Southeast Region Food Southeast Region Food

Safety Seminar Safety Seminar

FDA UpdateFDA Update

Anne ReidAnne Reid

Deputy Regional Director, Deputy Regional Director, Southeast RegionSoutheast Region

Southeast Regional Management TeamSoutheast Regional Management TeamMalcolm L. Frazier, Regional Food and Drug DirectorMalcolm L. Frazier, Regional Food and Drug Director

��District DirectorsDistrict Directors�� Patricia Schafer, New OrleansPatricia Schafer, New Orleans

�� Emma Singleton, FloridaEmma Singleton, Florida

Maridalia Torres, San JuanMaridalia Torres, San Juan�� Maridalia Torres, San JuanMaridalia Torres, San Juan

�� John Gridley, AtlantaJohn Gridley, Atlanta

�� Laboratory DirectorLaboratory Director�� Khalil Kerdahi, Southeast Regional Khalil Kerdahi, Southeast Regional LaboratoryLaboratory

Southeast Regional Management TeamSoutheast Regional Management TeamMalcolm L. Frazier, Regional Food and Drug DirectorMalcolm L. Frazier, Regional Food and Drug Director

�� Southeast Regional OfficeSoutheast Regional Office�� Anne P. Reid, Deputy Regional Food Anne P. Reid, Deputy Regional Food and Drug Directorand Drug Director

Laurie Farmer, Director, State Laurie Farmer, Director, State �� Laurie Farmer, Director, State Laurie Farmer, Director, State Cooperative ProgramsCooperative Programs

FDA Food FactsFDA Food Facts

�� Products under Jurisdiction: Seafood, Dairy, Products under Jurisdiction: Seafood, Dairy, Fruits, Vegetables, Juices, BeveragesFruits, Vegetables, Juices, Beverages

�� 80% of Nation’s Food Supply80% of Nation’s Food Supply�� 150,000 Registered Domestic Food Processing 150,000 Registered Domestic Food Processing FacilitiesFacilities

�� 230,000 Registered Foreign Facilities230,000 Registered Foreign Facilities�� 230,000 Registered Foreign Facilities230,000 Registered Foreign Facilities�� One Million Restaurants/Other Retail Food One Million Restaurants/Other Retail Food EstablishmentsEstablishments

�� Two Million FarmsTwo Million Farms�� Workplan Targets, Performance GoalsWorkplan Targets, Performance Goals�� Shared Responsibility with State and Local Shared Responsibility with State and Local Agencies in conducting food plant Agencies in conducting food plant inspections/investigations/retailinspections/investigations/retail

FDA FactsFDA Facts

�� FDA is responsible for overseeing the FDA is responsible for overseeing the safety and quality of imported foods, safety and quality of imported foods, drugs, devices, biologics, cosmetics and drugs, devices, biologics, cosmetics and radiation emitting devices.radiation emitting devices.

�� FDA faces enormous challenges from FDA faces enormous challenges from globalization because of the dramatic globalization because of the dramatic increase in the volume of imported FDAincrease in the volume of imported FDA--regulated products and the increasing regulated products and the increasing complexity of the global supply chain.complexity of the global supply chain.

Globalization of ProductionGlobalization of Production

� FDA-regulated products now account for approximately 10% of all imports to the U.S.

� Over the last 7 years importation of FDA regulated products has dramatically risen:• Food products have grown by an average of 10% per year• Pharmaceutical products have increased at nearly 13% per year• Medical Devices have grown at over 20% per year• Medical Devices have grown at over 20% per year

� Projected import growth rates range from low estimates of 5-8% to high of 15%, meaning that imports of FDA-regulated products would triple between 2007 and 2015.

� Products entering the U.S. come from new and different markets, flow through long, multi-step processes to convert globally sourced materials into finished products.

Changing Nature of Risk in Global Supply Changing Nature of Risk in Global Supply ChainsChains

FSMA & Nationally Integrated FSMA & Nationally Integrated Food Safety SystemFood Safety System

�� Building an integrated national food safety system has been a Building an integrated national food safety system has been a foundational element of FDA’s strategy for carrying out an foundational element of FDA’s strategy for carrying out an effective & efficient food safety program; one of key mandates of effective & efficient food safety program; one of key mandates of FSMAFSMA

�� System is premised on building full strategic & operational System is premised on building full strategic & operational partnerships with state & local food safety agencies partnerships with state & local food safety agencies –– FDA has FDA has engaged in this effort for last decade through the Partnership for engaged in this effort for last decade through the Partnership for Food Protection & other initiativesFood Protection & other initiativesFood Protection & other initiativesFood Protection & other initiatives

�� Now more important than ever as a result of Now more important than ever as a result of external drivers,external drivers,including: including: •• FSMA mandates to work in full partnership with the states FSMA mandates to work in full partnership with the states •• Calls by state/local officials to strengthen partnerships, Calls by state/local officials to strengthen partnerships, establish more seamless operations, create an atmosphere of establish more seamless operations, create an atmosphere of mutual reliance & respectmutual reliance & respect

•• BudgetBudget--driven driven -- make most efficient possible use of all make most efficient possible use of all available food safety resourcesavailable food safety resources

National Integrated Food Safety National Integrated Food Safety SystemSystem

Integration Task ForceIntegration Task Force�� Commissioner has charged: Commissioner has charged:

highhigh--level Integration Task Force to level Integration Task Force to oversee the development & implementation oversee the development & implementation of new strategies & action plans to achieve of new strategies & action plans to achieve full partnership with state/local agenciesfull partnership with state/local agencies

�� CoCo--chaired by Joe Reardon, ORA & Jeff chaired by Joe Reardon, ORA & Jeff Farrar, OFFarrar, OF•• Members: senior officials from FDA’s ORA, CFSAN, Members: senior officials from FDA’s ORA, CFSAN, CVM & state/local agencies involved in the CVM & state/local agencies involved in the Partnership for Food ProtectionPartnership for Food Protection

Nationally Integrated Food Safety System

Elevating Leadership and ManagementElevating Leadership and Management

�� Organizational ChangesOrganizational Changes•• ORA has initiated process ofORA has initiated process of creating an Office of Partnerships creating an Office of Partnerships & moving DFSR to that new office to ensure that the need to & moving DFSR to that new office to ensure that the need to work with state & local officials & other critical partners is fully work with state & local officials & other critical partners is fully recognized & addressed by ORArecognized & addressed by ORA

�� Senior Advisor for FederalSenior Advisor for Federal--State RelationsState Relations•• ORA is creating the new position of Senior Advisor for FederalORA is creating the new position of Senior Advisor for Federal--State State Relations, which will report to the ACRA; Relations, which will report to the ACRA; Joe ReardonJoe Reardon, who will work , who will work with the ACRA to provide the leadership & strategic direction necessary with the ACRA to provide the leadership & strategic direction necessary for achieving a national integrated food safety systemfor achieving a national integrated food safety system

�� Director of Intergovernmental Affairs and PartnershipsDirector of Intergovernmental Affairs and Partnerships•• OF is creating the new senior position of Director of Intergovernmental OF is creating the new senior position of Director of Intergovernmental Affairs and Partnerships, reporting to the Deputy Commissioner for Affairs and Partnerships, reporting to the Deputy Commissioner for Foods, with a charge that includes collaborating closely with ORA Foods, with a charge that includes collaborating closely with ORA leadership to enhance the federalleadership to enhance the federal--state partnership; state partnership; Dr. Jeff FarrarDr. Jeff Farrarwill play this leadership rolewill play this leadership role

Recently Posted FSMA ItemsRecently Posted FSMA Items

�� www.fda.gov/food/foodsafety/fsmawww.fda.gov/food/foodsafety/fsma

�� Preventative Controls for Registered Preventative Controls for Registered Human and Animal Food/Feed Human and Animal Food/Feed Facilities:11/1/2011Facilities:11/1/2011Facilities:11/1/2011Facilities:11/1/2011

�� Foreign Facility Reinspections, Recall, Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee and Importer Reinspection User Fee Rates for Fiscal Year 2012: Rates for Fiscal Year 2012: 10/1/201110/1/2011

Recently Posted FSMA ItemsRecently Posted FSMA Items

�� Burden of FSMA Fee Amounts on Burden of FSMA Fee Amounts on Small Business 10/18/2011Small Business 10/18/2011

�� Proposed Rule: Foreign Supplier Proposed Rule: Foreign Supplier Verification Program.Verification Program.Verification Program.Verification Program.

�� Building a Partnership for Prevention: Building a Partnership for Prevention: 11/2/2011.11/2/2011.

CantaloupesCantaloupes

�� September, 2011September, 2011-- 7 listeria cases 7 listeria cases reported to CDC from Colorado.reported to CDC from Colorado.

�� September, 2011September, 2011-- after inspections, traceafter inspections, trace--back investigations, voluntary recall back investigations, voluntary recall back investigations, voluntary recall back investigations, voluntary recall issued.issued.

�� October, 2011October, 2011--Warning Letter issued.Warning Letter issued.

�� Deadliest food borne outbreak in the Deadliest food borne outbreak in the United States in 25 years.United States in 25 years.

�� 139 cases, 28 states, 29 deaths139 cases, 28 states, 29 deaths

Arsenic and Apple JuiceArsenic and Apple Juice

�� Establish levels for inorganic arsenicEstablish levels for inorganic arsenic

Strategic PrioritiesStrategic Priorities

�� The Commissioner has selected five crossThe Commissioner has selected five cross--cutting cutting areas to serve as strategic priorities over the areas to serve as strategic priorities over the next five years.next five years.

�� 1) Advance Regulatory Science and Innovation 1) Advance Regulatory Science and Innovation

�� 2) Strengthen the Safety and Integrity of the 2) Strengthen the Safety and Integrity of the Global Supply ChainGlobal Supply Chain2) Strengthen the Safety and Integrity of the 2) Strengthen the Safety and Integrity of the Global Supply ChainGlobal Supply Chain

�� 3) Strengthen Compliance and Enforcement 3) Strengthen Compliance and Enforcement Activities to Support Public HealthActivities to Support Public Health

�� 4) Address the Unmet Public Health Needs of 4) Address the Unmet Public Health Needs of Special PopulationsSpecial Populations

�� 5) Advance Medical Countermeasures and 5) Advance Medical Countermeasures and Emergency Preparedness Emergency Preparedness

Budget 2012Budget 2012

�� House Version: significant cuts House Version: significant cuts overall.overall.

�� Senate Version: slight increase in Senate Version: slight increase in area of foods.area of foods.area of foods.area of foods.

�� President’s Version: slight increase President’s Version: slight increase overall.overall.

�� Decrease in Staffing: 1) natural Decrease in Staffing: 1) natural attrition 2) limited hiring, mostly attrition 2) limited hiring, mostly internal. internal.

Questions?Questions?