BASAI STATEMENT

BIOCHEMICAL SAFETY & ANIMAL WELFARE UNDER
GOOD LABORATORY PRACTICE ( GLP )

ON

EXISTING AND FORTHCOMING TOXICOLOGICAL SAFETY EVALUATION APPROACHES
IN
HARMONIZATION WITH OECD GUIDELINES UNDER GLP SCHEME

AND
ADHERENCE TO MUTUAL ACCEPTANCE OF DATA ( MAD )

Date of Issue: 14 July 2019

The importance of science in decision-making with respect to the safety of agrochemicals biological in nature is becoming more evident by the day than ever before. Acquiring scientifically valid information is crucial to risk assessment, risk management, and risk mitigation. Unfortunately improving the knowledge base on agrochemicals of biological nature is often linked to an increase in the number of animals used for toxicity testing.

There is a growing interest in moving away from extensive in vivo testing to intelligent testing strategies or tiered approaches where existing knowledge from alternative approaches (e.g., structure activity relationships, in silico and in vitro data, relevant in vivo data from existing studies of related substances). These are combined with estimates of exposure to determine what specific additional testing, if any, is appropriate to characterize potential risks with an adequate degree of scientific certainty.

OECD has provided an excellent forum for member countries and industry to join forces, share the work of chemicals evaluation, harmonize national regulatory requirements including test guidelines and thus eliminate unnecessary or duplicative testing and assessment, thereby reducing and refining the use of animals. OECD’s

mission to identify and fill gaps in our understanding about the safe use of agrochemicals biological in nature and to improve the methods available for assessing the associated and relevant risks, thereby enabling industry and regulators to make informed decisions based on high quality information.

This leads to improved efficiencies in animal welfare, testing, and chemical assessment, as well as, cost savings for both governments and industry.

BIOLOGICAL AGRI SOLUTIONS ASSOCIATION OF INDIA (BASAI), supports public concern for animal welfare in research and in the safety assessment of agrochemicals biological in nature. However, industry also recognizes that some aspects of safety assessment still require data derived from animal studies. Nonetheless, industry – in partnership with major stakeholders such as OECD – is exploring realistic opportunities to adhere to the 3R Principles i.e. Reduce, Refine and Replace while using of animals for safety assessment. BASAI is committed to promote and support wherever feasible the development and use of scientifically robust and reliable alternative approaches to safety assessment that embrace the 3Rs, while ensuring human and environmental safety.