Harmonization of biopesticide regulatory Framework By Paul N. Ngaruiya (Dr) Pest Control Products Board (PCPB) 4 th Technical meeting of the Regional SPS.

Harmonization of biopesticide regulatory Framework

By Paul N. Ngaruiya (Dr) Pest Control Products Board (PCPB)

4th Technical meeting of the Regional SPS subcommittee,

Lilongwe, Malawi 20-22 August 2012

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Scope Introduction Efforts towards harmonization Challenges Recommendations on way forward Conclusion

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Introduction Registration of PCP is an important legal

requirement All over the world US-EPA, UK-CRD, Canada- PMRA

Every government has an obligation to ensure the safety of its citizens, animals, plants and the environment.

The primary purpose of using pesticides is to control pests in crops and animals in order to reduce yield losses.– there are new emerging pests/diseases eg aflatoxin in maize with no registered products, food safety concerns

Pesticides are toxic Effects on environment eg DDT

Introduction- BiopesticidesBiopesticide regulatory systems in place– necessitated

by EU MRL requirementsInclude;1)Microbial pesticides (bacteria, viruses, fungi, etc)2)Biochemical pesticides eg

Semiochemicals eg insect sex pheromones, Enzymes (proteins) Botanical pesticides etc

3) Natural enemies Parasitoids Predators

Biopesticides; Current status in Kenya An increase in the number of applications About 10% the 1033 products are derived from

plants, microorganisms or macroorganisms (Pyrethrum based, neem, Bacillus thuringiensis etc)

Local and imported Biodegradable, environmentally and user friendly,

low pre-harvest intervals Most are specific to target pests Some data requirements waived through tiered

approach Residue data not required for most biopesticides

Biopesticide regulation– challenges faced in scaling up use

Most pesticide legislations are geared towards conventional chemicals– Not suitable for biopesticides

Some regulators unsure of the new products- biopesticides (with different defns.)

Capacity for Identification, quantification and culture collection More than one law regulates biopesticides-eg For importation

of live organisms KSTCIE, in addition to registration, Biosafety issues

Most biopesticides do not have a knock down effect Narrow spectrum of activity Storage under special conditions– some perishable Compatibility with other pesticides

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Biopesticide regulation in Africa—Most countries operating independently

Efforts towards harmonization Several Harmonization initiatives—

EAC, COMESA, SADC, ECOWAS, CILSS, CPAC, SEARCH

Most initiatives supported by legal instruments—treaties, procotols etc

Common objectives--- Harmonize policies, legislation and regulation

for enforcement of pest and disease control, promote the coordination and harmonisation cooperation and co-ordination of regional

agricultural policies promote economic integration

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Efforts towards harmonization

harmonization of bio-pesticide legislation was identified as a priority focus of the tripartite agreement between COMESA, EAC and SADC.

According to RECS procedures, technocrats have a responsibility to move draft guidelines up the policy makers for enactment into law.

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Benefits of harmonization Harmonized farm input regulation may reduce

the cost of farm inputs ease the need to generate technical data to

support registration or approval in the partner states

Shared technical expertise leading to farmers accessing new products for use in IPM

Synergism Reduces duplication of efforts.

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Regional Registration Strategy Round Table Facilitated by USDA-FAS and AATF on 12-13th

June 2012, Zanzibar Attended by COMESA, some representative

countries—Kenya, Tanzania, Zambia, Mozambique, USDA, COLEAP-PIP, IITA, AATF, regulatory experts

Meeting objectives to share information on biopesticide regulation Identify next steps in developing a possible regional

harmonization project for registration of bio-pesticides with a particular emphasis on microbial biopesticides

Project Goal: To Develop a regional microbial bio-pesticide regulatory guidance document 11

Facilitating StructuresA project Steering Committee established consisting of: Regulatory representatives from “pilot countries”,

including Kenya, Mozambique, Tanzania, and Zambia.

Additional representatives would be sought from two West African countries

Stakeholder organizations, including AATF, IITA, and USDA

Observers would be invited from COMESA, EAC, SADC, ECOWAS, and the AU --for eventual consideration of guidelines by RECs

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Terms of reference for Steering committee

to facilitate the coordination and planning in the development of a bio-pesticide (microbials) registration guidance document.

Implement “Plan of Action” Review drafts of the guidance document developed

by the working groups. Steer the project through regional bodies (e.g.,

COMESA, SADC, EAC, ECOWAS), where pilot countries present the draft documents and action plans. SPS meetings could be used to report on progress

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Working group

A Technical Working Group would subsequently be established to work on specific technical aspects of the guidance document, and would include three members from each of the pilot countries.

Regulatory and technical experts will be brought in as consultants to the project, as needed

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PLAN OF ACTION

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Component 1: Development of Guidance Document

USDA and AATF contract a regulatory/legal expert to review and summarize relevant existing documents – eg SADC guidelines, Kenyan, Ghanian, etc (by mid-July, 2012).

Common internet web portal for pilot countries to download and share relevant documents - (by mid-July, 2012).

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Component 1

Consultant will review, compare, and summarize relevant document and prepare a recommended course of action for the development of a common guidance document -September 15, 2012).

Project start-up workshop (bio-pesticide overview & table of contents for draft guidance document (by October 30, 2012).

Development of zero draft by technical working group. Steering Committee review (Initiated: October 30, 2012).

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Component 1 Steering committee Endorsement of draft 1 (by early

February, 2013). Draft 1 disseminated for in-country meetings for

additional stakeholder input from pilot countries (by end February, 2013).

Consultant revises/refines draft and circulates to technical working group (by end May, 2013).

Review and approval by Steering Committee pending recommendations from the RECs) (by mid June, 2013).

Final guidance document disseminated (by end June, 2013).

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Component 2: Endorsement of Guidance Document through the REC policy

organizations meeting of experts convened by RECs in

the tripartite framework to consider the guidelines

meeting of experts convened by ECOWAS

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Component 3: provide technical support to countries for

translating guidance into legal instruments

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Other activities—capacity building

establish links with other initiatives that are working to provide laboratory capacity building in parallel.

Capacity building in testing aflatoxin levels in specific value chains

formulation analysis of biocontrol products risk assessment

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Challenges in harmonization Different regulatory procedures – takes long

come to a compromise Legal barriers eg for a document to be

agreed upon and be deemed legal all partner states/member states have to be present

Limited experience in certain areas and variation among countries eg Biopesticide regulation, MRL setting and residue trials

Policy changes midstream Limited funding –

eg 1 meeting in a year leads to loss of momentum institutions facilitate the meetings using own

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Recommendations Have a common understanding of what

biopesticides are Political support is paramount Borrow a leaf from developed countries operating

a harmonised system– eg rapportuer states for ai, Joint meetings, work sharing, zonal submisions

Guidance on technical and procedural issues from international bodies eg FAO, COLEAP/PIP

Evaluation and Accreditation of trial institution for mutual recognition/ zoning

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Recommendations Embrace external support to facilitate harmonization

meetings Consultants/experts from other harmonized trading

blocks to share experience Capacity building

to facilitate decision making for regulators eg How to carry out health and risk assessment

to facilitate local testing institutions to conduct tier 1 studies– toxicology and ecotoxicology

To facilitate researchers/regulators to confirm identity of specific biopesticides

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CONCLUSION

Do you consider the initiative on harmonization of biopesticide regulation important?

What should be the next step?

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Thank you

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