting research proposals to its Alternatives Research Grant Program.
For over a decade, this innovative program has created partnerships with scientists who have the expertise and interest in alternatives research discovery.
Up to $40,000 in funding is available to support individual projects, with preference given to U.S. universities and research institutions.
Guidelines and Application form are now available online at: http://www.ardf-online.org Deadline for applications is 30 April 2004, with recipients announced on 15 July 2004.
E-MAIL: info@ardf-online.org
Source: NCA Newsletter no 16, March 2004
The IVTIP Secretariat received a letter on a new microbial assay for risk assessment (MARA). A pdf-file describing this method is available from the IVTIP Secretariat to IVTIP members
We quote:
'We are now in the process of producing a first series of our product and are interested to come in contact with people that could be interested to use our method in parallell with their standard in vitro assays to verify and give us feed-back on the MARA assay. This could be to determine the toxicity of a compound as made with for example with Microtox or people that are interested in screening chemicals/pharmaceuticals to make a classification of their bioactivity. One of our objectives for this assay is to build up a database of toxic fingerprints of chemicals with known bioactivity.For more information, please contact:
HÂkan Randahl, PhD, Managing director, PhPlate AB; Tel. +46 8 31 80 02; www.phplate.se
A significant new study shows steroids discharged into the environment are likely to produce reproductive and developmental effects. Industrial chemicals show no, or extremely low risk. The study will help the prioritisation of substance testing for endocrine effects.
The recent EC-sponsored study by WRC examined the potential endocrine-disrupting effects of 12 substances.
For the industrial substances evaluated the available data indicates that no adverse effects on reproduction and development in laboratory mammals occur at exposure levels at or below levels where general toxic effects are observed. Similar results were obtained for aquatic effects. Conversely, for steroids (natural hormones and ethinyl oestradiol) all cause effects on the reproduction and development of fish which are probably endocrine-mediated at environmentally relevant concentrations. Most of these hormones pass through sewage treatment works into the environment.
The study evaluated the industrial substances for potential for occupational or consumer exposure showing these industrial substances used in the manufacture of products have ìno or extremely limited consumer exposureî. Even for chemicals such as BADGE that can be found in food packaging, no risk to consumers (including children) from current exposure patterns was shown.
Further research is necessary to fully understand the potential for industrial substances to have endocrine-mediated effects; however there is a clear need for action on the natural substances which demonstrate effects on the environment.
More information from:
swe@cefic.be
Simon Webb; Research & Science; +32 2 676 74
92
Source: CEFIC news, issue 20, March 2004
More than 3000 pharmaceutical substances are used in the EU. A recent survey estimated that more than 100 tonnes of prescription drugs are used every year in Germany alone. European consumption of antibiotics is on the same scale as the production of certain pesticides. Pharmaceuticals are often persistent and lipophilic, properties which aggravate their polluting potential.
In 2000, three EU funded research projects focusing on environmental problems of pharmaceuticals were launched under the key action Sustainable Management and quality of Water under FP5. The results of the studies will form the basis for new regulations of pharmaceuticals under the REACH legislative initiative, which aims to regulate the impact of chemical products on the environment. The three projects were grouped in a Pharma Cluster to encourage data sharing and dissemination of research results. The three projects are looking at three main facets of the problem of waste of medicinal origin:
Eravmis: concentrates on the impact of veterinary antibiotics, with production running at over 5 000 tonnes/year.
Rempharmawater looked at the impact of a wide range of human medicines at the point of exit from sewage treatment plants (the effectiveness of the treatment is highly variable)
Poseidon studies the different water treatment technologies currently available.
The following websites give detailed information:
Eravmis: www.silsoe.cranfield.ac.uk/ecochemistry/research/project/evk1-ct.htm
Poseidon: www.eu-poseidon.com
Source: RTD Info no 40, February 2004
Stem cell research has been held back by the difficulty of isolating truly pluripotent cells in useful quantities. Recently, scientists Schultz and colleagues report on a molecule, termed reversin, that stimulate dedifferentiation of readily available adult cells into pluripotent or multipotent progenitors. From a screen of 50,000 compounds designed to interact with protein kinases, they isolated a compound that returns a mouse myogenic cell line (C2C12) to a progenitor state.
Source: J. Am. Chem. Soc. 126, 410-411, 2004
On March 5, 2004, Cefic presented its study 'Horizon 2015: Perspectives for the European Chemical Industry'. Envisaging four different scenarios, this study considers the industry's long-term prospects. A key conclusion is that the EU's future as a major chemical production region is at risk.
The study - conducted by a team of senior economists and strategic planners drawing on the experience of hundreds of people - outlines various scenarios and identifies the key drivers which are determining the future direction, including innovation and R&D, reputation, free trade, regulation and cost structures of logistics and energy. It finds that the competitiveness of the chemical industry is at risk and needs urgent action to be improved.
It was announced that Cefic was proposing to set up the ìChemical Advisory Group for Europeî. This group would include all major stakeholders: European and national authorities, trade unions, chemical industry and representatives from its main customers, such as automotive, electrical, electronics and pharmaceutical industry. The main objectives of this group would be to set a clear and agreed vision for the European chemical industry &endash; horizon 2015 &endash; and to develop a common, measurable action plan. The suggestion was welcomed by Commissioner Busquin. The Commission services were, he said, working actively with Cefic to develop the concept of a Technology Platform on Sustainable Chemistry. ìWorking together we may mobilize a critical mass of human and financial resources to make research and innovation the engines for boosting the competitiveness of the European chemical industryî, Busquin enthused.
More information: rvs@cefic.be René van Sloten ; International Trade and Competitiveness; +32 2 676 72 20
Source: CEFIC News, issue 21, April 2004
Ronald Plasterk, renowned scientist at the Hubrecht Laboratory in Utrecht, the Netherlands, has dared to attack a hype: systems biology. It is well known that systems biology exerts an attractive pull on those providing subsidies.
Dr. Plasterk argues that systems biology is nothing new, that what makes it worthwhile is not new, and what is new is untrue.
His arguing: In essence, systems biology starts with an entire biological system (say a cell, a rabbit or a sunflower). This biological system is then exposed to different conditions, after which a large number of variables are measured, for example, levels of gene expression or production of metabolites. The information gathered is processed in sophisticated computer systems, who will present solutions how this particular life form functions. This approach is faulty since it is impossible to deduce the functioning of life from a limited set of variables (an analogy: you cannot deduce the functioning of a piano by studying the sound that is produced). Striving to create a model of i.e. a cell before all possible mechanisms have been elucidated is a totally futile exercise, since all still to be discovered phenomena will be missed.
So why the enthusiasm and the hype? Possibly, biologists embrace the term in an effort to gain more sympathy for biology. Politicians champion a so-called new area of science, and young scientists are lured by the hype and excitement of working on a complex problem. But according to Plasterk, all biology is systems biology, and anyone calling himself a systems biologists surely must be a charlatan.
Source: Bionieuws, September 16, 2003
On 10 and 11 November 2003, the workshop "Retrieval Approaches for Alternative Methods to Animal Experiments" took place at ZEBET in Berlin. The meeting focused on appropriate search strategies and indexing systems for alternatives to animal experimentation.
During the meeting several of the currently available databases were discussed (see below), as well as the different search strategies and indexing systems. Some of the databases offer a comprehensive list of searchable scientific publications, while other specialized databases focus more on relevant information with respect to alternatives.
It was recognized during the workshop that it is extremely important for scientists nowadays to be able to retrieve relevant information on alternatives as is required by U.S. Policy 12 and European Directive 86/609/EEC.
During the workshop it was concluded that web-based search strategies should be developed to facilitate the seach for alternatives. To help scientists in their search for alternatives a worksheet was developed by the Animal Welfare Center (AWIC) of the US National Agricultural Library (NAL). The worksheet helps, as a check list, in the development of a search strategy for alternatives. The worksheet can be downloaded from www.nal.usda.gov/awic/alternatives/searches/searches.htm. A slightly adapted version is available on the NCA website (www.nca-nl.org/ and go to "documents").
It was also suggested to improve current indexing systems of databases. The (German) Center for the Documentation and Evaluation of Alternative Methods to Animal Experiments (ZEBET) has performed a study into indexing systems and concluded that these systems are not used to full potential.
NAL has developed the NAL Agricultural Thesaurus (NALT) which is used as CAB abstract thesaurus (original AGRICOLA indexing system). NALT includes terms which cover alternatives to animal testing in the subject category "Animal science and animal products". NALT is available on http://agclass.nal.usda.gov/agt/download.htm and the developers are open for comments and changes using a web form on http://agclass.nal.usda.gov/agt/contact1.htm
Currently, also the ECVAM Scientific Information Service (SIS) works on a ECVAM Thesaurus on Advanced Alternative Methods (TAMM). The project involves several organizations and works according to a "bottom-up approach". It is expected that the thesaurus will be published in 2006.
The following databases were discussed at the workshop and are worth visiting:
ECVAM Scientific Information Services: http://ecvam-sis.jrc.it/
Altweb - the internet clearinghouse on alternatives: http://altweb.jhsph.edu/
ALTBIB - Alternatives to animal testing database on the web (NLM): http://toxnet.nlm.nih.gov/altbib.html
AnimAlt-ZEBET - An Internet
database on alternatives to Animal Experiments:
www.dimdi.de/en/db/recherche.htm
(->databases -> databases a-z ->
AnimAlt-ZEBET)
More information on searching alternatives:
"Searching for alternatives" of the US Dept. of Veterans Affairs: www.researchtraining.org/
AWIC Tips for Searching for Alternatives: www.nal.usda.gov/awic/alternatives/tips.htm
Comprehensive Search Strategies for Animal Research Protocols: www.vetmed.ucdavis.edu/Animal_Alternatives/main.htm
Source: NCA Newsletter, no 16, March 2004
Results from the global Long-Range
Research Initiative, LRI programme on interactions between
chemicals, human health and the environment can now be
searched and accessed from a single website at:
www.icca-chem.org/section02c.html
Source: CEFIC News, issue 21, April 2004
Less well defined than the genome and the transcriptome, as different communities use the term protein interaction to refer to anything from physical interaction to broadly defined functional interactions, such as neighbors in metabolic networks. Even if restricted to physical interactions, it is important to discriminate between stable interactions and transient interactions. Lars J. Jensen, Peer Bork, Quality analysis and integration of large- scale molecular data sets. Drug Discovery Today: Targets, 3(2): 51-56.
This term can be found in CHI's
-Omes & -omics glossary
www.genomicglossaries.com/content/omes.asp
To view all glossaries, please visit www.genomicglossaries.com
A review which discusses the current status of proteomics research in two major market segments: proteomics for drug and biomarker discovery, and proteomics for drug development and manufacturing.
To view the complete article, as
well as previous articles, click here.
(http://www.healthtech.com/genomelink.asp)
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Information: www.chi-intelligentdrug.com
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