The role of BfR in PARC

BfR is one of the main beneficiaries of PARC. It participates to the governance of the partnership through a National Hub and two management bodies: the Grant Signatory Board and the Management Board. The National Hub is a network of decision makers, research funders, stakeholders, and the research community, that provides input and ensures synergies and collaboration with other initiatives. Read here for more information on the structure and activities of the German PARC National Hub. The Grant Signatory Board and the Management Board manage, plan and decide on activities and projects within PARC.

BfR also participates to PARC activities by co-leading and participating to its work packages (WPs). The BfR Unit “Testing and Assessment Strategies Pesticides” co-leads PARC WP5 “Hazard Assessment”. The BfR Unit "Coordination and Overall Assessment" co-leads PARC Task 2.2 “Knowledge management and uptake into policy”, within WP2.

Thus, BfR is involved in transversal activities of the partnership as well as in scientific projects of the named WP. In total around 35 employees of BfR are involved in PARC.

BfR participation to PARC work packages

PARC Work package 2 – “A common science to policy agenda”

PARC provides a unique opportunity of bringing scientists, regulators, national and European agencies and policy makers together in one partnership, thus concretely facilitating the uptake of innovation into regulatory practice. The objective of work package 2, “A common science-policy agenda”, is to ensure adequate links are made between research activities and regulatory needs. It is composed of three tasks:

  • Task 2.1 “Priority setting” gathers regulatory information and research needs from policy-makers, stakeholders and experts. On this basis, (groups of) substances with data gaps and/or knowledge needs are identified; PARC projects and activities are evaluated with respect to their priority from a regulatory perspective; recommendations regarding their uptake into the PARC research programme are formulated. Task 2.1 also develops a rapid response mechanism to allow national and European policy-makers to submit requests for specific information to the PARC Consortium outside of the formal timeframes.
  • Task 2.2 “Knowledge management and uptake into policy” develops and manages two activities: PARCopedia (knowledge management) and PARCroute (uptake into policy). PARCopedia provides an online platform for facilitating knowledge sharing and interaction across the professional chemical risk assessment community. PARCroute aims to develop concrete proposals to translate scientific innovation in chemical risk assessments into policy, thereby enabling its uptake into regulatory practice. Task 2.2 also coordinates the appointment and management of the so-called Chemical/Methodology Leaders (CL/ML) who are responsible for keeping track of the work done on “their” chemicals/methods (both within and outside of PARC) and use this knowledge to support the respective PARC activities, e. g. by pointing at possible synergies.
  • Task 2.3 “Sustainability” coordinates the PARC National Hubs in order to collect their input regarding gaps in knowledge and expertise as well as suggestions for capacity building programmes. It is also tasked with developing a sustainability strategy to maintain the collaborations and interactions within the partnership sustainable in the long-term.

BfR coordinates Task 2.2 together with the Portuguese partner authority INSA (Instituto Nacional de Saúde Dr. Ricardo Jorge). It is mainly responsible for coordinating and developing PARCopedia and PARCroute, while INSA coordinates the CLs/MLs. BfR also participates in Task 2.1 and Task 2.3.

About PARCopedia

PARCopedia provides a knowledge platform and community space for all members of the professional chemical risk assessment community with their diverse backgrounds in chemical risk assessment (e.g., research, risk assessment, risk management, policy-making) both inside and outside of PARC.

Online from November 2023, PARCopedia users will have access to a wiki-like knowledge base related to all aspects of chemical risk assessment, with a specific focus on new testing and assessment methodologies. It will also inform about ongoing activities in this field, both within and outside of PARC.

PARCopedia will also offer a social media-like community space made of profiles, posts and discussion fora where users can interact with a lively community to present their work and expertise, exchange points of view and comment on what´s new in the field, thereby helping to shape the chemical risk assessment of tomorrow.

About PARCroute

The PARCroute develops strategic roadmaps set to promote the uptake of innovative risk assessment methodology developed in PARC (and elsewhere) into regulatory practice. The first roadmap proposal developed by PARCroute is “NGRAroute”, a roadmap towards implementing an animal-free “Next-Generation Risk Assessment” (NGRA) framework as the first line of risk assessment in all major European chemicals legislations.

BfR and work package 5 – “Hazard Assessment”

The overall goal of WP5 is to focus on hazard assessment of poorly characterized contaminants or new chemicals for human and environmental health while promoting the use of innovative methods. It has 3 specific objectives:

a) To fill in the missing information that has been identified as important by key stakeholders (Task 5.1).

b) To improve the current hazard characterization by creating comprehensive testing strategies. This will help to make new and advanced testing methods (known as New Approach Methodologies or NAMs) more accessible and useful in the process of evaluating risks (Task 5.2).

c) To contribute to a better understanding of how toxicity works on a mechanistic level by analysing all available data. This includes using systems toxicology approaches and considering pathways that lead to adverse outcomes (known as Adverse Outcome Pathways or AOPs). Additionally, there is an emphasis on improving modelling techniques, such as Physiologically-Based Pharmacokinetic (PBPK) modelling (Task 5.3).

Currently, scientific experts, post-docs, and PhDs from BfR are participating in the following projects of WP5 “Hazard Assessment”:

 Hazard identification and hazard characterization of the mycotoxins enniatins and Alternaria toxins in order to close data gaps and improve risk assessment for human health. – Co-led by BfR.

Natural toxins have no manufacturer or supplier that is responsible for providing hazard data.?Due to climate changes, the human exposure to natural toxins will likely increase, and regulatory agencies have asked for more hazard data to improve the hazard and risk assessment. This project will initially focus on two classes of emerging mycotoxins, i.e. enniatins and Alternaria toxins where there is a pressing regulatory need for more specific hazard data.?

Non-genotoxic carcinogens (NGTxCs) – Co-led by BfR.

There is a need to understand which substances can cause cancer so we can reduce both exposure and the risk of cancer. Some chemicals directly affect our DNA or disrupt the systems that protect our genes, which can lead to mutations and chromosome changes. On the other hand, there are substances that can cause cancer through different mechanisms without damaging our genes, called non-genotoxic carcinogens.

This project will use various models of organs and cells like the liver, breast, colon, and fat cells, using advanced human-relevant methods. It will also improve computer-based tools to identify non-genotoxic carcinogens, all to help creating a system for assessing these substances in cooperation with other work packages and tasks within PARC. This way, we can better understand and minimize the risk of cancer from different types of chemicals.

Metabolic Endocrine Disruption – Co-led by BfR.

Although metabolism-disrupting chemicals are suspected to contribute to global metabolic disorders, there are currently no specific tests, both in the lab and in living organisms, that can reliably detect their harmful effects.

This project plans to extensively study the effects of metabolism-disrupting chemicals on nuclear receptors using specialized cell lines. This will help to understand the different ways metabolism-disrupting chemicals can affect our bodies, known as Modes of Action (MoA), and create pathways to evaluate these effects, known as adverse outcome pathways (AOP). This approach also involves the development of advanced methods known as New Approach Methodologies (NAMs) that utilize both liver and non-liver cell systems, allowing for communication between different tissues. This will improve our ability to assess how metabolism-disrupting chemicals can lead to obesity and other metabolic issues. By combining human and non-human models and developing accurate NAMs, we will better understand and address the risks associated with metabolism-disrupting chemicals and their impact on metabolic health.

Endocrine disruptors – Thyroid hormone system disruption

The current methods used to identify chemicals that disrupt the thyroid hormone system are not sufficient for conducting thorough risk assessment as needed for regulation. We require new and improved methods, known as New Approach Methodologies (NAMs), to effectively detect the effects of thyroid hormone disruption. These NAMs will help to establish a clear link between initial molecular events and adverse outcomes, such as disruptions in brain development.

The main objective of this project is to bridge this gap by gaining a deeper understanding of thyroid hormone system disruptors at a mechanistic level. This understanding will enable the development of targeted NAMs to detect thyroid hormone system disruptors accurately. Additionally, this project aims to uncover differences between species in how thyroid hormone system disruptors affect the thyroid hormone system. To do this, we will conduct focused studies in live rodents, use computer-based assays (in silico), employ human-derived cell systems that are relevant to our biology, and perform experiments on zebrafish, which serve as a whole organism model.

BfR publications within PARC:

A walk in the PARC: developing and implementing 21st century chemical risk assessment in Europe

Metabolism-Disrupting Chemicals Affecting the Liver: Screening, Testing, and Molecular Pathway Identification

Innovative tools and methods for toxicity testing within PARC work package 5 on Hazard Assessment

Development of new approach methods for the identification and characterization of endocrine metabolic disruptors—a PARC project

New approach methods to improve human health risk assessment of thyroid hormone system disruption–a PARC project

New approach methodologies to facilitate and improve the hazard assessment of non-genotoxic carcinogens—a PARC project

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