Expert opinions on the acceptance of alternative methods in food safety evaluations: Formulating recommendations to increase acceptance of non-animal methods for kinetics

Abstract

Inclusion of alternative methods that replace, reduce, or refine (3R) animal testing within regulatory safety evaluations of chemicals generally faces many hurdles. The goal of the current work is to i) collect responses from key stakeholders involved in food safety evaluations on what they consider the most relevant factors that influence the acceptance and use of 3R methods and to ii) use these responses to formulate activities needed to increase the acceptance and use of 3R methods, particularly for kinetics. The stakeholders were contacted by e-mail for their opinions, asking the respondents to write down three barriers and/or drivers and scoring these by distributing 5 points over the three factors. The main barriers that obtained the highest aggregated scores were i) uncertain predictability 3R methods/lack of validation, ii) insufficient guidance regulators/industry and iii) insufficient harmonization of legislation. The major driver identified was the possibility of 3R methods to provide more mechanistic information. Based on the results, recommendations are given to enhance the acceptance and application of 3R toxicokinetic methods in food safety evaluations. These include steering of regulatory data requirements as well as creating (funding) opportunities for development and validation of alternative methods for kinetics and development of guidances.

The Multi-Level Perspective in Research on Sustainability Transitions in Agriculture and Food Systems: A Systematic Review

“…Hassink et al [88] Care farming The Netherlands Ingram [84] Permaculture UK (England) Järnberg et al [94] Agricultural development Ethiopia Nygaard and Bolwig [95] Jatropha biofuel Ghana Punt et al [96] Animal testing in safety evaluations Multi-country/Europe To et al [71] Waste from sugar processing (bagasse) Mauritius Zwartkruis et al [97] Agricultural nature conservation The Netherlands…”

Next generation physiologically based kinetic (NG-PBK) models in support of regulatory decision making

“…2b), although such an increase was not seen for toxicology and veterinary medicine. Many risk assessors remain reluctant to apply these models within their work [43], [49], [50], as PBK models are not often included in current hazard characterization and risk assessment protocols. In addition, some regulatory agencies may often have limited experience in using PBK models, and the complexity associated with the evaluation of model performance has also contributed to this reluctance.

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Barreiras e facilitadores à inovação tecnológica: técnicas de laboratório sem o uso de animais em pesquisa

“…O que se sabe ao certo é que, para alguns métodos alternativos, mesmo aqueles que apresentem resultados confiáveis, a lei ainda exige que os resultados sejam confirmados com novos ensaios feitos em animais (Myers et al, 2017). As exigências da lei, a baixa propensão das pessoas para aceitarem riscos e as incertezas dos métodos alternativos, talvez sejam as causas pelas quais a barreira de validação apareça no segmento público, como um dos obstáculos de maior peso, assim como apontaram Punt et al (2018) e Schiffelers et al…”

“…Ainda assim, os financiamentos governamentais também são de suma importância para o crescimento do número de empresas que utilizam de métodos alternativos. Punt et al (2018), ao comparar barreiras e facilitadores à adoção de métodos alternativos na indústria alimentícia, recomendou que os governos da Europa deveriam melhorar os mecanismos de financiamento para validação e aceitação de métodos alternativos.…”

“…A segunda maior barreira para o subgrupo de entrevistados do segmento privado foi o fator "menos incentivos governamentais e financiamentos". Para o segmento privado a carência de linhas de financiamento e de incentivo que facilitem o desenvolvimento de métodos alternativos e viabilizem os processos de validação (Punt et al, 2018) tornam essa barreira muito relevante.…”