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Centers for Disease Control and Prevention Estimates each year 1 in 6 Americans (48 million

people) get sick, 128,ooo are hospitalized, and 3,000 die from foodborne disease

Know foodborne pathogens – 31 known to cause foodborne illness (20%); 8 account for majority

Unspecified agents that cause gastroenteritis. These include microbes, chemicals, and other substances known to be in food (80%)

Top six pathogens contributing to domestically acquired foodborne illnessesNorovirus (largest %)SalmonellaEscherichia coliClostridium perfringensCampylobacter speciesStaphylococcus aureus (smallest %)

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Surveillance for Foodborne Disease Outbreaks United States, 2016 Annual Report (Source CDC)839 foodborne disease outbreaks were

reportedResulting in 14,259 illnesses, 875

hospitalizations, and 17 deaths.Bacteria caused most outbreaks, followed by

viruses, chemicals, and parasites

Food Categories Commonly Implicated Fish Mollusks Dairy (Unpasteurized) Pork Chicken Vegetables (Greens & Beans)

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For the Record - No vegetable/fruit outbreaks of food borne illness in

Delaware At least since 1968Were 3 bacterial and 1 viral confirmed cases in 2016 – not

from vegetable or fruits

National incidents Spinach in California – 2006, 2018 Cantaloupes in Colorado – 2011 Lettuce/other greens – 2014, 2018 2018 43 people ill in 12 states along with 22 people in Canada

(E. Coli o157:H7) all from romaine lettuce (Source: Central and Northern CA)

Apple Cider – E. Coli (Cana, VA)

Risk/Benefit Ratio: Labelling

From “Minimum Regulated to Super-Regulated”

We all want safe food – What is the best way to ensure a safe food system?

Government/Grower/Industry/Agency Level

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FSMA is rooted in 1998 FDA Good Ag Practices Law – GHP and GAP

Important to be implementing practices or facilities for Good Handling Practices (GHP) and Good Agricultural Practices (GAP) with direct consumable products

While that’s good, more is needed

Shippers – important to pay close attention to FSMA

Core Fundamentals FDA (Food and Drug Administration) through FSMA is

charged with developing science-based standards and regulations for

Growing (GAP)Harvesting (GHP) Packing (GHP)Holding (GHP) Transport (GHP)

Fresh fruits and vegetables that are generally consumed in the raw state

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Farmer’s, Industry and States Express Concerns

Economic Burden Time and Operation Burden Is the investment worth the benefitsRelates to Risk

FSMA had much of its origins in safety concerns with imported fruits and vegetables

FSMA Goals Improve public health by strengthening food safety PREVENT food safety problems vs. REACTING to

problems after they occur Law provides Food and Drug Administration (FDA)

with new enforcement designed to achieve higher rates of compliance with prevention (food safety standards)

Gives FDA tools to hold imported foods to same standards as domestic foods

Builds an integrated national food safety system working with federal, state, and local authorities

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FDA Authorities/Mandates# 1 - Prevention

Prevention: Food facilities are required to implement written preventive control plans (potential hazards, steps to minimize hazards, monitoring controls and records, and actions to correct problems)

Produce Safety Standards: science based standards for safe productions and harvesting of fruits and vegetables (see next slide)

Protect against intentional contamination

Produce Safety Standards:Five Routes of Contamination

Agricultural Water IrrigationCleaning Operations

Farm Worker Hygiene Manure and other Bio-based additions to the soil Animals in the growing area Equipment, Tools and Buildings

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FDA Authorities/Mandates# 2 - Inspection & Compliance

Prevention controls work only to extent that producers and processors comply

Mandated Inspection: frequency, risk based. FDA inspects 600 foreign facilities with goal of doubling those over next five years

Access to Records: food safety plans and records Testing by Accredited Labs: testing must be done by

accredited/approved labs to reflect high quality standards

FDA Authorities/Mandates# 3 - Tools to Respond

Mandatory Recall: overrides a companies authority if they do not voluntarily recall product

Expanded Administrative Detention: Freeze movement of suspect food

Suspend Registration: company cannot distribute food Enhance Product Tracing Abilities: track and trace

domestic and imported foods; identify recipients of food

Additional Records on High Risk Foods

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FDA Authorities/Mandates# 4 - Imports (Imported food must

meet U.S. standards) Importer Accountability Third Party Certification: facilitates the entry of

imports and focuses on high risk foods Voluntary Qualified Importer Program: importers

provide for expedited review and entry of foods from participating importers

Authority to Deny Entry: Refuse entry of food into U.S. if denied access to facility from importing country

FDA Authorities/Mandates# 5 - Enhanced Partnerships

Focuses on government agencies collaborating (both domestic and abroad) with focus of achieving public health goals

State and Local Capacity: enhance food safety and defense capacities (ex. grants)

Foreign Capacity Building: focus is on comprehensive plan to expand the capacity of foreign governments and their food industries (trainings)

Reliance on Inspections by Other Agencies: leverages resources especially with seafood facilities (lab networks)

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