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Pesticide registration Process

Tea Research Institute Seminar 30th May 2014

Anura Wijesekara Registrar of Pesticides

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Regulatory Activities in Sri Lanka •Pesticides freely imported up to 1962 •1963 Controller of Imports & Exports limit imports to Rs. 5.23 mil •Committee appointed – list of agrochemicals drew up •DOA submitted ‘Act on Poisons Used in Agriculture’-draftsman 1964 •Pesticide Formulary Committee of DOA approved pesticide imports •1972 DOA consulted FAO to build National regulatory infrastructure •Open import policy continued-Imports controlled •1977 Imports liberalized – control system abandoned •1980 Control of Pesticides Act enacted -1980-33 •1983 Registrar of Pesticides appointed •1994 Control of Pesticides Act (Amended) -1994-6

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Control of Pesticides Act No. 33 (1980) /Amended Act No. 6 (1994) 1. Provisions to regulate imports, formulation, packing, labeling Storage, transport, sale and use of pesticides 2. Basis of regulation –through compulsory registration 3. Label and container requirements to be approved before sale 4. Successful applicants grant registration for 3 years 5. Import approval by controller imports only after ROP approval 6. Consumer protection covered – adulterated/deteriorated products. Storage with food stuff, deceptive advertising, harvesting interval to Avoid residues 7. Penalties

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Pesticide registration Process

•Types of Pesticides Agro Pesticides Domestic and Public Health use Pesticides Industrial Pesticides •Pesticides Technical & Advisory Committee (PeTAC) Agro Pesticides Subcommittee Domestic & Public Health Pesticide Sub Com. Industrial Pesticide Subcommittee

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The Committee (PeTAC) consist of – (a) the following ex officio members namely:- (i) the Director of Agriculture /officer nominated by him. (ii) the Registrar of Pesticides /officer nominated by him. (iii) The Government Analyst /officer nominated by him; (iv) the Secretary to the Ministry of Health /nominated by him. (v) the Commissioner of Labour /officer nominated by him; (vi) the Director of the Tea Research Institute /officer nominated by him; (vii) the Director of the Rubber Research Institute /officer nominated by him; (viii) a member of the Sri Lanka Standards Institution nominated by the Chairman; (ix) the Director of the Coconut Research Institute /officer nominated by him; (x) a Senior Officer of the Central Environmental Authority; and (b) not more than five persons who are experienced in the use of pesticides, pest control and related scientific disciplines who shall be appointed by the Minister: Provided however, that no person having a commercial interest in the manufacture, import, marketing, formulation, storage, transport or sale, of pesticides shall be appointed; and

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Pesticide Registration Process

Evaluation of Pesticide Registration Dossier

Risk/ Benefit analyses

Chemical, toxicological and env. Effects with respect to local conditions of use

Local tests on Suitability/ Bio-efficacy

Local standards

Agriculture, vector, public health etc.

Pre registration Evaluation

National policies

WHO Haz. Class, Chronic health, residue and env. Effects, available alternatives

REJEC

TION

OF A

PP

LICATIO

N

No

t Satisfacto

ry

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Stages of Registration

Provisional Permit

• Pending verification

License

• Restricted

• General

• Household

Re-registration

• Re-evaluation of the Risks/benefits based on updated information and knowledge

Use category/ Risk ranking

After 3 years

Assignment of risk

reduction measures

according to the product

and use profile

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Banned Pesticides in Sri Lanka

1970 – Enrin

1976 – DDT

1980 – Chlordimefom

1980 – Dieldrin

1980 – Phosphamidon

1980 – Thalium sulphate

1984 – 2, 4, 5, T

1984 – ethyl parathion

1984 – Methyl parathion

1986 – Aldrin

1986 – Lindane

1987 – HCH

1987 – Mercury compounds

1988 – Arsenic

1988 – Heptachlor

1988 – Leptophos

1989 – Captafol

1990 – Dichloropropane

1990 – Aldicab

1995 – Methamidaphos

1995 – Monocrotophos (restricted to coconut)

1995 – Chlordane

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2010

Fenthion

Paraquat

2012

Carbofuran

Carbaril

Chlorpyriphos

Propanil

2011

Cyromazine

Alachlor

Yet to Gazette but No imports allowed

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CKDu, WHO results & recommendations

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Hypothesis of CKDu in Sri Lanka

1. Cadmium in water & food (Bandara , 2007)- Findings refuted 2010

2. Fluoride in Drinking Water

3. Fluoride in Water & Aluminum cooking pots (Illeperuma, 2009)

4. Cyanobacterial toxins (Dissanayake, 2011)

5. Arsenic , pesticides & Hard Water (Jayasumana et al. 2011)

6. Aurvedic medicine, illicit liquor, pesticides, agro chemicals

7. Chronic Cadmium poisoning through food chain (WHO. 2012)

8. Multi-factorial including Genetics (Peradeniya + Kiyoto Universities)

(2012) 9. Glyphosat, Hard water and Heavy Metals (Jayasumana et al, 2014)

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The ‘battle’ over establishing the cause of chronic kidney disease of unknown aetiology (CKDu) in the North Central Province (NCP), the seat of Sri Lanka’s ancient civilisation, has been highlighted in many newspapers, television and radio programmes in recent years. The cause of CKDu is likely to be multifactorial. At this point in time there is insufficient evidence to pinpoint a cause(s). Wikramasinghe, A.R. et al. 2011. Ceylon Journal of Medical Science. 56(4). These finding may support the contention that chronic exposure to low levels of Cd may be playing a role in causation of CKDu in Sri Lanka. Co exposure to As is likely to aggravate the effect Cd on the kidney making the changes More pronounced than exposure to Cd alone. WHO report, 2012

6. Cause of unidentified Kidney Disease ?

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“Heavy metal analyses in rice and pathological analysis did not support cadmium and arsenic induced nephropathy. Taken together, no single factor can explain the pathogenesis of CKDu. Instead, the present study suggests the involvement of multiple factors in the pathogenesis of CKDu”. An Integrative Study on Genetic and Environmental Determinants of Chronic Kidney Disease of Unknown Etiology in Sri Lanka – Kyoto University submitted publication

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“CKDu represents an immerging [sic] new type of nephropathy, caused potentially by chronic arsenic poisoning with the contribution of heavy metals, pesticide residues, heat stress and chronic repeated Dehydration poor quality of drinking water and genetic variations (Specially AS3MT gene).” Jayasumana M.A.C.S., et al. 2013. Journal of Natural Sciences Research

I think the paper by Jayasumana et al has raised many questions than answers. My opinion is that as the findings of various studies are contradictory it is not possible to conclude that arsenic is a contributing factor for CKDu.

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Concerns & Questions of the Arsenic Hypothesis proponents

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Arsenic upheaval and the Bureaucratic bungling June 20, 2011, 5:18 pm

A response to the article of Dr. Anura Wijesekara, the registrar of pesticide published in The Island on 18th June.

•Trying to underestimate the magnitude of the crime of importing banned hazardous chemicals (not true) •Levels given for food items unbelievably very high and reference given to an authentic source (SLSI levels reference given) •WHO Codex elementrious [sic] has not set any minimum residual levels for arsenic or mercury in food items (not true for eg. Table salt 0.5 ppm As) •Layman question; customs claims more than 50 samples (brands), Kelaniya/Rajarata team claims that 28 brands tested positive for As,13 for Hg You have tested only 23 out of more than 1000 brands you have registered (misdirection). •How can you confidently tell the public that only 2-3 brands contain arsenic? And there is no mercury in pesticides? (mercury was not tested at the time)

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Arsenic upheaval and the hypocrisy of the Academia June 29, 2011, 7:33 pm

•Studied of the development of "Arsenic Issue" in the media. shows groups with vested interests were trying to cover up the core issue; importing banned agro-chemicals into the country (not true) •Need to do social research as to why Sri Lanka has banned only 25 out of about 80 chemicals banned world wide (uncertain of what chemicals) •Most dangerous thing happen to our farmers; the import of deadly Endofin from India. Recently Supreme Court in India banned Endofin (Endosulfan banned in India by Supreme court on May 13, 2011). Sri Lanka banned Endosulfan in 1998.

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•No country in the world has set so called minimum levels of As & Hg in pesticides, because agro-chemicals containing them are totally banned (not true see FAO specifications) •If anyone of our academics suggest for so called minimum levels that will be a violation of Rotterdam convention which Sri Lanka has ratified (not true RC is on PIC). •How academics accept the claims of the, pesticide registrar that only three brands of pesticides containing As and none containing Hg out of more than one thousand brands he has Registered (misleading)

Continued…………

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FAO Standards (As impurity) Sulphur 80% 400ppm Copper Oxychloride 50% 50 ppm Prophineb 70wp 21 ppm

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Misconceptions

1. No Arsenic in Bed rock of Sri Lanka therefore our soil cannot have As. a). Literature available to show presence of As in bed rock b). Credible scientific evidence for presence of As in non agricultural soils 2. Increased levels of As, Cd and Hg in water resources in CKDu endemic areas Evidence against this by many independent research groups including WHO, Japanese and Indian scientists. 3. Pesticides imported to Sri Lanka has more Arsenic and Mercury Evidence from other countries suggest differently WHO and Indian group findings give no such evidence 4. Arsenic is deliberately added to pesticides to increase effectiveness The level of As found in pesticides can not do this 5. Pesticides bought in Colombo has less Arsenic and Mercury Evidence given is not scientific & not verify as some imported already packed 5. Only 6 pesticides can have Arsenic as an impurity according to IU?? Publication This publication is based on published information on pesticide AI only (IUPAC)

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8. Arsenic & Hg should be considered as active ingredient even at ppb levels & there for pesticides with these cannot be imported to the country according to 2001 regulation ROP office use standered definition of AI used world over ROP has gazetted the 2001 notice of banning certain pesticides Control of pesticides act has given definition of ‘active ingredient’ Clarification of the definition can only be done by the courts 9. Arsenic and Hg levels in Pesticides should be zero (cannot measure) Good if possible but impossible to produce any chemical without impurities In addition to AI the inert material contain heavy metals 10. ROP supporting multi-national companies The actions taken due to As pressure group s are doing this not ROP

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0

1000

2000

3000

4000

5000

6000

7000

8000

9000

1 2 3 4 5 6 7 8 9 10 11

Pesticides imports to Sri Lanka

Value (CIF) US $ = 42,0022,90.00 (2011) 22

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year Total Weed Insect fung extent per ha

2001 3457 2055 848 553 7982.6 4.3

2002 3630 1994 892 443 8525.29 4.2

2003 4984 2731 1468 785 9826.17 5.07

2004 5037 3036 1256 745 7785.42 6.5

2005 6214 3623 1699 891 9371.81 6.6

2006 5620 3187 1576 847 9104.93 6.1

2007 6059 4143 1193 722 8167.16 7.4

2008 6266 3808 1585 872 10529.95 5.9

2009 4386 2749 1036 599 9775.62 4.5

2010 8258 5366 1843 1048 10652.8 7.7

2011 7693 5031 1712 949 12175.91 6.3

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What DOA has done since 2011

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What the DOA has Done

1. Re Activated the PeTAC and 3 subcommittees appointed – regular meetings

Agro Pesticide Subcommittee

Domestic & Public Health Subcommittee Industrial Pesticide Subcommittee 2. Analytical Reports for 9 heavy metals & Cyanide made mandatory (from accredited labs) for issuing import permits 3. Risk assessment for setting up maximum impurity levels initiated 4. Implemented FAO guideline for calculating worst case contribution by impurity to toxic hazard of pesticides (temporary solution) 5. Limit of Cyanide introduce as 2ppm 6. LOD for As, Ca & Hg 0.1 ppm and for other heavy metals & Cyanide 1 ppm 7. Random testing of imported chemicals for As & Hg from ITI 8. Container recycling/disposal program with Ministry of Environment/Industry 26

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What DOA has done 8. Trade name proliferation of pesticides stopped 9. Two Proposals submitted to the Ministry for improving quality control of pesticides 1). To appoint Assistant Registrars of Pesticides for each district establish 4 divisions in ROP office with required capacity & New spacious building with modern laboratory b) . Improve available laboratory facilities & implement awareness program 10. Regulations brought up by the minister to appoint Pesticides Sales and Technical Assistants for all sales outlets & registration of pesticides service providers. 11. Revision of pesticide recommendations by all crop research institutions (in progress) 12. Cooperative research with CKDU research group in Medical Faculty, Peradeniya University

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8. Quality analysis for pesticides at ROP lab continued – test for physical & chemical quality, level of AI, Major & minor impurities (>1% & >0.1%) 9. Database established – Pesticides import approvals given & amount imported available at any time. 10. Re-testing bio-efficacy for re-registration of pesticides introduced 11. All available credible scientific evidence evaluated to find out whether use of pesticides have increased heavy metals in soils or water – results negative

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PeTAC advice and ROP decision

New Policy on Agro-Pesticide Trade Names – Circular No. RP/2012/02 1. Arbitrary trade name allowed for Patented Products 2. Arbitrary trade name allowed for specialty products 3. Descriptive Trade name using generic name of pesticides mandatory for commodity products a) Company name + Generic name (Preferred) or B) Arbitrary name + Generic name •All product labels & Advertisements needs to be changed accordingly By 1st of January 2013

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Green Revolution

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Sri Lanka Paddy production Source: Department of Census and Statistics, Sri Lanka

1952 = 604,000 MT 2010 = 4,301,000 MT Increase of 712% in 60 yeas) Population 1953 = 8,097,900 2012= 20,277, 597 (Increase of 250%) (Value 2011 production = $ 1955,145,000 @ $590.5 Sept. 2012)

Possible due to Green Revolution but it has ill effects 32

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1. Degradation of land: 2. Weeds have increased: 3. Pest infestation has gone up: 4. Loss of bio diversity: 5. Chemicals in water & food: 6. Water scarcity: 7. Loss of indigenous varieties: 8. Health problems:

Costs of Green Revolution

“We cannot solve our problems with the same thinking we used when we created them” Albert Einstein

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Poison is in everything, and no thing is without poison. The dosage makes it either a poison or a remedy. Paracelsus

All Pesticides are Poisons!

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Insecticide Use Based on IPM Insecticide Use Based on FMCG

Based on rational decision

making skills. Judicious use

Driven by product packaging, brand

names, attractiveness, recalls.

Need to use knowledge on

pests, natural enemies,

predation.

Less (or no) thinking

needed. Example calendar

spraying schedules

Maximize value of knowledge Maximize value of sales

Based on economic rationales Based on emotions, viz status,

desire, fear, perceptions, sense of

power, price

Comparison of insecticide use based on IPM & Fast Moving Consumer Goods (FMCG)

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