PCPB/111/REG/VOL.III/20/228 22nd December, 2020 TO: ALL LOCAL AGENTS RE: ELECTRONIC SUBMISSION OF PEST CONTROL PRODUCTS DATA SUMMARY & LABELS: CHANGE TO THE EMAIL ADDRESS. Introduction: This guideline is for electronic submission of Data Summary Application and Other Supporting Documents for Consideration of Registration and Draft Commercial Labels communicated vide circular Ref: PCPB/III/REG/VOL.II/20/017 dated 15th April 2020 and PCPB/111/REG/VOL.I/20/145 dated 30th March 2020, respectively. Change of the email address To serve you better a dedicated email address has been set up. It is in this regard; within 10 days from the date of this circular you will be required to submit the data summaries and draft commercial labels electronically through email@example.com . Note that all other requirements remain as communicated vide the respective circulars. Dr. Esther Kimani CHIEF EXECUTIVE/SECRETARY Copy to: CEO, Agrochemicals Association of Kenya PCPB Registration Officers PCPB Accounts & Finance PCPB Research, Strategy, Planning & Performance Management PCPB ICT PCPB Compliance & Enforcement PCPB Analytical Services Download Circular on Submission Labels and Summaries
PCPB/111/REG/VOL.I/21/119 10th June 2021 TO ALL LOCAL AGENTS & Registrants REF: REQUIREMENT FOR RISK ASSESSEMENT FOR ALL PEST CONTROL PRODUCTS & LABEL EXTENSION PROPOSED FOR INTRODUCTION IN KENYA The Pest Control Products Board (PCPB) is a Statutory organization of Kenya Government established under an Act of parliament, the Pest Control Products Act, Cap 346, Laws of Kenya of 1982 to regulate the importation and exportation, manufacture, distribution, use and disposal of pest control products. One of the Mandate of PCPB is “Assessing the safety, efficacy, quality, merit and economic value of pest control products with a view to approving them, if found suitable in our local situation”. Following the risk assessment sensitization workshops undertaken on 12th November 2019 and 15th-16th April 2021, all applications for consideration of approval of pest control products must be accompanied by submission of risk assessment reports. To ensure that the pest control products introduced into Kenya do not pose unacceptable risks to the users, consumers, and the environment, when applied according to the Kenyan good agricultural practices (GAP), as of 1st July 2021, you will be required to provide detailed human (occupational and dietary) and environmental (Bees) risk assessment reports for all applications of new products and label extensions. This will inform the decision-making during consideration for introduction of pest control products, label extension and label communications to the users. The risk assessment Guidance documents can be downloaded from our website risk assessment Guidance documents The risk assessment report shall be submitted during submission of summary dossier for new products through the email: firstname.lastname@example.org and upon completion of efficacy trials for label extension. i.e., following the conclusion of the local experimental efficacy trials. The Applicant to provide the summary of risk assessment: 1. Brief on the quality of the data referenced for hazard assessment (e.g., Experimental design and quality of the critical study or studies) 2. Kenya Good agricultural practice (GAP) Table for efficacy and residue (GAP) Table for efficacy and residue 3. Operator exposure models and local risk assessment ; Worker exposure models and local risk assessment; consumer exposure models and local risk assessment; bee exposure model and the local situation should be provided in .pdf format. The Input and output page (enclosed) of the exposure should be attached (.pdf) 4. Brief discussion of conclusion arising from the model’s output 5. Discussion on the proposed realistic pesticide risk management Note that the Pest Control Products Board reserves the right to request for more information that will allow for an informed decision making. Dr. Esther Kimani CHIEF EXECUTIVE /SECRETARY Copied to: 1. PS, State Department for Crop Development & Agricultural Research 2. CEO, Agrochemicals Association of Kenya 3. Chairman, Pest Control Products Board encl: • GAP Table for Efficacy • Assessment summary table – Operator exposure modelling and local risk assessment • Assessment summary table – Worker exposure modelling and local risk assessment • GAP table for residue • Assessment summary table – Bee exposure modelling CIRCULAR: RISK-ASSESSEMENT-FOR-ALL-PRODUCTS-AND-LABEL-EXTENSION
GAP table for residue | Assessment summary table – Bee exposure modelling
PCPB/III/REG/VOL.III/20/143 15th October, 2020 TO ALL LOCAL AGENTS RE: ELECTRONIC SUBMISSION OF PEST CONTROL PRODUCTS TECHNICAL DOSSIERS (Version 1.0) Introduction: This guideline for electronic submission of dossiers has been developed taking cognizance of the prevailing international best practices and in order to scale down on use of bulky paper submissions. This will also prepare the groundwork for future fully fledged online submission of dossiers. The handling of the data provided will be governed by existing laws and regulations. This guideline shall be followed when submitting the application documents and supporting information in electronic format. A well-constructed, named and indexed submission expedites the screening and review process and reduces assessment time. The use of electronic dossier submission will enable the Pest Control Products Board (PCPB) review efficiently, safely and improve the quality of dossier submitted. It is the responsibility of the local representative to submit the dossier (s) in the format indicated below. Technical Dossiers that do not meet these requirements will not be accepted. Scope: This guideline is for the electronic submission of new technical dossiers and resubmission of previously deferred applications. This guideline does not replace the legal requirements for appointment of the local representative and thus an applicant who is not a resident in Kenya must appoint an agent permanently resident in Kenya and duly recognized by the Pest Control Products Board. Timeline for operationalization: Due to the current prevailing conditions occasioned by the Covid-19 pandemic, the guideline takes effect immediately from the date of this circular. Other requirements that continue to be in force: The Applicants are advised to submit dossiers in prescribed Application Forms, abide by all previous circulars i.e. Dossier submission appointment (PCPB/REG/VOL.II/10/03 dated 9th July 2010), Submission of Technical Dossiers for Generic products (Ref: PCPB/111/REG/VOL.I/19/116 dated 27th March 2020), the format of presenting electronic submission of Data Summary (Ref: PCPB/III/REG/VOL.II/20/017 dated 15th April 2020) and electronic submission of Labels (Ref: PCPB/111/REG/VOL.I/20/145 dated 30th March 2020). Method of electronic dossier submission: The technical dossier should be provided in encrypted compact disk (CDs) in .pdf format ONLY. The PDF should be secure removing features that enables printing, copying, deleting and converting to other formats e.g. word. To allow for preliminary check, the documents provided must not be scanned. Where the submitted documents are password protected, the password must be securely provided to Pest Control Products Board. i) Submission of the Confidential Business Information: The Confidential Business Information as indicated in the Circular (ref: PCPB/111/REG/VOL.IV/15/152 dated 11th November 2015) shall be provided in hardcopy accompanied by the hard copy of one Application Form, one hard copy of Form A6, the original letter (s) of appointment, hard copy of contract agreement, letter of access. Applicants are advised to provide the official email address (es) for correspondence. Documents in hard copy must be sanitized in line with Ministry of Health guidelines. ii) Submission of the Rest of the Technical Dossier: The dossier must be submitted in prescribed format (folders & subfolders corresponding to the Annexes in prescribed Application Form). The CD should be enclosed and protected from physical damage. The individual study reports provided must be clearly labelled representing the Annexes in the respective Application Form. Please note that each folder MUST contain individual study reports e.g. do not provide Acute Oral and acute dermal study in one folder. Where more than one data sets/ piece of information are presented in a single PDF file (e.g. physical chemical and stability studies present in a single chemistry PDF), the PDF file must have all the contents either indexed (table of contents (with automatic link)/index page) or bookmarked to enable navigation of the file and ease of review. Where the dossier does not conform to these guidelines it will be returned to the Applicant to review accordingly. Dossier arrangement: The dossier must be presented using appropriate subfolders (example is given below). The studies should be Annexed as in the Respective Application Form The study reports must be clearly labelled as per the relevant Application Form Submission of the Administrative Files: The letters e.g. Letters of appointment, letters of access, phytosanitary clearance (where applicable) etc., proof of registration, authentication documents, prescribed Application Forms (relevant Application Form, Application Forms C, A6) provided must be in .pdf format (the jpeg, .pub, .doc, .docxor other versions are not acceptable). Procedure of e-dossier submission: 1. Applicants are encouraged to have an online pre-consultation meeting with a Registration Officer. The applicant should book an appointment to have a skype (regdepartment) virtual consultation with a Registration Officer. 2. Applicant books an appointment through the registration department front desk and is recorded. 3. A registration officer shall be allocated to handle the application in line with PCPB internal procedures. 4. The Registration Officer shall process the Pay Advise for the Applicant to pay prescribed fee as determined by the Board from time to time. The official receipt shall be issued to the applicant a .pdf copy of which must be included in “Administrative folder” of the Dossier. 5. The Registration Officer shall give the date and time for the submission of the dossier. 6. The applicant/local agent shall provide the CBI dossier with the original letter of appointment from the registrant and e-dossier on the day of submission. The CD must be clearly labelled with indelible ink or preferably printed: “Trade name of the product + Active ingredient(s) + Local Agent e.g., PCP 250EC+Deltamethrin 250_Waiyaki E.A 7. The Applicant shall sign the CBI Submission Form (Form C) Form C1 CBI Submission and included in the CBI file. 8. The dossier shall undergo preliminary check and the applicant informed within two (2) working days of dossier submission of the outcome. a. Where the technical dossier meets the criteria as set out, the Applicant shall be informed that the dossier has been provisionally accepted and await the outcome of the PCPB internal processing. b. Where the technical dossier has not met the criteria as set out, the Applicant shall be informed of the deficiencies. 9. The outcome as prescribed in 8(a) will be communicated to the Applicant not more than ten (10) working days from the day of submission of the technical dossier. 10. Once the dossier is accepted, the Experimental Permit shall be issued within the period stipulated in the PCPB Service Delivery Charter Dr. Esther Kimani CHIEF EXECUTIVE OFFICER /SECRETARY Copy to: CEO, Agrochemicals Association of Kenya PCPB Registration Officers PCPB Accounts & Finance PCPB Research, Strategy, Planning & Performance Management PCPB ICT PCPB Compliance & Enforcement PCPB Analytical Services DOWNLOAD CIRCULAR ON PCPB GUIDELINES ON ELECTRONIC SUBMISSION OF DOSSIERS
IMPLEMENTATION OF GUIDANCE ON DOSSIER EVALUATION FOR THE REGISTRATION OF PEST CONTROL PRODUCTS IN KENYA
IMPLEMENTATION OF GUIDANCE ON DOSSIER EVALUATION
This document describes suggestions for further steps that can be taken with regard to the evaluation of pest control products in Kenya. The document should be read together with the document describing proposed guidance on dossier evaluation for the registration of pest control products in Kenya and as such both contribute to a future complete pesticide evaluation manual for Kenya. Both documents were developed within the Pesticide management initiative East African Region: Kenya (PEAR -Kenya) project. The project ran in the period 2016 – 2019 and was sponsored and supported by the Dutch Ministry of Agriculture, Nature and Food Quality and the Embassy of the Netherlands in Nairobi.
This document is intended to feed into discussions on further development of a complete pesticide evaluation manual for Kenya using the guidance mentioned as a starting point. Reflections on some of the methods proposed and also information on what is needed to implement the guidance developed in the project are provided. Additionally, suggestions for developing a framework for the risk assessment of aquatic organisms are given
GUIDANCE ON DOSSIER EVALUATION FOR THE REGISTRATION OF PEST CONTROL PRODUCTS IN KENYA
GUIDANCE ON DOSSIER EVALUATION FOR THE REGISTRATION
This document describes guidance on dossier evaluation for the registration of pest control products in Kenya. The document provides guidance for the assessment of a limited number of aspects that are part of evaluation of a pest control product registration dossier. It should therefore not be considered as a complete pesticide evaluation manual, though it is intended to contribute to a future complete pest control product evaluation manual for Kenya. The guidance should be read together with an implementation report which contains stepping stones for further development. The guidance was developed within the Pesticide management initiative East African Region: Kenya (PEAR -Kenya) project. The project ran in the period 2016 – 2019 and was sponsored and supported by the Dutch Ministry of Agriculture, Nature and Food Quality and the Embassy of the Netherlands in Nairobi.
The guidance addresses various aspects of a pest control product evaluation covering low risk pest control products, microbial pest control product, chemical pest control products and equivalence determination. The evaluation procedures developed covers a fast-track pathway for low risk products. For microbial products the procedure focusses on identification, human pathology and infectiveness and hazard and risk assessments for metabolites of potential concern. For chemical products the procedure includes methods for human health and pollinator risk assessments. The evaluation process of new pest control products can be speeded up if the active ingredient or active agent of a new product proves to be equivalent to an already registered product.
REF: PCPB/111/REG/VOL.I/20/145 30th March, 2020 TO ALL LOCAL AGENTS RE: GUIDANCE ON THE ELECTRONIC SUBMISSION OF DRAFT COMMERCIAL LABELS INTRODUCTION: This guidance has been prepared taking cognizance of the development in technology to facilitate trade and improve the efficiency of the commercial label approval process. Clients will no longer need to make numerous visits to the office for the physical presentation of the draft labels for either corrections and/or approvals. The legal requirement to have pest control products labels approved by the Pest Control Products Board (PCPB) is set out in Pest Control Products Act Cap 346 (Labelling, Advertising and Packaging) Regulations, 1984 [L.N. 89/1984, L.N. 127/2006.]. Over the years, a number of draft commercial labels submitted to PCPB have been illegible with little or no space for comments from PCPB Officers. The use of electronic labels will help increase PCPB review efficiency and improve the quality of labeling. The circular addresses submission of labels in 2 parts: PART A: Electronic submission of Draft Commercial Labels PART B: Submission of Original Commercial Labels PART A: Electronic submission of Draft Commercial Labels The draft commercial labels are submitted by the Applicant to the Regulator (PCPB). These are primarily for concurrence of the message to be contained in the proposed commercial labels with compliance to the PCP Act Cap 346.
It is in this regard; within 14 days from the date of this circular you will be required to submit the draft commercial labels electronically through email@example.com in MS word document (.doc or .docx format) (The .pdf, jpeg, .pub, scanned labels or other versions are not be acceptable). The implementation of these changes is designed to improve the efficiency of the process and to improve the tracking of label changes for both Applicants and the PCPB. The label must be done using text in paragraphs and tables; do not use columns. The word document should be saved as “Trade name of pest control product+PCPB REG NO.+Local Agent” e.g. REF_480_SC+0000+VICTORIA Co. Ltd. The body of the email should include the following particulars in tabular form: Product Trade Name
Active Ingredient & Concentration
New PCP/Renewal/Label Extension (indicate appropriately reason for application)
You are requested to comply with following guidelines: 1. The draft label(s) must be in .doc or .docx format, A4 paper size (8.27 × 11.69inches, Minimum margins: 0.5″ on all sides), minimum font size and style 11, Times News Roman and complying with all regulatory requirements. Applicants are strongly advised to include label version identification (the unique identifier is left to the applicant’s preference). 2. The draft label Logos, drawings, diagrams, photographs, background designs etc. are allowed but should comply with the PCP Act Cap 346. For: a. New pest control products submit together with scanned copy of Board notification b. Renewal of registration application: submit with duly signed and stamped Application Form in .pdf format 3. The PCPB Officer shall be allocated to review the draft label and either: a. If complies with set specification advise application as per part 4 below b. in case of minor deficiencies; track change or comment and send the draft label to the Applicant via email for action; c. In case of major deficiencies advise the applicant to adhere to labelling requirements 4. Once the Officer is satisfied with compliance to legal requirements and the set standards, he/she will inform the applicant via email to submit electronically a draft commercial label containing proposed artwork for approval in .pdf format (NB: The PDF must be created directly from electronic .doc or .docx). DO NOT SCAN PAPER LABELS PART B: Submission of Original Commercial Labels The original copy of the commercial label MUST comply with the provisions of PCP Act Cap 346 (Labelling, Advertising and Packaging) Regulations, 1984 [L.N. 89/1984, L.N. 127/2006.] printed on the paper or surface as will be presented in the local market. a. New products: Provide 3 hard copies for approval as draft (must contain proposed artwork which must comply with provisions of PCP Act Cap 346) b. Renewal: Provide 3 hard copies of approval as draft (must contain proposed artwork) and Registration Officer to prepare a payment advise to authorize accounts to accept payment. You are requested to declare your official email and alternative official emails; these shall be used to submit the draft labels to PCPB and for follow up communication.
We thank you for your continued cooperation.
Peter Opiyo CHIEF EXECUTIVE OFFICER /SECRETARY
Copy to: Agrochemicals Association of Kenya
PCPB Registration Officers, PCPB ICT Officer, PCPB Compliance & Enforcement Officers,
PCPB Laboratory Analysts Download – Guidance on Submission of Draftlables for PCPs