Regulatory Streamlining & Harmonization of BioAg (Need Globally Local)

Day 2: Session 3: Regulatory Streamlining & Harmonization of BioAg-Need Globally Local was chaired by Nicolas Cock Duque, President at BioProtection Global and External Affairs Manager at Ecoflora (Integrated Biosolutions from Gowan).  

Wherein, Nicholas gave an overview of the global biopesticides regulatory scenario followed by Marco Rosso, Director (Global Corporate Affairs) Valagro overview of the biostimulant regulatory scenario globally. 

A panel discussion on the Global Regulatory insights from 5 continents, Chaired by Nicolas Cock Duque wherein the following panellists gave their regions overview: 

Julia Emanuela, Regulatory Affairs Specialist, Biologicals, CropLife Brazil 

Jennifer Lewis, Executive Director IBMA 

Keith Jones, Exceutive Director BPIA,USA 

Luca Bonini, CEO Hello-Nature and President EBIC 

Vipin Saini, CEO Biological Agri Solutions Association of India (BASAI); Associate Editor, Content Crop Care Division, Krishi Jagran and ABP-GBAL 

Vipin Saini, CEO-BASAI, spoke at length on the “Revolutionizing of BioAg Regulatory Affairs in India with a focus during 2019-20’20-2021”. He touched upon the draft Biological Data Storage, Access and Sharing Policy of India that was published in 2019 and gave an insight on this policy document. This document aims to develop a repository of all collated data generated in the country using modern biotechnological tools & methods. Further the document aims towards harmonization along with international policies, but also ensuring that the national policies supersede at the same time. The country looks towards establishing a National Biological Data Centre once the policy is approved. 

However, the biostimulants have been much in debate these past couple of years since 2017 and were finally notified in February 2021. He went at length to explain the regulations in some depth touching upon the critical data requirements with respect to chemistry, bioefficacy and toxicological parameters. 

Speaking on Biopesticides, he stated that biopesticides were first encourage in the early 1980’s involving priority registrations for 2 microbials i.e. Bacillus thuringiensis and b.sphaericus. The latter being reclassified as Lysinibacillus sphaericus. This was done about the same time the government of India started promoting the concept of Integrated Pest Management in the country. Therefore, the regulations involving biopesticides, both botanical & microbial are not new to India and is now on the path of harmonizing the same along with global best practices. Harmonization with respect to registration requirements and safety evaluation test protocols. India is an EU MAD (Mutual Acceptance Data) signatory. 

He also touched upon the the Guidelines for Evaluation of nano-based Agri-input and Food Products in India that were released in August 20’20. 

Though the main differentiation in the 1. Guidelines for Evaluation of nano-based Agri-input and Food Products in India, and 2. The Fertilizer (Inorganic, Organic or Mixed) (Control) Amendment Order, 2021 (i.e. notifying the Biostimulant regulatory compliance procedure is with respect to in the safety evaluation requirements apart from the nano and non-nano criteria. Wherein the latter adapts the “Office of Chemical Safety and Pollution Prevention (OCSPP - formerly OPPTS) Harmonized Test Guidelines” and the former follows the EU OECD guidance protocols in majority. 

Guidelines issued before April 22, 2010, refer to "OPPTS" because the office name changed from "Office of Prevention, Pesticides and Toxic Substances" and "OPPTS" to "Office of Chemical Safety and Pollution Prevention" and "OCSPP." This name change does not otherwise affect the Guidelines. 

Charles (Billy) Smith, acting Division Director, Biopesticides and Pollution Prevention Division, Office of Pesticides Programs of EPA gave a talk on the status and future of biopesticides and what would further drive adoption.