The Joint Secretary (Plant Protection),
Room # 238,
Ministry of Agriculture & Farmers Welfare,
New Delhi 110 001.
Phone: 011-23382937 Ext. 4965
Sub: Inputs on the Pesticides Management Bill, which is supposed to be introduced in the Parliament
1. OUR BROAD COMMENTS AND SUGGESTIONS
(i) Reason for the Statute and its Objective(s) should be bio-safety:
The Insecticides Act 1968 which the Government is seeking to replace with a new Pesticides Management Bill rightly has the following objective: “An Act to regulate the import, manufacture, sale, transport, distribution and use of insecticides with a view to prevent risk to human beings or animals, and for matters connected therewith”. Compared to such a clear need, and objective for regulation, the Pesticides Management Bill being proposed has diluted objectives, and objectives that need not constitute regulatory objectives in the first instance. It is obvious that if the objective of the regulation is not right, many other provisions of the Act will be prone to faulty articulation too.
Biosafety, which is protection of human health and ecology/environment from the risks of synthetic pesticides, should be the core objective of this Bill. This is based on an enormous body of scientific evidence that shows that synthetic pesticides are not needed in agriculture, and also evidence of the numerous adverse effects of these toxins. Consequently, minimizing and eventually stopping of pesticide use must be a core objective of the bill.
(ii) Scope should cover all pesticides:
The definition of Pesticides should explicitly include Insecticides, Fungicides, Herbicides/Weedicides, Acaricides, Molluscicides, Rodenticides etc. in addition to this statute being applicable to pesticides in healthcare use and household use also.
(iii) Long-pending regulatory improvements need to be included:
Once the correct objective is re-installed, several long-pending regulatory improvements (principles and systems to be incorporated) need to be brought in, including:
(a) a precautionary approach that builds in a Needs and Alternatives Assessment into the regulatory regime where pesticides are to be registered only when there are no alternatives that fulfill a proven need;
(b) an automatic review of every registered pesticide periodically, say every 5 years, for its safety;
(c) that registration will take place only after transparent, independent, public-reviewed long-term safety testing undertaken in India, without any conflict of interest in the assessment;
(d) that registration will take into full consideration the end use conditions by farmers and others in India, and does not presume safe use;
(e) that safety testing will cover inert ingredients as well as metabolites or breakdown products;
(f) that pesticides banned or restricted elsewhere will automatically come up for review in India, in addition to pesticides not registered in a manufacturer’s home country due to health or environmental reasons not being allowed in India;
(g) that funds will be generated by charging the pesticides industry for independent safety data generation etc.;
(h) No provisional or deemed registration of any kind should be allowed;
(i) Strict regulation of advertising and aggressive marketing of pesticides;
(j) That surveillance and monitoring systems that capture adverse effects in a public database should be used for taking decisions around prohibition of particular pesticides;
(k) That state governments should be empowered to regulate in the best possible way to meet the objective of the statute, as explained in a point below.
Further, while Maximum Residue Levels are fixed in India under another Act (Food Safety and Standards Act), the inadequacy of an MRLs-based health safety regime should also be addressed by looking at the fact that MRLs are based on Good Agricultural Practices whereas Theoretical Maximum Daily Intake (TMDI) should be the basis for fixing tolerance limits (not even average daily intake which is not based on complete dietary exposure). The combination of different pesticide residues and their bio-magnification and bio-accumulation to which Indian citizens are exposed and their impact must be considered when considering safe exposure levels.
(iv) State Governments should be empowered:
Agriculture is a State subject as per the Constitution of India (Seventh Schedule). The Bill should empower the state governments not just in terms of licensing of trade, but to give them a role in registration process, and to prohibit or place restrictions on the sale of a pesticide, to regulate marketing and advertising and to lay down conditions that sale should be against prescription by specified authorities.
(v) There should be No Penalisation of Farmers as Users – Deterrent Penalties for all Others:
Penalties in this statute cannot be limited to only efficacy aspects of regulation. They should cover safety aspects too. Punishment must be spelt out for environmental and human toxicity caused by pesticides, and responsibility for remediation and redressal should be fixed too. Further, the distinction being made between different categories of offences in the Bill is not water-tight enough, with additional terms like ‘ineffective’ pesticide etc. laid down.
It is important to have penalty clauses which are in proportion to damage/losses caused to farmers and in proportion to the pesticides produced or stored by the offender and not just as fixed amounts. Penalties should also include seizure of the assets of the pesticide firm. This will then act as a real deterrent. There is a need to publish the names of all pesticide producers, dealers and pesticides which have been cancelled, de-registered or who have been found to be guilty of contraventions of the statute and repeated offences should result in black-listing of entities.
(v) Explicit Compensation, Redressal and Remediation Clauses should be included:
Farmers’ and affected persons’ interests are not being protected by this Bill, which lays down that they should take resort to the Consumer Protection Act when affected persons may not even be ‘consumers’ as defined in the said Act. For instance, an agricultural worker who gets affected by acute pesticide poisoning, or the survivors in the family of a pesticides poisoning victim who is fatally poisoned. This is not uncommon in India.
The Pesticides Management Bill itself should include time-bound, simple and accessible mechanisms as clauses for compensation, redressal and remediation.
(vi) Protection of farmers and farm workers as users of pesticides:
Provisions must be there to ensure safety of use of pesticides, which should be addressed by inclusion of appropriate clauses in the Bill. This should take into consideration the fact that ‘safe use’ may not be possible in all situations in our country.
In our attached feedback, we had given several other suggestions which merit serious attention and addressal, including about transparent functioning, building of data systems that will govern better regulation, labels on packages/containers to be in vernacular medium etc. We believe that regulation is not just about quality and efficacy based on which pesticide industry’s business is facilitated by framing a statute (Draft Pesticides Management Bill 2017 was mainly centred around this) but more importantly, regulation should be around safety from the deployment of a toxic technology, in a context when science of pest management has evolved to show that such a technology is certainly dispensable.
In either case, the Bill needs to protect the interests of common citizens, including farmers, farm workers and consumers and their environment. When regulation does not co-evolve with scientific developments and evidence as well as societal demand, then it obviously falls short of what is required.
Without taking care of the several lacunae in the existing regime as well as in the proposed Bill as available in the public domain as of now, the Government of India would have done disservice to citizens, especially after the recent unconscionable episodes of deaths and hospitalisations of dozens of citizens due to pesticide poisonings, not to mention of many chronic impacts. We would be in a position to present more precise amendments or changes needed, if we get to access the version of the Bill that the government intends to introduce in the Parliament. We hope that the Pesticides Management Bill 2019 will be passed with all the above suggestions incorporated into the provisions of the statute. Thank you.
Sd/- Kavitha Kuruganti
2. SPECIFIC CHANGES SOUGHT
1. OBJECTIVE OF THE LAW:
The current law regulating pesticides in India, called the Insecticides Act 1968, has safety as its central objective. It begins by saying that the Act is to “regulate the import, manufacture, sale, transport, distribution and use of insecticides with a view to prevent risk to human beings or animals, and for matters connected therewith”. The central objective of the Pesticides Management Bill 2019 must be the same: to regulate the import, manufacture, sale, transport, retail prices, distribution, quality and use of pesticides with a view to ensure bio-safety and to minimize pesticide usage to prevent risk to human beings, all living species and environment. Regulatory objective cannot be to control pests, or to facilitate the pesticide industry’s operations.
2019 also witnessed pesticide poisoning cases – including deaths – due to occupational exposure, and threw up the grim reality of use conditions and failure of regulation on the ground. The recent episodes of poisoning were only a sequel to other such instances in the past. Questions around the manufacture and use of deadly pesticides, the need for continuous independent generation of safety data on pesticides, lack of authority in the state government’s hands, weak penal clauses etc., in the extant statute received attention in the ensuing public debate. The Pesticides Management Bill 2019 must take cognizance of this. If the Pesticides Management Bill 2019 has biosafety (safety for human beings and the ecology) as its central objective, it will also mean that the Bill will have to focus on minimizing the usage of synthetic pesticides.
Meanwhile, it should be remembered that both the science of pest management based on greater understanding of agro-ecology, and the body of evidence on toxicity of pesticides has developed strongly in the past decade or so. On another front, it is also clear that India’s citizens, as with those around the world, are more aware of the toxic effects of pesticides than before, and are demanding safe food and environment. India’s Prime Minister has openly put out a call to farmers to reduce the usage of toxic chemicals in their farming.
It is apparent that any sound regulatory regime should co-evolve with both such scientific evidence as well as with societal demand. Therefore, the Objective of the Pesticides Management Bill 2019 must be bio-safety and reduction in the usage of chemical pesticides. The Government of India should immediately make the required changes in the very objective of the Bill before proceeding further.
Towards this objective, the following related clauses should definitely be inserted:
1. That any new pesticide will be registered only after a Needs and Alternatives Assessment, deploying NPM (non-pesticidal management) approaches;
2. That any pesticide will be registered only after transparent, independent, peer-reviewed, long term safety testing is cleared, if the condition above is met;
3. Given that there is a new body of scientific evidence on the toxicity of so-called “inert” materials used in pesticide formulations, other than the active ingredient, biosafety testing should necessarily include these ingredients too, which means that formulation registration is also required. All ingredients must be tested separately and collectively for endpoints such as mutagenicity, carcinogenicity, developmental toxicity, endocrine disruption etc., relevant to humans, mammals and all non-target species, such as bees and other pollinators, birds, frogs, and earthworms.;
4. Regulation must ensure that lifecycle management of pesticides is planned for – i.e. from production to disposal/return (in case of unused pesticides and of PPE/containers);
5. Biosafety testing should cover toxicology of secondary and tertiary half-life metabolites and the data should be put in the public domain;
6. That there should be rigorous biosafety testing for “combination” products, before they are registered and allowed to be manufactured, sold or used;
7. That there will be a periodic and automatic review of all pesticides, every five years from the time of registration – each registration should be valid for only five years;
8. No pesticide shall be registered for import or manufacture unless an antidote is specified and a Standard Medical Protocol has been notified under Indian Clinical Establishments Act, 2010. These antidotes must be made available at block level hospitals. Pesticides such as paraquat which do not have antidote must not be registered at all;
9. That any pesticide registered in India, which has been banned or severely restricted in at least two other countries will be reviewed and put up for comprehensive safety testing, based on which a ban or restriction decision (along with its import) will be taken here too without precluding the need for an interim ban or restriction;
10. Compounds most often associated with pesticide poisoning must be reviewed by the Central Pesticide Board for ban or restriction, including through a public database build-up as happens in Canada;
11. That the Government of India will generate and set aside funds, by collecting the same from the pesticides industry as a percentage of their turnover, to commission independent studies to generate safety data including long term data, that will feed into the periodic review;
12. Review processes should be transparent, scientific, participatory and devoid of any conflict of interest. It is often seen that the irregular, occasional reviews that the Government of India conducts, depend on the industry to produce safety data, ignoring the inherent conflict of interest;
13. Government research programmes shall prohibit industry-linked individuals from joining projects that design or evaluate risk assessment methodologies or take up actual assessment;
14. Ban moderately, highly and extremely hazardous pesticides (WHO classification) to allow only those pesticides with lowest risk to humans, living beings and environment must be done.
2. BIOSAFETY TESTING REGIME MUST BE SPELT OUT IN THE BILL:
The primary basis for registering a pesticide should be an established need, the fact that there are no alternatives, and importantly, clearance of a rigorous biosafety testing regime.
The proposed Bill must spell out mechanisms (institutional and otherwise) to ensure that independent, comprehensive, transparent and long-term testing for biosafety takes place, for registration and other regulatory decisions to be taken on a given pesticide.
3. STATE GOVERNMENTS SHOULD BE EMPOWERED IN THE STATUTE:
The Pesticides Management Bill, 2019 should use the experience of implementation of Insecticides Act 1968, and empower state governments in a stronger way in the new statute. Agriculture is after all, a State Subject as per the Indian Constitution.
State governments must have role in the registration process and prohibition process and not just licensing of sales or stocking. State governments, for instance, must be shown the biosafety data based on which, given the regional specificities of environment, communities and crops grown, they could have a say in the registration process itself.
In the case of prohibition of pesticides too, state governments should be empowered to take action in their own jurisdiction along with national action by central regulators. This could be on the basis of data that they generate locally, reviewed by a competent body.
State Governments should also be empowered to regulate marketing and advertising of pesticides, in addition to placing restrictions on sale and usage as required.
State Governments should be able to lay down conditions for sale against prescription for specific pesticides.
Local authorities such as panchayats and municipal bodies must be allowed to prohibit pesticides too, especially in and around areas declared as sensitive zones or declared as no-pesticide zones.
4. DEFINITION OF PESTS & PESTICIDES SHOULD BE COMPREHENSIVE IN THE BILL:
The definition spelt out in the proposed Bill for a Pesticide should be comprehensive and should explicitly include all household pesticides, pesticides used for vector control in healthcare systems, herbicides and weedicides, fungicides, rodenticides etc. Similarly, definition of Pests (which sometimes gets interpreted to cover wildlife too) should be clearly spelt out.
5. PENALTIES TO BE DETERRENT ENOUGH – THERE SHOULD BE NO PENALISATION OF FARMERS:
Regulatory decision-making should take into consideration the end-use conditions with our farmers. There should be no penalties on the farmer or farm worker as the user. Farmers are often victims of an aggressive toxic industry, when it comes to pesticides. There should be deterrent penalties for those “who cause to use a pesticide in contravention” of any provision of the Act.
Further, punishment for misbranded pesticide and sub-standard pesticide should not be kept at the same level, which does not make sense, given that there is a new categorisation of offences in the proposed Bill, as compared to extant law. Further, a category of “ineffective pesticide” was introduced in the Bill, with a higher punishment, though it is not clear how it is different from Sub-Standard pesticide, which is expected to manifest itself as an ineffective pesticide. Spurious pesticides must be punishable with the highest quantum of punishment in the proposed Bill.
Punishment must also be spelt out for environmental and human toxicity that is proven to be caused by a particular pesticide, as in the case of acute poisonings for instance.
6. COMPENSATION, REDRESSAL AND REMEDIATION CLAUSES SHOULD BE ADDED TO THE BILL:
The Pesticides Management Bill 2019 should not ask farmers and other affected persons to take refuge in a Consumer Protection Forum for compensation and redressal. It is not clear how affected persons (i.e. an agricultural worker who is poisoned due to occupational exposure, and is not the one who purchased the pesticide, or communities who are affected by large scale use of a cocktail of pesticides in states like Punjab, or consumers of highly contaminated food items), who may not be buyers/consumers of a pesticide are supposed to take resort in a law that is meant for Consumers.
What is needed in the proposed Bill is a clause that makes the pesticides industry as a whole, and particular manufacturers/marketers/retailers as liable for losses incurred by farmers, or effects experienced by any other affected persons. This must also include liability clause for pesticide drift. The procedure laid down should be simple, time-bound and accessible to all affected persons.
Block level committees, consisting of Agriculture and Health department officials, along with farmer/community representatives and independent experts must be created for the purpose of scrutinizing demands for compensation, redressal as well as remediation of pesticide toxicity, or failure to perform as promised.
7. LIABILITY NORMS AND SYSTEMS TO BE FIXED ON PRODUCERS/MANUFACTURERS AND SELLERS OF PESTICIDES, AND DRONE USERS AS PROVISIONS WITHIN THE BILL:
Pesticide manufacturers must be responsible and liable for ensuring that unused pesticides, expired materials, used pesticide containers and used PPEs are sourced back for safe disposal.
Their responsibility should also include provision of PPE to consumers, other than training of pesticide retailers, to ensure that risks of pesticides are communicated to pesticide buyers.
The labels on pesticide containers and packages should be in vernacular medium and the leaflets should contain all prescribed details in a readable manner.
Such pesticide producers/manufacturers and sellers should be made liable if seen indulging in unethical marketing practices including offers of junket trips or giving discounts on bunding of pesticides by retailers etc., based on sales targets.
Further, given the increasing use of drone technology for pest control in a country with a majority of land operated as smallholdings, there should be clear regulation of the same in terms of disallowing its use in the first instance without rules being formulated after widespread consultations, without prior permission and that too only in fully justifiable, rare situations.
An effective monitoring system to track retailers’ licenses must be evolved to ensure dangerous (not stocking PPE, decanting pesticides into unlabeled containers, selling spurious pesticides etc) and illegal handling processes can be tackled resulting in withdrawal of their licenses.
8. SEPARATE OUT BIO-PESTICIDES IN THE REGULATORY REGIME:
The proposed Bill, in its definition of Pesticides includes pesticides with a biological origin, along with chemical origin. Bio-pesticides also need regulation, but cannot be on par with hazardous chemicals. The regulatory regime for bio-pesticides has to be separated out, and only relevant clauses included here.
9. BRING IN TRANSPARENCY AND INDEPENDENT FUNCTIONING INTO REGULATION:
The pesticides regulatory regime, at all levels, starting from biosafety testing to periodic reviews after registration, should be rid of any conflict of interest, and should also be based on transparent functioning. This applies to all regulatory bodies created in this law, including licensing officers, inspectors, analysts and others. Like the 1968 Act, the proposed bill must ensure that Pesticide Inspectors should not have financial interest in pesticide industry. Data being generated, prosecution initiated, results of lab analyses and other such information should be mandated to be put in the public domain by respective authorities. The number of independent experts and public representatives (farmer/consumer) should be increased in all institutions of regulation.
10. INCORPORATE A PROVISION TO BUILD DATA SYSTEMS AND PUT OUT INFORMATION INTO PUBLIC DOMAIN, INCLUDING POISONING INSTANCES:
There is a need for data systems to be built within the pesticides regulatory regime, and such data being available in the public domain. These data systems should in turn rest on regular testing, biosafety testing before registration and surveillance and monitoring.
The following are some of the systems that should be put into place in a mandatory and not optional fashion:
§ Full biosafety information of all pesticides prior to registration for public scrutiny and feedback and thereafter; such results and data of all pesticide safety tests shall be published on the government website in a consistent and searchable format.
§ Information on acute poisoning cases, through hospital-based surveillance initially, followed by village-level systems (the Pesticides Management Bill, 2017 clause 32 spelled out that state government may require any person to report all occurrences of poisoning, rather than laying down that every state shall);
§ Information that is citizen-sourced on various impacts of pesticides from all over the country in well worked out formats;
§ Pesticide residue levels in all kinds of foods at different vending points (farmgate, wholesale markets, retail markets, packaged foods etc.), drinking water in identified areas, beverages, milk, meat, soils and even animal feed/fodder;
§ Traceability in a supply chain from production till end consumption of a given pesticide;
§ Pesticide residue levels in various foods in different wholesale and retail points including those of street vendors (i.e. not only supermarkets);
§ List of manufacturers, sellers, stockists and others charged with contraventions to the Act;
§ Database of scientific and other research studies on efficacy and inimical effects of pesticides around the world must be maintained.
Further, half-life data and toxicology reports of all registered pesticides and formulations must be put in public domain by the regulator. Surveillance should include information on developments in other countries including fresh bans and restrictions, which should trigger reviews within India.
11. ADD A PROVISION TO REGULATE ADVERTISING/AGGRESSIVE MARKETING OF PESTICIDES:
There should be powers vested with state government to curb any aggressive marketing of pesticides, and to prohibit advertising. The abuse of pesticides that one witnesses is because today, the pesticides industry is built on aggressive marketing where retailers and farmers are incentivized around greater use of pesticides, rather than reduction in the use of pesticides, and where pesticide usage is projected as ever-safe with visuals showing unsafe use conditions etc.
12. SPECIFY AND INCREASE SCOPE OF PESTICIDE INSPECTORS’ DUTIES:
The proposed Bill notably positions the discussion on Pesticide Inspectors in a chapter called ‘Analysis of Pesticides’. The job description of Pesticide Inspectors needs to be specified and it should not be limited to taking and testing samples of pesticides. The Inspectors’ duties should include, for example, ensuring input dealers stock all the mandated protective equipment, and ensuring dealers provide farmers with the leaflets that accompany pesticides (these leaflets must also contain information about how to handle spillage, leaks, safe storage of pesticides, PPE, understanding wind direction, pesticide antidote, disposal and return of unused pesticides/containers, safe washing after spraying pesticides, symptoms which could be observed on pesticide exposure).
Another duty of Inspectors should be to identify, fine and ban pesticide sellers without licenses. It should be mandatory for states to appoint a sufficient number of full-time Inspectors, able to deal with the burgeoning number of formal and informal dealers.
Pesticide analysts must collect air, water, soil, crop and food samples through prescribed procedures periodically, as may be specified by an appropriate authority and have them analysed at a specific laboratory and send them to Central Pesticides Board.
PESTICIDES MANAGEMENT BILL SHOULD BE CONVERTED INTO AN OPPORTUNITY TO MAKE LONG-PENDING CORRECTIONS IN OUR REGULATORY REGIME:
· The proposed Bill needs to re-look at concepts liked “deemed” registration and provisional registration, and delete the same. This is an opportunity to generate and align all data required for all pesticides, so that bio-safety can be upheld. Provisional registration is unacceptable and this clause should be deleted completely.
· MRLs as a concept, based on “Good Agricultural Practices” would not be adequate to ensure safety from a pesticide – these are being faultily equated with “tolerance limits for residues on crops and commodities”. Theoretical Maximum Daily Dietary Intake should become the basis for fixing MRLs by the Health Ministry agencies, without which no pesticide should be registered. Fixing of tolerance limits should be comprehensive, for all uses of a given pesticide. This should be based keeping in mind the combination of various pesticides that citizens are exposed to daily, and their combined impact.
· Currently millions of farmers have no idea about the dangers of exposure to pesticides other than that direct consumption is deadly. The Bill should make it mandatory for states, at the block level, and through news media etc., to create awareness about the toxic effects of pesticides. For this, funds should be collected from the industry – a clause to this effect should be put into the proposed Bill.
· While there is regulation around imports for food, import of feed must be incorporated as well in regulation. The proposed Bill and all its clauses should apply completely to pesticides used in healthcare and household pest control.
· There is a need to include representatives of farmers, consumer organisations, environmental NGOs and independent toxicologists and epidemiologists into the Central Pesticides Board (CPB). Similarly, senior officials like Director, CSIR-Indian Institute of Toxicology Research and representative of Central Pollution Control Board should also be made as members of CPB. Include independent researchers and scientists into the Registration Committee.
· Authorities must conduct routine independent post-approval monitoring of the effects of pesticides on environment and health. The monitoring must be paid for out of a fund supplied by the pesticides industry but managed by an independent body. There must be no contact on these matters between the monitoring authorities and industry.
· Import – Allowing import of formulations without registering technical details or information about active ingredients must not be allowed. FAO/WHO and even USA, EU, Australia, Brazil, China, amongst others mandate registrations of Technical Grade Pesticides before granting registrations for Formulation.
· There have been recent attempts to circumvent rigorous regulation for upholding bio-safety by tweaking the labelling norms, and our feedback on this is present here: https://new.kisanswaraj.in/2019/08/20/ashas-submission-comments-on-the-report-of-the-committee-on-labeling-of-pesticides-as-per-toxicity/
· Children must be protected from the ill-effects of pesticides. For this regulation should include creation of pesticide-free zones in and around schools, anganwadis, parks, playgrounds etc. Residues must be tested for, and safe food ensured in supplementary food schemes in ICDS, MDMs etc.
Kavitha Kuruganti, ASHA (Alliance for Sustainable & Holistic Agriculture), Bangalore
1. Hon’ble Minister for Agriculture and Farmers’ Welfare, Government of India.