harmonization efforts- biocontrol lilongwe malawi august 2012-
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Transcript harmonization efforts- biocontrol lilongwe malawi august 2012-
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
1
Scope
Introduction
Efforts towards harmonization
Challenges
Recommendations on way forward
Conclusion
2
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
7
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.
9
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
13
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
14
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
20
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
21
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
22
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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