Process, Chemical, and Pesticide Safety: The Challenge of Environmental and Consumer Protection
New laws and regulations such as REACH as well as a growing sense of environmental awareness have led to an increased demand for expert assessment and appraisal of new and existing substances. In order to reconcile people’s need for safety, legal assurance, and economic efficiency, costly analytical investigations must be planned with care. By considering exposure and environmental scenarios and structure-activity relationships, the Fraunhofer Group for Life Sciences can establish the first outline data. The large variety of data pools to which the Group has access thanks to its networked structure is of particular benefit here. Besides the traditional test methods in compliance with GLP and in accredited laboratories (DIN EN ISO/IEC 17025), the Group can also perform complex environmental simulations such as fate studies and micro- and mesocosm studies for the assessment of plant protection products.
Using new powerful screening methods such as in vitro tissue models or high-throughput systems for toxicological in vitro tests, the Group is paving the way: more safety with fewer animal experiments. The Group’s fish cell lines, for example, offer a promising alternative to conventional fish tests. The debate about the potential risks to man and the environment resulting from nanotechnology is still ongoing. The Fraunhofer Group for Life Sciences utilizes all its expertise to achieve quick assessments.
A properly functioning water supply and disposal system is an essential requirement for any civilization. This covers the supply of clean drinking water and the hygienic disposal of wastewater. The result of DEUS 21, a research project in which the Group has played a pivotal role, provides an interesting model for efficient wastewater disposal – a decentralized solution without complex piping networks which can be adapted to local requirements. The on-line broadband sensor AquaBioTox means the Group is contributing to increasing the safety of drinking water.
Testing and assessment of chemicals, biocides, and drugs
Various EU directives require the thorough testing of chemicals and biocides, including substances that are already on the market. The European REACH policy (Registration, Evaluation and Authorisation of Chemicals), for instance, demands extensive investigations on industrial chemicals.
Consulting and support
The Fraunhofer Group for Life Sciences can advise you from the very beginning through to successful project completion, in all phases of chemical, biocide, and drug testing and assessment. Following a structured plan of the process, we proceed step by step towards the goal. In doing so, we utilize and link existing knowledge from a wide variety of data pools as a first important step towards filling data gaps. We have many years of experience in developing substance-specific strategies for generating valid data for uncovered endpoints. For this purpose, we resort to the evaluation of structure-activity relationships (QSAR), read-across, and chemical categories and analogy concepts. We use exposure scenarios to describe the ways in which there can be exposure to a substance; this enables us also to clarify whether exposure waiving – that is, the non-carrying out of certain studies due to the fact that there is no relevant exposure – can be applied. Environmental scenarios provide information about the behavior and fate of the chemical substance in the environment. All steps of this process are aimed at minimizing subsequent experimental studies.
The Fraunhofer Group for Life Sciences offers combined expertise in toxicology and ecotoxicology as well as laboratory testing capacity and has many years of experience in common methods for substance testing. Exposure to different groups of chemicals and their toxicological and ecotoxicological hazards are thus tested and evaluated by the Group in accordance with international guidelines. The tests are performed in compliance with GLP regulations or in accredited laboratories (DIN EN ISO/ IEC 17025). Expert reports and dossiers are prepared and a final risk assessment is compiled. Where the available data is insufficient, the Fraunhofer Group for Life Sciences develops testing strategies, scientifically supervises the tests, and performs the necessary analyses required for registration.
Innovative screening methods
Depending on the type of substance and the scope of testing, traditional methods are often too costly. The Fraunhofer Group for Life Sciences develops novel procedures that save time and costs, in particular in the fields of chemical risk assessment and substance property screening. Existing exposure models for human beings and the environment are enhanced and databases for structure-activity relationships created. In addition to the competencies offered in the areas of structure-activity relationships (SAR) and inhalation toxicology, the Fraunhofer Group for Life Sciences establishes, for example, in vitro test models. These allow basic toxicological data to be obtained without animal experiments. The three-dimensional in vitro tissue models possess many typical properties which are characteristic of the corresponding organ in the organism. Cell-biological and molecular-biological analyses of the toxicity of chemicals, for instance of cell toxicity, genotoxicity, and embryo toxicity, can be performed close to the real-life situation. A certified in vitro skin model allows the skin penetration by chemicals to be mimicked, and it can also be used for toxicity tests. Coupling 3D cellular spheroids with a capillary chip even allows high-throughput systems for toxicological in vitro tests.
Validated fingerprints obtained by gene expression analysis allow the potential for inducing chronic and in particular also carcinogenic effects to be reliably estimated.
Marine ecosystems – development of alternative methods for the testing and risk assessment of chemicals
The increasing introduction of pollutants into the environment by man represents a considerable hazard for marine habitats. The ever growing number of chemical compounds getting into the sensitive ocean ecosystem makes it necessary to obtain information about the potential toxic effects of substances on marine organisms.
Over recent years, in vitro toxicity tests in cultured fish cells have become increasingly important. Primary fish cells and permanent fish cell lines not only represent an excellent alternative to traditional tests in fish (in-vivo fish assay according to the German standard DIN 38412) in aquatic (eco-)toxicology, but furthermore offer the possibility to investigate the mechanisms of toxicity of chemical compounds. The Fraunhofer Group for Life Sciences has already established several fish cell lines and has gathered expertise in this domain. Fish cell cultures possess great self-renewal ability and are therefore highly suitable for use in in-vitro toxicity tests, in particular for investigating toxic substances which accumulate in the marine food chain. Compared to corresponding long-term cultures of human and murine cell lines, fish cell lines exhibited higher sensitivity to environmentally relevant toxic substances that are introduced into waters.
For further information about the testing and risk assessment of chemicals under the European chemicals policy REACH, please refer to the “REACH Consultancy and Support” brochure of the Fraunhofer Group for Life Sciences.
Authorization of plant protection products
Plant protection products are necessary for economically sustainable agriculture. However, their active ingredients interact with the environment. In order to maintain the ecological balance and to protect human health, it has to be ensured that any effects on ecosystems are only of a minor and temporary kind.
Minimization of uncertainties in the assessment
The Fraunhofer Group for Life Sciences tests and assesses plant protection products according to national and international regulations on plant protection. Besides standardized testing procedures to determine intrinsic substance properties, the Fraunhofer scientists also use complex environmental simulations. The experimental focuses include studies on behavior and fate in the environment (e.g. in lysimeters), micro- and mesocosm studies, fish full life cycle studies, and species sensitivity distributions. The scope of services is complemented by exposure and effect modeling, expert reports, and consulting. The Fraunhofer Group for Life Sciences identifies and quantifies risks and minimizes assessment uncertainties (higher tier risk assessment). By integrating these methods early in the product development process, unnecessary development costs can be avoided. The Group also looks upon itself as a scientific intermediary between industry and authorities.
Authorization of a plant protection product requires not only information about the active ingredient, but also data on degradation and reaction products (metabolites). Studies to this end are performed in relevant plants and in productive livestock; the residue analyses also have to include processing studies so as to get insight into the impact of treatment and processing on the crop or foodstuff. In addition, it has to be elucidated whether the active ingredient remaining in the soil will be absorbed and metabolized by or accumulate in subsequent crops.
A major challenge in such studies on the metabolism of plant protection products in soils, plants, and productive livestock is the elucidation of the chemical structure of the degradation products. For this purpose, the Fraunhofer Group for Life Sciences has at its disposal state-of-the-art analytical equipment including high-resolution MS and LC-NMR. Metabolism studies can be performed in open-land facilities, greenhouses, or climate chambers. The spectrum of plants that can be used ranges from field farming plants that are common in central Europe via vegetable and fruit cultures through to cultures of subtropical agricultural crops such as peanuts, cotton, and rice. Depending on the precise issue to be investigated, different soils can be used; the Group always has access to reference soils accepted by the authorities.
In the area of animal metabolism, studies on the metabolism of lifestock and fish can be performed. Alternative concepts for fish studies based on in vitro tests and modeling approaches are under development.
All studies can be performed with 14C-labeled materials and in compliance with GLP guidelines. Many years of experience enable us to customize the test systems to our clients’ specific requirements.
Risk assessment of new technologies
Anybody wanting to efficiently and sustainably use next-generation technologies such as nanotechnology is required to actively look into the potential consequences and carry out risk assessment of these technologies in good time.
The wide spectrum of possible applications in medicine, environmental protection, packaging technology, production engineering, and the economic potential make nanotechnology a truly compelling field of research and motivate mankind to exploit the benefits. Past experience, however, has shown that technological innovation may also involve risks. According to the precautionary principle, therefore, special research effort in the area of hazard assessment and safety evaluation is imperative. Many questions still remain unanswered, for example, what happens to nanoparticles when they enter the human body or the environment?
The special properties and high reactivity of nanomaterials are due to their small size. Indeed, this is the reason why existing methods for hazard and exposure assessment need to be modified in order to account for nano-specific aspects.
The institutes of the Fraunhofer Group for Life Sciences are researching a wide range of aspects of nanotechnology, for example new applications in medicine and novel methods for pollutant degradation to protect the environment. Another focus within the Fraunhofer Group for Life Sciences is sustainability, which aims foremost to ensure an appropriate balance between the preservation and use of resources. This is why Fraunhofer researchers are also intensively studying the potential hazards of nanotechnology and are pioneers in a novel scientific discipline – nanotoxicology. They are developing methods to show to what extent and under which conditions nanomaterials may have toxicological significance. They are conducting studies to find out whether nanomaterials have an impact on natural habitats such as water and soil, how they behave in biological systems such as cells, organs, and organisms, and to what extent nanoparticles in packaging materials may be released and migrate into the packaged goods. In addition, potential emissions of nanoparticles during the processing of nanoparticle-containing composites as well as the effect of nanoparticle additives in products are being investigated.
A high degree of safety in the field of nanotechnology can be achieved by developing preventive recommendations. In this regard, the Fraunhofer scientists are acting according to the precautionary principle – for the sake of man and the environment.
For further information about nanotechnology research in the Fraunhofer Group for Life Sciences, please refer to our brochure entitled “Nanotechnology Research for Man and the Environment”.
In Europe, the development of a properly functioning wastewater disposal system allowed the great epidemics to be overcome. And even though the human right to have access to safe drinking water has not been legally stipulated, the international debate has made clear the essential role of water as a comestible product. The researchers in the Fraunhofer Group for Life Sciences are contributing to ensuring that this basic need can be met in a safe, humane, and environmentally compatible manner even during times of increasing demand.
Wastewater disposal to protect man and the environment
Besides containing inorganic and organic contaminants, wastewater also contains pathogens which, if inadequately treated, will be spread via the material cycles and may lead to outbreaks of disease. In industrialized countries, high-tech solutions are available in many domains and these are mostly implemented in centralized systems and treatment plants. The quality standards are very high, but operation and maintenance of these systems also involves considerable costs, which are passed on to the users and hence society. An enormous cost factor is the highly branched network of pipes. Their maintenance costs a fortune, and substantial effort is required to ensure contaminants do not get into the drinking water supply network and to prevent contamination of the environment by wastewater. However, despite the large effort that is required, maintenance and repair are normally well managed.
If, however, an unforeseen incident occurs within such centrally organized and complex structures, the consequences could be beyond control, in particular in large and growing cities. In decentralized supply and disposal systems, failures and disturbances can be localized faster, and unwanted or detrimental impacts can be limited by appropriate measures.
Decentralized systems are manageable, and with the common control systems that are nowadays in use they can be operated by significantly less staff than would have been possible only a few years ago. The research project DEUS 21, which is funded by the German Federal Ministry of Education and Research, initiated and coordinated by the Fraunhofer ITEM, and performed in collaboration with partners from industry, has shown that decentralized systems, when customized to the specific requirements of a particular location, can treat wastewaters very efficiently and safely in small quantities (Scheme 2).
Monitoring of water infrastructure systems
In Germany, sewage treatment plants as well as drinking water purification plants are subject to routine monitoring to ensure that they comply with the legal requirements for consumer protection. Drinking water is regarded as a comestible product and thus requires particularly careful monitoring. This is currently achieved by routine sampling and comprehensive chemical and microbiological analyses of the drinking water samples. German drinking water suppliers have to satisfy the high quality standards of the national Drinking Water Ordinance (2001, 2006).
The methods used for routine examination of in particular the piping network are in most cases rather time-consuming. Measurement methods which indicate unforeseeable incidents such as accidental or deliberate contamination that poses a threat to the water supply networks are vital so that immediate action can be taken to avert danger.
In the Fraunhofer Group for Life Sciences, Fraunhofer experts in information and data management are working with users and manufacturers of measurement devices for water body monitoring to develop sensors suitable for on-line monitoring. The higher safety standard thus achieved allows drinking water suppliers to respond quickly in the event of contamination of the drinking water. The AquaBioTox project, funded by the German Federal Ministry of Education and Research, has its focus on a broadband sensor. As the core element of this system, it combines microbiological and mammalian cell systems with a daphnia toximeter and with physico-chemical measurement parameters and reports any incidents or malfunctions to a decision-maker, who can then promptly initiate appropriate actions.