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4 results on '"Pelkonen O"'

1. Integration of epidemiological findings with mechanistic evidence in regulatory pesticide risk assessment: EFSA experiences.

Author

Pelkonen O, Bennekou SH, Crivellente F, Terron A, and Hernandez AF

Subjects
Adverse Outcome Pathways, Agrochemicals, Animals, Europe, Food Safety, Humans, United States, United States Environmental Protection Agency, Epidemiologic Studies, Pesticides toxicity, Risk Assessment
Abstract

Toxicological risk assessment of plant protection products (PPP) is currently carried out with the principal input from regulatory toxicology studies following OECD test guidelines, with little input from epidemiological data. An EFSA-commissioned systematic review of pesticide epidemiological studies (Ntzani et al. in Literature review on epidemiological studies linking exposure to pesticides and health effects. EFSA supporting publication 2013:EN-497, 2013) revealed statistically significant associations, among others, between pesticide exposures, and Parkinson's disease and childhood leukemia. Thereafter, EFSA launched a project with a mandate for the plant protection products and their residues (PPR) Panel to set the ground for the use of epidemiological data in the risk assessment of pesticides, as requested by Regulation (EC) 1107/2009. The project culminated with the publication of two EFSA's scientific opinions on the potential contribution of experimental investigations and epidemiological studies in PPP risk assessment and with the scientific conference held on 20 November 2017, in Parma, Italy. The application of modern methodologies in exposure assessment, toxicology and epidemiology would improve the pesticide risk assessment process and support a mechanistic shift for the integration of these three disciplines under a novel paradigm in risk assessment. The application of the adverse outcome pathway (AOP) conceptual framework to this approach would contribute to gain insight into the biological plausibility of a hazard identified in epidemiological or experimental studies and would inform an Integrated Approach to Testing and Assessment (IATA) within a regulatory context.

Published
2019
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2. Scientifically unfounded precaution drives European Commission's recommendations on EDC regulation, while defying common sense, well-established science and risk assessment principles.

Author

Dietrich DR, von Aulock S, Marquardt H, Blaauboer B, Dekant W, Kehrer J, Hengstler J, Collier A, Gori GB, Pelkonen O, Lang F, Nijkamp FP, Stemmer K, Li A, Savolainen K, Hayes AW, Gooderham N, Harvey A, and Barile FA

Subjects
Animals, Europe, Government Regulation, Humans, Risk Assessment, Endocrine Disruptors toxicity
Published
2013

3. Scientifically unfounded precaution drives European Commission's recommendations on EDC regulation, while defying common sense, well-established science and risk assessment principles.

Author

Dietrich DR, Aulock Sv, Marquardt H, Blaauboer B, Dekant W, Kehrer J, Hengstler J, Collier A, Gori GB, Pelkonen O, Lang F, Barile FA, Nijkamp FP, Stemmer K, Li A, Savolainen K, Hayes AW, Gooderham N, and Harvey A

Subjects
Animals, Ecotoxicology, Europe, Expert Testimony, Humans, Risk Assessment, Toxicology, Advisory Committees, Endocrine Disruptors standards, Endocrine Disruptors toxicity
Published
2013
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4. A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing.

Author

Basketter DA, Clewell H, Kimber I, Rossi A, Blaauboer B, Burrier R, Daneshian M, Eskes C, Goldberg A, Hasiwa N, Hoffmann S, Jaworska J, Knudsen TB, Landsiedel R, Leist M, Locke P, Maxwell G, McKim J, McVey EA, Ouédraogo G, Patlewicz G, Pelkonen O, Roggen E, Rovida C, Ruhdel I, Schwarz M, Schepky A, Schoeters G, Skinner N, Trentz K, Turner M, Vanparys P, Yager J, Zurlo J, and Hartung T

Subjects
Animal Experimentation legislation & jurisprudence, Animal Experimentation standards, Animal Testing Alternatives ethics, Animal Welfare legislation & jurisprudence, Animal Welfare standards, Europe, Legislation, Drug, Animal Testing Alternatives methods, Cosmetics adverse effects, Toxicity Tests ethics, Toxicity Tests methods
Abstract

Systemic toxicity testing forms the cornerstone for the safety evaluation of substances. Pressures to move from traditional animal models to novel technologies arise from various concerns, including: the need to evaluate large numbers of previously untested chemicals and new products (such as nanoparticles or cell therapies), the limited predictivity of traditional tests for human health effects, duration and costs of current approaches, and animal welfare considerations. The latter holds especially true in the context of the scheduled 2013 marketing ban on cosmetic ingredients tested for systemic toxicity. Based on a major analysis of the status of alternative methods (Adler et al., 2011) and its independent review (Hartung et al., 2011), the present report proposes a roadmap for how to overcome the acknowledged scientific gaps for the full replacement of systemic toxicity testing using animals. Five whitepapers were commissioned addressing toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, and reproductive toxicity testing. An expert workshop of 35 participants from Europe and the US discussed and refined these whitepapers, which were subsequently compiled to form the present report. By prioritizing the many options to move the field forward, the expert group hopes to advance regulatory science.

Published
2012
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