Can Alternatives Inform the Risk Assessments of Mixtures in Food?
March 27, 2018
8:30 am-12:50 pm ET (GMT-4)
Wiley Auditorium, US FDA, College Park, Maryland
Chair: A. Wallace Hayes, University of South Florida College of Public Health, Tampa, FL, and Institute for Integrative Toxicology, Michigan State University, East Lansing, MI
Co-chair: Suzanne Compton Fitzpatrick, US FDA, College Park, MD
Registration for On-site Participation Deadline: March 19, 2018
Registration for Webcast
SOT and the US FDA Center for Food Safety and Applied Nutrition (CFSAN) cordially invite you to join us for our March colloquium, “Can Alternatives Inform the Risk Assessments of Mixtures in Food?” Current risk assessments of chemicals in food do not generally consider exposure to multiple substances but rely instead on the assessment of individual substances in individual food commodities. Humans however are routinely exposed simultaneously to numerous chemicals in food. These mixtures can be variable and constantly changing and defining them presents a challenge. Models could be used independently and in an integrated manner to assess health impacts. This symposium will examine whether new testing approaches such as in vitro, in silico models, and non-mammalian in vivo models could be used to assess the potential health impacts of exposure to chemical mixtures in food.
|8:30 AM–8:35 AM
||US FDA Welcome and Overview, Conrad J. Choiniere, Director, Office of Analytics and Outreach, CFSAN, US FDA, College Park, MD
|8:35 AM– 8:45 AM
||Welcome from SOT and Introductions, Suzanne Fitzpatrick, CFSAN, USFDA, College Park, MD
||Speaker Introductions, A. Wallace Hayes, Colloquium Chair, University of South Florida College of Public Health, Tampa, FL, and Institute for Integrative Toxicology, Michigan State University,East Lansing, MI
|8:45 AM– 8:50 AM
||Why a New Approach is Needed, A. Wallace Hayes, University of South Florida College of Public Health, Tampa, FL, and Institute for Integrative Toxicology, Michigan State University, East Lansing, MI
|8:50 AM– 9:30 AM
||Can High Thru-put Assays/Tox 21 Inform the Risk Assessment? Michael J. Devito, NTP, Research Triangle Park, NC
|9:30 AM– 10:10 AM
||Proposed In Silico Approach for Botanical Mixtures
Catherine Mahoney, Procter & Gamble Technical Centres Ltd, Surrey, UK
|10:30 AM–11:10 AM
||Non-Mammalian In Vivo Models: C. elegans as a Model System to Inform Hazard Identification
Piper Reid Hunt, US FDA, Laurel, MD
|11:10 AM–11:50 AM
||Extrapolating New Approaches into a Tiered Approach to Mixtures Risk Assessment
Mike Dourson, Toxicology Excellence for Risk Assessment, Cincinnati, OH
|11:50 AM–12:50 PM
Moderator: A. Wallace Hayes
Successful workshop on developing the IPCHEM data platform to support the assessment of chemical mixtures
On 11 and 12 December 2017 a workshop was held at the EC Joint Research Centre (JRC) in Ispra, Italy, aiming to discuss the further development of the IPCHEM data platform (https://ipchem.jrc.ec.europa.eu) for supporting the assessment of chemical mixtures. A number of selected experts and the European Commission services (ECHA, EFSA, EEA, DG ENVI, DG RTD) as well as representatives form European research projects were invited and present at the meeting.
The European Commission is aiming to have one access point for all chemical occurrence data in Europe. The European authorities EFSA, EEA and ECHA are cooperating on this initiative by contributing relevant data. European projects as for example HBM4EU (https://www.hbm4eu.eu/) will organise their biomonitoring data in the IPCHEM platform.
Jacob van Klaveren from RIVM and Hilko van der Voet from Wageningen University & Research presented the EuroMix project and the EuroMix model platfom. It was seen as a complementary tool to the IPCHEM database. The EuroMix presentations were well received. JRC intends to implement web services to facilitate data access from the EuroMix toolbox, and to provide on their website a link to the EuroMix toolbox for performing mixture risk assessments.
With the IPCHEM platform we expect that data needed for mixture risk assessment will become available in a more coherent manner. It will include dietary and non-dietary chemical occurrence data as well as detailed properties of chemicals.
These developments will certainly boost the discussion on how to maintain the EuroMix tools after the project will end and how to continue to work on the EuroMix concept (risk assessment based on AOP data). It was also discussed how to link EuroMix better to HBM4EU data or how HBM4EU observation might prioritise our next case studies. We will start considering useful links and new case studies soon and plan to discuss these possibilities in the next EuroMix consortium meeting.
JRC will make an official communication of this workshop including the presentations given.
EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches (2017) is now available.
EuroMix was included in this Science for Policy report published by the Joint Research Centre (JRC), the European Commission’s science and knowledge service. It aims to provide evidence-based scientific support to the European policy-making process and presents an update on the development, validation and regulatory acceptance of alternative methods to animal testing.
EuroMix contributed to EPAA Partners Forum: Finding synergies for 3Rs Toxicokinetics and read‐across
On November 21st 2017, partners in the European Partnership for Alternative Approaches to Animal Testing (EPPA) met in Brussels to build synergies on the development and acceptance of Toxicokinetics (TK) and read‐across. The EPAA Partners Forum brought together 33 expert participants from industry and European Commission (EC), along with selected representatives from regulatory agencies and invited researchers from two EU‐funded H2020 research projects (EuroMix and EUToxRisk). Dr. Vikas Kumar from University of Rovira I Virgili (Spain) represented the EuroMix project in this meeting. Dr. Kumar presented “Toxicokinetics and read across in EuroMix” and discussed how research in EuroMix is helpful for the wider stakeholders and why collaboration is necessary for the society. This EPAA Partners Forum was part of EPAA activities to address one of 6 challenges as a priority i.e. to improve intra and inter sectorial collaboration and coordination. EPAA is a relevant platform to build synergies across sectors, given its multi‐sectoral structure encompassing different business sectors. Besides exchanging information between sectors about their respective research agendas and activities in the sectorial flagship initiatives, the event was meant as an opportunity for the partners to identify possibilities for synergies, receive feedback and present scientific input relevant for EPAA. Discussions revolved around four balanced sessions aiming at covering the whole spectrum of stakeholders working on Toxicokinetics (TK) and read‐across i.e. regulators, the regulated, method developers and downstream users.
At the end of the day, a scientific consensus was achieved on the following four items:
- TK data play an important role in risk assessment across all industry sectors and are subject to significant research effort by all relevant stakeholders
- TK data strengthen the read across weight of evidence; TK data should ideally be anchored towards human relevance, preferably generated using in silico and in vitro tools
- Identification and characterization of Metabolism is a key component of TK assessment in read-across
- The forum expressed confidence that significantly more progress in TK can be made if collaboration between sectors is enhanced and synergies are captured.
The participants’ discussion was captured by a scientific writer and a scientific publication is currently under preparation.
SEAFAST International Seminar “Current and Emerging Issues of Food Safety : Innovation Challenges” held on November 20 – 21, 2017 in Bogor – Indonesia.
Work in EuroMix WP3 presented both as poster and oral presentation with the title: “Analysis of Head Skeletal Malformation in Zebrafish Embryos for Chemical Mixture Assessment: Case for Mixture between Azole Compounds and TCDD“.
The poster was awarded as the best poster presentation of the seminar.
EuroMix activities were presented at the International Society of Exposure Science (ISES) 2017 Annual Meeting in Raleigh, North Carolina, USA, October 15-17 2017
Three members of the EuroMix consortium presented recent advancements in the PBPK modelling approaches and model integration within the EuroMix project during a distinct EuroMix session on „The Role of PBPK Modelling in Holistic Exposure and Risk Assessment – Case Studies and Developments within the EU Project EuroMix” at the world’s largest exposure conference. The session was led by Cecile Karrer and Dr Natalie von Goetz from ETH Zurich. A talk given by Cecile Karrer (ETH Zurich, Switzerland) initiated the session on a new PBPK model for the bisphenol A substitutes BPF and BPS, this was followed by Paul Quindroit (Ineris, France) who presented a new PBPK model for pyrethroids and finally Waldo de Boer (Biometris, The Netherlands) presented and discussed the new features of the integrated model environment for the web-based EuroMix toolbox.
For more information on the presentations listed below, please access the abstract book here.
TU-SY-E2-284: “PBPK Modelling of Bisphenol S and Bisphenol F” – Karrer, C.
TU-SY-E2-285: “Development of a toxicokinetic modeling approach to estimate the cumulative exposure to pyrethroids” – Quindroit, P.
TU-SY-E2-286: “A web-based toolbox linking kinetic models to risk assessment” – de Boer, W.
EuroMix efforts on international harmonisation on cumulative risk assessment were presented in a lecture by Angelo Moretto, form University of Milan, partner of EuroMix, at the “ECPA Residues Workshop 2017, The current and future challenges”, held in Brussels, 16-17 October 2017. The title of the presentation was ““Looking at harmonisation opportunities – the Euromix project and JMPR considerations” and it was well received by the about 80 attendants from different parts of the world and different sectors (food industry, pesticide producers, regulatory, farmers’ associations) and discussion continued after the session ended. There appears to be a lot of interest in any effort towards harmonization and consistency of approaches to risk assessment of pesticides.
Recruitment goals achieved!
We are happy to announce that the EuroMix human cohort (WP7) has reached the projected number of participants. In total 145 persons (99 women and 46 men, aged 23-70) were recruited among employees at the Norwegian Institute of Public Health (NIPH) and their family and friends, as well as students and employees at universities, hospitals and health institutions in the region of Oslo, Norway. Participation included self-monitoring of foods and cosmetic use for 24 hours, and in parallel the collection of 24 hours urine. Skin wipes and blood samples were taken at the end of the 24-hour study period.
Dissemination activities in order to recruit volunteers
The EuroMix human cohort has been presented at internal meetings at NIPH and communicated through e-mails, the intranet (three headline-stories), and trough posters and stands during a research event on 16th of June 2017. Externally, two targeted Facebook campaigns were initiated (June + August), and several institutions were asked to shared information about the human cohort on their intranet.
Photo: NIPH employees visiting the EuroMix human cohort stand during a research event on 16th of June 2017
The 45th European Teratology Society Meeting was held in Budapest, Hungary on September 4-7, 2017. Elena Menegola and the team at the Univeristy of Milan were awarded during the meeting with „The Teddy Edward’s memorial Prize for Research into Congenital Malformation“ for their work in EuroMix work package 3 on the effects of teratogens on crania-facial morphogenesis.
The ETS (European Teratology Society) was created in 1971 and are dedicated to the prevention of adverse effects on reproduction and development. The core objectives of the European Teratology Society are to stimulate interest in, and promote the exchange of ideas and information about, the causes and prevention of adverse effects on reproduction and development allowing the exchange of knowledge among experts from academia, regulative agencies and industries.
The Teddy Edwards Prize for Research into Congenital Malformations is an award to the poster or free communication, which best exemplifies the aims of the Society. It’s the main appreciation award assigned directly from the ETS committee.