Implementing FSMA: CDC s Surveillance Provisions

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Implementing FSMA: CDC s Surveillance Provisions Dale Morse, MD, MS Food Safety Forum on Foodborne Illness Surveillance November 3, 2011 National Center for Emerging and Zoonotic Infectious Diseases Division of Foodborne, Waterborne, and Environmental Diseases

Foodborne Illness in the United States Each year, 1 out of 6 Americans (or 48 million people) gets sick and 3,000 die of foodborne diseases. 2011 Estimates of Foodborne Illness in the United States "These estimates provide valuable information to help CDC and its partners set priorities and further reduce illnesses from food. CDC Director Thomas Frieden, M.D., M.P.H.

THE IMPACT OF PREVENTION Reducing foodborne illness by 10% would keep 5 million from getting sick. Prevention of a single fatal case of E. coli O157 infection would save an estimated $7 million.

CDC and state/local Partners Provide the Vital Link Public Health provides the vital link between illness in people and the food safety systems of government regulatory agencies and food producers

CDC s Role in Food Safety CDC and state/local partners provide this vital link by: Monitoring human illness Tracking the occurrence of foodborne diseases Defining the public health burden of foodborne illness Attributing illness to specific foods and settings Investigating outbreaks and sporadic cases Empowering state and local health departments Targeting prevention measures to meet food safety goals Informing food safety action and policy

Informing food safety policies* Using CDC data and expertise 1994 USDA declared E. coli O157:H7 an adulterant in ground beef; 1996 HACCP Pathogen Reduction Regulation changed meat and poultry inspected throughout the US CDC data linked large number of E. coli O157:H7 outbreaks to beef; concern about pathogens in raw meat and poultry 2005 FDA withdraws approval of Enrofloxacin (a ciprofloxacin-like antibiotic) for use in poultry CDC data showed antibiotic-resistant human infections originating from poultry 2009/ FDA mandates regulations of egg farms with 3,000 or more laying 2010 hens CDC/state investigations linked shell eggs and Salmonella Enteritidis *Highlights only

The Food Safety Modernization Act (FSMA) Enacted January 2011 Primarily effects FDA Authorization, but not appropriation 4 provisions directed at CDC Multiple other provisions for which CDC has a role Main Themes of the Legislation Informed by strong evidence base

The Food Safety Modernization Act: CDC s task The act requires CDC to strengthen the capacity of state and local health departments to respond to foodborne outbreaks and improve the coordination and integration of surveillance systems and laboratory networks. -Thomas R. Frieden, MD, MPH, Director, CDC

At a Glance: CDC and FSMA CDC FSMA Lead Activities CDC FSMA Supporting activities (FDA lead) 205(b)1 Surveillance Systems 205(b)2; 210, 399V-5: Working Group Development 210: Centers of Excellence 112(b): Food Allergies 103: Processing Sector Study 104: Performance Standards, Contaminants 105(a): Produce Safety Regulation 110(a): Report on Domestic Capacity 110 (g): Food Safety Research Plan 202(b): FERN Report (DPEI) 203: ICLN (DPEI) 204(d)(2): High Risk Foods 205(c)(1): Enhance S&L Capacity 205(c)(2): Review S&L Capacity

CDC FSMA Enhanced Surveillance Responsibilities Coordinating and integrating Federal, State and local foodborne illness surveillance systems Increasing participation in national networks Facilitating timely sharing of information Developing improved epi and lab tools Improving attribution of illness to specific foods

CDC s Foodborne Disease Surveillance Systems: The GOOD World recognized experts State-of the-art networks FoodNet, PulseNet, etc. Credible, independent disease burden data Successful outbreak investigations Increased data quality via CIFOR http://www.imdb.com/title/tt0060196/

CDC s Foodborne Disease Surveillance Systems: The BAD Surveillance systems are underfunded, understaffed, poorly integrated, often outdated and siloed (e.g. in June 2011: Last state FOOD website data from 2008 Last outbreak summary from 2007 Last PHLIS website data from 2006 http://www.imdb.com/title/tt0060196/ State and local HDs on life support

CDC s Foodborne Disease Surveillance Systems: The UGLY For better timeliness, consumer groups http://www.imdb.com/title/tt006019/ (e.g. Center for Science in the Public Interest) publish their own Foodborne outbreak data Congress found it necessary to legislate that a Work Group monitor and recommend enhancements to CDC s foodborne illness surveillance

Chinese Symbol for Crisis Danger (top) + Opportunity (bottom)

CDC s Foodborne Disease Surveillance Systems: Already the BAD is getting BETTER http://www.westernclippings.com/hutch/hutch_ 2008_08.shtml Significant progress in updating the CDC website and surveillance reports, e.g.: http://www.cdc.gov/foodborneburden/surveillanc e-systems.html State FOOD data for 2009 Outbreak summary data for 2008 Salmonella lab data for 2007, 2008, and 2009 NARMS data for 2009 More updates coming

CDC FSMA Enhanced Surveillance Current Components and Plans Maintain critical components of existing epidemiological, laboratory, environmental networks Continued improvements in sharing existing data Develop new investigation tools and laboratory methods Enhance collaboration with partners Augment capacity, to more accurately attribute illness to specific foods Expand the number of FoodCORE sites (funds permitting)

Progress on Creating FSMA Working Group(s) Combined working groups on surveillance and Centers of Excellence Established under the CDC Board of Scientific Counselors (BSC) FACA Members were named by July 1 Members include representatives from Federal, state, and local government Academia Industry Consumers First meeting to be held November 7 and 8 Summary to be presented at BSC on Nov 9

FSMA Integrated Food Safety Centers of Excellence Public/private/academic partnerships State Health Department lead Partnership with 1 or more academic institution Specified activities are related to surveillance* Training Education Program evaluation/research Existing networks can serve as building blocks* FoodNet FoodCORE *Examples are not limited to these activities

Questions? CDC Food Safety Site: http://www.cdc.gov/foodsafety/ For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases Division of Foodborne, Waterborne, and Environmental Diseases

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