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.

BIOLOGICAL AGRI SOLUTIONS ASSOCIATION OF INDIA

  • Encourages the use of alternative approaches to animal testing when the scientific data generated by these alternatives are useful for risk assessment and is acceptable to Regulatory Authorities.
  • Link the validation and implementation of alternative methods to existing regulations, in order to agree on a common interpretation of results achieved with alternative methods.
  • Encourages further research to develop new testing paradigms, with a systematic transition to these new approaches once they are sufficiently validated.
  • Works to introduce & implement integrated (tiered) testing approaches that use results-based prioritization to focus testing on agrochemicals ( pesticides and chemicals ) of greatest concern to public health, thus reducing the total amount of testing and animal research necessary to protect public health and the environment.
  • Supports using available exposure and hazard data to prioritize substances for further evaluation, to efficiently use resources and reduces use of laboratory animals.
  • Supports integrating various government and industry agrochemicals biological in nature, evaluation initiatives, grouping chemicals with similar characteristics, reducing duplication of testing and, therefore, the total number of laboratory animals used.
  • Supports coordinated testing programs and mutual acceptance of data for agrochemicals (pesticides and chemicals) that minimize requirements for individual countries or industries to duplicate testing or require additional testing.
  • Encourages regulatory authorities and allied departments to work within the National & International, to ensure the acceptability of data from alternative approaches in the context of science- and risk-based decision-making on chemical safety.
  • Align National Regulatory Compliance to harmonize India’s obligations under the OECD-MAD

 

Therefore, BASAI encourages authorities to update their regulations and requirements to reflect and permit the use of new scientific approaches.

BIOLOGICAL AGRI SOLUTIONS ASSOCIATION OF INDIA supports the development of alternative safety evaluation methodologies, which in the future may replace traditional animal-based studies following scientific & regulatory validation.

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We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

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We offer full range of garage services to vehicle owners in Tucson. Our professionals know how to handle a wide range of car services. We can handle any problem on both foreign and domestic vehicles.

  • We make auto repair and maintenance more convenient for you
  • We are a friendly, helpful and professional group of people
  • Our professionals know how to handle a wide range of car services
  • We get the job done right — the first time
  • Same day service for most repairs and maintenance

We offer full range of garage services to vehicle owners in Tucson. Our professionals know how to handle a wide range of car services. We can handle any problem on both foreign and domestic vehicles.

  • We make auto repair and maintenance more convenient for you
  • We are a friendly, helpful and professional group of people
  • Our professionals know how to handle a wide range of car services
  • We get the job done right — the first time
  • Same day service for most repairs and maintenance
BASAI

Organic farming is beneficial to a wide range of organisms. It restores the biodiversity of the core resources and habitat of the region. The symbiosis between flora and fauna, animals, and humans with a chemical-free environment is paradise on Earth.

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Phone: +1 (2) 345 6789
Fax: +1 (2) 345 6789

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