pesticide registration - processes andhlld challenges dr...

Pesticide Registration d h ll- processes and challenges

Dr Henry Wainwright

www.realipm.comh l ( ) d

© The Real IPM CompanyThika, Kenya

The Real IPM Company (Kenya) Ltd

Scope of Presentation

• Commercialising a pesticide in Kenya (East Africa)in Kenya (East Africa)

• Pesticide Regulations

• Pesticide Registration.

© The Real IPM CompanyThika, Kenyawww.realipm.com

Qualifications to speak

Bi l i l lBiological control company based in Kenyay

Production and sale of BCAs

BCAs need registration just like h lliother pest controlling agents

Registrations in Kenya, Ethiopia, Ghana, Mozambique and SA


q

Why register a pest control product

S f d ffiSafety and efficacy

S f l (Safety – people (consumer, operator, public), crop, environment, p p ) pnon- target organisms.

Efficacy – does it work, does it do what the label says, yconsumer protection.


Once registered

R i i i l b hRegistration is approval by the authorities

Approval to:Use, Ad tiAdvertise, Sell, ,Store and S l


Supply.

Approval terminology

C t tiCrop protection

Pest Control Products – hence the Pest Control Products Board inPest Control Products Board in Kenya (PCPB).

Plant Protection Products (PPPs).


Approval – the African situation

E i diff ( l )Every country is different (nearly)

Differing degrees of transparency.

Need for clarity on:y- what is required, - interpretationinterpretation,- consistency of risk assessment.


Registration process - simplified

Pre-sub consultation (local help)( p)

Submission of application andSubmission of application and technical dossier of information

Independent efficacy trials –three seasonsthree seasons

Review of dossier and trials reports and subsequent committee approval – hopefully!


committee approval hopefully!

Application form and dossier


Application form

Information on the both:Information on the both: - active ingredient (a. i.), and

f l t d d t- formulated product

Statement made in application form supported in technical dossierpp

e g LD for ratse.g. LD50 for ratsSource of independent evidence


Application form

Major component:Major component:

T i l d- Toxicology and - Eco-toxicology information.

from independent source.from independent source.


Cost of registration

Depends on many factorsDepends on many factors

In the EU this would costIn the EU this would cost 500,000 - 750,000 USD

In Africa ranges from: 30 000 200 000 USD30,000 – 200,000 USD

C t i d b thCost incurred by the manufacturer/distributor


Time taken for registration

Again variable:Again variable:

How much informationHow much information already available?

Ghana - one to two yearsK h fKenya – three to four years

If GMO th 10If a GMO then 10 years.


Scope for harmonisation

EU has harmonised approval ofEU has harmonised approval of active ingredients (a.i. s)a.i. s go into harmonised list –Annex 1.eFormulated products approved at EU i l d l l lEU national and zonal level.

N h i ti i Af i tNo harmonisation in Africa apart from CILLS countries.


Kenya – Case study

TransparentTransparent

P d f il blProcess and forms available on www.pcpb.or.kep p

Annual published list of registered dproducts.

U d d d l thUnder resourced and lengthy decision time.


Ghana – Case study

Just publishedJust published “Guide to registration ofregistration of biological control agents” in Ghana

Funded by DFID’s Research Into Use (RIU)Research Into Use (RIU) programmewww.researchintouse.com


Botanical pesticides in Europe

Rotenone withdrawnRotenone – withdrawn

Nicotine - withdrawn

Neem (azadirachtin) – never i t d/ dregistered/approved

N t l th i dNatural pyrethrins - approved


On farm production

Regulators ignore “on farm” production for home useproduction for home use.

Regulators only activatedRegulators only activated when sold in market place


Commercialising?

Size of the market crops areaSize of the market - crops, area, target pests.

Cost of bringing to market place?

Registration and marketing costsRegistration and marketing costs

Competitive products


Commercialising?

Why will the famer buy our product?Why will the famer buy our product?

P i i ll i t t f thPrice – especially important for the small farmer

Efficacy – linked to resistance

Availability – distribution issues

Residues – more for export crops© The Real IPM Company

Thika, Kenyawww.realipm.com

p p

Commercialising?

Specific or broad spectrum?Specific or broad spectrum?

R l i IPM ?Role in an IPM programme?

Shelf life at ambient temperatures

Reliability of production

Consistent Quality


Commercialising?

Compatibility with pesticidesCompatibility with pesticides


Commercialising?

Finally:Finally:

What will be our return on investment?

What are the risks (do a SWOT)?( )

D i i ti YES NODecision time: YES or NO


Conclusion

Regulations are important

Opportunities for harmonisation and regional mutual recognitionand regional mutual recognition

S f t i th t i t tSafety is the most important aspect in PPP use

Thank you


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