CFSAN Update Michael M. Landa

Transcription

1 CFSAN Update Comments by Michael M. Landa Director, Center for Food Safety and Applied Nutrition JIFSAN Fall Advisory Council Meeting November 14,

2 CFSAN Plan for Program Priorities ( ) Reduce foodborne illness rates and cosmetic injury rates each year. Establish regulations, policies, guidances, and inspection and compliance strategies based on best science, prevention, and public health risk. Increase compliance with newly created preventive control standards across the farm-to-table continuum. Improve public health indicators through better nutrition and dietary choices. Develop and swiftly deploy the fastest most effective methods for identifying, containing, and eliminating food and cosmetic hazards. Achieve optimal use of staff and resources. 2

3 CFSAN Science and Research Strategic Plan For information on CFSAN s Science and Research Strategic Plan, see FDA s Intranet site at arch/researchstrategicplan/default.htm 3

4 Strategic Plan for Science and Research Better control and prepare for hazards Create faster and validated methods Influence consumer behavior toward healthy dietary choices Develop leading edge technology for understanding and evaluating scientific information Improve our adaptability and responsiveness 4

5 Strategic Plan Working Groups Knowledge Gap Groups Science Capability Groups Allergens and Gluten Dairy Products Dietary Supplements Egg Safety Food & Color Additives Fresh Produce Nanoparticles & Cosmetics Retail Foods Seafood Safety Spice Control Analytical Chemistry Botulinum Control Molecular Epidemiology Virology Toxicology (new 2013) Packaging (in planning stage) 5

6 Working Group Roles and Responsibilities Working Groups: Composed of research and regulatory staff charged with identifying specific research needs that are important to CFSAN s regulatory and public health mission. Senior Science Advisor Staff: Organizes working group meetings and manages tracking and reporting of research across CFSAN s scientific enterprise. Responsibilities: Determine and track progress toward Research Outcomes (ROs) to fulfill knowledge gaps Assure that regulatory goals and knowledge gaps are clear and current Provide guidance to work plan modification when regulatory goals change or new information needs to guide the work plan Plan and prioritize future research needs Working Group Plan Responsibilities: Assists working groups in planning and process implementation Fosters communication among program and research offices Helps identify and resolve corrective action needed for delayed or unsuccessful projects Provides project status updates to senior leadership and OFVM 6

7 2014 Prioritization of Research Outcomes 10 Knowledge Gap Working Groups 5 Science Capability Working Groups 115 Research Outcomes Ranked by Working Groups 83 Top-Ranked Research Outcomes Prioritized by CFSAN Management Council 43 Expected Research Outcomes (EROs) Designated in EROs Tracked by Knowledge Gap Working Groups in EROs Tracked by Science Capability Working Groups in

8 Tracking Research Outcomes 8

9 FDA Food Safety Modernization Act (FSMA) 9

10 Four Proposed Rules Establish Food Safety Framework Produce Safety Standards January, 2013 Preventive Controls for Human Food - January, 2013 Foreign Supplier Verification Program July, 2013 Accredited Third Party Certification July,

11 Other FSMA-Related Work Most significant foodborne contaminants and high risk foods lists Revised draft guidance on new dietary ingredients to increase premarket oversight of dietary supplements Proposed rule for safely transporting food A proposed rule on intentional contamination 11

12 Initiatives to Reduce Risk of Illness of Injury 12

13 Initiatives to Reduce Risk of Illness or Injury Gluten-free Labeling published final rule defining gluten-free and on using the term on food labels (August, 2013) Arsenic - published draft action level for arsenic in apple juice (July, 2013) Acrylamide published draft guidance to reduce acrylamide in foods (November, 2013) Infant Formula publish final rule on quality factors and cgmps 13

14 Arsenic in Rice and Rice Products Post analytical results Conduct risk assessment and any necessary risk management and risk communication 14

15 Risk and Safety Assessment Salmonellosis Associated With the Consumption of Tree Nuts (July, 2013) A Quantitative Assessment of Inorganic Arsenic in Apple Juice (September, 2013) Listeria monocytogenes in Retail Delicatessens (September, 2013) Pathogens and Filth in Spices (November, 2013) 15

16 Nutrition (the N in CFSAN) 16

17 Top Priority Nutrition Initiatives Trans Fat published notice preliminarily determining that partially hydrogenated oils are not generally recognized as safe (November, 2013) Menu and Vending Machine Labeling publish final rules Nutrition Facts Label (NFL) and Serving Sizes publish proposed rules to update the NFL and serving sizes Dietary Guidance Statements publish proposed rule Sodium advance strategies for reduction Fish consumption publish updated advice 17

18 Internal Initiatives 18

19 Chemical Safety Program Review Focus: Scientific capacity and the management of the program s multiple elements across CFSAN and CVM. Process: Contractor has completed interviews of employees in CFSAN and CVM as well as alumni, colleagues in other agencies, and stakeholders outside the U.S. government. Goal: Determine overall program needs and then determine not only how to meet the needs but also how to further improve our chemical safety program. Outcome: Implementation of recommendations to help improve the program to better meet today s chemical safety challenges. 19

20 Nutrition Review Focus: Current nutrition and related activities in CFSAN. Process: Contractor has completed interviews of CFSAN employees, and is in the process of obtaining views of colleagues in other agencies and stakeholders outside the U.S. government. Goal: Identify, with respect to nutrition in America, what problems we have now, in the near future, and in the next years. Outcome: Implementation of recommendations to better address the problems/opportunities within budgetary, statutory, and other realities. 20

21 Office of Food Safety (OFS) Review Focus: Current structure and functions of OFS. Process: Three CFSAN senior managers completed interviews with OFS staff and other CFSAN managers outside of OFS. Goal: Identify a sound structure and set of functions for OFS that will enable it to achieve and maintain highly efficient operations, especially in light of the need to implement FSMA. Outcome: Implementation of recommendations to improve the structure and/or functions of OFS 21

22 Review of OFVM Microbiology Laboratory Programs Focus: Scientific capacity, efficiency and management of microbiology work in OFVM laboratories. Process: Contractor will interview CFSAN and CVM employees doing laboratory-based microbiology work. Goal: Determine if microbiology research is meeting program needs; identify if there is unnecessary duplication; and ensure that microbiological research yields mission-relevant outcomes. Outcome: Recommendations to improve the program to better meet today s microbiology challenges. 22

23 Signal Detection of Chemicals in Food Goal is to improve detection of signals of problems with the safety of chemicals in the food (including dietary supplements), food and color additives, and cosmetics supplies. A CFSAN work group developed a proposed pilot process that will identify potential chemical contaminant hazards of concern in CFSANregulated products. 23

24 Food Advisory Committee Meeting The committee discussed detection signals for noteworthy chemical hazards in foods, dietary supplements, and cosmetics. They considered possible sources of information, data on chemical hazards, and how CFSAN might recognize and best take advantage of those data. They reviewed and considered the proposed pilot process developed by the CFSAN work group for identifying potential chemical contaminant hazards of concern. 24

25 Thanks for listening 25