The 2018 AgChem Summit agenda will feature speakers from USDA, EPA, Bayer US, TSG, Adama, APIS, BASF and more.
This workshop will focus on the major regulatory challenges for the registration of biocontrol products, from product development to marketing, using hypothetic case studies in different geographies.
Jose Carvalho, PhD, Head of Global Business Development and Policy at Knoell
Rejane de Moraes, PhD, Director of Business Development NAFTA at Knoell USA
An introduction to the current global regulatory context for biopesticides will be presented followed by Q&A, group discussion and case studies. The workshop is intended to be interactive and participants will have the opportunity to exchange ideas while defining a strategy to register their “product” in different countries. Each group will select a biocontrol solution to focus on and define the registration process leading to market access.
During the preparation of the registration strategy there will be many opportunities for extensive exchange of views.
Neil Hoffman | Chief Scientific Advisor in the Office of the Deputy Administrator in Biotechnology Regulatory Services of USDA
Bob McNally | Director, Biopesticides and Pollution Prevention Division of EPA
Dr. Sheryl Reilly | Senior Regulatory Consultant of TSG USA
Biological products including biochemicals, microbials, and biostimulants, are derived from natural materials, such as plants, animals, fungi, and some minerals. Regulatory requirements are based on product type, claims, and intended uses. As with other plant protection and health products, biological products must meet safety and efficacy requirements before they can be registered and sold to consumers. Depending on the type of biological product, it may be registered at the federal level by the US Environmental Protection Agency (EPA), at the state level, or both. While federal or state registration is the first step in bringing biological products to market, the registrations must also be maintained annually to ensure continued compliance. This includes fulfilling reporting requirements and paying appropriate maintenance fees. The EPA and states monitor products under their regulatory purview for compliance to ensure that the regulated community obeys environmental laws and regulations. Compliance monitoring can occur on-site, where the product is being used, or off-site, such as during laboratory audits, and record reviews, or when following up on tips or complaints.
Jeff Blackwood | Senior Manager of Government Affairs of BASF
Panelists: USDA, TSG, BASF
Robert Kennedy, PhD. | Chief Scientific Officer of Vestaron
Vestaron is introducing a new biopesticide SPEAR™ that is based on a peptide isolated from spiders. While these peptides are very potent insecticides presenting them to insects in a way that they are bioavailable. SPEAR™ is active both topically and orally however formulation and application differs for these two modes of presentation. In the course of this presentation Vestaron learnings with a soluble granule and a liquid concentrate will also be discussed.
Dr. Wendelyn Jones | Director Global Policy and Scientific Affairs of DuPont Crop Protection
Roy Chen, Ph.D. | Formulation Lab Team Lead of Adama
This talk will cover one to two tough microbial biopesticide formulation cases (examples) and address issues with incompatibilities and stability, amid others
This session will focus on regulations, trends and challenges in EU, Asia and Latin America.
Moderator: Dr. Wendelyn Jones, Director Global Policy and Scientific Affairs, DuPont
Dr. Mariola Kopcinski | Director Scientific Alliances of Plant Health Care
Regulatory process in Brazil is extremely complex, which requires authorization from four agencies (MAPA, IBAMA, ANVISA, CNTBio)
The Experimental Use Permit (RET) takes several months and can only be received if company has established legal presence in Brazil or through consulting companies
Efficacy trials are required for the registration in Brazil, and there are very strict rules which have to be followed or trials will not be accepted
OECD guidance has to be used for all the regulatory studies, and US methodology and guidance is usually not sufficient for Brazilian registration
José Carvalho, PhD | Head of Business Development Crop Protection of Knoell Group
Sarah Hovinga | Project and Product Support Lead, Disease Management, Biologics R&D of Bayer US
Panelists Include: Bayer US, Smithers Viscient
Dr. Mark Whittaker | Managing Director of APIS
Standard ecotoxicology studies designed for agrochemicals are often unsuitable for the ecological risk assessment of microbial pesticides. In some cases, modifications to the protocols will address these deficiencies, but in others the test organisms are fundamentally unsuitable models for detecting adverse effects from the use of this class of biopesticides.
Dr. George Lazarovits | Research Director, A&L Biologicals of Agroecological Research Services Centre, Canada
The interaction between plants and their associated microbes varies from being beneficial to neutral to deleterious. The development of ecological agriculture, where greatly less extraneous inputs will be used, requires us to identify and deploy microorganism that form beneficial relationships with crops and act to enhance their health and yields. Robust and inexpensive molecular techniques have allowed for rapid identification of key players and their interactions with plants but there is still a need to discover what factors regulate these interactions and to develop methods for delivering microbial products to the environments where they are needed. There is ample evidence that examining agroecosystems where production methods have resulted in exemplary high productivity of plants are the ideal conditions from which to isolate, identify and examine the factors that allow microorganisms to optimally exert their influences on host plants. With the introduction of aerial monitoring of crops, we could identify site specific locations within fields there were significant differences in the microbial interactions and that allowed us to examine factors associated with the variable productivity of plants within a field. Although we are still at the early stages of such studies there is a high probability that an agroecological approach will allow for the identification of the chemical, physical, environmental and microbiological factors that regulates
The United States is the world’s top exporter of food and agricultural products with over $130 billion in export sales annually. The global demand for U.S. agricultural products is expected to grow 60% by 2050. The Department of Agriculture Foreign Agricultural Service (FAS) is responsible for linking U.S. agriculture to the world to enhance export opportunities and promote global food security. FAS does this through cooperation between U.S. farmers and other governmental agencies, trade policy, capacity building, and trade promotion. One aspect of the agricultural process that is heavily involved in trade policy is the setting and regulating of pesticide maximum residue limits (MRLs). An MRL is the maximum amount of pesticide residue that is expected to remain on food products when a pesticide is used according to label directions. In recent years, public concern over pesticide MRLs has caused governments to impose much more stringent MRLs, causing trade barriers. The Codex Alimentarius (Codex) is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety. FAS works with the Environmental Protection Agency (EPA), with Codex, and with countries importing U.S. agricultural products with the goal of ensuring that MRLs are science-based and harmonized to international standards. When countries propose trade restrictive MRLs or MRLs that are not based on science, FAS challenges these proposals through the World Trade Organization. This talk will include an overview of the main trade challenges related to MRLs in various regions and what FAS is doing to address them.
Dr. Paul Reibach | Technical Director Chemistry of Smithers Viscient
Timothy Johnson, Ph.D. | VP Field Development and Technical Services of Marrone Bio Innovations
During the past 30 years the crop protection business has been undergoing a continuous realignment away from the use of active ingredients discovered in the mid-20th century to more target specific and environmentally friendly pesticides. This realignment has occurred alongside a tremendous consolidation of the industry as well as a merging of interests between seed and chemical companies and the use of genetic traits on broad acre crops. Often overlooked during this period is the growth of organic agriculture and the number of biologically based pesticides (biopesticides) used in both conventional and organic production that have largely been developed by smaller and more entrepreneurial companies. This presentation will review where we are, how we got to where the biopesticide industry is today and discuss possible future directions regarding target pests, crops and delivery methods. Several case studies will be described in detail including management of invasive pests such as spotted wing drosophila on fruit and berries, zebra mussel in industrial water uses, key pests such as corn rootworm and key diseases and plant parasitic nematodes in broad acre crops.
Maximilienne Giannelli, Ph.D. | Counsel of Finnegan, Henderson, Farabow, Garrett & Dunner LLP
As we look to the future of crop protection, including greener technologies and biologicals, what strategies will help maximize the value of your intellectual property? In today’s marketplace, all companies recognize the value of a robust patent portfolio. Historically, in the traditional crop protection market, patents covering new agrochemicals often served as the centerpiece, with patents covering inventions such as methods of use, methods of manufacture, formulations, and crystalline forms (polymorphs) often following in a second wave of patent applications. This presentation will use real-world case studies to show how various types of second-wave agrochemicals patents have fared in post-grant challenges at the U.S. Patent & Trademark Office, litigation in federal district courts, and actions at the U.S. International Trade Commission and will provide insights on the types of patents that have fared best in terms of validity, infringement, and damages. Finally, this presentation will comment on how shifts in U.S. patent law may shape the next wave of protection for biological crop protection.