Transcript How safe is safe? The health imperative in setting

Session 3
Reform
pesticide
policy
Briefing
workshop
August 4-5,
2004
Centre for Science and Environment
Safety in our food.
Two studies. Many questions.
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“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.
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Determine safe limit
Determine ADI (acceptable daily intake)
of pesticides
— Tests on rats for toxicity (NOAEL/LOAEL)
— Safety factor: 100 times more for humans
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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
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ADI: For Indian pesticides – double
zero and lower most toxic
Name of pesticide
Production
2000-01
(tonnes)
JMPR-ADI
(mg/kg bw)
YEAR OF
REVIEW
US-EPA CRfd
(mg/kg bw)
D.D.T.
3766
0.005 (Conditional)
1983
0.0005
MALATHION
5103
0.3
1997
0.024
0.5
2000
METHYL PARATHION
1979
0.003
1995
0.00002
0.00011
1999
Dichlorovos--D.D.V.P.
2648
0.004
1993
0.00017
0.01666
1998
MONOCROTOPHOS
8118
0.0006
1995
0.00005
PHORATE
6044
0.0005
1996
0.00017
0.00083
1999
ETHION
3456
0.002
1990
0.0005
0.0017
1999
ENDOSULPHAN
7462
0.006
1998
0.006
1993
CYPERMETHRIN
3388
0.05
1996
0.01
1996
ACEPHATE
3347
0.01
2002
0.0012
0.005
2000
CHLORPYRIPHOS
7000
0.01
1999
0.0001
0.0017
1999
LINDANE
473
0.005
2002
0.0047
1993
ENDRIN
0.0002 (PTDI)
1994
0.0003
1988
DIELDRIN
0.0001(PTDI)
1994
0.00005
1987
0.008
2001
0.014
1993
CARBARYL
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US-EPA YEAR OF
Arfd
REVIEW
(mg/kg bw)
1994
1986
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…..
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Step 2: Limits for residues
Determine ADI
(acceptable daily intake)
Set MRL (maximum residues
limit)
— Tests on rats for toxicity
(NOAEL/LOAEL)
— Based on field tests on crops
— Safety factor: 100 times
more for humans
— Compare with other countries’
MRL
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— Best-possible residue
2: calculate limit of residue
• Supervised crop trials. Determine what is the bestpossible 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.
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Step 3: Determine intake
Determine ADI
(acceptable daily intake)
Set MRL (maximum residues limit)
— Tests on rats for toxicity
(NOAEL/LOAEL)
— Based on field tests on crops
— Safety factor: 100 times more for
humans
— Compare with other countries’ MRL
— Best-possible residue
Multiplied by
diet (exposure)
DIETARY INTAKE (TMDITheoretical Maximum Daily
Intake) The sum of what we eat:
diet by section of population
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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.
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Diets of the world: WHO/FAO regional diets
(in grams per person per day)
Commodity
Middle
eastern
Far eastern
African
Latin
American
European
Cereals
430.8
452.3
318.4
252.2
226.3
Root and tubers
61.8
108.5
321.3
159.3
242.0
Pulses
24.6
19.8
17.8
23.1
12.1
Total sugars and honey
95.8
50.5
42.7
104.3
107.3
Total nuts and oilseeds
12.8
50.0
34.2
57.5
29.9
Total vegetable oils and
fats
40.3
14.2
23.3
21.8
38.6
Total stimulants
8.2
1.7
0.6
5.5
14.4
Total spices
2.5
3.0
1.8
0.5
0.5
233.1
179.0
77.1
150.5
371.8
13
34.7
36.5
45
46.3
Eggs
14.6
13.1
3.7
11.9
37.6
Total fruits
204.4
85.4
94.7
271.3
212.4
Milk and milk products
132.3
32.7
42.2
167.8
340.8
Meat and offals
71.3
47.0
30.4
78.0
217.3
1
1.9
0.7
5.5
10.7
1346.1
1093.8
1045.3
1354.1
1907.6
Total vegetables
Total fish and seafood
Total animal oils and
fats
Total diet in grams per
person per day
Source: World Health Organization
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What We Eat:
Daily per capita intake of food commodities in India as
per 2001 food balance sheet of FAO
Product
Per capita supply (kg/year)
Per capita supply (gm/day)
Percentage of total diet
Total cereals
162
445
37.1
Total pulses
11
29
2.4
Total vegetables
87.32
239
19.9
Total spices
1.97
5.4
0.4
Total fruits
40.66
111
9.3
Total meat
5.2
14.2
1.2
Eggs
1.54
4
0.4
Fish
4.43
12
1.0
Milk, excluding butter
65.49
179
15.0
Total sugar and honey
38.3
105.0
8.7
Animal Fats ( ghee, butter)
2.25
6
0.5
Vegetable Oils
9.49
26
2.2
Oil Crops
7.1
19
1.6
Treenuts
0.68
2
0.2
Total stimulants
0.74
2
0.2
Approximate average per capita
daily diet
Source: FAO 2001, Food balance sheet.
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1200.0
Average daily intake of food commodities by a 10
kg child in India (data in grams/day)
Age and sex Cereals Pulses Leafy
groups
vegt.
Roots Other vegt. Fruits Condiment Meat,
Milk Fats/oils Sugar
s & spices fish and products
and
egg
tubers
Total
1-3 yrs
male
126
21
8
41
16
18
4
9
163
8
21
434
1-3 yrs
female
113
19
5
35
16
23
5
10
165
7
18
417
Average
for 10 kg
child (1-3
years
child)
119
20
7
38
16
20
4
10
164
7
19
425
Source: GOI 1998, India Nutrition Profile, Ministry of Human Resource Development.
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Regulating toxins
Determine ADI
(acceptable daily intake)
Set MRL (maximum residues limit)
— Tests on rats for toxicity
(NOAEL/LOAEL)
— Based on field tests on crops
— Safety factor: 100 times more for
humans
— Compare with other countries’ MRL
— Best-possible residue
Multiplied by
diet (exposure)
— Ensure
exposure is
lower than ADI
Cross check
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DIETARY INTAKE (TMDI-Theoretical
Maximum Daily Intake) The sum of what
we eat: diet by section of population
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…
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Estimating exposure
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How unsafe is our exposure?
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Even more exposed…
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Safety: not to exceed the TMDI
EU Example of TMDI: Aldicarb
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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.
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Improving estimation
• If TMDI has space – less than ADI – can do more
realistic estimations and if necessary increase MRL.
1.
Measured Pesticide Residue
Intake (total diet study etc)
2.
Best estimate: Estimated Daily
Intake (EDI)
3.
Intermediate Estimate: Estimated
Maximum Daily Intake (EMDI)
4.
Crude estimate: Theoretical
Maximum Daily Intake (TMDI)
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Australia estimates on basis on Estimated
Daily Intake (EDI)
We exceed ADI but Australia uses only 13% EDI
Carbaryl
Chlorpyrifos-methyl
Fenitrothion
Iprodione
Methamidophos
Parathion-methyl
Propargite
Vinclozolin
0
1
2
3
4
5
6
7
8
9
Percentage ADI
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10
11
12
13
14
15
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.
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Actual exposures?
European Union (1996)
USA (1996)
Above MRL (1.4%)
Within
MRL
(35.6)
Free
from
residues
(63%)
Within
MRL
(67.2%)
Above MRL (4.8%)
Free from
residues
(28%)
India (1965-98)
Within
MRL
(39%)
Above MRL
(20%)
Free from
residues
(41%)
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Source:
G S Dhaliwal &
Balwinder Singh,
2000: 208
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)
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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.
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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.
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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), interministerial meeting decided that pesticides can
only be registered after fixing MRL.
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BUT…proposed and disposed
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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.
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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.
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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.
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Health ministry’s calculation…
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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.
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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…
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Database of failure of samples
• ..\..\..\Desktop\3rd November File\nidhi.xls
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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.
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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
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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 healthregulations once we have allowed use of substance.
Regulation has to be part of use (registration) process.
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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.
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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.
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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?
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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 environmentfriendly products.
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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.
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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.
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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.
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