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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 FDA published the draft guidance Determining the Number of Employees for Purposes of the “Small Business” Definition of Parts 117 and 507: Guidance for Industry in March 2018, and this is an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.

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.

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

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.

NOTE: The author is proud to be a cheesehead from Wisconsin. She is passionate about food safety… and football.

Pre-season football has begun, and the tourists have descended upon my hometown of Green Bay, Wisconsin. Each year there is a bit of quiet during the months of May and June – after the NFL draft and before training camp in July. The rest of year, my town revolves around Packer games and activities. I can’t help but think about how food safety is like football.

Score is kept; records are established.
This year is the hundredth season for the Packers. There are 99 years of rosters, wins, losses, and stellar plays. Every adult in Green Bay over the age of 70 claims to have been at the Ice Bowl.

How does your company keep score? There are records for manhours, number of lines, number of SKUs, and how much of each product is manufactured daily, weekly, monthly, quarterly, and annually. Keeping documentation is critical to business. Management will know if it is a winning year or a losing year by analyzing the numbers made.

The organization has a reputation.
What do people say about your company and your product? Every detail of your organization from CEO to ball-inflater is not discussed on sports radio, but the details are discussed at the photocopier, on the line, and in the breakroom. What do your employees think? One way to see what your employees or former employees think is on the website glassdoor. Glassdoor is used by job seekers to see comments by your employees about your company. Check it out. You will probably be surprised, because it is mostly likely going to be the “armchair coaches” complaining about the company. It is easy to say what we would do if we were in charge.

What do your neighbors and community know about you, the company next door? Like the Packer organization, your company may be a large employer in a small town, where everyone knows someone who works for the organization. As an employee, you represent the organization and have an opportunity to help establish a good reputation. You see each other at the grocery store and in church. (Yes, I must brag for a moment that I see Packer players with their families at church.)

Another group you hear from is your customers. The company collects consumer complaints and feedback on the product. Routinely review this information with the food safety team to know what your customers think.

You need a good team to win.
It helps to have a superstar like Aaron Rodgers to lead your team, but manufacturing a safe product is teamwork and the effort of many. Every employee has a role, a position, if you will, to play. Individuals require training and development to learn their role and for you to provide resources to perform their job using best practices. When you invest in your players, they can do great things. Make training and development a part of the culture. Year after year, fill key positions with the best talent you can find. Players will move into new positions, and you will lose players. Recruit the best players. Surround yourself with excellence.

People are passionate about your product.
If you are not a sports fan, think of something you are passionate about – your family, your hobbies, etc. If you do follow a team, you feel the passion I’m referring to. You have clothes and paraphernalia with the team logo branded on them. You enjoy being with people who share your same passion. You celebrate wins and analyze and mourn the losses. You are willing to dedicate time to your passion; it is a priority. Instill this passion in your employees regarding food safety and best practices.

Your customers are loyal to the product, and your company takes brand loyalty seriously. The greatest sign of loyalty I have seen is customers during a recall saying they are going to eat the product anyway! While I am not a proponent of the decision, I respect the sentiment. Blue Bell ice cream has such a loyal following that when manufacturing was shut down and their ice cream was not available in the store, Blue Bell ice cream could be found for sale on eBay.

You need depth in key positions.
Life happens. Who would have predicted that Aaron Rodgers, the Packer’s 20+ million dollar man, would have a broken collar bone twice and be out the rest of each season? Employees get ill or go on vacation, often at the most inopportune time. How is your depth in food safety? If you only have one Preventive Controls Qualified Individual (PCQI), what do you do if they leave? We are seeing companies have multiple PCQIs trained per facility to avoid issues if a situation were to arise. Companies that value food safety and want a food safety culture will invest in their key players.

Will your team have a winning season?
Like the football season, we don’t know what lies ahead for wins and losses. Who will step up to lead the team? Who will throw the Hail Mary for the exhilarating last-second win?! Many of my clients are now in their busy season leading to Halloween, then Thanksgiving, Christmas, and New Year. As you follow your team, I will be following my favorite team, the Green Bay Packers, until February and the Super Bowl in Atlanta. Go Pack Go!

Always remember: the way you practice is the way your company will perform.

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
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 delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in 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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dry operations are tricky. They are called dry operations not only because the finished product may indeed be dry, but also because water is the enemy of the products. Water creates a greater risk for the pathogen Salmonella in the environment. When I think of dry operations, I think of dry ingredients: powders, spices, gums, thickeners, vitamin and mineral blends, flour, salt, and sugar. All food companies have dry storage for these dry ingredients; I am not addressing storage here, but processing and manufacturing of these ingredients. For every dry ingredient purchased by a food facility, there is a food company making that dry ingredient.

Being from America’s Dairyland (Wisconsin), I have been in five different spray-dry facilities in the past two and a half years that were producing spray-dried milk or whey – or both. Dry. Nut roasting is dry. Peanut butter operations are dry. Chocolate – as an ingredient and chocolate manufacturing – are dry. Water is the enemy and creates an environment where the risk of Salmonella is greater.

This brings us to cleaning and sanitizing. For most of dry operations, production does not stop. (Everyone working in a wet-clean operation just gasped!) It’s true. If the equipment can keep running, it does. There may be short shutdowns for minor repairs or adjustments, but the equipment keeps running. Most of these dry-ingredient manufacturers do business on a small profit margin and can’t afford to shut down. When the equipment does go down for cleaning, it is a big deal and may take days or a week to clear the lines, make repairs, clean, sanitize, completely dry, and start back up. Most companies discard a substantial portion of the first product out in case a pathogen in the lines was cleared at start up. The cost to the company is significant.

Then there is the equipment that is never cleaned. In some operations, it is just not possible during a normal shutdown to take apart and open certain pieces of equipment for cleaning. In the event of a recall, it means that there never was truly a clean break. FDA looks to companies to inform them on when the last clean break occurred. With a clean break, a company has evidence to shorten the span of a recall back to that last clean break. This reminds me of a company I was in that had four large tanks of melted chocolates, and the different chocolates were drizzled on the top of the product. It was heaven for this chocoholic, until I learned that the large tanks were never emptied. Never. This is standard practice throughout industry. The company had a clever way of cleaning the equipment that dispensed the chocolate, but not the mother tanks. The question becomes: in the event of a recall, would the company recall all product in market with that particular chocolate?

Without a clean break, how does a company determine how far back to go for a recall? One way to determine the cut-off date is to stop production, call in a consultant to investigate, and collect hundreds of swabs for the determination of root cause. This takes time, and the company has an obligation to inform customers of the recall and may not have enough time.

My suggestion to owners of dry operations is to schedule an annual shutdown for repairs and complete cleaning and sanitizing. I know this is a huge cost. Your CFO can calculate the ultimate cost for this shutdown of production. Then calculate the cost of a recall. In addition to the cost of recalling all product from the market, what is the cost of loss of customers? This Cheesehead is going to continue to learn from clients of dry operations and formulate best practices for cleaning and sanitizing of dry operations. Please share your thoughts with me. Food safety is not competitive.

Matthew Botos, CEO of ConnectFood.com agrees, saying: “Dr. Knutson makes excellent points in this post. When dealing with any good manufacturing operation you must understand the hazards. This is why FSMA plans require a hazard analysis. Dry plants, as pointed out, have moisture as a concern for potential human health issues.”

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! The online service allows you to complete a facility hazard analysis. Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting
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 delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in 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 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

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

There are several truisms about food companies and documentation:

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

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

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

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

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

About the Author:


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

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

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

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

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.