Harmonization of biopesticide regulatory Framework

1
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

2
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

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Introduction- Biopesticides

• Biopesticide regulatory systems in place
  necessitated by EU MRL requirements
• Include
• Microbial pesticides (bacteria, viruses, fungi,
  etc)
• Biochemical pesticides eg
• Semiochemicals eg insect sex pheromones,
• Enzymes (proteins)
• Botanical pesticides etc
• 3) Natural enemies
• Parasitoids
• Predators

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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

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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 AfricaMost 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
  instrumentstreaties, 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
  countriesKenya, 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 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 activitiescapacity 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