PSCA - Croplife is an associated member of croplife south africa members bound by a code of conduct & adherence to responsible use principles

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

http://www.croplife.co.za/

http://www.croplife.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]

http://www.daff.gov.za/

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


-Insecticides / Fungicides / Household products

Mr Maxhobandile Siguba


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


Tel: 012 319 6966

Web: www.daff.gov.za


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


Agricultural Inputs Control

Department of Agriculture, Fisheries and Forestry

Tel: 012 319 6708


e-mail: [email protected]


mailto:[email protected]



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.


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


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


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




Tel: 012 319 6708






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


REQUIREMENTS

29

CURRENT LOCALITIES CHOSEN

These trials are done

in the same season


REQUIREMENTS

30

SUGARCANE

+

CROP RANGE

BIOCLIMATIC AREAS


REQUIREMENTS

31

SEASONS + Not enough bioclimatic areas

in the crop /pest range?

USE SEASONS

=

SUGARCANE


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


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



Tel: 012 319 7025

Fax: 012 319 7179





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




Tel: 012 319 7301






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)


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


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)


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).


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.


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).


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


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



Tel: 012 319 6979



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

Commodity Clearance Approvals_.pdf

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.

Documents

PSCA - Croplife is an associated member of croplife south africa members bound by a code of conduct & adherence to responsible use principles