Tag Archive for: food news

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.

How badly did I NOT want to put Coronavirus (Covid-19) in the title of this article?
This article is focused on the best practices that we should all be practicing in our food facilities, global pandemic or not. I was torn on the addition of “Covid-19,” but decided to go with the most important things keeping our food manufacturing and food preparations running and keeping jobs and creating commerce: food safety. This article is focused on the best practices that we should all be practicing in our food facilities, global pandemic or not.

“We have always had best practices in sanitation (SSOPs) and good manufacturing practices (GMPs) that are the foundation of our food safety plans.” Said one manufacturer. “Working with organizations like ConnectFood allows us to continue to refine our best practices and paperwork and have continuous improvement on our already stellar best practices.” ConnectFood food is not the only organization (nor anywhere near the largest) tackling global food safety issues and the impact Covid-19 has on our manufacturing.

The above quote is what I really want to talk about. ConnectFood works with thousands of companies to help them understand Good Manufacturing Practices (GMPs), Standard Sanitation Operating Procedures (SSOP’s), and food safety. In a time of crisis, the most important thing to continue is communication. Do all of your employees fully understand the areas of your GMPs and their impact on food safety and human health?

Covid-19 is not a foodborne illness issue, but transmission can be impacted by sanitation and personal hygiene best practices (GMPs).

We can keep producing safe, healthy food with a safe, healthy workforce in this environment. Having all organizations working together in the fight to keep manufacturing growing, collectively we can use the resources set out by Industry, Academia, and Government.

Constant education in a food manufacturing facility is the way we address new, current, and part-time employment. It is the way we address corrective actions. Sanitation and hand washing is not a new concept, but in a time like this we need to make sure all members of our companies understand the importance. Your company should have these practices in place, so a refresher course on the procedures may be wise during this time of heightened awareness for human health for all and encourage your employees to take these best practices home.

Some other questions that we are fielding refer to food that was manufactured in other countries that have been on the news for transmitting cases of Covid-19. The main question has been, “is that food safe?” My response was that if you felt comfortable eating that food in the past, you should continue to use that product from a trusted manufacturer.

What happens if there is an issue?
If public health is notified that a household has had contact or a potential infection, follow guidance from clinicians and your department of public health. In a manufacturing setting, if an employee does not feel “well” they should stay home just as with any illness to prevent spreading it throughout the facility.

Keeping the food supply safe and operating is crucial to all communities around the world so that households not only have food for active healthy lifestyles and the ability to pay bills, but also to enjoy themselves. I suggest to you that food safety plays a monumental role in this and how we address the current Covid-19 situation.

Speak with your employees frequently, but especially more so in a time of crisis or on an allotted timetable. We can all work together to keep a safe and healthy food supply. This includes keeping people at work and in jobs that make a difference.

Here are some links that I found helpful while researching Covid-19:
FDA Resource: https://www.fda.gov/food/food-safety-during-emergencies/food-safety-and-coronavirus-disease-2019-covid-19
USDA Resource: https://www.usda.gov/media/press-releases/2020/03/17/usda-ensures-food-safety-during-covid-19-outbreak

Stay safe, stay healthy, and don’t forget to wash your hands!

About the Author
Matthew Botos is the CEO of ConnectFood. ConnectFood offers an online food safety plan generator to help companies comply with Food Safety Regulations and the Food Safety Modernization Act. ConnectFood provides On-Demand plan reviews and writing services from a national network of food experts. Matthew Botos is the former Director of the Illinois Center for Food Safety and Technology, a non-profit consortium of Illinois food companies, regulatory personnel and academics focused on food safety and the advancement of science and technology for both local and global food sources. Mr. Botos is currently on the Food Safety and Preventive Controls Alliance (FSPCA) International Subcommittee. He is also one of approximately 40 approved Train the Trainer instructors of the FSPCA Lead Instructor program launched in October 2015 and has taught over 1,000 of the nation’s leading food safety experts.

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.


    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

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.