Simplifying Food Regulation

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FDA Reader: Simplifying Food Regulation

Posts tagged incubator kitchen
Picking The Right Storage Containers For Your Shared Kitchen
 

Introduction to Shared Kitchen Storage

Your customers will probably want multiple options based on their business size

Your customers will probably want multiple options based on their business size

Storage can be a thorny area for shared kitchen operators. Food producers are typically interested in storing some combination of equipment, ingredients, and finished product onsite. Often, designated storage spaces are shared among multiple businesses. This requires the shared kitchen user to store their product in a set of containers.

This section is devoted to helping you find the best storage containers for use in a shared kitchen. It is informed by the FDA regulations, collaboration with health agencies nationwide, and the best practices I’ve observed in shared kitchens.

Or, you can skip to the FDA Reader List of Best Shared Kitchen Storage Containers.

Factors to Consider

Here are the major considerations:

  • Material

  • Size

  • Airflow

  • Secure

  • Compatibility with other systems

Material

Food Safe: The material for your storage should be food safe — presumably there will be some contact between raw food (or packaging) and the container it will reside in. Ideally, the container is NSF approved, but if not, you should be able to discern whether it is made from food safe materials by reviewing the product spec.

Strong: You want a material that is going to be strong enough to endure the abuse of a kitchen. These containers will be full of heavy items, slammed down on tables, and dragged across wire shelves. It should be strong and also capable of enduring the temperatures of a refrigerator or freezer. While I recommend using metal bun-cabinets for easy storage, the cold can burn your hands when it has been sitting at -10ºF.

Color: Finally, it’s worth considering the color of the container. Since these containers might crack and they will be in close proximity to food, it’s best to get a color that will easily stand out (like blue). This is not necessary, but if color is a consideration, pick blue, the best color for minimizing foreign object contamination.

Water/Rust Proof: The storage container is going to get dirty and require washing. If it goes in the freezer, it will get covered in ice. Pick something that won’t rust and that can tolerate a lot of moisture. Wood and cardboard are no-no’s. Plastic and certain types of metal tend to work best.

Shape/Size

There are a few considerations when it comes to picking a storage solution. Ultimately, the most important considerations are what you are actually storing. You’ll want to make sure that your storage containers don’t affect the product stored inside them.

Weight An oversized plastic tote might fit all of your ingredients and equipment with ease… but it’s impossible to lift onto the shelf. If your container will live on a shelf, then pick a storage container that you can comfortably lift when it’s full.

Shape Avoid shapes that will minimize the amount of usable space, such as a box with walls that taper. Make sure the containers that you choose maximize the total space available on the shelf or in the space where they will live. Remember, finding the right storage container is being realistic about what is being stored.

Vented

If your storage container is going to live in a refrigerated or frozen environment, then it needs to be vented. Refrigeration works by blowing cold air across the surface of the food items in the space. If food is stored in a solid-walled container — e.g. a typical plastic storage box— the container will insulate the food and prevent it from cooling down.

This is a problem. Airflow is important for cooling purposes. This is why milk crates are crates not solid walled boxes.

The storage container should be vented to allow air to pass through it and across the surface of the food inside.


 
FDA Registration For Shared Kitchens
 

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.


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.


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

An FDA Draft Guidance about Shared Kitchen Facility Registration

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.


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


 
Breaking Down Shared Kitchen Terminology
Shared Kitchens Ghost Kitchens Blog Post.png
 

Shared Kitchen? Cloud Kitchen? Ghost Kitchen? Commissary Kitchen? Black Box Kitchen? Incubator Kitchen?

Unfortunately, these terms are often used interchangeably throughout the food industry. Not only in news articles but in government regulation, there are a litany of confusing and inconsistent definitions.

Fortunately, they have one commonality: They refer to a food production space which includes some shared infrastructure across multiple businesses.

Some of these terms have a more specific definition or were created to reflect a particular context. The sections below are an attempt to sort this out so we can find consistency in this sector:

Shared Kitchen:

At it's broadest, this entails multiple food businesses operating in a single location which makes use of some shared infrastructure. This term encompasses all of the other terms described in the article and I favor it as the overarching industry descriptor for these business models.

Other equivalent terms include: shared-use kitchen, licensed commercial kitchen (LCK) and commissary kitchen. However, the term commissary kitchen or simply commissary may also refer to a large food processing space operated by a single tenant. For this reason, I prefer not to use this term to describe shared processing spaces.

Incubator Kitchen

This refers to a shared kitchen specifically designed for early-stage food businesses where the site management takes an active role in growing the tenant businesses. Adopting the term incubator from the tech industry, the term Incubator Kitchen implies that the management supports the entrepreneurs to refine their idea and their business model. This may include taking an equity stake in the fledgling businesses but not necessarily.

Incubator Kitchen ≠ Shared Kitchen

Incubator Kitchen is often mistakenly used interchangeably with shared kitchen, especially when the majority of tenants in a shared kitchen are early-stage businesses. However, this does not alone make the business an “incubator kitchen” and the use of this term is misleading when the site management’s offering does not actually “incubate” these businesses in any meaningful way.

There’s a second reason for this term’s popularity: “incubator” is a buzzy term from the tech-sector that people associate with rocket ship growth trajectories, venture capital, and million dollar buyouts. In other words, it’s good marketing.

Here’s an easy way to differentiate the two: the goal of an incubator kitchen is to develop and grow the tenant businesses operating in the space, not maximize occupancy. If the operator is measuring success through occupancy, they probably aren’t an incubator.


Ghost Kitchens, Dark Kitchens, Black Box Kitchens & Cloud Kitchens

For simplicity, I’ll use the term ghost kitchen throughout this section.

These terms all refer to the same thing: a food processing facility which has no dine-in retail component. Typically, all of the food produced in a ghost kitchen is delivered to the customer, often via a food delivery service such as Seamless, Grub Hub, or Deliveroo.

A ghost kitchen is not necessarily a shared kitchen — a single delivery-only food production space would still be a ghost-kitchen but not a shared kitchen. However, these terms overwhelmingly imply a cluster of ghost kitchens in a single location. And when those tenants make use of common infrastructure (such as refrigeration, dishwashing, or cooking equipment), then they would fall into the category of “shared kitchen".

Regardless of whether they fall under the “shared kitchen” umbrella, multi-unit ghost kitchens tend to be focused on delivery food service with restaurants making up the bulk of their users. The equipment and layouts of these kitchens generally supports this type of user although a food business not requiring a walk-in retail component (such as a small-scale manufacturer) could also operate out of this space.

Finally, it’s worth noting that Cloud Kitchens is also the name a of a prominent ghost-kitchen provided started by uber founder Travis Kalanick.

The Bottom Line

The shared kitchen industry is still in its infancy and the terminology continues to formulate. If you subscribe to a different definition than the ones provided above, that’s fine. However, it’s important to acknowledge that there is currently a lack of consensus on naming conventions and that while terms may be tossed around interchangeably, they can have a specific connotation.


 
HACCP Implementation in a Shared Kitchen Environment

HACCP Implementation in a Shared Kitchen Environment

Outgoing FDA Commissioner Gottlieb released his 2nd letter concerning the legal fate of Cannabidiol (CBD) in the last 6 months

Introduction

This paper examines the challenge of HACCP implementation in a shared kitchen context. The first sections aim to guide a shared kitchen operator in assessing whether they can accommodate user-managed HACCP programs in their facility. The second half of the paper offers recommendations for how a shared kitchen operator may align their operations to support HACCP implementation. These recommendations are also provided in the sections below.

Enter your email below to download the white paper, HACCP Implementation in a Shared Kitchen Environment

Table of Contents

  • Preface

  • A Quick Primer on HACCP

  • The Feasibility of HACCP Implementation in a Shared Kitchen

  • When is a HACCP Plan Required?

  • Liability

  • Recommendations for Shared Kitchen Operators

    • General

    • User Relationships

    • Operations

    • Facility Layout

    • Facility Maintenance

  • Conclusion


Recommendations For Shared Kitchen Operators

General

Comply with applicable regulations The first step in supporting HACCP programs is to comply with all applicable health regulations (federal, state, local). If there are outstanding health-code violations, the operator should consider addressing those first.

Understand HACCP Principles The simplest way to do this is to take a HACCP course (they are available online) and read through several HACCP plans. It is absolutely critical for an operator to have a thorough understanding of HACCP so that they can assess the plans and practices of shared kitchen users.


User Relationships

Appendix 1 lists commonly occurring process steps and hazards found in shared kitchens. Food processors can use this as a guide when building their hazard analysis.

Appendix 1 lists commonly occurring process steps and hazards found in shared kitchens. Food processors can use this as a guide when building their hazard analysis.

Set expectations with prospective users An operator should set clear expectations about how their shared kitchen may (or may not) be able to support HACCP implementation. A comprehensive tour of the space and candid explanation about how operations are conducted will support a prospective user in assessing the site’s suitability for their HACCP implementation. If an operator already has HACCP programs operating in their space, they may be able to offer more practical details about how those programs are effectively managed.

Assess each case individually Since each production process entails unique food safety risks and HACCP supports a risk-based approach, the shared kitchen operator must consider each prospective HACCP program individually. At minimum, the operator should consider the final product, the process steps and the associated hazards. Then, the operator will be able to assess whether effective HACCP implementation is feasible in their facility. Note that this oversight is meant to reduce the shared kitchen’s liability exposure, not to micromanage the user’s operations.

Protect public health and liability If a user is producing illegally without a HACCP plan or is implementing their HACCP program improperly, the operator should immediately suspend that processor’s use of the space until they are able to faithfully enact their HACCP program. This should not be viewed as punitive but rather as an effort to protect the shared kitchen and all of the users operating in the space.


Operations

Good news! HACCP is most easily implemented in shared kitchens where the operator has a “hands off” approach. Here’s why: HACCP requires the food processor to maintain tight control over their process steps and keep records proving that those processes were performed correctly.

If the shared kitchen operator provides services that are related to food safety— for example, cleaning processing areas on a recurring basis— the user working under a HACCP plan cannot (legally) trust that those activities are being performed properly. Instead, the user must confirm that those cleaning activities are effective and verify that they are being performed according to schedule and keep records to prove it. Maintaining this kind of coordination with the shared kitchen operator is sufficiently difficult that most users implementing a HACCP program choose to conduct all sanitation activities themselves— even if the operator is already providing those services. Below are some specific recommendations for building HACCP-aligned operations in shared kitchens:

Define who is responsible for maintaining prerequisite programs (PRPs) Operators should define who is responsible for maintaining prerequisite programs and share this information with users before they begin operating in the space. This way, both the operator and user understand what systems they are accountable for maintaining and where they can demand accountability. PRPs may be grouped into three broad categories:

Operator’s responsibility: This refers to prerequisite programs which the operator is responsible for maintaining and documenting. These programs typically favor centralized management, and may include:

◈ Pest control

When dedicated cold storage spaces are not available, lockable, vented totes can minimize contamination risks.

When dedicated cold storage spaces are not available, lockable, vented totes can minimize contamination risks.

◈ Maintenance of shared equipment

◈ Waste management

◈ Clean water supply

User’s responsibility: This refers to PRPs which the user must enact and maintain on their own. Typically, these programs are unique to each food processor and may include:

◈ Product traceability

◈ Supplier verification

◈ Food handling practices

Overlapping Responsibility: This refers to PRPs that may be maintained by both the operator and the user. For example,

◈ Control of employee health -- both the operator and user have employees who must comply with employee health policies.

◈ Allergen control -- The operator may control allergens through the structural zoning of space while users must maintain allergen control through their production process and storage methods.

◈ Sanitation activities -- The operator may offer a basic sanitation program while the user conducts additional sanitation activities on their own.

By defining responsibilities and enforcing accountability (even among their own staff), the operator protects the kitchen from a “tragedy of the commons” scenario where facility conditions deteriorate over time.

Allow users to retain process control Users should be allowed to pursue a high degree of autonomy so that they can maintain total control of their process and ensure their pre-requisite programs are effective. Any “concierge” services or prerequisite programs offered by the shared kitchen operator should be structured so that a business can “opt out” and conduct those activities themselves, according to their HACCP plan.

Make food safety records available: When the operator performs a prerequisite program related to food safety, a record of that activity should be produced and made available for users to access. This may include:

◈ Sanitation records

◈ Records of equipment maintenance and calibration

◈ Refrigeration logs

◈ MSDS records and product specs for all chemicals/consumables onsite

◈ Pest control reports

◈ Receiving logs (if raw ingredients are received by the operator on behalf of the user)

Strive for operational consistency and communicate changes A processor’s HACCP plan will define not only the details of their specific process but also details pertaining to the overall facility and the prerequisite programs applied by the operator. In the same way that a change to the business’s production process would require them to update their HACCP documentation, so would operational changes implemented by the shared kitchen operator at the site level.

While it is important for operators to continuously improve their systems, it is also important to acknowledge that each user’s HACCP documentation must reflect these changes once they occur. For this reason, the operator should communicate any upcoming changes to food safety systems with the entire user base. This will give users an opportunity to consider those changes and adjust their HACCP plans accordingly.


Facility Layout

Physical separation between workstations is a simple solution for minimizing cross contamination.

Physical separation between workstations is a simple solution for minimizing cross contamination.

The arrangement of workstations, storage, and utility areas in a shared kitchen can be optimized to support HACCP implementation. While it may be prohibitively expensive to undertake large scale infrastructure improvements, an operator may be able to address hazards in the facility layout by adjusting the use-of-space. Fortunately, HACCP is a flexible system that allows a processor to minimize hazards using any method that is safe and effective. An operator may consider the following strategies:

Offer dedicated access processing spaces If possible, an operator should offer dedicated-access processing spaces that a single business can occupy long term. This arrangement allows users to operate with high levels of process control, favoring a simpler HACCP program.

Use distance and barriers to minimize contamination risks in shared spaces If businesses operate in a shared space, an operator can structurally mitigate contamination risk through physical barriers (e.g. partitions) or a buffer zone between processing areas. Avoid layouts where prep tables are directly adjacent to each other and where cross contamination may easily occur.

Zone food processing and storage activities based on risk profile An operator may zone the space based on the types of risks presented by processing activities. This structurally minimizes opportunities for contamination. Types of zoning include:

◈ Allergen-based zoning: This may confine certain allergens to specific zones

◈ Hygienic zoning: Higher risk processing activities are confined to areas where higher standards of hygiene and sanitation are in place.

◈ Ingredient-based zoning: The use of certain ingredients are confined to specific zones, based on associated microbiological hazards

Offer dedicated-access storage spaces An operator may offer dedicated-access storage spaces to protect stored goods from interference or contamination. Possible solutions may include individually lockable storage closets or cages. In cold storage, dedicated reach-in refrigerators allow for individual temperature control, product security, and minimization of contamination risk from other users’ products.


Facility Maintenance

Implementing a HACCP program requires the food processor to assess any risk that may occur— including hazards that originate from the building itself. Even in a conventional food processing facility, it is common for the renter to assess a hazard that the only the building owner can repair, such as a leaky roof. In the shared kitchen environment, the user has even less control over facility conditions than a food processor operating in a conventionally rented space, and this may be the cause of some anxiety. Below are some ways that a shared kitchen operator can support HACCP programs through effective facility maintenance.

Conduct professional repairs Repairs should be conducted by professionals and DIY-fixes (e.g. duct-taped pipes) should be avoided. Because these types of temporary repairs may introduce a food safety hazard, users operating under a HACCP plan will be unable to use that piece of equipment until it is completely repaired and the hazard is eliminated.

Align facility conditions with cGMPs In order to create a safe environment for food processing, operators should meet the Current Good Manufacturing Practices outlined in the Code of Federal Regulations. Regardless of whether the users in the space are FDA-regulated, this section provides a widely accepted set of standards for safe food processing. Below are several linked guides and the original text of the regulation:

Additional Resources

FDA Reader Guides:

Plants & Grounds

Sanitary Operations

Equipment & Utensils

Regulation Summary

Source Texts:

Code of Federal Regulations §117 CGMPs

 
What You Need to Know Before Joining an Incubator Kitchen

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