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Harmonization of biopesticide regulatory Framework. By Paul N. Ngaruiya (Dr) Pest Control Products Board (PCPB ) 4 th Technical meeting of the Regional SPS subcommittee, Lilongwe, Malawi 20-22 August 2012. Scope. Introduction Efforts towards harmonization Challenges - PowerPoint PPT Presentation
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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
budgets22
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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