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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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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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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More About Operating Requirements

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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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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Introduction

Great! You have already confirmed that your business is regulated somehow by the FDA. 

The easiest way to understand what regulations apply to your business is to identify what kind of food you make.

Some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn about their special requirements. Otherwise, keep reading

Do you make one of these specially regulated foods?

• Dietary Supplements

• Fish / Fishery Products (Seafood)

• Juice

• Animal Food (Includes pet treats)

• Infant Formula

• Bottled Water

If you make one of these foods, check out our section on Specially Regulated Foods 
Otherwise, your product likely falls under Part 117 (See Below)

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Part 117 Overview

If you are producing human food, then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117.  This section contains the majority of requirements for typical food producers.

What You Need To Know To Be FDA Compliant:

Everything a food producer needs to know is located in Subpart B. To find exactly what you're looking for, read the sections below:

Subpart B -- Current Good Manufacturing Practices: This contains Requirements for Facilities, Employees, and Sanitation.
     Guide to Subpart B

Subpart C -- Hazard Analysis and Risk Based Preventive Controls: This section outlines the requirements for a Food Safety Plan and other requirements related to the implementation of preventive controls.
    Guide to Subpart C

Subpart F -- Requirements Relating to Records that Must Be Established and Maintained: This section dictates the record keeping requirements for food businesses. 
     Guide to Subpart F

Subpart G -- Supply-Chain Program: This section outlines the requirement for verifying supplier partners and documenting this process.
Guide to Subpart G

Other Parts of 117:

These sections relate to a minority of food processors. In case you are interested, I have linked them below:

Subpart A -- General Provisions:This section contains definitions, exemptions, and the training requirements for employees working in a food production space.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart A: General Provisions

Subpart D -- Modified Requirements: This section describes modified requirements that apply to Qualified Facilities and Storage Facilities.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart D: Modified Requirements

 Subpart E -- Withdrawal of  a Qualified Facility Exemption: This section describes how a business would transition from being exempt to provisions of the code to non-exempt status. This only applies to businesses who previously but no-longer apply for the Very Small Business Exemption
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart E: Withdrawal of a Qualified Facility Exemption

This Article is For You if…

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

∆ Your food product enters interstate commerce

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References

FDA Human Food Regulation (Part 117)

Products Requiring Supplemental Registrations & Notifications

Specific product types require additional registration beyond a Food Facility Registration. They include:

• Acidified Foods & Low-Acid-Canned-Foods

• Infant Formula

• New Dietary Ingredient

• Shell Egg Producer

Acidified Foods & Low-Acid-Canned-Food Registration

This category of foods includes many fermented foods, sauces, salsa, and other food that are kept shelf-stable in a sealed container.

A commercial processor created Acidified Foods (AF) or Low-Acid-Canned-Foods must file with the FDA. Their filing will include the following information:

• Establishment details

• List of food processed

• Processing method

If you are unsure whether this definition applies to your product, check out the glossary below or this guidance document from the FDA:

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Infant Formula Registration

If you produce or distribute infant formula, then you must register prior to introducing your product to interstate commerce.

**Note that some of these filings must be made 90 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This registration will require the following information:

• Establishment details

• Product Details

  • name and description

  • An explanation of why it is a new infant formula

  • The quantitative details of the product

  • A description of any reformulation of the product or change in process.

  • Assurance that the infant formula will not be marketed unless in meets FDA criteria.

For specific details about infant formula registrations, click here

New Dietary Ingredients

Dietary supplements that contain a "new dietary ingredient" (anything not marketed before 1994) must notify the FDA about those ingredients. This notification includes information that the new ingredient will be safe to consume as prescribed by the product label.

**Note that this filing must be submitted 75 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This notification will contain the following information:

• Your personal details

• The name of the new dietary ingredient

• A description of the supplement that contains the new product

  • Levels of the new ingredient in the product

  • Ordinary conditions of use

  • History or evidence of safe use (i.e. scientific literature, historical evidence, etc.)

Consider consulting this FDA resource about New Dietary Ingredients in Dietary Supplements

Shell Egg Producers

Producers of shell eggs (i.e. an egg hatchery or poultry house) must register the details of their facility. This is due to the high frequency of food borne illnesses associated with shell eggs, largely due to temperature abuse and the transportation of this product. This registration will require the following details:

• Establishment details

• Dates/Size of operations

• Owner information

For more information about requirements for shell egg producers, click here

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Contents

Acidified Foods & Low-Acid-Canned-Foods
Infant Formula
New Dietary Ingredient
Shell Egg Producers

More About FDA Registration

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References

Is Your Product an Acidified Food or a Low-Acid-Canned Food?

What You Need to Know about CBD and the FDA

The FDA Regulation on CBD is not as lenient as the widespread presence of CBD would lead you to believe

This article provides a background on the FDA's current regulation of CBD. To learn about more recent updates, see 5 Things we Learned from the FDA Update on CBD Foods

CBD is a Drug Ingredient, Not a Food Ingredient or a Dietary Supplement

CBD (Cannabidiol) is an active ingredient in an FDA-approved drug (Epidiolex) which was subject to the rigorous drug-approval process. According to FDA regulation, substances which are active ingredients in a drug cannot be introduced as ingredients into food or marketed as dietary substances.

Even if the FDA hasn't yet approved the drug yet, its active ingredients are typically disallowed as food or dietary supplement ingredients insofar drug trials are underway and publicly known.

This is the crux of the FDA's argument for disallowing CBD in food products prior to the June 2018 approval of Epidiolex, a CBD-based epilepsy drug. In 2017, the FDA sent warning letters to producers of CBD-infused food and cosmetic products, arguing that the use of CBD was illegal because publicly known drug trials for Epidiolex were already underway.

CBD Dietary Supplements are easy to come by

There is an exception to the rule: if the substance in question was marketed as a dietary supplement or conventional food ingredient before it became an drug ingredient, then it may continue to be used as a food ingredient. In the case of CBD, the FDA has determined that there isn’t sufficient evidence of it’s historic use as a food ingredient.

Still, in late 2018, the FDA acknowledged that they have the authority to approve the use of a pharmaceutical ingredient in a food or dietary supplement. And according to the commissioner’s statement in December 2018, they are currently deciding whether to pursue this as it relates to CBD (and THC too). What would compel the FDA to allow CBD in FDA-regulated foods? At this point, it’s unclear.

Bottom Line: It is unlawful to sell any food or dietary supplement containing CBD if that product enters interstate commerce.

CBD-Containing Cosmetics

CBD-containing cosmetics are widely available both online and in retail locations nationwide. What’s the legal status of CBD cosmetics with the FDA?

Are CBD Cosmetics Considered Drugs?

The difference between a cosmetic and a drug is whether the product "affects the structure or function of the body." Simply, if the product causes any sort of physiological change that is beyond "cleansing, beautifying, promoting attractiveness, or altering the appearance", then it is considered a drug.

The FDA Defines a cosmetic as

“(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap."

For example anti-perspirant is considered an over-the-counter drug because its effects are not merely cosmetic: anti-perspirant causes a physiological change -- it blocks our pores-- which prevents the wearer from sweating.) While deodorant would be considered a cosmetic (it’s merely perfume), sunscreen is considered a drug.

CBD has a physiological effect on the body —it’s the active ingredient in the FDA-approved prescription drug Epidiolex — so any product containing CBD would seem be classified as a drug.

But here’s the twist: while the FDA has made this argument as it relates to food and dietary supplements, they have not (as of 2020) made it for cosmetics.

So what is the FDA stance on CBD Cosmetics?

The FDA does not explicitly disallow cannabis products in cosmetics and they aren’t going after CBD cosmetic companies (so far).

However, the FDA has made it clear that they intend to take enforcement action brands who make false claims about their drug’s ability to treat or cure a disease. CBD cosmetic brands which list the therapeutic effects of CBD or directly state its ability to alleviate certain symptoms will continue to receive warning letters (see the FDA Warning Letter to Rooted Apothecary)

Bottom Line: CBD cosmetic brands are unlikely to be subject to FDA enforcement insofar as they do not make drug-claims on their product or in their marketing.

For more information, see

FAQ - CBD and FDA Regulation

Does it matter that the CBD is hemp-derived?

No. Regardless of the origin of the CBD, substances which are active ingredients in a drug cannot introduced as ingredients into food or marketed as dietary substances.

What if my CBD/THC product doesn't enter interstate commerce?

If a food product's packaging and ingredients (including the CBD) were sourced entirely in-state and your product is sold in-state, then the product may not be considered as participating in inter-state commerce.

In this case, the product would not be subject to FDA regulation. (Learn more in our article Does the FDA Regulate My Food Business?)

However, this doesn't mean you're in the clear -- check with your state and local health authorities to confirm there's no local law that automatically adopts FDA regulation at the local level or expressly prohibits CBD as a food ingredient.

Why are some companies allowed to sell CBD in foods?

They're not. Many food companies are operating in violation of FDA regulation. The FDA has sent warning letters to food products which contain CBD or cannabis-derived ingredients. However, due to the reactive nature of the FDA and a large array of responsibilities, not all of these companies have been approached.

The FDA regulates all types of new ingredients that are added to food. Whenever any sort of new compound (either a dietary supplement or something that wasn't considered "food") is added to a food, the FDA must first approve that new dietary ingredient.

Can hemp be used as a food ingredient if it doesn't contain CBD or THC?

Yes. There are hemp products that do not contain CBD or THC, such as hemp-seed-derived food ingredients. Three of these products have been added to the list of "generally recognized as safe (GRAS)" ingredients. They are:

1. Hulled hemp seed

2. Hemp seed protein powder

3. Hemp seed oil

The reasoning is that they do not contain CBD or THC. If these food ingredients are manufactured in a way that is consistent with FDA regulations, then they are allowed as ingredients in FDA-regulated foods.

Is CBD GRAS? (Generally Recognized as Safe)

No. While other hemp products (see above) are considered GRAS, cannabidiol (CBD) is not one of them.

If you’d like to check whether a specific ingredient is allowable in food, consider searching this database of .

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More About CBD

Table of Contents

What You Need to Know

CBD is a Drug not a Food

CBD Cosmetics

FAQ

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Resources

FDA Overview of Cannabis Regulation

Read the FDA Commissioner's Dec. 2018 Statement on CBD and the FDA

Read this 2017 letter from the FDA to a CBD-infused candy company

FAQ from the FDA about Marijuana and related products

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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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Contents

If You Warehouse and Distribute Only Packaged Foods

If You Import Foods

If You Transport Food Yourself or Hire a Carrier

If you warehouse and distribute only enclosed, packaged foods...

Then you are exempt from two major components of FSMA :

• 117 Subpart C which requires you to have a hazard analysis and a food safety plan, and

• 117 Subpart G, which requires you to have a Supply Chain Program.
  

This means you don't need a food safety plan, a recall plan, or a supplier verification plan.

What You Need To To:

Control Food Temperature

If you warehouse/distribute food that is kept refrigerated or frozen, then you must have systems to ensure that proper temperature is being kept at all times. Specifically, you must:

• Establish temperature controls. This means outlining what are safe temperatures for refrigerated and frozen foods in your space and having this information written.

• Regularly monitor temperatures of all of your refrigerated spaces (including vehicles) either manually with a log or through an automatic temperature monitoring system.

• Take corrective action. If there is a temperature deviation that impacts the product, then you must take a corrective action. This means producing a written record showing that you corrected the problem, evaluated the product, and reduced the likelihood that it will recur.

• Verify your temperature controls. You must calibrate your thermometers or check them for accuracy to make sure you're recording information accurately.

• Verify your records. This means a supervisor must review the temperature logs (from your trucks or walk-ins) to make sure there was no deviation from the acceptable temperature ranges. You must also review corrective action records within 7 working days and calibration records within reasonable time.

• Keep Records. You must be able to show that you have records of temperatures records, any corrective actions, and that they have been verified.

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If you Import Foods From other Countries…

You are most likely required to implement a Foreign Supplier Verification Program (FSVP). Check out our guide to FSVP.

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If you transport food yourself or hire a carrier to transport it for you…

If you are in any way involved in the transportation of food, then you are subject to the Sanitary Transportation of Human & Animal Food. We let you know exactly what you need to do to comply with that in our guide to Sanitary Transport

This article is for you if…

∆ You are an FDA-regulated food distributor

∆ You are an FDA-regulated food business and you distribute food yourself

∆ You are unsure about what FSMA requirements apply to you.

Find the Right Tools

More About FSMA

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To learn more about foreign supplier verification and imported foods, see our guide

Importers of seafood products must verify that the foreign supplier is compliant with FDA regulations -- even though the food is processed outside the US.

There are two ways to verify a supplier of imported fish / fishery (a.k.a. seafood) products from another country:

1. The importer obtains the product from a country that has an active memorandum of understanding (MOU) with the FDA that documents the equivalency of their food safety systems, or

2. The importer implements verification procedures for ensuring the fishery products being importer were processed in accordance with FDA seafood requirements.

Memorandum of Understanding:

An importer can check if there is a MOU with the exporting country looking it up on the FDA website, here. Note that MOUs are not particularly common.

Verification Requirements for Importing Fish / Fishery Products

If you are unable to obtain the fish / fishery products from a country that has an active MOU, then you must conduct your own verification to confirm that the product was produced in compliance with FDA regulations. This verification may be completed by a competent 3rd party.

The importer's verification process must be written and must include the following, at minimum:

• Product specs for each imported product that ensure that product is not adulterated.

• One or more of the following:

  • HACCP and sanitation monitoring records that relate to the specific lot of fish being imported.

  • A lot-by-lot or continuing certificate from a government authority or 3rd party certifying that the food was processed in accordance with FDA regulation on fish / fishery products (21 CFR §123)

  • Regularly inspecting the foreign processor's facilities to ensure that the imported product is being processed according to FDA regulation.

  • Maintaining on file a copy of the foreign processors HACCP plan and a written guarantee (English) that the imported product is being processed according to FDA regulation.

  • Periodically testing the imported products and maintaining on file a written guarantee (English) that the imported product is being processed according to FDA regulation.

  • Another equivalent method of verification.

All verification records must be kept on file by the importer.

What’s next:

Guide to Developing a Foreign Supplier Verification Program (FSVP)

More About Supply Chain

Businesses involved in the transportation of food in the US must follow 'Sanitary Transport' rules to ensure the food does not become unsafe during travel.

Contents

Applicability
Exemptions
General Requirements
Specific Requirements
Requirements for Shippers
  Requirements for Loaders
  Requirements for Receivers
  Requirements for Carriers

Applicability

The "Sanitary Transport Rule" applies to nearly every businesses involved the transportation cycle.

To understand the requirements for your business, assess what role(s) your business plays in the transportation process and review the requirements below.

You can click  to see the requirements for that specific role

Carrier: A person who physically moves food by rail or motor vehicle in commerce within the US (excluding parcel delivery services).

Shipper: A person who arranges for the transportation of the food by carriers.

Loader: A person who loads food onto a motor or rail vehicle as part of the transportation operation.

Receiver: a person who receives food in the US, regardless of whether it is the final destination of that food.

Source

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Exemptions:

The following is a list of exemptions to the Sanitary Transport of Human Food regulations:

Non-Covered Businesses:

Certain small businesses are exempt from this rule. There are two ways to achieve the "non-covered business" exemption:

1. A business that is not a motor vehicle carrier (i.e. doesn't physically transport food themselves) and employs fewer than 500 full time employees.

2. A motor vehicle carrier that is not a shipper (i.e. doesn't arrange for shipping of food by other carriers) and has <$27.5 million in annual receipts.

Other Exemptions

The following operations are exempt from this rule:

• Transportation activities performed by a farm.

• Food that is merely passing through the US on its way to another country.

• The transportation of food that is regulated entirely by the USDA.

• Transportation of the following products:

  • Food gases

  • Food contact substances.

  • Food that is completely enclosed by a container and does not require a temperature control for safety (i.e. a refrigerated food).

  • Live animals, excluding shellfish (they are not exempt)

  • food byproducts that will be used for animal food without further processing.

Waivers

A company may apply for a waiver to waive a specific requirement in this subpart. You can learn more about waivers in 21 CFR §1.914

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What are the Requirements for Sanitary Transport?

The goal of this regulation is to ensure that food does not become unsafe during transportation. In order to protect food, all parties involved in transportation must adhere to the following general rules. Additionally, there are rules specific to shippers, carriers, loaders and receives, listed below.

General Requirements:

Protect food from contamination from other items in the same load. It's important that food doesn't get contaminated from other food (i.e. raw fish in the same truckload) or non-food (chemicals that are being shipped in the same truckload). Some ways to do this include:

• Segregation - physically separate items that could contaminate one another

• Use of packaging - Use packaging to protect food from contamination

Protect food that is transported in bulk-vehicles or not completely enclosed by a container. For example, if you are shipping a tanker full of milk (bulk-vehicle) or an open truck bed full of corn (no enclosed container) then it must be protected from contamination.

Control the temperature of food that requires it. If a food requires refrigeration or freezing, then this must be maintained during transportation.

If the food is exposed to temperatures that render the food unsafe (i.e. the refrigerator in a truck fails during transport), then the food may not be sold or distributed. However, If a qualified individual (someone with adequate training) determines that the food was not rendered unsafe by this deviation, then the food may be sold and distributed.

Consider the type of food and the stage of production. It's important to understand whether the nature of the food (human food or pet food) when determining how you will keep it safe. Additionally, you should understand the production stage: is the food going to be further processed or is it on it's way to a supermarket?

Food that is going to undergo additional inspections and processing may not need to be transported under as strict conditions than if it is being transported directly to the consumer. For example, The carrier may assess that a truck full of corn can be exposed to a certain amount of dirt during transportation because it is being shipped to a cannery that has agreed to wash it prior to further processing.

Source: CFR §1.908

Specific Requirements:

There are specific requirements for the actors involved in transportation. Note that an entity subject to these requirements may re-assign them in writing to another party.

For example, let's say the shipper is a meal-kit service that delivers meals in individual refrigerated coolers loaded with dry ice. In turn, the shipper doesn't have to pay the expensive cost of refrigerated transportation, since each package is itself refrigerated. Instead, they can ship via a carrier who operates un-refrigerated trucks. Whereas the requirement in this section states that the carrier is responsible for maintaining the proper temperature of the food, they may assign this responsibility to the shipper, who is clearly responsible for making sure each product is packaged with enough ice and in the right container to arrive sufficiently cold.

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Requirements for Shippers:

A shipper is the person who arranges for the transportation of food by a carrier (who physically transports the food on trucks/rail). The shipper must do the following:

• Inform the carrier of all necessary sanitary specifications required to keep the food safe during transportation. This may be a specific design requirement for a carrier's vehicle or a cleaning procedure required to keep the food safe.

• Inform the carrier of the temperature requirement for the food during transportation. This must be written.

• Implement written procedures that prevent the food from becoming unsafe during transportation. Although the shipper must develop these procedures, they may be enacted by another party during the transportation process (i.e. the carrier), and this must be agreed upon in writing. For example, if the shipper requires the temperature of their product to be taken and recorded every 24 hours throughout transportation, then the carrier and the receiver may complete this task.

• If food is being shipped in bulk (i.e. a tanker full of milk), then the shipper must develop written procedures to make sure the previous cargo doesn't make the food unsafe.

• If the food requires temperature control (i.e. refrigeration) then the shipper must have written procedures to ensure the food is transported under adequate temperature.

Source 21 CFR -- 1.908(b) Requirements applicable to shippers

Record keeping Requirements for Shippers:

Shippers must maintain the following records and provide them to officials upon request. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity).

• Records that the shipper provides specifications and operating temps to carriers

• All written procedures and policies

• The assignment of any responsibility to another party

Source 21 CFR -- 1.912

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Requirements for Loaders:

• Before loading food that isn't enclosed in a container, the loader must determine that the vehicle is appropriate to transport the food safely. This could be a visual inspection to ensure the truck doesn't have pest infestation or filth that would make the food unsafe.

• Before loading the food that requires temperature control, the loader must confirm that the refrigerated area is properly cooled and sufficiently clean to transport the food safely.

  Source 21 CFR -- 1.908(c) Requirements applicable to loaders

Record Keeping Requirements for Loaders:

Loaders must maintain records of any written agreements that assigns tasks required by this regulation. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity). These records must be provided to officials upon request.

Requirements for Receivers:

Upon receipt of food requiring temperature controls, the receiver must assess whether the food was subject to temperature abuse (i.e. a safe temperature was not maintained during transport.) This could be achieved by one of the following measures.

• Taking the temperature of the product upon arrival

• Taking the temperature of the vehicle's refrigerated space upon arrival.

• Visually inspecting the food - consider how easy it is to tell if ice cream has melted and been re-frozen.

• Smelling it - products subject to temperature abuse may produce foul odors.

Source 21 CFR -- 1.908(d) Requirements applicable to receivers

Record Keeping Requirements for Receivers:

Receivers must maintain records of any written agreements that assigns tasks required by this regulation. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity). These records must be provided to officials upon request.

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Requirements for Carriers:

• The carrier's equipment/vehicles must meet the shippers specifications for keeping food safe.

• The carrier must demonstrate to the receiver that they maintained the agreed upon temperature conditions during transportation. This could be the product's temperature at loading, unloading and at various intervals during transportation.

• The carrier must pre-cool any refrigerated vehicle before transporting food.

Source 21 CFR -- 1.908(e) Requirements applicable to carriers

Requirements for Carriers who use bulk-vehicles

A bulk-vehicle means food is stored openly in a bulk container, such as a tanker full of milk or a truck bed full of loose ears of corn

• The carrier must be able to provide information to the shipper about the identity of the previous cargo.

• The carrier must be able to provide information to the shipper describing the most recent cleaning of the bulk-vehicle.

Training Records for Carriers

• When a carrier is responsible for sanitary conditions during transportation, they must train their staff to be aware of and address potential problems that may arise.

• Carriers must have records documenting the training that includes: the date of the training, type of training, the persons trained.

Source -- 21 CFR 1.910

Record Keeping Requirements for Carriers:

Carriers must maintain the following records and provide them to officials upon request. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity).

• The written procedures for cleaning, sanitizing, and (if applicable) inspecting their equipment/vehicles

• The written procedures for maintaining temperature control.

• The written procedures for maintaining bulk-vehicles.

• Training Records

• Any other written agreements that assigns tasks required by this regulation.

Source -- 21 CFR 1.912

More About Distribution

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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

More Posts

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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:

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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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More Posts

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What is FSMA?

The Food Safety Modernization Act was a piece of legislation that went into effect in 2016. It shifted the focus of food safety from responding to foodborne illness outbreaks towards preventing foodborne illness outbreaks. FSMA updates the requirements for many food businesses who fall under FDA Jurisdiction. FSMA has six major sections:

1. Preventive Controls for Human Food (Part 117) - Requires processors of human food to develop risk-based systems focused on food safety through prevention. This includes,

   • Current Good Manufacturing Practices

   • Hazard Analysis and Risk Based Preventive Controls

   • Record Keeping Requirements

   • Supply Chain Program
     

2. Foreign Supplier Verification - Ensures imported food is produced to FDA standards.
   

3. Sanitary Transportation Aims to protect food in transportation
   

4. Intentional Adulteration (Part 121) - Aims to protect from terrorist acts of contaminating the nation's food supply by establishing "Food Defense" requirements.
   

5. Preventive Controls for Animal Food (Part 507) - Requires processors of animal food to develop risk-based systems focused on food safety through prevention.
   

6. Produce Safety (Part 112) - Increases the standards of processing produce.
   

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What Businesses Does FSMA apply to?

• Human food processors

• Animal food processors

• Food transporters /shippers

• Farms

• Food Importers

• Food Warehouses / Food Storage facilities

When Does FSMA Take Effect?

FSMA is being rolled out over the course of several years. Smaller businesses have been given longer timeframes for compliance. See the image below for compliance dates.

Timeline of FSMA Compliance Dates

Selected FSMA Implementation Dates

Deadline for Preventive Controls for Human Food

• Very Small Businesses (<$1mm sales/Yr) - 9/17/2018

• Small Business (<500 employees) - 9/18/2017

• Large Business (>$1mm sales/yr and >500 employees) - 9/19/2016

Deadline for Intentional Adulteration (Human food):

• Very Small Businesses - July 26, 2021

• Small Businesses - July 27, 2020

• Large Businesses - July 26, 2019

FAQ

What are the FSMA requirements for my business?

All content on this website is FSMA-aligned and all articles have been updated to reflect FSMA provisions. You can learn about the major provisions of FSMA by reading this summary or browse by category to understand the specific requirements for your business.

The requirements imposed by FSMA have also been integrated into the FDA regulations, so feel free to dive into the Code of Federal Regulations and find your answers.

What is the difference between FSMA and the FDA Regulation?

FSMA is a law that was passed by congress. This updated the FDA regulation, which is a set of rules put forth by the FDA. If your business practices are aligned with the latest version of the FDA regulations, then your business is also FSMA aligned

This website is FSMA-aligned so you don't have to worry about additional FDA requirements.

What are the record keeping requirements for FSMA?

The record keeping requirements for FSMA are outlined in our summary of Part 117 Subpart F

What is a PCQI?

A PCQI is a preventive-controls-qualified-individual. This is someone who has been trained in the risk-based practices required by FSMA. There are many PCQI courses available in-person and online.

All businesses except those exempt from Part 117 Subpart C - Hazard Analysis and Risk Based Preventive Controls are required to have a PCQI to do the following:

• Prepare the food safety plan and review as necessary

• Supervise daily production on site.

The PCQI can be a permanent employee for the food processor but is not required to be.

More about FSMA

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More Posts

What you Need to Know:

If you are unsure of whether your product is an acidified food, see Introduction to Acid Foods

Contents

Food Canning Establishment Registration
Food Process Filing
Requirements for Processing

• If you produce an acidified food, you must conduct additional filings with the FDA (free)

• Producers of acidified foods must complete the "Better Process Control School" or an equivalent training course (available online)

Required Registrations/Filings for Acidified Food Producers

If you produce an acidified food, you must register your facility and file each acidified foods you process with the FDA.

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Food Canning Establishment Registration

Paper Form: Food Canning Establishment Registration

If you produce an acidified food, you must register the location where you produce that food. This filing is in addition to the normal food-facility-registration.

This filing simply notifies the FDA that acidified foods (which can be higher-risk food products) are being produced at this location. Completing this registration will not trigger an inspection.

File Electronically:Food Canning Establishment Registration (Form 2541).

File in Paper: Food Canning Establishment Registration (Form 2541)

If you have addition questions about completing Form 2541 see Instructions on Registering a Food Canning Establishment

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Food Process Filing for an Acidified Food

Paper Form: Food Process Filing for an Acidified Food (Form 2541e)

Producers of acidified foods must file a scheduled process for each acidified product that they produce. If a salsa company produces 5 SKUs that are all acidified foods, then they must submit 5 process filings, one for each SKU.

There is no requirement to file for products that do not fit the definition of an "acidified food".

File Electronically:Food Process Filing for an Acidified Food (Form 2541e)

File in Paper:Food Process Filing for an Acidified Food (Form 2541e)

If you have questions about the filing process, see Instructions on filing Form 2541e

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Requirements for Processing Acidified Foods

Always follow your scheduled process and contact your process authority if something goes wrong.

Process and Controls

Scheduled Process

• The manufacturer must follow a scheduled process.

• The schedule process must be established by a person who as expert knowledge about the acidification and processing of acidified foods.

Processing Operations

• The food must be thermally-processed (i.e. a heat-based kill step) to eliminate bacteria capable of reproducing in the finished product. Preservatives may be used in lieu of thermal processing for controlling the growth of microorganisms that are not harmful (i.e. spoilage bacteria that would ruin the food but not cause illness in humans).

• Keep your production records onsite (digital is fine) for at least 3 years.

Source: §114.80 (a) (1)

Acidification Procedures

Some acceptable methods used to acidify foods include:

• Blanching ingredients in acidified solutions

• Immersing blanched ingredients in acidified solutions

• Directly adding a measured amount of acid solution into a batch of food.

• Directly adding a measured amount of acid into individual containers during product.

Source 114.80 (a) (3)

Measuring pH

• The equilibrium pH of the final product must be below 4.6 and it must reach this within the timeframe set in the scheduled process.

• The pH of the product must be measured and recorded to maintain control throughout the process. If the final pH of the product is ≥4.0, then a potentiometric pH meter must be used (these are more accurate). If the final pH is <4.0, any type of pH meter may be used.

• pH readings should be taken at a temperature of 20ºC-30ºC (68º-86ºF). Optimal temperature for pH test accuracy is 25ºC (77ºF).

Source 114.80 (a) (1) & (2)

For a full explanation of pH and testing methodology, see §114.90

Containers and Coding:

• You must test and examine your containers to confirm that they protect your final product from leakage or contamination

• Each container must be labeled with a code that specifies the following:

  • Where the product was packed

  • The contents of the container

  • The date of packing

  • The code must be changed for each personnel shift, at minimum.

Deviations from Scheduled Process

If the equilibrium pH is measured at >4.6 the processor must take one of the following steps:

• Fully reprocess the food using a process approved by a process authority (this can be simply re-processing according to your usual method)

• Thermally process the food as a low-acid-canned food

• Set aside the food for evaluation by a process authority

• Destroy the food.

Make a record of this incident, regardless of the outcome.

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FAQ

Do I need to register my facility and products if I operate outside the US?

If you produce a product that meets the definition of an "acidified food" for consumption inside the US, then you must register your facility (Form 2541) and each of your acidified food products (2541e).

Processors located outside the US must also complete these registrations if their food will be exported for consumption inside the US.

Wholesalers, importers, distributors and brokers are not required to register and file processes

Source

Does compliance with Subpart 114 exempt me from other requirements?

A business operating under Acidified Food Regulations ( Subpart 114 ) is still subject to the requirements in Subpart 117 B: Current Good Manufacturing Processes as it relates to determining whether a product is adulterated.

More

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Foods with a pH of <4.6 are called "Acid Foods" Some types of acid foods, such as acidified foods, are subject to specific regulation.

What are Acid Foods?

Acid Foods: A food with a natural pH of ≤4.6. There are many naturally acidic foods, including apples, yogurt, peaches, onions, tomatoes, strawberries and lemons.

"Acid Foods" as a general group are not regulated, although certain sub-groups of acid foods are.

Types of Acid Foods

There are two main types of acid foods

Acidified Food: These are low-acid foods that has been acidified by adding something acidic so that the end product is ultimately acidic has an equilibrium pH of ≤4.6) . This includes foods such as: dill pickles, hot sauce, and pickled fish.

The FDA does not include the following to be Acidified Foods:

• Carbonated Beverages

• Jams, jellies & preserves

• Naturally acid foods like peaches and most fruit juices

• Foods with a water activity of ≤0.85

• Foods which are stored under refrigeration

• Fermented foods (i.e. kimchi, sauerkraut, natto)

The FDA regulates acidified foods in 21 CFR Part 114.

Formulated Acid Foods: These are composed mostly of acid foods to which a small amount of low-acid ingredients are added (generally less than 10% by weight). The low proportion of low-acid ingredients means that the pH doesn't change significantly from the pH of the dominant ingredients. Examples include:

• Barbecue Sauce

• Salad Dressings

• Marinades

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Use this key to determine if your food is an acidified food.

FAQ

Is my product an Acidified Food?

Consider this flow chart to determine if your product is regulated by the FDA as an Acidified Food:

Click to enlarge

What's the difference between an acidified food and a formulated acid food?

The difference between these two types acid foods depends on the proportion of low acid and high-acid ingredients in each product:

Acidified foods are typically low acid foods with an added acid (which acidifies the low acid food.)

Formulated Acid foods are composed mainly of high acid foods with a small amount of low acid foods added.

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Formulated Acid Foods

In order to qualify as a "formulated acid food", the low-acid ingredients must not significantly shift the pH of the product from the natural pH of the high-acid ingredients.

For a food product whose equilibrium (final) pH is <4.0, then a shift of up to 0.4 is considered insignificant.

For a food product whose equilibrium (final) pH is >4.0, then a shift of up to 0.1 is considered insignificant.:

Example #1:  Ned's BBQ Sauce.

Ingredients by weight: Tomato paste (93%), Sugar (5%), Spices (2%)

Ned's BBQ Sauce Equilibrium pH: 3.9

pH of only High-Acid Ingredients: 3.6

Change between high-acid ingredients and final product = 0.3

Since the equilibrium pH of Ned's BBQ Sauce is below 4.0, only an increase of 0.4 or more would be considered significant. Since the low-acid ingredients only increase the pH by 0.3, this change is considered insignificant.

Outcome: Ned's BBQ Sauce is a Formulated Acid Food. It is not subject to 21CFR Part 114

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Example #2: Ned's Marinade

Ingredients by weight: Tomatoes (60%) Onion (10%) Vinegar (20%) Sugar (7%) Spices (3%)

Ned's Marinade Equilibrium pH: 4.2

pH of only High-Acid Ingredients: 4.0

Change between high-acid ingredients and final product = 0.2

Since the equilibrium pH of Ned's BBQ Sauce is above 4.0, an increase of above 0.1 would be considered significant. Since the low-acid ingredients increase the pH by 0.2, this change is considered significant.

Outcome: Ned's BBQ Sauce is an acidified food. As a result, it is subject to The regulations in 21 CFR Part 114.

More on Specially-Regulated Foods

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To learn about nutrition and health claims generally, see Introduction to Food Product Claims

What You Need to Know:

A Qualified Health Claim is a statement approved by the FDA for use on food labels that has strict wording requirements. 

When there is emerging evidence between a food and the reduced risk of a disease or health condition, but not enough for the FDA to issue an Authorized Health Claim, the FDA may approve a "Qualified Health Claim"

Example of a Qualified Health Claim:

"Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive."

What Qualified Health Claims Can I Use?

Qualified Health Claims 2000-2013

The attached PDF contains a list of qualified health claims released by the FDA in their 2013 Food Labeling Guide. This represents Qualified Health Claims Through 2013.

Qualified Health Claims 2013-2018

A number of Qualified Health Claims have been released since the FDA Food Labeling Guidance Document. The links below are the FDA's response, known as a "Letter of Enforcement Discretion". This includes the qualified health claim that the FDA will allow (usually in the conclusion) and the specific requirements associated with using that qualified health claim.

Cardiovascular Disease

• Oleic Acid and Coronary Heart Disease (2018)

• Macadamia Nuts and Reduced Risk of Coronary Heart Disease (2017)

• Soybean Oil and Reduced Risk of Coronary Heart Disease (2017)

Diabetes

• High-Amylose Maize Starch and Reduced Risk Type 2 Diabetes Mellitus (2016)

• Psyllium Husk and a Reduced Risk of Type 2 Diabetes (2014)

• Whole Grains and a Reduced Risk of Diabetes Mellitus Type 2 (2013)

Peanut Allergy

• Ground Peanuts and Reduced Risk of Developing Peanut Allergy

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References

The attached file contains a list of qualified health claims released by the FDA in their 2013 Food Labeling Guide. This represents Qualified Health Claims Through 2013

What You Need to Know:

The label "gluten-free" is meant to protect people who have celiac disease. A "gluten-free" claim is considered neither a health claim or a nutrient content claim. 

A food processor may make a "gluten-free" claim on their food product without any additional registration or notification insofar as they meet the FDA requirements for making this claim.

The following common grains contain gluten:

• Wheat (genus Triticum)

• Rye (genus Secale)

• Barley (Genus Hordeum)
  

Any food whose label says "Contains Wheat" should be understood to contain gluten unless there is a disclaimer stating that the gluten has been removed in the manufacturing process.

Requirements for Using a Gluten Free Claim:

The following are specific product requirements for a food labeled as "gluten free". Such a food must:

• Cannot contain any gluten containing ingredients or grains (wheat, rye, barley)

• Cannot contain any ingredients derived from gluten-containing ingredients (i.e. "wheat flour")

• May contain an ingredient that has been processed to remove gluten (i.e. wheat starch). However, your food must ultimately contain less than 20mg gluten per 1kg of food.

• If your product contains wheat or lists "wheat" on the ingredient label and bears a "gluten-free" claim, then you must state the following "the wheat has been processed to allow this food to meet the FDA requirements for gluten free foods."

No additional registration or notification is required to make this claim.

How to Create an FDA Compliant "Gluten-Free" Claim

1. Make sure your product complies with the requirements above (i.e. it doesn't contain gluten)

2. Check all of the labels of ingredients in your product to confirm that none of the component ingredients in your food product contain gluten.

3. Review all of the ingredients each time you change ingredients, suppliers, or recipes to confirm that your claim is still valid.

4. Confirm that there is no way your product could be contaminated with gluten in the production process.

5. Confirm that your gluten free claim is aligned with the requirements described in this section.

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FAQ

WHAT ARE FOODS THAT TYPICALLY CONTAIN GLUTEN?

Wheat

• Bread

• Baked Goods

• Pasta

• Cereal

• Salad Dressing

Rye:

• Rye Bread

• Cereals

Keep an Eye On:

• Soups

• Processed Meats

• Salad Dressing/Marinades

• Potato Chips

Other Gluten-Containing Grains:

• Durum

• Farro

• Semolina

• Bulgur

• Kamut

• Spelt

• Triticale

Barley:

• Malt

• Food Coloring

• Soups

• Malt Vinegar

• Beer

WHAT FOOD PRODUCTS DOES THE FDA REGULATION COVER?

This covers all FDA-regulated packaged foods, including dietary supplements. The rules exclude products under the USDA (eggs, poultry, meat, generally) and products under the TTB (liquor, wines an malted beverages)

IS THERE AN ACCEPTABLE LEVEL OF GLUTEN IN A "GLUTEN-FREE" PRODUCT?

The FDA regulations stipulates that, when unavoidable, there is an acceptable threshold of 20ppm (parts-per-million) or 20mg of gluten per 1kg of food. 

Practically, in order to use the label "gluten-free" your product must not cause adverse reaction in someone with celiac disease (which is more serious than a gluten sensitivity). 

A product that is labeled "gluten-free" and creates an adverse reaction to someone with celiac disease may draw scrutiny, investigation and possible recall from the FDA, even if the product falls under the acceptable threshold.

ARE TERMS SUCH AS "NO GLUTEN", "FREE OF GLUTEN", AND "WITHOUT GLUTEN" REGULATED?

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Terms such as "no gluten", "free of gluten", and "without gluten" are all regulated by the FDA and are subject to the same requirements as a "gluten free" label claim.

You may make the claim "made with no gluten-containing ingredients" without adhering to the specific requirements of this section (listed above or found in §Subpart F 101.91) insofar as your claim is truthful and not misleading.

CAN I MAKE A GLUTEN-FREE CLAIM IF GLUTEN IS PROCESSED IN MY FACILITY?

Yes. Ultimately what matters is that your product will not cause an adverse reaction in someone who has celiac disease. In that case, the FDA would test your product too see if it passes the standard for gluten-free products (<20ppm gluten)

If gluten is processed in a facility where you make your gluten-free product, your ability to make a truthful claim depends on how you are able to separate your product from gluten and eliminate any threat of allergen contamination between products. Generally, this can be achieved through following Current Good Manufacturing Practices and addressing any possible scenario where gluten-contamination of your product could occur.

If you are still unsure of your ability to make this claim, you may consider making the following claim on your product: "made with no gluten-containing ingredients". 

This term is not regulated according to the FDA requirements for gluten-free labeling (found in §Subpart F 101.91) and can be made insofar as the claim is truthful and not misleading.

AM I REQUIRED TO CONDUCT TEST FOR GLUTEN IF I MAKE A GLUTEN-FREE CLAIM?

No, you are simply responsible for ensuring your product meets the requirements for gluten free. A food processor may wish to test their product for gluten as a quality control measure but it is not required.

WHAT IS "CERTIFIED GLUTEN-FREE"?

Note that, while certification bodies exist, certification is not required to label your product as "gluten-free"

There are several private organizations that provide certification for gluten-free claims. It works like this: food businesses pay the certifying body to conduct certification activities. If the food business passes, then they can use the certifying organizations logo on their product.

These certification names and logos may provide some consumers with assurance that the product is safe to consume.


Examples of these certifying groups include:

• Gluten Free Certification Organization

• Celiac Support Association

• Allergen Control Group

Each of these programs dictates their own standards for certifying a product as "gluten-free" . This may include specific ingredient requirements, sending your product to the organization for gluten testing, and a facility inspection.

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References

To read the FDA Regulation on gluten-free regulations, see §Subpart F 101.91