1

FDA Foods Program Update

Comments byMichael M. Landa

Acting Director, Center for Food Safety and Applied NutritionJIFSAN Advisory Council Business Meeting

Greenbelt, MDApril 28, 2011

2

FDA Food Safety Modernization Act

3

Main Themes of the LegislationPrevention

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

4

Prevention: Cornerstone of the Legislation

• Comprehensive preventive controls for food facilities – Prevention is not new, but Congress has given

FDA explicit authority to use the tool more broadly

– Strengthens accountability for prevention• Produce safety standards• Intentional adulteration standards

5

Inspection, Compliance, and Response

• Mandated inspection frequency– Considering new ways to inspect

• New tools– Mandatory recall – Expanded records access– Expanded administrative detention– Suspension of registration– Enhanced product tracing– Third party laboratory testing

6

Import Safety: Most Groundbreaking Shift

• Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place

• FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements

• Can require mandatory certification for high-risk foods• Voluntary qualified importer program--expedited

review• Can deny entry if FDA access for inspection is denied• Requires food from abroad to be as safe as domestic

7

Partnerships• Centers of Excellence

-- Institute for Food Safety and Health (formerly National Center for Food Safety and Technology)

-- Joint Institute for Food Safety and Nutrition-- National Center for Natural Products Research-- Western Center for Food Safety

• International Food Protection Training Institute• Asia Pacific Economic Cooperation

(APEC)/Partnership Training Institute Network (PTIN) Steering Committee

8

Enhanced Partnerships: Vital to Success

• Reliance on inspections by other agencies that meet standards

• State/local and international capacity building• Improve foodborne illness surveillance • National agriculture and food defense strategy• Consortium of laboratory networks• Easier to find recall information

9

Implementation: FDA is Prepared

• Experience in preventive controls • Implementation process in place• Much work already underway

10

But, Many Challenges• Enormous workload

– 50 new rules, guidance documents, reports in 3 years

• Tight deadlines • Changes won’t appear overnight

– Building new system will be a long-range process• Resources

11

Implementation Approach• Coalition needed • Transparency a priority• Focus on public health protection • Engage with stakeholders to help

determine reasonable and practical ways to do so

12

Priorities• Prevention

– Mandatory preventive controls for facilities (FR 18 months)– Produce safety standards (FR 2 years)– Intentional contamination (FR 18 months)

• Inspection, Compliance, and Response – Administrative detention (IFR 120 days)– Recall (Upon enactment)– Suspension of registration (180 days)

• Imports– Foreign supplier verification program (Guidance and FR 1

year)– Accredited third-party certification program (FR 2 years)– Mandatory certification for high risk foods (Upon

enactment)

13

Public Meetings on FSMA

14

Public Meetings on FSMA• Imports (3/29)• Comparability of Food Safety Systems

(3/30 – 3/31)• Preventive Controls (4/20)• Inspections and Compliance (TBD)

15

For More Information

• www.fda.gov• www.foodsafety.gov

16

Nutrition Activities

17

Nutrition Activities Proposed rule on menu and vending

machine labeling

Publish a proposed rule for manufacturers that choose to put dietary guidance statements on packaged food products

Publish a proposed rule to modernize the Nutrition Facts label

Initiate a process to support reduction of sodium in foods

Develop an evidence-based approach for nutrition labeling on front of packages that consumers will notice, understand and use

18

Coordinated Outbreak Response Team

19

Coordinated Outbreak and Response Team (CORE)

• Will be led by a Chief Medical Officer/National Outbreak Director

• Dr. Susan Lance is heading the program on an interim basis

• Goal is to strengthen and streamline FDA's approach to identifying, investigating, and responding to foodborne disease outbreaks, and to analyze and address the root causes of those outbreaks to prevent future outbreaks