US Environmental Protection Agency Office of Pesticide Programs Agenda - 2011 NAFTA Biopesticide Registration Improvement Course April 13-15, 2011 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE DAY 1 (April 13th, 2011) ITEM Time Function Proposed Presenter(s) 7:00 - 8:00 am REGISTRATION 1 8:00 - 8:20 am WELCOME/ INTRODUCTIONS/TRAINING COURSE GOALS Part 1 I Part 2 Steven Bradbury, Director, Office of Pesticide Programs Keith A. Matthews, Director, Biopesticides and Pollution Prevention Division 8:20 - 8:25 am Moderator's Remarks W. Michael McDavit, Associate Director, Biopesticides and Pollution Prevention Division 1.1 8:25 - 8:40 am Overview of the Biopesticide Industry Alliance Bill Stoneman Biopesticide Industry Alliance Inc. 1.2 8:40 - 8:55 am Overview of Mexico's Biopesticides Industry Association of Oraanic, Bioloaical and Ecoloaical Producers Guillermo Cadena Avila, President, Associacion Mexicana de Productores, Formuladores Y Distribuidores de insumos organicos, Biologicos Y Ecologicos, A. C. 1.3 8:55 - 9:10 am Overview of EPA's Biopesticides and Pollution Prevention Division Reaulatorv Activities W. Michael McDavit, Associate Director, Biopesticides and Pollution Prevention Division 1.4 9:10 - 9:25 am Overview of Health Canada's PMRA Biopesticide Reaulatorv Activities Terry Caunter, A/ Section Head, Risk Reduction in Agriculture Section, Value and Sustainability Assessment Directorate 1.5 9:25 - 10:25 am Overview of Mexico's Biopesticide Regulatory Activities Part 1 I Part 2 I Part 3 M.C. Oscar Morales Galvan, Sub-director for Certification and Recognition, DGIAAP/SENASICA/SAGARPA Biol. Jose Humberto Cuevas Garcia, Sub-director for Evaluation of Risk and Infectious Biological Residues, DGGIMAR/SEMARNAT Jose Jesus Herrera Bazan Gerente de Muestreo y Monitoreo Comision federal para la Protection contra Riesgos Sanitarios (COFEPRIS) 10:25- 10:40 am HEALTH BREAK 2 BIOPESTICIDE RESEARCH, USE AND VALUE ASSESSMENT 2.1 10:40-11:25 am Lisa M. Brines, Agricultural Marketing Specialist, National Organic Program, USDA 1 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE Relationship between Biopesticides and Organics: Regulation in US, Canada and Mexico Part 1 I Part 2 I Part 3 Canada Organic Office Canadian Food Inspection Agency M.C. Oscar Morales Galvan, Sub- director for Certification and Recognition, DGIAAP/SENASICA/SAGARPA 2.2 11:25- 11:45 am Biopesticide Use in IPM Practices Tom Brennan Chief, Environmental Stewardship Branch, Biopesticides and Pollution Prevention Division 2.3 11:45 am -12:30 pm Research and Support Programs: IR-4, AAFC- PMC Part 1 I Part 2 Michael Braverman, Manager, Biopesticide and Organic Support Program, IR-4 Project, Rutgers University Tobias Laengle, Senior Biopesticide Coordinator, Pesticide Risk Reduction Program, Pest Management Centre, Agriculture and Agri-Food Canada 12:30- 1:30 pm LUNCH 2.4 1:30 -2:00 pm Efficacy trial design requirements (Regulatory, Research, Demonstration) Part 1 I Part 2 Terry Caunter, A/ Section Head, Risk Reduction in Agriculture Section, Value and Sustainability Assessment Directorate Clara Fuentes, Entomologist, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division 2.5 2:00 -2:15 pm Value requirements: data requirements and new value accroach Terry Caunter, A/ Section Head, Risk Reduction in Agriculture Section, Value and Sustainability Assessment Directorate 2.6 2:15-2:35 pm Efficacv of Public Health Products Clara Fuentes, Entomologist, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division 2:35 - 3:05 pm Panel Discussion on Product Performance 3:05 - 3:20 pm HEALTH BREAK 3 CHALLENGES IN SUBMISSION MANAGEMENT SESSION 3.1 3:20 - 4:00pm Regulatory Processes - (EPA PRIA re- negotiation, PMRA MOSP, etc) Part 1 I Part 2 Martha Farkas, Section Head, Registration Directorate Sheryl K. Reilly,Chief, Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division 3.2 Joseph Mikhael, Business Analyst Business Analysis, Data Management 2 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE 4:00 - 4:30 pm e-Submissions Part 1 I Part 2 and Protection Section, Registration Directorate Robert Schultz , Information Technology and Resources Management Division 3.3 4:30 - 5:30 pm Panel Discussion on Common Challenges in the Regulatory Process Joseph Mikhael, Business Analyst, Business Analysis, Data Management and Protection Section, Registration Directorate Sheryl K. Reilly, Chief, Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division 5:30 - 5:35 pm WRAP UP Moderator, Reception at Renaissance Arlington Capital View Hotel; 6 p.m. to 8:30 p.m DAY 2 (April 14th, 2011) ITEM Time Function Proposed Presenter(s) 4 MICROBIALS SESSION 8:15 - 8:30 am Introduction Moderator 4.1 8:30 - 9:00 am Product Characterization and Analysis Part 1 I Part 2 Jonas Ptasinski, Senior Evaluation Officer, Microbial and Biochemical Evaluation Section, Health Evaluation Directorate John Kough, Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division 4.2 9:00 - 9:35 am Health Assessment: Data requirements; scientific waiver building; OECD templates Part 1 I Part 2 Brian Belliveau, Section Head, Microbial and Biochemical Evaluation Section, Health Evaluation Directorate, Annabel Waggoner, Microbial Pesticides Branch Biopesticides and Pollution Prevention Division 4.3 9:35 -10:10 am Environmental Assessment: Data requirements; scientific waiver building; OECD templates Part 1 I Part 2 Jonas Ptasinski, Evaluation Officer Microbial and Biochemical Evaluation Section, Health Evaluation Directorate, Shannon Borges, Microbial Pesticides Branch Biopesticides and Pollution Prevention Division 3 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE 10:10-10:25 am HEALTH BREAK 4.4 10:25- 11:00 am Risk Assessment and Decision Making on Microbial Biopesticides Part 1 I Part 2 Brian Belliveau, Section Head, Microbial and Biochemical Evaluation Section, Health Evaluation Directorate, Sheryl K. Reilly, Chief, Microbial Pesticides Branch Biopesticides and Pollution Prevention Division 4.5 11:00 am -12:00 pm Panel Discussion on Scientific Challenges of Microbial Assessments Brian Belliveau and Jonas Ptasinski, Microbial and Biochemical Evaluation Section, Health Evaluation Directorate, Alan Reynolds, Team Leader, Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division 12:00 - 1:00 pm LUNCH 5 BIOCHEMICALS/ NON-CONVENTIONALS SESSION 5.1 1:00 - 1:35 pm Overview of Classification and Modes of Action Part 1 I Part 2 Russell S. Jones, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division Valerie Hodge, Section Head, Environmental Risk III Section, Environment Assessment Directorate, 5.2 1:35 -2:15 pm Biochemical / Non- conventional Product Chemistry Assessment Part 1 I Part 2 Jacob Moore, Chemist, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division James Nyangulu, Chemistry Evaluator, Chemistry Evaluation Section, Compliance, Lab Services and Regional Operations Directorate, 5.3 2:15-2:55 pm Health Assessment: Data requirements; scientific waiver building Part 1 I Part 2 Angela L. Gonzales Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division Jonas Ptasinski Senior Evaluation Officer, Microbial and Biochemical Evaluation Section, Health Evaluation Directorate, 2:55 - 3:10 pm HEALTH BREAK 4 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE 5.4 3:10 - 3:50 pm Environmental Assessment: Data requirements; scientific waiver building Part 1 I Part 2 Miachel Rexrode and Gina M. Casciano, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division Valerie Hodge, Section Head, Environmental Risk III Section, Environment Assessment Directorate, 5.5 3:50 - 4:30 pm Risk Assessment and Decision Making on pheromones and biochemicals/ non- conventionals Part 1 I Part 2 Russell S. Jones, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division Brian Belliveau, Section Head, Microbial and Biochemical Evaluation Section, Health Evaluation Directorate, 5.6 4:30 - 5:30 pm Panel Discussion on Scientific Challenges of Biochemical/ Non-conventional Assessments Linda A. Hollis, Chief, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division Brian Belliveau and Jonas Ptasinski, Microbial and Biochemical Evaluation Section, Health Evaluation Directorate, 5:30 - 5:35 pm WRAP UP Moderator DAY 3 (April 15th, 2011) ITEM Time Function Proposed Presenter(s) 6 NAFTA OPPORTUNITIES 8:30 - 8:45 am Introduction Moderator 6.1 8:45 - 9:15 am Joint Reviews Driss Benmhend, Biologist, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division Martha Farkas, Section Head, Registration Directorate 9:15-10:00 Panel Discussion on Joint review process 10:00-10:15 am HEALTH BREAK 6.2 10:15-10:40 am EPA Oraanic Labelling Chris Pfeifer, Biochemical Pesticides Branch, Biopesticides and Pollution Prevention Division 5 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE 7 10:40- 11:05 am General Workshop Participant Comment Period 8 11:05- 11:30 am CLOSING REMARKS AND ADJOURNMENT M.C. Oscar Morales Galvan Terry Caunter Keith A. Matthews 6 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE Speakers List and Information: Michael Braverman, Ph.D. Manager, Biopesticide and Organic Support Program IR-4 Project, Rutgers University Tel (732) 932-9575 ext 4610 Fax 609.514.2612 Driss Benmhend, Biologist, Biochemical Pesticides Branch Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs U.S. Environmental Protection Agency benmhend.driss@epa.gov (703) 308-9525 (phone) (703) 305-0118 (fax) Clara Fuentes, Ph. D., Entomologist Biochemical Pesticides Branch Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs U.S. Environmental Protection Agency ph. 703-308-0171 fax 703-308-7026 Fuentes. Clara@epa.gov W. Michael McDavit, Associate Director Biopesticides and Pollution Prevention Division Office of Pesticide Programs 703-305-7761 (tel) 703-308-7026 (fax) Sheryl K. Reilly, Ph.D. Chief, Microbial Pesticides Branch Biopesticides and Pollution Prevention Division Office of Pesticide Programs (7511P) U.S. Environmental Protection Agency reilly.sheryl@epa.gov 703-308-8269 (phone) 703-308-7026 (fax) Visit http://www.epa.gov/pesticides Linda A. Hollis, MS Chief, Biochemical Pesticides Branch Biopesticides and Pollution Prevention Division Office of Pesticide Programs (7511P) U.S. Environmental Protection Agency hollis.linda@epa.gov (703) 308-8733 (phone) (703) 308-7026 (fax) Visit http://www.epa.gov/pesticides Russell S. Jones, Ph.D., Senior Biologist Biochemicals Branch Science Review Process Leader 7 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE Biopesticides & Pollution Prevention Division Office of Pesticide Programs Ph: 703/308-5071 FAX: 703/308-7026 jones.russell@epa.gov Annabel Waggoner, Environmental Protection Specialist U.S. Environmental Protection Agency Office of Pesticide Programs Biopesticides and Pollution Prevention Division Microbial Pesticide Branch (703) 308-0340 waggoner.annabel@epamail.epa.gov Mailing Address: Keith A. Matthews, Director Biopesticides and Pollution Prevention Division Office of Pesticide Programs U.S. Environmental Protection Agency 703.308.8712 (office) 703.308.7026 (facsimile) Gina M. Casciano, M.S. Biochemical Pesticides Branch Biopesticides and Pollution Prevention Division Office of Pesticide Programs U.S. Environmental Protection Agency casciano.gina@epa.gov (703) 605-0513 (phone) (703) 305-0118 (fax) Terry Caunter M.Sc., A/ Section Head Risk Reduction in Agriculture Section Minor Use and Risk Reduction Division Value and Sustainability Assessment Directorate T: 613-736-3779 F: 613-736-3964 Terrv.caunter@hc-sc.qc.ca Lilian de Luna PhD, Senior Evaluation Officer Fungicides Section Value and Sustainability Assessment Directorate T: 613-736-3938 F: 613-736-3770 Lilian.deluna@hc-sc.qc.ca Jonas Ptasinski, Senior Evaluation Officer Microbial and Biochemical Evaluation Section Health Evaluation Directorate T: 613-736-3894 F: 613-736-3489 Jonas. ptasinski@hc-sc.qc.ca Brian Belliveau PhD, Section Head Microbial and Biochemical Evaluation Section 8 ------- AGENDA 2011 NAFTA BIOPESTICIDE REGISTRATION IMPROVEMENT COURSE Health Evaluation Directorate T: 613-736-3737 F: 613-736-3489 Brian. belliveau@hc-sc.qc.ca Valerie Hodge, Section Head Environmental Risk III Section Environment Assessment Directorate T: 613-736-3719 Valerie. hodqe@hc-sc.qc.ca James Nyangulu Ph.D., Chemistry Evaluator Chemistry Evaluation Section Compliance, Lab Services and Regional Operations Directorate T: 613-736-3913 James. nvanqulu@hc-sc.qc.ca Lisa M. Brines, Ph. D. Agricultural Marketing Specialist National Organic Program US Department of Agriculture (202) 720-3252 Lisa.brines@ams.usda.gov Martha J. Farkas. Ph.D. Section Head Review & Science Integration Division Registration Directorate Pest Management Regulatory Agency Health Canada T: 613-736-3772 F: 613-736-3666 Martha.fa rkas@hc-sc.qc.ca Joseph Mikhael, Ph.D., Business Analyst Business Analysis, Data Management and Protection Section Registration Directorate Pest Management Regulatory Agency Health Canada T: 613-736-3742 F: 613-736-3707 Joseph. mikhael@hc-sc.qc.ca Tobias Laengle, Ph,D,, Senior Biopesticides Coordinator Pest Management Centre Agriculture and Agri-Food Canada T: 709-772-3653 F: 709-772-6064 Tobias. Iaenqle@aqr.qc.ca 9 ------- |