What are the Requirements for FDA Registration Inside of a Shared Kitchen?

The FDA doesn’t offer a lot of information about shared kitchens. However, the growth of this business model means many shared kitchen operators are looking for answers, particularly around the issue of food facility registration.

Below are the answers you’re looking for.

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Does the Shared Kitchen User Need to Register as an FDA Food Facility?

In brief, FDA food facility registration is required for any food business which is (1) not a retail food service establishment and which (2) packs, holds, or processes food which will enter interstate commerce.

When this type of business is operating in a shared kitchen, it means that multiple FDA food facility registrations may be associated with a single location

If you’re looking for more specific answers about registration requirements, we have sections devoted to the topic of FDA jurisdiction and FDA facility registration.

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Does The Shared Kitchen Itself Need to Be Registered as an FDA Food Facility?

An FDA Draft Guidance about Shared Kitchen Facility Registration

The question of whether a shared kitchen needs to register with the FDA hinges upon one critical question:

Does the shared kitchen operator (i.e. the host) pack, hold or process any food which will enter interstate commerce? In other words, does the shared kitchen operator ever take custody of any food?

If the answer is yes, then the shared kitchen must register with the FDA as a food facility. If the answer is no, then the shared kitchen does not need to be registered as an FDA food facility.

Here are examples of activities that would require the shared kitchen to register as a food facility with the FDA:

• The shared kitchen operator receives incoming food products on behalf of the shared kitchen users and hands them over to the tenant when they arrive onsite.

• The shared kitchen operator purchases a bulk supply of commonly-used food ingredients and sells them to the tenant businesses.

• The shared kitchen operator purchases finished food products from the users businesses, stores them onsite, and sells them.

• The management of the shared kitchen also has their own food brand and they manufacture their product out of the shared kitchen alongside other tenants.

Remember, if the shared kitchen packs, holds, or processes food, then they will be required to register with the FDA.

If you want to avoid registering your shared kitchen with the FDA, then you should never take physical control over any food products in your space.

If you allow tenant businesses to store product in a shared storage space onsite, it must be clear that the tenant business maintains possession of that product while it is in storage.

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What’s Next

If you need to register as a food facility you can check out our step-by-step guide.

Also, if your business does less than $1mm in annual sales, then you may be a Qualified Facility (aka Very Small Business). This means fewer record keeping requirements for the business and a lower likelihood of inspection within the first several years of operation. If you think this is for you, then check out our guide to registering as a Qualified Facility

Or, return to our section on Shared Kitchens

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Keep Reading

Introduction to the FSMA Produce Safety Rule

Contents

Introduction
Exemptions
Requirement Areas

• Agricultural Water
• Biological Soil Amendments
• Sprouts
• Domesticated and Wild Animals
• Worker Training, Health & Hygiene
• Equipment, Tools, & Buildings

Introduction

The produce safety rule is a section of FSMA which provides standards for the growing, harvesting, packing, and holding of fruits and vegetables. The regulation acknowledges that farms may not be currently implementing these practices and it aims to educate before strictly enforcing these provisions. 

It includes six requirement areas, which are described below:

• Agricultural Water

• Biological Soil Amendments

• Sprouts

• Domesticated and Wild Animals

• Working Traning and Health and Hygiene

• Equipment, Tools, and Buildings

Exemptions

For an overview of exemptions to the Produce Safety Rule see this flowchart

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Requirement Areas

Agricultural Water:

The Produce Safety Rule regulates water based on how it will be used. There are several different uses for water in agricultural contexts — for example irrigation water versus water used in produce washing —  and each of them has specific requirements for quality and testing. There is no expectation that a farm achieve a perfect result in every test. Rather, the goal is to understand water quality over time and support farms in accessing viable long term water sources.

Requirements for Water used in Produce Processing 

This includes water used for produce washing, hand washing, and cleaning food contact surfaces. Any water used after harvesting that could reasonably contaminate produce product is held to this standard. The requirements are

• All water used for these purposes must be treated (e.g. you cannot use un-treated well-water) 

• There can be no detectable presence of E. coli in these water types.

• If any E. coli is detected, that water use must be immediately discontinued.
  

Requirements for Water used in Growing Produce

This refers to water which is directly applied to growing produce (e.g. irrigation water). There are two values that are used to determine whether this use of water achieves the requirement. Collectively, these two figures are referred to as “microbial water quality profile”: 

• Geometric Mean (GM) Test: There must be an average of fewer than 126 E. Coli CFU (a.k.a. colony forming units, which is how bacteria is commonly quantified) per 100ml of water. 

• Statistical Threshold Value (STV) Test: The maximum STV is 416 E. Coli CFU per 100ml of water. You can think of the STV as the level at which 90% of samples fall below this value.

What Happens When You Receive a Failing Result?

This section demonstrates the flexibility of the regulation. Corrective action is required “as soon as possible” and no later than the following year. Examples of corrective action that a farm may take after receiving a positive E Coli test result include,

• Treating the water supply

• Implementing a time interval between last irrigation and harvest (which allows bacteria that may have been present in irrigation water to die off)

• Using washing or other commercial activities to reduce microbe levels

Testing Water Supply

This section describes testing requirements based on water source.

Public Water: This is typically the safest source of water, insofar as it aligns with national water standards. There is no requirement to test agricultural water drawn from a public water supply.

Untreated Surface Water: This is considered the most vulnerable type of water supply. When untreated surface water is applied to growing produce, farm must order tests for GM and STV (see above) using the following timeframe:

1. Initial survey: twenty samples must be taken at a time that is as close to harvest as possible. These samples may be taken over the course of 2-4 years.

2. Annual surveys: five new samples must be taken annually to replace the oldest results.

Untreated Ground Water (For Direct Application to Growing Crops: When untreated water is applied to growing crops, the following testing procedure is required:

1. Initial survey: four samples must be taken at a time that is as close to harvest as possible. These samples must be taken during the growing season (i.e. in a single year)

2. Annual survey: one new sample must be taken annually to replace the oldest result.
   

Untreated ground Water Used in Food Processing (where there is a zero-tolerance threshold for E. coli), a different testing schedule applies. 

1. Initial survey: four samples must be taken at a time that is as close to harvest as possible. These samples must be taken during the growing season (i.e. in a single year)

2. Annual survey: If the initial survey results meet the “no detectable E. coli” standard, then only one annual sample is required. If the initial result does not meet the standard (or any subsequent result) then four samples must be tested the following year.

Biological Soil Amendments (e.g. Compost)

Use of Raw Manure:

While the FDA regulations are still being developed as of 2019, there are two general requirements:

1. Raw manure must be applied in a way that does not contact the produce when it is applied. 

2. The farmer minimizes the potential for contact between manure and produce.

In the absence of clearer regulation, the FDA recommendation is that farmers adopt the standards outlined in the USDA’s national Organic Program. These call for:

• 120 day interval between application of raw manure on crops that contact the soil (e.g. melon)

• 90 day interval between the application of raw manure on crops that do not contact the soil (e.g. tomatoes)

Stabilized Compost:

For compost which has been processed to reduce pathogens, there are specific threshold levels for soil-based pathogens. This section offers guidance for how a farm may choose a suitable method for treating their soil amendments

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Sprouts

Sprouts are particularly vulnerable to the growth of dangerous microbes because of the conditions required to grow them — warm moist environments. The major requirements for farming sprouts includes:

• Treating seeds that will be used as sprouts (or sourcing pre-treated seeds)

• Re-collecting and testing the water which was used to irrigate sprouts. Sprouts may not legally enter commerce until negative results are achieved.

• Environmental testing for Listeria.

• Taking appropriate corrective action if any tests come back positive.

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Domesticated and Wild Animals

This section acknowledges that farms may have animals onsite. At the same time, fecal contamination from livestock is a frequent source of produce contamination.  Although the rule does not mandate that animals be excluded from outdoor growing areas it does describes some requirements for managing animals reduce the contamination hazard. They describe:

• All farming areas and produce must be inspected for sources of contamination.

• When contamination has occurred (from either wild or domestic animal droppings), these areas should be marked and corrective action taken.

• Although it is not required, the FDA recommends that farms implement waiting periods between when land is grazed on and when produce is harvested from that land.

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Worker Training, Health and Hygiene

This section outlines measures to prevent contamination of produce by sick employees. To reduce this risk, may exhibit the following programs (you can also read about them in our Personnel guidance)

• Using basic hygiene practices (e.g. hand washing)

• Implementing an employee health policy which requires sick food handlers to notify their employers if they may have a contagious disease which could contaminate food.

• Training farm workers to safely handle produce.

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Equipment, Tools, & Buildings

This section of the rule describes the standards for equipment, tools and buildings. This may cover areas such as greenhouses, germination areas, and also toilet/hand washing facilities and outlines specific requirements for

• Design and construction requirements

• Recommendations for toilet and hand washing facilities

• Pest control

• Maintenance of sewage systems

• Plumbing requirements

• Waste disposal requirements 

To access those requirements in detail, consider the guidance document for this chapter.

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More About Food Safety Plans

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It’s not always clear where  the FDA has jurisdiction when it comes to food businesses. This table provides an overview of FDA Jurisdiction. Specific examples are provided below.

Regulated By the FDA	Not Regulated By the FDA
Foods that enter interstate commerce	Food Service Establishments
Most packaged foods	Restaurants
Most foods solid online	Restaurant Chain
Human and animal food	Food Truck
Imported Foods	Caterer
Farms (if they grow and process food)	Grocery Stores
	Food Bank
	Cafeterias / Institutions
	Markets
	Home-Food Processor
	Alcoholic Beverages
	Butcher Shop
	Slaughterhouses (USDA)
	Farms (if they only grow food)

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*Note: Domestic food processors of any kind must still register as a Food Facility even if their products do not enter interstate commerce. This is free and purely for record keeping purposes (it will not subject a business to FDA inspections or oversight)

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Examples of FDA Jurisdiction Businesses

FDA Jurisdiction	Examples
Food products that enter interstate commerce (i.e. businesses whose foods leave the state)	Most foods sold online
	Most non-meat products that are made and sold in a package
	A central kitchen that prepares and distributes foods to locations in multiple states
	A transporter that distributes food nationwide
	Any business that processes, packs, transports, distributes, receives, or holds food which crosses state lines.
Imported Foods	Food distributor that imports foods and sells it
	Food importer that warehouses food

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Businesses Not Under FDA Jurisdiction

Not FDA Jurisdiction	Example	Who typically regulates
Restaurant (Individual)	Fast Food Restaurant	Local/State health dept.
Restaurant (Chain)	Chain of frozen yogurt restaurants	Each would be regulated individually by its respective local or state health department
Restaurant (Delivery only)	Meals are ordered via app/web and delivered hot to the consumer	Local/State health dept.*
Food Truck	Korean food truck	Local/State health dept. *
Caterer	Facility where a caterer prepares food for immediate service	Local/State health dept.*
Grocery Store	Grocery store that also serves some hot food or includes a deli	Local/State health dept.
Food Bank	Food bank that accepts food donations and distributes that food locally	Local/State health dept.
Cafeteria / Institution	Hospital cafeteria, School lunch cafeteria	Local/State health dept.
Farmers Market	Weekly market that offers various prepared foods and ingredients for sale	Local / State Health Dept
Seafood Market	Retail market that supplies seafood products to consumers	Local / State Health Dept
Alcoholic Beverage Producer, Importer, Distributor, Wholesaler	Winery, Brewery, Distillery	State Health Dept / TTB (Note that alcoholic beverages <7% ABC are subjected to FDA labeling standards)
Butcher Shop	Retail market that butchers and retails meat for consumers	Local/State Health Dept. OR USDA. (This depends on what level of processing is being done to the meat before it is sold)
Home Food Processor	Business conducted from the home that involves making food	Local / State – Note that many cities and states prohibit or specifically regulate home processing
Meat Product Processor	Frozen meat pies, Bone broth, High-quality cuts of steak delivered via mail	USDA
Poultry Product Processor	Frozen buffalo wings, Roast Chickens	USDA
Processed Egg Products	Frozen omelets, Egg whites	USDA

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*If you serve or prepare food in multiple areas you may have to license with the local health department for each of those jurisdictions. If the food is crossing state lines, then FDA regulation would apply.

Still Unsure Whether Your Business is Regulated by the FDA?

Ask a question in the comments and I’ll answer it

Try using this dichotomous key

What’s Next?

Understand about Registering a Food Facility with the FDA

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This is an overview of record keeping requirements. For a more in-depth review, see our Guide to 117 Subpart F: Record Keeping

What You Need To Know

Part 117 Subpart F contains the requirements for record keeping

• Keep all of your records related to your food safety lan.

• Records can be electronic or paper.

• You must store records onsite for at least 2 years

• All records must be made available upon request

Record Keeping Requirements

How Records Must Be Kept

• Records must be kept as originals, true copies (i.e. scans, photocopies) or electronic records.

• They must contain the actual values and observations, not summaries.

• They must be accurate, unchangeable (i.e. pen) and legible

• They must have been created in real-time with the activity being documented.

Required Information on All Records

The following information is required on all records you keep:

1. information about the plant identity

2. The date (and time, if necessary)

3. Signature or initials of the observer

4. Product name and lot code, if applicable

How long do I need to keep them for?

All records must be retained onsite for 2 years. Additionally, you must be able to retrieve records within 24 hours if an authorized request is made.

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Looking for More?

Check out our comprehensive guide to Part 117 Subpart F, Record Keeping or the FDA Reader Complete Guide to FSMA

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This Article is For You if…

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

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

∆ You are any type of FDA regulated food business

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All of our food safety plan templates are aligned with this section.

Resources

FDA Regulation On Record Keeping

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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.

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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.

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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

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Resources

Verification vs. Validation

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FDA Regulation on Validation

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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.

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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).

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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)

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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

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Resources

Verification Log Template

FDA Regulation on Verification

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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)

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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)

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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

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Resources

FDA Regulation on Corrective Actions

Corrective Action Template

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

What You Need To Know:

• Monitoring means observing some activity in your production— such as checking the temperature of your walk-in refrigerator

• Monitoring is required for all preventive controls to ensure they are implemented properly.

• You must have written procedures for how and how often you will monitor preventive controls.

• You must monitor preventive controls enough to ensure they are being performed.

Record Keeping Requirements

1. You must document your monitoring actions, store them, and also verify them (see verification)

2. Exception records are acceptable type of monitoring record (this means records are only taken when a deviation occurs.) For example, a refrigeration log may shows records only when the temperature is outside the acceptable range.

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Resources

FDA Regulation on Monitoring Preventive Controls

This Article is For You if…

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

∆ You have implemented a preventive control

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Find the Right Tools

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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.

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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)

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Resources

Food Safety Plan Templates

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References

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

What you need to know:

• A hazard analysis is the process of identifying all of the hazards present in your process that could potentially cause a customer injury.

• Creating a Hazard Analysis is the first step in developing a food safety or HACCP plan.

• You can read the requirements below or just use our self-guided hazard analysis template

Requirements for a Hazard Analysis:

1. You must conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility.

2. Your hazard analysis must be written.

Steps in Creating a Hazard Analysis

1. Download our Hazard Analysis Template

It’s available for free here, and it will be much easier if you can follow along.

Example Process Flow - Each box corresponds to a process step.

2. Identify the steps in your process from start to finish.

It’s important that you have every step in your process identified so that you don’t miss anything in your hazard analysis. Often, it’s easiest to conduct a process flow diagram to identify all of the steps in your process.

3. Conduct a Hazard Identification:

In this step, you review all of your process steps and identify if there are any hazards present at each step. For each step, you will consider 3 types of hazards:

• Biological Hazards (bacteria, parasites, etc.)

• Chemical hazards (i.e. toxins, pesticides, food allergens)

• Physical hazards (i.e. stone, glass, metal fragments)

Your hazard identification should also include hazards that could be present in the food because:

• The hazard occurs naturally (i.e. toxins in fish)

• The hazard may be accidentally introduced (jewelry from employee falls into food)

• The hazard may be introduced intentionally for economic gain (i.e. sabotage by a competitor)

4. Conduct Hazard Evaluation

The hazard evaluation is the last step in creating your Hazard Analysis. Here, you must evaluate each hazard that you identified to assess the probability that it would occur if left unaddressed.

If the probability is high that this hazard would cause an injury if unaddressed, then you must implement a “preventive control”.

You also must consider the effects of these things in your hazard evaluation.

• Formulation of the food

• Condition and design of the facility

• Raw materials and other ingredients

• Transportation practices

• Processing procedures

• Packaging and labeling activities

• Storage and distribution

• Intended use of the product

• Sanitation, including employee hygiene

• Any other relevant factors (i.e. weather, natural toxins)

• Environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment before packaging.

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

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Resources

Hazard Analysis Template

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References

These requirements are a part of the Current Good Manufacturing Practices that relates to Facility Requirements. You can see the full guide to cGMPs here

Plants & Grounds

Grounds must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests
2. Maintain roads, yards, parking lots
3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination
4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.

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Plant Construction and Design

The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)

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Sanitary Facilities

Plumbing

Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

Plumbing must

1. Carry adequate amounts of water around the plant.
2. Remove sewage from the plant.
3. Avoid contaminating food, equipment, water supply, utensils, ec.
4. Provide floor drainage in spaces where floors get very wet
5. Avoid back flow between plumbing systems

Sewage Disposal: Sewage must be disposed of adequately

Toilet Facilities: Each plant must have clean toilet facilities.

Hand-washing facilities: Each plant must provide hand washing facilities.

Rubbish: store rubbish to minimize odor, pests, and contamination

ATP Testing

ATP testing is a popular method for determining the effectiveness of a sanitation program. Check out our article on ATP testing and Environmental Monitoring to learn more.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ You are seeking to understand facility requirements for your FDA-regulated food business.

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

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More About Operating Requirements

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

These requirements are a part of the Current Good Manufacturing Practices that relates to Processes and Controls. You can see the full guide to cGMPs here

Requirements For Processes and Controls

Below are the processes and controls requirements for FDA regulated food businesses.

General Requirements

1. All operations involving food must align with sanitation principles.

2. Quality control must be used to ensure food and packaging is safe.

3. One or more competent individuals must be responsible for sanitation

4. You must protect your food from allergens and contamination.

5. Testing must be used to identify sanitation failures or possible product contamination.

6. Any contaminated food must be discarded or treated to eliminate the contamination.

Raw Materials & Ingredients

1. Ingredients must be inspected for cleanliness and stored safely. If necessary, raw materials should be washed using clean water.

2. Ingredients must be safe for consumption or treated to make them safe (i.e. washed or cooked).

3. Ingredients susceptible to toxins must comply with FDA regulations.

4. Ingredients that are contaminated must comply with FDA regulations if they are to be used.

5. Ingredients must be held in containers that prevent contamination and at an acceptable temperature and humidity level.

6. Frozen ingredients must be kept frozen.

7. Ingredients stored in bulk must be safe from contamination.

8. Ingredients that contain allergens must be identified and held in a way that prevents cross-contact.

Manufacturing Operations:

1. Equipment must be maintained in clean condition.

2. All operations should be controlled to minimize growth of bacteria, contamination and spoilage.

3. Food requiring refrigeration must be refrigerated throughout the operation.

4. Measures used to prevent bacteria growth (i.e. cooking, sterilizing, refrigerating) must be adequate.

5. Re-work must prevent contamination and bacteria growth.

6. When ingredients are unprotected they must not be handled in a way that could cause contamination. Food on conveyor belts must be protected.

7. Equipment, containers, and utensils must be constructed and used in a way that doesn’t contaminate food.

8. You must take measures to protect your product from metal or foreign objects.

9. Contaminated food must:

i. Be disposed of OR

ii. Re-worked and re-examined,

10. Food that is being processed must be protected from contamination.

11. Heat blanching --if used-- must be performed properly

12. Foods that are used repeatedly (i.e. dipping sauces, breading) must be protected from contamination and bacteria growth

13. Filling, assembling, and packaging processes must not contaminate food.

14. Dry foods that rely on low moisture for safety must be sufficiently dry.

15. Acidified foods that rely on acid for safety must be sufficiently acidic (pH≤4.6)

16. Ice that touches food must be food quality.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

This Article is For You if…

∆ Your business is regulated by the FDA

∆ Your business makes, packs, or holds food.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

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These requirements are a part of the Current Good Manufacturing Practices. You can see the full guide to cGMPs here

Personnel Requirements

Employees working in food processing spaces are subject to basic requirements about disease control and cleanliness. The aim of these requirements is to make sure a food processor does contaminate their own food product which could cause a customer to become sick.

Disease Control:

Sick employees must be excluded from operations that could result in food contamination.

The typical way of doing this implementing an Employee Hygiene Policy that excuses sick employees from work. This may require food production employees who have been exposed to a serious contagious illness to refrain from working until they are no longer contagious.

Cleanliness:

This section states that employees must have clean practices

1. Clothing that protects against contamination
2. Adequate personal cleanliness
3. Hand washing
4. Removing unsecured jewelry
5. Wearing gloves in a safe manner
6. Wearing hair restraints
7. Storing other belongings in areas where food is exposed/equipment is washed.
8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.
9. Taking other precautions

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ Your business is regulated by the FDA

∆ You have employees who work in a space where food is handled, packed, or produced.

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More About Operating Requirements

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

As incubator kitchens (commonly known as "shared-kitchens" or "commissary kitchens") pop up at an unprecedented rate, little attention has been paid to the regulation of these multiple tenant food processing facilities.

In this presentation to the Central Atlantic States Association of Food and Drug Officials, Ned Klein explains the regulatory landscape surrounding this business model and how food businesses and shared kitchen operators alike can protect themselves.

Bottom Line: FSMA has a severe impact on shared kitchens operate. For more about FSMA and food businesses, check out our detailed FSMA Guide

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These requirements are a part of the Current Good Manufacturing Practices that relates to Sanitary Operations. You can see the full guide to cGMPs here

Requirements For Sanitary Operations

Inadequate storage of chemicals and poor sanitation indicate a breakdown in food safe systems

General Maintenance:

Your space and everything in it must be in good repair to prevent food from being contaminated (i.e. no leaky ceilings, which could drip in food). Your cleaning processes should protect your food, packaging, and workspace from contamination.

Cleaning Chemicals:

1. You must only use safe cleaning chemicals. Toxic chemicals may only be allowed in food areas if they are:

• Required for cleaning

• Used in lab testing

• Necessary for equipment maintenance

• Absolutely necessary

2. You must store toxic chemicals in a way that protects food from contamination (Label it with the everyday name and keep it away from food and packaging)

Pest Control

Pests aren’t allowed in any area of the plant. You must exclude pests in the space and only use pesticides when it won’t result in contamination of food, packaging or work spaces.

Sanitation

You must clean food contact surfaces, including utensils, tables, equipment, to protect against contamination.

1. If you process low moisture (dry) food, your food contact areas must be clean and dry before use.

2. In “wet processing” food processing areas must be cleaned before use and after any contamination occurs.

3. Paper towels, paper cups and other single-use items must be protected from contamination.

ATP Testing

ATP testing is a popular method for determining the effectiveness of a sanitation program. Check out our article on ATP testing and Environmental Monitoring to learn more.

Non-food-contact-surfaces

These surfaces (i.e. walls, ceilings or anything that doesn’t touch food) must be cleaned as much as necessary to prevent contamination of food, packaging, or work areas.

Portable equipment and utensils must be stored in a way that doesn’t contaminate work areas.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ Your business is regulated by the FDA

∆ You operate a space where food is handled, packed, or produced.

∆ You want to understand cleanliness standards for your space.

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More About Operating Requirements

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

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ATP Testers

3M Clean-Trace Luminometer

Hygiena SystemSure Luminometer ATP Test Meter

What You Need to Know:

Sections

• What You Need to Know

• Key Terms

• Examples of Low Acid Canned Foods

• Is My Product a Low Acid Canned Food?

• Requirements for Producers of Low Acid

• Canned Foods

• Methods for Processing Low Acid Canned Foods

• Exemptions for Producers of LACF
  FAQ

• They are commonly referred to as low-acid-canned-foods (or "LACF") even though they may not be packaged in a can.

• Low Acid Foods in Hermetically Sealed Containers are by definition (1) shelf stable, (2) heat-treated (3) have a pH of >4.6 and (4) a water activity of 0.85

• Examples of Low Acid Foods in Hermetically Sealed Containers include: shelf-stable milk in pouches, canned beans, vegetable broth in a pouch.

• There are 2 primary methods for processing LACF: Using a Retort (pressuring cooker) and Aseptic Processing (a sterile packaging process)

• They are regulated in 21 CFR Part 113: Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

Key Terms

Low Acid Foods have a pH of >4.6 and a water activity of >0.85

Hermetically Sealed Container is packaging which prevents the entry of microorganisms and maintains the commercial sterility of the contents.

Commercial Sterility means there is zero microbiological activity (including bacteria, spores or anything that could reproduce under shelf-stable conditions

LACF ("Low-Acid-Canned-Food"): This term is used interchangeably with "Low Acid Foods Packaged in Hermetically Sealed Containers". It may apply to foods packaged in containers other than cans (i.e. flexible pouches or jars) which is why the term "hermetically sealed container" is used.

Examples of Low Acid Canned Foods:

View fullsize

This list only includes food products that would be governed under the FDA. Foods that fit the definition of LACF and contain >2% meat content are governed under the USDA.

• shelf-stable milk (commonly packaged in pouches)

• Canned tuna

• Canned black beans

• Canned corn

• Canned mushrooms

• Canned Cauliflower

• Shelf-stable vegetable broth

Does Part 113 Apply to your food product?

Is my product a Low-Acid-Canned-Food (LACF)?

Even if your product is not "canned", it may fall under the regulation of Part 113. Use the flow (above) to the right to determine whether your product is considered a LACF (aka "low acid food in a hermetically sealed container")

Requirements for Producers of LACF

Personnel

The operators of a processing system that produces LACF must have attended an FDA approved course that instructs on how to safely process these foods. An example of an approved course is "The Better Process Control School" which is offered online or in person.

Source: Part 113.40

Equipment and Procedures

The bulk of regulation under Part 113 relates to the requirements for thermal processing and aseptic processing.

Methods for Processing LACF

The two primary methods for processing low-acid-canned-foods are retort and aseptic processing.

Retort

A retort is a large pressure cooker. Sealed containers of food (typically cans, jars, or pouches) are loaded into the retort and heated using steam and pressure. This thermal treatment kills all of the microbiological activity in the containers.

In a retort process, products are treated after they are packaged and sealed.

The use of high pressure allows the retort to achieve temperatures above boiling, which allows for products to rapidly achieve sterility.

Examples of Foods Processed by Retort: Canned beans, canned vegetables, canned soup, canned tuna

Aseptic Processes

In an aseptic process, the food products are heat processed prior to packaging. Since there is a risk that the packaging or food may become contaminated in the packaging step, the entire process takes place under sterile conditions (hence the term aseptic).

Aseptic manufacturing requires tremendous control to maintain a sterile environment during processing. The machinery to perform this type of process is typically very expensive.

Examples of Foods Processed by Aseptic Process: Shelf-Stable Milk, juice boxes

Exemptions for Producers of Low Acid Canned Foods (LACF)

Processors who operate under Part 113 are exempt from the following requirements:

• Subpart C (Hazard Analysis and Risk Based Preventive Controls)

• Subpart G Supply Chain Controls

However, this exemption only applies in regards to microbiological hazards regulated under Part 113. Simply -- if the food processor identifies chemical or physical hazards in their production process, they must address those hazards as they are outlined in Subpart C.

Additionally, if the processor identifies a hazard that requires a supplier-applied preventive control, then the processor would have to conduct supplier verification activities as described in Subpart G.

Source: Part 117.5 (d) (1) & (2)

FAQ

Are fermented foods regulated under Part 113?

If the fermented food has a pH of >4.6 and a water activity > 0.85, then it is considered a "low-acid-canned food" (LACF) and is regulated under Part 113.

If the fermented food has a pH of <4.6 then it is not regulated as a Low-Acid-Canned-Food (Part 113) OR an acidified food (Part 114).

Are Alcoholic Beverages Regulated Under Part 113?

No. Alcoholic beverages are not regulated under Part 113 (Low Acid Foods in Hermetically Sealed Containers) or Part 114 (Acidified Foods).

Sources

21 CFR Part 113 -- Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

More About Specialty Foods

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Interstate commerce refers to products that cross state lines prior to consumption, or products composed of ingredients that have crossed state lines.

What is Interstate Commerce?

If a product crosses state lines between the start of the manufacturing process and when it is received by the individual who purchases it, then it has entered "interstate commerce".

Additionally, if the product is composed of ingredients from out-of-state, then it is considered to be a part of "interstate commerce" -- even if the product was created and consumed in state.

The technical definition of interstate commerce is:

"(1) commerce between any State or Territory and any place outside thereof,

and

(2) commerce within the District of Columbia or within any other Territory not organized with a legislative body."

FD&C Act [21 U.S.C. 321(b)] 

Examples of food that enters interstate commerce:

• A frozen pizza business that has a website and ships to buyers nationwide.

• A food processing facility that operates in New York and supplies cookies to bakeries in New Jersey.

• A distributor that holds food products created by local food producers in a warehouse and distributes them to a local retailer who, in turn, sells them in several states

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How Does Interstate Commerce  Relate to the FDA?

Whether a product enters interstate commerce is a major factor in determining whether a food business falls under FDA Jurisdiction. The other major factor is what type of food business it is. 

However, it is worth noting that all domestic facilities that engage in food processing, production, packing, or holding, must register as a Food Facility.

Additionally, the FDA may regulate any product that is adulterated or misbranded, even if that product doesn't enter interstate commerce.

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Sources

Learn more about interstate commerce in US Code Title 21 §331

More About Jurisdiction

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References

Learn more about interstate commerce in US Code Title 21 §331

What You Need to Know

Part 117 Subpart B is called Current Good Manufacturing Practices (CGMPs). 

These CGMPs outline the major requirements that a food processor must adhere to, including:

• Facility requirements

• Employee requirements

• Equipment requirements

• Cleaning requirements

• Warehousing & Distribution requirements

Summary of Current Good Manufacturing Practices

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease.

For example,  you have a question about my wording in §117.110 (b) (2) then just look up this same code in the CFR.

117.10 Personnel:

For a reduced summary of this section, see Personnel

a. Disease Control: Sick employees must be excluded from operations that could result in food contamination

b. Cleanliness: Employees must have clean practices:

1. Clothing that protects against contamination

2. Adequate personal cleanliness

3. Hand washing

4. Removing unsecured jewelry

5. Wearing gloves in a safe manner

6. Wearing hair restraints

7. Storing other belongings in areas where food is exposed/equipment is washed.

8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.

9. Taking other precautions

§117.20 Plants & Grounds

For a reduced summary of this section, see Facility Requirements

a. Grounds: They must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests

2. Maintain roads, yards, parking lots

3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination

4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.

b. Plant Construction & Design: The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)

§117.35 Sanitary Operations

For a reduced summary of this section see Sanitary Operations in Food Processing Facilities

a. General Maintenance: Your space and everything in it must be in good repair to prevent food from being contaminated (i.e. no leaky ceilings, which could drip in food). Your cleaning processes should protect your food, packaging, and workspace from contamination.

b. Cleaning chemicals:

1. You must only use safe cleaning chemicals. Toxic chemicals may only be allowed in food areas if they are:

i. Required for cleaning

ii. Used in lab testing

iii. Necessary for equipment maintenance

iv.  Absolutely necessary

2. You must store toxic chemicals in a way that protects food from contamination (Label it with the everyday name and keep it away from food and packaging)

c. Pest Control - Pests aren’t allowed in any area of the plant. You must exclude pests in the space and only use pesticides when it won’t result in contamination of food, packaging or work spaces.

d. Sanitation - You must clean food contact surfaces, including utensils, tables, equipment, to protect against contamination.

1. If you process low moisture (dry) food, your food contact areas must be clean and dry before use.

2. In “wet processing” food processing areas must be cleaned before use and after any contamination occurs.

3. Paper towels, paper cups and other single-use items must be protected from contamination.

e. Non-food-contact-surfaces (i.e. walls, ceilings or anything that doesn’t touch food) must be cleaned as much as necessary to prevent contamination of food, packaging, or work areas.

f. Portable equipment and utensils must be stored in a way that doesn’t contaminate work areas.

§117.37 Sanitary Facilities and Controls

For a reduced summary of this section see Facility Requirements

a. Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

b. Plumbing: Must

1. Carry adequate amounts of water around the plant.

2. Remove sewage from the plant.

3. Avoid contaminating food, equipment, water supply, utensils, ec.

4. Provide floor drainage in spaces where floors get very wet

5. Avoid back flow between plumbing systems

c. Sewage Disposal: Sewage must be disposed of adequately

d. Toilet Facilities: Each plant must have clean toilet facilities.

e. Hand-washing facilities: Each plant must provide hand washing facilities.

f. Rubbish: store rubbish to minimize odor, pests, and contamination

§117.40 Equipment and Utensils

For a reduced summary of this section see Equipment and Utensils

a. Equipment and Utensils

1. Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

2. Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

3. Equipment must be installed in a way that they can be cleaned and maintained.

4. Food-contact surfaces must be corrosion-resistant.

5. Food-contact surfaces must be non-toxic

6. Food-contact surfaces must be maintained to protect food from allergen cross-contact

b. Seams on food-contact surfaces must be seamless to minimize accumulation of particles.

c. Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

d. Machinery must be designed in a way that can be kept clean

e. Each freezer and refrigerator must have a thermometer in it.

f. pH meters, thermometers, and other measuring devices must be accurate.

g. Compressed air must be treated in a way that it does not contaminate food.

§117.80 Processes and Controls

For a reduced summary of this section see Processes and Controls

a. General:

1. All operations involving food must align with sanitation principles.

2. Quality control must be used to ensure food and packaging is safe.

3. One or more competent individuals must be responsible for sanitation

4. You must protect your food from allergens and contamination.

5. Testing must be used to identify sanitation failures or possible product contamination.

6. Any contaminated food must be discarded or treated to eliminate the contamination.

b. Raw Materials & Ingredients

1. Ingredients must be inspected for cleanliness and stored safely. If necessary, raw materials should be washed using clean water.

2. Ingredients must be safe for consumption or treated to make them safe (i.e. washed or cooked).

3. Ingredients susceptible to toxins must comply with FDA regulations.

4. Ingredients that are contaminated must comply with FDA regulations if they are to be used.

5. Ingredients must be held in containers that prevent contamination and at an acceptable temperature and humidity level.

6. Frozen ingredients must be kept frozen.

7. Ingredients stored in bulk must be safe from contamination.

8. Ingredients that contain allergens must be identified and held in a way that prevents cross-contact.

c. Manufacturing Operations:

1. Equipment must be maintained in clean condition.

2. All operations should be controlled to minimize growth of bacteria, contamination and spoilage.

3. Food requiring refrigeration must be refrigerated throughout the operation.

4. Measures used to prevent bacteria growth (i.e. cooking, sterilizing, refrigerating) must be adequate.

5. Re-work must prevent contamination and bacteria growth.

6. When ingredients are unprotected they must not be handled in a way that could cause contamination. Food on conveyor belts must be protected.

7. Equipment, containers, and utensils must be constructed and used in a way that doesn’t contaminate food.

8. You must take measures to protect your product from metal or foreign objects.

9. Contaminated food must:

i. Be disposed of OR

ii. Re-worked and re-examined,

10. Food that is being processed must be protected from contamination.

11. Heat blanching --if used-- must be performed properly

12. Foods that are used repeatedly (i.e. dipping sauces, breading) must be protected from contamination and bacteria growth

13. Filling, assembling, and packaging processes must not contaminate food.

14. Dry foods that rely on low moisture for safety must be sufficiently dry.

15. Acidified foods that rely on acid for safety must be sufficiently acidic (pH≤4.6)

16. Ice that touches food must be food quality.

§117.93 Warehousing and Distribution

Storage and transportation of food must protect the food from contamination.

(That’s it!) See source code 21 CFR 117.93 to see for yourself

§117.95 Holding and distribution of Human food by-products for use as animal food

a. By-products held for use as animal food must be protected from contamination:

1. Containers must be safe

2. Food by-products must be protected from contamination

3. By-products used for animal food must be labeled

b. Labeling must use common name

c. Shipping containers must be inspected for contamination prior to use

§117.110 Defect Action Levels

a. Quality control must be used to minimize defects

b.Mixing contaminated food with uncontaminated food to dilute the contamination level is not permitted.

Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

---

This Article is For You If…

∆ You produce, pack or pack food that is consumed in the US.

∆ Your food product enters interstate commerce

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Table of Contents

§117.10 Personnel
§117.20 Plants and Grounds
§117.35 Sanitary Operations
§117.37 Sanitary Facilities and Controls
§117.40 Equipment and Utensils
§117.80 Processes and Controls
§117.93 Warehousing and Distribution
§117.95 Holding and Distribution of Human Food Byproducts for Use as Animal Food
§117.110 Defect Action Levels
Exemptions

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More About Operating Requirements

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References

FDA Regulations on cGMPS

These requirements are a part of the Current Good Manufacturing Practices that relates to Equipment and Utensils You can see the full guide to cGMPs here

Equipment Requirements

• Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

• Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

• Equipment must be installed in a way that they can be cleaned and maintained.

• Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

• Machinery must be designed in a way that can be kept clean

• Each freezer and refrigerator must have a thermometer in it.

• pH meters, thermometers, and other measuring devices must be accurate.

• Compressed air must be treated in a way that it does not contaminate food.
  

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Food Contact Surface Requirements

• Food-contact surfaces must be corrosion-resistant.

• Food-contact surfaces must be non-toxic

• Food-contact surfaces must be maintained to protect food from allergen cross-contact

• Seams on food-contact surfaces must be seamless to minimize accumulation of particles.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

This Article is For You if…

∆ Your business is regulated by the FDA

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

∆ You use equipment and utensils in your operation

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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: A manager in a cookie factory reviews production records to confirm that the cookies were baked to the temperature described 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: A food safety manager collects scientific research to demonstrate that the cooking temperature used in the recipe is effective in eliminating harmful bacteria in the raw 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.

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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

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.

SOURCE: Sources

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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	Validation Required?	Why?	Validation 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. While it's largely accepted that a 15 second exposure to 165ºF temps will kill salmonella, it's good to cite a source showing that this control is valid. You can simply link or reference any reputable text which states this fact.	5D reduction for Salmonella: 15 seconds at 165ºF Table A4.1, “Limiting Conditions for Pathogen Growth” FSPCA Preventive Controls for Human Food 1st Ediiton, 2016
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature	Yes	You'll need to describe exactly how you know that this combination of controls are effective in controlling specific bacterial pathogens. The validation must be specific to the hazards you are controlling. You can cite a study showing that a certain concentration of bacteria produced by the ferment is effective in limiting the growth of relevant, harmful pathogens. You might also link a source which describes the pH threshold for specific bacteria growth.	For example: pH is an effective limiter for pathogenic bacteria growth in lactic acid producing fermented products if a <4.6 pH is maintained. Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry, Chapter 4 “Preventive Controls” p.27
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw	Yes	This is a less common type of control (using preservatives to make raw chicken edible) so you would need to make a compelling case that this preservative is effective in eliminating harmful bacteria. You can state the simple facts of the study in one of two sentences and then cite the source.	[cite your source]
Chlorine sanitizer used to sanitize dishes	No	Validation is not required for sanitation controls. In this case, it is widely accepted that chlorine is an effective sanitizer.	N/A
Items containing peanuts are stored in different-colored containers from non-peanut products	No	Validation is not required for allergen controls	N/A

SOURCE: Sources

This Article is For You if…

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

∆ You are an FDA regulated food facility.

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Resources

Food Safety Plan Guide to Validation

Food Safety Plan Guide to Verification

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