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FDA or USDA Jurisdiction?

What You Need to Know:

  • The USDA regulates the production of meat, poultry and egg products. USDA-regulated businesses are required to have a USDA inspector onsite at all times.

  • The FDA regulates the production of everything else (non-meat foods, unusual meats, and fish products). No inspector is required onsite during production.

  • A business that conducts activities falling under both umbrellas is regulated by both agencies.

  • Food produced and sold in a retail environment (i.e. restaurant, deli) is not typically regulated by either the USDA or the FDA.

How to determine food business jurisdiction: Start with USDA. If you can’t positively identify how it falls under USDA jurisdiction, then it’s regulated by the FDA.

Determining USDA Jurisdiction

The USDA typically regulates the following business types:

  • Slaughterhouses

  • Meat Processors*

  • Poultry Processors*

  • Egg Processors

  • Food processors whose products contain meat*

Food products with the following characteristics are regulated by the USDA.

  • Contains >2% cooked meat

  • Contains >3% raw meat

  • Contains >2% cooked poultry meat

  • Contains >10% cooked poultry skins

*For more detail, see the tables below


Examples of Business Regulation

Business Description of Operations Federal Jurisdiction
Meat Product Processor Producer of frozen meat pies, bone broth, steak delivered via mail USDA
Poultry Product Processor Poultry processor USDA
"Egg Product" Processor Producers dried, frozen, or liquid eggs USDA
Egg processing plant Egg washing, sorting, packing FDA
Slaughterhouse Slaughter and processing of carcasses for sale. *Slaughter for personal consumption is not regulated by the USDA USDA
Commissary for retail outlets A commissary produces deli meats to sell at multiple delis, all owned by the same company. Products are shipped ready-to-eat. FDA
Restaurants and retail establishments Retail establishment that sells meat to typical consumers in retail quantities. Not typically regulated by the federal government
:

Examples of Food Product Regulation

Misc Products Regulator
Spaghetti Sauce (2% meat) FDA
Sliced Egg sandwich (closed face) FDA
Shrimp flavored instant noodles FDA
Venison Jerky FDA
Closed Face Sandwiches FDA
Open face sandwiches USDA
Pork Sandwich (open faced) USDA
Corndogs USDA
Frozen Beef pot pie USDA
:
Meat Products Regulator
Cow USDA
Sheep USDA
Pig USDA
Horse USDA
Mules USDA
Goat USDA
Domesticated Birds (chicken, turkey, ducks, geese, guineas, geese) USDA
Wild Birds FDA
Rabbit FDA
Bison FDA
Game animals FDA
Deer, Elk, Moose FDA
Zoo animals FDA
:
Egg Related Products Regulator
Dried Eggs USDA
Frozen Eggs USDA
Liquid Eggs USDA
Egg Substitutes FDA
Dried Custard Mixes FDA
Egg Nog Recipes FDA
Egg Noodles FDA
Milk and Egg Dip FDA
Cake Mixes FDA
French toast Sandwiches Containing Egg FDA
Products containing egg FDA
:

FAQ

What does the USDA inspector do?

The USDA inspector inspects:

  • Slaughtered animals to confirm they were healthy

  • Sanitation conditions of a plant

  • Operations to confirm that they align with the firm’s HACCP plan

  • Product is correctly labeled and packaged to be transported

What it FSIS?

The Food Safety and Inspection Service (FSIS) is the inspection arm of the USDA. So if you see the term FSIS, think USDA.

 
 

This article applies to you if…

∆ You are unsure whether your product is regulated by the FDA or the USDA.

References

USDA Inspection Requirements Overview

USDA Inspection Requirements Overview

FDA vs. USDA Jurisdiction Guide

FDA vs. USDA Jurisdiction Guide


More About Supply Chain


More Posts


Corrections vs. Corrective Actions in Food Processing
Corrective Action Blog Post Image.png

What You Need to Know

Correction

A correction means taking action in a timely manner to identify and correct a minor and isolated problem that does not directly impact product safety.

Examples of corrections include:

  • Re-cleaning the production line if it appears dirty after the first clean.

  • An employee is asked to leave the production area and put on the proper attire before re-entering the production area.

  • The temperature of a walk-in refrigerator is adjusted because it is a time of high traffic and the temperature is approaching the critical limit.

Corrections occur in the moment and don't require any documentation

Corrective Action

A corrective action is a procedure that must be taken if a corrective action is not properly implemented. This must be documented and the record should describe:

  • What occurred

  • How the problem was corrected

  • How it will be avoided in the future

  • What was done with the product in question

Examples where corrective action is required include:

  • A sample of canned salsa is tested and the pH exceeds the requirement of <4.3.

  • A refrigerator is found to have exceeded the temperature requirement of ≤41ºF for several hours.

  • The producer of bottled juice realizes that during the last production run, numerous bottles were not properly sealed by the capping machine, possibly due to defective packaging.

For more about corrective actions, see our full guide


Correction or Corrective Action?

The following examples illustrate how an operator may choose between a correction and a corrective action


Scenario Type of Action Required Why Recommended Action
Cookies on a conveyer oven are finished in 8 minutes instead of the required 10 minute cook time Corrective Action The cook step is (presumably) a preventive control used to kill bacteria present in raw cookie dough. Because the product failed to achieve the 10 minute cook time, then the preventive control has failed and a corrective action is required. 1. Adjust the belt temperature to reseet to 10 minute cook time.
2. Test to confirm the belt speed has increased the cook time to 10 minutes.
3. Re-cook the cookies for an additional 2 minutes (or discard)
4. Record this on a corrective action form.
Cookies on a conveyer oven are completed in 12 minutes instead of the required 10 minute cook time Correction Since the product was overcooked, it still achieved the preventive control that requires a >10 minute cook time. Adjust the belt speed to reduce the cook time to 10 minutes. Consider testing the overcooked product for quality
Sheet pans are observed to be unclean immediately after being run through the dishwasher Correction This is a minor problem that poses no risk to the safety of the food if it is corrected. Re-run the dishes through the dishwasher and confirm they are clean.
The dispenser for dishwasher sanitizer chemical is discovered to be empty after a day of production Corrective Action It is possible that many utensils and dishes were used in production without having been sanitized. This directly impacts food safety of product that was produced and so corrective action should be taken. 1. Refill the sanitizer chemical in the dish machine and confirm it is being applied during the cycle.
2. Assess why the sanitizer ran out and whether chemical levels should be checked more frequently to avoid this problem recurring.
3. Evaluate the food that contacted the un-sanitized utensils/dishes and determine whether it should be discarded, re-worked or served. If the food cannot be proven to be safe then it should be discarded.
 
Validation

What You Need To Know:

  • Validation answers the question “How do you know it works?”

  • You must validate that the preventive controls that you implement actually work.

  • Validation activities includes using scientific and technical evidence (or conducting your own studies)

Example of Validation: Collecting scientific research, and conducting tests to prove that the cooking temperature in your recipe is effective in killing the harmful bacteria in the product.

Hint: you can find information to validate many food processing practices on the FDA website.


What is Validation?

Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

21 CFR 117(c)(1)(i)

When is Validation Required?

You are required to validate every preventive control you are implementing. This means that if you use cooking as a means to kill bacteria, then you need to show that the time and temperature are a valid method for killing that bacteria type. This can often be achieved by referencing FDA guidance materials.

You are not required to validate the following types of preventive controls:

  • Sanitation Preventive Controls

  • Food Allergen Controls

  • Recall Plan

Who Conducts Validation?

All validation activities must be performed by a preventive controls qualified individual.


When do I need to validate my preventive controls?

You must validate your preventive controls:

  • Within 90 days of beginning production or there must be written justification for why if  >90 days after production begins.

  • Whenever a change is made that could impact how a hazard is controlled.

  • Whenever the food safety plan is reanalyzed.

What Part of My Food Safety Plan Require Validation?

Some parts of your food safety plan do not need to be validated. Sanitation activities, for example, do not need to be validated because most people use a small set of scientifically proven processes (i.e. soap and water, common chemical sanitizers). As a result, there is no need to require each business to prove their sanitation practices actually work.

The following activities do not require validation

  • Food allergen controls

  • Sanitation controls

  • Recall plan

  • Supply chain program

  • Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.


 
 

This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or identified a hazard that requires a preventive control


FDA Regulation on Validation


More About Food Safety Plans

More Posts


Verification

If you are unsure whether corrective action is required, see Verification vs. Validation

What You Need To Know

  • Verification means confirming that other parts of the food safety plan have been undertaken as specified.

  • Verification can take the form of a supervisor regularly reviewing records and verifying them with a signature.


What is Verification?

Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

21 CFR 117(c)(1)(i)

Examples of Verification

Common examples of verification include:

  • Reviewing cooking records to confirm the required temperature and cook time was reached

  • Reviewing refrigeration records to confirm food was held sufficiently cold

  • Observation that employees are following good food-handling practices

  • Calibrating thermometers – this verifies that they are reading properly

  • Sampling your own product for pathogens to verify that your process was faithfully performed

  • Environmental monitoring – testing your production space for pathogens living on surfaces, in drains, etc.

  • Supplier Verification – reviewing a supplier’s records to confirm they are faithful to their food safety practices and claims.

When is Verification Required?

All records which monitor a preventive control must be verified within 7 days of their creation.

All corrective action records must be reviewed within 7 days of their creation.

Other verification records, such as instrument calibration, product testing, and environmental monitoring, must be verified “within a reasonable amount of time” as determined by the producer.

Who Conducts Verification?

All verification activities must be performed by a preventive controls qualified individual (PCQI).


What You Need to Do:

  • Verify that your preventive controls are being implemented and monitored. You can do this by checking that monitoring records were completed.

  • Verify that corrective actions are taken when necessary and that the right decisions are being made in relation to any process deviations.

  • You must keep your verification records on file (digital is fine)


 
 

This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or have identified a hazard that requires a preventive control

∆ You take any records as part of your food safety plan


Resources

Verification Log Template

Verification Log Template

FDA Regulation on Verification

FDA Regulation on Verification


More About Food Safety Plans

More Posts


Corrective Action

If you are unsure whether corrective action is required, see Corrective Action vs. Correction

What You Need To Know:

  • Corrective Action is a response that must be taken if a preventive control is not properly implemented.

  • Corrective Actions must be written and are often completed using a standard form (see our free Corrective Action template)


What You Need to Do:

1. Write Corrective Actions Procedures

You must establish and implement written corrective action procedures. These procedures must describe the steps to be taken to ensure that:

  • Appropriate action is taken to correct a problem associated with a preventive control.

  • Appropriate action is taken to reduce the likelihood that the problem will recur.

  • All affected food is evaluated for safety

  • All affected food is prevented from entering commerce.

2. Take Corrective Action When it is Required

When to Take Corrective Action:

You must take a corrective action if

  • A preventive control fails and a corrective action hasn't been established.

  • A preventive control is found to be ineffective

  • Verification records are found to be incomplete or improper decisions were made about corrective action

3. Keep Records of Your Corrective Actions

All corrective actions taken in this section must be documented. We recommend using a pre-written form so that it’s easy to complete and no details are missing. Check out our corrective action template here

Corrective actions must also be verified (See Verification or §117.155)


 
 

This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or identified a hazard that requires a preventive control


Resources

FDA Regulation on Corrective Actions

FDA Regulation on Corrective Actions

Corrective Action Template

Corrective Action Template


More About Food Safety Plans

More Posts


Preventive Controls

These requirements are a part of our comprehensive Food Safety Plan Guide

What You Need To Know:

  • A preventive control is a strategy implemented to eliminate a hazard in a food manufacturing environment

  • You must identify and implement preventive controls when you identify a hazard that is reasonably likely to cause injury to a customer if left unaddressed.

  • Preventive controls include Critical Control Points and other types of controls.

  • Preventive controls must be written

Types of Preventive Controls

Process Controls:

These are procedures and processes that are used to control parameters of processing (i.e. acidifying, refrigerating, cooking.) They must be written in a way that is specific to your process and they must include:

  • parameters associated with controlling the hazard (i.e. if you are using cooking as a process control, then you must include the required cook temperature and cook time)

  • The maximum or minimum values required to control the hazard.


Food Allergen Controls

These include processes to control food allergens. These are implemented to:

  • Protect food from allergen cross contact

  • Label food properly with allergens to ensure it isn't misbranded


Sanitation Controls:

These are practices to ensure the facility is kept clean and to minimize biological hazards. They relate to:

  • Cleanliness of food-contact surfaces (equipment, utensils, tables)

  • Prevention of contamination of food from dirty sources (i.e. dirty people, dirty food, dirty packaging, dirty raw ingredients)


Supply Chain Controls:

Supply Chain Controls are described fully in Part G


Other Controls

You may have other types of controls (i.e. hygiene training and current good manufacturing practices)

What To Do If You Implement a Preventive Control

If you implement one or more preventive controls then you must conduct the following activities for each one:

  1. Monitoring activities

  2. Corrective actions

  3. Verification activities

Circumstances Where Preventive Controls Are Not Required

You aren't required to implement preventive controls if any of the following apply:

  1. The food cannot be consumed without application of an appropriate control (i.e. coffee beans cannot be consumed without pouring boiling water on them, which would kill any bacteria on the bean. By preparing coffee the consumer is inherently applying the necessary control)

  2. You rely on your customer, who is subject to this subpart, to ensure that the hazard is mitigated. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

3. You rely on the customer who is not subject to this subpart to eliminate the hazard. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

4. You rely on the customer to provide assurance that the food will be processed to control the hazard by a subsequent entity in the supply chain

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that your customer will:

A. Disclose in documents accompanying the food that it is "not processed to control [identify hazard]"

B. Will only sell to another entity that agrees in writing that it will mitigate the hazard and obtain similar written assurance from subsequent customers.

5. You have established and implemented a system that ensures control of the hazards in your product, at the distribution step.

Note: You must document any circumstance (related to the section above) that applies to you, including written assurances from customers.


 
 

This Article is For You if…

∆ You manage a facility that makes, holds, or packs food.

∆ You are developing a food safety plan or HACCP plan.

∆ You have identified a hazard in your hazard analysis

∆ You are subject to Part 117 Subpart C (very small businesses are exempt from this requirement)


Resources

Food Safety Plan Templates

Food Safety Plan Templates


More About Food Safety Plans

More Posts


References

Verification vs. Validation
Verification vs. validation.png

What You Need to Know:

Verification means conducting a review to confirm a process was performed correctly. Verification answers the question "How do you know it actually happened?"

Example: Reviewing production records to confirm that the product was heated to the temperature dictated in the recipe.

Validation refers to the requirement that a food processor use scientifically proven methods to control a hazard. Validation answers the question "How do you know it works?"

Example: Collecting scientific research, and conducting tests to prove that the cooking temperature in the recipe is effective in killing the harmful bacteria in the product.

Why Verification and Validation are Important:

Both verification and validation are required or else food-safe outcomes may not be achieved.


Validation Without Verification...

Hand washing with soap is a valid method for removing dirt/grime from hands. However, if verification does not occur and employees do not actually wash their hands, then it doesn't matter how scientifically-proven the strategy is.

Verification Without Validation...

Hand washing without soap is not a valid method for cleaning hands. Even if a manager verifies that hand washing is occurring as required, it doesn't matter because hand washing without soap is not a valid method for cleaning hands.


Verification

Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

21 CFR 117(c)(1)(i)

Examples of Verification

  • Reviewing cooking records to confirm the required temperature and cook time was reached

  • Reviewing refrigeration records to confirm food was held sufficiently cold

  • Observation that employees are following good food-handling practices

  • Calibrating thermometers - this verifies that they are reading properly

  • Sampling your own product for pathogens to verify that your process was faithfully performed

  • Environmental monitoring - testing your production space for pathogens living on surfaces, in drains, etc.

  • Supplier Verification - reviewing a supplier's records to confirm they are faithful to their food safety practices and claims.

When is Verification Required?

All records which monitor a preventive control must be verified within 7 days of their creation.

All corrective action records must be reviewed within 7 days of their creation.

Other verification records, such as instrument calibration, product testing, and environmental monitoring, must be verified "within a reasonable amount of time" as determined by the producer.

Who Conducts Verification?

All verification activities must be performed by a preventive controls qualified individual.

Examples of Verification

Example of Preventive Control Verification Required? Why? Verification Example
Cooking Chicken to a temp of 165ºF as a preventive control to reduce the hazard of Salmonella Bacteria Yes The cook step is a preventive control. Therefore, the production record containing the cook temp/time must be verified A manager reads the cook log and confirms that all chicken cooked that day was cooked to 165º
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature Yes Low pH is a preventive control applied to stop bacteria growth. Therefore, the pH records must be verified. A manager reviews the daily production records to confirm the pH was below the required threshold in all batches. If there is a deviation, the manger verifies that the appropriate corrective action was taken.
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw Yes This is a preventive control and must be verified A manager confirms that the appropriate level of preservative was used to render the product safe. Additionally, in such a high-risk scenario, it may be advisable to test the chicken for pathogens.
Chlorine sanitizer used to sanitize dishes Possibly Depending on the nature of the product, it may not be a requirement to verify that the appropriate concentration of sanitizer was used. Manager verifies a record showing that the sanitizer was tested and the chemical concentration fell into the designated range.
Items containing peanuts are stored in different-colored containers from non-peanut products No There is no requirement to verify the implementation of storage practices to mitigate an allergen concern, although it may be a good idea. A manager may inspect storage spaces occasionally to confirm that practices are being followed to avoid allergen contact.

Validation:

Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

21 CFR 117(c)(1)(i)

When is Validation Required?

You are required to validate every preventive control you are implementing. This means that if you use cooking as a means to kill bacteria, then you need to show that the time and temperature are a valid method for killing that bacteria type. This can often be achieved by referencing FDA guidance materials.

You are not required to validate the following types of preventive controls:

  • Sanitation Preventive Controls

  • Food Allergen Controls

  • Recall Plan

Who Conducts Validation?

All validation activities must be performed by a preventive controls qualified individual.

Examples of Validation

Example of Preventive Control Verification Required? Why? Verification Example
Cooking Chicken to a temp of 165ºF as a preventive control to reduce the hazard of Salmonella Bacteria Yes The cook step is a preventive control. Therefore, the production record containing the cook temp/time must be verified A manager reads the cook log and confirms that all chicken cooked that day was cooked to 165º
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature Yes Low pH is a preventive control applied to stop bacteria growth. Therefore, the pH records must be verified. A manager reviews the daily production records to confirm the pH was below the required threshold in all batches. If there is a deviation, the manger verifies that the appropriate corrective action was taken.
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw Yes This is a preventive control and must be verified A manager confirms that the appropriate level of preservative was used to render the product safe. Additionally, in such a high-risk scenario, it may be advisable to test the chicken for pathogens.
Chlorine sanitizer used to sanitize dishes Possibly Depending on the nature of the product, it may not be a requirement to verify that the appropriate concentration of sanitizer was used. Manager verifies a record showing that the sanitizer was tested and the chemical concentration fell into the designated range.
Items containing peanuts are stored in different-colored containers from non-peanut products No There is no requirement to verify the implementation of storage practices to mitigate an allergen concern, although it may be a good idea. A manager may inspect storage spaces occasionally to confirm that practices are being followed to avoid allergen contact.