In India the import/manufacture and use of pesticides are regulated under a comprehensive legislation, called the Insecticides Act, 1968 which interaliaincludes the registration of pesticides only after satisfaction of their safety to humans, animals, and the environment. As a component of data requirements for registration, until end of 2010, applicants seeking registration had to undertake health monitoring study of spray operators and livestock as per the protocol approved by India's pesticide regulatory authority, the Central Insecticides Board and Regulatory Committee. However, taking into account the ethical consideration as well as the retrospective analysis of data, the regulatory authority concluded that these data do not aid the risk assessment and decided to discontinue the existing practice.  In 2013 the regulatory authority appointed a committee to investigate developing a suitable model approach for estimating/assessing the extent of potential risk of exposure to pesticide spray applicators under field conditions prevelant in India. The committee has evaluated various model approaches used around the world based on sound science. The committee is looking at a robust model approach based on validated/updated exposure data with conditions that are representative of India and have been used by other regulatory bodies around the world. Based on the committee's interaction with industry stakeholders since October 2013 and after reviewing different model approaches the committee is considering adoption of a PHED type database, with scientifically validated and updated underlying data sets for defined spray conditions, to develop reliable and robust model approach associated with numerical values that could be recommended for adoption by India's regulatory authorities.

Pesticide spray operator exposure risk assessment approach in India

248th National Meeting (2014)

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