Tag Archive for: fda

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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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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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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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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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Fresh-Cut Produce: Part II

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

Produce Safety Rule Exemptions:

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

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

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

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

Farm Mixed-type Facilities:

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

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

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

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FSMA Final Rule for Preventive Controls for Human Food

FSMA Final Rule on Produce Safety

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

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FSMA Intentional Adulteration Rule

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

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

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

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

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

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

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

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Don’t Fear the New FDA Sanitary Transport Rule

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

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

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

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

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

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

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

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Logs & Record Keeping

In this blog we are going to talk about logs and record keeping. If you seem to continue seeing this topic as a constant theme within the food safety industry, it is because it is the way that all companies have to keep “score” in the food safety world. Documentation is what allows us to benchmark our progress. Records and logs exist so that an organization can tell their food safety story to both regulators and to their customers. Logs are a necessity for your food safety chain, and you can find example forms for logs and record keeping on connectfood.com.

An example of where records are important is if you have a deviation in the food production process. An instance of this would be that your chart recorder ceases to work during a thermal process, say batch heating a product with a pH below 4.1, and at the end of the run you realize that you do not have the chart-recorded log. In this case, other measurements such as handheld temperature monitoring or visual readouts of a redundant thermocouple could be used to showcase that you still have a safe product for the target consumer. You will then use these records and logs to show that you did, in fact, follow your process and that with adequate testing and record review the product would be safe to ship.

    “Implementation records document the actual implementation of the Food Safety Plan. In other words, implementation records demonstrate that you did what you were supposed to do. Examples of implementation records include, where applicable, records that document the actual monitoring of preventive controls, corrective actions taken, different verification activities performed, validation activities performed (if needed), the supply‐chain program checks and applicable training records.” –FSPCA Preventive Controls for Human Food course curriculum.

Records and logs tell a story: from the time a supplier provides an ingredient until the time the product is delivered to the consumer, there is documentation. This story can include a manufacturer asking for the records and logs of how an ingredient was processed to how it was shipped and stored before arriving. This story could follow the documentation of a low moisture ingredient that is shipped at ambient temperature but needs certain humidity controls. Or, it could be an example of fresh fish where the records must show temperature control and amount of time the product has been in transit. These records are all things that an FDA regulator will ask for and that a facility must be able to provide within the 24-hour restriction set by the Food Safety Modernization Act’s Preventive Controls for Human Food rule.

Another area that companies wonder about in regards to record keeping is: how long do I need to keep records, and what if I want to use electronic records?

“Electronic or computerized records are acceptable in a preventive controls system as long as they are equivalent to paper records and electronic signatures are equivalent to traditional handwritten signatures. Controls are necessary to ensure that records are authentic, accurate and protected from unauthorized changes.” – FSPCA Preventive Controls for Human Food course curriculum. ConnectFood talked about the move towards electronic records in a recent online interview with Food Safety News.

When it comes to how long records need to be kept, the answer is a minimum of two years from the date the log or the record was created. The records that relate directly to the food safety plan and the product’s completed food safety plan must be kept on site. Collecting proper records and logs and having them readily available is how companies demonstrate that the food safety plan is working. You can find many of these best practices in the FSPCA manual.

Most important to remember when it comes to records and logs are that, 1. you know what you are monitoring and, 2. you have trained personnel in your facility. All the logs and records in the world will not make a difference if the person tracking and monitoring the records do not know why they are taking these records and how they impact the food safety plan. Having A Preventive Controls Qualified Individual on site that can review and sign off on logs is a critical part of your food safety process. The worst-case scenario is to have a complete plan and a detailed hazard analysis but then have records and logs that do not reflect the accuracy of your production. This can lead to recalls and other issues that jeopardize the company and the consumer.

Your recordkeeping is your product’s story: make sure you’re telling a good one. ConnectFood can help you get your documentation in order and provide you with example sheets for logging. Send us a message.

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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