1. Prepared but not RTE foods – Challenges faced by the industry IAFP Latin America Symposium on Food Safety Campinas, SP, Brazil May 26, 2008 Robert E. Brackett, Ph.D. Senior Vice President and Chief Science and Regulatory Affairs Officer Grocery Manufacturer’s Association

2. Modern Food Industry New Generation of Food Products –Ready-to-eat or RTE Fully cooked or needs no cooking Ready to be eaten as-is or after reheating

3. Modern Food Industry New Generation of Food Products –Ready-to-eat or RTE Fully cooked Ready to be eaten as-is or after reheating –Not-ready-to-eat or NRTE Prepared with ingredients that are not fully cooked Require further cooking to assure microbial safety

4. Food Industry Challenges Assuring the Safety of NRTE Products

5. Vehicle for Outbreaks Increasingly being recognized as a vehicle for outbreaks by the CDC

6. Vehicle for Outbreaks Increasingly being recognized as a vehicle for outbreaks by the CDC –S. Heidelberg and S. Enteritidis associated with raw “flash-fried” or “par fried” breaded chicken nuggets and chicken strips in Canada and Australia –Salmonellosis associated with raw, frozen, microwavable, breaded, pre-browned stuffed chicken products in the United States (Minnesota) S. Typhimurium associated with chicken Kiev and other stuffed chicken products S. Heidelberg associated with chicken Kiev S. Enteritidis associated with multiple brands and multiple varieties of stuffed chicken products

7. Common Themes Frozen, microwavable processed foods Consumer confusion over the raw or cooked nature of products Consumers did not follow package cooking instructions

8. Vehicle for Outbreaks Outbreaks highlight the need for NRTE foods to be thoroughly cooked before consumption.

9. The Consumer Frozen foods sales in the U.S. are up 5% from 2007 –Sales represent 12% of U.S. food and beverage sales Third largest category in the marketplace

10. The Consumer Frozen foods sales are up 5% from 2007 Labeling Confusion –How to determine RTE from NTE Products look similar Subtle differences in labeling

11. The Consumer Frozen foods sales are up 5% from 2007 Labeling Confusion Reliance on consumer for adequate handling

12. Industry Responsibility Assure ingredients are of the highest microbiological quality –Minimize the potential for consumer preparation errors to result in illness

13. Industry Responsibility Assure ingredients are of the highest microbiological quality Validate consumer cooking instructions –Important and effective tool for ensuring safe consumption of NRTE products by consumers FOR FOOD SAFETY AND QUALITY, FOLLOW THESE COOKING DIRECTIONS: Microwave Oven (Ovens vary; cooking time may need to be adjusted) PLACE tray on microwave-safe plate; slit top crust MICROWAVE on HIGH. Med. OR High Wattage Microwave 4 mins Low Wattage Microwave 6 mins LET STAND 3 minutes. CAREFULLY remove as PRODUCT WILL BE HOT Conventional Oven (fine print: Do not prepare in toaster oven) PREHEAT oven to 400F. Place tray on cookie sheet, slit top crust. BAKE in oven 30 to 32 minutes. CAREFULLY remove as PRODUCT will be hot. Let Stand 5 minutes.

14. Cooking Instruction Validation Types of validation –Product temperature Cook following instructions on label Determine product temperatures

15. Cooking Instruction Validation Product temperature What temperature is appropriate? –Is the same temperature appropriate/needed for all products? –Single temperature or time/temperature combinations? –What level of lethality is required?

16. Cooking Instruction Validation Product temperature What temperature is appropriate? –Is the same temperature appropriate/needed for all products? –Single temperature or time/temperature combinations? –What level of lethality is required? »In general, 160°F (165°F for products containing raw poultry) provides adequate lethality »Target lethality may be different for products containing cooked meat or poultry components

17. Cooking Instruction Validation Types of validation –Product temperature –Microbiological inactivation

18. Cooking Instruction Validation Microbiological inactivation –Temperature studies Products with a higher risk of microbial contamination (e.g., products containing raw meat) Cases were validation testing results show inconsistent attainment of product target temperature –Justification for the log reduction targeted for microbiological inactivation should be provided.

19. Validation Challenges Variability factors –Product and package factors Composition Size Shape Components Package configuration Initial temperature

20. Validation Challenges Variability factors –Product and package factors –Cooking device Stovetops Fryers Conventional and toaster ovens Microwave oven

21. Microwave Cooking Practices Follow all of the Cooking Instructions Flip, rotate, or stir during the microwave cooking process Increase or decrease cooking time based on my microwave Check microwave wattage Use a food thermometer to be sure food reaches required temperature

22. Validation Challenges No single approach to conducting validation studies All cooking instruction validation studies have a common goal –Ensure NRTE cooked according the instructions are safe to consume

23. Regulatory Focus Collecting relevant data in NRTE operations

24. Regulatory Focus Collecting relevant data in NRTE operations –Microbiological profile of environment and product

25. Regulatory Focus Collecting relevant data in NRTE operations –Microbiological profile of environment and product –Validation document in support of cooking instructions Evidence that consumers understand and will follow the instructions

26. Regulatory Focus Collecting relevant data in NRTE operations –Microbiological profile of environment and product –Validation document in support of cooking instructions –Address labeling and GMPs

27. Regulatory Focus Collecting relevant data in NRTE operations Outreach and education

28. Regulatory Focus Collecting relevant data in NRTE operations Outreach and education –Reinforce safe cooking guidance Use a thermometer Cook poultry to at least 165° Cook non-intact meat products to at least 160°

29. Summary Food industry is providing many new and exciting products to consumers. Consumers are often mistaking NRTE with RTE products. Consumers need clear, obvious information about the product they are purchasing and its cooking requirements. Industry needs to validate consumer cooking instructions to ensure pathogenic microorganisms are inactivated during cooking. Industry and regulators must work together to find appropriate solutions.