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FDA Reader: Simplifying Food Regulation

Introduction to Participatory Guarantee Systems
 
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What is a Participatory Guarantee System (PGS)?

A participatory guarantee system is an alternative method for regulating standards of food production. A PGS can be easily understood by contrasting it with the traditional 3rd party certification system.  In that model, a food producer (e.g. a farm) aligns with a set of standards that have been defined by a government or private certification scheme. The farm’s implementation of these standards is enforced via an occasional audit which is conducted by a representative of the auditing firm.

Participatory Guarantee Systems were inspired by the early organic food producers of the 1970s and 80s who wanted to implement the standards of food production which we now recognize as principles of the organic movement. These pioneers in the sustainable foods movement developed their own standards and implemented a system of self governance based on participation, trust, and transparency. This framework is the model for the participatory guarantee system.

A participatory guarantee system (PGS) is a ‘locally focused quality assurance systems that certify producers based on the active participation of stakeholders and are built on a foundation of trust, social networks, and knowledge exchange’
— International Federation of Organic Agriculture Movements (IFOAM)

Participatory Guarantee Systems are not currently recognized as certification tools in the EU or the United States. However, PGS are recognized as comparable to 3rd party certification schemes in several Latin American countries and they are being assessed as a potentially viable alternative to 3rd party certifications.

Comparing Participatory Guarantee Systems and 3rd Party Certification 
Subject Area Participatory Guarantee System 3rd Party Certification System
Enforcement party Stakeholders A private auditing firm (or government agency)
Enforcement mechanism Continuous evaluation of materials, sites and practices through site visits and meetings Infrequent, scored audits
Consequence of repeated failure to achieve standards Removal from the PGS an dthe los of associated benefits (marketing and sales opportunities) Loss of certification
Themes Total transparency and universal accessibility of documentation.

Stakeholder participation in decision making and enforcement of standards
Confidentiality between food producer and auditing firm.

The food producers are non-participants in the creation of standards and the auditing process.

Assessing the Merits of the 3rd Party Certification System and its Impact on an Increasingly Self-Regulated Food Industry
 
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Introduction

My work as a consultant often entails teaching food manufacturers about 3rd party audits and supporting them to achieve certification so they can expand their sales opportunities. The story is often the same — my client has wholesale buyers lined up for their product, but the buyer won’t ink the deal until a 3rd party audit result is provided. While some clients can afford invest in the consulting fees and facility upgrades to meet achieve the private certification standards, other cannot make this investment. Their sales opportunities and growth will suffer until they can achieve that shiny gold star, the 3rd party certification.

This piece offers two claims about how the rising importance of private certification impacts the food industry. Under each heading, I explore some of the benefits and drawbacks experienced by various actors in the food industry, including food manufacturers, public health regulators, and consumers.


The private certification system has become the dominant mechanism by which food businesses are deemed sufficiently safe and high quality to be sold in mainstream markets.

At one time a government inspection report was a valuable indicator of a food manufacturer’s food safety and quality performance. Recently, the authority of these documents has declined while an audit report from a private certification body is a trusted symbol.

Pros: 

  1. 3rd party certifications are internationally accepted. Certification schemes transcend jurisdictional and national boundaries, creating global recognized standards of food safety and quality. This means that a food retailer with a catalog of international suppliers can verify the quality of their suppliers’ products without having to understand the food regulations of the country of origin. Instead, they simply ask their suppliers to align with one of the top certification schemes. This is an enormous convenience for wholesale buyers, who can trust 3rd party certification as a uniform standard of product quality, regardless of  the country of origin. 

  2. A food manufacturer can request and pass a 3rd party audit on their own schedule. If a beverage manufacturer is confronted with a huge sales opportunity that requires a 3rd party audit, they could feasibly schedule the audit, pass the audit and present that documentation to their retail partner in a matter of weeks. On the other hand, a food manufacturer may only be inspected by the FDA every few years. A well-established food producer may not have a government-issued inspection report when a prospective buyer requests it, or else the inspection report may be old enough that the buyer refuses to accept it.

Cons: 

  1. The central role of the 3rd Party Certification System creates a pay-to-play system. Procuring an expensive certification from one of several private certification schemes is a de facto requirement for selling food in mainstream markets. Whether supplying food to a major supermarket, a hospital, a university cafeteria, or a specialty outlet such as QVC or an airline caterer, these buyers will uniformly require 3rd party certification from their suppliers. A food manufacturer which is unable or unwilling to pay-to-play sacrifices the opportunity to participate in these major markets.

  2. A food manufacturer whose operations meet FDA requirements may still have to spend tens of thousands of dollars to achieve the exalted standards of the 3rd party certification scheme. Achieving 3rd party certification comes at a cost. While the audit itself may cost several thousands of dollars (by contrast, FDA registration and inspections are free), preparing for an audit will easily cost cost tens of thousands of dollars in consulting fees and facility upgrades.  This disproportionately hurts small-to-medium food producers and translates to higher food costs for consumers.

The dominance of the 3rd Party Certification System is contributing to a self-regulated food industry

Pros of Industry Self-Regulation: 

  1. The FDA cannot possibly keep up with the task of protecting the nation’s food supply. Despite a wealth of corrupt incentives, private-sector oversight generally supports the preservation of public health.  

  2. The standards set by 3rd party certification schemes typically exceed the standards published by government health agencies (e.g. the FDA). In turn, higher standards can translate to better consumer protection mechanisms and public health outcomes. 

  3. The private sector is a more effective enforcer of food availability than the government. For example, despite the clear illegality of CBD as a food ingredient, the FDA is entirely incapable of keeping CBD-containing items off of shelves. However, when Whole Foods implemented a no-CBD policy in September 2018, the products vanished from all store shelves.

Cons of Industry Self-Regulation:

  1. Industry self-regulation creates corrupt incentives (Ahem, financial collapse of 2009).

  2. Certification bodies (auditing firms) are supposed to be the referees, but their incentives are misaligned. When a certification body audits a food business, they are paid for that audit. If the firm passes the initial certifying audit, then a subsequent yearly audit is required for that food business to maintain certification with the scheme. By providing a passing score to an audit, a certification body nearly guarantees future income from subsequent audits — after all, why would a food business switch auditing firms if their current auditor is giving them passing grades?

    At the same time, the certification bodies have a negative incentive for providing a failing audit score — A food manufacturer would likely pursue the same audit from a different firm in hopes of finding a more lenient auditor who will provide a passing score.

  3. Individual certification schemes also face corrupt incentives — namely to stoke public uncertainty about the food supply and to build a massive food-safety-complex which further entrenches the necessity of private certification schemes and consultants.

    One way food certification schemes preserve their place in the food-safety-complex is by continuously updating their standards. The rhetoric here typically emphasizes the changing science of food safety and need for industry to align with these findings. The schemes don’t disclose the actual impact of these changes in terms of public health because they don’t have to —  both retailers and consumers are quick to accept any marginal improvement in our food supply. But, while a new food safety standard will be heralded as a landmark contribution to improved public health, the actual change might only take a tiny fraction of the food supply from “very safe” to “very very safe”.

    The impact on the food industry is less murky: food manufacturers have no choice but to upgrade their operations so that they can maintain their certification and their place on supermarket shelves. This may require hiring an “official” consultant dispatched by the certification scheme or additional audits to confirm that the latest standards have been faithfully implemented. These costs — easily tens of thousands of dollars per manufacturer — filter back up to the certification scheme.

    “Upgrading” their standards is the easiest way for a certification scheme to inject capital into their business and preserve their continued existence in the food industry. And over time a convenient macro-trend emerges: the standards of private and public regulations continue to diverge — with the private certification schemes requiring a much higher set of food safety and quality standards than the government.

    All else aside, when confronted with the choice between “more safe” and “less safe”, the consumer will always demand “more safe”. But it’s impossible to compare the two frameworks without a consensus about what is safe food?  Would you add a dollar to the price of yogurt if it meant reducing the chances of sickness from 1 in 10 million to 1 in 100 million?  The self-regulated food industry may have already made this choice for you. You’ll pay the extra dollar for the extra-safe yogurt because the supermarket refused to carry the “less safe” brand which only offers a 99.99999% assurance of product safety. Is this a valuable protection of public health or a sign that self-regulation in the food industry has gone too far?


 
 

Glossary of Terms:

Certification Scheme - The companies that write and maintain private certification standards (e.g. BRC, SQF)

Certification Body - the auditing firm which actually conduct the audit. An auditing firm may serve as a certification body for multiple certification schemes so that they can provide the type of certification that their client is seeking.

Keep Reading


How to Legally Sell CBD-Infused Foods
 
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Contrary to popular belief, Cannabidiol (CBD) does not exist in a legal gray zone. In fact, the regulations surrounding cannabis and CBD are clear, and for food producers looking to get into the market, there’s good news: There may be a legal route for selling CBD infused foods, supplements, and cosmetics, even if recreational cannabis use is not legal in your state.

Here are some guidelines about how to stay between the lines when it comes to selling CBD food products:

Verify Your CBD Ingredients

The 2018 Farm Bill legalized hemp as an agricultural commodity. This means it’s legal to possess, grow, sell, and transport hemp throughout the country, just like corn or sugar. Here’s the catch — it has to have a THC content of <0.3% and be hemp derived. Most importantly, it’s your responsibility as a food manufacturer to make sure your hemp- is compliant.

Tip #1: Only use CBD which is hemp-derived and with a THC content of below 0.3%. If you are sourcing CBD to include in a food product, it’s important that you work with reputable suppliers so that you can ensure your CBD ingredients are indeed legal. If your CBD ingredient exceeds the THC threshold then the ingredient will be classified as a Schedule 1 substance and your business could face serious legal repercussions. You may wish to request a certificate of analysis from your CBD supplier or consider sending out a sample of the product to a lab yourself.


Avoid FDA Oversight

At this point, the FDA has been very clear that CBD is not a legal ingredient in foods, cosmetics, and dietary supplements. However, FDA jurisdiction doesn’t cover all foods, so it’s possible to avoid FDA jurisdiction and legally sell CBD food products. Here’s how you can avoid falling under FDA Jurisdiction (Or check out our comprehensive guide to FDA Jurisdiction)

Tip #2 Sell CBD at your food service establishment. The FDA doesn’t regulate foodservice businesses — for example, food trucks, restaurants, and other places where food is served to customers for immediate consumption. These businesses are typically regulated by local health departments, most of which don’t explicitly disallow CBD as a food ingredient (see below). This is potentially good news for a cafe owner seeking to add CBD products to their menu. However, it doesn’t mean that a food manufacturer can avoid FDA jurisdiction merely by selling to food service establishments.

Another major factor which would trigger FDA jurisdiction is interstate commerce. This means that if you sell your product to a buyer which resides in a different state, then the FDA has jurisdiction over your food business.

Tip #3: Sell In-State. Limit the sales of your product to the state where you’re producing the product. This doesn’t mean “no ecommerce” but it does mean limiting your ecommerce to in-state buyers. Whether your customers are wholesale buyers or retail consumers, make sure they’re in-state.

Tip #4: Source In-State. If your product contains ingredients or packaging that was sourced from out of state, then your product has technically already entered interstate commerce, even before you assembled it. This gives a near-total breadth to the’s FDA jurisdictional claim since few items are 100% composed of ingredients sourced in-state. However, the FDA is unlikely to assert this broad of a jurisdictional claim. Bottom line: source your ingredients in state

Tip #5: Avoid making claims about the health benefits of CBD. So far, the FDA has only gone after CBD products which make claims about the health benefits of CBD. Avoid making any claims on your product label, marketing materials, or even your website — about the healing powers of CBD. Even if the claim is delicately worded “CBD may treat…”, it can still cause problems. Here are some examples of problematic health claims that the FDA has struck down:

“Cannabidiol may treat depression”

“CBD may be used to avoid or reduce withdrawal symptoms.”

“Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling."

“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”


Understand and Follow The Local/State Laws

Even if you are able to strategically avoid FDA oversight, food production and sales will still be regulated by the local or state government.

Tip #6: Confirm your local or state jurisdiction has no specific regulation against CBD in food. Most jurisdictions have not specifically regulated against CBD as a food ingredient. However, if you are producing a CBD food product, it’s best to confirm this yourself before you receive an inspection from local health agencies. If CBD is an unlawful ingredient in your jurisdiction, then the health authorities may have the power to recall or quarantine your products. Here’s how you can figure out whether CBD is allowed for use in food.

  • Search online for the health code which governs food processing and see if CBD is among ingredients which are explicitly banned. Often the state regulates food processing and the city/local government regulates restaurants and each agency will have their own health code.

  • Confirm that your state/local health dept. doesn’t automatically operate under the FDA regulations. Some states, in order to avoid the hassle of writing and maintaining their own health regulations, merely adopt the FDA regulations as their own. You can find this out by searching online for the state/local health code. If your region adopts the FDA code, then this will be stated prominently at the beginning of the code (and it’ll be a short health code)

  • Call the health dept yourself and ask whether CBD is banned in food. This should be a last resort because, even if there’s no law to support it, the health dept will say that CBD is disallowed— this is because they want to avoid the hassle of dealing with this type of complexity Most CBD food businesses would rather quietly permit and operate their business and handle issues with the health dept if and when they appear organically.’’

Tip #7: Follow Industry-Standard Practices. If you producing and selling a CBD-infused product, you probably face more scrutiny than food products with less controversial ingredient compositions. Demonstrate your commitment to food safety and manufacturing standards by following the general health-code rules that apply to your product. If you’re creating a food product, this means operating in a suitable facility, following industry labeling standards, and following the local health dept regulation.

Have any questions? Email info@fdareader.com


How to Pass Quality Assurance and Get Your Product Into Major Retailers
 
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It’s More Than Winning Over the Buyers

What is Quality Assurance?

At a food retailer, the QA team is responsible for maintaining the quality and safety of products sold by that retailer. In the case of a supermarket, this would include products sourced from suppliers, products made through contracted manufacturers, and even ready-to-eat food prepared at the onsite deli. The QA Team conducts quality inspections, handles food recalls, and conducts supplier verification.

The Quality Assurance team may be the reason your food product doesn't make it into major retailers and distribution chains. This would happen if you are unable to prove that you are following industry-standard practices. For this reason, it's important to understand what your purchaser's QA Team is looking for and how to work with them so that you can get your product onto retailer shelves and grow your sales.

Even after a major buyer has pledged to place an order, there’s another hurdle before you can start selling your products to a new retailer: The Quality Assurance (QA) Team.

The QA team’s job is to uphold quality standards and protect the company’s reputation. They evaluate hundreds of prospective (and current) suppliers to determine whether their products meet the company’s quality and safety standards.

They are the gatekeeper for all new products and if the product doesn’t pass quality assurance, then the retailer won’t risk carrying that product.

Don’t let this frighten you. The QA team has no incentive to arbitrarily reject new suppliers and they are often willing to work with new suppliers to help them pass QA and get their products onboard.

Before we go into strategies for working with QA teams, let’s review how the process typically works.

How QA Teams Approve Suppliers

After the buying team expresses interest carrying a new product, the QA team steps in to conduct some due diligence about the supplier.

The QA team will typically email the prospective supplier requesting information, such as a third party audit result or records showing your company’s food safety practices.

After, there may be some back-and-forth with your contact on the QA team. This depends on your company’s ability to provide the requested documents and demonstrate the safety and quality of your product.

Finally, the QA team will either give your products a “pass” or they will delay the company’s purchase of your products until you can achieve specific requirements.

With this in mind, having a positive relationship with your a prospective buyer’s QA team can mean the difference between winning a huge account or not. To stay in their good graces, consider the following tips:

  1. Before asking a question or requesting a piece of material from the QA team, check and see if it’s available on the company’s supplier facing website.

  2. Avoid asking them to explain food safety concepts or regulation to you. Instead, look it up on FDAreader.com or, if we’ve failed you, then google it.

  3. Fill out all forms and documents as completely as possible and provide all requested documents.

  4. Collate your submissions a minimum number of attachments and present it in the most straightforward possible manner. Your QA contact reviews thousands of these documents per month and will appreciate your efforts towards clarity.

  5. Be honest. The QA team doesn’t demand perfect manufacturing programs as a prerequisite for approval and they appreciate when suppliers are honest about their process.

What the Quality Assurance Team is Looking For

QA teams want a supplier who presents them with a straightforward case about “why our product’s safety and quality is not worth worrying about.”

The most compelling evidence is a third party audit result— which reads like a physical exam for your company’s food safety practices. In the absence of that, a thoughtfully compiled and organized set of food safety policies and records can signal that your business is serious about food safety. Ultimately, the QA team will describe their needs — and it’s important to listen. Dozens of times, I’ve been able to get my clients’ products into new retailers despite their inability to meet the “official” supplier qualifications. All I did was follow the instructions we were given, provide the documents that we were able to come up with, and present it in an easy-to-read format.

Honesty is the Answer (Even When the Truth is Imperfect)

When confronted with a shortcoming in my clients’ food safety practices I have found that honesty is the answer. Specifically, I candidly explain the current state of that food safety issue and how the supplier is working to fix it. The following anecdote from my consulting career illustrates how this has worked in my favor:

One time, a distributor hired me to fix some trouble they were having with a nationwide supermarket chain. The supermarket had already been selling the distributor’s product for almost a year but the distributor was ignoring all of QA team’s emails. Eventually, the supermarket’s buying team threatened to halt all business with the distributor unless they responded to the QA team’s requests, and so the distributor hired me as a consultant to sort it all out. I quickly put together a basic food safety plan— a set documents showing how the distributor managed food safety across their operation— and sent it off to the supermarket’s QA team.  

The QA manager who was reviewing the documents noticed a problem and called me. He explained that, while the warehouse operation looked safe enough, the distributor didn’t have any evidence that the actual foods they were buying were safely manufactured. In other words, he pointed out that the distributor hadn’t done any supplier verification. He was 100% right and this could have been a deal breaker for working with the distributor.

I took a deep breath and told him the truth— that the distributor hadn’t verified the safety of any of the foods in their catalog prior to hiring me that week. I had just begun sending out requests to the distributor’s suppliers a few days before. So far only one supplier of ninety had responded. I sent the QA manager an overview of how I was beginning to implement a supplier verification program on behalf of the distributor. I also shared the records showing we had collected information from and approved one supplier. Then I waited.

To my surprise, the QA manager was grateful for the honesty and he approved the distributor to continue supplying the supermarket. We were able to organize a timeline by which the distributor would verify all of their suppliers over the course of several months and communicate this to the supermarket.

In my experience, displaying honesty— even about imperfections in my client’s food safety program— actually instilled a greater confidence in the program overall. QA teams are constantly being lied to (I’m sure they don’t like it) and they are quick to acknowledge that even the best suppliers have imperfect programs.

So how should you approach working with a new purchaser and their QA team?

  • Figure out exactly what they want and don’t waste their time

  • Be honest about where you can and and can’t meet their expectations

  • Present your documents in an organized fashion.


Understanding Date Labels
Forget everything you think you know about expiration dates.

Forget everything you think you know about expiration dates.

What You Need to Know:

  • Date labels have nothing to do with product safety — they indicate quality.

  • A date label should show the last date of expected peak quality.

  • The recommended wording for is “Best if Used By”

  • The FDA doesn’t require a date label on any food products except infant formula.


Introduction: 

The American food consumer is misreading date-labels and mistakenly throwing out $32 billion dollars worth of food because of it. The FDA is trying to minimize food waste and so they are providing specific guidance to manufacturers about how to write date labels and guidance to consumers about how to interpret them properly.


How to Read a Date Label

What does a date label mean? 

A date label on a food should indicate the last date where the food maintains peak quality and flavor. Date labels are meant to reflect quality not food safety.

A Best-if-Used-By Date “indicates to the consumer that the product may not taste or perform as expected but is safe to be used or consumed”

Wording is inconsistent and confusing to consumers

Wording is inconsistent and confusing to consumers

Can I eat a food after the “expiration date”?

Yes! This is because it’s not an expiration date. A food which doesn’t show signs of spoilage after the specified date can still be eaten. 

Remember that food manufacturers have an incentive for you to only consume products in their “peak quality” because then you will buy their products more often. 

How do I know when a product is unsafe to eat? 

Major food industry groups have endorsed the use of “Use By” to indicate when a product should be discarded for food safety reasons but, as of 2019, the FDA hasn’t taken a stance on this topic.


How to Write a Date-Label

What wording should I use For my Date Label?

The recommended terminology is “Best If Used By”. This indicates that the date is an indicator of quality, not food safety.

The FDA recommends not using words like “sell by” or “expires on” because this obscures the meaning of a date label.

How do I pick a Best-If-Used-By date for my food product? 

Food manufacturers can collect this information by either conducting tests themselves to assess quality. You can do this by storing multiple versions of your product in the recommended storage condition and then tasting them at various time intervals to assess the point when quality begins to decline.

It’s important that you don’t produce, package or store these test-products any differently than you normally would. Finally, your Best-If-Used-By date should pass before any sort of decline in product quality.

You can also enlist a reputable testing lab to conduct testing on your behalf.

Since best-if-used-by dates are an indicator of quality, it’s important that your product is safe for consumption well beyond the date you print on the label.

Do I need to change my packaging If I am not aligned with these Standards?

No. The FDA is trying to minimize confusion to consumers and food waste nationwide. These guidelines won’t be enforced by the FDA — they are simply setting a standard for the industry to adopt.

Should I remove the date label from my product?

You can, but many retailers and some local agencies have their own requirements for printing a “use-by” date of some type. Your best bet is to adopt the FDA-approved wording and print a use-by date that you can stand behind.

Do I need a date label if my product is non-perishable?

Not to satisfy FDA standards (only infant formulas require a “use by” date.) However, large retailers may require a date label on all foods they carry, so it’s worth building the capacity to print date labels, even if you don’t use them at this time.


 
Introduction to Good Manufacturing Processes (GMPs)
This article supports food producers answer the question, “What are GMPs?”

This article supports food producers answer the question, “What are GMPs?”

Introduction to GMPs

Good Manufacturing Practices (GMPs) are the set of production standards that have been embraced by regulators, retailers and consumers in the food and drug industries. 

GMPs provide a basic assurance that a product was produced under industry-standard conditions. Some of the areas addressed in GMPs include:

  • Building & facility conditions

  • Equipment design and maintenance

  • Employee practices

  • Sanitation conditions

  • Raw ingredient sourcing

  • Maintaining strong production controls

  • Records and reports


There are several sets of GMP standards which have been endorsed by different governments. Fortunately although they are nearly identical. Some versions of GMPs include:

  • CGMP* (food) addresses the production of food for the US.

  • CGMP* (drug) addresses the production of pharmaceutical drugs for the US

  • EU-GMP addresses the production of pharmaceutical drugs for the European Union

  • Guide 104 GMP addresses the production of pharmaceutical drugs for Canada

If you are considering aligning your business with GMPs, adopt the set of standards that reflects where your processing is located and where your product will be sold. If this includes more than one set of GMPs, you will want to make sure your operations are aligned with both. Again, they are nearly identical.

*CGMP stands for “Current Good Manufacturing Practices” and is regulated by the FDA.

Food vs. Drug GMPs

In the United States, the FDA defines two distinct sets of GMP standards — Food and Pharmaceutical (Drug).

Food CGMPs: These describe the “methods, equipment, facilities, and controls for producing processed food.” (FDA, 2004). These are meant to ensure that the food is safe to eat.

Drug CGMPs: These assure “the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations”. (FDA, 2018).

The sections below reflect the GMP requirements for food.

Understanding the GMP Certification Process

After a food manufacturer aligns their operations with GMPs, they may consider going through the certification process through a private auditing firm. This is how the certification process typically works:

  1. A manufacturer adopts the GMP standards and makes the required adjustments to align with the standards. Depending on the preexisting practices and conditions, this could take 3-12 months.

  2. The manufacturer chooses a private auditing firm (there are many) to conduct the GMP audit.

  3. The auditing firm conducts the audit, which may include an inspection of the facility and a review of records. 

  4. The manufacturer will correct any areas of non-compliance and, if they achieve a passing score, they will receive a certificate from the auditing firm.

  5. The manufacturer can provide this certificate to prospective buyers as an indication of their alignment with industry standards.

Why You Should Align Your Operations with GMPs

Regardless of whether your business chooses to pursue certification, aligning your operations with GMPs will have the following benefits:

  • Decrease in food safety risk to your customers

  • Lower level of product defects

  • When your buyers conduct supplier verification activities, they will want to want to know that your operations are GMP-aligned — even if you’re not certified


The Benefits of Achieving GMP Certification

  • It will unlock access to the many buyers who require GMP certification from their suppliers.

  • It will satisfy most supplier-verification requirements — meaning less back-and-forth between your team and the companies you sell to.

  • You will have an advantage over competitors who haven’t been certified to this industry standard.

GMP Requirements

For a detailed set of FDA-aligned GMP requirements, see our comprehensive guide to GMPs

Or, you can learn about the individual good manufacturing practices by topic:


 
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.

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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

 
Introduction to the FSMA Produce Safety Rule

Introduction to the FSMA Produce Safety Rule

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Introduction

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

It includes six requirement areas, which are described below:

  • Agricultural Water

  • Biological Soil Amendments

  • Sprouts

  • Domesticated and Wild Animals

  • Working Traning and Health and Hygiene

  • Equipment, Tools, and Buildings

Exemptions

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



Requirement Areas


Agricultural Water:

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

Requirements for Water used in Produce Processing 

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

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

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

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

Requirements for Water used in Growing Produce

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

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

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

What Happens When You Receive a Failing Result?

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

  • Treating the water supply

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

  • Using washing or other commercial activities to reduce microbe levels

Testing Water Supply

This section describes testing requirements based on water source.


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

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

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

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

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

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

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

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

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

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

Biological Soil Amendments (e.g. Compost)

Use of Raw Manure:

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

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

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

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

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

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

Stabilized Compost:

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


Sprouts

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

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

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

  • Environmental testing for Listeria.

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


Domesticated and Wild Animals


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

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

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

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


Worker Training, Health and Hygiene

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

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

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

  • Training farm workers to safely handle produce.


Equipment, Tools, & Buildings

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

  • Design and construction requirements

  • Recommendations for toilet and hand washing facilities

  • Pest control

  • Maintenance of sewage systems

  • Plumbing requirements

  • Waste disposal requirements 

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


 
How to Understand a Food Recall

How to Understand a Food Recall

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

You are probably overreacting when it comes to food recalls. When an FDA food recall is issued, most people interpret it to mean “that food isn’t safe. I should stop buying it in grocery stores and eating it in restaurants.”  This is an understandable and cautious reaction, but it is completely unnecessary. Coupled with media-fueled fear mongering, it can lead to “food scares” which can shatter industries and wipe out small businesses and farms which played no part in causing the recall. Here are a few things to consider when you hear about an FDA food recall.

The Scope of a Food Recall is Much Smaller Than You Think:

When a recall notice is recalled, it typically refers to a single batch of product created in one factory under a single brand. The batch details are listed in the recall notice released by the FDA, although the media won’t likely include this detail when they report it. Let’s use the recent recall of Pilsbury Unbleached All-Purpose Flour(5lb) as an example: only lots 8 292 and 8 293 of Pilsbury Unbleached All-Purpose Flour(5lb) were suspected of being unsafe and therefore were recalled.

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With that in mind, consider the following:

  • It’s probably unsafe to eat Pilsbury Unbleached All-Purpose Flour(5lb) labeled with lot code 292-8 or 292-9. That’s it.

On the other hand:

  • It’s safe to eat all other lots of Pilsbury Unbleached All-Purpose Flour 5lb

  • It’s safe to eat any other type of Pilsbury flour (there’s probably no safer time, in fact)

  • It’s safe to eat any other Pilsbury product

  • It’s safe to eat all other brands of flour

Unfortunately, most people who read the news will gloss over the details and simply stop buying flour or pilsbury products for a few months. The impact of this “food scare” may be sufficient to shutter smaller producers who, unlike Pilsbury ,may not be able to weather the dip in sales until public confidence is restored.

How “Food Scares” Occur

Of the Last 25 FDA Food Recalls (2019):

  • 14 were due to labeling errors.

  • 9 were due to the possible presence of illness-causing bacteria

  • 2 were related to the possibility of a foreign object in the food (soft plastic in one case, unknown in the other)

It’s rare that an entire group of foods (e.g. cantaloupe) is recalled. When this does occur, it’s in response to a widespread foodborne illness outbreak. The general nature of the recall is a reflection that investigators are still working to figure out the exact source of the problem. This type of urgent warning is always temporary, although the reverberations may harm those industries for years.

Let’s say that hospitals in three midwestern states have seen an unusual spike in Salmonella cases. Epidemiologists would use patient tests to see the if cases are related and also interview the patients to see what they had been eating. Eventually, they will be able to identify the commonalities in cases and determine use statistical analysis to determine that cantaloupe, for example, was the food to have caused the outbreak. 

Normally, epidemiologists would continue investigating and, by understanding where the victims shopped and ate, be able to trace the supply chain to a particular processing plant. Rarely, illnesses are reported at a faster rate than epidemiologists can trace the problem. If an atypical number of hospitalizations related to salmonella continue to be reported with cantaloupe as the likely culprit, public health officials may be forced to go public with whatever information they have collected at that time —  if only to stop the spread of illness. 

At worst, this will be a food-wide recall, which may recommend consumers in those midwestern states to discard and avoid eating all cantaloupe for fear that it is contaminated with salmonella. This sort of alert can be effective in curbing new cases of the illness outbreak, but it also prompts sensational media reports. This can create a “food scare”, where consumers who are not necessarily exposed to that risk (i.e. outside of those midwestern states where the danger has been identified) forsake cantaloupe in the misguided notion that they are preserving their safety. This can cause financial hardship for cantaloupe farmers globally and tarnish the reputation of the entire industry for years.

Ultimately, the epidemiologists will trace the illness to a farm or processing center and the scope of the recall will be narrowed to only concern the cantaloupe which is bears some risk to the consumer. But the resulting food scare may sink those small farmers who can’t weather the lasting decline in sales. They are unfortunate, collateral damage caused by a negligent food processor, sensational reporting, and misguided consumers.

Most Recalled Foods Are Still Safe to Eat

Most recalled food items won’t actually make you sick. In fact, 56% of the FDA food recalls so far this year were based on labeling errors. Here are two common scenarios where a labeling error would lead to a recall:

In one scenario, the manufacturer accidentally put coffee ice cream in the container labeled Strawberry Ice Cream. Here, a recall is required because the nutrition label and ingredients list — which are heavily regulated—  don’t match the product inside the packaging. From the perspective of the FDA, this is no different than a manufacturer lying about the ingredients in their product, so a recall is typically initiated.

A second common cause of recalls is due to “undeclared allergens”. This means that the manufacturer failed to state a major allergen that their product contains. For example, Bachman pretzels recently recalled a batch of their product for failing to state that it “Contains Milk”.  For the small group of people who are allergic to milk, this failure to disclose the allergen in the product could trigger an allergic reaction. This recall is important because someone with a milk allergy wouldn’t typically avoid pretzels and so the allergen declaration is a critical measure of consumer safety. For most people however, the presence of an undeclared milk allergen would not pose a health hazard.

You Are Unlikely To Get Sick Even If You Consume A Recalled Food

The complexity of our food systems and scope of supply chains present a statistical unlikelihood that you will become sick from a product implicated in a reported food recall. The following hypothetical aims to illustrate this point:

Recall Illustration (3).png



 
Environmental Monitoring in Food Processing

Introduction: Environmental Monitoring Program

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As food processor’s grow and face increased scrutiny from auditors and inspectors, they begin to wonder about environmental monitoring and whether they should implement this type of program in their facility. This section aims to answer those questions.

What is environmental monitoring in food processing?

Environmental monitoring is a process used in facilities that produce ready-to-eat (RTE) foods that assesses how effectively the plant is being cleaned.

This typically means swabbing various surfaces (e.g. cutting blades, tables, conveyers) for pathogens and sending those samples out to a lab for analysis. 

The goal is to determine whether any pathogens (e.g. listeria, salmonella) are living in facility and to respond accordingly if a positive result is found. 

It’s important to recognize that a clean test result doesn’t confirm that your food is safe, rather it verifies that your cleaning processes are effective. 


Do I need an environmental monitoring program in my food facility?

Legally, the FDA leaves this decision up to the food processor. GFSI-aligned 3rd party audits typically require environmental monitoring programs to be in place for producers of ready-to-eat food that are exposed to the environment post-kill step.

An easy way to determine whether you need an environmental monitoring program is to answer the following questions (a “yes” would suggest that you may need one)

  1. Does your process have a kill-step (e.g. cooking)

  2. Is your product exposed to the environment after the kill step and before packaging?

  3. Is your product a collection of ready-to-eat products combined to produce a ready-to-eat food that doesn’t include a kill-step?

  4. If your product is refrigerated, is it one that is conducive to the growth of listeria monocytogenes (e.g. deli meat, raw cheese/milk, seafood, sprouts)

Because ready-to-eat foods are typically not processed by the consumer before consumption, it’s important to know that there’s no chance they might be contaminated by pathogens in an unclean facility.

While testing the product itself can may inform you about the safety of that sample, testing the facility verifies that your cleaning activities are working and that each batch is being produced in a pathogen-free environment.


Am I ready to implement an environmental monitoring program?

If you’ve already confirmed that you should have an environmental monitoring program, consider the following questions before diving into a plan:

  • Do you have a thorough sanitation program? Your environmental monitoring program is a test of your cleaning, so if you have doubts about the thoroughness of your sanitation practices, address those first.

  • Do you have the resources to enact it faithfully? Once you launch your program, it’s important to follow it. If you doubt your ability to adhere to the program you’ve created or respond appropriately to a test result, then you should address those gaps prior to implementing the program.


What pathogens should I test for in my environmental monitoring program?

The most common pathogens which can be found living in the nooks and crannies of a facility are

  • listeria monocytogenes

  • salmonella

  • E. coli.


You may test for these directly or indicator microorganisms that represent each pathogen.

Additionally, you may conduct environmental monitoring for specific allergens to confirm that there is no allergen residue in your space. This would only be a consideration if you were processing both allergen containing and non-allergen containing products on the same equipment.


What does an environmental monitoring program actually consist of?

Environmental monitoring program typically includes the following components:

  • A risk assessment of the hazards you’ve identified: Looking at your ingredients and the nature of your operation, you should be able to identify the specific pathogens that may exist in the environment. You may have started this in your hazard analysis.

  • Your methodology

    • A map of your facility separated into hygienic zones (e.g. Zone 1 is the highest risk part of the production process and Zone 4 is the office)

    • A process for exactly how you will collect your samples 

    • A description of how often you will conduct your environmental monitoring (see below)

    • A description of where you will swab. These should be the highest risk areas where bacteria may be hiding and could get into your product.

  • A description of how you will have the tests analyzed (most likely by an external party, but it also may be in an in-house lab). You must list the specific lab conducting the analysis and confirm they’re properly accredited.

  • Corrective Action procedures, i.e. how you will respond if you receive a positive result.


How often should I conduct environmental monitoring? 

The frequency of environmental monitoring is determined by your process and the hazards you identified in your hazard analysis.

Raw Foods Example: Let’s say your facility produces snack packages of raw carrots and ranch dressing. Since the product will be consumed raw, you’ll want to have extremely high standards of hygiene in your space. After conducting initial, pre-operation environmental monitoring, you may choose to conduct monitoring activities weekly in high risk zones (e.g. blades, conveyers, tables) and monthly in lower risk zones  (walls, floors, drains). Ultimately, the decision of “how often” is up to you — you simply have to be able to justify that your frequency of sampling and testing is sufficient to determine that your sanitation efforts are effective.

Still not sure? Consider researching industry standards for environmental monitoring in plants producing products similar to yours. Start with that and then you can use historical data from your own site once your program is operational.You may only have to conduct environmental monitoring one time, such as when you move into a new facility and after you’ve completed a deep clean. This result would just be to confirm that you’re starting with a clean, pathogen-free space.


What happens if a pathogen is discovered in the test result?


If you get a positive hit in your environmental monitoring you will enact the corrective actions you’ve outlined in your plan. Depending on the type of result received, this may include re-cleaning, re-testing, holding product, and possibly a product recall. Check out This article to learn about hygienic zoning in an EMP and developing corrective actions


 
5 Things We Learned From the FDA Update on CBD Foods

5 Things We Learned From the FDA Update on CBD

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

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

Earlier this year I wrote an article in response to FDA Commissioner Scott Gottlieb’s update on the regulatory status of CBD. As I explained, despite the passage of the 2018 Farm Bill (which legalized hemp as an agricultural commodity) CBD is still illegal as a food ingredient under FDA regulation.

Alarmed by the widespread misinterpretation of the 2018 Farm Bill and the FDA regulations concerning CBD,  the outgoing FDA commissioner released another statement on April 2nd, 2019.

Here’s what we learned:

  1. The FDA Is Targeting CBD Products Which Make Drug Claims

The FDA appears most concerned with CBD-product manufacturers who make claims about the ability of CBD to cure or treat disease (aka ‘drug claims’). They have issued warning letters to several brands of CBD foods, including Relievus, Nutra Pure, and PotNetwork for illegally stating the therapeutic affects of CBD without sufficient evidence and the required FDA approval. These companies have made unsubstantiated claims related to CBDs ability to treat addiction, alzheimer’s disease, tumors, cancer, among other ailments.

The imminent concern of the FDA is this: a consumer reads those drug claims and purchases a CBD product to treat a serious health ailment. If this individual chooses to treat their disease with CBD over a drug whose effectiveness has been endorsed by the FDA, that individual’s health might deteriorate. 

Gottlieb vowed that the FDA will continue to go after companies making these illegal drug claims on CBD products.


2. Expect Enforcement of Most CBD Foods to be Minimal


If you read the statement closely, you’ll find great news for the majority of CBD food producers.

As it relates to CBD products which do not contain egregious drug-claims, the FDA described their enforcement in milder terms. The agency offered a tepid commitment to “monitor the marketplace and take enforcement action as needed to protect the public health”. CBD products which do not make drug claims and which contain reasonable doses of CBD are not a major public health concern. It appears that the FDA will not invest resources in taking down the manufacturers and retailers of CBD food products, for now at least.

3. The FDA Still Isn’t Convinced CBD is Safe

Gottlieb outlined some concerns related to CBD in his statement. When CBD was successfully trailed as an active ingredient in the epilepsy drug Epidiolex, it was administered in specific dosages under medical supervision and marketed with FDA labeling. Because scientists currently don’t understand the effects of high consumption levels or the cumulative effects of CBD over time, the risk assessment of CBD as a food ingredient remains incomplete. The commissioner also noted a possibility of liver damage resulting from ongoing CBD usage, which needs to be explored further.


4. The FDA is Clarifying their Current Stance and Seeking Possible Paths Towards Legal CBD in Food

In a nod to the opacity of their own regulation, the FDA has promised to update their website with plain-language explanations of CBD regulation and an FAQ section. They also outlined two steps towards considering the lawful marketing and sales of CBD products: the creation of an internal agency group tasked with exploring regulatory pathways to legality and an upcoming public hearing to gather stakeholder input about cannabis-derived products.

The agency also re-affirmed their commitment to building a transparent regulatory framework surrounding CBD and cannabis-derived products. While the FDA regulations are mind-numbingly convoluted and the legal nuances of CBD outshine most prospective food ingredients under FDA consideration, I am hopeful that their efforts can provide clarity on this popular issue.

5. The FDA Won’t Undermine Its Own Policies to Legalize CBD

As stated in my previous article, there are many reasons why the FDA currently assesses CBD as unfit to be a food ingredient. In his statement, Gottlieb reaffirmed that CBD would have to comply with all facets of regulation — including the FD&C Act and the standards set for new dietary ingredients and food additives— before they give CBD the green light. While the allocation of agency resources may expedite this process, CBD will have to fit into the regulatory framework of the FDA and not visa versa.

Conclusion


It appears that CBD is on the pathway towards legal acceptance as a food ingredient. Despite political pressures, the process may take a year or more as it navigates the standard regulatory path for a innovative food ingredient.

The short term viability of CBD food products may hinge on the willingness of major retailers to carry CBD-containing products, which are still illegal. As of February 2019, Whole Foods included CBD on their list of banned ingredients while the FDA commissioner criticized CVS and Walgreens for continuing to carry CBD products.

 
Getting Started: Small Food Importers

What You Need to Know:

There are reduced requirements for small food importers. Here’s how to answer critical questions and determine the requirements for your business:

Step 1: Determine the Foreign Supplier Verification Requirements for Your Business

All food import businesses are required to confirm that their foreign supplier is handling food in a way that does not pose a risk to the consumer in the US. This burden falls on the importer and is called Foreign Supplier Verification (you can check out our guide, here)

However, certain business types, including very small importers are exempt from the bulk of foreign supplier verification program (FSVP). requirements.

To qualify as a Very Small Importer, you must import <$1mm in food product value (or $2.5mm for animal feed).

In this case, you are subject to modified requirements as it relates to verifying your suppliers. You can see those modified requirements in our guide to FSVP or in the federal regulation in 21 CFR §1.512

If not, then another exemption might apply, or else you will be required to conduct a more robust Foreign Supplier Verification Program (FSVP). If are looking to implement this type of program, we have a step-by-step guide

Step 2: Determine the FDA Requirements for the Other Activities you Conduct

If your business warehouses, re-packs, processes, distributes or arranges transport for the food that you import, then those activities are likely subject to additional FDA regulation. See below to learn how specific activities are regulated.

Transportation

If you transport or arrange for someone else to transport your product, then you are subject to the Sanitary Transport Rule. The requirements are contingent upon your role in the process:

  • If you ship a product for someone else to transport then you are accountable for specifying the conditions (e.g. frozen, refrigerated) under which your product is shipped. This can be as simple as a written agreement with the company transporting your business (i.e. the carrier), This is not required when using postal services as your carrier.

  • If you load a product (e.g. you put product onto your own or someone else’s trucks) then you must ensure that the truck is suitable for transporting products.

  • If you receive product, then you’re required to make sure it arrives in safe condition (e.g. temperature and quality)

  • If you are the carrier for a food product (i.e. you operate the trucks which transport the product), then you must ensure the product is kept safe (e.g. temperature, quality) throughout the transportation process.

Warehousing

Warehousing refers to the storage of fully packaged foods. If you store your product in the US, then you’ll need to align your space with the FDA standards. This typically entails keeping your facility reasonably clean and keeping refrigerated product sufficiently refrigerated.

Check out our FSMA for Food Distributors guide for more details.

Re-Packing or Processing

If you modify the food after it has been imported — even repacking the product into new containers— then you will be required to meet the requirements for a normal food processor.

The basic operational requirements for a food operation are known as Current Good Manufacturing Practices (cGMPs), and they are summarized in our guides below:

You can also see our Guide to 117 Subpart B for a more comprehensive guide to cGMPs,

Next, there are requirements related to maintaining a safe supply chain and managing risks in your production process. Businesses which conduct under $1mm sales per year (they are called Very Small Businesses) typically qualify for the Qualified Facility Exemption. If you apply for the exemption and notify the FDA, then you don’t need to worry about the sections below. If you are not a qualified facility, then you’ll need to consider these sections:

1. Hazard Analysis and Risk Based Preventive Controls If your imported product is refrigerated, frozen, or requires any sort of control (e.g. cooking, sanitizing) before consumption, then you are likely required to implement a food safety plan. Writing and implementing a food safety plan is a comprehensive process that requires an employee who has been certified to author this plan.

If you’re looking to move quickly, a 3rd party consultant (like us) can be the best choice.

Learn more in our Guide to Subpart C Hazard Analysis and Risk Based Preventive Controls

2. Supply-Chain Program: If your process involves non-foreign suppliers, then you may have to conduct the same types of supplier verification activities described above for your domestic suppliers.

Learn more in our Guide to Subpart G

Step 3: Register Your Food Facility

If you have a site where you are holding, packaging, or processing food (including the food that you import), then you must register it with the FDA. Don’t worry, this won’t trigger an inspection, it just let’s the FDA know where you are operating from, what you’re doing, and that someday they’ll want to stop by and make sure you’re following the rules.

Check out our guide to learn more about facility registration

 
Why is the FDA Picking a Fight with Plant-Milk?
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The only thing harder than developing and selling an innovative food product is figuring out a legal name for it. The FDA has long sought to protect consumers from imitation products and false advertising by implementing Standards of Identity which define parameters for what we can call certain types of foods. 

These protections ensure that our milk is not diluted with cheap fillers and that a package of imitation crab clearly describes what is doing the imitating. The FDA’s stated goal is for a consumer to glance at a product on a shelf and know exactly what they’re buying. 

But when it comes to innovative products, things get tricky. If you pulled everything off the shelf labeled “milk” in your local supermarket, you’d likely end up with equal parts rice, almond, oats, and soy extracts as true dairy milk. The dairy lobby is not happy about this.

Is it clear that oat milk did not come from a cow? Most likely, yes. The plant-based-milk industry is adamant about this and is quick to remind us of the absurd image in which a dairy worker milks a lactating almond. Nothing is unclear about plant-based-milks, they contend. In a 2013 ruling supporting the alt-milk industry, Judge Samuel Conti expressed that the hypothetical consumer confused by the terms “almond milk” and “soymilk” also probably thinks ebooks are made of paper. According to his decision, the notion that this consumer exists “stretches the bounds of credulity.

On the other hand, is it possible that consumers of oat milk assume it has similar nutritional properties as dairy milk? Yes. At least I assumed so, until now. 

This is the crux of the FDA’s argument for why oat milk is a misleading product name — that a mother would substitute her child’s dairy milk with a “milk” product that, unbeknownst to her,  has a substantially diminished nutritional profile. As a result, her child could come become under-nourished and at risk for chronic disease —  which the FDA was specifically created to eradicate.

Continuing with the agency’s reasoning, this wouldn’t have happened if the product weren’t labeled as milk. An “Oat Non-Dairy Beverage” has no presumed nutritional profile, and this is why it’s a safer name to put on the label.

As it turns out oat milk has substantially less protein, calcium and iron than dairy milk, although oat milk producers often fortify their products with vitamins and minerals to make them more nutritionally robust.

Stroll down a supermarket aisle and you’ll notice the risk-averse brands who opt for more conservative, descriptive names for their products. They’ll do anything they can to offset the clunkiness of these monikers, from maximizing the word “Oat” to the largest legally allowable size to cluttering the panel with reminders that it is Certified Organic and Gluten-Free.

Some companies have shrewdly labeled their products as “soymik” or “almondmilk”, (spelled deliberately as a single word) and argue that this frees them from various provisions governing “milk” products. And the plant-based milk industry is fighting back on multiple fronts. The Good Food Initiative highlights the labeling restrictions as a constitutional violation of free speech and sees the FDA as perpetuating consumer confusion by “picking winners”. 

It’s true that powerful food lobbies have continually sought to manipulate the FDA to boost sales and deter new entrants to the market — in 2018 fourteen senators voted to prohibit the FDA from studying the use of the term “milk”. And as the controversy about plant-based milks transforms into one about food product marketing, the FDA regulation is ill-equipped to provide consistent answers.

The conflict between plant-based-milks and the FDA is premised on the fact that plant-milks don’t fit the Standard of Identity for “milk”. But the Standards of Identity were written to prevent food manufacturers from trickery on the production line, not to police food naming conventions. It’s no surprise that innovative products foods are so hard to name.

Why Is Oat Milk Everywhere?

The widespread presence of oat milk on supermarket shelves is hardly an indicator of the FDA’s stance on the product’s legality. The agency takes a notoriously reactive stance and will often observe regulation-defying-products for months or years before intervening (e.g. CBD, which is plainly illegal as a food ingredient yet seemingly everywhere as a food ingredient).

According to commissioner Scott Gottlieb, the FDA is working to overhaul the standard of identities for product categories — such as milk and cheese—  whose names have been adopted by innovative plant-based foods. This seems prudent and long overdue, but in the mean time, are plant-based milks really worth going after? 

Perhaps. These regulatory outcomes will set a precedent for an impending food category that expects to be even tougher to regulate and more disruptive than plant-based milks: meat-alternatives. Although “clean meats” such as Impossible and Beyond Burger currently make up less than <1% of domestic meat sales, they are gaining traction in the $90 billion dollar global meat industry. Both the USDA and FDA face an onslaught of regulation-defying food products that are perfectly safe to eat but just don’t fit the framework. Who would have guessed that the hardest part of creating vegan bacon would be deciding what to call it?


 
How the FDA Regulates Nutraceuticals
FDA regulates nutraceuticals image post.jpg

What Exactly Are Nutraceuticals?

According to the industry, nutraceuticals are ‘pharmaceutical grade’ nutrients that are consumed for a health benefit. In reality, they are vitamins, minerals, herbs, and extracts.

But you won’t find the word “nutraceutical” in federal law. The only place it appears on the FDA website is in the names of companies that have received warning letters for violating the FDA regulations.

According to the FDA regulations, most nutraceuticals would be categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances  “for use by man to supplement the diet by increasing the total dietary intake.”

When is a Nutraceutical a Drug?

One of the primary indicators between dietary supplements and drugs relates to health claims. Whereas a dietary supplement is meant to provide nutrients, a drug is designed to treat illness or disease.

So, in order to maintain classification as a dietary supplement (and avoid the FDA’s strict drug approval process), Nutraceuticals must maintain that they are not intended to treat, diagnose, prevent, or cure diseases. So, no label claims about treating pain, or preventing cancer.

How Are Nutraceuticals Regulated?

Producers of nutraceuticals classified as dietary supplements are required to register their facility with the FDA. Much like foods, producers of nutraceuticals are expected to comply with Current Good Manufacturing Practices -- these outline facility standards, employee practices, and sanitation requirements, to ensure that the product is produced in a safe manner.

Labeling standards for dietary supplements are lumped together with those for foods. However, there are unique expectations for how dietary supplements are marketed and what claims they can make.

For the complete set of regulations on producing dietary supplements, check out the guided question set in 21 CFR 111


 
FDA or USDA Jurisdiction?

What You Need to Know:

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

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

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

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

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

Determining USDA Jurisdiction

The USDA typically regulates the following business types:

  • Slaughterhouses

  • Meat Processors*

  • Poultry Processors*

  • Egg Processors

  • Food processors whose products contain meat*

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

  • Contains >2% cooked meat

  • Contains >3% raw meat

  • Contains >2% cooked poultry meat

  • Contains >10% cooked poultry skins

*For more detail, see the tables below


Examples of Business Regulation

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

Examples of Food Product Regulation

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

FAQ

What does the USDA inspector do?

The USDA inspector inspects:

  • Slaughtered animals to confirm they were healthy

  • Sanitation conditions of a plant

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

  • Product is correctly labeled and packaged to be transported

What it FSIS?

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

 
 

This article applies to you if…

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

References

USDA Inspection Requirements Overview

USDA Inspection Requirements Overview

FDA vs. USDA Jurisdiction Guide

FDA vs. USDA Jurisdiction Guide


More About Supply Chain


More Posts


Standards of Identity: How Do We Name Innovative Foods?

What You Need to Know

What Are Standards of Identity?

A “standard of identity” is an agreed upon legal definition for what a food actually is. Standards of identity were introduced as a means of consumer protection. Although “common name” is the most applicable facet of Standards of Identity, there are actually three components to consider:

  1. Common Name (Identity): The standardization and definition of common food names ensures that consumers know what a food product actually is. Typically, the common name is required to be written on the label of a food container.


    Example: A food marketed as “canned tuna” must legally be tuna and not some other fish

  2. Standard of Quality: The food meets certain quality standards described in the regulations for that standardized food. (This doesn’t apply to most foods).

    Example: A food marketed as canned tuna cannot contain ingredients or additives that the consumer would not typically associate with canned tuna

  3. Standard of Fill of Container: The packaging contains a minimum fill defined for that standardized food. This doesn’t apply to most foods)

Example: If canned tuna is advertised as 8oz of canned tuna in broth, then you are getting 8oz of tuna and not 7oz of broth and 1oz tuna.

Does My Food Product Have a Standard of Identity?

The best way to find out what the regulatory requirements are for your particular food product is to understand exactly which one of the following groups it falls into:

1. Foods for which there categorically is no definition or standard of identity

According to the FD&C act, no standard of identity or definition may be established for:

  • Fruits (fresh and dried)

  • Vegetables (fresh and dried)

  • Avocados,

  • Cantaloupes

  • Citrus fruits

  • Melons

This means there’s no specific definition for what is an apple and it means there’s no regulation that the word “apple” must appear on an apple that is being sold. If you produce a product that falls into this category, then you don’t need to be particularly concerned about misbranding your product due to standards of identity/definitions.

2. Non-standardized foods subject to specific requirements

These foods don’t have standards of identity per se, but they are subject to some requirements. You can quickly review this small list of foods in 21 CFR Part 102.

If the food you produce falls into this category, then it’s important to understand these requirements, but otherwise your product is not a standardized food.

3. Standardized Foods (Foods which have a standard of identity)

These are foods that the FDA has decided to define because there is a public expectation of what that food is . Anyone who makes a” standardized” food must make sure it satisfies the standards outlined for that food. These requirements range from mandated ingredients to packaging standards, to banned ingredients.

The categories for all standardized foods are listed in the sidebar to the right.You can also access these categories in CFR Parts 131-170

4. Non-standardized foods

These are foods that simply are not addressed in any of the sections referenced above. Since they are non-standard then they don’t have specific requirements for calling your food that name. Non-standardized foods must be labeled using the common or usual name for that food.

Many innovative products fall into this category. However, if you wish to market your product as something for which there is a standard of identity, then you must adhere to those standards or market your product differently.

For example, if you make a fermented chia-seed snack food that you wish to market as Chia Yogurt, then you must comply with the standards of identity definition for “yogurt” —since that’s how you are marketing the product. If your product is categorically unfit to meet the definitions of yogurt, then you may consider marketing it using descriptive terms (i.e. “fermented, plant-based snack food).

Identity Labeling Requirements

Packaged foods must be labeled with the product’s identity (common name). The requirements are as follows:

  • The statement of identity must be presented in bold type on the Principal Display Panel

  • If the food is marketed in multiple forms (i.e. whole, sliced, diced) then the form of the product is deemed to be part of the statement of identity

Formatting:

  • The text must be bolded and in a size “reasonably related to the most prominent printed matter on the panel”

  • The wording must be parallel to the base of the packaging so it reads normally when displayed (not sideways or upside down).

Less Common Requirements:

  • Dietary supplements must be identified in the identity statement in one of three ways:

    • Using the term “dietary supplement”

    • Using the convention “[nutrient name] supplement” (i.e. “Iron supplement)

    • Using a descriptive term indicating the ingredients in the product (i.e. herbal supplement with vitamins)

  • Substitution or imitation foods must be identified as such in the identity statement (i.e. imitation crab) A substitute food resembles another food and is meant to substitute it. An imitation food is the same except that it is nutritionally inferior to the food it imitates.

Source: 21CFR 101.3

FAQ


What if My Product Doesn’t Have A common Name Because It’s an Innovative PRoduct?

In that case, you may use a descriptive term in the identity statement

What if My Product falls under a Standard of Identity but fails to meet the regulated standard?

A food producer may apply for a Temporary Marketing Permit (TMP) which allows them to sell their product for 15 months even though it may not confirm to some art of the applicable “standard of identity”.

For example, according to the FDA, Canned Pacific Salmon can only contain pacific salmon, water, and salmon oil.

In 1988, Bumblebee applied for a TMP which would allow them to add a tasteless, odorless preservative called sodium tripolyphosphate to the product. Normally, Bumblebee would not be allowed to sell the product as Canned Pacific Salmon, since the product would not fit the standard of identity.

However, the TMP gave them the permission to temporarily circumvent the standard of identity and sell their product (it’s worth nothing that sodium tripolyphosphate was an allowable food additive at that point.)

 
Guide to Developing a Foreign Supplier Verification Program (FSVP)

To learn more about Foreign Supplier Verification Programs overall, see our introduction article

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How Do I Develop a Foreign Supplier Verification Program?

If you import products for consumption into the US, you likely are required to develop a foreign supplier verification program (FSVP).


Below is a step by step guide to developing and implementing an FSVP.


1. Determine your Qualified Individual

First, The FSVP must be prepared by a "qualified individual" who has the education, training or experience necessary to perform the activity. If this person is a 3rd party or consultant, that's fine. However, note that supplier verification is an ongoing process and it must always be completed by a qualified individual. For most companies, the easiest solution is to have someone on staff undergo a 2 day training course on developing a Foreign Supplier Verification Program.

Source 21 CFR 1.503


2. Decide How Your Program Works

Before you begin approving suppliers, you must establish the procedures you will use to approve suppliers. The goal is to provide assurance that hazards in the food you import are being prevented.

You can rely on a 3rd party to conduct your supplier verification if you review and assess the documentation yourself and document your review and assessment of the materials.

Examples of appropriate verification activities:

  • Onsite audit by a qualified individual

  • Sampling & testing

  • Review of foreign suppliers food safety records

  • Other appropriate supplier verification activities


3. Conduct Your Verification Activities

This step is the bulk of the process: collecting information from your suppliers, reviewing it, and documenting your review process.

You may rely on a 3rd party to conduct supplier verification activities (i.e. a 3rd party audit) if you assess their documentation with appropriate frequency. You must document your review and assessment of the activities and document that the activities were performed by a qualified individual.

The following are common verification methods for approving suppliers:

Hazard Analysis

You are required to review a hazard analysis for each type of food you import. Hopefully, each of your foreign suppliers has completed one and can provide this to you. If not, then you must conduct a hazard analysis to determine whether there are any hazards requiring a control. This hazard analysis must be written and contain an evaluation of environmental hazards.

Some key points about the hazard analysis:

  • You must either conduct a hazard analysis for each type of food you import OR use a supplier hazard analysis.

  • If you are importing Raw Agricultural Commodities (RACs) then no biological hazards need be considered in the Hazard analysis.

  • If you are reviewing a hazard analysis supplied by the supplier or a 3rd party, then you must document your review of the hazard analysis and confirm that it was conducted by a qualified individual.

  • If no hazards are identified which require a preventive control, then no verification is required for those products. Still you must have a hazard analysis on file to show that this has been determined. This provision does not apply to produce.

Subpart L  - FSVP for Food Importers

Onsite Audit

Certain importers may wish to independently conduct onsite audits of the foreign supplier. Or, they may simply review the audit results conducted by a reputable 3rd party auditor.

An audit is required as part of the supplier verification process when there is "reasonable probability that exposure to the hazard will result in serious adverse health consequences or death" you must conduct or obtain documentation of an onsite audit at least annually. (1.506 (d) (ii) (2)

In this case, an audit may be replaced by written inspection results by the FDA, USDA, or a food safety authority of a country whose food safety system is equivalent to that of the US.

Sampling & Testing of Food

If you choose to use product testing and sampling as part of your verification, you must retain documentation of the following:

  • The number and type of samples tested

  • identification of the food tested (lot numbers)

  • tests conducted and the methods of the testing

  • Any corrective action taken into detection of hazards

  • Information identifying the lab

  • Documentation that the tests were performed by a qualified individual.

Review of Foreign Supplier's Food Safety Records

The most common method of supplier verification is the review of a foreign supplier's food safety records.

If you choose to use your foreign supplier's food safety records as part of your verification, you must retain the following information:

  • The records reviewed

  • Dates of review

  • General nature of the records reviewed

  • Conclusions of review

  • Any corrective actions taken in response to significant deficiencies identified.

  • Documentation that the review was conducted by a qualified individual.

You may not allow on the foreign supplier to conduct supplier verification activities for their own business.

Final Considerations:

Hazards Not Controlled by the Foreign Supplier

Does a 3rd party control one of the hazards on behalf of your supplier (i.e. your overseas milk supplier has their pasteurization completed offsite by another company.) If so, you must collect this verification data from the 3rd party or have your supplier send it to you.

Supplier Performance & History

It is perfectly acceptable to take into consideration your supplier's history, procedures, practices, storage, transportation, etc as part of your verification activities.

Document Your Verification Activities

Remember, it's not enough to simply collect these documents from your foreign suppliers -- you have to assess them and document that assessment.

For example, let's say I'm an importer of Ned's Italian Tomato Sauce and they send me their most recent audit result. Beyond having that audit result on file, I need to record that I reviewed that audit, that it showed me they controlling the hazards in their process, and that my review occurred on such-and-such date.

The Whole Picture

For fear of stating the obvious, you must approve your foreign suppliers on the basis of your evaluation. In other words, you must consider all the information you gather in your approval process and cannot discount any piece of information simply because it is contrary to the result that you're looking for.

This doesn't mean that one failed audit in your supplier's history means you cannot approve them. However, you must acknowledge this information if it is revealed in your verification activities or outside of them.

Source 21 CFR -- 1.504


4. Approve your Suppliers and Maintain the Program

Once you have completed your verification activities, you may add the relevant supplier's to your approved supplier list and begin sourcing product from them. At that point, the program should require only occasional ongoing maintenance

Keeping Records of Your Foreign Supplier Verification Program (FSVP)

Your records should comply with the following provisions:

  • They must be originals, photocopies or digital records

  • You must keep them for 2 years unless otherwise specified

  • They must be available for review by the FDA

  • You do not need to have a specific copy of each record for the FDA (e.g. you can have one copy of a record to satisfy both a state requirement and a federal requirement)

Source 21 CFR §1.510

There are several exemptions to Foreign Supplier Verification Requirements. This section applies to:

Taking Corrective Actions

You must take corrective actions if you determine that the food you are receiving is not meeting the requirements of the FDA regulations. Simply put, if the food you receive could cause harm to a consumer or is unsafe, then you must take some type of corrective action. This determination could be based on customer complaints or verification activities that you conduct (i.e. records review or viewing an inspection result.)

The appropriate corrective action to take could include discontinuing your use of that supplier until the hazards have been addressed.

If this determination occurs outside of the scope of your supplier verification activities, then it may reveal that your verification activities are not comprehensive. Simply put -- you didn't catch the mistake in your normal supplier verification practices therefore something is inherently wrong with your process. In this case you are obligated to update your plan so that you are able to adequately verify your suppliers.

Source 21 CFR §1.508

Re-evaluating Suppliers

You must re-evaluate your foreign suppliers (and document it),

  • Every 3 years, at minimum

  • When you learn anything new or when anything has changed that would warrant a re-evaluation.

You may use a 3rd party foreign supplier review as your re-evaluation, insofar as you document your assessment of that evaluation. The evaluation must be performed by a qualified individual.

Source 21 CFR -- 1.504

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

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

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


Examples of FDA Jurisdiction Businesses

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

Businesses Not Under FDA Jurisdiction

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

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

Still Unsure Whether Your Business is Regulated by the FDA?

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

Try using this dichotomous key

What’s Next?

Understand about Registering a Food Facility with the FDA

 
Intro to Foreign Supplier Verification Program

For step-by-step instructions, see Guide to Developing an FSVP

Supplier Verification Post Image.jpg

What You Need to Know about FSVP

  • Nearly all food imported into the US must be produced in alignment FDA Regulations

  • Foreign Supplier Verification Program (FSVP) is a major component of FSMA which requires US businesses to only import food products from suppliers they have vetted and approved.

  • Most businesses which import food products for consumption inside the US must verify that the food is produced in alignment with FDA regulations. This is done through the implementation of a Foreign Supplier Verification Program (FSVP). When a certain type of food (i.e. seafood) is subject to specific regulation, a foreign supplier must also comply with those specific standards.

  • The verification process may include, among other methods: an assessment of the supplier's food safety records, a review of an audit report, or a site visit.

 

FSVP post photo.jpg

Applicability and Exemptions

Generally, foreign supplier verification is required for most importers, for most imported foods, and for most foreign suppliers. To better understand what types of businesses and products may not be regulated under Subpart L (Foreign Supplier Verification Program), see the exemptions below:

Very Small Importer Exemption

A "Very Small Importer" is a company that imports $<1mm year in product value for imported human food (or <$2.5mm year in value for imported animal food)

Modified requirements for "Very Small Importers"

  • A very small importer must document that they meet the qualification for this exemption (i.e. be able to prove they are doing less than $1 million in imports)

  • Receive a written assurance from each foreign suppliers, prior to importing any food. The written assurance must be obtained every 2 years and include the following

  1. A brief description of the preventive controls being applied to control hazards in the food. This must be provided for each food that is imported.

  2. A statement that the foreign supplier is compliant with FDA regulations or (when equivalent) the relevant laws of their own country

  • You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

  • You must keep signed and dated records of these activities for > 2 years.

Foreign Suppliers Requiring No Verification

An importer is not required to conduct verification activities for certain foreign suppliers, including

  • Qualified Facilities, or

  • farms that grow produce and are not covered under part 112, or

  • A shell egg producer that has fewer than 3,000 laying hens.

  • Suppliers operating in countries with an officially recognized or equivalent food safety system

If you are importing products from a foreign supplier that is exempt, the modified requirements are as follows:

  • You must obtain a written assurance of their exemption type (i.e. farm or qualified facility or small shell egg producer)

  • You must initially evaluate your foreign supplier's performance history as it relates to compliance with FDA regulations. You must re-evaluate this if you become aware of any relevant changes or information or ever 3 years at minimum.

  • You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

  • You must keep signed and dated records of all verification activities for > 2 years.

  • You must approve your foreign suppliers based on the activities described above.

  • You must establish written procedures to ensure that you are using only approved foreign suppliers. You may import from unapproved suppliers on a temporary basis, if you have other, adequate verification prior to import.

Source 21 CFR §1.512

 

Countries with Officially Recognized or Equivalent Food Safety Systems

If you are importing from a country with a recognized equivalent food system, you may be free from the following the majority of FSVP requirements (§1.504-§1.508). As of 2018, the only countries who have achieved this are: Australia, Canada, and New Zealand.

However, your program still must be developed by a qualified individual, your company must be identified upon food import, and you must maintain your FSVP records in compliance with §1.510.

Source 21 CFR §1.513   

Foods Subject to Special Foreign Supplier Verification Regulations:

Certain foods are exempt from Subpart L (the requirements for Foreign Supplier Verification Programs outlined in this article) and are subject to different requirements.

Imported Seafood Products (aka Fish / Fishery Products)

Since seafood products are subject to specific FDA regulations found in Part 123, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 123. You can read about the specific requirements for verifying a foreign seafood supplier here

Imported Juice Products

Juice products are subject to specific FDA regulations found in Part 120, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 120 (specifically, that they have and follow a HACCP plan).

Meat Products

The Foreign Supplier Verification Program does not apply to meat products that, at the time of import, are under USDA jurisdiction.

 

Food that cannot be consumed without the hazards being controlled

You aren’t required to conduct an evaluation or foreign supplier verification when:

  • The food can’t be consumed without controlling for the hazard

  • You rely on the customer (who must be subject to 117C) to control the hazards. In this case you must disclose this to the customer and obtain annual assurance that they are controlling for the hazard

  • You rely on a subsequent entity in the supply chain (further downstream from you and the customer) to control for the hazard.

Source 21 CFR §1.507


FSVP FAQ

How must the importer be identified at entry?

You must identify your firm as the importer and include your FDA identification (DUNS) number and email address when filing for entry. The foreign owner or consignee of the food oversees must designate a US representative as the importer as the food.

Source 21 CFR §1.509

What are some consequences of failing to comply with the requirements of this subpart?

  • The food may be inadmissible for import.

  • The importer may be found in violation of federal law.

Source 21 CFR §1.514

What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?

Source 21 CFR Section 1.511

Corrections vs. Corrective Actions in Food Processing
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What You Need to Know

Correction

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

Examples of corrections include:

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

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

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

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

Corrective Action

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

  • What occurred

  • How the problem was corrected

  • How it will be avoided in the future

  • What was done with the product in question

Examples where corrective action is required include:

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

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

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

For more about corrective actions, see our full guide


Correction or Corrective Action?

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


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