Session 3 Reform pesticide policy Briefing workshop August 4-5, 2004

1. Session 3Reform pesticide policyBriefing workshopAugust 4-5, 2004

2. Safety in our food. Two studies. Many questions.

3. “The right dose differentiates the poison and remedy” • Regulation across the world defines the acceptable daily intake (ADI) of pesticide – • what is safe to take daily, • over a lifetime, • for what age/bodyweight. • ADI is the touchstone of pesticide risk management. Cannot exceed ADI, otherwise deadly.

4. Determine safe limit Determine ADI (acceptable daily intake) of pesticides — Tests on rats for toxicity (NOAEL/LOAEL) — Safety factor: 100 times more for humans

5. Step 1: The acceptable limit • Toxicological studies, both chronic and acute on animals – mostly rats and dogs – to determine the level at which no adverse effects on experimental animals. • Lowest observed or No observed adverse levels (LOAEL or NOAEL). • Safety factor used – factor 10 for inter-species (between animals-humans). Factor 10 for intra-species = ADI (based on body weight). • Growing debate in US for having extra safety factor of 10 (total 1000) for kids, especially for organophosphates

6. ADI: For Indian pesticides – double zero and lower most toxic

7. Calculate what you can eat… • Your malathion diet… As per JMPR (WHO/ FAO) 0.3x 60 kg = 18 mg/ day for you or 0.3x10 kg = 3 mg/day for your child or take USEPA ADI 0.024x 60 kg = 1.44 mg/day for you or 0.024x 10 kg = 0.24 mg/day for your child ADD ALL PESTICIDES LIKE THIS…..

8. Step 2: Limits for residues Set MRL (maximum residues limit) — Based on field tests on crops — Best-possible residue — Compare with other countries’ MRL Determine ADI (acceptable daily intake) — Tests on rats for toxicity (NOAEL/LOAEL) — Safety factor: 100 times more for humans

9. 2: calculate limit of residue • Supervised crop trials. Determine what is the best-possible residue level on crops. • What is least amount of residue that is feasible. • Used to determine the Maximum Residue Level (MRL) for each crop for pesticide used on them. • The MRL is not the safety standard. It is legal limit that is allowed on the crop/food. SAFETY IS DEFINED BY ADI. MRL MUST BE WITHIN ADI.

10. Step 3: Determine intake Determine ADI (acceptable daily intake) — Tests on rats for toxicity (NOAEL/LOAEL) — Safety factor: 100 times more for humans Set MRL (maximum residues limit) — Based on field tests on crops — Best-possible residue — Compare with other countries’ MRL Multiplied by diet (exposure) DIETARY INTAKE (TMDI-Theoretical Maximum Daily Intake) The sum of what we eat: diet by section of population

11. Step 3: Determining exposure • Critical step: have to determine what we will eat and how much. Our diet. • WHO/FAO compiles diet charts from governments. • Most governments collect their own data. • Daily pesticide intake arrived: • Average diet (theoretical intake) • Accurate diet (Estimated intake) • Or total diet (Measured intake) on cooked food.

12. Diets of the world: WHO/FAO regional diets (in grams per person per day) Source: World Health Organization

13. What We Eat: Daily per capita intake of food commodities in India as per 2001 food balance sheet of FAO Source: FAO 2001, Food balance sheet.

14. Average daily intake of food commodities by a 10 kg child in India (data in grams/day) Source: GOI 1998, India Nutrition Profile, Ministry of Human Resource Development.

15. Regulating toxins Determine ADI (acceptable daily intake) — Tests on rats for toxicity (NOAEL/LOAEL) — Safety factor: 100 times more for humans Set MRL (maximum residues limit) — Based on field tests on crops — Best-possible residue — Compare with other countries’ MRL Multiplied by diet (exposure) Cross check DIETARY INTAKE (TMDI-Theoretical Maximum Daily Intake) The sum of what we eat: diet by section of population — Ensure exposure is lower than ADI

16. ADI: determining exposure • Remember that pesticides standards are about total exposure. That means we have to know what we eat and how much we eat. And how much pesticide is allowed in the food we eat. • The food basket is also the pesticide basket. It’s a trade-off: between nutrition and poison. • Exposure=MRL x Diet (what we eat and how much) • If we calculate what the law today allows: then…

17. Estimating exposure

18. How unsafe is our exposure?

19. Even more exposed…

20. Safety: not to exceed the TMDI EU Example of TMDI: Aldicarb

21. ADI cannot be exceeded. • ADI calculation must at the time of registration. • If daily intake is below ADI. Pesticide will be registered. • If intake exceeds ADI then: • A. Go back to MRL -- review and rework the legal limits allowed in food residues. Remove the use from some crops. Adjust.Public health at stake. • B. If ADI cannot be established, set the MRL at “no detection” – no residue allowed.

22. Improving estimation • If TMDI has space – less than ADI – can do more realistic estimations and if necessary increase MRL.

23. Carbaryl Chlorpyrifos-methyl Fenitrothion Iprodione Methamidophos Parathion-methyl Propargite Vinclozolin 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Percentage ADI Australia estimates on basis on Estimated Daily Intake (EDI) We exceed ADI but Australia uses only 13% EDI

24. Actual pesticide exposure in India: • Therefore, even if legal standards (MRLs) met in India, our exposure is unsafe. Because ADI is exceeded. • Our standards (MRLs are too high). They are unsafe. • We will have to revise standards to make sure ADI is not exceeded. • Then we have to make sure that the standards are enforced.

25. European Union (1996) USA (1996) Above MRL (1.4%) Above MRL (4.8%) Within MRL (35.6) Free from residues (28%) Within MRL (67.2%) Free from residues (63%) India (1965-98) Above MRL (20%) Within MRL (39%) Free from residues (41%) Actual exposures? Source: G S Dhaliwal & Balwinder Singh, 2000: 208

26. Our pesticide quota..our daily bread.. • Pesticide regulation is about managing the nutrition-poison tradeoff. • We ingest pesticides because we need to eat food. But exposure has to be kept below ADI. • The pesticide basket is also the food basket. • If pesticide quota over-consumed then we have no space for anything outside essential diet • In this situation, no pesticide can be allowed in soft drinks (not part of essential diet)

27. Towards a pesticide policy • We need a review of the regulatory framework. • Cannot allow the use of pesticides without stringent, science-based regulations. • Industry wants weak regulations. Is getting it.

28. Policy: Registration+ MRLs • Registration done by Central Insecticide Board and Registration Committee (RC) • 178-183 pesticides registered for use in the country; Lists the crops for which the pesticide is “recommended”. • MRLs are set by the Ministry of Health. Committee for Food Standards (CCFS) sets on basis of recommendations of sub-committee on pesticide residues. Mandated under PFA.

29. Registration: with or without MRLs?? • In India MRL setting at the time of registration is not compulsory. In US and EU, for instance, pesticides cannot be registered if tolerance is not set. • Till recently, out of 181 pesticides, MRLs for only 71 fixed. Now for another 50 pesticides MRLs fixed. • In June 2003 (post-bottle water study), inter-ministerial meeting decided that pesticides can only be registered after fixing MRL.

30. BUT…proposed and disposed

31. MRL-ADI: knowing it is safe.. • Cannot “harmonise” with other countries. Highly influenced by agriculture, diet and economic and trade consideration. • Important to set our own MRLs based on scientific data of GAP. • Ensure that the ADI is not exceeded.

32. Can we harmonise? • In many cases Indian MRLs more stringent than CODEX; harmonisation will mean making our standards less stringent. • EU MRLs are set to reflect dietary pattern of population. MRLs not set for commodities which are not part of essential diet. • Indian MRLs no relationship to diet. Sugarcane major diet in India, but PFA regulates only 4. Sugarbeet, not part of diet, regulates 6 pesticides. • No standard for honey. • PFA regulates 3 pesticides in tea, 2 in coffee. CODEX 10 in tea, 17 in coffee. EU 150 in tea. This creates problems in trade.

33. ADI: not checked. • Our analysis not disputed by government. Given in Supreme Court. • But government says “we check ADI”. • We checked government’s ADI-system. • Flawed. Careless. Not serious. • Safety threshold breached. All MRLs will need to be reviewed. Revised downwards…Fitted to our diet.

34. Health ministry’s calculation…

35. 3. Enforcement and surveillance • Surveillance through the All India Coordinated Project. • But no responsibility for enforcement. • Data not in public domain. Often old data released. Data unused for enforcement. • Data finds roughly 10-20 per cent samples above MRLs. In some states, samples fail by 50 per cent. • Data for milk and milk products, honey and baby food extremely worrying. No corrective measures taken.

36. Our food: of concern • Analysis by government. Should worry us. • Baby food: All samples checked had pesticide residues. (no standard in India) • 2001 data • Fruits and vegetables: 12% above MRLs. 61% contaminated. • Milk and milk products: 15 % above MRLs • Animal feed…soil..irrigation water..rainwater…honey..jam…jelly…

37. Database of failure of samples • ..\..\..\Desktop\3rd November File\nidhi.xls

38. Enforcement.. • Enforcement responsibility for Central and state laboratories under PFA. They say “no problem”. • No public disclosure of data for enforcement. EU publishes annual report on analysis of its programme and action taken. Started programme on “naming and shaming” suppliers and wholesale agencies where samples exceed MRLs. • In US, EPA sets tolerances. FDA enforces tolerances. Extensive annual programme to check and enforce. Conducts Total Diet Study – to check residues in prepared food.

39. Regulation for drinking water • In India the guideline for pesticide residues in water is: Pesticide should be “Absent”. • Water is not included in diet. No pesticide can be consumed through water. • WHO says chemical contamination has to be “tolerated” not “permitted” in water. Toleration varies between 1-10% of ADI. • Setting standard for water will require adjustment in food ADI

40. Regulation costs: Who pays? • The more the chemicals registered, the higher the cost of regulation; • In USA, managing pesticide risks cost 7.4 per cent of gross pesticide sale between 1971-95. • The greater the registered/in use pesticide, the more the costs of surveillance, residue analysis, enforcement etc. Can we afford this cost? Who will pay? • Cannot say that we are poor to enforce health-regulations once we have allowed use of substance. Regulation has to be part of use (registration) process.

41. Issues: Comparative risks • Countries learning to determine “comparative risk assessment” of new products, before being registered. It favours lower risk products. • Already being done in Sweden and part of wider EU policy approach on chemicals. • New product can be registered only if its acute and chronic toxicity is less than existing pesticides. • Need generation of data from independent sources. All data on RfD (acute and chronic) generated by industry.

42. Way ahead: reinventing the treadmill • 1939: DDT discovered. Paul Muller awarded Nobel Prize. • 1972: DDT found to be persistent. Bioaccumulative. Banned in US. • Industry introduces alternatives: Methoxychlor and dicofol – relatively close to DDT. Endosulfan – with sulfur in structure. • Persistence still a problem. Organophosphates introduced. Discovered in 1930s – used as nerve gas. Higher acute toxicity. Reduce the ability of enzyme cholinesterase to regulate signals between neurons..can cause muscle weakness etc.

43. Treadmill..costly • 1990s: concern for children health grows. Scientists find that chemicals less persistent. But residues found in food. Organophosphates indicted for childhood developmental problems. • Review of organophosphates. • USEPA considering “common mechanism of toxicity” – cumulative toxic effects. Planning also cumulative risk assessment. Has revised all RfDs for many OPs. • USEPA to review 9728 tolerances by August 2006. • We have multiple residues of pesticides – what do we do?

44. No liability – profits in new • Commercial interests in new products and substitutes. Politics of science and data. • Need a global product assessment and liability convention. • Inventors get incentives through IPRs. • Inventors of products that are found to have adverse impacts should also stand to lose – strict liability on each product. • Will force companies to do careful assessment and may be create incentives for environment-friendly products.

45. Indian trade at risk. • Indian food, fruit, spice, tea, seafood exports are at risk because of high pesticide residues and quality of product. • We have to reduce our residues. We have to enforce standards. We have no choice. • Where export standards are too stringent and irrational, we must fight on basis of good science. • Thailand has decided to become “Kitchen of the world” to produce quality and safe food.

46. Reform policy: conclusion • Urgently revise standards for all pesticide residues in food to stay below ADI. Enforce those standards. Use most stringent ADI in the world to set your own. • Set most stringent standard for pesticide residue in water. Cannot afford any contamination. • Set standards for finished products. This will create right incentive all along the supply chain. • Cannot judge against finished product standards in industrialised countries. They do not have a contamination problem. We will have to get more stringent standards. We will have to regulate.

47. Reform policy: conclusion • Pesticide residue in food should be allowed based on nutritional value of the item in question • Fruit juice has nutritional value, and hence is included in diet chart. Accordingly standard can be set for the finished product. • But no pesticides can be allowed in food and beverages with low/nil nutritional value.