Safer products & safer working environments – May, 31st from 15:15-16:45

This session will address the area of both safe-by-design principles when developing new products (such as consumer products, chemicals, medicines) and safety in the working place. Elements that will be discussed are why safer products should be developed and how it can be done taking safety aspects into consideration at the drawing table. Also, it will be discussed how early safety screening data can be used to aid in the design of safer products. For existing products with may possess certain safety issues, this session will discuss how the working environment can be improved to reduce health risks arising from those. Speakers in this session come from various backgrounds which will give a broad perspective on the issue. For more detail the reader is referred to the speaker abstracts: Dr. Dinant Kroese (TNO), Dr. Margriet Park (RIVM), Dr. Josje Arts (AkzoNobel), and Dr. Freddy van Goethem (Johnson and Jonhson Belgium)

Dr. Dinant Kroese, TNO

Safe sustainable products: what can a toxicologist contribute?

Increasing use of biobased materials and reuse of materials are important for a sustainable planet, but human and environmental safety should be ensured. The involvement of a toxicologist in the product design stage as well as in the waste treatment stage can be of added value in order to advise on product safety issues based on which it can be decided which application fits from both sustainability as safety perspective. In this presentation, some illustrative examples will be given of the (added) value of a toxicologist in this field as well as which innovative tools can be used in this respect and what areas need more attention for further research (dealing with mixture effects, unknowns, and variations between batches).

CV Dr. Dinant Kroese

Dinant Kroese (PhD, ERT) is senior scientist at TNO, with well over 20 years of experience in toxicological risk assessment (Existing and New substances, participation in EC and OECD working groups on e.g. GHS, TGD for Testing Strategies, in EU Specialized Experts Group on C&L, Guidance development for REACH (RIPs), member of NVT board (1999-2005), Registration Board (since 2014), and more recently engaged in (inter)national research projects on innovative hazard prediction tools (various CEFIC LRI projects, OSIRIS (EU-FP6), ChemScreen (EU-FP7), EU-ToxRisk (H2020), and most recently ReSolve (EU-BBI) for finding substitutes to toluene and NMP.

Dr. Margriet Park, RIVM

Considerations for Safe Innovation: The Case of Graphene

Over the last decade, a lot of knowledge has been generated on the potential human and environmental health risks of nanotechnology-based materials and products. This knowledge can now be implemented in ‘ Safe innovation’ and ‘Safe(r)-by-design’ approaches, i.e. considering safety aspects already at an early stage of the innovation process of (nano)materials and nano-enabled products.
This will be demonstrated by presenting the possibilities of considering safety aspects during various stages of the innovation process of graphene, outlining what information is already available for assessing potential hazard, exposure and risks. Suggestions on how potential nano-specific safety issues can be addressed, by who and at what stage of the innovation process will be given to promote the safe production and safe use of graphene.

CV Dr. Margriet Park

Dr. Margriet Park has been working on safety of nanomaterials at the National Institute for Public Health and the Environment (RIVM) for over 10 years. She has a background in risk assessment and focuses her work on facilitating the safety assessment of nanomaterials and nanomedicine. She has participated in various EU and national projects related to the risk assessment of nanomaterials and recently was WP co-leader in the EU funded GUIDEnano project, where she was responsible for developing the human hazard assessment approach in the web-based guidance tool for risk assessment & mitigation of nanomaterials and nano-enabled products. She has published various articles on safety assessment strategies, doses metrics and testing methods for nanomaterials and nanomedicine.
Currently, she leads the regulatory WP in the EU funded nTRACK project, which is developing a nanotechnology based imaging material intended for monitoring advanced cell therapies. She is also supervising the design of an immunotoxicity testing strategy for nanomedicinal products. Moreover, she is contributing to education on Safe(r)-by-Design approaches for innovation processes involving nanotechnology, implementing RIVM’s knowledge on risks of nanomaterials and nanomedicine.

Dr. Josje Arts, AkzoNobel

Safer products & safer working environment: AkzoNobel’s priority substances program

In 2011 we started our Priority Substance Program; all chemicals used and produced within AkzoNobel were scored on human and environmental health effects. Public concern was also taken into account. Chemicals with a predefined score or higher were taken up in the program. These chemicals were risk assessed according to the REACH methodology and the outcome would either be ‘prohibited’ or ‘restricted’. For prohibited chemicals a phase out date is set and alternatives sought; for restricted chemicals, only safe uses are permitted (incl strictly controlled conditions). In parallel, we started working with the Occupational Hygiene Risk Management (OHRM) tool, a method used to address safer working conditions at our production sites, especially in NL due to strict requirements of the 4-step procedure by Dutch law (Inspectorate SZW). Both tools will be discussed and presented.

CV Dr. Josje Arts

Josje Arts studied Human Nutrition (with Toxicology as main subject) at the Wageningen University. After graduation in 1986, she started working as Inhalation Toxicologist at TNO (now Triskelion) in Zeist; in this period she also worked on her PhD thesis on respiratory allergy (Utrecht University 2001). Since 2008 she is working at AkzoNobel as Toxicologist and PSRA manager.

Dr. Freddy van Goethem, Mechanistic & Investigative Toxicology, Janssen R&D, Beerse, Belgium.

"The integration of High Dimensional Data into Early Safety Screening.

Within predictive toxicology and early safety screening, there is a current need to better understand the underlying mechanisms of in vitro positive toxicity screening results. This paradigm-shift to a more mechanistically-based hazard identification/classification relies heavily on the development and use of innovative technologies, hereby employing human in vitro cell cultures and translational biomarkers. To allow the identification of early hazard, prioritize chemical series and steering chemical design, safety assessment should ideally be integrated into the early phases of the discovery process. To exemplify this strategic objective, we previously demonstrated the integration of high-dimensional transcriptomics and high content image analysis in a proof-of-concept approach for early safety (genotoxicity) screening. This data integration approach showed the potential to flag toxicity issues by utilizing data from exploratory experiments that are typically generated for target evaluation purposes during early drug discovery. Besides the use of gene expression-based signatures, next-generation screening test platforms can be applied to translate and classify in vitro micronucleus results (Tier-1 hazard flags) into a more mode of action-based analysis. It is known that indirect DNA damaging compounds (e.g. spindle poisons, kinase inhibitors) typically induce non-linear dose-responses, which allow the use of a threshold concept and thus a better risk assessment.

CV Dr. Freddy van Goethem

Freddy van Goethem studied biology and obtained a PhD in 1995 at the Free University of Brussels (VUB). Following this, he was a post-doc at the VUB for 1 year where he identified and validated new sensitive biomarkers for the biomonitoring of workers exposed to potential mutagens/carcinogens. In 1996 he joined Janssen Pharmaceutica (Johnson & Johnson Pharmaceutical R&D) in Beerse (Belgium) where he has taken up positions with increasing responsibilities. Currently, he holds a position as scientific director at the Mechanistic & Investigative Toxicology department and is responsible for the Early Safety Screening Strategy to optimize the selection & prioritization of safe NME candidates.