PSCA
I S A N A S S O C I AT E D M E M B E R O F CROPLIFE S O U T H A F R I C A
M E M B E R S B O U N D B Y A CODE OF CONDUCT
& A D H E R E N C E T O RESPONSIBLE USE P R I N C I P L E S
W W W.C RO P L I F E .CO. ZA
PROVIDES A PROFESSIONAL SERVICE TO:
• LOCAL & INTERNATIONAL CLIENTS
• USERS OF CROP PROTECTION, ANIMAL HEALTH & FERTILIZER PRODUCTS
• REGISTRAR ACT 36/1947 & GOVERNMENT AGENCIES
• AVCASA, CROPLIFE SA & AFFILIATES
PLANT SCIENCE CONSULTANTS’ ASSOCIATION
(PSCA)
• SPECIALIST (PROFESSIONAL WITH EXPERTISE IN ONE OR MORE FIELDS)
• PROFESSIONAL (GRADUATE WITH VOCATIONAL EXPERIENCE)
• TECHNOLOGIST (MEMBER IN TRAINING)
TRIAL CONTRACTORS/CONSULTANTS/RESEARCHERS
based on academic qualifications & relevant field &/or practical experience
PSCA MEMBERSHIP CATEGORIES
• PROTOCOL DEVELOPMENT
• REGULATORY CONSULTANCY
• PRODUCT DEVELOPMENT
• DATA EVALUATION / PREPARATION
• CONDUCTING FIELD TRIALS
• PREPARATION OF REGISTRATION DOSSIERS
• INVOLVED IN GUIDELINE DEVELOPMENT
PSCA SERVICES OFFERED
TO INTERNATIONALLY ACCEPTABLE LEVELS
• WORKSHOPS
• CIRCULATE INFORMATION / PUBLICATIONS
• PARTICIPATE IN AVCASA/CROPLIFE COMMITTEES
• INTERFACE WITH ACT 36
• UPDATE MEMBERS ON RELEVANT MATTERS
PSCA ACTIVITIES
DAFF/PSCA REGISTRATION WORKSHOPS
PRETORIA 2016
REGISTRAR OF ACT 36 OF 1947
9
Jonathan Maluta Mudzunga Registrar: Act No. 36 of 1947
Agricultural Input Control
Department of Agriculture, Forestry and Fisheries
Tel: 012 319 7303
Web: http://www.daff.gov.za
E-mail: [email protected]
STRUCTURE
10
Our Team – Technical Agricultural Remedies Mr JonathanMudzunga
The Registrar Act 36 of 1947
Mr Thilivhali Nepfumbada
National CODEX Pesticides Residues Coordinator & Management
Advisor
Ms Thembisa Majola
Production Scientist / Technical Advisor
-Insecticides / Fungicides / Household products
Ms Precious Mkula Production Scientist / Technical Advisor
-Herbicides
Dr Janine Kelly
Production Scientist / Technical Advisor
-Insecticides / Fungicides / Household products
Mr Maxhobandile Siguba
Production Scientist / Technical Advisor
Chemistry
Ms Molebatsi Malungane
Technician
In addition external Technical advisors are also utilised
Our Team – Administration
Mr David Motloi
Management Administration
Ms Stephen Skosana
Senior Administration Officer - Supervisor
Ms Portia Mojale
Senior Administration Clerk - Inbound
Ms Rachel Nxumalo
Senior Administration Clerk - Outbound
Ms Ndakene Lefading
Senior Administration Clerk - Inbound
INTRODUCTION
11
The Department regulates the manufacturing, distribution, sales, use
and advertisement of pesticides in terms of the Fertilizers, Farm
Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act No.
36 of 1947).
The Act is supported by the regulations and guidelines in respect of
the requirements for registration, manufacturing, labelling and
packaging requirements, fees, advertising and other matters.
• The Department administers the legislation in partnership with other
government, Industry, Farmers, Academics, NGO, International
organizations and the general public.
INTRODUCTION
12
The Minister of DAFF has the overall responsibilities for Act No 36
of 1947 and its related regulations. The Minister appoints the
Registrar: Act 36 of 1947 to administer the Act and also appoints
Technical Advisors to advise the Registrar.
The DAFF has the responsibility to ensure that pesticide
registered for use in South Africa are:
• safe to the host, the user, consumers and the environment;
• efficacious; they do the job they are supposed to do
• properly labelled; and
• not negatively affect trade
INTRODUCTION
Applicants who wish to manufacture, import and sell pesticides in
South Africa must submit detailed information and data for evaluation
by the Registrar.
Data must be generated from studies carried out according to
approved guidelines. The guidelines that are used by the Registrar’s
office are largely based on international guidelines (OECD
guidelines, WHO/FAO, Croplife International). All laboratory data
should be generated from an accredited laboratory
The Registrar performs a full evaluation and does not consider
approval by another regulatory authority as criteria for registration.
13
INTRODUCTION
14
Interim procedure for new active ingredient (s)
Reports and summary on the pharmacology, toxicology and
environmental impact studies of the active ingredient and its
metabolites and/or degradation products according to OECD
guidelines
If a remedy containing a new active ingredient is already registered
by one or more of the registration authorities of the USA, EU, UK,
Japan or Australia, toxicological risk assessment reports from the
registration authorities concerned, together with a toxicological risk
assessment, by an independent and accredited toxicologist, can be
submitted in support of a provisional registration.
LIST OF GUIDELINES REVISED/NEW
15
REVISED & IMPLEMENTED GUIDELINES
Guideline of the registration process for agricultural remedies.
Guidelines on the data and documents required for registration of Agricultural Remedies
in South Africa
Guidelines on residue study requirements for registration of Agricultural Remedies and
setting of maximum residue limits (MRLs) in South Africa
Guidelines on the data required for registration of biological / bio pesticides remedies in
South Africa
Guideline for extension of shelf life in South Africa
REVISION IN PROGRESS
Guidelines for the registration of household agricultural remedies
Guidelines on the management of the risk of Agricultural Remedies on insect pollinators
Guidelines for the registration of adjuvants in South Africa
Guidelines on equivalence of agricultural remedies (Pesticides)
Guidelines for registration of swimming pool and spa pool remedies
Guideline for registration of Organic Inputs
http://www.daff.gov.za/daffweb3/Branches/Agricultural-Production-Health-Food-Safety/Agriculture-Inputs-Control
PROCESS OF REGISTRATION
16
Molebatsi Malungane
Plant and Quality Technician
Agricultural Input Control
Department of Agriculture, Forestry and Fisheries
Tel: 012 319 6966
Web: www.daff.gov.za
E-mail: [email protected]
PROCESS OF REGISTRATION
17
Receipt and acknowledgement of
application
Screening and capturing of info into
register Payment Verification
Technical Evaluation DAFF and other Departments and Recommendations
Scientific Screening
Allocate Reg. Number and Prepare registration
documents
Verification by Admin Supervisor
Registrar:
Approval/Rejections
TIMEFRAMES
18
TYPE OF APPLICATION TIMEFRAME
New Applications containing new molecule 627 Days
Generic, new formulations and biological Applications 418 Days
Label amendments/extension 418 Days
Renewal Registration 90 Days
Re-instatement registration 118 Days
Additional or change of source/ manufacturer/ formulator/ Composition alignment/shelf
life/hazard group classification
208 Days
Admin changes/ trade name change 118 Days
Parallel/Transfer/Daughter 118 Days
Additional or change of Packaging size/type 118 Days
Cancellation of Registration 35 Days
Import permits 16 Days
Advertisement 35 Days
Free sale certificate 7 Days
Fulfilment of registration conditions 90 Days
Protocols 14 Days
PROBLEMS EXPERIENCED WITH PROCESS OF DOSSIERS
19
Incorrect identification of dossier (i.e. herbicide, adjuvant etc.)
Incorrect classification (i.e. generic, new formulations etc.) of
dossiers
Submission of parallel/sister/daughter application when mother
products are not already approved
Que-booking by submitting incomplete dossiers
Not using lever arch files lead to missing dossiers
Slow responses from applicants
GENERAL DATA REQUIREMENTS
Dr Janine Kelly
Production Scientist / Technical Advisor
Agricultural Inputs Control
Department of Agriculture, Fisheries and Forestry
Tel: 012 319 6708
Web: www.daff.gov.za
e-mail: [email protected]
GENERAL DATA REQUIREMENTS
21
Proof of payment of the prescribed application fee.
A covering letter outlining the purpose of the application.
Three copies of the “Application for the Registration of an Agricultural
Remedy” form.
Reports and summary on the pharmacology, toxicology and
environmental impact studies of the active ingredient and its metabolites
and/or degradation products
Reports and summary on formulation toxicity.
Reports and summary on the physical properties and storage stability of
the formulated product.
Three copies of the proposed label.
GENERAL DATA REQUIREMENTS
22
Experimental data, plus a summary of the data, on the
biological efficacy and, if specified in the relevant guidelines,
phytotoxicity on the commodity or commodities concerned.
Residue data from relevant production areas as per the
Agricultural Remedies Residue Trial and Data Requirements
Document.
For fungicides applied in wine grapes, fermentation studies
In case of tobacco, smoking studies for pesticides
A Safety Data Sheet for the formulated product.
PROBLEMS EXPERIENCED WITH GENERAL DATA
REQUIREMENTS
23
Proof of payment
- Incorrect / partial payment of fees. Tariffs on webpage.
- Bulk payments (no longer accepted)
A covering letter outlining the purpose of the application
- Covering letter state clearly what the application is covering (details)
- Give a reference standard.
- Spell out what the details such as “We are applying for aphids on citrus.
- In the case of label amendments, do not just refer to a changed label, give all
the changes in the letter, both the administrative changes and any new
claims.
- List the data sets that have been included in the Dossier.
- Transfer (requires legal agreement) versus company name change
(company registration documents).
- Reference the guidelines used
- Sign letter
PROBLEMS EXPERIENCED WITH GENERAL DATA
REQUIREMENTS
24
Application for the Registration of an Agricultural Remedy form
- Complete EVERY field of the form, if it is not applicable,
indicated n/a. List i and list ii must be completed fully. Do not just
write refer to the product label or MSDS.
- Sign the form.
- Formulation details
Major data sets to be discussed individually
Pharmacology, toxicology, environmental impact, formulation
toxicity, physical properties, storage stability, experimental data,
residue data
PROBLEMS EXPERIENCED WITH GENERAL DATA
REQUIREMENTS
25
Three copies of the proposed label
For fungicides applied in wine grapes, fermentation studies
In case of tobacco, smoking studies for pesticides and
fungicides
Safety Data Sheet for the formulated product
- SDS’s are supposed to be constructed from the data of the
product and not the other way around.
- Applicants incorrect contact details
EFFICACY DATA REQUIREMENTS
Dr Janine Kelly
Production Scientist / Technical Advisor
Agricultural Inputs Control
Department of Agriculture, Fisheries and Forestry
Tel: 012 319 6708
Web: www.daff.gov.za
e-mail: [email protected]
EFFICACY DATA REQUIREMENTS
Trial material
Number and Localities of Trials
Efficacy Trials
Phytotoxicity / Selectivity Trials / Yield Trials
Experimental Design
Application method and water volume
Data Requirements (Trial Reports)
27
PROBLEMS EXPERIENCED WITH EFFICACY DATA
REQUIREMENTS
Trial Material
- Sample material used in registration trials must be no more than two years old when
the trials are conducted.
Localities of trials (Efficacy, Phytotoxicity, Selectivity Trials, Yield Trials)
- must be done for each end use (crop/pest species)
- over a range of environmental conditions - spanning the bioclimatic regions
- irrigation practices, cultivars and soil characteristics
- new active ingredients, the trials must be conducted over a minimum of two
seasons or cropping cycles
- registered active ingredients one season’s trial work will suffice provided that the trials
are conducted under a range of environmental conditions, alternatively, trials
should also be conducted in different growing seasons if the crop occurs in one
geographic area or bioclimatic zone
- the use of different cultivars is highly recommended
3 things to consider: CROP RANGE * BIOCLIMATIC AREAS *
SEASON
28
PROBLEMS EXPERIENCED WITH EFFICACY DATA
REQUIREMENTS
29
CURRENT LOCALITIES CHOSEN
These trials are done
in the same season
PROBLEMS EXPERIENCED WITH EFFICACY DATA
REQUIREMENTS
30
SUGARCANE
+
CROP RANGE
BIOCLIMATIC AREAS
PROBLEMS EXPERIENCED WITH EFFICACY DATA
REQUIREMENTS
31
SEASONS + Not enough bioclimatic areas
in the crop /pest range?
USE SEASONS
=
SUGARCANE
PROBLEMS EXPERIENCED WITH EFFICACY DATA
REQUIREMENTS
Experimental Design
- a statistical evaluation (randomised block design)
- adequate pest pressure – use of trial sites with less than 5% pest infestation /
infection or worse the pest did not occur in the control
- treatments must be replicated at least four times (Error Degrees of Freedom
should be 12 or more)
- design must include an untreated Control treatment
- the remedy being tested must be compared to an appropriate reference product
- efficacy trials with new formulations or generic remedies must include the optimum
rate(s) of active ingredient
- phytotoxicity trials must contain at least a single (1x) and double (2x) dosage to
demonstrate crop safety.
- herbicide safener trials must be done under conditions conducive for phytotoxicity
- mixtures (tank mixtures or adjuvant/fertilizer/botanical mixes) - trials must be
designed so as to demonstrate the all properties of these combinations,
phytotoxicity and residue data will be needed
32
PROBLEMS EXPERIENCED WITH EFFICACY DATA
REQUIREMENTS
33
- Three trials need with the same GAP (crop, pest,
application rate, application number, loading). Three
trials is the minimum requirement for registration.
- Number or application rate (GAP) in the trial does not
match the GAP given on the proposed label (nor the
reference standard).
- Generic application, GAP does not match the GAP given
by the reference standard. Any deviation must be
supported by additional data.
- Use of incorrect reference standards
- Use a control
- Aerial applications – only 1 trial, untreated control difficult
Proposed Label
Trial Design
Reference Standard
(Generics)
PROBLEMS EXPERIENCED WITH SPRAY PROGRAM
34
Example
Proposed label recommends only 2 applications of the product, alternated with
products from a different chemical group. But the trials are done with 5
applications of the product?
The data only supports the 5 applications of the product, there is no evidence
that the product will still work if it is used only with 2 applications.
The proposed label gives the
GAP of the product, the
same GAP must be used in
the trials
Proposed Label
Trial Design
Reference Standard
(Generics)
Spray Programs
PROBLEMS EXPERIENCED WITH EFFICACY TRIALS
(Experimental Design)
35
Application method and water volume
- Equipment must be properly calibrated and use
commercially available equipment
- Spray volumes range significantly between trials on
the same crop at the same growth stage nor from
label recommendation..
- Trial data must be generated to support all
application methods recommended
Data Requirements (Trial Reports)
- Changing of reports (applies to residues too) – Not
acceptable
- Trial report must be signed
- Not all information is given (refer to guidelines-appendix)
Proposed Label
Trial Design
Reference Standard
(Generics)
The proposed label
gives the GAP of
the product, the
same GAP must be
used in the trials
GENERAL PROBLEMS EXPERIENCED WITH EFFICACY
TRIALS
36
GENERAL PROBLEMS
- Pre-counts or infection/infestation levels
- Incomplete reporting or mistakes
- Applicants not reading the reports before submission
Some mistakes
• Where trials yielded unexpected results no scientific explanation given,
comments such as “the trial gave inclusive results” or “the pest incidence
was too low” and these trials are submitted as “successful” trials.
• Pest x is reported, but the applicant is applying for pest y.
• Wrong product used in trials.
• Too many products tested in the same trial and wrong conclusions are given.
• Raw data not available when requested.
37
CHEMISTRY DATA REQUIREMENTS
Maxhobandile Siguba Agricultural Management Advisor
Agricultural Inputs Control
Department of Agriculture, Forestry and Fisheries
Tel: 012 319 7025
Fax: 012 319 7179
Web: www.daff.gov.za
E-mail: [email protected]
CHEMISTRY DATA SETS
Five batch chemical equivalence (technical material /
concentrates)
Formulation studies
Major formulation
Minor formulation
38
FIVE BATCH ANALYSIS REPORT REQUIREMENTS
Five batch chemical equivalence
Minimum of 5 batch analytical data
Letter of supply from the manufacturer (sponsor relationship)
GLP compliant / ISO 17025 accredited laboratory
Manufacturing process outline
Identification and quantification of active ingredient and impurities using scientific techniques e.g. GC, HPLC, GC-MS etc
Toxicological profile of impurities >0.1% or new impurities should be declared
Accreditation certificate must be attached
The analysis results must meet FAO, Australian and EU specifications
39
FORMULATION STUDIES REQUIREMENTS
Formulation studies
Formulation agreement letter
Formulation composition
Formulation tests done according to FAO/WHO specification
Formulation types according to FAO/WHO
Accelerated formulation studies
Long term formulation studies
Summary and report of formulation tests should be submitted
40
FORMULATION CHANGE
41
Major formulation
Any change in the inerts / formulants that is >10%
Change of <10% with change in hazardous classification
Change in Active ingredient (outside the FAO/WHO tolerances)
FORMULATION CHANGE CONT.
Minor formulation
Any change in the inerts/formulants that is <10%
Change in Active ingredient (within the FAO/WHO tolerances)
42
PROBLEMS WITH CHEMISTRY DATA REQUIREMENTS
43
Covering letter – lack of details
Explanation on the letters of supply
Incorrect recording of active ingredient purity (FAO/WHO, Australian and EU
specifications)
Analysis of impurities using incorrect methods
Formulation studies not done according to FAO/WHO specification
Shelf life based on accelerated formulation tests, outside of the FAO/WHO specs.
Formulation tolerances as in the FAO/WHO specifications
Difference in formulation change (minor / major)
Correlation of the studies submitted
44
RESIDUES DATA REQUIREMENTS
Ms Precious Mkula
Production Scientist / Technical Advisor
Agricultural Inputs Control
Department of Agriculture, Fisheries and Forestry
Tel: 012 319 7301
Web: www.daff.gov.za
e-mail: [email protected]
RESIDUES DATA REQUIREMENTS
45
Trial Design Selection of trial sites
Number of sites and trials
Plot size, layout and replications
Number of seasons
Crop variety/cultivars
Crop Maintenance and Agricultural Practices
Soil Type
Timing of applications
Method of application
Dosage rate and number of applications
Additional crop maintenance measures
Test Substance Formulation
Tank mixes
Adjuvants
Collection and handling of
residue samples Field sampling
Storage and shipping conditions
Residue decline studies
Terminal residue studies
Analysis of residues Analytical methods
Storage stability tests for analytical samples
Residue metabolism studies Plant metabolism
Animal metabolism
Soil metabolism and mobility
Metabolism residue definition
Crop groups and extrapolation of MRLs
Residue trial requirements for setting of
maximum residue limits (MRLs)
(Residues Report - lab)
RESIDUES DATA REQUIREMENTS
46
Trial Design
Selection of trial sites
Number of sites and trials / Number of seasons
- General rule, a minimum of five trials for major crops (or three for minor crops)
are required from three different bio-climatic areas per crop at the highest
recommended rate.
- In cases where production of a particular crop occurs only in a single bio-climatic
area, trial sites should be situated at least 100 km apart. If this is not possible, trials
should be done over a minimum of two seasons.
Plot size, layout and replications
CAUTION: using efficacy
trials for residues must be
done with care
RESIDUES DATA REQUIREMENTS
47
Trial Design continued…
Crop variety/cultivars
Crop Maintenance and Agricultural Practices
Method of application (same as efficacy)
Soil analysis must be submitted
Timing of applications Any time that a specific PHI is indicated on the label that specific PHI must be used in the crop field
trials as a component of the GAP.
Dosage rate and number of applications - Trials must include the highest recommended rate. The number of applications and the
intervals between applications should reflect the closest use to harvest and the maximum use
of the product.
- Additional crop maintenance measures
- GAP in relation to spray programs (similar to efficacy trials)
Proposed Label
Trial Design
Reference Standard
(Generics)
RESIDUES DATA REQUIREMENTS
48
Test Substance
Formulation - residue data must be generated for any additional formulation types (number of trials
will depend on the use pattern and the relative risks involved)
- consider mode of application, timing of application and crop growth stage, and
formulation type.
- In cases of a different formulation type where the agricultural practice and loading of
a.i. are the same and the PHI is >7 days, residue studies will not be required
Tank Mixes - When residue data have already been generated for a particular active ingredient,
there are no additional data requirements for tank mixes provided the cGAP of all the
active ingredients has not changed (the active loading has not increased, the PHI
has not been shortened and the number of applications has not increased).
- PHI is 7 days or less for any active ingredient(s) in the tank mixture, then residue
data will be required for that/those active ingredient(s).
RESIDUES DATA REQUIREMENTS
49
Test Substance continued…
Adjuvants - Adjuvants such as wetting agents, spreaders, stickers, surfactants and crop oil
concentrates may result in better deposition, penetration, or persistence of pesticide
residues in or on the plant.
- Therefore, when testing products with a label allowance for the use of an adjuvant,
crop field trials must include the recommended adjuvant applied according to the
label recommended rate. This information must be recorded in the laboratory residue
test report. In such cases it will not be necessary to determine residues both with and
without the addition of the adjuvant.
RESIDUES DATA REQUIREMENTS
50
Collection and handling of residue samples
Residue decline studies (for new end uses) - New end use(s)/claim(s)/ agricultural practices (GAP) of an agricultural remedy; or
active ingredient which is registered for the first time on a crop.
- New nanotechnology based formulations, regardless of data already available for
other formulations of the same active ingredient
Terminal residue studies (mainly generic) - Addition of a diluents(s) or carrier other than water; change in content of
adjuvants/fertilizers/botanical extracts i.e. wetting agents and surfactants etc. that
may lead to better penetration of the active substance
- Changes in parameters such as (cGAP) e.g. increase in concentration of the active
ingredient/s, application rates, application methods, timing of applications and
frequency, area of application (indoor versus outdoor); The data requirements
guidelines provide such explanations.
- Postharvest treatment applications (This must be done at zero (0) days only).
RESIDUES DATA REQUIREMENTS
51
Terminal residue studies continued...
Official withholding period is 7 days or less and when the application rate of the active
ingredient is the same as for an already registered formulation, terminal residue data
will be required
- A new formulation type is introduced for an already registered active ingredient, on a
particular crop, where the dosage rate of the active ingredient remains the same.
- A formulation type similar to that already registered (Act No. 36 of 1947) on the
particular commodity whether originating from a source other than those already
acknowledged or not, but which is to be applied using a different method of
application which has not yet been registered for use on that particular commodity.
- A formulation type similar to that already registered (Act No. 36 of 1947) on a
particular commodity but originating from a source other than that of the original
formulator or other formulators holding registration (commonly referred to as Generic
Registration).
Analysis of residues Analytical methods
Storage stability tests for analytical samples
RESIDUES DATA REQUIREMENTS
52
Residue metabolism studies (New ai) Plant metabolism
Animal metabolism
Soil metabolism and mobility
Metabolism residue definition
Crop groups and extrapolation of MRLs Refer to the relevant tables
Residue trial requirements for setting of maximum residue limits (MRLs) Refer to details on reporting in the guidelines regarding the lab report Introduction
Materials and Methods
Site Details
Application details
Sampling
Preparation of sample
Analysis Details
Storage Stability
Other information
Discussion and Conclusions
53
BIOLOGICAL REMEDIES REQUIREMENTS
Mr. Thilivhali Nepfumbada
Management Advisor Agricultural Remedies/
CODEX Coordinator Pesticides Residues
Agricultural Inputs Control
Department of Agriculture, Fisheries and Forestry
Tel: 012 319 6979
Web: www.daff.gov.za
E-mail: [email protected]
BIOLOGICAL REMEDIES REQUIREMENTS
54
Micro-organisms.
Macro-organisms
Biochemical products and semio-chemicals
Enzymes, hormones and plant extracts
Legume inoculants and other inoculants (Bio-fertilizers)
Plant growth or plant characteristic promoters, (bio-stimulants and biological
fertilizers)
RNAi (Novel Technology)
IMPORTATION OF EXOTIC ORGANISMS
55
Macrobial = Committee exists for approving release permits applications (DAFF,
DEA,SANBI, ARC, & Researchers (Classical biological control)
Microbials = ? No structure/committee
NEMBA (DEA) and Biological Weapons (DTI) Regulations
IDENFICATION TECHNIQUES OF BIOLOGICALS
56
Techniques for identification
• Bacteria = Cultural, microscopic and molecular sequencing technique
• Fungi = Morphological, Molecular Techniques (ITS gene region) and DNA bar-
cording
• Insects = Morphological and DNA bar-cording
• Nematodes = Morphological and DNA bar-cording
• Viruses = Cultural, microscopic and molecular sequencing technique
• Plants extracts/Hormones etc = Chemical analysis (5 batch or Certificates of
Analysis (COAs)
• An accession number assigned to the organism by the manufacturer of the
product provided.
• A representative sample/voucher specimen of the active ingredient needs
to be deposited and registered in an appropriate collection/culture
Agricultural Research Council (ARC), South African Museums, University
collections or in SANBI collections.
MACRO ORGANISMS
57
e.g. Entomopathogenic nematodes (EPNs) Entomopathogenic nematodes are soft
bodied, non-segmented roundworms that are obligate parasites of insects
• The full taxonomic description (i.e. genus, species)
• The history of the organism and its uses (if applicable)
• The life cycle and growth characteristics of the organism
• Site of infection, mode of action and of entry into host
• The label must include the state and stage of the organism
• Efficacy trials are required
• Any known metabolites i.e. primary/secondary must be reported.
NB: Toxicology studies should be submitted for formulated products.
MICRO ORGANISMS
58
Micro-organisms
• Shelf life - the product should be viable for at least six months
• For change in strains , new efficacy data, toxicology must be supplied.
• The formulation should not exceed contaminants ≥ 100,000 cfu/g or ml/or do
not exceed limits set by the Department of Health.
• Toxicology data required, any known metabolites i.e. primary/secondary must
be reported .
LEGUME INNOCULANTS
59
• Efficacy data required from fields free from the legume in question for at least
three years.
• 1x and 2 x rates should be tested.
• Shelf life should not exceed six moths as per the 2006 agric remedies
regulations.
BIOLOGICALS DOSSIERS
60
Biochemical products and semio-chemicals
Enzymes, hormones and plant extracts
Plant growth or plant characteristic promoters, biostimulants (non micro / macro)
DATA requirements are similar
to conventional pesticides
Ribonucleic Acid Interference (RNAi Novel Technology –
History
• Fortune Magazine 2003 “Biotech’s Billion Dollar Breakthrough”
• The process was discovered in the 1990’s and additional research in the area led
to winning a Nobel Prize for their work in 2006 by Drs. Andrew Fire and Craig
Mello.
• (RNAi) is a natural process cells use to turn down, or suppress the activity of
specific genes (dimer switch). It was previously known as (co-suppression, post
transcriptional gene silencing or quelling).
• GMO Definition
Genetically modified organism = means an organisms genes or genetic
material of which has been modified in a way that does not occur naturally
through mating or natural recombination or both and “genetic
modification shall have corresponding meaning.
• Current GMO = (What about Triazine Tolerant canola?)
61
RNAi Novel Technology – Wide Applications/Use Patterns
• Agricultural Uses: (SAFETY!)
• RNAi has been used to generate male/female sterility, which is valuable in
the hybrid seed industry and public health uses i.e. vector control.
• Introduce novel plant traits and increase crop yield.
• Modification of metabolic pathway to enhance plant nutrients uptake and the
possibility to reduce toxins production.
• Ability to apply a single liquid with multiple uses in plants i.e. drought
tolerance, plant stress adaptation, disease control and plant nutrition
combined in one.
• Changing seed characteristics for therapeutic or pharmacological uses in
the lab as well as in the field (Drug resistance management strategies
required).
• Plant growth regulatory effects, color formation or alter oil content in
oilseed.
• Environmental remediation purposes/Classical biocontrol for weed control
or alien or invasive species management?
62
Trait Target Gene Host Application
Enhanced
nutrient content
Lyc Tomato Increased concentration of lycopene
(carotenoid antioxidant)
DET1 Tomato Higher flavonoid and b-carotene contents
SBEII Wheat, Sweet
potato, Maize
Increased levels of amylose for glycemic
management and digestive health
FAD2 Canola, Peanut,
Cotton Increased oleic acid content
SAD1 Cotton Increased stearic acid content
ZLKR/SDH Maize Lysine-fortified maize
Reduced alkaloid
production
CaMXMT1 Coffee Decaffeinated coffee
COR Opium poppy Production of non-narcotic alkaloid,
instead of morphine
CYP82E4 Tobacco Reduced levels of the carcinogen
nornicotine in cured leaves
Heavy metal
accumulation ACR2 Arabidopsis
Arsenic hyperaccumulation for
phytoremediation
Reduced
polyphenol
production
s-cadinene synthase
gene Cotton
Lower gossypol levels in cottonseeds, for
safe consumption
Ethylene
sensitivity
LeETR4 Tomato Early ripening tomatoes
ACC oxidase gene Tomato Longer shelf life because of slow ripening
Reduced
allergenicity
Arah2 Peanut Allergen-free peanuts
Lolp1, Lolp2 Ryegrass Hypo-allergenic ryegrass
Reduced production
of lachrymatory
factor synthase
lachrymatory factor
synthase gene Onion “Tearless” onion
63
Role In Medicine
GLP
INVESTIGATION OF THE FACTORS
RELEVANT TO THE INTRODUCTION
OF GLP IN SOUTH AFRICA
SANA
S
QA
FIELD
PHASE
SOP’s CR
O
LAB
PHAS
E
ACCREDITATIO
N
RESIDUE
S
Principles of GLP
Adopted by member countries
Mutual acceptance of data
Basis for determination of risk / hazard
applied to non-clinical testing of items in pesticides, food & feed additives, industrial
chemicals
Studies include work in laboratory, greenhouse and field
Covers all studies presented for registration or licencing
GLP implementation - factors
Availability of accredited laboratories
Availability of accredited CRO’s
Availability of trained QA personnel
Industry standard SOP’s (guidelines) for defined aspects
Training of all stakeholders
Government capacity
Scope of GLP in RSA
Ag remedies, stock remedies, …?
5-batch, phys-chem, residues (field & laboratory)?
CRITERA FOR CONTRACTORS DOING TRIALS WITH AGRICULTURAL REMEDIES FOR THE PURPOSE OF REGISTRATION UNDER ACT NO. 36 OF 1947
In order to be approved for conducting contract trials for the registration of Agricultural Remedies in terms of Act no. 36 of 1947, it is proposed that contractors meet the following criteria:
QUALIFICATIONS: EDUCATIONAL REQUIREMENTS AND EXPERIENCE
An appropriate degree in Natural Sciences (Plant Sciences), plus 2 years post graduate experience in Agrochemicals/Crop Protection Research & Development,
or
An appropriate diploma in agriculture plus 5 years practical experience in Agrochemicals/Crop Protection Research & Development,
or
A Matric certificate with mathematics plus science and/or biology, or other appropriate subjects, plus at least 10 years practical experience in Agrochemicals/Crop Protection Research & Development.
PLUS
AVCASA Crop Protection Certificate
or
A Certificate of qualification from an accredited Crop Protection course obtained after December 2014.
ADDITIONAL CRITERIA
A sound knowledge of field trial techniques for the testing of agricultural remedies
A sound knowledge of the requirements for registration of agricultural remedies
A sound knowledge of the major crops in the area in which he/she operates, their cultivation and the pests, diseases and weeds associated with them.
Attendance of a workshop on field trials techniques, and/or registration requirements and procedures, to be arranged by CropLife / PSCA, at least once per annum
Letters from at least two clients verifying the quality of work of the contractor, to be submitted with each application for renewal of the contractor’s approval.