ECHA

Assessing the hazards and risks of chemicals is complex. Chemical assessments may be hampered by data gaps, which can sometimes result in lengthy discussions and controversies about how hazardous a substance really is. We spoke with Dr Marlene Ågerstrand, from the Department of Environmental Science and Analytical Chemistry (ACES) at Stockholm University to ask how academic research could be used to ensure that chemicals policy is based on all reliable and relevant information.

Marlene Ågerstrand. Image: Thomas Ärlemo.

Which factors determine whether research is used for regulatory purposes?

In the EU, producers and importers of chemicals are responsible for providing data on human health and environmental hazards. According to legislation, new (eco)toxicity studies should be performed according to good laboratory practice (GLP) and validated test guidelines, such as those adopted by the Organisation for Economic Cooperation and Development (OECD).

Industry can also – or under some legislation is obliged to – include peer-reviewed studies in the information package submitted for assessing a chemical’s hazards.

The EU chemicals legislation specifies that all available data of sufficient reliability and relevance – including peer-reviewed studies – should be used. But before they are, their design, performance and analysis have to be evaluated to make sure that they are trustworthy.

“Reliability deals with the inherent quality of the study and addresses issues such as whether appropriate controls are performed and if tested concentrations have been verified. Relevance looks at how appropriate a study is for a particular assessment and whether tested endpoints and life stages are suitable to assess the hazards or risks of a substance,” Dr Ågerstrand explains.

Some researchers perform studies only with a view of the scientific community, while others also think about regulatory decision making when doing research. “In any case, it is up to the risk assessor to decide whether a study can be used in a regulatory setting. Whether it is performed by academia or by industry is not a criterion that should affect the evaluation,” she adds.

Promoting peer-reviewed studies for regulatory use

Peer-reviewed studies are sometimes excluded from regulatory processes because they lack crucial information on the test organism, test substance or test design. As such, it is important for risk assessors to differentiate between poorly-reported studies and those that have low reliability.

“A poorly-reported study could still be useful for regulatory purposes as long as the missing information can be made available on request. It is also important for researchers to publish open access studies, to make raw data available and to answer information requests from regulators,” Dr Ågerstrand tells.

Test guidelines and good laboratory practice

Regulatory agencies try to ensure that the (eco)toxicity studies they use are credible and useful, and that they follow test guidelines and GLP. However, Dr Ågerstrand maintains that studies that follow these principles are not always the best choice.

“It is a problem to assume that studies performed according to test guidelines and GLP are always better. These standard studies are limited in number, and they do not always address the most relevant or most sensitive endpoints, test species or life stages. For instance, there is a lack of test guidelines that sufficiently deal with endocrine disruption or nanomaterials,” Dr Ågerstrand tells.

“Another important aspect to consider is that studies performed according to test guidelines and GLP are often produced by parties that also have an economic interest in showing low toxicity. Therefore, to ensure the credibility of the system, it is important to combine the use of both industry studies and peer-reviewed research studies in the regulatory process, if they are judged to be of sufficient reliability and relevance,” she adds.

Increasing researchers' own regulatory awareness

To contribute to decision making, it is important for researchers to learn how regulatory systems work. Researchers could interact more with authorities by commenting and submitting their studies to public consultations, creating a dialogue with relevant stakeholders, and writing scientific reports for policy makers.

“This requires an in-depth knowledge of relevant legislation, guidance documents and decision-making procedures, as well as being able to understand and evaluate the content and conclusions of regulatory assessments,” Dr Ågerstrand suggests.

“There should also be an onus on researchers to train the next generations so that future academics are in a better place to be able to understand regulatory processes,” she encourages.

Increasing the usefulness of data

While researchers can improve their own knowledge on regulatory matters, one key action that could boost the use of their studies for regulatory assessment is thorough reporting of their findings.

“Studies need to be transparently reported so that regulators can easily assess how appropriate they are for regulatory assessment. This means that all the parameters that are normally reported in test guideline studies need to be available, including details on validity criteria, controls, which compounds and organisms have been tested, what the exposure conditions are, dose-response relationships and how the study is statistically designed,” Dr Ågerstrand highlights.

Researchers could help regulators by comparing new study results with the current regulatory assessment, explaining why it does or does not support the conclusions and clarifying the significance of new research results. “Researchers can also ensure that their peer-reviewed studies are easy to find by giving them informative titles and abstracts, and by making them publicly accessible,” she adds.

Where regulatory agencies can play a bigger role

Regulatory agencies and bodies are the gatekeepers of research studies and key disseminators of information, which is why Dr Ågerstrand calls on regulators to make more effort to reach out to academia and to encourage industry to start using all available studies.

“I would like to see more forums where regulators and academics can meet to discuss different scientific questions that are relevant for chemicals legislation. This would help to deepen the understanding between the regulatory authorities and academia and to create an environment that is naturally more collaborative,” Dr Ågerstrand says.

Encouraging participation in public consultations

To increase the amount of comments provided during public consultations, Dr Ågerstrand feels that agency procedures and guidance documents should explicitly encourage academia to take a more active part. To increase academic participation, two things are needed – awareness-raising campaigns and incentives for researchers.

“While it would require significant resources, direct contact with relevant researchers is always better than waiting for them to respond during public consultations. For the majority of academic researchers, time is limited and as long as external relations are not rewarded within the academic system, participation in agencies’ public consultations will continue to be low,” Dr Ågerstrand explains.

Technical solutions could also be utilised better. “It is possible for regulatory authorities to link their own databases to those that publish research results so that finding suitable research would become easier,” she adds.

Transparency is the key to success

To maintain a high level of credibility, it is important for authorities to be transparent in how they conduct themselves throughout regulatory processes and to promote a full understanding of the steps undertaken when assessing the hazards and risks of a chemical.

“Risk assessments performed by industry, Member States and expert committees should always be reported transparently – not only in terms of which data and methodologies are used, but also in terms of how data is valued and how any uncertainties are handled,” Dr Ågerstrand insists.

“The public should have full access to industry studies so that they can be evaluated externally and so the results can be trusted based on the scientific merits rather than the affiliations of those performing the studies,” she concludes.

Dr Ågerstrand is a researcher at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University. Her research concerns regulatory (eco)toxicology, with a focus on assessing and managing chemicals – including reliability and relevance of (eco)toxicity data, weight of evidence, systematic review, bias and uncertainty in risk assessment. The aim of her work is to improve the scientific basis and increase the transparency and predictability of hazard and risk assessments of chemicals.

She has developed reporting recommendations to help researchers perform studies that will enable risk assessors to fully evaluate their studies.

Department of Environmental Science and Analytical Chemistry (ACES)   Stockholm University's Department of Environmental Science and Analytical Chemistry (ACES) is a multidisciplinary department that gathers scientists from diverse fields in the natural sciences to study environmental phenomena and contribute to a sustainable society. In addition to its core responsibilities in teaching, research and outreach, the department is strongly engaged in supporting government agencies, such as the Swedish Environmental Protection Agency, the Swedish Chemicals Agency and the Swedish Agency for Marine and Water Management among others. The department's research spans across five major areas: chemical contaminants, atmospheric aerosols, biogeochemical cycles of carbon and nutrients, ecotoxicology, and analytical chemistry. ACES website

Further information:

Recommendations for toxicity and ecotoxicity studies

Science in Risk Assessment and Policy - Risk and hazard assessment of chemicals

Interview by Paul Trouth

Published on: 17 May 2018

Top image: IStock.com/Romolo Tavani

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