Regulatory Committee Update & Major Issues 2019
Stay informed with the latest update from the Regulatory Committee to the Board of Directors, featuring current committee members and major issues discussed in 2019, including IR-4 Crop Grouping Changes, USDA Proposed Rules for Genetically Engineered Organisms, and more.
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Regulatory Committee Update to the Board of Directors September 23 2019
Current Committee Members 14 Group (Jeanette Von Krosigk) Conn & Smith, Inc (Cindy Smith) OmniLyticsInc (Tyler Homer) Acadia Regulatory Consulting (John Fournier) CortevaAgriscience (Meghan Oneal, Lesley Czochor ) Pathway BioLogic (Marleny Burkett) AgBiome (Katie Holmes) Delta Analytical Corporation (Damon Cory-Watson*, Rob Jones) Pivot Bio (Natalie Hubbard) Agrinos (Janet Reed, Terry Stone) Redox (Chris Burnside) FMC (Denise Spellman, Driss Benmhend, Wendy Wang ) Amo ba(Jean-Baptiste Eberst) SciReg (Terri Spanogle) Fred Betz Regulatory Strategies (Fred Betz) AmVac (Jeannie Hemiller) Sipcam Advan (Lizbeth Rea) Gowan Company (Nina Wilson**, Adam Pilkington, Jenny Qu ) Andermatt Biocontrols Syngenta (Tammy Tyler, George Aux) Indigo Ag (Eda Reinot) APIS (Mark Whittaker) Suttera (Ruth Trager) Ingevity (Mariola Kopcinski) Arysta (Rodney Akers) Terramera (Gabriel Lee) Intrinsik (Roger Breton, Yvonne Clemow) BASF (Jennifer Lilly*) TSG (Sheryl Reilly**, Megan Priest) IR4 (Michael Braverman) Bayer (Melissa Hey, Natasha Dixon, Tammy Zimmer, Keith Reding, Paul Loida, Sherry Heins) Toxcel(Nicole Perkinson) Knoell USA (Rejane de Moraes, Teresa Cox) Valent BioSciences(Maria Herrero, Jayne Walz) Bedoukian (Lacy Jenson) Koch Companies Services (Eric Ma) BioSafe Systems (Donna Bishel) Lallemand(Amy Plato Roberts**, Zephyr Papin-Tillery) *Committee co-chair Bioworks(Mike Cordaro) Liebergesell Regulatory Strategies (Matthias Libergesell) **RC Advisory Committee Brassard Pesticide Regulatory Solutions (Candy and David Brassard) MacIntosh & Assoc. (Sue MacIntosh) Marrone Bio (Maggie Rodriguez, Carrie Link, Erika Rohr Luke) Central Life Sciences (Steve Spaulding) NewLeaf Symbiotics(Rachel Floro) Certis (Susan Gallager) Novozymes (Mathew Sonier) Certis USA (Karen Warkentien** , Janice E. Asato) OMC Ag Consulting (Olav Messerschmidt) Compliance Services International (Melinda Bowman)
Major Issues: 2019 Comments IR-4 Crop Grouping Changes USDA Proposed Rules for Genetically Engineered Organisms Biostimulant Guidance Hemp Uses Document Hemp New Uses Topics of Discussion during monthly calls Global MRLs and Tolerance Exemptions Metabolites of Concerns Microbial Pathogen Testing
Major Issues: 2019 International Harmonization Global MRLs (and acceptance of Tolerance Exemptions) The disconnect in country regulation(s) for biostimulants. No consistent definition (4 minimum EU/EPA/USDA/Industry) Different data requirements Multiple agency involvement per country Draft guidance and changing policy in multiple countries has been very time consuming and difficult to track and respond Hemp and cannabis regulations Tolerance Exemption Clarify EPA science and regulatory policies on dietary risk assessments and options for how an exemption may still be justified when the active ingredient data show potential human health (toxicity) issue.
Major Issues: 2019 USDA PPQ implementation of their authority to regulate biocontrol organism and process for eventual commercialization without the need for a permit. Regulatory Training Microbial Data Requirements State Issues
Topics of Discussion with EPA For meeting with EPA on 9/24 and after: Use of biological products on hemp. what does EPA expect the timelines to be for getting labels approved? Does EPA expect products to be approved in time for the next growing season including 24(c) products? Also, states seem unsure about what they should be doing with regard to pesticide use on hemp. Is anything being done to assist the states? BPPD s effort to address non-PRIA backlog EPA s opinion regarding Canada s Response to EU. See attached. Secondary Metabolites globally, our members are seeing an increase in questions from regulators about secondary metabolites. Where does EPA see things going with regard to secondary metabolites? M009 PRIA Concerns This is new. Are companies using it? If yes, how is it working? Is there anything industry could do to make it work better? Any other updates BPPD would like to give industry
Priorities: 2019 Creation of Hemp Taskforce New Meeting Format (discussion every other month) New Subcommittees (based on group survey feedback) International Harmonization Regulatory Training NOSB
