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 August

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 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 6

7 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 8

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  Reduces duplication of efforts. 10

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

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 15

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). 16

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). 17

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). 18

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 19

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 23

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 24

CONCLUSION  Do you consider the initiative on harmonization of biopesticide regulation important?  What should be the next step? 25

Thank you 26