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
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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- Biopesticides
Biopesticide regulatory systems in place– necessitated
by EU MRL requirements
Include;
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 productsbiopesticides (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
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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
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 promote economic integration
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
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 Reduces duplication of efforts.
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
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Facilitating Structures
A 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
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eventual consideration of guidelines by RECs
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
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June, 2013).
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
budgets
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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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