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Keeping Food Safe with a Food Safety Plan

If you are a domestic or foreign facility covered under the preventive controls rule, you must implement a food safety plan.  The rule on Preventive Controls for Human Food is mandated by the 2011 FDA Food Safety Modernization Act.  The food safety plans will help identify food safety hazards the require a preventative control and implement preventive controls to minimize or prevent hazards. Here are some helpful tips to provide a cleaner workflow for your staff and a cleaner environment for your consumers.

What is a food safety plan?A food safety plan consists of documents that provide an approach to identify hazards that need to be controlled to prevent the possibility of illness. The documents show proactive measures, which are enacted to minimize the risk of illness related to contamination. This continues ongoing evaluation of the policies, Standard Operating Procedures (SOPs), and records.   

The food safety plan must include:The Product Description, Incoming Materials, and Process Flow, Risk Evaluation, Hazard Analysis, Critical Control Points (CCPs), Monitoring Procedures, Corrective Actions, Supplier Evaluation, Recall Plan, Verification Procedures, Supply Chain Control Program, and Preventive Controls. 

Why is it beneficial to have all these documents within a food safety plan?Having a product description can identify some food safety hazards in how to control them. It is important to understand the process flow of the facility because it shows from the receiving of ingredients to the distribution of your product to help identify cross contamination points. A Hazard Analysis is used to identify any known or potential biological chemical and physical hazards and determine if any of those hazards require a preventive control. If the hazard analysis identifies a hazard that requires a preventive control, you are required to develop and implement a control to significantly minimize or prevent the hazard. The preventive controls must be written in the food safety plan and include as appropriate procedures, monitoring, corrective actions, verification, records, and in some cases, validation. 

A food safety plan can outline preventive controls and associated requirements that could include process controls, food allergen controls, sanitation controls and supplier controls. It is important to remember that a hazard to your consumer is a hazard to your business.  

If you fail to prevent to eliminate the hazard at a critical control point, you will not be able to prevent or potential illness. In other words, having a food safety plan that states control points are critical to keep your food product and the consumers safe. Careful monitoring procedures help ensure that your process facility is operating safely and within critical limits at each critical control point. Implementing monitoring procedures from a food safety plan can assist your company in a practical and realistic way by identifying unsafe food quickly and record keeping. Knowing who, what, how, and when to check when monitoring is conducted, will keep your company be in an organized manner. 

If there happens to be a non-conformance that occurs, it is a must to be prepared by following within a food safety plan to take Corrective Action. By taking Corrective Actions, you can investigate the cause, put products on hold, continue the process until it is safe, and recording any non-conformance taken to prevent reoccurrence. 

It is important that your facility is following food safety fundamentals. HACCP Prerequisite programs are fundamental and to see if verification procedures are being applied. It also vital that your facility is structured by keeping records. Obtaining records demonstrates how well your food safety plan and that your product is being made safely. Overall, food safety plans are valuable to have because they create a clean environment and good manufacturing practices for your establishment to make sure everything is running smoothly.  

Are there resources?There are resources available to help facilities develop a food safety plan. ConnectFood is a great resource!  ConnectFood uses a software program that has food safety professionals that can help you develop a customized food safety plan for your facility. It is in compliance with the USDA, FDA, and local regulatory bodies. ConnectFood’s plans are up to date with the latest information and has a variety of plan templates already available from dairy, beverages, seafood, and protein products. Following a food safety plan is very essential towards a company to avoid outbreaks and to ensure regulatory compliance. 

A Note From ConnectFood CEO Matthew Botos: 

We manufacture food every day both globally and locally. Food safety plans are different for every facility. You can make the same product in two different locations and have two slightly different plans.  Each facility is responsible for bringing a team together, as discussed above, to identify potential hazards and put measures in place to protect consumers and the supply chain.  It is important to analyze not only the physical characteristics of your product but also who in your facility is responsible and are the employees trained. Companies must also look at their facilities and equipment for areas of potential contamination.  Management commitment along with good manufacturing practices and proper sanitation are foundations of strong impactful food safety plans.

About the Author:

Daniela Jugueta received a B.S. degree from SUNY Buffalo State College. She is currently pursuing a M.A.S. degree in Food Safety and Technology in the Food Science and Nutrition department, Illinois Institute of Technology. She is also an intern for ConnectFood as a Food Safety Specialist.

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Food Defense: A Shield for Businesses and Consumers

In an era of globalization, the world has become a smaller space. It has become easier to travel and transport things from one corner of the world to another. Likewise, the complexity, diversity and dependency on intertwined domestic and global processes continue to grow in the food system. At the same time, there are increasingly possible causes of deliberate adulteration that continue to develop, become more complex, and will simultaneously have a direct effect on public health. So: to prevent, plan, respond to, and recover from acts of deliberate adulteration of the distribution of food, Food Defensebecame an important part for shielding food businesses and consumers from any potential threats. 

Food Safety and Food Defense

To protect and prevent food from any adulteration – whether it is intended or not, regulatory requirements have been put into place, which are based on food safety and food defense procedures. In other words, food defense and food safety contribute to the prevention of adulteration. The key difference between these two types of training is that food safety prevents food from unintentional adulteration. Food defense is responsible for protecting and preventing the public from intentional adulteration, which in turn may cause harm to consumers. 

What is Food Defense?

The Food & Drug Administration (FDA) states “Food defense is the effort to protect food from acts of intentional adulteration.” So, more basically stated, it prevents consumers’ health from any physical, chemical, and biological impurities deliberately added to food that could harm the consumers’ health. Due to increasing need for food defense, FDA issued a rule in May 2016 under the Food Safety Modernization Act (FSMA). The main objective of the rule is to prohibit deliberate adulteration of actions designed to cause systemic damage to public health, including acts of terrorism targeted at food sources. Although these actions are unlikely to occur, they could potentially cause disease, death, and economic destruction to the food chain if there are no prevention strategies in place. Additionally, FDA has developed a range of instruments and tools to help food facilities prevent, plan, respond to, and recover from acts of deliberate adulteration of food facilities. 

Food Defense Plan

In accordance with FDA, it is required for both domestic and foreign companies that are registered with FDA as food facility to formulate and execute food defense plan. A food defense plan must include a vulnerability assessment, mitigation strategies, food defense monitoring of the implementation of mitigation strategies, corrective actions, verification procedures, and logs or records. Every three years or where conditions have failed (such as mitigation techniques that are found to be poorly applied) a reanalysis is required. A detailed overview of what needs to be included in a food defense plan is outlined in 21CFR121. This plan will help the facility to find out what precautions one must take to reduce the risk of food items in the facility being tampered with or deliberately poisoned. A food defense plan will strengthen the preparedness of a food processor. These protocols will also enhance the ability to respond efficiently during a crisis, where stress levels are elevated and reaction time is minimal. As it is a very new concept for the industry, FDA has published a number of tools and assistance on their website (https://www.fda.gov/food/food-defense).

Future and Present Situation

With intentional food adulteration and food fraud on the rise, it is crucial for food facilities to keep their food defense plan updated. Manufacturers should make sure to revisit and review their food defense plans for any improvements to facility designs or techniques, product changes, and protection upgrades. Facilities should also track their workers on a daily basis, both in terms of satisfaction and understanding. This will benefit the facility, the health of consumers, and eventually the economy of the country. 

A Note from ConnectFood CEO Matthew Botos:

Food Defense is the protection of food products from contamination or adulteration intended to cause public health harm or economic disruption. The mission of the Food Defense Programs is to protect the U.S. food supply from dynamic and evolving threats. ConnectFood and the Institute for Food Safety and Health conducted a two-day workshop on Food Defense last week. The workshop focused on how Food Defense is developed and the fundamental building blocks of our existing food safety plans. We taught with the understanding that we are facing trying times locally and globally. The class was interactive across abroad range of companies and allow for discussion and training allowing companies to supplement their existing best practices. Food is a vector that has long been used to disrupt supply chains and cause unfavorable conditions for consumers. ConnectFood.com strives to keep the food supply safe and secure by providing documentation that meets requirements for Food Defense.

About the Author

Saloni Shah 

Saloni Shah received a Bachelor’s degree in Biotechnology from India. She is currently pursuing an M.S. in Food Safety and Technology from the Illinois Institute of Technology. She is also a research assistant working on a thesis focusing on food packaging materials and additives under a FDA scientist and is currently working as part of the Food Safety Specialist internship at ConnectFood.com.

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Food Recalls: Why We Take Them Seriously

In January 2021 a food retailer recalled cartons of their ice cream due to metal fragments in the product. Only one consumer reported metal pieces found in their ice cream; however, due to this incident, as many as 11,000 cartons were recalled due to the concern that there could be metal fragments found in other cartons that were shipped out during the period of production and quality control. A popular microwaveable meal was also recalled recently due to possibility of plastic and glass contamination. Last year, there was also an E.coli outbreak due to Romaine lettuce. This article focuses on how severe recalls can be but the majority of recalls do not pose a threat to human health.

What is a food recall? A food recall is when a food manufacturer must remove their product for consumers to purchase due to reported cases of illnesses caused from the product. Food recalls are common and there have been countless cases of illnesses that have been linked to recalled products. These recalls have affected customers greatly by ways of adverse health consequences, or – in some extreme cases – even leading to death. When individuals go inside a grocery store or market, it is often not their first priority to think about the consequences of what may happen if they were to purchase tainted goods.

There are many reasons why food recalls occur: Biological hazards, misleading claims, chemical hazards, physical foreign objects, and undeclared allergens are all primary reasons. Food can also be recalled if health inspectors spot faults within a food plant and they want to prevent individuals from getting sick. Due to the following reasons, consumers should take major precautions when it comes to food recalls. Food recalls, if they are not followed, have the potential to be detrimental and can lead to further outbreaks of contamination towards healthy individuals. 

As a consumer, what should you do and look out for? It is possible for any food or product to be recalled suddenly. So before running to grab groceries, take a minute to research and keep up-to-date with what goods are under active recall. There are a lot of resources online to do this! Depending what product it is, the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA), have links on their main websites to trace current recalls. When grocery shopping, look at the physical state of the product. One should ask themself – Is it damaged? If yes, then choose another. For individuals that have allergies, read the labels! There can always be undeclared allergens and misleading claims to look out for. Lastly, rinse the produce before use. Not all raw produce goes through a vigorous sanitation process. Food should be disposed when they are recalled. There is also another choice, which is to go back to the store and return the product for a refund. If product is consumed after finding out about the recall – do not panic! Food recalls are often done as a precautionary measure. There are a lot of other precautions to look out for, but these are some of the vital safety measures.

How serious are food recalls actually? Food recalls have become fairly common nowadays, but you should never underestimate the seriousness of the recall. Consumers should double check what they are purchasing to consume and ask themselves: “Is it safe to eat?”

A note from ConnectFood CEO Matthew Botos: When teaching Preventive Controls for Human Foods we look at recall plans as a building block in our overall food safety system. After completion of a company’s hazard analysis and understanding what needs to be monitored and why it needs to be monitored, we create a living recall plan. We must emphasize that an effective recall plan can reduce the financial impact for the company by facilitating rapid retrieval of adulterated products. An effective recall plan can also reduce the number of people who become ill. It is important to note that not all recalls are food safety issues but can come from other issues such as quality, mislabeling, etc. Knowing your product, knowing where that product is distributed, and having a capable team will keep the food supply safe with a recall plan.

If you’re looking for assistance with recall documentation for your facility or products, ConnectFood can help! Contact us today to schedule a consultation for your recall plan, or take a look at our subscription tiers for more services.

About the Author:

Daniela Jugueta received a B.S. degree from SUNY Buffalo State College. She is currently pursuing a M.A.S. degree in Food Safety and Technology in the Food Science and Nutrition department, Illinois Institute of Technology. She is also an intern for ConnectFood as a Food Safety Specialist.

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UPDATE: FDA Helps Small Businesses Determine Their Size: Will My Facility Be Inspected?

FDA Publishes a Final Guidance Document
That headline is part of the big news here. We are living in the world of draft FDA guidance documents for food safety that are the FDA’s current thinking on a topic. I applaud the FDA for releasing the final guidance document on this topic in June 2019. FDA published the draft guidance Determining the Number of Employees for Purposes of the “Small Business” Definition of Parts 117 and 507: Guidance for Industry in March 2018, and this is an update on my blog post from that month.

Why did FDA publish this guidance?
The purpose of the guidance is to raise awareness of compliance deadlines for Part 117, the human food rule, and Part 507, the animal food rule through the calculation of number of employees. All food facilities are now under enforcement for the human food rule regardless of the number of employees, making the guidance unnecessary for the human food rule. Only very small businesses can qualify for an exemption from Subparts C and G of Part 117 Preventive Controls for Human Food rule and are defined as earning less than $1 million in annual revenue and not by the number of employees.

The guidance is helpful in defining subsidiary, affiliate, facility and full-time equivalent (FTE) employee. There are clear examples to showcase types of facilities and calculations of FTEs. The purpose for calculating FTEs is to determine if a facility is defined as a small business of less than 500 FTE employees.

Wait. What about the Intentional Adulteration rule?
If you are on top of your FSMA rules game, you know that the last FSMA rule to come under enforcement is the Intentional Adulteration rule in July 2019. Guess what food facilities are first to come on board? Yes, facilities with more than 500 FTE employees! Does your facility have a written and implemented food defense plan? I have blog posts here on food defense to get you started; search “food defense.”

Will my facility be inspected with a preventive controls inspection?
FDA prioritizes their inspections, so FDA must know if a facility is exempt from inspection as a very small business. For all other businesses, there are other factors used by FDA to prioritize inspections.

    • FDA inspection goals for the number of domestic and foreign facilities
    • Facilities posting a recall on the FDA Reportable Food Registry
    • Facilities with a current or previous Class I recall or warning letter
    • Facilities in the same product sector as a facility with a Class I recall
    • Facilities making a high-risk ingredient or product

      1. Ready-to-eat foods
      2. Foods identified in FDA’s Listeria risk assessment
      3. Foods otherwise with a history of risk

Most inspections are Good Manufacturing Practices (GMP) inspections. Every year the goal for the number of preventive control inspections increases and more FDA inspectors are trained. Some states have FDA contracts to inspect on behalf of FDA, and state inspectors go through the same training process as FDA inspectors.

While it is not possible to know if your facility will be inspected until the FDA inspectors are at your door, you can determine the likelihood by using the same tools FDA has to prioritize inspections, i.e. the links above. Very small business can qualify for an exemption of a written food safety plan and recall plan, but all other food businesses will be more prepared for an inspection with a current food safety plan and recall plan.

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.

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Are Food Laboratories Required to be Certified?

If you have heard of ISO 17025, you either work in a food testing laboratory or send samples to a food testing laboratory. Clients in the food industry have asked me, is ISO 17025 a requirement? There is no simple answer. For example, state labs are now going through the process of getting accredited to ISO 17025 as a requirement by the federal government. Let’s work through the other answers to the question.

Why is International Organization for Standardization abbreviated as ISO?
As a microbiologist, we have an acronym for everything, so I was curious about the meaning of ISO. International Organization for Standardization is what I learned as the full name of ISO in English, and I confirmed this on the ISO website. ISO is an international organization based in Geneva, Switzerland, so I used to believe the original name was in French, but now I believe that is wrong. In 1946 when the first delegates met in London, they met to discuss International Standards, i.e. IS. I read in a history of ISO there may have been the use of iso from Greek meaning “equal.” Today, most of the use is with ISO without the complete spelling of the full term, with scientists just understanding what ISO is and does. ISO has 162 countries represented in membership and has published over 22,000 voluntary International Standards.

Is laboratory accreditation to ISO/IEC 17025 required?
ISO and the International Electrotechnical Commission (IEC) develop joint ISO/IEC documents under the management of the ISO Committee on Conformity assessment (ISO/CASCO).-ISO/IEC 17025:2017 Forward. Following ISO standards is voluntary, so this answer is no, ISO 17025 is not required. ISO/IEC 17025:2017 is the international standard for competent laboratory operations, validity of results, and instills confidence between laboratory personnel and their clients. When a food testing laboratory works through the process of earning and then maintaining the accreditation, the laboratory sees benefit to their operations and for marketing to industry. ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories is the International Standard. Any lab achieving ISO 17025 is functioning at the highest level.

You want your laboratory ISO 17025 accredited.
As a member of the food industry, you want your food testing laboratory to be accredited to ISO/IEC 17025:2017, even though it is not required. It is now normal in the food testing lab business to be accredited. Right now, go to the testing laboratory website and search for their ISO certificate. Most labs will post this on their website. If not, call your laboratory’s customer service and request a PDF of the certificate. On the certificate, tests will be listed for microbiological, chemical or physical testing for which the lab has proven competency. Cross-check the methods on the certificate to the methods on your laboratory report. If you have questions, talk to your customer representative.

The Preventive Controls for Human Food rule under FSMA requires a written hazard analysis and 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.

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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FDA Responds to Failures in Recall Process

Caliente! Hot Topic!
Have you heard? FDA is going to initiate recalls and announce recalls to consumers. Technically, the FDA initiating a recall is not new, because FDA gained the authority to initiate a recall in 2011 with the signing of the Food Safety Modernization Act (FSMA). FDA has pumped out three new guidance documents on public notification of a recall. The last of the three, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019, was recently published.

What is the Purpose of the February 2019 Guidance?
FDA is communicating to industry and providing recommendations for its own staff for when they will initiate a recall and publish a public warning of a recalled food. FDA has seen, in rare cases, where there is not cooperation from the recall firm or there is slow announcing of a recall. FDA calculated the average time for a firm to announce a recall is four days; it is implied that four days is too long for hazardous food to be in commerce. FDA intends to work cooperatively with the recall firm. The FDA must first provide the responsible party with an opportunity to voluntarily cease distribution and recall the article of food. FDA gives the first opportunity for initiating and announcing a recall to the Owner, Operator, or Agent-in-charge. Infant formula recalls are mandated separately, but all food, ingredients and chewing gum are otherwise covered by the guidance.

It’s not all bad news!
For fiscal year 2018, there were 7420 recalls and 831 classified as a high risk. Since 2012, the 2018 numbers are the lowest number of recalls. What happened after 2012? February 2013 was the start of FDA uploading whole genome sequences to GenomeTrakr and the transition away from PulseNet which uses the method of pulsed field gel electrophoresis. The greater sensitivity of whole genome sequencing has led to more recalls.

Timeline: April 2016
Given a head’s up on a pending report from the Office of the Inspector General (OIG), FDA created a team of senior leaders with oversight of recalls; the team meets at least weekly. Named Strategic Coordinated Oversight of Recall Execution (SCORE), SCORE expediated the process for suspending the registration of two facilities as of December 2017.

This is where the E. coli hit the fan.
The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply, December 2017. The 2017 report published from the OIG found FDA failures in food recall practices. The OIG made a series of recommendations on how the agency might improve its management of recalls.

Timeline: January 2018
FDA draft guidance [the January 2018 draft guidance is no longer available] on FDA’s policy and notification of recalled products and posting recalls to the FDA Enforcement Reports was published to assist the food industry in working with FDA through a recall.

What products are covered?
Food, drug, or device intended for human or animal use; cosmetic and biologic intended for human use; tobacco product; and any item subject to quarantine regulation. Radiation emitting electronic products are not covered.

Timeline: April 2018
I wanted to know when and how FDA used its new authority under the Food Safety Modernization Act (FSMA) in 2011. Last year I wrote what I learned in a ConnectFood blog post, which included 3 cases:

    1. Sunland peanut butter sold finished product containing Salmonella.
    2. Kasel dog treats recalled after Salmonella found.
    3. Triangle Pharmanaturals’ kratom dietary supplements contain Salmonella.

One of my favorite sentences from the Kasel recall notification is as follows:

    If you do not voluntarily cease distribution and conduct a recall in the time and manner described in this section, FDA may, by order, require you to immediately cease distribution of the affected pet treats.

Timeline: September 2018
FDA Draft Guidance, Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff September 2018, was the first of three guidance documents published by the FDA. If known, FDA will notify the public of stores where recalled food was sold. Retail consignees include grocery store, pet food stores, convenience stores, but not restaurants or distributors.

Timeline: November 2018
In this FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market November 2018, two examples were given for when FDA has notified the public of a recall:

    • FDA Investigated Multistate Outbreak of Vibrio parahaemolyticus Linked to Fresh Crab Meat Imported from Venezuela, September 2018
    • FDA Alerts the Public Regarding Recalled Vegetable Products, October 2018 McCain’s Ready-to-cook and ready-to-eat (RTE)

While I appreciate the explanation, the following sentence stopped me in my tracks:

We’ve already acted on these draft guidances.

I had previously heard that FDA was acting on a different unpublished draft guidance document, but here I saw it in print. It is not clear if the FDA is working from the published draft guidance shared with the food industry or from unpublished, draft guidance documents.

The second guidance document was published: Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff, November 2018. The Q & A addresses three questions.

1. When will the FDA publicize retail consignee lists?
FDA will determine the likelihood of serious adverse health consequences or death of humans or animals (SAHCODHA) resulting in the food being adulterated and in most cases a class I recall. Some class II recalls or unclassified recalls will be publicized. I was very interested to see examples of what FDA considers high risk foods:

    Listeria monocytogenes-smoked salmon, pumpkin seeds
    Salmonella in ready-to-eat food-peanut butter, alfalfa sprouts, deli products
    Certain undeclared allergens in food
    E. coli O157:H7 in leafy greens
    Botulinum toxin- e.g. under processed canned chili
    Choking hazard in baby food, and
    Misbranded food with missing or incorrect food allergen labeling

For notification by FDA and in most cases, the retail packaging will make recalled food difficult to identify, and the food will be likely to still be in homes or stores. For example in the spring 2018 Romaine lettuce recall, much of the Romaine was beyond its shelf life and was not expected to be available in stores or homes by the time the recall was announced. From the Q & A guidance: There may be situations where both criteria are not met and FDA notifies the public. The FDA is not required to contact the firm before issuing a public warning or allow its review of the proposed statement. FDA may supplement or correct [the] warning.

What information will the FDA provide?
When FDA notifies the public of a recall, they wish to have information that help the consumer identify the product. Such information includes name of the food, lot or code dates, product description, photographs, geographic information, retail-related information, e.g. by naming the retail store chain, and potentially store specific information such as city and state. FDA will describe the risks and information about similar food that is not affected by the recall. FDA will state that the information may be under or over inclusive.

How will the FDA publicize this information?
FDA Public Warnings will come as a press release posted on the FDA website, alerts, and public notices by email, web or social media. Public notification of a recall is published in the weekly FDA Enforcement Report.

Timeline: February 2019
The FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls February 2019, and FDA Guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019, detail the FDA’s current thinking on when FDA will notify consumers of a recall. Companies which do not cooperate with the FDA for a recall or communicate a recall slowly to the public may experience the FDA announcing a recall.

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.

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.

References

    1. Food Safety Modernization Act (FSMA) January 2011
    2. FDA Rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food September 2015
    3. Office of the Inspector General (OIG) Report, The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply December 2017
    4. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls December 2017
    5. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls January 2018
    6. ConnectFood blog post, FDA Uses New Authority Under FSMA to Order a Mandatory Recall, April 2018
    7. FDA Draft Guidance, Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance for Industry and FDA Staff September 2018
    8. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market November 2018
    9. FDA Guidance, Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff November 2018
    10. FDA Statement, Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls February 2019
    11. FDA Guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, Guidance for Industry and FDA Staff February 2019
    12. 21 CFR Part 7 FDA Enforcement Policy, Subpart C–Recalls (Including Product Corrections)–Guidance on Policy, Procedures, and Industry Responsibilities
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HACCP vs. Preventive Controls

The world of HACCP (Hazard Analysis and Critical Control Points) versus Preventive Controls is an interesting conversation we are seeing at connectfood.com and across the entire food industry. FDA has trained hundreds of inspectors in Preventive Controls for Human Food and there are thousands of Preventive Controls Qualified Individuals (PCQI’s) across the country and the world. There are tens of thousands of HACCP trained individuals. I have used the analogy that food safety best practices are like a sport; the more you train and the more you focus on “basics done well,” the better your plan will be on a day-to-day basis. The focus is making the food supply safer. This does not mean that HACCP is not valid, as a matter of fact HACCP and Good Manufacturing Practices (GMP’s) should be looked at as the foundation of Preventive Controls for Human Food. Local departments of public health still rely on HACCP as their main line of defense for the food safety industry. We have seen so many small processors and restaurants that have inspections at which HACCP is still the focus, even though Preventive Controls has some more advanced techniques for protection.

Both HACCP and Preventive Controls focus on making sure you have good sanitation practices, employee training and have done a hazard analysis for biological, chemical and physical hazards. I feel like the lines are blurring a bit as companies, academics, and regulators don’t often understand the differences between the two and – to be honest, the differences are not that great from a fundamental level. Here is where I come in with some definitions for you…

    “HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.

    HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

    HACCP System: The result of the implementation of the HACCP Plan.

    HACCP Team: The group of people who are responsible for developing, implementing and maintaining the HACCP system.

    Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

    Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.” FDA.gov

The fundamental principles of HACCP come through in Preventive Controls with some additional areas to focus on as we enhance our food safety plans.

    “In general, you are a covered facility if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Covered facilities are required to have and implement a written food safety plan that includes:

Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).

If the hazard analysis reveals one or more hazards that require a preventive control, the facility must have and implement written preventive controls for the identified hazards.

Preventive controls: Facilities have the flexibility to tailor preventive controls to address hazards that occur in the products they manufacture. The preventive controls, which must be written, must be implemented to ensure that any hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated. The rule includes the following preventive controls:

Process controls include procedures that ensure the control parameters are met. Process controls can include operations such as cooking, refrigerating, and acidifying foods. They must include parameters and values (e.g., critical limits), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.

Food allergen controls are written procedures the facility must have and implement to control allergen cross-contact and ensure allergens are appropriately listed on the labels of packaged food products.
Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards.

Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.

Oversight and management of preventive controls: Once a facility has identified a preventive control for a hazard, the facility must make sure that the controls are being met.

Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include recording temperature values. Monitoring must be documented.

Corrections: These are steps taken, in a timely manner, to identify and correct a minor, isolated problem that occurs during food production.

Corrective actions: These include actions to identify and correct a problem implementing a preventive control, reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent that food from entering commerce if you cannot ensure that the affected food is not adulterated. Corrective actions must be documented with records.

Verification: These activities are required to ensure that preventive controls are consistently implemented and effective in minimizing hazards. Examples of verification activities include scientifically validating process preventive controls to ensure that the control measure is capable of effectively controlling an identified hazard and calibrating (or checking the accuracy of) process monitoring and verification instruments such as thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (if necessary) are being conducted. Verification activities must be documented.

Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control.

Supply chain program: Manufacturers must have and implement a risk-based supply chain program if the hazard analysis identifies a hazard that

    (1) requires a preventive control and
    (2) the control will be applied in the facility’s supply chain.

Facilities do not need to have a supply-chain program if they control the hazard in their own facility, or if a subsequent entity (such as another processor) will control the hazard, and the facility follows applicable requirements.

Manufacturers are responsible for ensuring that raw materials and other ingredients requiring a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. (Suppliers are approved by the facility after the facility considers several factors, such as a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.)

Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity’s documentation that they verified the supplier’s control of the hazard.

Recall plan: 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.” FDA.gov

In conclusion, HACCP and Preventive Controls are both food safety risk management systems. connectfood.com provides the ability for all facilities that handle or process food to create a plan depending on what the regulatory authority or a clients needs. Contact us and let us assist you in your food safety planning.

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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Food Safety in 2019

The Food Safety Modernization Act has changed the food manufacturing landscape and will continue to do so in the new year. The industry has embraced the proactive approach by the federal government, but there is still much work to be done. ConnectFood’s customers had a banner year in 2018 with the launch of several new technologies and the adoption of the small and medium-sized industries realizing that the federal, state, and local regulators will be looking to work with industry to ensure that the food supply continues to be safe.

The food industry has spread from a local community to a global community and then back to a local community. I know that is an interesting statement, but as we look at the globalization of food from local farms and communities to the spread of large manufacturing and a global society we have also trended back to small manufacturers selling to restaurants and restaurants selling small batches to grocery stores.

The Government Shutdown has also recently had an impact on inspections. With that being said, FDA is still on point for the rest of this new year.

The partnership between the segments of the food industry has never been stronger. We must focus on fundamentals. As we have previously discussed, there are key areas we as a food industry will need to focus on as we move forward.

FSMA focuses on seven basic areas:

    • Preventive Controls for Human Food.
    • Preventive Controls for Food for Animals.
    • Standards for Produce Safety.
    • Foreign Supplier Verification Programs (FSVP)
    • Accredited Third-Party Certification.
    • Sanitary Transportation.
    • Intentional Adulteration (Food Defense)

It is my belief that the backbone of the act is the Preventive Controls for Human Food – and my personal favorite graphic is:

Each component of The Food Safety Modernization Act is asking and at times telling our industry that we must look at all of the hazards that could be possible in our facilities. A hazard is defined as:

    • Hazard requiring a preventive control: a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.
    • Known or reasonably foreseeable hazard: A biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.
    Human Food asks us to look at facilities that process, package and hold food. This is just asking what all components are that could potentially harm humans during consumption.

The Animal Food Regulation

“The final rule was published in September 2015 and larger animal food facilities were required to comply with the Current Good Manufacturing Practice (CGMP) requirements by September 2016.
Now larger animal food facilities have been required to comply with the preventive controls requirements since September 18, 2017, and facilities that are small businesses were required to implement the CGMPs by that date.

Because compliance dates are staggered by the size of the business, the next major compliance dates come in September 2018, when small businesses will also have to meet preventive controls requirements and very small businesses must implement the CGMPs.
This rule requires animal food facilities to have a food safety plan in place that includes an analysis of hazards to determine which ones need control and risk-based preventive controls to minimize or prevent those hazards” (FDA.gov)

Produce Safety

This rule establishes “science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables” for human consumption.

The Produce Safety Rule has six core components – as all of the rules are, they are connected to reducing the risk of contamination of produce:

    • Agricultural water.
    • Biological soil amendments.
    • Sprouts.
    • Domesticated and wild animals.
    • Worker training and health and hygiene.
    • Equipment, tools, and buildings.

This rule has a long list of exemptions and variances which can be found at this link.

The Transportation Regulation

The Sanitary Transportation Rule establishes requirements for sanitary practices, this helps to reduce the risk of food becoming contaminated during transportation. This rule applies to “shippers, receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle.”

Foreign Supplier Verification Programs (FSVP)

Foreign Supplier Verification applies to companies that are importing food into the United States. These companies must have verified food safety plans and need to have evaluated their hazards for their products. Once again, this rule is set up to protect the United States consumer. The ultimate goal is to establish program that make foreign manufacturers as responsible as domestic manufacturers.
Accredited Third-Party Certification

This rule establishes the framework, procedures and requirements for accreditation bodies seeking recognition by the FDA, as well as requirements for third-party certification bodies seeking accreditation. As discussed by the FDA, this helps promote international consistency when all the components are used together.

Intentional Adulteration (Food Defense)

One of the most important components in my mind is making sure we keep out food supply from being compromised. FDA is working hard at putting components that will allow for companies to protect themselves from intentional acts of contamination and potential terrorism. Some of these components include:

    • Vulnerability assessment.
    • Mitigation strategies.
    • Mitigation strategy management components.
    • Training and record keeping.

All of these components together have created a proactive environment for the food industry. In the past we had been in a position to be rather reactive. Following these components, having active management commitment and working with your regulators will continue to help create he safest food supply in the world. We must now become more proactively involved.

The important thing from 2018 is that we have seen more reported recalls due to the diligence of the consumer, the industry, and the government. This means that the trend of understanding the importance of food safety is increasing, allowing more people easy accessibility to food safety information. The trends in local manufacturing, produce, and the security of our food supply will continue to increase.

In the coming weeks, connectfood.com will be covering all of these topics while highlighting the ways to tackle those food safety topics within our software. Our experts will weigh in and give you the information you need as it is available.

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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Romaine Recall – Round 2

CNN Lets ‘Food Babe’ Spout Pseudoscience on Lettuce Outbreak
There’s another wonderful headline. Everyone has something to say about Romaine lettuce and pathogenic E. coli. Everyone I know anyway. I do not spout pseudoscience, but I have previously written about our first Romaine recall of 2018 here, and I use credible sources for my information like CDC and FDA.

The United States is currently in a second E. coli O157:H7 outbreak linked to Romaine.
Our friends to the north in Canada are with us in this outbreak too. The CDC reported on November 26, that 43 cases in the US have been diagnosed across 12 states, with 16 hospitalizations and no deaths. The illness for at least one person has resulted in hemolytic uremic syndrome (HUS), i.e. kidney failure. The outbreak started the beginning of October, and more cases are expected to be reported.

Romaine is currently not harvested from Arizona.
The first 2018 outbreak of pathogenic E. coli was traced to Romaine grown in Arizona. It took some time to detect, but the source of the Romaine for the current outbreak is California, not Arizona. In fact, the search has narrowed to six counties in California where Romaine was grown and harvested.

Where was my Romaine grown?
In the last outbreak, family members were asking me if they really had to throw away the old Romaine in the refrigerator and the fresh Romaine they just bought at the store. Yes! All Romaine was discarded in the supply chain. Growers, processors, stores and restaurants are understandably upset at having to dispose of Romaine again. Thanks to government and industry working together, FDA is urging processors to label Romaine with used by dates, harvest location and harvest date.

Do you remember the outbreak of 2017?
Yes, we were in a similar spot a year ago with an E. coli outbreak in the United States and Canada. Data pointed to leafy greens, but the source of the outbreak was never found, and a recall was never announced by the FDA. Canada’s traceback investigation landed on Romaine as the source. In the US, there were 25 cases across 15 states with the outbreak starting the beginning of November. By the end of February, two people had HUS and one person had died. Canada saw 42 cases and one death.

Are all these E. coli the same? No, and Maybe.
No. The FDA states that the E. coli O157:H7 from the first outbreak of 2018 and from Arizona Romaine is different genetically from the E. coli O157:H7 of California, like non-identical twins. Close, but not the same.
Maybe. However, when comparing the E. coli O157:H7 of the current outbreak to the E. coli O157:H7 of the outbreak this time last year, they are identical twins:

    Genetic analysis indicates that illnesses reported in this current outbreak are caused by the same strain of E. coli O157:H7 seen in a previous outbreak that occurred in fall of 2017 that affected consumers in both Canada and the U.S.

Smart people are working on this problem in the United States and Canada. In the meantime, toss away any Romaine you have in your refrigerator. 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.

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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FDA Will Initiate A Recall if a Company Does Not

“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.

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