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Food Processing RegulationsFood Processing Regulations22152215

Steven C SeidemanSteven C SeidemanExtension Food Processing SpecialistExtension Food Processing Specialist

Cooperative Extension ServiceCooperative Extension ServiceUniversity of ArkansasUniversity of Arkansas

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IntroductionIntroduction

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

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Agencies InvolvedAgencies Involved

There are primarily 2 federal agencies involved in food There are primarily 2 federal agencies involved in food regulations.regulations.

1)The Food Safety and Inspection Service (FSIS)1)The Food Safety and Inspection Service (FSIS) is part of is part of the USDA and regulates food items that have 3% of the USDA and regulates food items that have 3% of more red meat and 2% or more poultry meat. more red meat and 2% or more poultry meat.

2) 2) The Food & Drug Administration (FDA)The Food & Drug Administration (FDA) regulates all regulates all other foods. other foods.

The laws from these 2 agencies tend to be similar in The laws from these 2 agencies tend to be similar in content but different in implementation. FSIS has content but different in implementation. FSIS has inspectors in meat processing plants almost on a full inspectors in meat processing plants almost on a full time basis whereby FDA generally performs only annual time basis whereby FDA generally performs only annual reviews of food processing plants.reviews of food processing plants.

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Where to Find Food RegulationsWhere to Find Food Regulations

Go to Go to www.gpoaccess.gov/topics/food.htmlwww.gpoaccess.gov/topics/food.html

Click on Title 9 for USDA/FSIS regulations Click on Title 9 for USDA/FSIS regulations

Click on Title 21 for FDA regulationsClick on Title 21 for FDA regulations

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USDA/FSIS RegulationsUSDA/FSIS Regulations

Once you are in Title 9 regulations, click on Once you are in Title 9 regulations, click on Parts 300- 599.Parts 300- 599.

Part 317-Part 317- Covers the labeling of meat products to Covers the labeling of meat products to include nutritional labelinginclude nutritional labeling

Part 319-Part 319- Covers the standards of identity of Covers the standards of identity of various meat products.various meat products.

Part 416Part 416 –Covers the regulations dealing with –Covers the regulations dealing with plant design, operation etc. It also covers plant design, operation etc. It also covers SSOPsSSOPs

Part 417Part 417 –Covers meat HACCP regulations –Covers meat HACCP regulations

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FDA RegulationsFDA Regulations

Once you are in Title 21, go to Parts 100-169.Once you are in Title 21, go to Parts 100-169.

Parts 101 and 104 deal with labeling and Parts 101 and 104 deal with labeling and nutritional labeling respectively.nutritional labeling respectively.

Part 110 –Covers food GMPsPart 110 –Covers food GMPs

Part 113- Covers low acid canned foodsPart 113- Covers low acid canned foods

Part 114- Covers acidified foodsPart 114- Covers acidified foods

Part 120 – Covers HACCPPart 120 – Covers HACCP

Parts 130-169 –Covers food standards of identityParts 130-169 –Covers food standards of identity

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FDA RegulationsFDA Regulations

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

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Food LawsFood Laws

Most food regulations revolve around 2 Most food regulations revolve around 2 central concepts;central concepts;

1) Food must be safe1) Food must be safe

2) Avoiding deception of the customer2) Avoiding deception of the customer

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Food SafetyFood Safety

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

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Avoiding Deception of the Avoiding Deception of the CustomerCustomer

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

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FOOD REGULATION FOOD REGULATION PROGRAMSPROGRAMS

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HACCPHACCP

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What is HACCP?What is HACCP?

HACCP is short for ‘Hazard Analysis HACCP is short for ‘Hazard Analysis Critical Control Point”.Critical Control Point”.

HACCP is a scientifically-based HACCP is a scientifically-based management system for food safety. management system for food safety.

HACCP uses a written plan which focuses HACCP uses a written plan which focuses on how potentially hazardous foods are on how potentially hazardous foods are handled in a food processing environment.handled in a food processing environment.

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What is HACCP?What is HACCP?

HACCP is a state–of-the-art approach to HACCP is a state–of-the-art approach to consistent safe food production.consistent safe food production.

HACCP is proactive and prevention HACCP is proactive and prevention oriented focusing on preventing or oriented focusing on preventing or controlling food safety hazards that fall into controlling food safety hazards that fall into three main categories; biological, chemical three main categories; biological, chemical and physical.and physical.

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HACCPHACCP

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

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The HACCP CONCEPTThe HACCP CONCEPT

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

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The Seven Principles of HACCPThe Seven Principles of HACCP

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

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The Seven Principles of HACCPThe Seven Principles of HACCP

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

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HACCP HACCP

USDA/FSIS requires HACCP plans in all USDA/FSIS requires HACCP plans in all red meat and poultry processing facilities.red meat and poultry processing facilities.

FDA only requires HACCP in facilities that FDA only requires HACCP in facilities that process fruit and vegetable juices and process fruit and vegetable juices and seafoods, fish and fish products.seafoods, fish and fish products.

Additional information on HACCP can be Additional information on HACCP can be found in another module.found in another module.

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GMPsGMPs

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GMPsGMPs

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

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SSOPsSSOPs

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SSOPsSSOPs

SSOPs stands for “Sanitation Standard SSOPs stands for “Sanitation Standard Operating Procedures”.Operating Procedures”.

SSOPs are required in all USDA/FSIS SSOPs are required in all USDA/FSIS establishments and are a prerequisite to establishments and are a prerequisite to HACCP.HACCP.

Detailed regulations on SSOPs can be Detailed regulations on SSOPs can be found in Title 9 Part 416 under Sanitation found in Title 9 Part 416 under Sanitation regulations.regulations.

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SSOPsSSOPs

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

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Regulations On Preventing Regulations On Preventing Consumer DeceptionConsumer Deception

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Preventing DeceptionPreventing Deception

In order to prevent consumer deception, In order to prevent consumer deception, both FDA and USDA/FSIS have both FDA and USDA/FSIS have regulations centered on labeling, regulations centered on labeling, nutritional labeling and standards of nutritional labeling and standards of identityidentity

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USDA/FSISUSDA/FSIS

Title 9;Title 9;

Part 317Part 317 – Covers the Labeling of meat and – Covers the Labeling of meat and poultry products including nutritional poultry products including nutritional labeling.labeling.

Part 319Part 319 – Covers the standards of identity – Covers the standards of identity or composition of meat and poultry or composition of meat and poultry products.products.

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FDAFDA

Title 21;Title 21;

Part 101Part 101 –Covers food labeling –Covers food labeling

Part 104Part 104 – Covers Nutritional labeling – Covers Nutritional labeling

Parts 130-169Parts 130-169 – Are standards of identify – Are standards of identify for various food products.for various food products.

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Parts of a Food LabelParts of a Food Label

There are basically 4 to 5 parts to an There are basically 4 to 5 parts to an acceptable food label:acceptable food label:

1) Name of the Product – On PDP1) Name of the Product – On PDP2) Quantity of Product- On PDP2) Quantity of Product- On PDP3) Name of the Manufacturer or Distributor3) Name of the Manufacturer or Distributor4) List of Ingredients4) List of Ingredients5) If USDA inspected, must have inspection 5) If USDA inspected, must have inspection

seal.seal.

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Other Label PartsOther Label Parts

Depending on the product and situation, labels Depending on the product and situation, labels may also be required to contain the following;may also be required to contain the following;

1) Nutritional Labeling1) Nutritional Labeling2) Code Dates and Handling instructions2) Code Dates and Handling instructions3) Number of Servings3) Number of Servings4) Sulfites4) Sulfites5) Percentage Juice5) Percentage Juice6) Allergens6) Allergens7) Although not required, a food label usually 7) Although not required, a food label usually

contains a UPC code.contains a UPC code.

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NUTRITIONAL LABELINGNUTRITIONAL LABELING

The Nutritional Labeling and Education Act The Nutritional Labeling and Education Act (NLEA) of 1990 provided for a mandate for (NLEA) of 1990 provided for a mandate for the food industry to provide food nutrient the food industry to provide food nutrient data on food packages. data on food packages.

Detailed information on the NLEA Detailed information on the NLEA regulations can be found in ”A Food regulations can be found in ”A Food Labeling Guide” at Labeling Guide” at http://vm.cfsan.fda.gov/~dms/flg-toc.htmlhttp://vm.cfsan.fda.gov/~dms/flg-toc.html. .

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Parts of a Nutritional LabelParts of a Nutritional Label

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

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Parts of the Nutritional LabelParts of the Nutritional Label

Required nutrientsRequired nutrients- There are fourteen - There are fourteen (14) nutrients or nutrient facts that must be (14) nutrients or nutrient facts that must be specified on all nutritional labels.specified on all nutritional labels.

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Fourteen Required NutrientsFourteen Required Nutrients

CaloriesCalories

Calories from FatCalories from Fat

Total FatTotal Fat

Saturated FatSaturated Fat

CholesterolCholesterol

SodiumSodium

Dietary fiberDietary fiber

Total CarbohydratesTotal Carbohydrates

SugarSugar

ProteinProtein

Vitamin AVitamin A

Vitamin CVitamin C

Calcium Calcium

IronIron

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Standards of IdentityStandards of Identity

Standards of identity are regulations that Standards of identity are regulations that specifically state what a certain product must be specifically state what a certain product must be or contain to be called a specific name. or contain to be called a specific name.

For example, some of the standards of identity For example, some of the standards of identity to call a food “Catsup” include;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 2) Must have a final consistency to flow not more than 14 centimeters in 30 seconds at 20C when than 14 centimeters in 30 seconds at 20C when tested in a Bostwick Consistometer. tested in a Bostwick Consistometer.

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Standards of IdentityStandards of Identity

Some standards of identity require that Some standards of identity require that quality control procedures be set up to quality control procedures be set up to monitor the final product standards.monitor the final product standards.

Examples would be the pumping of hams Examples would be the pumping of hams to determine PFF of ham as to their to determine PFF of ham as to their classification as “ Water- Added”, “Ham classification as “ Water- Added”, “Ham and Water Product” etc and the moisture/ and Water Product” etc and the moisture/ protein ratio of dry and semi-dry sausages.protein ratio of dry and semi-dry sausages.

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Bioterrorism ActBioterrorism Act

The The Public Health Security and Bioterrorism Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Preparedness and Response Act of 2002 requires domestic and foreign facilities that requires domestic and foreign facilities that manufacture, process, pack or hold food for manufacture, process, pack or hold food for human or animal consumption in the United human or animal consumption in the United States register with the FDA.States register with the FDA.

More information on the Act and how to register More information on the Act and how to register with the FDA can be found at;with the FDA can be found at;

www.cfsan.fda.gov/~furls/ovffreg.htmlwww.cfsan.fda.gov/~furls/ovffreg.html

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SummarySummary

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

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