Insight into FDA’s Fresh-Cut Produce Draft Guidance: What is a Farm, Farm Mixed-type Facility, or Receiving Facility?

As Romaine lettuce is planted in Arizona, the FDA has overwhelmed the produce industry with draft guidance documents. When the Food Safety Modernization Act (FSMA) was signed in 2011, the importance of growing, harvesting and processing of fruits and vegetables was recognized as the start of food safety for the familiar term of farm-to-fork. One of FSMA’s foundational rules is the Produce Safety rule. Today we deviate from the traditional focus of the ConnectFood blog at the middle step of the Preventive Controls for Human Food rule to start at the very beginning where crops are grown.

As a Lead Instructor grounded in the latter rule, I have presented dozens of times the difference between a farm as a supplier and a food factory as a receiving facility. In the simple world of instruction those two are obvious. Consider a farm that harvests melons and then washes the melons. Is the location of washing considered a farm and under the Produce Safety rule or considered a receiving facility and under the Preventive Controls for Human Food rule? I don’t want to leave you hanging; I identify the washing facility as a receiving facility and subject to the Preventive Controls for Human Food rule. FDA has made my choice clearer with their guidance documents. Across the nation and internationally there are hundreds of examples of farms harvesting a crop and then another step being applied, before the fruits or vegetables reach a traditional food factory.

FDA has done a momentous job in publishing draft guidance for the farm and food industries. See my resources listed below. In keeping with starting at the beginning, key definitions are discussed here.

Supplier: the farm that grows the crop or raises the animal. A supplier to a food factory can in turn be a food factory, e.g., when a food factory purchases dried ingredients. For the purpose of discussion here, the supplier is a farm that grows a crop.

Receiving facility: food factory that receives the crop and registers with FDA as a facility that processes, manufactures, packs or holds food. The draft guidance documents are FDA’s current thinking on the definition of receiving facilities that handle crops. Facilities which in the past have been considered farms must now register as a food facility.

Farm mixed-type facilities: this is the location of the next step after harvesting, but before getting to a traditional food factory like a spaghetti sauce manufacturer. FDA looks at processing, packing and holding. For example, located conveniently to fields are packing houses. In our grocery stores, we find fruits and vegetables that have been washed and chilled, sorted and packed into wrapped trays, mesh bags or boxes. Those steps are considered processing. In the past, FDA has left farm mixed-type facilities as farms, and now FDA sees farm mixed-type facilities as receiving facilities under the enforcement of the Preventive Controls for Human Food rule. This is a big change and will cause hundreds of facilities to register as a food facility, implement a food safety plan, and have a trained Preventive Controls Qualified Individual (PCQI) to oversee food safety.

In my next blog post, read about different types of produce and exemptions from the rules.

Matthew Botos, CEO of ConnectFood, and the whole Expert Services team can guide you.

    “As with all food manufacturing we must focus on “basics done well”, this mean employee training and a focus on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs). The FDA has set a very good standard for all produce companies.” – Matthew Botos, CEO, ConnectFood

The folks at ConnectFood are here to help! Contact us.

Resources:
Guide to Minimize Food Safety Hazards of Fresh-cut Produce: Draft Guidance for Industry

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry, Draft Guidance

AT A GLANCE: KEY POINTS IN THE PRODUCE SAFETY RULE DRAFT GUIDANCE: CHAPTER 1: GENERAL PROVISIONS (SUBPART A)

FSMA Final Rule for Preventive Controls for Human Food

FSMA Final Rule on Produce Safety

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.

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Foreign Supplier Verification

We continue to do blogs on the importance of food safety and the regulatory environment that we, as a food-manufacturing ecosystem, find ourselves. Products come into the United States from all over the world and from many different cultures with many different ways to process food. In September of 2018 FDA produced an introduction in which the beginning stated:

“The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.”

Foreign supplier verification is a method for assuring that these products from all over the world adhere to the best practices and regulation being implemented in the United States. We will be walking you through the fundamentals as listed on the FDA website. These areas include:

    • Scope
    • Hazard Analysis
    • Evaluation of Food Risk and Supplier Performance
    • Supplier Verification
    • Corrective Actions
    • Exemptions and Modified Standards
    • Unique Facility Identifier

Each of these areas is define as a key requirement and we will walk through some of the basics included. A comprehensive overview can be found at https://www.fda.gov/food/guidanceregulation/fsma/ucm361902. connectfood.com is not here to interpret guidance but is here to help food manufacturers and importers on their journey towards a globally safe food supply.

Scope:
The scope covers making sure that an importer understands the responsibility of food safety. The importer must collect the information that they will have to provide regarding the safety of incoming products. The companies that are shipping products into the country must have food safety plans for the incoming products that matches the current standards of preventive controls and produce safety.
“Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.” FDA.gov

The scope is not a simple process and it requires detailed information reaching into countries across the globe.

Hazard Analysis:
The importer must understand what reasonable hazards are like likely to occur in a food and make sure that these hazards are addressed by a food safety plan and controls. The importer does not necessarily have to “do” the hazard analysis but must be able to review the documents that have been done by a qualified individual assuring the safety of the food. Ultimately the importer is the gatekeeper of food safety for products that are coming into the country.
Evaluation of Food Risk and Supplier Performance
There is a set list of task that an importer must look at to help assure supplier performance and this will allow them to understand what the companies supplying products are doing to protect the integrity of the food supply. The below points are straight from the FDA website mentioned above:

    • The hazard analysis
    • The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier’s raw material or ingredient supplier
    • A foreign supplier’s procedures, processes and practices related to the safety of food,
    • Applicable FDA food safety regulations, and information regarding the foreign supplier’s compliance
    • The foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems
    • Other factors as necessary, including storage and transportation practices

Supplier Verification:
An importer must be confident that that a supplier is doing the right thing and has a food safety plan that has analyzed hazards and controlled them. There different ways to go about this including annual audits by a qualified individual, sampling and testing. Review of the food safety plan by outside experts and the supplier.
“What supplier verification activities must be conducted? Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure, in most instances, that it only imports from approved foreign suppliers and must conduct appropriate supplier verification activities.” FDA.gov

Corrective Actions:
If something happens that is outside of the food safety plan the issue must be evaluated and decided if the product is a danger to the consumer. When this happens it must be decided what to do with the product and how much product was adulterated and where that product is in the supply chain. This will also impact if the supplier should continue to be used by the importer.
“The appropriate corrective measure will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.” FDA.gov

Exemptions and Modified Standards:
The exemptions are listed on the FDA website and should be reviewed; however, it is our viewpoint that all products should have GMP’s and a food safety plan. Some of these exemptions could include the size of the establishment or the type of product being supplied such as dietary supplements but all of these products must be evaluated by the importer and compared with the FDA requirements.

Unique Facility Identifier
The FSVP rule requires information about importer and the products that are coming into the country so that if there is an issue it can be stopped and contained before there are any human health issues. Below is some of the information from the FDA.

    • The final FSVP rule requires that an importer provide its name, electronic mail address, and unique facility identifier (UFI) recognized as acceptable by the FDA for each line entry of food product offered for importation into the United States.
    • The FDA has recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.
    • DUNS numbers, assigned and managed by DUN & Bradstreet, are available free of charge to importers by visiting FDAdunslookup.com.

In conclusion, the FSVP Rule is set up so that there are checks and balances for the importers and the companies that are supplying them from all over the world. The FSVP requirements are right in line with the rest of the Food Safety Modernization Act that is assuring the safety of consumers and protecting the safest food supply in the world. Remember, as an importer you must understand risk associated with the products coming in and understand what is being done by the supplier to control any hazards. It is the importer’s job to set up a system that complies with the above points.

ConnectFood is here to help. Contact us.

About the Author
Matthew Botos is the CEO and Founder of ConnectFood. ConnectFood offers a step-by-step, “Do-It-Yourself” food safety plan generator to help companies comply with the Food Safety Modernization Act and On-Demand plan reviews from a national network of food experts. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of few approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 800 of the nation’s leading food safety experts.

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FSMA Intentional Adulteration Rule

Looming on the FDA horizon is the enforcement of the last of seven foundational rules in the Food Safety Modernization Act (FSMA). Intentional adulteration, commonly called food defense, is the deliberate addition to an ingredient or food of a hazard to cause illness or injury which makes the food adulterated. This criminal act could be the work of an outside group or individual who gains access before an ingredient crosses the perimeter of your facility and is delivered at Receiving. Thinking inside the box requires you to consider the access of a disgruntled or temporary employee from Receiving through to the sealing of packaging, i.e. an inside job. Addressing both perspectives is required.

The deadline is July of 2019 for businesses with more than 500 employees. The description of the first companies to come under enforcement aligns with the PCHF rule. In July of 2020, small businesses with an annual revenue of $10,000,000 come under enforcement. You can see where is says ten million here. Yes, that means that businesses with an annual revenue under $10,000,000 are defined as very small businesses by FDA and are exempt from requirements other than providing documentation of the very small business status. The very small business exemption aligns with the PCHF rule. I have written more on the food defense rule in a previous blog post on ConnectFood.

Businesses with more than 500 employees are writing their food defense plan. Quality managers schooled in Hazard Analysis and Critical Control Points (HACCP) will see the parallel of steps in a vulnerability assessment to the hazard analysis process in HACCP or PCHF. However, a food defense plan and program have completely different outcomes compared to food safety. Your food safety team may not be the right people to address food defense, so now you have another team, and most companies bring in food defense experts for a fresh pair of eyes and their experience. I have previously written about resources for food defense. I teach a one-day workshop on food defense. My recommendation is to bring on-site a food defense trainer and consultant for one day of training with your cross-functional team, followed by two days in the facility for a vulnerability assessment with the food defense team leaders-no more than three people. Our own Matthew Botos, CEO of ConnectFood, is an excellent source of information on food defense.

“Any supply chain has the potential of being vulnerable from a multitude of unstable individuals who have both the operational capability and the behavioral resolve to inflict damage on products, people, or facilities. We have the most sophisticated and safest food supply in the world and FDA is only trying to bolster that with their continually proactive regulations. Companies need to not only look after food safety in a traditional sense, (look for hazards and protect the consumer) but also look at non-traditional methods that may impact the safety of the food supply. ConnectFood stands ready to help companies and protect people.” – Matthew Botos, CEO.

Food defense plans are facility-specific. My recommendation is that you choose one site from your company and completely finish its food defense plan. Once the team has learned the process, you can get the other sites started and either bring in the trainer again or create a corporate food defense team that goes to each of the sites to implement food defense with the local team. Because this is the first time that your food facility is required by FDA to address food defense, be prepared for large investments in monitoring of employees, capital expense, or reconstruction. One company I worked with is way ahead of the curve on food defense, yet I left them with a long action item list following one day of training and one day of touring the facility to identify vulnerabilities. We needed another day. After the company completes the action item list, I will review their draft food defense plan.

To get started on your food defense plan, FDA has publicly available and free documents. Go to the webpage for FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration. You want to start with the Fact Sheet and the Explanatory Diagram. The Question and Answer document is good. Scroll down to the questions on Intentional Adulteration, because the Q & A covers all FSMA rules. When you are ready, go through the first Guidance document. Others will be published through this next year. Matthew, the other ConnectFood food safety experts, and I can guide you through the system using the Expert Services; the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through connectfood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.

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