1. 1 Food Processing Regulations 2215 Steven C Seideman Extension Food Processing Specialist Cooperative Extension Service University of Arkansas

2. 2 Introduction This modules covers some of the most common regulations involving food processing which include HACCP, SSOPs, GMPs, food labeling and nutritional labeling and bioterrorism. Although this module may not be complete, it does provide websites for the reader to go to for a deeper understanding. There are also other modules in this series that more deeply discuss these topics in more detail.

3. 3 Agencies Involved There are primarily 2 federal agencies involved in food regulations. 1)The Food Safety and Inspection Service (FSIS) is part of the USDA and regulates food items that have 3% of more red meat and 2% or more poultry meat. 1)The Food Safety and Inspection Service (FSIS) is part of the USDA and regulates food items that have 3% of more red meat and 2% or more poultry meat. 2) The Food & Drug Administration (FDA) regulates all other foods. 2) The Food & Drug Administration (FDA) regulates all other foods. The laws from these 2 agencies tend to be similar in content but different in implementation. FSIS has inspectors in meat processing plants almost on a full time basis whereby FDA generally performs only annual reviews of food processing plants.

4. 4 Where to Find Food Regulations Go to www.gpoaccess.gov/topics/food.html www.gpoaccess.gov/topics/food.html Click on Title 9 for USDA/FSIS regulations Click on Title 21 for FDA regulations

5. 5 USDA/FSIS Regulations Once you are in Title 9 regulations, click on Parts 300- 599. Part 317- Covers the labeling of meat products to include nutritional labeling Part 317- Covers the labeling of meat products to include nutritional labeling Part 319- Covers the standards of identity of various meat products. Part 319- Covers the standards of identity of various meat products. Part 416 –Covers the regulations dealing with plant design, operation etc. It also covers SSOPs Part 416 –Covers the regulations dealing with plant design, operation etc. It also covers SSOPs Part 417 –Covers meat HACCP regulations Part 417 –Covers meat HACCP regulations

6. 6 FDA Regulations Once you are in Title 21, go to Parts 100-169. Parts 101 and 104 deal with labeling and nutritional labeling respectively. Part 110 –Covers food GMPs Part 113- Covers low acid canned foods Part 114- Covers acidified foods Part 120 – Covers HACCP Parts 130-169 –Covers food standards of identity

7. 7 FDA Regulations Once in Title 21 regulations, one can go to Parts 170- 199 which deals primarily with food additives, packaging, irradiation and part 197 which deals with Seafood Inspection.

8. 8 Food Laws Most food regulations revolve around 2 central concepts; 1) Food must be safe 1) Food must be safe 2) Avoiding deception of the customer 2) Avoiding deception of the customer

9. 9 Food Safety The regulations regarding food safety are based on the agencies power to prevent “Adulteration”. Adulteration refers to food that contains any added substances which are poisonous or deleterious. This would include foreign matter such as glass, metal etc and harmful bacteria. This is where regulations covering GMPs, HACCP, SSOPs have their basis.

10. 10 Avoiding Deception of the Customer Consumers have a right to know what ingredients go into foods and have some confidence in what they are buying is really what it is. This is the basis for regulations on food labeling, nutritional labeling and standards of identity.

11. 11 FOOD REGULATION PROGRAMS

12. 12 HACCP

13. 13 What is HACCP? HACCP is short for ‘Hazard Analysis Critical Control Point”. HACCP is a scientifically-based management system for food safety. HACCP uses a written plan which focuses on how potentially hazardous foods are handled in a food processing environment.

14. 14 What is HACCP? HACCP is a state–of-the-art approach to consistent safe food production. HACCP is proactive and prevention oriented focusing on preventing or controlling food safety hazards that fall into three main categories; biological, chemical and physical.

15. 15 HACCP HACCP is really all about prevention. Knowledge of the hazards and procedures to control the hazards will prevent foodborne illness in food processing plants. Identify a potential problem early and prevent it from becoming a real problem later.

16. 16 The HACCP CONCEPT In maybe what is an over-simplification, under the HACCP concept, a “hazard analysis ”is conducted to assess potential food safety hazards throughout the entire process for producing a given product. This is generally production people figuring out what can go wrong. Then they figure out critical control points (CCPs) on where to monitor hazards. Then a written plan is drafted to address various situations that might come up and how to handle them.

17. 17 The Seven Principles of HACCP 1)Conduct a hazard analysis. Prepare a list of steps in the process where significant hazards could occur and describe the preventive measures. 2)Identify the Critical Control Points (CCPs) in the process. 3)Establish critical limits for preventive measurements associated with each identified CCP. 4)Establish CCP monitoring requirements. Establish procedures for using the results of monitoring to adjust the process and maintain the control.

18. 18 The Seven Principles of HACCP 5)Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit. 6)Establish effective record-keeping procedures that document the HACCP system. 7)Establish procedures for verification that the HACCP system is working correctly.

19. 19 HACCP USDA/FSIS requires HACCP plans in all red meat and poultry processing facilities. FDA only requires HACCP in facilities that process fruit and vegetable juices and seafoods, fish and fish products. Additional information on HACCP can be found in another module.

20. 20 GMPs

21. 21 GMPs The term “GMPs” stands for “Good Manufacturing Practices”. GMPs for FDA food products can be found in Title 21 Part 110 GMPs for USDA/FSIS are found in Title 9 Part 416 under the word Sanitation. GMPs are regulations on the grounds & facilities, equipment & utensils, sanitary operations and employee hygiene. Additional information on GMPs can be found in another module.

22. 22 SSOPs

23. 23 SSOPs SSOPs stands for “Sanitation Standard Operating Procedures”. SSOPs are required in all USDA/FSIS establishments and are a prerequisite to HACCP. Detailed regulations on SSOPs can be found in Title 9 Part 416 under Sanitation regulations.

24. 24 SSOPs Sanitation SOPs are written documents that establish procedures to be followed routinely to maintain a sanitary environment for producing safe and unadulterated food products. Plant management must develop SSOPs that describes daily sanitation procedures to be performed by the establishment. A designated establishment employee must monitor the SSOPs and document adherence to the SOP and any corrective actions taken.

25. 25 Regulations On Preventing Consumer Deception

26. 26 Preventing Deception In order to prevent consumer deception, both FDA and USDA/FSIS have regulations centered on labeling, nutritional labeling and standards of identity

27. 27 USDA/FSIS Title 9; Part 317 – Covers the Labeling of meat and poultry products including nutritional labeling. Part 319 – Covers the standards of identity or composition of meat and poultry products.

28. 28 FDA Title 21; Part 101 –Covers food labeling Part 101 –Covers food labeling Part 104 – Covers Nutritional labeling Part 104 – Covers Nutritional labeling Parts 130-169 – Are standards of identify for various food products. Parts 130-169 – Are standards of identify for various food products.

29. 29 Parts of a Food Label There are basically 4 to 5 parts to an acceptable food label: 1) Name of the Product – On PDP 2) Quantity of Product- On PDP 3) Name of the Manufacturer or Distributor 4) List of Ingredients 5) If USDA inspected, must have inspection seal.

30. 30 Other Label Parts Depending on the product and situation, labels may also be required to contain the following; 1) Nutritional Labeling 2) Code Dates and Handling instructions 3) Number of Servings 4) Sulfites 5) Percentage Juice 6) Allergens 7) Although not required, a food label usually contains a UPC code.

31. 31 NUTRITIONAL LABELING The Nutritional Labeling and Education Act (NLEA) of 1990 provided for a mandate for the food industry to provide food nutrient data on food packages. Detailed information on the NLEA regulations can be found in ”A Food Labeling Guide” at http://vm.cfsan.fda.gov/~dms/flg-toc.html. http://vm.cfsan.fda.gov/~dms/flg-toc.html

32. 32

33. 33 Parts of a Nutritional Label Serving Size- Serving size is based on a reference amount which is defined in the regulations. In most cases, if a retail unit’s contents are less than 200% of the reference amount, the container would be labeled as 1 serving. There are many other rules and exemptions in the calculation of a serving size.

34. 34 Parts of the Nutritional Label Required nutrients- There are fourteen (14) nutrients or nutrient facts that must be specified on all nutritional labels.

35. 35 Fourteen Required Nutrients Calories Calories from Fat Total Fat Saturated Fat CholesterolSodium Dietary fiber Total Carbohydrates SugarProtein Vitamin A Vitamin C CalciumIron

36. 36 Standards of Identity Standards of identity are regulations that specifically state what a certain product must be or contain to be called a specific name. For example, some of the standards of identity to call a food “Catsup” include; 1) Must be made of red or reddish tomatoes. 1) Must be made of red or reddish tomatoes. 2) Must have a final consistency to flow not more than 14 centimeters in 30 seconds at 20C when tested in a Bostwick Consistometer. 2) Must have a final consistency to flow not more than 14 centimeters in 30 seconds at 20C when tested in a Bostwick Consistometer.

37. 37 Standards of Identity Some standards of identity require that quality control procedures be set up to monitor the final product standards. Examples would be the pumping of hams to determine PFF of ham as to their classification as “ Water- Added”, “Ham and Water Product” etc and the moisture/ protein ratio of dry and semi-dry sausages.

38. 38 Bioterrorism Act The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States register with the FDA. More information on the Act and how to register with the FDA can be found at; www.cfsan.fda.gov/~furls/ovffreg.html www.cfsan.fda.gov/~furls/ovffreg.html

39. 39 Summary This module has covered some of the more commonly used USDA and FDA regulations involving food to include HACCP, SSOPs, GMPs, food labeling and nutritional labeling and the Bioterrorism Act of 2002. More detailed information on these programs can be found in other modules within this series or by going to the specific regulations.

40. 40