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Food and Drug Administration

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Presentation on theme: "Food and Drug Administration"— Presentation transcript:

1 Food and Drug Administration
Wendy Fanaselle MS, RS Food and Drug Administration Center for Food Safety and Applied Nutrition Division of Cooperative Programs Retail Food Protection Branch General greetings and introduction This slide presentation is designed for FDA personnel to use for the 1999 Food Code Slide #1 W Fanaselle, AoA Nutritionists conf, 6/4/02

2 Food Security Information available on the web:
Food safety and terrorism: Bioterrorism: “Countering Bioterrorism and other threats to the food supply”:

3 Food Security Preventive Measures Guidance
AID to operators of food establishments Firms that produce, process, store, repack, relabel, distribute, or transport food or ingredients Firms that prepare or distribute food at retail IDENTIFIES preventive measures to minimize the risk that food under their control will be subject to tampering or criminal or terrorist actions

4 Food Security Preventive Measures Guidance
RECOMMENDS review of current procedures and improvements as needed ENCOURAGES the commitment of management and employees to be successful ACKNOWLEDGES not all preventive measures are appropriate for every operation SUPPORTS use of operational risk management to prioritize improvements

5 Food Establishment Operations Management of Food Security
Security procedures Assign responsibility to qualified individual(s) Encourage all staff to be alert Investigation of suspicious activity Investigate suspicious activity Alert local law enforcement

6 Food Establishment Operations Physical Security
Visitors Observe incoming and outgoing vehicles Restricted entry Restrict access to food handling and storage areas and locker rooms Ensure there is a valid reason for the visit Rules apply to everyone

7 Food Establishment Operations Employees
Pre-hiring screening Work references Check of immigration status Criminal background checks Apply to all employees

8 Food Establishment Operations Employees
Training Provide food security training to new employees Provide periodic reminders Ensure employee buy-in

9 Food Establishment Operations Raw Materials and Packaging
Suppliers Use known sources Ensure suppliers/transporters practice security measures and audit for compliance Authenticate labeling and packaging configuration in advance of receipt of shipment

10 Food Establishment Operations Raw Materials and Packaging
Suppliers Inspect incoming products for signs of tampering or counterfeiting Report evidence of tampering or counterfeiting

11 Food Establishment Operations Raw Materials and Packaging
Suppliers Reconcile the amount received with the amount ordered and the amount invoiced Supervise off-loading of products

12 Food Code Represents FDA’s Best Advice for:
Uniform system of regulation; Safe food service through researched and recommended practices; Food is properly protected, unadulterated, and honestly presented.

13 Intent of the Food Code Provide guidance / tools to prevent Foodborne illness Uniform standards 3,000 local regulatory food agencies Implementation supported by other program elements The Code may not be perfect, but it does identify critical issues that if met can reduce foodborne illness. Reduction of foodborne illness IS the Intent of the Food Code. Uniform standards are necessary considering the large number of agencies regulating the retail food industry. It is particularly helpful to the industry if all agencies apply food protection criteria uniformly. All program elements must be considered when implementing uniform standards, such as: Trained Staff Program Resources Enforcement and Compliance Foodborne Illness investigation Application of the HACCP approach W Fanaselle, AoA Nutritionists conf, 6/4/02

14 Major Food Safety Subject Areas
Personnel Food Equipment, facilities, related supplies Compliance & enforcement Review major subject areas of the Food Code. Personnel was moved up to Chapter 2 because it is often people who contravene food safety. In older codes, personnel matters were further back in the code. W Fanaselle, AoA Nutritionists conf, 6/4/02

15 5 Identified Major Risk Factors
Poor personal hygiene Improper holding temperatures Inadequate cooking: Such as undercooking raw shell eggs Contaminated equipment Food from unsafe sources

16 Food Code 5 Key Interventions
1. Demonstration of knowledge 2. Employee health 3. Time / temperature 4. Hands a vehicle of contamination 5. Consumer advisory The Key interventions to foodborne illness were introduced with 1993 Food Code; it is not surprising that they have been debated to a great extent. Who must have Knowledge? The manager or Person-in-Charge Employee Health What are the health concerns? Addressed in Chapter 2 Time / Temperature Founded in science and located in Chapter 3 Hands as a Vehicle of Contamination Reduce foodborne illness by eliminating bare hand contact of ready-to-eat food Consumer Advisory This item is designed to provide information for the person who knows they are at risk of foodborne illness because they are immunocompromised. With a little information relative to certain raw or undercooked animal foods, that person may choose to avoid those foods. This is addressed in Chapter 3. W Fanaselle, AoA Nutritionists conf, 6/4/02

17 CDC Estimated Data on Foodborne Disease in the United States
5000 deaths 325,000 hospitalizations 76 million gastrointestinal illnesses On September 16, 1999, the CDC released the most complete estimate to date on the incidence of foodborne disease in the United States. The data is published in Emerging Infectious Diseases, and comes from a variety of sources including new and existing surveillance systems, death certificates and published studies from academic institutions. According to CDC Director Jeffrey Koplan, these are the most complete estimates ever calculated and should not be compared to previous estimates since the estimates are a result of better information and new analyses rather than changes in disease frequency over time. Bacteria account for 72% of deaths associated with foodborne transmission, parasites for 21%, and viruses for 7%. W Fanaselle, AoA Nutritionists conf, 6/4/02

18 CDC Estimated Food-related Deaths: 5 Pathogens = 90% of Total
W Fanaselle, AoA Nutritionists conf, 6/4/02

19 CDC Estimated % of Total Foodborne Illnesses, Hospitalizations, and Deaths
W Fanaselle, AoA Nutritionists conf, 6/4/02

20 Specific Product Concerns
Eggs Juice Produce Imported foods W Fanaselle, AoA Nutritionists conf, 6/4/02 21 4

21 Imported Foods 1/2 of all fish & shellfish imported
1/3 of all fresh fruit 12% of all vegetables GAO study: only 1.7% of 2.7 million shipments are inspected by FDA With the recent foodborne illness outbreaks involving imported foods, focus on imported food safety has been initiated. PROBLEMS INCLUDE: A recent GAO study showed that FDA was able to inspect only 1.7% of the 2.7 million shipments of imported fruit, vegetables, seafood, and processed food. *One half of all fish and shellfish eaten by Americans is now imported. *One third of all fresh fruit and 12% of all vegetables consumed in the U.S.. are now imported. *Some of these countries that are exporting fresh fruits and vegetables have faulty food safety systems and unsafe water sources. * This is resulting in exotic microbes entering the U.S.., that are rarely seen here. W Fanaselle, AoA Nutritionists conf, 6/4/02 6 24

22 Highly Susceptible Population
Juice Sprouts Eggs W Fanaselle, AoA Nutritionists conf, 6/4/02

23 Microbiological Hazards Fresh Fruits and Vegetables
E.coli 0157: H7 Cyslospora Salmonella & E. coli Lettuce in California Guatemalan raspberries Mexican cantaloupes Alfalfa sprouts / Netherlands Foodborne illness outbreaks from fresh fruits and vegetables have been seen recently in the U.S., such as: * E. coli associated with lettuce that was washed in polluted water and packed under filthy conditions in California * the Cyclospora outbreak in 1996 along the East Coast of the U.S. and Canada, involving over 1400 illnesses, which were traced to fresh raspberries imported from Guatemala, * the Vibrio Cholera outbreak in Maryland, involving coconut milk from Thailand, * Salmonella associated with cantaloupes from Mexico, * And the salmonella and E.coli outbreaks involving alfalfa sprouts from the Netherlands, have helped bring the issue to the forefront. W Fanaselle, AoA Nutritionists conf, 6/4/02 5

24 Juice Microbiological Hazards
E. coli 0157:H7 Salmonella spp. Crytosporidium 1996: Apple juice 66 ill & 1 death Unpasteurized orange juice Apple cider W Fanaselle, AoA Nutritionists conf, 6/4/02 12

25 Juice Microbiological Hazards
Bacillus Vibrio cholera Orange juice Frozen coconut milk Maryland W Fanaselle, AoA Nutritionists conf, 6/4/02 11

26 Eggs Salmonella stereotype Enteritidis
65 Billion eggs produced annually 1% Contain SE 10.2 Million servings contain SE Pooling eggs increases SE The incidence of SE has been increasing worldwide, including North America, South America, Europe, and even Africa. In the United States, the proportion of Salmonella isolates reported to the CDC that were SE increased from 6% in 1980 to 25% in Between 1985 and 1991 in the U.S., grade-A shell eggs were implicated in 82% of SE outbreaks in which information on the specific vehicle was available. The emergence of SE is related to the ability of the organism to infect the ovaries of egg laying hens, resulting in contamination of the internal contents of intact shell eggs. SE can be transmitted vertically from breeding flocks to egg-laying hens, which in turn produce contaminated eggs. Once present in a flock, the infection is difficult to eliminate because transmission is sustained through environmental sources, including rodents, feed, and other hens. Changes in egg production have also made the control of SE more difficult. The size of a typical hen house has grown from 500 hens in 1945, to 100,000 hens and multiple houses which are linked by common machinery, in The result is large flocks with common risk profiles. Geographically, commercial egg production in the western United States is concentrated in California, and in the east it is centered in Ohio, Indiana, and Pennsylvania. About 65 Billion eggs are produced and 47 billion eggs are consumed as shell eggs annually in the U.S. Of these eggs, about 1% contain SE, which is about 4.5 million SE contaminated eggs. There is an average of about 10.2 million servings of eggs in the U.S., served annually with SE contamination and each egg has an average of 20 SE bacteria per egg. Pooling the eggs is especially hazardous, because it results in rapid SE growth. W Fanaselle, AoA Nutritionists conf, 6/4/02 16 22

27 Eggs – Salmonella Enteritidis
2.4 million persons exposed / year 661,000 see physician 390 die from SE 2.4 million persons are exposed to SE from eggs each year. Of this number 661,000 infected persons see a physician each year and 390 die each year from SE in the U.S. W Fanaselle, AoA Nutritionists conf, 6/4/02 17 23

28 Highly Susceptible Populations
HSP are 10 fold more susceptible to SE Pooling eggs = highest incidence of SE Most SE outbreaks occur in institutions Nursing homes The practice of egg pooling is found in institutions where highly susceptible populations are 10-fold more vulnerable to SE infection. SE outbreaks due to pooled eggs have been especially severe in nursing homes. W Fanaselle, AoA Nutritionists conf, 6/4/02 18

29 Part 3-8 Specialized Topics
Highly susceptible populations: Use of pasteurized packaged juice required Raw seed sprouts prohibited Use of pasteurized eggs Allowance for restricted use of shell eggs Time as a public health control prohibited Each topic identified here will be discussed in the next few slides. W Fanaselle, AoA Nutritionists conf, 6/4/02

Emergency Point of Contact FDA 24 hour contact: (301) Or LOCAL FDA District Office: listed at FDA’s website (

31 For Further Information ...
Center for Food Safety & Applied Nutrition Division of Cooperative Programs Retail Food Protection Team 5100 Paintbranch Parkway (HFS-627) College Park, MD 20740 You are invited to participate in the Food Code revision process, which occurs every two years. We receive concerns and recommendations from regulatory agencies, individuals, and organizations. The Agency is especially responsive to organizations that provide a process that encourages representative participation in deliberations by government, industry, and academic and consumer interests, followed by public health ratification such as a state--by-state vote by officially designated delegates. Examples of such organizations include the Conference for Food Protection, the National Conference on Interstate Milk Shipments, and the Interstate Shellfish Sanitation Conference. CFP Executive Secretary : phone: Slide #26 W Fanaselle, AoA Nutritionists conf, 6/4/02 42 25

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