Tag Archive for: haccp

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Keeping Food Safe with a Food Safety Plan

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

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

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

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

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

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

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

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

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

A Note From ConnectFood CEO Matthew Botos: 

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

About the Author:

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

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HACCP vs. Preventive Controls

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Recall plan: If the hazard analysis identifies a hazard requiring a preventive control, the facility must have a written recall plan that describes the procedures to perform a recall of the product. The recall plan must include procedures to notify consignees, to notify the public when necessary, to conduct effectiveness checks and to appropriately dispose of recalled product.” FDA.gov

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

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

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FDA Publishes First Guidance Documents on Food Defense

The FDA published the first of three announced guidance documents on June 19, 2018 for food defense. This release was less than one month after announcing they were “tantalizingly close” to releasing the first guidance at the 2018 Food Protection and Defense Institute conference. In the past, “tantalizingly close” has not been anywhere near soon, so I am happy for the FDA team that got this guidance done. The food defense rule for the prevention of intentional adulteration (IA) is the last of seven foundational rules of the Food Safety Modernization Act to be rolled out. If you are thinking “Whoa, I just figured out PCQI and my food safety plan,” then I suggest you start with the excellent FDA Final Rule Fact Sheets that summarize the FSMA rules and then go to the guidance documents.

Who needs to follow the Intentional Adulteration rule?
The FDA was very clear that the owner, operator or agent in charge is responsible.

    The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/ processes, packs, or holds food for consumption in the United States.

Here are some specific details. Just like the other FSMA rules, FDA rolls out the enforcement of the rule based on three sizes of businesses:

Businesses with more than 500 employees must comply in July 2019 by following a written food defense plan. FDA allows great flexibility on how a food defense plan is written and implemented, while providing detailed guidance. The food defense plan is a program for a facility and does not include the farm. The facility does not consider transportation to their location or transportation from their location in the food defense plan.

$10,000,000 is not a typo! The IA rule has a different definition of very small from the Preventive Controls for Human Food rule, the Produce rule or the Foreign Supplier Verification Program rule. Any business with less than $10,000,000 in annual revenue is exempt from compliance, and the business does not have to submit documents annually to the FDA to qualify. The business does have to provide documentation of annual revenue in person to an FDA inspector upon request for review and confirmation of the size of the business. Why, you ask?

The Intentional Adulteration rule is meant to prevent wide scale harm to public health.

From the guidance: Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality… acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA [i.e. economically motivated adulteration] is intended to obtain economic gain.

Note! Businesses whose sole operation is the storage of packaged food are exempt, except for the holding of liquid food in tanks. See the guidance IV. Exemptions B. Holding of Food.

Note! Once the food has been wrapped in its initial food-contact packaging, subsequent packaging and labeling of the individually-wrapped portions into packs or cases for sale is not included in the food defense plan.

What training is available now?
FREE training is available now. Ahead of the guidance document, online and free training was posted. The training was designed for line workers and their supervisors for food defense awareness. The best defense is a trained and informed workforce. At the end of the 20-minute session, a certificate is printed and added to the employee’s personnel file. Additional training will be rolled out over the next year from the Food Safety Preventive Controls Alliance and other organizations.

The first guidance from FDA has so much more information. Even if you are exempt from the rule, I encourage you to read over the guidance and provide the free training to your employees. 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

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Written Procedures are Required in the Control of Food Safety

The FDA inspector shows up at your door and requests to see your approved suppliers in 2017. Can you retrieve those records easily? The Preventive Controls for Human Food rule requires you to retrieve records within 24 hours upon request. Think of the nuts, seasoning, and cheese used as ingredients requiring supplier approval. With electronic record management in the “cloud,” you can display the record on the spot.

Written procedures are required. Those four words can put the best owner or quality manager over the edge. Writing documents is time-consuming. I was recently writing a HACCP plan with a restaurant owner and trying to capture all the required written procedures. We know most training and learning at a restaurant is achieved with verbal instruction and shadowing. Restaurants operate by “do-as-I-do” methods and “this is how we do it.” It was difficult to write procedures for steps that have no written documents. Maybe you know the feeling. However, written procedures and other documents are required for FDA compliance with the Preventive Controls for Human Food rule.

Because recordkeeping and record management are so important, I have written many times about specific topics which require record management. For example, supplier verification starts with supplier approval and includes an on-site audit, Certificates of Analysis, sampling and testing and possibly more. All those records must be managed. In a previous blog post on records management, I discussed what counts as a record. The perspective of that writing was focused on worksheets, bench sheets and electronic records. In other words, that was data input. Here my focus is on written procedures.

If the procedure controls food safety, the procedure must be written.

The food industry is rising to a higher level of food safety through written procedures. Written procedures are helpful for several reasons.

    1) Once the procedures are written, the requirement will be met. You must write out the procedures to be in FDA compliance.

    2) When forced to write the procedure, the action of writing makes you question why procedures are done the way they are and if the procedure is correct. For example, let’s say you are writing the procedure for mixing a sanitizer concentrate with water. What is the concentration of the concentrate? How much concentrate is mixed with how much water? What tools are used, and where are the tools located? Finally, why? How do you know this solution is correct? Once you know the solution is correct, will the solution adequately act as a sanitizer? This type of questioning will be applied with the writing of each procedure.

    3) You will review each method at some frequency to confirm the procedure is still being done as written. With review, any drift from the intended procedure is streamlined to get back on track. Using the preparation of sanitizer solution again, what if the measuring cup for the concentrate cracks and is replaced by a different cup? The new cup looks close to the original cup, but by following up on the procedure, it is determined that the new cup is bigger and too much concentrate is being added. That is money down the drain! You may find one employee who does the procedure differently from another employee. The review is a step in continuous improvement.

    4) The written procedure will be used for training and re-training employees. The written procedure provides a recipe for training employees. Everyone gets trained by the written procedure, in addition to on-the-job training. If there is a food safety issue with a procedure, the written procedure can be reviewed for compliance by employees and changed if needed. Supervisors can use the written procedure as a guide for observations during an internal audit or employee review.

Under Expert Services (go to the bottom of the webpage) from ConnectFood, you can partner with a food safety expert for the writing and review of your company’s procedures. The ConnectFood website also 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

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With GMPs, You Lay the Foundation for HACCP & Food Safety

With formidable GMPs, you lay the foundation for HACCP and Food Safety.

When the FDA or state inspector steps inside your facility, they may not want to immediately go to a conference room and review your written Hazard Analysis and Critical Control Points (HACCP) or food safety plan. The written plan is important, but the inspector will potentially want to walk the facility for a current Good Manufacturing Practices (GMPs) inspection. There will be inspection checklists and notes of observations. Shortcomings could result in a Form FDA-483 to the facility from the inspector. Companies should continue to work hard on their risk management programs and that starts with the food safety fundamentals of GMPs.

In the same way that you can’t run a business without funds, people, equipment and supplies, you can’t have a functioning HACCP or food safety plan without a foundation of good current GMPs.

Lynn Knipe of Ohio State University said it well,

    GMPs can support a processors’ HACCP programs, however, they cannot be used to directly control a hazard.

As I work with clients on HACCP or food safety plans, I have been reminded several times this week of the importance of GMPs in my work, which brings me to write about GMPs again. In a previous post, I wrote a review of GMPs on connectfood.com. When I reviewed the weekly post of FDA Warning Letters for food issues, I found mostly GMP issues, not HACCP or preventive controls issues. In most cases, a food facility receives an Warning Letter as a follow up to an inspection and Form 483, when the FDA is not satisfied with the actions taken to address the issues. Sometimes it is a matter of timeliness in that the facility has not responded by a deadline or is lacking documentation to prove corrective action. Warning Letters can be juicy reading for those of us that live food safety and for customers and clients because they are very specific in naming the issue.

Let’s play a game of “Name the GMP that was not followed.”

Case study: Cakes and Biscotti Bakery

    [a] live rodent was observed running across the east end of the production area, into the laundry room and into a hole in the wall at the northeast corner of the room.

Name the GMP that was not followed: Pest Management & Plant and Grounds

    [d]ough residues were observed on the edge of the (b)(4) north prep station and on the (b)(4) south prep station after (b)(4) sanitation was conducted.

Name the GMP that was not followed: Sanitary Operations

    [t]he interior of the stove hood was observed with a build-up of dust and debris directly above the stove and prep table where uncovered in-process foods are prepared. Employees were observed melting chocolate and gelatin, heating cream, and preparing blueberry topping on the stove directly below the hood.

Name the GMP that was not followed: Plants and Grounds

    [i]n the men’s restroom, the floor was observed soiled in front of both toilets, the urinal, and both sinks. One of the toilets was observed soiled. A toilet brush was observed on the hand wash sink. No hot water was available at the hand wash sinks and no paper towels or hand drying device were observed. The trash can was observed with overflowing toilet paper tubes, used paper towels, and other waste.

Name the GMP that was not followed: Sanitary Facilities and Controls

    [a]n employee was observed handling biscotti with a bare hand that was bandaged. She was observed removing the bandage and continuing to package biscotti without washing her hands.

Name the GMP that was not followed: Personnel

In the latter example, there are so many problems to address. Because of the bandaged hand, the employee should be removed from the packaging station. Without the need for a bandage, the employee should be following hand washing procedures and the glove use policy. This observation shows a lack of food safety culture and the need to train the entire workforce at packaging.

This food safety culture is key. Being part of the team in the position of writing a HACCP or food safety plan, please take time for an internal audit of GMPs. Without good GMPs, food safety cannot be realized. The search for GMP forms and checklists can be overwhelming, and the ConnectFood website has free resources. Sign in and find information under cGMPs. Do you have questions about GMPs? 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

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What I Learned from an FDA Seafood Guidance

I was on a flight to Boston, and in my hand was the FDA draft guidance, Seafood HACCP and the FDA Food Safety Modernization Act: Guidance for Industry. HACCP is hazard analysis and critical control points, and the Seafood HACCP rule was published in 1995. I had received the FDA guidance document at the previous Preventive Controls for Human Food (PCHF) workshop that I taught in Seattle. In Seattle, I had several workshop participants who worked in the seafood industry. I had dined on delicious salmon in Seattle and was dreaming of eating fresh seafood in Boston.

A substantial difference between the Seattle workshop and the Boston workshop was that the Boston workshop was comprised of people from the milling and baking industry, not seafood. Darn. Seafood HACCP has a life of its own in regulation, and I was looking forward to learning more about seafood from the workshop participants. Reading the guidance would not further my expertise as a Lead Instructor for the Boston workshop, but nevertheless I was in the mood to read this compact document. As I skimmed the introductory material, I came to a nice question and answer (Q & A) format. The FDA always does a nice job of communicating important information through the format of Q & A. Sometimes it is just nice to see plain English from the FDA, and that’s what a Q & A provides.

I did learn some information specific to the seafood industry from the guidance document, but it was the general information from the Food Safety Modernization Act (FSMA) that piqued my interest. Do you know the following three facts?

    1. Training and training records are now required.
    FDA is making a big deal out of training. Every person employed in the manufacturing, processing, packing or holding of food must be trained in food safety. There must be training records kept for each individual showing the individual is a “qualified individual” to perform his or her job. Supervisors must have additional training to demonstrate they are qualified to do their job.

    Who organizes the training records at your facility? The inspector will ask to see training records of employees. The more organized your company is, the easier it will be to show these records to the inspector. Training records can be paper, electronic, or a combination. FDA is focusing on training, so be prepared.

    2. Written sanitation procedures are not required for GMPs.
    Subpart B of the PCHF rule is Good Manufacturing Practices (GMPs) and replaces GMPs found in 21 CFR 110. Subpart B does not require written sanitation procedures. This means that the chemical concentrations, equipment, times and temperatures for a cleaning or sanitizing procedure are not required to be written, but you should. See my previous blog post on Sanitation Standard Operating Procedures (SSOPs).

    The sanitation crew at most facilities has a lot of turnover and little supervision for an extremely important job. Writing the procedures will facilitate training, consistency and effectiveness of cleaning and sanitizing. Written monitoring procedures and corrective action records are required.

    3. Written sanitation procedures are required for sanitation preventive controls.
    In Subpart C of the PCHF rule, this is how the logic flows in the rule:

    1. A written food safety plan is required 21 CFR 117.126(a)(1).
    2. A food safety plan includes preventive controls 21 CFR 117.126(b)(2).
    3. Preventive controls must be written 21 CFR 117.135(b).
    4. Sanitation preventive controls are procedures, practices and processes 21 CFR 117.135(3).

Therefore, if a facility identifies a sanitation preventive control in the hazard analysis, written sanitation procedures are required.

If a facility has an allergen in one product, but not in another product from the same line, the facility will have a sanitation preventive control for the allergen clean procedure. If a facility produces a ready-to-eat product, the facility will have a sanitation preventive control for the cleaning and sanitizing procedure to control pathogens. Like Subpart B, written monitoring procedures and corrective action records are required.

Even with plain English, information can be confusing. When I am teaching the PCHF course, I warn the participants that the answer to a question may be, “You have to take that to legal.” I encourage you to visit the FSMA website and review FDA guidance documents. Boston was my 17th PCHF workshop, and I am still learning.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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2017 Illinois Food Safety Symposium: A Review

On August 8th and 9th, 2017, the ConnectFood team hosted the 2017 Illinois Food Safety Symposium in Bloomington-Normal, Illinois. There were nearly 250 food industry professionals that attended the two day event. ConnectFood organized and led the Symposium in order to continue the tradition, previously established by the Illinois Department of Public Health of bringing together regulators, academia, and industry professionals in order to work towards continuous improvement of the food safety environment in Illinois.

If you were unable to join us at the Symposium, we hope you enjoy this short overview of what you missed, and that you’ll be interested in attending next year!

The Symposium was started the Keynote address from Mike O’Grady, Vice President of the Bloomington-Normal Economic Development Council, and Molly Lamb, Deputy Director at Illinois Department of Public Health. Both touched on the fact that the food safety industry in Illinois is incredibly strong, but that there are many areas that are being expanded and strengthened. Matthew Botos, CEO of ConnectFood, introduced two of our exhibitors: Cheryl Hodges from Miller & Stryker, and Renee Hoggay from the National Restaurant Association, and encouraged them to speak about their products and businesses.

Matthew Botos, CEO, ConnectFood, welcoming the crowd to the 2017 Illinois Food Safety Symposium.

As participants refilled their coffee mugs and grabbed morning snacks, Dr. Robert Brackett, Director of Institute for Food Safety and Health set up for his discussion of Food Safety Modernization Act (FSMA) & Compliance. He began by introducing the foundation of FSMA – why is it necessary? In the shortest summary possible: FSMA is necessary because food supply is more complex, and an increased percentage of the population is at risk for foodborne illnesses. Dr. Brackett also covered the seven rules of FSMA: Preventive Controls for Human Foods and Animal Foods, Produce Safety, Foreign Supplier Verification Program, Accredited Third Party Certification, Sanitary Transport, and Intentional Adulteration. The first FSMA Compliance dates are right around the corner (this month, in fact): September 17-19th, 2017, so if you need help making sure you’re compliant, now is the time to act.

Dr. Bob Brackett at the 2017 Illinois Food Safety Symposium.

After lunch, Dave Park, Principal, Food Defense, LLC spoke on the topic of Food Defense. He touched base on the history of food defense, food fraud, the intentional adulteration rule, and the comparison of new regulations to HACCP. Mr. Park highlighted food defense audit failures, threats and risks, imports and refusals, and food fraud incidents. “The general Hazard Analysis and Vulnerability Assessment procedure is the same, but the perspectives and expert knowledge bases used are different.” We are told to “Remember: Food Safety + Food Defense = Food Protection.”

Dave Park speaking at the 2017 Illinois Food Safety Symposium.

Next, Matthew Botos moderated a panel regarding Distribution and Transportation of Products, featuring the expertise of Tanesia Cole, Manager of Food Regulatory Compliance at US Foods, and Jeff Newey, Manager of Deseret Transportation. Both members of the panel highlighted their individual company’s background; explaining what they ship, how their shipment process works, and the procedures that are in place to ensure safety in the distribution step. Both touched on the transportation rule of FSMA, urging folks to shift their way of thinking to match the safety regulations of the new rule.

Tanesia Cole & Jeff Newey at the 2017 Illinois Food Safety Symposium.

To close out day one, Matthew Botos, CEO of ConnectFood, and Chris Metz, CTO of ConnectFood, hosted a demonstration of the connectfood.com software. I won’t dive too much into detail here, but if you’re interested in a software demonstration, please contact us & we would be pleased to show you around our website. We wrapped up the day with a short reception, and set our focus on day two.

Matt Botos, CEO, and Chris Metz, CTO, ConnectFood, at the 2017 Illinois Food Safety Symposium.

Day two opened with William Weissinger, District Director at FDA Chicago District, speaking about FDA Inspections & Enforcement Then and Now: Changes Over 5 Years. Ultimately, Weissinger said that the current goal of FDA inspections is to educate while regulating, meaning that the industry shouldn’t attempt to know exactly what to expect during an inspection, as inspections are by special assignment. In addition, it was stressed that all food manufacturers (regardless of size) must be registered with the FDA. (If you need help with that, contact us.)

William Weissinger speaking at the 2017 Illinois Food Safety Symposium.

Jessica McAnelly, Chief, Division of Food, Drugs, and Dairies at Illinois Department of Public Health (IDPH), took over the podium next. She spoke on the state of public health in Illinois, which ended up being a major talking point for a lot of attendees. She spoke about new legislation and updates to the existing legislation. Allergen awareness training is included in these updates – a main change included was that the certified food protection manager must get allergen training within 30 days of employment at a high-risk restaurant. Another major announcement of this presentation was that IDPH will no longer validate hours for Food Service Sanitation Manager Certification (FSSMC) – the Certified Food Protection Manager is a required, national certification.

Jessica McAnelly speaking at the 2017 Illinois Food Safety Symposium.

After lunch, it was Eric Greenberg, Principal Attorney, Eric F. Greenberg, P.C.’s turn to chat with participants about Labeling & Nutrition. The finalized changes for the FDA for Nutrition Facts Label are as follows: calories presented more prominently, an altered format, and added sugars included. Unfortunately, these changes have been postponed indefinitely. In Mr. Greenberg’s words: “One thing’s for sure in the future: Label compliance will always be primarily the responsibility of food companies, and this is especially so given the FDA’s enforcement patterns.”

Eric Greenberg at the 2017 Illinois Food Safety Symposium,

ConnectFood team member Dr. Kathy Knutson moderated our second day panel. (You’ve probably read her outstanding blogs for ConnectFood – if not, check them out here.) This panel included members Joseph Cooper, Emergency Response Coordinator, Chicago District Office, Mancia Walker, Supervisor, Indianapolis Resident Post OHAFO 6E, and Christinae Hudson, Consumer Complaint Coordinator, Chicago District Office. They discussed Recalls & Outbreaks – what they’d seen, effective ways to handle them, and how important recall plans are for the safety of a company. A crowd pleaser that was discussed was the Blue Bell ice cream recall that was enforced across the state of Texas after the delicious ice cream was contaminated with Listeria.

Dr. Kathy Knutson and Matt Botos moderate the Recalls and Outbreaks panel.

The final speaker at the Symposium was Laurie Jahn, Senior Environmental Health Program Specialist of Lake County Health Department, talking about juice production & safety. The objectives of this presentation were to understand the methods of fresh juice processing, determine the code regulations, and present labeling requirements for bottling fresh juice. The main concerns with fresh juice are the possibilities of cross contamination and that there is no kill step, which leaves the juice untreated.

Laurie Jahn speaking at the 2017 Illinois Food Safety Symposium.

Matthew Botos wrapped up the Symposium with a final “thank you!” to everyone that joined us. If you attended the Symposium and have some feedback or need to obtain your certificate of completion, please complete this survey. As always, the ConnectFood team is always available to help you understand food safety. All you need to do is contact us.

Johanna Seidel has been a team member with ConnectFood since July 2016. She holds a B.F.A. from West Texas A&M University. She helped organize and run the 2017 Illinois Food Safety Symposium. https://www.linkedin.com/in/johanna-seidel-3a98b6130/

Johanna Seidel, ConnectFood, celebrating the completion of the 2017 Illinois Food Safety Symposium.

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The Language of the Preventive Controls for Human Food Rule

Recently, I sat in a room with 20-some food safety experts eager to learn about the curriculum for the Preventive Controls for Human Food rule. The FDA-recognized curriculum is used as the primary means to call oneself a Preventive Controls Qualified Individual. At the start and at hearing the use of “preventive,” my colleagues and I whipped out our cell phones to look up the existence and meaning of the word. Well, I will tell you it is a word, is chosen for use by FDA, and means the same as “preventative.” Out loud, say to yourself, “preventive measures.” Sounds good, doesn’t it?

Preventive is not the only new word to the rule. The terms of HARPC, still in its infant stage, and its older siblings of HACCP, CCPs, and critical limits are fading into the sunset. If you are a food safety expert who has grown up on the use of HACCP and CCPs, don’t worry. FDA is not making you use the new language. There is still room for use of HACCP and CCPs when identifying process preventive controls. After all, processing is where much of the highest risk in food safety is controlled. Water is removed to prevent growth of mold and production of harmful toxins. Heat is used in pasteurization, canning and baking to kill pathogens. We use metal detectors. The youth in our business will label these process preventive controls, not CCPs. The youth will be studying the rule and the language of the rule.

There are three additional labels of preventive controls-allergen, sanitation, and supply chain. We do not apply the terms of HACCP, CCPs or critical limits to preventive controls in these three areas. Your hazard analysis will identify if you need a preventive control in any of these areas. We identify preventive controls for known or reasonably foreseeable hazards, and set parameters and values. Parameters are just the name of the measurement like temperature, time, belt speed or bed depth. Values are the number and corresponding unit which must be achieved for safety like 185oF, 25 minutes, 1 foot per second, or 2 cm.

Another new kid on the block is the term “correction.” We will still issue corrective action when a food safety issue affects finished product. What about when product has not been affected? The wrong label is moved from storage to the packaging line. Get the right label. A post-sanitation inspection observes areas not cleaned properly. Reclean. A correction allows the righting of a wrong at a preventive control step and before any product is affected.

It takes practice to adopt the new language of the rule. As an educator, I encourage you to say the terms out loud. After some time and in our future, we will hear a colleague say, “What’s HACCP?”

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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