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“FDA Seizes Food and Medical Products Held Under Insanitary Conditions at an Arkansas Grocery Warehouse.” This FDA News Release grabbed my attention. I have known since my first year of Food Science courses that FDA has the authority to seize product but does so rarely. After the Department of Justice filed the complaint in a U.S. District Court, armed marshals of the U.S. Marshals Service entered the Alma, Arkansas warehouses to detain products and keep products from entering interstate commerce. Does this sound like too much authority? This is from the FDA News Release:

    The complaint alleges that an inspection of J and L Grocery that the FDA conducted in September and October 2018 revealed insanitary conditions including multiple live and dead rodents, rodent nesting, live racoons, live cats, a dead possum, animal feces, and urine-stained products in and around the company’s seven warehouses and sheds used to store food, medical products and cosmetics.

The FDA got its hand slapped when the Office of Inspector General published findings in a 53-page report in 2017 detailing:

    FDA could not always ensure that firms initiated recalls promptly and that FDA did not always
    (1) evaluate health hazards in a timely manner,
    (2) issue audit check assignments at the appropriate level,
    (3) complete audit checks in accordance with its procedures,
    (4) collect timely and complete status reports from firms that have issued recalls,
    (5) track key recall data in the RES [Recall Enterprise System], and
    (6) maintain accurate recall data in the RES.

Remarkably, FDA agreed with the findings and started addressing the deficiencies before the final report was published. FDA was given more authority under the Food Safety Modernization Act (FSMA). My previous blog post described the first uses of FDA’s FSMA authority, including the first mandatory recall for a dietary supplement, kratom.

FDA has stepped up the game by publishing FDA Statements from FDA Commissioner Scott Gottlieb [author’s note: I find these FDA Statements very helpful], a final guidance of Questions and Answers Regarding Mandatory Food Recalls, and two draft guidance documents – Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls and Public Warning and Notification of Recalls. These documents coming from FDA allow us to get inside the head of FDA, learn the expectations for a recall, and work cooperatively with FDA in recall situations. I have been present at the start of recalls with industry and have been brought in for root cause analysis after the announcement of recalls. During crisis management in the food industry there is always the question of what FDA will do. Through these documents, FDA is telling us what they plan to do. Here is part of the Commissioner’s statement:

    The guidance further outlines how the FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, as the law requires. It offers more detail about the evidence or circumstances the FDA may consider when deciding to move forward with a mandatory food recall and provides clarity around situations when the FDA would deem a food product a serious health risk. Providing this additional clarity can enable the FDA to make more robust use of this recall authority.

Recalls are stressful situations. The Preventive Controls for Human Food rule under FSMA requires a written recall plan. ConnectFood can help you meet the requirement of the rule and be prepared for a potential recall. The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

From Dr. Kathy Knutson, a photo from the U.S. Department of Justice, Marshals Service.

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.

As a high school teacher in Chicago, in a past career, I was on a school bus headed south to the university campus of Champaign-Urbana, riding through the flat cornfields of Illinois. One of my students pointed out the window and asked, “Dr. Knutson, what are those… factories over there?” My reply was, “that is a farm.” In light of the new FDA guidance, the question is valid. Do on-farm processing steps change a location from a traditional farm to a factory? My previous blog post started with the definitions of supplier, receiving facility, and farm mixed-type facility. Farms are not required to implement a food safety plan, and farm mixed-type facilities have been under enforcement discretion while FDA figures this out. FDA took a giant step in sharing their current thinking on the definitions of produce covered by the Produce Safety rule and the Preventive Controls for Human Food rule. FDA recognizes the variety of produce grown on farms and approaches to building in food safety.

Produce Safety Rule Exemptions:

Farms with an annual average revenue under $25,000 are exempt. This makes sense from a public health view. Small farms are not going to cause wide-scale harm, in general. There are other exemptions for farms with an annual average revenue above $25,000 and based on how much is sold directly to customers through a farm stand-like store, local grocery store or restaurant. Another exemption is based on the sale of other products like hay or wine. For farms that don’t know where they fall, my advice is to ask an accountant and attorney to interpret the farm’s sales of commodities regarding the rule. See COVERED FARMS.

Produce is the edible portion of fruits and vegetables for human consumption. Produce grown for animal feed or other uses is exempt from the Produce Safety rule.

Grains are exempt from the Produce Safety rule because grains are always going to be further processed. Produce that is rarely consumed raw (RCR) is exempt from the Produce Safety rule. Examples include potatoes and beans.

Don’t worry about your backyard garden. Produce that is grown for personal use or on-farm consumption is exempt from the Produce Safety rule.

Farm Mixed-type Facilities:

The bottom line is that as soon as produce is processed in any way to make it a new food, the activity is under the Preventive Controls for Human Food rule. Most of us understand that roasting of nuts is a processing step that requires preventive controls to create a safe product. The same is true for making bags of chopped lettuce and sliced apples. These raw agricultural commodities (RAC) have been changed into processed food, and processed food is under the Preventive Controls for Human Food rule.

Until now, FDA has been hands-off on processing of RAC on the farm. If processing is done on a farm in a farm mixed-type facility, the process is under the Preventive Controls for Human Food rule. The facility must have a written hazard analysis, implement a food safety plan, and have a Preventive Controls Qualified Individual (PCQI). The FDA is seeking comments on their published guidance for farm mixed-type facilities. In some ways, the FDA guidance seems like too much. Do we really need this for farms? Then I am reminded of Salmonella outbreaks from cantaloupe. In one outbreak the melons were only washed as a processing step, but in such a way as to not remove or kill pathogens. The outbreak covered 28 states with 143 hospitalizations of 147 documented cases. There were 33 deaths. Yes, we need this.

    “If you’re a farmer or anyone processing food whose company is interested in using ConnectFood to write or compile your food safety plan, check out our Enterprise tier. This Enterprise-level subscription allows you to experience full systems management, including having multi-facility supplier management, multi-facility records management, and direct access to food safety experts.” – Matthew Botos, CEO.

The ConnectFood website has free resources, and 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.

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.

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.

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.

By Dave Seddon, MBA RD LD (PEAKCORE, a ConnectFood Partner)

For many, change can be daunting. This includes the new FDA Sanitary Transportation of Human and Animal Food Rule. With increasing regulations, such as with the implementation of Electronic Logging Device (ELD), transportation companies are wondering what impact will this new rule have on the bottom line and operations. Fortunately, the changes that have come about since the 2005 Sanitary Transportation of Food Act, provide more flexibility and a preventative scope on top of the existing industry’s best practices.

The FDA’s Food Safety Modernization Act (FSMA) final rule on Sanitary Transportation of Human and Animal Food’s foundation is a “risk-based” model for food safety, clearly defines who is covered by the rule, and highlights certain preventative operational areas that help to ensure product food safety, such as temperature, is being maintained throughout the course of transport. The final compliance date for most businesses, barring any waivers, are upon us. We have provided a few bullet points of those requirements that are now being monitored to help you implement an improved food safe environment.

    ● The final rule establishes clear definitions of the transport role you play in transport. Those identified are Shippers, Carriers, Loaders, and Receivers. Some of the operational guidelines also will enhance and impact cGMPs (Current Good Manufacturing Practices) and SOPs (Standard Operating Procedures). Since, businesses can play multiple roles, a food safety plan should state each of these.
    ● FDA states “any movement of food in commerce by motor vehicle or rail vehicle,” all Transport Operations, Vehicles, and Transport Equipment are subject to the requirement.
    ● Temperature monitoring operations for foods are now required for temperature control safety. Thus businesses need to be able to provide temperature maintenance documents upon request. Clearly, these requests are becoming more prevalent and you should be prepared to show evidence for your clients.
    ● Training certificate and internal training programs are a few ways that businesses can illustrate compliance for training employees on food safe handling practices.
    ● The final rule requires maintenance and retention of records of written procedures, agreements, and trainings have been completed. Procedures should include ways to address pre-cooling, prior cargo handling (post), and vehicle/transport vehicle cleaning records. Cleaning, sanitizing, and inspecting of vehicles and transport equipment procedures must be written and maintained. Retention length depends upon the type of record and when the activity occurs.

Raising the bar for food transport adds to the increasing awareness that improved food safety transport systems strengths the diverse and complicated food procurement system. Creating a Sanitary Food Safety plan is a great way and first step for some to help your company meet many of these new requirements and ease the burden of compliance. Tools, such as ConnectFood, provide a resource for templates, models, and a framework to develop your own plan in short period of time. Best of all, all records can be maintained for ease of access for your client and the regulatory bodies. If you need further assistance, experts are available as well.

As always, ConnectFood is ready to help. A transportation plan guidance is available on the ConnectFood website, and a template with information is available to be loaded for your company upon request. Contact us.

About the Author
Dave Seddon, MBA RD LD (PEAKCORE, a ConnectFood Partner) is a food safety consultant with 25+ years of financial, operational, and managerial experiences in for-profit and non-profit organizations. He is well versed in food safety, SQF, HACCP, operational control, business development, entrepreneurship, M/A, risk analysis, and ERP/system implementation. Dave is a ConnectFood partner as part of the Expert Services.

The Food Safety Modernization Act (FSMA), which was signed into law in January of 2011, was created with the intent to regulate the way foods are grown, harvested, and processed. This rule allows the Food and Drug Administration (FDA) to step into the food safety chain to protect the public by assessing, regulating, and ultimately strengthening the food safety system. FSMA focuses on five main topics according to the FDA’s fact sheet, each of which has subtopics that relate to your food safety depending on the classification, facility size and employee count, and the purpose of your food company:

    1. Prevention
    2. Inspection and Compliance
    3. Response
    4. Imports
    5. Enhanced Partnerships

Back in November of 2016, we released a blog entitled “What is the Food Safety Modernization Act?”, which began our continuous discussion of FSMA. For the past few months, ConnectFood has been releasing blogs that touch upon the topics most relating specifically to the safe production and hazards around human food. For example, we discussed every aspect of record management regarding safe production, documentation, logs and records, and food safety plans. (Part 1, Part 2, Part 3, Part 4, Part 5, Part 6) We also discussed the importance of practicing mock recalls and the more specific and intimate details of recall planning and writing your food company’s recall plan.

Whether you are a food manufacturer, a distribution plant, a restaurant, small food producer, or anything in between, your facility or kitchen must be compliant with FMSA regulations. You should assume that an FDA Inspector will arrive to perform an audit on your facility at any time, on any day of the week. Sometimes, these visits are scheduled, but often, you should be ready for a surprise. Get ready to hand over your required documentation, explain your processes, justify your Good Manufacturing Practices (GMPs), and most of all, get ready to be expected to implement some changes.

Over the next few weeks, ConnectFood’s goal is to continue to educate you on the segments of FSMA and the regulations surrounding food safety policies. We will be having food safety experts write on the following topics:

1. Sanitary Transportation of Human & Animal Food
Sanitary transportation is an element of FSMA that has a rule finalized by the FDA. According to their online documentation, “The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation… The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law.”

2. Foreign Supplier Verification
The final rule on foreign supplier verification began implementation on May 30th, 2017. The online documentation states: “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.”

3. Preventive Controls for Animal Food
As you know, ConnectFood talks about human food constantly, but there is equal importance in making sure our pets are fed safely. Let’s not forget our furry friends in our safety planning. Check out the FDA’s final rule fact sheet here until we release our blog on the subject.

4. Strategies to Protect Food from Intentional Adulteration
Intentional Adulteration is not a topic to skim through – we will be having our own Kathy Knutson, Ph.D., PCQI, (who is trained in the prevention of Intentional Adulteration) write a post focusing solely on the topic. Until you get to read her writing on the subject, take a read through of the FDA’s webpage here.

All of this information may be overwhelming no matter if it is old news or fresh news. As always, if you have any questions regarding FSMA and how it relates to your food company, the team at ConnectFood is always here to help. Don’t hesitate to reach out for help if you need it. The time for compliance is the present – don’t be caught without a FSMA-compliant food safety plan in place. Contact us.

About the Author

Johanna Seidel, PCQI

Johanna Seidel is an administrative member of the ConnectFood team, where she works as manager of operations and manager of social content. Johanna received her Preventive Controls Qualified Individual (PCQI) certification in November of 2017. She received a Bachelor of Fine Arts Degree upon graduation from West Texas A&M University in May of 2016. When she is not working with food safety experts, Johanna also works as a dance instructor for The Chicago School of Ballet, as well as a professional contemporary dancer in the city of Chicago.

Last week we talked about the importance of mock recalls. It was inferred that companies find mock recalls painful, but maybe some companies love them. That being said, mock recalls are crucial to the survival of a company if a full recall is necessary. “The Preventive Controls for Human Food regulation requires the development of a written Recall Plan when a hazard analysis identifies a hazard requiring a preventive control.” The rule discusses “reviews definitions of recall classes, required elements of a Recall Plan, who to notify when a recall is necessary, how to conduct effectiveness checks and methods that can be used to dispose of affected product.”

Recently I received a call and a company had an adulterated product from a source overseas. The call started with an attorney and ended with company management over a series of conversations in just days. The outcome was a Class III recall, and it was not a danger to human health – just an ingredient that was not for use in the United States. The company took all of the right actions and, even though a tremendous amount of work was put in over a short period of time, the proper actions were followed. This is why mock recalls are so important for the viability of a company. Knowing what to do and having an internal team and external advisors can and will save time, money, and possibly a brand if handled correctly.

“Recalls are actions taken by an establishment to remove an adulterated, misbranded or violative product from the market. In other words, a product for which FDA or a state could take legal action against the company would be subject to recall. If a company withdraws a product that does not violate food law or the product has not entered the marketplace, these situations dealing with quality issues are not usually considered recalls but may be considered a stock recovery or market withdrawal. Three classes of recalls are defined based on the potential health effects.

    • A Class I recall is the most serious and involves product that has a reasonable probability of causing serious injury, illness or death.
    • Class II recalls may cause temporary illness that typically resolves in full recovery. For Class II recalls, death and other serious consequences are not likely.
    • Class III recalls are not likely to cause illness but are still in violation of the law. Typically, a company voluntarily conducts a product recall, either on their own accord or at the request of FDA or a state.

FDA has the authority to require a company to conduct a recall in Class I situations.” (Preventive Controls for Human Food Curriculum)

The largest factor in determining a recall is understanding your hazard analysis. If you do not understand where a person is reasonably likely to become injured or ill then your company cannot fully implement a product’s recall. There are many factors that work in conjunction with one another to establish when a recall should be implemented. You must understand your process and what products are coming in as ingredients and what products are leaving your facility. A Class I, II, or III recall may not even be your company’s fault from the beginning. For example, a company could receive an adulterated ingredient or could have been shipped the wrong labels. However, a company could also be at fault because they did not properly check their labels or they could not have followed another preventive control that allowed for a product to be potentially harmful to the consumer.

I have been involved in a Class I recall where the manufacturer had data that led the regulatory authority to believe that a raw material came from a supplier that had a pathogen in the raw material. At this point, the game changes because a company must find and isolate any potentially adulterated product. They must then work with the recall team to make sure that specific product has not been sent to the consumer until such time as proper testing and evaluation of the product has been conducted. These recalls are time consuming and are tough decisions that must be made – but ultimately the safety and the security of the food supply in the most important factor.

Recall teams are critical to the process of deciding when a recall is necessary and what is to be done in case a recall is, in fact, initiated. “The owner, operator or agent in charge of a facility is accountable for the safety of the food and must ensure that a Recall Plan is written. A recall coordinator and recall team are typically identified ahead of time. The recall team should include all functions necessary to collect accurate and complete information. For example, production, shipping, quality assurance, sales and administrative personnel should be considered as members of the recall team. If the firm has multiple locations, the team may include corporate team members from different departments (e.g., safety, quality assurance, distribution, etc.). Each recall team member should have clearly defined roles.”

A recall plan must have a hazard analysis and dedicated team to make sure that an effective recall, if necessary, can be completed with maximum efficiency. There are many ways to have your written documentation to prepare for a recall and there is an abundance of work that must be completed before, during and after a recall. If you have a recall you must be prepared for one and understand the impact, you must be ready to act and you have to have programs in place to implement documented corrective actions. ConnectFood.com has recall planning tools available for companies, so if you need help we are here for you to contact at ConnectFood.com.

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.

Let’s spend some time addressing a topic that not one single food manufacturer or distributor enjoys discussing: product recalls. Let’s face it, a product recall could be one of the largest headaches your company has to face, but if completing a smoothly operated and well-organized recall means no consumer gets ill or passes away, it is worth the preparation and action.

Mock recalls are a vital part of your company’s food safety chain. The way you plan for an event, such as a recall, will determine how the event will go in the case of a time-sensitive emergency. To begin, “what is a mock recall, and why do we need to do one?” Jumping right in, a mock recall is a test run at carrying out a product recall and a way of finding the insufficiencies in your written recall plan. During a mock recall, a consultant or simply your facility manager will oversee the process of what a specific product recall would look like. The overseer will take a good look at your recall team -who you have assigned to each task, they will double check the phone numbers and contact information for your U.S. Food & Drug Administration (FDA) representative, the statement you would release to the public, etc. Ultimately, they will make sure that your facility would be able to smoothly execute what your documentation outlines without straying from your written food safety and recall plan.

According to the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food: “If the hazard analysis identifies a hazard requiring a preventive control, the facility must have a written recall plan that describes the procedures to perform a recall of the product. The recall plan must include procedures to notify consignees, to notify the public when necessary, to conduct effectiveness checks and to appropriately dispose of recalled product.”

A mock recall can be conducted as a scheduled event or as a surprise to the facility employees. Of course, there are advantages to both. Scheduling your mock recall will ensure that you’ve organized your documentation to the best of your ability, and can run the mock recall with absolutely no surprises or hiccups. This will be your “best case scenario” situation. However, springing a surprise test of your emergency preparedness system will give you a more accurate representation of how equipped your facility is for an emergency recall. Think of this as your stress test – you’ll find the holes your recall team’s plans that may not have caught in a controlled, scheduled test. It is entirely up to you which plan of action you’d like to take.

Document everything! We at ConnectFood.com cannot shout this statement loudly enough from the highest rooftops! As you’ve read in prior posts from us, CEO Matthew Botos frequently says, “If you didn’t document it, you didn’t do it.” This includes your mock recall testing. Record it all – what went well, what did not go so smoothly, the original plan, and the newly edited documentation. Being able to provide documents describing your emergency planning to an FDA inspector during an audit will keep your company compliant with the requirements of your written food safety plan. The FDA released an updated set of requirements in May 2018 regarding recalls, which can be found here. This regulatory procedures manual outlines exactly what your facility needs to have prepared as part of your written recall plan. This manual may be 87 pages long, but it is necessary information for your food safety manager and recall team to be familiar with. Review and get comfortable with what is required as a part of your recall plan – this is what you will assess during your mock recall.

Though FSMA does not require a mock recall as part of your written food safety plan, take a moment to think of the chaos your facility could avoid by choosing to get ahead of the issue. Brian Honigbaum of Quality Assurance Magazine says “practice makes perfect” in his article on mock recalls, and he is absolutely correct. The more effort and seriousness you put into your mock recall, the more prepared and confident your facility will be in the case of initiating and carrying out a product recall. Recalls are high-pressure situations, but you can be prepared to handle the stresses and surprises with a bit of preparation.

Want more information on recalls? Dr. Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), wrote a series of “Recalls: Lessons Learned” blogs for ConnectFood.com last summer just for you! Check them out here: Part 1 & Part 2.

ConnectFood.com can help you get your recall team, hazard analysis, and recall documents organized and in place. If you need assistance with any of these items or would like to schedule a consultant to conduct a mock recall for your facility, contact us. We are here to help you achieve the utmost food safety status.

About the Author
Johanna Seidel, PCQI
Johanna Seidel is an administrative member of the ConnectFood team, where she works as manager of operations and manager of social content. She is a certified Preventive Controls for Human Food Qualified Individual (PCQI). She received a Bachelor of Fine Arts Degree from West Texas A&M University in 2016. When she is not working food safety, Johanna also works as an instructor for The Chicago School of Ballet.

Eric F. Greenberg, a private attorney with a practice concentrated in representing FDA-regulated food companies and others.
Informational only, not legal advice

There are several truisms about food companies and documentation:

MORE DOCUMENTS THAN EVER
First, companies producing FDA-regulated foods these days are required to make and keep more documentation than ever, mostly due to the Food Safety Modernization Act of 2011. Companies are required to generate, for example, food safety plans with a hazard analysis and preventive controls, a supply chain program and a recall plan. Then, after setting up these systems, companies need to generate and keep documentation proving they are following the programs they established.
Also, companies who recall food should remember that they might have reporting obligations, within 24 hours of discovery, about food that might be a danger to health, via the Reportable Food Registry portal.

DOCUMENTS ARE NOT ENOUGH: ALSO TRAIN
Second, once you have set up those documented programs, don’t neglect to train your employees on what they require. This goes for recall plans as surely as any other aspect of your program. FDA inspectors think perty documents are fine, but they would rather see confirmation that your people have a thorough knowledge of what’s in them and operate under them all the time. Which leads to the third point…

DOCUMENTS ARE NOT ENOUGH: ALSO DO WHAT THE DOCUMENTS SAY
Third, for gosh sakes, be sure to follow your own procedures. It’s the easiest thing in the world for an FDA inspector to cite your company (that is, make an inspectional observation) for your failure to follow your own written procedures. There are a lot of interesting policy debates one could have about the wisdom or necessity of any particular detail of a company’s safety plan or preventive controls, but those debates really don’t matter if you said in your own SOP that you would check the temperature of your cake mix after baking, but didn’t do so.

DOCUMENTS AND RECALLS
Finally, documentation is relevant to recalls in at least two important senses. One is that the company will have in place the requisite recall plan, having thought through in advance the necessary steps to undertake or consider when problems arise. The value of preparing in advance cannot be underestimated, particularly because circumstances in which safety concerns arise or are suspected can be high-pressure, fluid, and even emotionally charged.
Second, of course, documentation of production can help a company identify causes or potential causes and define a limited scope for the affected product, and then identify the consignees who received the product within that scope. Without such documentation, the prospect exists that a company might decide its only reasonable option is to recall everything it’s made that is still out in commerce, which is often a very expensive and burdensome option.

Have more questions about documentation or would like to get in touch with the author? Contact ConnectFood.

About the Author:


Eric F. Greenberg is Principal Attorney of the law firm Eric F. Greenberg, P.C., with a practice concentrated in food and drug law, packaging law, and commercial litigation.

His food and drug work has included regulatory counseling, label and claims review, new product development, GRAS and food contact materials evaluations and clearances, negotiations with the U.S. Food and Drug Administration and state agencies, handling recalls, and defending enforcement actions.

In addition to his law practice, Eric is a member of the Adjunct Faculty of the Chicago-Kent College of Law, where he teaches Food and Drug Law and Administrative Law, and graduate and undergraduate Packaging Law and Regulation at California Polytechnic State University (CalPoly).

Eric wrote the book, Guide to Packaging Law, the Second Edition of which was published in October 2007. He serves as Legal Editor and monthly legal columnist for Packaging World Magazine. Eric has served as General Counsel of the Contract Packaging Association for over 15 years. His firm is based in Chicago and represents clients based all over the world.