FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 1 1 2 U.S. FOOD AND DRUG ADMINISTRATION 3 4 Public Hearing: Strategic Partnerships to Enhance the 5 Safety of Imported Foods: Capacity Building, Risk-Based 6 Decision Making, Recognition of Commodity Food Control 7 Programs, and Systems Recognition 8 9 Conducted by Camille Brewer, M.S., R.D. 10 Tuesday, February 14, 2017 11 9:00 a.m. 12 13 U.S. Food and Drug Administration (FDA) 14 Center for Food Safety and Applied Nutrition 15 FDA, Wiley Auditorium, 5001 Campus Drive 16 College Park, MD 20740 17 (240)402-6411 18 19 20 21 Reported by: Natalia Thomas, RPR/CSR 22 Capital Reporting Company www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 2 1 A P P E A R A N C E S 2 3 Camille Brewer, M.S., R.D 4 Director, International Affairs Staff 5 Center for Food Safety and Applied Nutrition (CFSAN) 6 Office of Foods and Veterinary Medicine (OFVM), FDA 7 Stephen M. Ostroff, M.D. 8 Acting Commissioner of Food and Drugs, FDA 9 Mary Lou Valdez, MSM 10 Associate Commissioner and Director 11 Office of International Programs, FDA 12 Julie Moss, Ph.D. 13 Acting Third Party Program Director, CFSAN, FDA 14 Lystra Antoine, M.B.A., J.D. 15 CEO, Global Food Safety Partnership, The World Bank 16 Brian G. Bedard, DVM 17 Executive Director, Grocery Manufacturers Association 18 (GMA).Science and Education Foundation 19 Robert E. Brackett, Ph.D. 20 Vice President and Director, Institute for Food Safety 21 and Health, Illinois Institute of Technology 22 Kelley Cormier, Ph.D. www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 3 1 Division Chief, Inclusive Market Development 2 Office of Market and Partnership Innovations 3 Bureau for Food Security 4 U.S. Agency for International Development 5 Melvin Spreij, Counsellor and Secretary 6 Standards and Trade Development Facility 7 World Trade Organization (WTO) 8 Susan Berndt, M.B.A. 9 Acting Deputy Director, International Affairs Staff 10 CFSAN, FDA 11 Joann Givens, Human and Animal Food Program Director 12 Office of Regulatory Affairs, FDA 13 Mickey Parish, Ph.D. 14 Senior Science Advisor, Office of the Center Director, 15 CFSAN, FDA 16 Bettye Walters, DVM, International Policy Analyst 17 Office of the Center Director, Center for Veterinary 18 Medicine (CVM), FDA 19 Karil Kochenderfer, North American Representative, 20 Global Food Safety Initiative 21 Hank Karayan, Global FSMA Program Director, SGS 22 Shannon Cooksey, GMA www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 4 1 Jason Cochran, Branch Chief 2 Office of Capacity Building and Development 3 Foreign Agricultural Service, USDA 4 Weng Xinyu, First Secretary, People's Republic of China 5 Jennifer Miner, Canadian Food Inspection Agency 6 Janie Dubois, Joint Institute for Food Safety and 7 Applied Nutrition (JIFSAN) 8 Susan T. Mayne, Ph.D., F.A.C.E. 9 Director, CFSAN, FDA 10 Ritu Nalubola, Ph.D. 11 Senior Policy Advisor, Office of Policy 12 Office of the Commissioner, FDA 13 Mark Burgham, Senior Director 14 Program Policy Integration, Canadian Food Inspection 15 Agency (CFIA) 16 Herman Diricks, Chief Executive Officer 17 Federal Agency for the Safety of the Food Chain, 18 Belgium 19 Steve Wearne, Director of Policy 20 Food Standards Agency, London, United Kingdom 21 Mark Abdoo, Assistant Commissioner for Global 22 Regulatory Policy, Office of Global Regulatory www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 5 1 Operations and Policy, FDA 2 Jenny Scott, Senior Advisor 3 Office of Food Safety (OFS), CFSAN, FDA 4 Steven Solomon, DVM, Director, CVM, FDA 5 Sharon L. Mayl, J.D. 6 Senior Policy Advisor, OFVM 7 Brian Pendleton, J.D., Senior Policy Advisor, Office of 8 the Commissioner, FDA 9 Raina Spence, Director, of Producer Solutions, 10 GlobalG.A.P. 11 Ron Tanner, Specialty Food Association 12 Bill Folkerts, Vice President 13 Strategy and Program Operations, U.S. Pharmacopeia 14 15 16 17 18 19 20 21 22 23 www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 6 1 C O N T E N T S 2 3 SPEAKER PAGE 4 Camille Brewer 8 5 Stephen Ostroff 11 6 Mary Lou Valdez 20 7 Julie Moss 29 8 Lystra Antoine 43 9 Brian Bedard 58 10 Robert Brackett 74 11 Kelley Cormier 86 12 Melvin Spreij 97 13 Susan Berndt 110 14 Karil Kochenderfer 127 15 Hank Karayan 132 16 Shannon Cooksey 135 17 Jason Cochran 137 18 Weng Xinyu 140 19 Jennifer Miner 142 20 Janie Dubois 147 21 Susan Mayne 160 22 Julie Moss 164 www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 7 1 Ritu Nalubola 170 2 Mark Burgham 194 3 Herman Diricks 206 4 Melvin Spreij 218 5 Steve Wearne 228 6 Sharon Mayl 239 7 Raina Spence 287 8 Ron Tanner 291 9 Bill Folkerts 296 10 11 12 13 14 15 16 17 18 19 20 21 22 www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 8 1 P R O C E E D I N G S 2 MS. BREWER: Good morning. Could we please 3 take our seats? 4 I'd like to welcome everyone. My name is 5 Camille Brewer. I'm the director for International 6 Affairs here at the Center for Food Safety and Applied 7 Nutrition and the Office of Foods and Veterinary 8 Medicine. 9 This meeting -- this hearing is a public 10 hearing, and it's the opportunity for FDA to hear from 11 key stakeholders on a number of compelling issues for 12 us. It's a little bit of changing the tables in that 13 we are the ones who get to answer the -- to ask the 14 questions. And the experts here today will address the 15 issues that have been outlined in the Federal Register. 16 So we really appreciate all of you taking time 17 from your busy schedules to be here with us today. 18 Let me just spend another moment talking about 19 the purpose of the public hearing. It's one of many 20 administrative tools that FDA can use to obtain 21 information from external experts and stakeholders. 22 Typically, we use this tool when we're in the very www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 9 1 early stages of considering policy options. 2 Again, it's the opportunity for FDA to ask 3 questions and obtain information in a way that's 4 transparent to all stakeholders. 5 We've established a docket in the Federal 6 Register that outlines our interest. And any 7 stakeholder can provide information, comments, data, 8 studies, anything that's relevant to the questions 9 raised by FDA. 10 In addition, we have a panel of FDA experts 11 who will be posing the questions. If they raise a 12 question that's not in the Federal Register, you can 13 still respond to that question via the docket. 14 This hearing will be transcribed. And that 15 will give FDA the opportunity to go back and reflect on 16 the debate over the next two days. 17 So for today and for tomorrow, we've planned 18 four panels that address four different areas of 19 partnerships, including capacity building, private 20 standards, commodity-specific recognition programs, and 21 systems recognition. 22 With respect to the format of the hearing, www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 10 1 each panel with -- will start with a very short FDA 2 presentation that will set the stage simply by 3 describing our activities in the topic area under 4 discussion. 5 The audience here in the room and on the web 6 via WebEx have the opportunity to ask clarifying 7 questions of the FDA presenters. 8 Next, we'll have a series of presentations by 9 stakeholders, followed by questions from the roster of 10 FDA experts. 11 Finally, we will receive testimony from those 12 who have registered to provide testimony. FDA may also 13 ask questions of those stakeholders who are providing 14 short testimony. Again, I can't overemphasize that 15 this is the opportunity for FDA to deepen our own 16 understanding as we develop and improve our programs. 17 With that, it's my honor to introduce the FDA 18 speakers who are up front with us today. First, we 19 will have the keynote address by Dr. Stephen Ostroff, 20 Acting Commissioner for the U.S. Food and Drug 21 Administration. 22 Following his presentation, we will move www.CapitalReportingCompany.com (202) 857-3376 FDA Food Safety Modernization Act Public Meeting: 2/14/2017 Page 11 1 immediately into Segment 1, Partnerships to Improve 2 Food Safety Capabilities with a focus on capacity 3 building. And we will hear from Mary Lou Valdez, 4 Associate Commissioner and Director of the Office of 5 International Programs, and then to Dr. Julie Moss, 6 Acting Third Party Program Director. 7 So please join me in welcoming Dr. Ostroff. 8 (Applause.) 9 DR. OSTROFF: Well, thank you very much, 10 Camille. And let me welcome all of you to today's 11 public hearing.