The Pesticides Management Bill 2020 (PMB) that was tabled in the Rajya Sabha during budget session is a great opportunity for the Government to include the experts’ recommendations of the National Academy of Agricultural Sciences (NAAS) and the Trust for Advancement of Agricultural Sciences (TAAS), which were prepared after comprehensive consultation with all stakeholders, including farming community.
The Pesticide Management Bill, 2020, is a long-overdue law in the making since 2008. It will replace the old Insecticides Act, 1968. Considering advances in the modern pest management sciences and the effects of synthetic pesticides in our food, nutrition, health, wealth, and environment security,the Pesticide Management Bill should bring India’s pesticide sector in line with the latest global norms, with a robust Regulatory System.
Prof R.B. Singh, Former President, National Academy of Agricultural Sciences (NAAS), said, “The PMB in the present form is not based on scientific facts and doesnot adequately address the concerns of the farmers.The internalization of the NAAS and TAAS recommendations into the PMB will not only enhance the credibility of the Bill, but would also greatly augment the agro-ecological and socio-economic impact of pesticides as plant health chemicals towards Greening Agricultural Transformation in the country”.
He reiterated that pesticides play an important role in increasing agricultural productivity and preventing crop losses. However, despite very low intensity of pesticide use in the country, less than 0.5 kg/ha, against over 13 kg/ha in China, due to their indiscriminate use, negative impact on the health of humans, animals, biodiversity, and environment are not uncommon. The PMB 2020 has several loopholes and is silent on critical issues which will allow miscreants to compromise farmers’ welfare and socio-economic and environmental security. The NAAS and TAAS, involving the stakeholders along the value-chain, have scientifically identified the shortcomings and made science-informed recommendations to render the bill transparent and effective to meet peoples’ aspirations and to serve the farmers.
Prof Singh underpinned the highlights of the NAAS recommendations contained in NAAS Policy Brief entitled Better Management of Pesticides in India: Policy Perspectives, June 2020. These include:the essentiality of explicit and unambiguous definition of the terms used in the Bill; streamlining the import and registration of technical grade pesticides; strengthening research, technology, innovation, and public-corporate collaboration to locally produce efficient new green molecules (Aatmnirbhar Bharat); centrality of quality control, zero spurious pesticides, needed infrastructure and quality human resources; pesticide grouping for pest resistance management; ensuring safety of workers and related handling/application; decriminalization of the system, but fixing differentiated accountability along the value chain; and promoting data protection and building comprehensive data base for need-based use through applying data analytics.
He further highlighted that the TAAS-led Virtual Dialogue on Current Challenges and Way Forward for Pesticides Management, held on July 24, 2020, Chaired by Prof R S Paroda and Co-chaired by himself, had, likewise, deliberated on reorienting the regulatory mechanism, creating enabling environment for growth of pesticide industries, and strengthening pesticide research and innovation for development.
In concluding, Prof Singh emphasized that timely and effective use of the NAAS and TAAS recommendations in updating the PMB 2020, which is under active consideration in the Parliament, will greatly strengthen the cause of the Government to serve the farmer, the youth, the women, the economy and the ecology. By doing so, the Government will be humanizing science, becoming more vocal for local, harmonizing the Bill with the international provisions and procedures leading to increased international trade, thus promoting internationalization and rendering local more global. Most importantly, by accomplishing the needful, we shall glorify Jai Kisan, Jai Vigyan, and Jai Anusandhan.
Shri Bhupinder Singh Mann, National President All India Kisan Coordination Committee and National President of Bhartiya KisanUnion said, “PMB 2020 is an excellent opportunity to replace the old Insecticides Act, but, unfortunately it has again placed farmers back under the Banyan tree. It promises to address some of the agriculture sector’s longstanding demands and must provide “Right to technology to Farmers for quality Crop Protection” byoverhauling the regulatory system. Introduction of new technology pesticides on priority, data protection, use of bio-seeds, regulating spurious pesticides, and upgraded new technology will help the agriculture sector in transition to contemporary farming practices.
He further added, “The PMB 2020 is critically important as it’ll address various issues and concerns about pesticides and their handling to ultimately empower farmers by providing them with all the information about the strengths and weaknesses of pesticides, the risks, and alternatives, as in our Country at present, only 292 pesticides are registered out of a total of 1125 pesticides available in the world while our neighboring countries like Pakistan and Vietnam already have more than 500 pesticides, leaving very limited choice for our farmers.”
NAAS & TAAS, both scientific bodies, examined PMB 2020 and highlighted below concerns and plausible policy suggestions:
- Registration process (need for time bound, predictable, stable and transparent process for product registration)
- The process of registration should be transparent and time-bound with a system of built-in accountability and punishments for the delays and information leakages. Online registration can help towards this. Priority registration for new chemistries and products, importable products to meet national exigencies in a time bound manner needs to be defined. The duration of registration process should not exceed one year for new molecules and six months for me too registration. The data generation for new molecules should preferably be through notified/ accredited laboratories.
- More than 95% discovery of molecules have been done internationally, and introduced first in our country via imports from developed countries. Faster registration of new promising molecules which are used in very low dose, and safer to the environment need to be ensured for early introduction to save the crops from new species of insects, diseases, weeds etc. for which already registered products have developed resistance.
- Granting me too registrations liberally without verifying the credentials of applicants encourages malpractices, which need to be curbed through effective post-monitoring inspections and requirement for submission of periodic data on production and sale besides imports and exports of such approved pesticides. Registrations and licenses to fly-by-night operators must be curbed at all cost and the defaulters be quickly penalized under the law. It is also a source of terror funding as outlined in Media by Union Minister Shri Rajnath Singh.
- Provision of tentative emergency registration of pesticides for an invasive pest before its widespread is highly desirable. If a molecule has already been tested for efficacy or has a history of safe use, the codex MRL may be adopted temporarily to meet the mandatory registration requirements. There is a need to focus on enabling policies for trade/ agri-exports through adoption of Codex maximum residue limits (MRLs) and harmonized import tolerances/MRL standards.
- The data requirement for exports may be kept at barest minimum parameters, as the imports in the importing countries are governed by their rules and regulations. Representation of the industry in the Registration Committee, Central Pesticides Board and other such Committees is suggested so that practical and pragmatic policies are made.
- Quality control, sampling, testing and analysis infrastructure including quality human resource, reference analytical standards, and, quality reagents for analysis
- As per the Insecticides Act 1968, State pesticides testing laboratories are notified by the respective State, and the Central Government has notified Central Insecticides Laboratory (CIL) which are known as referee laboratory. Apart from this, the Central Government has notified two regional pesticides testing laboratories to provide the testing facility or States where no laboratory is established or the samples can’t be analyzed by the State pesticides testing laboratories. It is quite painful while all good companies’ laboratory are NABL accredited while none of the Government laboratories are NABL accredited while all good private companies are NABL accredited equivalent to International Standard ISO 17025. Earlier, there were 3 CIL at Mumbai, Hyderabad and Faridabad. We don’t know why a monopoly has been creating by closing Mumbai and, Hyderabad laboratories by creating a monopoly at the Faridabad laboratory, which is against the Policy of government of Competition Act.
- All the Government laboratories shouldn’t only be NABL accredited equivalent to International Standard ISO 17025, and till their accreditation is done, such laboratories shouldn’t be allowed to test the statutory samples. This provision has already been made by the Government that no food sample will be tested by any Government laboratory until and unless it is NABL accredited. Under FSSAIAll the Government laboratories should be networked together to get a holistic pool of database to be managed through big data analytical tools so as to tracing culprits responsible for manufacturing sub-standard, fake, duplicate, and, spurious products which can be caught and simultaneously the Chemist who are analyzing the sample with malafide intention can also be caught.Government earlier made an agency to provide the reference analytical standards to all the Government and Private laboratories on payment basis, but, unfortunately, this project of providing reference standards hasn’t moved forward except constructing a building at Faridabad. There is a provision under Section 16 of the Insecticides Act 1968, to allow private NABL laboratories to work as CIL, but till date, no private laboratory has been appointed by the Government to work as CIL, thus the monopoly of only 1 laboratory continues.
“Section 16 of the Insecticides Act 1968:
Provided that if the Central government so directs by a notification in the Official Gazette, the functions of the Central Insecticides Laboratory shall, to such extent as may be specified in the notification, be carried out at any such institution as may be specified therein and thereupon the functions of Director of the Central Insecticides Laboratory shall, to the extent so specified, be exercised by the head of that institution.”
Government should immediately take up this issue so that analysis in all the Government and Private laboratories can be standardized, as Government has rationalized metric system of weight which are certified by Government;similarly for measurement, certified tools and for liquid, certified measuring tools, for example all the petrol pumps’ delivery system after calibration are sealed by the Inspector to avoid manipulations. But, in case of pesticides, there are no certified standards – in this situation, without proper reference standards, how one can expect a proper analysis?
- In the event of a test report of a sample being challenged, its retesting is suggested at multiple accredited laboratories located at different locations, ensuring secrecy of the sample source. If there are contradictions, a provision of joint analysis by the representative of the challenging party and the laboratory analyst must be made compulsory to ensure a fair and transparent system.
- The toxicological assessments should be risk based rather than hazard based. World over, thetoxicological assessments is done on risk based including the USA, Japan, Australia and other developed countries, in India also the same process is followed, which should continue.In our country, the Ministry has also considered that for formulated pesticides, toxicology should be considered based upon formulations not on technical which is the present system, and to rectify the same.
- Uniform sampling guidelines should be provided for sampling as per BIS specifications, and so far as possible, the sampling should be done only in the original packing, as in the field, the Inspectors don’t have proper tools to draw the sample, and if it isn’t properly packed, they absorb moisture, and in that case, the pesticides deteriorate very fast. To avoid this, the sample should be drawn in its original pack to avoid the risk of exposure. As per RTI information, 90% sampling is done from 100 companies only, while as per CIB&RC information, they have issued registrations to around 6,000 companies. Why this discrimination? Repeated sampling of the same company is just a wastage of taxpayers money, and leaving the manipulators / culprits intentionally out of the quality control and monitoring system, which is again a proof of the malafide intentions of the inspectors and the analysts.
- Offences and Punishments clauses
- The Government of India policies sayEase of Doing business, Vocal for Local, making an AtmaNirbhar Bharat, Less Government and More Governance, Transforming India into a US$ 5 Trillion economy by 2025, Doubling Farmers’ Income by 2022, Standup India Startup India; and doing decriminalization from all the commercial acts, which was stated by our Finance Minister in her Budget Speech in February 2020 under point no. 82 (“There has been a debate about building into statutes, criminal liability for acts that are civil in nature. Hence, for Companies Act, certain amendments are proposed to be made that will correct this. Similarly, other laws would also be examined, where such provisions exist and attempts would be made to correct them.”). Our Hon’ble Prime Minister on 6th March 2020, while addressing the ET Global Business Summit announced in his speech that yesterday on 5th March 2020, they have removed 72 sections from Criminal Act to Civil Act, and from “fine” to “penalty”. Recently, theFinance Minister has proposed removal of Criminal Act from 19 various commercial laws. In this situation, keeping these provisions in PMB 2020 under Criminal Act of fine uptoRs. 50 lacs and 5 years jail terms isn’t at all justified, and it should be brought under Civil law, and, for minor variations, there should be a provision of compounding as the Government of India has done provisions under FSSAI Act that for minor variation and for unintentional error, it’ll be compounded.
- Bio-pesticides quality control is a matter of serious concern as most products are reportedly laced with chemical pesticides, yet these product manufacturers have been hardly punished. The current market for spurious, sub-standard, fake, smuggled, duplicate and misbranded pesticides is estimated to be between 25-40%, while as per the Ministry of Consumer Affairs report, it is around 58%. While prescribing punishments, it is essential to distinguish between genuine and spurious manufacturers, and for this, the Government should advise all the States to maintain a data of last 5 years, and share the same transparently company wise how many samples drawn, how many passed, and how many failed, and the Central Government can compile after getting the data from all the States in line of Rajasthan State which is followed by them from the last so many years. Based upon this data, the Government categorized the manufacturers on the line of grading the export houses, and accordingly, 1 to 5 stars are given to export houses.
- Punishment should not be for only the offenders of the Act by the Private parties only, but also, for those who are working in the Government, and violating the Act by issuing license and registrations in violation of the Insecticides Act 1968 and Insecticides Rules 1971, and the decision of CIB&RC recorded in their own minutes. Chemists and Inspectors who are analyzing the sample with malafide intentions , and giving them protection being Government servants isn’t at all justified, and most stringent action should be taken against such dishonest officials.
- Data protection as per International norms
- We are signatory of WTO and TRIPS, and as per TRIPS Clause 29.3, Data protection is to be provided when it is generated for a specific country, and, this data generation is entirely different from the Patents Act. Even if you have a patent of a molecule, and if you want to market a pesticide in any country, then you have to generate the data as per the norms and guidelines of the Country, only after which the dossier is submitted to the registration authority, and if they are satisfied from the data, only then they issue a registration certificate, otherwise they refuse to issue the registration certificate. World over, data protection is provided for 5 to 15 years, while in new molecule research, it costs around US$ 300 million (Rs. 2,000 Crores) and 10 to 12 years’ time while in our country also in registration, there is an investment of Rs. 30 to 40 Crores in registration for generating various data, and the time taken is 5 to 8 years. After registration, a huge amount is required for training the dealers and farmers about the right use of the pesticide, which also needs investment of Rs. 50 – 100 crores in our Country, as the land holding is very small, and more than 14 crore farmers live in around 6.5 lac villages, and to reach there is a herculean task.A special provision for data protection needs to be made for safer and new molecules/formulations that are introduced/developed in the country for the first time, even if off- patent, for a minimum of 5 years from the date of its provisional registration in India. In such cases, there has to be a mandatory clause that concerned applicant must get the molecule registered with required technical data generated through accredited laboratories/institutions within India during the period of protection.
- Protection of regulatory data (PRD) encourages innovators to discover, protect, register and produce new solutions. In addition to manufacturing and R&D capabilities, this ensures India’s position as an investor’s hub. The benefits which will accrue from PRD include accelerated introduction of newer and safer crop protection products (CPP), ensure proper product use through stewardship, protecting sensitive proprietary know-how (impurity profile and product composition) from disclosure to prevent unfair commercial use, increasing agricultural exports, setting-up of R&D facilities in India, outsourcing studies/data generation to Indian research institutes, giving employment to Indian scientists and engineers. PRD will help farmers grow more and better food by getting solutions to new invasive pests, disease, weeds, to which the existing pesticides have developed resistance, and the farmer needs new solutions.
- 46th Standing Committee of Agriculture in 2009 had recommended vide point no. 33 for 5 years data protection to encourage introduction of newer pesticide molecules. Mrs. Satwant Reddy Committee (Secretary Chemicals & Petrochemicals in 2007)had recommended three years data protection for the first registrant. Recently, Dr. Ashok K Dalwai committee appointed by the Hon’ble Prime Minister for Doubling the Farmers Income has recommended 2-3 years data protection.
- We appreciate the Government by providing latest armory to our forces who are in position today to face the challenge from China and Pakistan together. On similar lines, we need to provide not only latest pesticides, but, all other latest technology like Artificial Intelligence, drones, hybrid seeds, drip irrigation to our farmers so that the Indian GDP from Agriculture in comparison to China also grows to rightly realize its potential of being a Sone kiChidiya.Currently, China’s GDP from Agriculture is nearly 3 times more compared to India’s whereas our Agriculture land is 142 million hectares and the Rain fall in our country is 1083 mm plus while in China, Agriculture land is 128 million hectares and Rain fall is 645 mm. The GDP contribution from Agriculture (as per FAO) for India is US$ 401 billion and China’s is US$ 991 billion.
- Reformsin Central Insecticides Board and Registration Committee (CIB&RC), and other bodies
- The heavy workload on Central Insecticides Board and Registration Committee (CIB&RC), currently with limited staff, has adversely impacted registration timelines for import of new molecules intended for import. The existing process leads to inordinate delays in scrutiny of dossiers requiring a multi-layered approval process. As per Insecticides Act 1968, and Insecticides Rules 1971, a new 9(3) product registration should be granted in a period of 1 year, and can be extended by maximum 6 months, but, at present, such registrations are taking more than 5 years’ time which can be corrected only by appointing competent staff.
- A strong cell within CIB&RC must be established on priority with required trained manpower and Big Data facility for receiving, reviewing and fast tracking of registration applications for the new molecules or formulations and also those for emergency solutions.
- A Centre of Excellence (CoE) on Agrochemicals with multifaceted wide spectrum and modern bioscreening facilities needs to be established urgently at the Indian Agricultural Research Institute (IARI), to be gradually elevated to a National Research Centre (NRC) on Agrochemicals, to lay high priority on developing new molecules and undertake related multifarious R&D activities using best techniques and the latest facilities.
- There is an urgent need to strengthen the Institute of Pesticide Formulation Technology (IPFT) under the Ministry of Chemicals & Fertilizers (MoC&F) in Gurugram to promote PPP, skill development, product commercialization, and infrastructure improvement, and, use of artificial intelligence (AI) and digital technology. This will require Government commitment for much higher investments.
- The Chairman of CIB&RC should be appointed one of the most senior Scientists from Agriculture field who knows the priority of Agriculture with integrity, and the old incompetent staff should be replaced and sufficient manpower should be provided by investing few crores of rupees in the system, a gain of lacs of crores in Agriculture production can be achieved.
- Encourage Indigenous R&D for newer technology and molecules to Make in India
- The Bill needs to state clearly about the enabling environment for promotion of indigenous research, technology and product development such as new molecules. In view of limited progress towards developing newer molecules, there is a need to establish a dedicated center for research for development of newer molecules and greener technologies.
- The unmanned aerial vehicle (UAV)/drone technology is coming-up as a viable alternative of manual spray, which will ensure reducing human exposure at the time of application of pesticides. Spraying operations by the pesticides companies or trained youth as technology agents on custom hire basis will go a long way in safe and timely application of right pesticides. These new application techniques may need ultra-low volume (ULV) formulations of pesticides. There is also the need to develop civil aviation framework and standard operation procedures (SOP), set-up crop protection application standards, provide farmers/applicators access to technology through good quality drones, and provide training to rural youth on usage of new technology including drones.
- Greater attention needs to be given to:
- successful development, commercialization, and adoption of biopesticides in public-private partnership (PPP) mode;
- strong academic-industry alliance for scaling-up commercialization; product quality, integrity, bioefficacy testing, application and marketing;
- developing safety indices for biopesticidal formulations;
- data and IPR protection;
- effective implementation and monitoring of biopesticides usage;
- selection of proper strains/species of biocontrol agents; and
- rationalization of registration requirements.
- Safety of farm workers finds no mention in the Bill. Handling pesticides before, during and post-application is a neglected aspect in India which needs attention by providing the proper procedure in the Bill itself.
- The Bill needs to prescribe remedies about pesticides through education of farm work force to avoid the dermal, respiratory and other toxicity and related effects of pesticides when farmers/ farm workers often manually prepare dilutions of formulations to achieve the required concentration.
- Definitions of some of the terms such as ‘Pesticide’, ‘Biological’ are vague in PMB 2020, and, needs reconsideration. The listing of the approved pesticides in a Schedule to the Act as practiced earlier in Insecticides Act 1968 and Insecticides Rules 1971 must be continued to avoid any confusion and misuse of the same by the Inspector. The word ‘handling’ may be added in the preamble of the Bill to make the statement more comprehensive.