Registration of Biological Remedies vs. Bio- Fertilizers in South Africa 15 November 2017 CSIR CONFERENCE CENTRE

Transcription

1 Registration of Biological Remedies vs. Bio- Fertilizers in South Africa 15 November 2017 CSIR CONFERENCE CENTRE THILIVHALI NEPFUMBADA TECHNICAL ADVISOR ACT 36 OF

2 Agricultural Remedies An agricultural remedy: is defined as any chemical substance or biological remedy, or any mixture or combination of any substance or remedy intended or offered to be used for the destruction, control, repelling, attraction or prevention of any undesired microbe, alga, nematode, fungus, insect, plant, vertebrate, invertebrate, or any product thereof (PGRs desiccants and legume inoculants), but excluding any chemical any chemical substance, biological remedy or other remedy in so far as it is controlled under Medicines and Related Substances Act 101 of 1965 or the Hazardous Substances Act 15 of

3 Scope of Agricultural Remedies Regulated INPUTS REGULATED UNDER ACT 36 Fertilizers Insecticides Fungicides DAFF Act No. 36 of 1947 Agricultural Remedies Animal Feeds Herbicides Bio-pesticides and legume inoculants Plant Growth Regulators Swimming pool remedies Stock Remedies Wood Preservatives Adjuvants

4 Scope of Biological Remedies Regulated Microbials, PGRs, Legume inoculants (e.g. fungi, viruses, bacteria) Macrobials (e.g. Preditory mites & EPNs) Botanical/Plant Extracts (e.g. Sea weed extract) Novel Technologies (e.g. RNAi) Semiochemical/ Hormones (e.g.auxins & gibberellins) 4

5 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). 5

6 Agricultural Uses: (SAFETY?) RNAi USE PATTERNS 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/pest control and plant nutrition combined in one. Plant growth regulatory effects, color formation or alter oil content in oilseed. 6

7 Why Register Agricultural Remedies? Section 3: 2 (a) of Act 36 of 1947, agricultural remedy in respect of which registration is applied for should be suitable and sufficiently effective for the purposes of which it is applied for. Complies with prescribed requirements. It should not be contrary to the public interest (Bill of Rights). The establishment where it is manufactured must be suitable.

8 OTHER LEGISLATIONS IMPACTING ON IMPORTATION OR REGISTRATION OF BIOLOGICAL ORGANISMS Non Proliferation of Weapons of Mass Destruction Act, 1993 (Biological weapons). National Environmental Management: Biodiversity Act, 2004 (Alien and invasive species). Agricultural Pest Act,1983). Genetically Modified Organisms Act, Animal Disease Act, National Health Act, Medicine and Related Substances Control Act, 1965 Food stuff, cosmetics and disinfectant act, 1972 etc 8

9 INTERNATIONAL STANDARDS/CONVENTIONS FOR PHYTOSANITORY MEASURES 1. FAO Guidelines for export, shipment, import and release of biological control agents and other beneficial insects (2005) NB: The scope of this standard does not include living modified organisms, issues related to registration of biopesticides, or microbial agents intended for vertebrate pest control. 2. FAO: Code of conduct for the import and release of exotic biological control agents (1996) NB. The standard describes the Code of conduct for the import and Release of Exotic Biological Control Agents (parasitoids, predetors, parasites, phytophagous arthropods and pathogens) for research and release into the environment including those packed or formulated as products. Governments that are already fulfilling the objective of this Code by regulation or other means may consider adapting their existing systems in the light of this code. 9

10 INTERNATIONAL STANDARDS/CONVENTIONS FOR PHYTOSANITORY MEASURES 3. NAGOYA PROTOCOL: Access to genetic resources and their fair and equitable sharing of benefits arising from their utilization to the Convention On Biological Diversity (2011) NB: The scope of the protocol shall apply to genetic resources within the scope of Article 15 of the Convention and to the benefits arising from the utilization of such resources. This protocol also apply to traditional knowledge associated with genetic resources within the scope of the Convention and to the benefits arising from the utilization of such knowledge. 4. International Plant Protection Convention- IPPC (1997) NB. The purpose of the convention is to secure common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control. PREAMLE: Parties should take into account international principles governing the protection of plant, humans and animal health and the environment. 10

11 SECTORS USING BIOLOGICAL PRODUCTS Agriculture (bio-fungicides, bio-insecticides, growth regulators etc) Public health (Bt for vector control) Forestry (similar to agricultural uses) Environmental remediation (e.g. odor suppression does not fall under the scope of Act 36)? 11

12 DATA REQUIREMENTS IN GENERAL Locally generated efficacy/phytotoxicity /residues» A minimum of three efficacy trials per crop done in three bioclimatic zones done in one season or over two seasons» For residues =, a minimum of five trials done over one season or two seasons Toxicology data (OECD GLP accredited lab studies using OECD test guidelines)» Department of Health Guidance document is available on request - Botanical pesticides -Microbiological pest control agents -Biochemical pest control agents» Scientific publication submitted as supporting data 12

13 REPORTING TOXICOLOGICAL DATA Each report should include a copy of Good Laboratory Practice certificate (OECD) Full description of tests results, test procedures and analytical methods Test method(s) description should be supplied (OECD, US EPA, CIPAC/AOAC etc)» Supporting literature studies - A copy of the journal article/publication - Motivation for including such information 13

14 BIOCHEMICAL/SEMIOCHEMICALS TOXICOLOGICAL DATA REQUIREMENTS Active ingredient(s) and active constituents Formulation composition/declaration Kinetics and metabolism studies Level one: Toxicological data of active ingredient Formulation toxicology data Level 2:Supplemental toxicological studies (chronic studies with the active ingredient) Storage stability test Analytical methods if it is a new product 14

15 MICRO ORGANISMS GENERAL DATA REQUIREMENTS Toxicology studies should be submitted (Human and environmental FATE) Shelf life and the active ingredients If an applicant changes the strain of micro-organism for a registered product, new efficacy data, toxicology must be supplied Any known metabolites i.e. primary/secondary must be reported 15

16 IDENFICATION OF BIOLOGICALS CONTROL AGENTS Bacteria = (Cultural, microscopic and molecular sequencing technique) Fungi = (Morphological, Molecular Techniques (ITS gene region) and DNA barcording) Insects = (Morphological and DNA bar-cording) Nematodes = (Morphological and DNA bar-cording) Viruses = (Cultural, microscopic and molecular sequencing technique) Plants extracts/hormones = (Chemical analysis = 5 batch or Certificates of Analysis - COAs) 16

17 LABEL CLAIMS General label claims not encouraged (e.g. all crops recommendations) Codex Crop Groups are used Number of applications Timing of application Pre-harvest intervals (normally not an issue with biological products with no dietary requirements or residues) Shelf life 17

18 CODEX CROP GROUPING FOR THE REDUCTION OF COSTS ASSOCIATED WITH DATA Berries (Blueberry group) Blackberry or Raspberry; Blueberry or Currants, etc Whole group Stone fruit (Peaches) Apricots, Nectarines, Plums, Peaches and Cherries Whole group

19 GLOBAL HARMONIZED SYSTEM FOR THE CLASSIFICATION AND LABELLING OF CHEMICALS (GHS) Labeling of agricultural remedies Labeling of fertilizers and bio-fertilizers» Hazard Classes (WHO Hazard Classes)» OECD testing guidelines (Dosage of 5000 mg/kg /bw for acute studies) 19

20 List Of Biological Control Agents vs Bio-Fertilizers Multiple use patterns ORGANISM Agrobacterium radiobacter Agrobacterium vitis Function(s) Plant growth promotion/biofungicide Plant growth promotion/biofungicide Bacillus subtilils Growth promotion/bio-fungicide Trichordema harzianum Pseudomonas fluorescens Growth promotion/bio-fungicide Growth promotion/bio-fungicide 20

21 List Of Biological Control Agents vs Bio-Fertilizers CATEGORY Microbials Legume Inoculants and Growth Promoting Organisms Plant Extracts/Botanicals Bio-chemicals/Hormonal Substances (e.g. Auxins and Giberellins) Novel Technologies e.g. RNAi (Pesticide and Nutritional Benefits) OVERLAPING FUNCTION STATUS YES/NO YES YES YES Yes Yes 21

22 HARZARD VERSUS RISK DEFINITIONS Toxicological studies Eco-toxicology and Environmental fate Mammalian toxicology Hazard Versus Risk Hazard: ability to cause harm or damage Risk: is the porability for damage or harm to occur HAZARD X EXPOSURE = RISK Pesticide X No of applications = Residues risk Biopesticides X NO applications = Contaminants risk

23 BIOLOGICAL PRODUCTS RISKS Toxins/metabolic by-products of toxicological concern Inerts or formulants of toxicological concern (NPE Surfactants) Contaminants Human pathogens (e.g. E-coli, Shingella typhi, Salmonella dysenteriae and Vibrio cholerae etc) OECD RERENCE PAPER (Issue Paper on Microbial Contaminants Limits 2011) - Carriers Heavy metals etc

24 BIOPESTICIDES REVIEWS BY EFSA EFSA doi: /j.efsa = Risks for public health related to the presence of Bacillus cereus and other Bacillus spp. Including Bacillus thuringiensis in foodstuffs (Toxins and residues limits) EFSA (2015; 13(4):3056): Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma atroviride, strains IMI , T11 (Secondary metabolites) 24

25 WHAT IS A POISON? Paracelsus (Alle ding sind gift und nichts ohn gift; alein die dosis macht das ein ding kein gift ist) (All is poison, nothing is without poison; only the dose determines what is not a poison) Lowest observed effect level Non observed effect level

26 GLOBAL MARKET

27 TRENDS

28 RESOURCE TO USE WHEN ATTEMPTING TO APPLY FOR AGRICULTURAL REMEDIES REGISTRATIONS OECD test guidelines SA guidelines ( Health-Food-Safety/Agriculture-Inputs-Control) Scientific publications Data sourced from the internet Legal agreement and authorization to access the data Laboratory accreditation certificates are required 28

29 THANK YOU 29