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FDA Foods Program Update. Comments by Michael M. Landa Acting Director, Center for Food Safety and Applied Nutrition JIFSAN Advisory Council Business Meeting Greenbelt, MD April 28, 2011. FDA Food Safety Modernization Act. Main Themes of the Legislation. Prevention.

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Fda foods program update

FDA Foods Program Update

Comments by

Michael M. Landa

Acting Director, Center for Food Safety and Applied Nutrition

JIFSAN Advisory Council Business Meeting

Greenbelt, MD

April 28, 2011

Fda food safety modernization act

FDA Food Safety Modernization Act

Main themes of the legislation
Main Themes of the Legislation


Enhanced Partnerships

Inspections, Compliance,

and Response

Import Safety

Prevention cornerstone of the legislation
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

Inspection compliance and response
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

Import safety most groundbreaking shift
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


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

Enhanced partnerships vital to success
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

Implementation fda is prepared
Implementation: FDA is Prepared

Experience in preventive controls

Implementation process in place

Much work already underway

But many challenges
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


Implementation approach
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



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)


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)

Public meetings on fsma1
Public Meetings on FSMA

Imports (3/29)

Comparability of Food Safety Systems (3/30 – 3/31)

Preventive Controls (4/20)

Inspections and Compliance (TBD)

For more information
For More Information



Nutrition activities1
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

Coordinated outbreak and response team core
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