FDA Foods Program Update

Comments byStephen F. Sundlof, D.V.M., Ph.D

Director, Center for Food Safety and Applied Nutrition Conference for Food Protection

Providence, Rhode Island April 10, 2010

“The Food Safety Working Group will bring together cabinet secretaries and senior officials to advise me on how we can

upgrade our food safety laws for the 21st century; foster coordination throughout

government; and ensure that we are not just designing laws that will keep the

American people safe, but enforcing them."

President Obama, 3/14/09 Radio Address

3 Core Food Safety Principles

1. Preventing harm to consumers is our first priority.

2. Effective food safety inspections and enforcement depend upon good data and analysis.

3. Outbreaks of foodborne illness should be identified quickly and stopped.

FDA Office of Foods and Deputy Commissioner for Foods• The President’s Food Safety Working

Group called for the establishment of a Deputy Commissioner for Foods position to enhance food safety at FDA

• Dr. Hamburg has charged the Office of Foods and the Deputy Commissioner for Foods -- Michael R. Taylor -- with the responsibility of leading a functionally unified FDA Foods Program

“One Mission, One Program”Initiative

To provide vision, strategy and commitment across all of the FDA to build a unified FDA

Foods Program that works effectively to prevent foodborne illness and improve

nutrition in a dynamic and innovative U.S. food marketplace and increasingly complex

food system.

“One Mission, One Program” Launch

• This Initiative involves nearly 100 experts from throughout FDA who are charged with tackling cross-cutting issues critical to our success.

• From those in the field, to the lab, to the office, we are working together to modernize our food safety program.

“One Mission, One Program” Launch

Core Groups are identifying key inter-dependencies, synergy and gaps in 10areas: 1. Preventive Controls2. Risk-Based Decision- making3. Inspection & Compliance

Strategy4. Import Safety5. Federal/State Integration

6. Information Systems7. Incident Preparedness &

Response8. Science, Technology & Research Integration9. Strategic Communication10.Resource Planning

New FDA Authorities?• Mandatory preventive controls• Performance standards authority• Risk-based inspection schedule• Records access• Product tracing• Administrative detention• Mandatory recall authority• Importer controls

Integrated National Food Safety System

• Develop standards to ensure consistency

• Train and certify a highly skilled workforce

• Work across jurisdictions to ensure protection of the entire food supply from farm to table

• Create mechanisms for data sharing

• Ensure use of quality systems• Build oversight and accountability

An Integrated Food Safety System will result in:

• National Standards – Uniform inspectional coverage and sample

collection and analysis – Greater use of each other’s analysis and

observations in protecting public health

• National Work Plan – Improved targeting of resources – Expanded inspections and sample collection

coverage

An Integrated Food Safety System will result in:

• Training and Certification Programs – High level of scientific quality in data

collection and inspections– Consistent best-practice approaches and

capacity across state and local agencies• Laboratory Program

– Consistent and meaningful data for compliance, surveillance, and environmental samples

An Integrated Food Safety System will result in:

• Integrated Response– Coordinated, faster and more effective

response to food safety events

• Program Oversight– Auditing to ensure performance meets the

program standards

What is necessary for success?

• Support from stakeholders

• Engagement from partners

• Multi-year investment- Federal - Local - Territorial

- State - Tribal

• Information sharing infrastructure

Summary of the Change • Build on current collaborations • Provide stronger, more uniform coverage

from farm to table• Maintain credibility through oversight• Sustain public health infrastructure through

multi-year investment

Outcome: Reduced incidence of foodborne illness

Strengthening Focus on Nutrition

• Nutritional efforts to reduce the risk of such illnesses as heart disease, diabetes, and stroke and address the epidemic of obesity

• Give consumers better, easier-to-use information

• Reduce misleading, confusing information• Motivate industry to offer healthier food

choices

Nutrition Initiative• Better Nutrition Information

– Targeted enforcement of violative front of package (FOP) claims

– Nutrition Facts Panel Modernization• Calories• Serving Size• % Daily Value• Sugar

– Dietary Guidance Proposed Rule – FOP Symbols

• Sodium Reduction• Trans Fat Reduction

Health Care Reform

• Requires chain restaurants to post calorie counts on menus, menu boards and drive-through displays, as well as on vending machines.

• The federal legislation applies to chains with 20 or more outlets; the law also requires the chains to provide additional nutrition information on request.

Produce Safety• Issued draft commodity-specific guidances (leafy

greens, melons, tomatoes) – July 2009• Established public docket – February 2010

(75 FR 8086)• Participating in regional listening sessions and

other engagements• Drafting a proposal to establish safety standards

through regulation

Revisions to Current Good Manufacturing Practice Regulations

● Working group formed and codified text and preamble development underway

● Writers and economists making visits to industry to learn more about how 21 CFR 110 is currently being translated into corporate policy and implemented by industry

● FDA grateful for all of the willing assistance received from industry

● Food GMP survey

Product Tracing for Foods• A top priority for the Administration and for

Congress• FDA/USDA joint public docket (11/09) • FDA/USDA joint public meeting (12/09) • 2 IFT Reports released in 12/09 -- Industry

“best practices” and tomato traceback exercise• Next steps: Evaluate feedback and affect of

legislation, if enacted

Retail Food Regulatory Program Standards

• 363 Enrollees • >93% of US Population reside in a State with at

least one enrolled State-level Agency• 50% of US Population reside where the Local

Agency has enrolled or where there is no local program and the State is enrolled

• In 2009-2010 FDA provides $550,000 to enrollees to promote progress on Program Standards implementation

Emphasis on Employee Health and Hygiene at Retail

• Enhancements to the Food Code over the years• Employee Health & Personal Hygiene Handbook

– Available in hard copy and online (www.fda.gov)

• Satellite Broadcast and Webcast – May 27, 2010– “Using Employee Health and Personal Hygiene

Measures”

• Educational Materials for Oral Culture Learners– Posters, exercises & storyboards directed at

foodworkers

“The challenges of the Foods Program have neverbeen as great as they are today. They are inherentin the complexity and dynamism of the global foodsystem and are reflected in the growing scope and

impact of illness outbreaks and contamination incidentsaffecting food and feed. Further, nutrition-related public

health challenges, such as obesity and diet-relatedchronic disease, complicate food policy decision making.Finally, the steady stream of new food technologies and

new manufacturing and marketing practices and theflood of food imports constantly change the food

supply.”

FDA Commissioner Margaret Hamburg

12/15/09 Memo to Foods Program

Management and Staff