Biologicals at Bayer /////////// Feb. 2018

Transcription

1 Biologicals at Bayer /////////// Feb. 2018

2 Registration Paths Crop Protection Products Crop Efficiency Products Biologicals at Bayer 2

3 Biologicals Registration Paths 3 /// Biologicals at Bayer /// September 2017

4 Registration of Biological Crop Protection Products

5 EPA AND BIOLOGICALS 1948 First microbial pesticides registered in the US First regulatory agency to develop separate data requirements and study guidelines for biopesticides 1994 Biopesticides and Pollution Prevention Division (BPPD) was established in to streamline registrations Reduce Regulatory Burden Bring safer pesticide products to market Encourage uses in IPM strategies Page 5

6 EPA AND BIOLOGICALS Two divisions under BPPD Microbial Pesticides Branch pesticides consisting of a microorganism (e.g., a bacterium, fungus, virus or protozoan) (includes plant-incorporated protectants) Biochemical Pesticides Branch naturally occurring substances that control pests by non-toxic mechanisms (includes pheromones) Because it s difficult to determine if a substance meets the biochemical criteria, EPA established a special committee to make the determination Non-toxic mode of action against target pest (No chemical or biological interaction of the biopesticide molecule occurs with the physiology of the target pest organism such that direct lethality to that pest organism results) Naturally occurring or synthetically similar History of exposure to humans & environment demonstrating minimal toxicity Page 6

7 TIERED TESTING APPROACH Page 7

8 ADDRESSING DATA REQUIREMENTS Every Biologics product is unique - data required for registration depends on the identity and biological properties of the product, the nature of the product and intended use patterns More than one way to fulfill the data requirement: Actual test data performed on TGAI and/or EP Published scientific literature Surrogate data or bridging to another strain/species, if both belong to a well-known (familiar) taxon A rationale to waive the requirement because it is unnecessary or impractical Must be supported by sound scientific reasoning and supporting evidence to address underlying concern behind the data requirement Page 8

9 PRE-SUBMISSION MEETINGS Presubmission meetings are strongly recommended for microbial pesticides during development Identify required and conditionally required data as well as non-required data elements Determine appropriate test substances, study protocol, and data required for registration and info. required to support data waivers. Page 9

10 Registration of Biological Crop Efficiency Products

11 United States Label claims and intent as well as mode of action determines pathway EPA (FIFRA) Pesticides, Plant Regulators State Fertilizer Agencies Fertilizers, Soil Amendments, etc. Pesticide: prevent, destroy, repel, or mitigate pests; Plant regulator: physiological action, accelerates or retards rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof Plant inoculant: microorganisms applied to the plant or soil for the purpose of enhancing the availability or uptake of plant nutrients through the root system. Soil amendment: substance(s) intended for the purpose of improving soil characteristics favorable for plant growth Biostimulant: No accepted definition or defined regulatory pathway Page 11

12 Biostimulants Biostimulants are a new class of products for which Legal definitions do not exist and regulatory pathways are unclear Biostimulants are NOT Pesticides and have no direct effects on controlling plant pests Fertilizers Biostimulants Pesticides Description Provide macro and micro nutrients. Improve nutrient use efficiency. Abiotic stress. Crop quality / Vigor. Preventative or curative effects. Specific targets. PGR Regulatory Well known regulatory pathways. Low to medium level of requirements. Regulatory pathways are unclear / under construction. Legal definitions are not established. Well known regulatory pathways. High level of requirements.

13 Industry Advocacy Bayer is working with the Biological Products Industry Alliance (BPIA) and regulatory stakeholders to advocate for: Legally accepted definition for plant biostimulants Clearly defined regulatory pathway Outreach and Education Promote Benefits of Biostimulants BPIA supports the following definition: Plant biostimulants are substance(s) and/or micro-organisms whose function when applied to seeds, plants or the rhizosphere is to stimulate natural processes to enhance/benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, crop quality and/or yield 13

14 Bayer 14

15 Societal trends trigger a new wave of integrating Biologicals into conventional farming Bayer is developing competencies and pragmatic, efficacious solutions for growers Drivers: On Farm / customer needs Residue Management to maintain marketability of produce Maintain efficacy/consistency of the program, flexibility of harvest and logistics Protection of ROI Solution: Use of biologicals in CAS* Ensure meeting MRLs, import tolerances and 2ndary standards Resistance Management to maintain marketability of produce Maintain efficacy/consistency of the program Protection of ROI Solution: Use of biologicals in CAS* Provide alternate modes of action to manage resistance Better yield and quality to drive ROI, to compensate for incr. input costs (at farm level) Root health, EPE, PGP Marketable yield, nutritional value, shelf life Solution: Use of biologicals in CAS* in SGR, infurrow, drip and drench depending on crop Key drivers for BLX Drivers: Societal trends Regulatory restrictions on chemical crop protection Limitations in the application of chemical crop protection products (or a complete ban) Difficulty to register chemical crop protection products Societal Values Consumers around the globe demand high quality, healthy, sustainably-sourced food ( zero residues, no/less chemicals ) NGOs and media challenge modern Ag production practices and perpetuate societal perception Food Chain Global retailers expect sustainable ag production Transparency in crop production practices including reduced chemical crop protection load 15

16 Bayer Strategic Acquisitions in Biologicals 2009 acquisition of certain assets and technology of the Israeli biological crop protection company AgroGreen. Acquired assets include Bacillus firmus against nematodes 2012 acquisition of US-based AgraQuest Inc. with expertise in biological pest management, R&D and production based on bacterial microbes 2013 acquisition of German-based Prophyta Biologischer Pflanzenschutz GmbH, expertise in biological crop protection based on microbial fungi 2014 acquisition of Biagro Group*, a producer and distributor of biological seed applied plant growth promoting microorganisms inoculants, based in Argentina These acquisitions further strengthen our excellent portfolio in integrated crop solutions spanning Seeds, chemical and biological Crop Protection, and Services Page 16 *The acquisition remains subject to regulatory approval of the Argentinian antitrust authorities.

17 Biologicals are part of Bayer s Crop Science division with its extensive global footprint Global network of Bayer s Crop Science R&D and production Manufacturing sites Major R&D sites Research, Testing, Process Dev., Pilot Plant, West Sacramento 2012 RTP Fungal Research, Solid State Production Wismar 2013 Monheim Submerged Production, Tlaxcala 2012 Inoculants Production Argentina / Brazil

18 An Integrated Approach to World-class Development of Microbial Biological Products Active Ingredient 120,000+ microbes Screening against prioritized targets crop protection and enhancement Genetic sequencing and computational tools Characterize natural compounds and ability to colonize expertise in strain optimization, biomarker characterization, quantitative analytics Manufacturing Process Development Formulations to maximize shelf life Compatibility with chemicals Optimal fermentation conditions for maximum yields and lowest CoGs QC/QA methods to ensure consistency in manufactured lots Performance Product Safety Comprehensive approach to product safety Early screening to identify potential concerns High quality regulatory studies to meet global requirements Continued Stewardship throughout the life cycle of the product Regulators Sales Greenhouse and field Global network of stations northern and southern hemisphere Stand-alone and in integrated programs (tank mix and alternation) Efficacy, and benefits like residues, yield, plant health

19 Each of our Biologicals are building blocks of our Customized Agronomic Solutions (CAS) Bayer s six key Biological products Product family Active ingredient Scope Mode of action Bacillus firmus strain I-1582 SGR, nematode suppressant & plant growth promoter / BRA, EU Root colonization, dissolves cell wall of nematode eggs, induced systemic resistance Bacillus subtilis strain QST 713 Fruit rots, bactericide, root activation / global scope Fungal cell wall disruption, direct antibacterial activity and induced resistance Coniothyrium minitans strain CON / M / Sclerotinia / EMEA (Selective) parasitism of mycelium and sclerotia of Sclerotinia spp. Paecilomyces lilacinus strain PL 251 Nematicide and yield promoter / LATAM, EMEA (Selective) parasitism of nematode eggs Terpenoid blend QRD 460 Sucking pests F&V, oilseed rape / EMEA, LATAM Multiple physical and chemical modes of action 19

20 Biologicals Can Impact Plant, Environments & Pests Induce host defenses Disease state Alter abiotic factors (Biofilm; Fe-Chelation) Pathogen Antibiosis Alter microbiome Mycopathogens Biologicals complement Bayer CropScience crop product portfolio and will help us meet customer needs Page 20

21 Our Biological product portfolio allows us to rejuvenate conventional chemical solutions Example: Poncho/VOTiVO Referenced products are registered for use in certain countries and national label instructions must be read and followed. Please check the approval status Poncho/VOTiVO and Poncho/VOTiVO 2.0 TM in your country. For specific instructions, please consult the product labels. Poncho/VOTiVO and Poncho/VOTiVO 2.0 TM are trademarks of Bayer 21

22 Bayer sees Biological Inputs as an Important Contributor for Crop Production Third leg of agricultural science Opportunity for a new wave of agricultural inputs that are also sustainable products Chemical inputs Plant genetics Agronomic conditions Microbial inputs Adoption of Integrated Pest & Crop Management in agriculture, meeting the requirements of the Food Chain Opportunity for Bayer offer Customized Agronomic Solutions (CAS) by combining chemical crop protection with biological control

23 Forward-Looking Statements This website/release/presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer s public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forwardlooking statements or to conform them to future events or developments. 23

24 Thank you!